[House Report 107-481]
[From the U.S. Government Publishing Office]
107th Congress
2d Session HOUSE OF REPRESENTATIVES Report 107-481
_______________________________________________________________________
PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT
OF 2002
__________
CONFERENCE REPORT
to accompany
H.R. 3448
May 21, 2002.--Ordered to be printed
107th Congress
2d Session HOUSE OF REPRESENTATIVES Report 107-481
======================================================================
PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT
OF 2002
_______
May 21, 2002.--Ordered to be printed
_______
Mr. Tauzin, from the Committee of conference, submitted the following
CONFERENCE REPORT
[To accompany H.R. 3448]
The committee of conference on the disagreeing votes of the
two Houses on the amendment of the Senate to the bill (H.R.
3448), to improve the ability of the United States to prevent,
prepare for, and respond to bioterrorism and other public
health emergencies, having met, after full and free conference,
have agreed to recommend and do recommend to their respective
Houses as follows:
That the House recede from its disagreement to the
amendment of the Senate and agree to the same with an amendment
as follows:
In lieu of the matter proposed to be inserted by the Senate
amendment, insert the following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Public
Health Security and Bioterrorism Preparedness and Response Act
of 2002''.
(b) Table of Contents.--The table of contents of the Act is
as follows:
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
Sec. 101. National preparedness and response.
Sec. 102. Assistant Secretary for Public Health Emergency Preparedness;
National Disaster Medical System.
Sec. 103. Improving ability of Centers for Disease Control and
Prevention.
Sec. 104. Advisory committees and communications; study regarding
communications abilities of public health agencies.
Sec. 105. Education of health care personnel; training regarding
pediatric issues.
Sec. 106. Grants regarding shortages of certain health professionals.
Sec. 107. Emergency system for advance registration of health
professions volunteers.
Sec. 108. Working group.
Sec. 109. Antimicrobial resistance.
Sec. 110. Supplies and services in lieu of award funds.
Sec. 111. Additional amendments.
Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures
Sec. 121. Strategic national stockpile.
Sec. 122. Accelerated approval of priority countermeasures.
Sec. 123. Issuance of rule on animal trials.
Sec. 124. Security for countermeasure development and production.
Sec. 125. Accelerated countermeasure research and development.
Sec. 126. Evaluation of new and emerging technologies regarding
bioterrorist attack and other public health emergencies.
Sec. 127. Potassium iodide.
Subtitle C--Improving State, Local, and Hospital Preparedness for and
Response to Bioterrorism and Other Public Health Emergencies
Sec. 131. Grants to improve State, local, and hospital preparedness for
and response to bioterrorism and other public health
emergencies.
Subtitle D--Emergency Authorities; Additional Provisions
Sec. 141. Reporting deadlines.
Sec. 142. Streamlining and clarifying communicable disease quarantine
provisions.
Sec. 143. Emergency waiver of Medicare, Medicaid, and SCHIP
requirements.
Sec. 144. Provision for expiration of public health emergencies.
Subtitle E--Additional Provisions
Sec. 151. Designated State public emergency announcement plan.
Sec. 152. Expanded research by Secretary of Energy.
Sec. 153. Expanded research on worker health and safety.
Sec. 154. Enhancement of emergency preparedness of Department of
Veterans Affairs.
Sec. 155. Reauthorization of existing program.
Sec. 156. Sense of Congress.
Sec. 157. General Accounting Office report.
Sec. 158. Certain awards.
Sec. 159. Public access defibrillation programs and public access
defibrillation demonstration projects.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Subtitle A--Department of Health and Human Services
Sec. 201. Regulation of certain biological agents and toxins.
Sec. 202. Implementation by Department of Health and Human Services.
Sec. 203. Effective dates.
Sec. 204. Conforming amendment.
Subtitle B--Department of Agriculture
Sec. 211. Short title.
Sec. 212. Regulation of certain biological agents and toxins.
Sec. 213. Implementation by Department of Agriculture.
Subtitle C--Interagency Coordination Regarding Overlap Agents and Toxins
Sec. 221. Interagency coordination.
Subtitle D--Criminal Penalties Regarding Certain Biological Agents and
Toxins
Sec. 231. Criminal penalties.
TITLE III--PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY
Subtitle A--Protection of Food Supply
Sec. 301. Food safety and security strategy.
Sec. 302. Protection against adulteration of food.
Sec. 303. Administrative detention.
Sec. 304. Debarment for repeated or serious food import violations.
Sec. 305. Registration of food facilities.
Sec. 306. Maintenance and inspection of records for foods.
Sec. 307. Prior notice of imported food shipments.
Sec. 308. Authority to mark articles refused admission into United
States.
Sec. 309. Prohibition against port shopping.
Sec. 310. Notices to States regarding imported food.
Sec. 311. Grants to States for inspections.
Sec. 312. Surveillance and information grants and authorities.
Sec. 313. Surveillance of zoonotic diseases.
Sec. 314. Authority to commission other Federal officials to conduct
inspections.
Sec. 315. Rule of construction.
Subtitle B--Protection of Drug Supply
Sec. 321. Annual registration of foreign manufacturers; shipping
information; drug and device listing.
Sec. 322. Requirement of additional information regarding import
components intended for use in export products.
Subtitle C--General Provisions Relating to Upgrade of Agricultural
Security
Sec. 331. Expansion of Animal and Plant Health Inspection Service
activities.
Sec. 332. Expansion of Food Safety Inspection Service activities.
Sec. 333. Biosecurity upgrades at the Department of Agriculture.
Sec. 334. Agricultural biosecurity.
Sec. 335. Agricultural bioterrorism research and development.
Sec. 336. Animal enterprise terrorism penalties.
TITLE IV--DRINKING WATER SECURITY AND SAFETY
Sec. 401. Terrorist and other intentional acts.
Sec. 402. Other Safe Drinking Water Act amendments.
Sec. 403. Miscellaneous and technical amendments.
TITLE V--ADDITIONAL PROVISIONS
Subtitle A--Prescription Drug User Fees
Sec. 501. Short title.
Sec. 502. Findings.
Sec. 503. Definitions.
Sec. 504. Authority to assess and use drug fees.
Sec. 505. Accountability and reports.
Sec. 506. Reports of postmarketing studies.
Sec. 507. Savings clause.
Sec. 508. Effective date.
Sec. 509. Sunset clause.
Subtitle B--Funding Provisions Regarding Food and Drug Administration
Sec. 521. Office of Drug Safety.
Sec. 522. Division of Drug Marketing, Advertising, and Communications.
Sec. 523. Office of Generic Drugs.
Subtitle C--Additional Provisions
Sec. 531. Transition to digital television.
Sec. 532. 3-year delay in lock in procedures for Medicare+Choice plans;
change in Medicare+Choice reporting deadlines and annual,
coordinated election period for 2003, 2004, and 2005.
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE.
(a) In General.--The Public Health Service Act (42 U.S.C.
201 et seq.) is amended by adding at the end the following
title:
``TITLE XXVIII--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC
HEALTH EMERGENCIES
``Subtitle A--National Preparedness and Response Planning,
Coordinating, and Reporting
``SEC. 2801. NATIONAL PREPAREDNESS PLAN.
``(a) In General.--
``(1) Preparedness and response regarding public
health emergencies.--The Secretary shall further
develop and implement a coordinated strategy, building
upon the core public health capabilities established
pursuant to section 319A, for carrying out health-
related activities to prepare for and respond
effectively to bioterrorism and other public health
emergencies, including the preparation of a plan under
this section. The Secretary shall periodically
thereafter review and, as appropriate, revise the plan.
``(2) National approach.--In carrying out paragraph
(1), the Secretary shall collaborate with the States
toward the goal of ensuring that the activities of the
Secretary regarding bioterrorism and other public
health emergencies are coordinated with activities of
the States, including local governments.
``(3) Evaluation of progress.--The plan under
paragraph (1) shall provide for specific benchmarks and
outcome measures for evaluating the progress of the
Secretary and the States, including local governments,
with respect to the plan under paragraph (1), including
progress toward achieving the goals specified in
subsection (b).
``(b) Preparedness Goals.--The plan under subsection (a)
should include provisions in furtherance of the following:
``(1) Providing effective assistance to State and
local governments in the event of bioterrorism or other
public health emergency.
``(2) Ensuring that State and local governments
have appropriate capacity to detect and respond
effectively to such emergencies, including capacities
for the following:
``(A) Effective public health surveillance
and reporting mechanisms at the State and local
levels.
``(B) Appropriate laboratory readiness.
``(C) Properly trained and equipped
emergency response, public health, and medical
personnel.
``(D) Health and safety protection of
workers responding to such an emergency.
``(E) Public health agencies that are
prepared to coordinate health services
(including mental health services) during and
after such emergencies.
``(F) Participation in communications
networks that can effectively disseminate
relevant information in a timely and secure
manner to appropriate public and private
entities and to the public.
``(3) Developing and maintaining medical
countermeasures (such as drugs, vaccines and other
biological products, medical devices, and other
supplies) against biological agents and toxins that may
be involved in such emergencies.
``(4) Ensuring coordination and minimizing
duplication of Federal, State, and local planning,
preparedness, and response activities, including during
the investigation of a suspicious disease outbreak or
other potential public health emergency.
``(5) Enhancing the readiness of hospitals and
other health care facilities to respond effectively to
such emergencies.
``(c) Reports to Congress.--
``(1) In general.--Not later than one year after
the date of the enactment of the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002,
and biennially thereafter, the Secretary shall submit
tothe Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor, and
Pensions of the Senate, a report concerning progress with respect to
the plan under subsection (a), including progress toward achieving the
goals specified in subsection (b).
``(2) Additional authority.--Reports submitted
under paragraph (1) by the Secretary (other than the
first report) shall make recommendations concerning--
``(A) any additional legislative authority
that the Secretary determines is necessary for
fully implementing the plan under subsection
(a), including meeting the goals under
subsection (b); and
``(B) any additional legislative authority
that the Secretary determines is necessary
under section 319 to protect the public health
in the event of an emergency described in
section 319(a).
``(d) Rule of Construction.--This section may not be
construed as expanding or limiting any of the authorities of
the Secretary that, on the day before the date of the enactment
of the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, were in effect with respect to preparing
for and responding effectively to bioterrorism and other public
health emergencies.''.
(b) Other Reports.--
(1) In general.--Not later than one year after the
date of the enactment of this Act, the Secretary of
Health and Human Services (referred to in this
subsection as the ``Secretary'') shall submit to the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health,
Education, Labor, and Pensions of the Senate, a report
concerning--
(A) the recommendations and findings of the
National Advisory Committee on Children and
Terrorism under section 319F(c)(2) of the
Public Health Service Act;
(B) the recommendations and findings of the
EPIC Advisory Committee under section
319F(c)(3) of such Act;
(C) the characteristics that may render a
rural community uniquely vulnerable to a
biological attack, including distance, lack of
emergency transport, hospital or laboratory
capacity, lack of integration of Federal or
State public health networks, workforce
deficits, or other relevant characteristics;
(D) the characteristics that may render
areas or populations designated as medically
underserved populations (as defined in section
330 of such Act) uniquely vulnerable to a
biological attack, including significant
numbers of low-income or uninsured individuals,
lack of affordable and accessible health care
services, insufficient public and primary
health care resources, lack of integration of
Federal or State public health networks,
workforce deficits, or other relevant
characteristics;
(E) the recommendations of the Secretary
with respect to additional legislative
authority that the Secretary determines is
necessary to effectively strengthen rural
communities, or medically underserved
populations (as defined in section 330 of such
Act); and
(F) the need for and benefits of a National
Disaster Response Medical Volunteer Service
that would be a private-sector, community-based
rapid response corps of medical volunteers.
(2) Study regarding local emergency response
methods.--The Secretary shall conduct a study of
effective methods for the provision of emergency
response services through local governments (including
through private response contractors and volunteers of
such governments) in a consistent manner in response to
acts of bioterrorism or other public health
emergencies. Not later than 180 days after the date of
the enactment of this Act, the Secretary shall submit
to the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health,
Education, Labor, and Pensions of the Senate, a report
describing the findings of the study.
SEC. 102. ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY PREPAREDNESS;
NATIONAL DISASTER MEDICAL SYSTEM.
(a) In General.--Title XXVIII of the Public Health Service
Act, as added by section 101 of this Act, is amended by adding
at the end the following subtitle:
``Subtitle B--Emergency Preparedness and Response
``SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO
BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES.
``(a) Assistant Secretary for Public Health Emergency
Preparedness.--
``(1) In general.--There is established within the
Department of Health and Human Services the position of
Assistant Secretary for Public Health Emergency
Preparedness. The President shall appoint an individual
to serve in such position. Such Assistant Secretary
shall report to the Secretary.
``(2) Duties.--Subject to the authority of the
Secretary, the Assistant Secretary for Public Health
Emergency Preparedness shall carry out the following
duties with respect to bioterrorism and other public
health emergencies:
``(A) Coordinate on behalf of the
Secretary--
``(i) interagency interfaces
between the Department of Health and
Human Services (referred to in this
paragraph as the `Department') and
other departments, agencies, and
offices of the United States; and
``(ii) interfaces between the
Department and State and local entities
with responsibility for emergency
preparedness.
``(B) Coordinate the operations of the
National Disaster Medical System and any other
emergency response activities within the
Department of Health and Human Services that
are related to bioterrorism and other public
health emergencies.
``(C) Coordinate the efforts of the
Department to bolster State and local emergency
preparedness for a bioterrorist attack or other
public health emergency, and evaluate the
progress of such entities in meeting the
benchmarks and other outcome measures contained
in the national plan and in meeting the core
public health capabilities established pursuant
to 319A.
``(D) Any other duties determined
appropriate by the Secretary.
``(b) National Disaster Medical System.--
``(1) In general.--The Secretary shall provide for
the operation in accordance with this section of a
system to be known as the National Disaster Medical
System. The Secretary shall designate the Assistant
Secretary for Public Health Emergency Preparedness as
the head of the National Disaster Medical System,
subject to the authority of the Secretary.
``(2) Federal and state collaborative system.--
``(A) In general.--The National Disaster
Medical System shall be a coordinated effort by
the Federal agencies specified in subparagraph
(B), working in collaboration with the States
and other appropriate public or private
entities, to carry out the purposes described
in paragraph (3).
``(B) Participating federal agencies.--The
Federal agencies referred to in subparagraph
(A) are the Department of Health and Human
Services, the Federal Emergency Management
Agency, the Department of Defense, and the
Department of Veterans Affairs.
``(3) Purpose of system.--
``(A) In general.--The Secretary may
activate the National Disaster Medical System
to--
``(i) provide health services,
health-related social services, other
appropriate human services, and
appropriate auxiliary services to
respond to the needs of victims of a
public health emergency (whether or not
determined to be a public health
emergency under section 319); or
``(ii) be present at locations, and
for limited periods of time, specified
by the Secretary on the basis that the
Secretary has determined that a
location is at risk of a public health
emergency during the time specified.
``(B) Ongoing activities.--The National
Disaster Medical System shall carry out such
ongoing activities as may be necessary to
prepare for the provision of services described
in subparagraph (A) in the event that the
Secretary activates the National Disaster
Medical System for such purposes.
``(C) Test for mobilization of system.--
During the one-year period beginning on the
date of the enactment of the Public Health
Security and Bioterrorism Preparedness and
Response Act of 2002, the Secretary shall
conduct an exercise to test the capability and
timeliness of the National Disaster Medical
System to mobilize and otherwise respond
effectively to a bioterrorist attack or other
public health emergency that affects two or
more geographic locations concurrently.
Thereafter, the Secretary may periodically
conduct such exercises regarding the National
Disaster Medical System as the Secretary
determines to be appropriate.
``(c) Criteria.--
``(1) In general.--The Secretary shall establish
criteria for the operation of the National Disaster
Medical System.
``(2) Participation agreements for non-federal
entities.--In carrying out paragraph (1), the Secretary
shall establish criteria regarding the participation of
States and private entities in the National Disaster
Medical System, including criteria regarding agreements
for such participation. The criteria shall include the
following:
``(A) Provisions relating to the custody
and use of Federal personal property by such
entities, which may in the discretion of the
Secretary include authorizing the custody and
use of such property to respond to emergency
situations for which the National Disaster
Medical System has not been activated by the
Secretary pursuant to subsection (b)(3)(A). Any
such custody and use of Federal personal
property shall be on a reimbursable basis.
``(B) Provisions relating to circumstances
in which an individual or entity has agreements
with both the National Disaster Medical System
and another entity regarding the provision of
emergency services by the individual. Such
provisions shall address the issue of
priorities among the agreements involved.
``(d) Intermittent Disaster-Response Personnel.--
``(1) In general.--For the purpose of assisting the
National Disaster Medical System in carrying out duties
under this section, the Secretary may appoint
individuals to serve as intermittent personnel of such
System in accordance with applicable civil service laws
and regulations.
``(2) Liability.--For purposes of section 224(a)
and the remedies described in such section, an
individual appointed under paragraph (1) shall, while
acting within the scope of such appointment, be
considered to be an employee of the Public Health
Service performing medical, surgical, dental, or
related functions. With respect to the participation of
individuals appointed under paragraph (1) in training
programs authorized by the Assistant Secretary for
Public Health Emergency Preparedness or a comparable
official of any Federal agency specified in subsection
(b)(2)(B), acts of individuals so appointed that are
within the scope of such participation shall be
considered within the scope of the appointment under
paragraph (1) (regardless of whether the individuals
receive compensation for such participation).
``(e) Certain Employment Issues Regarding Intermittent
Appointments.--
``(1) Intermittent disaster-response appointee.--
For purposes of this subsection, the term `intermittent
disaster-response appointee' means an individual
appointed by the Secretary under subsection (d).
``(2) Compensation for work injuries.--An
intermittent disaster-response appointee shall, while
acting in the scope of such appointment, be considered
to be an employee of the Public Health Service
performing medical, surgical, dental, or related
functions, and an injury sustained by such an
individual shall be deemed `in the performance of
duty', for purposes of chapter 81 of title 5, United
States Code, pertaining to compensation for work
injuries. With respect to the participation of
individuals appointed under subsection (d) in training
programs authorized by the Assistant Secretary for
Public Health Emergency Preparedness or a comparable
official of any Federal agency specified in subsection
(b)(2)(B), injuries sustained by such an individual,
while acting within the scope of such participation,
also shall be deemed `in the performance of duty' for
purposes of chapter 81 of title 5, United States Code
(regardless of whether the individuals receive
compensation for such participation). In the event of
an injury to such an intermittent disaster-response
appointee, the Secretary of Labor shall be responsible
for making determinations as to whether the claimant is
entitled to compensation or other benefits in
accordance with chapter 81 of title 5, United States
Code.
``(3) Employment and reemployment rights.--
``(A) In general.--Service as an
intermittent disaster-response appointee when
the Secretary activates the National Disaster
Medical System or when the individual
participates in a training program authorized
by the Assistant Secretary for Public Health
Emergency Preparedness or a comparable official
of any Federal agency specified in subsection
(b)(2)(B) shall be deemed `service in the
uniformed services' for purposes of chapter 43
of title 38, United States Code, pertaining to
employment and reemployment rights of
individuals who have performed service in the
uniformed services (regardless of whether the
individual receives compensation for such
participation). All rights and obligations of
such persons and procedures for assistance,
enforcement, and investigation shall be as
provided for in chapter 43 of title 38, United
States Code.
``(B) Notice of absence from position of
employment.--Preclusion of giving notice of
service by necessity of Service as an
intermittent disaster-response appointee when
the Secretary activates the National Disaster
Medical System shall be deemed preclusion by
`military necessity' for purposes of section
4312(b) of title 38, United States Code,
pertaining to giving notice of absence from a
position of employment. A determination of such
necessity shall be made by the Secretary, in
consultation with the Secretary of Defense, and
shall not be subject to judicial review.
``(4) Limitation.--An intermittent disaster-
response appointee shall not be deemed an employee of
the Department of Health and Human Services for
purposes other than those specifically set forth in
this section.
``(f) Rule of Construction Regarding Use of Commissioned
Corps.--If the Secretary assigns commissioned officers of the
Regular or Reserve Corps to servewith the National Disaster
Medical System, such assignments do not affect the terms and conditions
of their appointments as commissioned officers of the Regular or
Reserve Corps, respectively (including with respect to pay and
allowances, retirement, benefits, rights, privileges, and immunities).
``(g) Definition.--For purposes of this section, the term
`auxiliary services' includes mortuary services, veterinary
services, and other services that are determined by the
Secretary to be appropriate with respect to the needs referred
to in subsection (b)(3)(A).
``(h) Authorization of Appropriations.--For the purpose of
providing for the Assistant Secretary for Public Health
Emergency Preparedness and the operations of the National
Disaster Medical System, other than purposes for which amounts
in the Public Health Emergency Fund under section 319 are
available, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2002 through
2006.''.
(b) Sense of Congress Regarding Resources of National
Disaster Medical System.--It is the sense of the Congress that
the Secretary of Health and Human Services should provide
sufficient resources to entities tasked to carry out the duties
of the National Disaster Medical System for reimbursement of
expenses, operations, purchase and maintenance of equipment,
training, and other funds expended in furtherance of the
National Disaster Medical System.
SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL AND
PREVENTION.
Section 319D of the Public Health Service Act (42 U.S.C.
247d-4) is amended to read as follows:
``SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND
PREVENTION.
``(a) Facilities; Capacities.--
``(1) Findings.--Congress finds that the Centers
for Disease Control and Prevention has an essential
role in defending against and combatting public health
threats and requires secure and modern facilities, and
expanded and improved capabilities related to
bioterrorism and other public health emergencies,
sufficient to enable such Centers to conduct this
important mission.
``(2) Facilities.--
``(A) In general.--The Director of the
Centers for Disease Control and Prevention may
design, construct, and equip new facilities,
renovate existing facilities (including
laboratories, laboratory support buildings,
scientific communication facilities,
transshipment complexes, secured and isolated
parking structures, office buildings, and other
facilities and infrastructure), and upgrade
security of such facilities, in order to better
conduct the capacities described in section
319A, and for supporting public health
activities.
``(B) Multiyear contracting authority.--For
any project of designing, constructing,
equipping, or renovating any facility under
subparagraph (A), the Director of the Centers
for Disease Control and Prevention may enter
into a single contract or related contracts
that collectively include the full scope of the
project, and the solicitation and contract
shall contain the clause `availability of
funds' found at section 52.232-18 of title 48,
Code of Federal Regulations.
``(3) Improving the capacities of the centers for
disease control and prevention.--The Secretary, taking
into account evaluations under section 319B(a), shall
expand, enhance, and improve the capabilities of the
Centers for Disease Control and Prevention relating to
preparedness for and responding effectively to
bioterrorism and other public health emergencies.
Activities that may be carried out under the preceding
sentence include--
``(A) expanding or enhancing the training
of personnel;
``(B) improving communications facilities
and networks, including delivery of necessary
information to rural areas;
``(C) improving capabilities for public
health surveillance and reporting activities,
taking into account the integrated system or
systems of public health alert communications
and surveillance networks under subsection (b);
and
``(D) improving laboratory facilities
related to bioterrorism and other public health
emergencies, including increasing the security
of such facilities.
``(b) National Communications and Surveillance Networks.--
``(1) In general.--The Secretary, directly or
through awards of grants, contracts, or cooperative
agreements, shall provide for the establishment of an
integrated system or systems of public health alert
communications and surveillance networks between and
among--
``(A) Federal, State, and local public
health officials;
``(B) public and private health-related
laboratories, hospitals, and other health care
facilities; and
``(C) any other entities determined
appropriate by the Secretary.
``(2) Requirements.--The Secretary shall ensure
that networks under paragraph (1) allow for the timely
sharing and discussion, in a secure manner, of
essential information concerning bioterrorism or
another public health emergency, or recommended methods
for responding to such an attack or emergency.
``(3) Standards.--Not later than one year after the
date of the enactment of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, the
Secretary, in cooperation with health care providers
and State and local public health officials, shall
establish any additional technical and reporting
standards (including standards for interoperability)
for networks under paragraph (1).
``(c) Authorization of Appropriations.--
``(1) Facilities; capacities.--
``(A) Facilities.--For the purpose of
carrying out subsection (a)(2), there are
authorized to be appropriated $300,000,000 for
each of the fiscal years 2002 and 2003, and
such sums as may be necessary for each of the
fiscal years 2004 through 2006.
``(B) Mission; Improving capacities.--For
the purposes of achieving the mission of the
Centers for Disease Control and Prevention
described in subsection (a)(1), for carrying
out subsection (a)(3), for better conducting
the capacities described in section 319A, and
for supporting public health activities, there
are authorized to be appropriated such sums as
may be necessary for each of the fiscal years
2002 through 2006.
``(2) National communications and surveillance
networks.--For the purpose of carrying out subsection
(b), there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 2002
through 2006.''.
SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS; STUDY REGARDING
COMMUNICATIONS ABILITIES OF PUBLIC HEALTH AGENCIES.
(a) In General.--Section 319F of the Public Health Service
Act (42 U.S.C. 247d-6) is amended--
(1) by striking subsections (b) and (i);
(2) by redesignating subsections (c) through (h) as
subsections (e) through (j), respectively; and
(3) by inserting after subsection (a) the following
subsections:
``(b) Advice to the Federal Government.--
``(1) Required advisory committees.--In
coordination with the working group under subsection
(a), the Secretary shall establish advisory committees
in accordance with paragraphs (2) and (3) to provide
expert recommendations to assist such working groups in
carrying out their respective responsibilities under
subsections (a) and (b).
``(2) National advisory committee on children and
terrorism.--
``(A) In general.--For purposes of
paragraph (1), the Secretary shall establish an
advisory committee to be known as the National
Advisory Committee on Children and Terrorism
(referred to in this paragraph as the `Advisory
Committee').
``(B) Duties.--The Advisory Committee shall
provide recommendations regarding--
``(i) the preparedness of the
health care (including mental health
care) system to respond to bioterrorism
as it relates to children;
``(ii) needed changes to the health
care and emergency medical service
systems and emergency medical services
protocols to meet the special needs of
children; and
``(iii) changes, if necessary, to
the national stockpile under section
121 of the Public Health Security and
Bioterrorism Preparedness and Response
Act of 2002 to meet the emergency
health security of children.
``(C) Composition.--The Advisory Committee
shall be composed of such Federal officials as
may be appropriate to address the special needs
of the diverse population groups of children,
and child health experts on infectious disease,
environmental health, toxicology, and other
relevant professional disciplines.
``(D) Termination.--The Advisory Committee
terminates one year after the date of the
enactment of the Public Health Security and
Bioterrorism Preparedness and Response Act of
2002.
``(3) Emergency public information and
communications advisory committee.--
``(A) In general.--For purposes of
paragraph (1), the Secretary shall establish an
advisory committee to be known as the Emergency
Public Information and Communications Advisory
Committee (referred to in this paragraph as the
`EPIC Advisory Committee').
``(B) Duties.--The EPIC Advisory Committee
shall make recommendations to the Secretary and
the working group under subsection (a) and
report on appropriate ways to communicate
public health information regarding
bioterrorism and other public health
emergencies to the public.
``(C) Composition.--The EPIC Advisory
Committee shall be composed of individuals
representing a diverse group of experts in
public health, medicine, communications,
behavioral psychology, and other areas
determined appropriate by the Secretary.
``(D) Dissemination.--The Secretary shall
review the recommendations of the EPIC Advisory
Committee and ensure that appropriate
information is disseminated to the public.
``(E) Termination.--The EPIC Advisory
Committee terminates one year after the date of
the enactment of Public Health Security and
Bioterrorism Preparedness and Response Act of
2002.
``(c) Strategy for Communication of Information Regarding
Bioterrorism and Other Public Health Emergencies.--In
coordination with working group under subsection (a), the
Secretary shall develop a strategy for effectively
communicating information regarding bioterrorism and other
public health emergencies, and shall develop means by which to
communicate such information. The Secretary may carry out the
preceding sentence directly or through grants, contracts, or
cooperative agreements.
``(d) Recommendation of Congress Regarding Official Federal
Internet Site on Bioterrorism.--It is the recommendation of
Congress that there should be established an official Federal
Internet site on bioterrorism, either directly or through
provision of a grant to an entity that has expertise in
bioterrorism and the development of websites, that should
include information relevant to diverse populations (including
messages directed at the general public and such relevant
groups as medical personnel, public safety workers, and
agricultural workers) and links to appropriate State and local
government sites.''.
(b) Study Regarding Communications Abilities of Public
Health Agencies.--The Secretary of Health and Human Services,
in consultation with the Federal Communications Commission, the
National Telecommunications and Information Administration, and
other appropriate Federal agencies, shall conduct a study to
determine whether local public health entities have the ability
to maintain communications in the event of a bioterrorist
attack or other public health emergency. The study shall
examine whether redundancies are required in the
telecommunications system, particularly with respect to mobile
communications, for public health entities to maintain systems
operability and connectivity during such emergencies. The study
shall also include recommendations to industry and public
health entities about how to implement such redundancies if
necessary.
SEC. 105. EDUCATION OF HEALTH CARE PERSONNEL; TRAINING REGARDING
PEDIATRIC ISSUES.
Section 319F(g) of the Public Health Service Act, as
redesignated by section 104(a)(2) of this Act, is amended to
read as follows:
``(g) Education; Training Regarding Pediatric Issues.--
``(1) Materials; core curriculum.--The Secretary,
in collaboration with members of the working group
described in subsection (b), and professional
organizations and societies, shall--
``(A) develop materials for teaching the
elements of a core curriculum for the
recognition and identification of potential
bioweapons and other agents that may create a
public health emergency, and for the care of
victims of such emergencies, recognizing the
special needs of children and other vulnerable
populations, to public health officials,
medical professionals, emergency physicians and
other emergency department staff, laboratory
personnel, and other personnel working in
health care facilities (including poison
control centers);
``(B) develop a core curriculum and
materials for community-wide planning by State
and local governments, hospitals and other
health care facilities, emergency response
units, and appropriate public and private
sector entities to respond to a bioterrorist
attack or other public health emergency;
``(C) develop materials for proficiency
testing of laboratory and other public health
personnel for the recognition and
identification of potential bioweapons and
other agents that may create a public health
emergency; and
``(D) provide for dissemination and
teaching of the materials described in
subparagraphs (A) through (C) by appropriate
means, which may include telemedicine, long-
distance learning, or other such means.
``(2) Certain entities.--The entities through which
education and training activities described in
paragraph (1) may be carried out include Public Health
Preparedness Centers, the Public Health Service's Noble
Training Center, the Emerging Infections Program, the
Epidemic Intelligence Service, the Public Health
Leadership Institute, multi-State, multi-institutional
consortia, other appropriate educational entities,
professional organizations and societies, private
accrediting organizations, and other nonprofit
institutions or entities meeting criteria established
by the Secretary.
``(3) Grants and contracts.--In carrying out
paragraph (1), the Secretary may carry out activities
directly and through the award of grants and contracts,
and may enter into interagency cooperative agreements
with other Federal agencies.
``(4) Health-related assistance for emergency
response personnel training.--The Secretary, in
consultation with the Attorney General and the Director
of the Federal Emergency Management Agency, may provide
technical assistance with respect to health-related
aspects of emergency response personnel training
carried out by the Department of Justice and the
Federal Emergency Management Agency.''.
SEC. 106. GRANTS REGARDING SHORTAGES OF CERTAIN HEALTH PROFESSIONALS.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq.) is amended by inserting after section 319G
the following section:
``SEC. 319H. GRANTS REGARDING TRAINING AND EDUCATION OF CERTAIN HEALTH
PROFESSIONALS.
``(a) In General.--The Secretary may make awards of grants
and cooperative agreements to appropriate public and nonprofit
private health or educational entities, including health
professions schools and programs as defined in section 799B,
for the purpose of providing low-interest loans, partial
scholarships, partial fellowships, revolving loan funds, or
other cost-sharing forms of assistance for the education and
training of individuals in any category of health professions
for which there is a shortage that the Secretary determines
should be alleviated in order to prepare for or respond
effectively to bioterrorism and other public health
emergencies.
``(b) Authority Regarding Non-Federal Contributions.--The
Secretary may require as a condition of an award under
subsection (a) that a grantee under such subsection provide
non-Federal contributions toward the purpose described in such
subsection.
``(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2006.''.
SEC. 107. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF HEALTH
PROFESSIONS VOLUNTEERS.
Part B of title III of the Public Health Service Act, as
amended by section 106 of this Act, is amended by inserting
after section 319H the following section:
``SEC. 319I. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF HEALTH
PROFESSIONS VOLUNTEERS.
``(a) In General.--The Secretary shall, directly or through
an award of a grant, contract, or cooperative agreement,
establish and maintain a system for the advance registration of
health professionals for the purpose of verifying the
credentials, licenses, accreditations, and hospital privileges
of such professionals when, during public health emergencies,
the professionals volunteer to provide health services
(referred to in this section as the `verification system'). In
carrying out the preceding sentence, the Secretary shall
provide for an electronic database for the verification system.
``(b) Certain Criteria.--The Secretary shall establish
provisions regarding the promptness and efficiency of the
system in collecting, storing, updating, and disseminating
information on the credentials, licenses, accreditations, and
hospital privileges of volunteers described in subsection (a).
``(c) Other Assistance.--The Secretary may make grants and
provide technical assistance to States and other public or
nonprofit private entities for activities relating to the
verification system developed under subsection (a).
``(d) Coordination Among States.--The Secretary may
encourage each State to provide legal authority during a public
health emergency for health professionals authorized in another
State to provide certain health services to provide such health
services in the State.
``(e) Rule of Construction.--This section may not be
construed as authorizing the Secretary to issue requirements
regarding the provision by the States of credentials, licenses,
accreditations, or hospital privileges.
``(f) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $2,000,000 for fiscal year 2002, and such sums as
may be necessary for each of the fiscal years 2003 through
2006.''.
SEC. 108. WORKING GROUP.
Section 319F of the Public Health Service Act, as amended
by section 104(a), is amended by striking subsection (a) and
inserting the following:
``(a) Working Group on Bioterrorism and Other Public Health
Emergencies.--
``(1) In general.--The Secretary, in coordination
with the Secretary of Agriculture, the Attorney
General, the Director of Central Intelligence, the
Secretary of Defense, the Secretary of Energy, the
Administrator of the Environmental Protection Agency,
the Director of the Federal Emergency Management
Agency, the Secretary of Labor, the Secretary of
Veterans Affairs, and with other similar Federal
officials as determined appropriate, shall establish a
working group on the prevention, preparedness, and
response to bioterrorism and other public health
emergencies. Such joint working group, or subcommittees
thereof, shall meet periodically for the purpose of
consultation on, assisting in, and making
recommendations on--
``(A) responding to a bioterrorist attack,
including the provision of appropriate safety
and health training and protective measures for
medical, emergency service, and other personnel
responding to such attacks;
``(B) prioritizing countermeasures required
to treat, prevent, or identify exposure to a
biological agent or toxin pursuant to section
351A;
``(C) facilitation of the awarding of
grants, contracts, or cooperative agreements
for the development, manufacture, distribution,
supply-chain management, and purchase of
priority countermeasures;
``(D) research on pathogens likely to be
used in a biological threat or attack on the
civilian population;
``(E) development of shared standards for
equipment to detect and to protect against
biological agents and toxins;
``(F) assessment of the priorities for and
enhancement of the preparedness of public
health institutions, providers of medical care,
and other emergency service personnel
(including firefighters) to detect, diagnose,
and respond (including mental health response)
to a biological threat or attack;
``(G) in the recognition that medical and
public health professionals are likely to
provide much of the first response to such an
attack, development and enhancement of the
quality of joint planning and training programs
that address the public health and medical
consequences of a biological threat or attack
on the civilian population between--
``(i) local firefighters, ambulance
personnel, police and public security
officers, or other emergency response
personnel; and
``(ii) hospitals, primary care
facilities, and public health agencies;
``(H) development of strategies for
Federal, State, and local agencies to
communicate information to the public regarding
biological threats or attacks;
``(I) ensuring that the activities under
this subsection address the health security
needs of children and other vulnerable
populations;
``(J) strategies for decontaminating
facilities contaminated as a result of a
biological attack, including appropriate
protections for the safety of workers
conducting such activities;
``(K) subject to compliance with other
provisions of Federal law, clarifying the
responsibilities among Federal officials for
the investigation of suspicious outbreaks of
disease and other potential public health
emergencies, and for related revisions of the
interagency plan known as the Federal response
plan; and
``(L) in consultation with the National
Highway Traffic Safety Administration and the
U.S. Fire Administration, ways to enhance
coordination among Federal agencies involved
with State, local, and community based
emergency medical services, including issuing a
report that--
``(i) identifies needs of
community-based emergency medical
services; and
``(ii) identifies ways to
streamline and enhance the process
through which Federal agencies support
community-based emergency medical
services.
``(2) Consultation with experts.--In carrying out
subparagraphs (B) and (C) of paragraph (1), the working
group under such paragraph shall consult with the
pharmaceutical, biotechnology, and medical device
industries, and other appropriate experts.
``(3) Use of subcommittees regarding consultation
requirements.--With respect to a requirement under law
that the working group under paragraph (1) be consulted
on a matter, the working group may designate an
appropriate subcommittee of the working group to engage
in the consultation.
``(4) Discretion in exercise of duties.--
Determinations made by the working group under
paragraph (1) with respect to carrying out duties under
such paragraph are matters committed to agency
discretion for purposes of section 701(a) of title 5,
United States Code.
``(5) Rule of construction.--This subsection may
not be construed as establishing new regulatory
authority for any of the officials specified in
paragraph (1), or as having any legal effect on any
other provision of law, including the responsibilities
and authorities of the Environmental Protection
Agency.''.
SEC. 109. ANTIMICROBIAL RESISTANCE.
Section 319E of the Public Health Service Act (42 U.S.C.
247d-5) is amended--
(1) in subsection (b)--
(A) by striking ``shall conduct and
support'' and inserting ``shall directly or
through awards of grants or cooperative
agreements to public or private entities
provide for the conduct of''; and
(B) by amending paragraph (4) to read as
follows:
``(4) the sequencing of the genomes, or other DNA
analysis, or other comparative analysis, of priority
pathogens (as determined by the Director of the
National Institutes of Health in consultation with the
task force established under subsection (a)), in
collaboration and coordination with the activities of
the Department of Defense and the Joint Genome
Institute of the Department of Energy; and'';
(2) in subsection (e)(2), by inserting after
``societies,'' the following: ``schools or programs
that train medical laboratory personnel,''; and
(3) in subsection (g), by striking ``and such
sums'' and all that follows and inserting the
following: ``$25,000,000 for each of the fiscal years
2002 and 2003, and such sums as may be necessary for
each of the fiscal years 2004 through 2006.''.
SEC. 110. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.
Part B of title III of the Public Health Service Act, as
amended by section 107 of this Act, is amended by inserting
after section 319I the following section:
``SEC. 319J. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.
``(a) In General.--Upon the request of a recipient of an
award under any of sections 319 through 319I or section 319K,
the Secretary may, subject to subsection (b), provide supplies,
equipment, and services for the purpose of aiding the recipient
in carrying out the purposes for which the award is made and,
for such purposes, may detail to the recipient any officer or
employee of the Department of Health and Human Services.
``(b) Corresponding Reduction in Payments.--With respect to
a request described in subsection (a), the Secretary shall
reduce the amount of payments under the award involved by an
amount equal to the costs of detailing personnel and the fair
market value of any supplies, equipment, or services provided
by the Secretary. The Secretary shall, for the payment of
expenses incurred in complying with such request, expend the
amounts withheld.''.
SEC. 111. ADDITIONAL AMENDMENTS.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq) is amended--
(1) in section 319A(a)(1), by striking ``10 years''
and inserting ``five years'';
(2) in section 319B(a), in the first sentence, by
striking ``10 years'' and inserting ``five years''; and
(3) in section 391F(e)(2), as redesignated by
section 104(a)(2) of this Act--
(A) by striking ``or'' after ``clinic,'';
and
(B) by inserting before the period
following: ``, professional organization or
society, school or program that trains medical
laboratory personnel, private accrediting
organization, or other nonprofit private
institution or entity meeting criteria
established by the Secretary''.
Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures
SEC. 121. STRATEGIC NATIONAL STOCKPILE.
(a) Strategic National Stockpile.--
(1) In general.--The Secretary of Health and Human
Services (referred to in this section as the
``Secretary''), in coordination with the Secretary of
Veterans Affairs, shall maintain a stockpile or
stockpiles of drugs, vaccines and other biological
products, medical devices, and other supplies in such
numbers, types, and amounts as are determined by the
Secretary to be appropriate and practicable, taking
into account other available sources, to provide for
the emergency health security of the United States,
including the emergency health security of children and
other vulnerable populations, in the event of a
bioterrorist attack or other public health emergency.
(2) Procedures.--The Secretary, in managing the
stockpile under paragraph (1), shall--
(A) consult with the working group under
section 319F(a) of the Public Health Service
Act;
(B) ensure that adequate procedures are
followed with respect to such stockpile for
inventory management and accounting, and for
the physical security of the stockpile;
(C) in consultation with Federal, State,
and local officials, take into consideration
the timing and location of special events;
(D) review and revise, as appropriate, the
contents of the stockpile on a regular basis to
ensure that emerging threats, advanced
technologies, and new countermeasures are
adequately considered;
(E) devise plans for the effective and
timely supply-chain management of the
stockpile, in consultation with appropriate
Federal, State and local agencies, and the
public and private health care infrastructure;
and
(F) ensure the adequate physical security
of the stockpile.
(b) Smallpox Vaccine Development.--
(1) In general.--The Secretary shall award
contracts, enter into cooperative agreements, or carry
out such other activities as may reasonably be required
in order to ensure that the stockpile under subsection
(a) includes an amount of vaccine against smallpox as
determined by the Secretary to be sufficient to meet
the health security needs of the United States.
(2) Rule of construction.--Nothing in this section
shall be construed to limit the private distribution,
purchase, or sale of vaccines from sources other than
the stockpile described in subsection (a).
(c) Disclosures.--No Federal agency shall disclose under
section 552, United States Code, any information identifying
the location at which materials in the stockpile under
subsection (a) are stored.
(d) Definition.--For purposes of subsection (a), the term
``stockpile'' includes--
(1) a physical accumulation (at one or more
locations) of the supplies described in subsection (a);
or
(2) a contractual agreement between the Secretary
and a vendor or vendors under which such vendor or
vendors agree to provide to the Secretary supplies
described in subsection (a).
(e) Authorization of Appropriations.--
(1) Strategic national stockpile.--For the purpose
of carrying out subsection (a), there are authorized to
be appropriated $640,000,000 for fiscal year 2002, and
such sums as may be necessary for each of fiscal years
2003 through 2006.
(2) Smallpox vaccine development.--For the purpose
of carrying out subsection (b), there are authorized to
be appropriated $509,000,000 for fiscal year 2002, and
such sums as may be necessary for each of fiscal years
2003 through 2006.
SEC. 122. ACCELERATED APPROVAL OF PRIORITY COUNTERMEASURES.
(a) In General.--The Secretary of Health and Human Services
may designate a priority countermeasure as a fast-track product
pursuant to section 506 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356) or as a device granted review priority
pursuant to section 515(d)(5) of such Act (21 U.S.C.
360e(d)(5)). Such a designation may be made prior to the
submission of--
(1) a request for designation by the sponsor or
applicant; or
(2) an application for the investigation of the
drug under section 505(i) of such Act or section
351(a)(3) of the Public Health Service Act.
Nothing in this subsection shall be construed to prohibit a
sponsor or applicant from declining such a designation.
(b) Use of Animal Trials.--A drug for which approval is
sought under section 505(b) of the Federal Food, Drug, and
Cosmetic Act or section 351 of the Public Health Service Act on
the basis of evidence of effectiveness that is derived from
animal studies pursuant to section 123 may be designated as a
fast track product for purposes of this section.
(c) Priority Review of Drugs and Biological Products.--A
priority countermeasure that is a drug or biological product
shall be considered a priority drug or biological product for
purposes of performance goals for priority drugs or biological
products agreed to by the Commissioner of Food and Drugs.
(d) Definitions.--For purposes of this title:
(1) The term ``priority countermeasure'' has the
meaning given such term in section 319F(h)(4) of the
Public Health Service Act.
(2) The term ``priority drugs or biological
products'' means a drug or biological product that is
the subject of a drug or biologics application referred
to in section 101(4) of the Food and Drug
Administration Modernization Act of 1997.
SEC. 123. ISSUANCE OF RULE ON ANIMAL TRIALS.
Not later than 90 days after the date of the enactment of
this Act, the Secretary of Health and Human Services shall
complete the process of rulemaking that was commenced under
authority of section 505 of the Federal Food, Drug, and
Cosmetic Act and section 351 of the Public Health Service Act
with the issuance of the proposed rule entitled ``New Drug and
Biological Drug Products; Evidence Needed to Demonstrate
Efficacy of New Drugs for Use Against Lethal or Permanently
Disabling Toxic Substances When Efficacy Studies in Humans
Ethically Cannot be Conducted'' published in the Federal
Register on October 5, 1999 (64 Fed. Reg. 53960), and shall
promulgate a final rule.
SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND PRODUCTION.
Part B of title III of the Public Health Service Act, as
amended by section 110 of this Act, is amended by inserting
after section 319J the following section:
``SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND PRODUCTION.
``(a) In General.--The Secretary, in consultation with the
Attorney General and the Secretary of Defense, may provide
technical or other assistance to provide security to persons or
facilities that conduct development, production, distribution,
or storage of priority countermeasures (as defined in section
319F(h)(4)).
``(b) Guidelines.--The Secretary may develop guidelines to
enable entities eligible to receive assistance under subsection
(a) to secure their facilities against potential terrorist
attack.''.
SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND DEVELOPMENT.
Section 319F(h) of the Public Health Service Act, as
redesignated by section 104(a)(2) of this Act, is amended to
read as follows:
``(h) Accelerated Research and Development on Priority
Pathogens and Countermeasures.--
``(1) In general.--With respect to pathogens of
potential use in a bioterrorist attack, and other
agents that may cause a public health emergency, the
Secretary, taking into consideration any
recommendations of the working group under subsection
(a), shall conduct, and award grants, contracts, or
cooperative agreements for, research, investigations,
experiments, demonstrations, and studies in the health
sciences relating to--
``(A) the epidemiology and pathogenesis of
such pathogens;
``(B) the sequencing of the genomes, or
other DNA analysis, or other comparative
analysis, of priority pathogens (as determined
by the Director of the National Institutes of
Health in consultation with the working group
established in subsection (a)), in
collaboration and coordination with the
activities of the Department of Defense and the
Joint Genome Institute of the Department of
Energy;
``(C) the development of priority
countermeasures; and
``(D) other relevant areas of research;
with consideration given to the needs of children and
other vulnerable populations.
``(2) Priority.--The Secretary shall give priority
under this section to the funding of research and other
studies related to priority countermeasures.
``(3) Role of department of veterans affairs.--In
carrying out paragraph (1), the Secretary shall
consider using the biomedical research and development
capabilities of the Department of Veterans Affairs, in
conjunction with that Department's affiliations with
health-professions universities. When advantageous to
the Government in furtherance of the purposes of such
paragraph, the Secretary may enter into cooperative
agreements with the Secretary of Veterans Affairs to
achieve such purposes.
``(4) Priority countermeasures.--For purposes of
this section, the term `priority countermeasure' means
a drug, biological product, device, vaccine, vaccine
adjuvant, antiviral, or diagnostic test that the
Secretary determines to be--
``(A) a priority to treat, identify, or
prevent infection by a biological agent or
toxin listed pursuant to section 351A(a)(1), or
harm from any other agent that may cause a
public health emergency; or
``(B) a priority to diagnose conditions
that may result in adverse health consequences
or death and may be caused by the administering
of a drug, biological product, device, vaccine,
vaccine adjuvant, antiviral, or diagnostic test
that is a priority under subparagraph (A).''.
SEC. 126. EVALUATION OF NEW AND EMERGING TECHNOLOGIES REGARDING
BIOTERRORIST ATTACK AND OTHER PUBLIC HEALTH
EMERGENCIES.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
promptly carry out a program to periodically evaluate new and
emerging technologies that, in the determination of the
Secretary, are designed to improve or enhance the ability of
public health or safety officials to conduct public health
surveillance activities relating to a bioterrorist attack or
other public health emergency.
(b) Certain Activities.--In carrying out this subsection,
the Secretary shall, to the extent practicable--
(1) survey existing technology programs funded by
the Federal Government for potentially useful
technologies;
(2) promptly issue a request, as necessary, for
information from non-Federal public and private
entities for ongoing activities in this area; and
(3) evaluate technologies identified under
paragraphs (1) and (2) pursuant to subsection (c).
(c) Consultation and Evaluation.--In carrying out
subsection (b)(3), the Secretary shall consult with the working
group under section 319F(a) of the Public Health Service Act,
as well as other appropriate public, nonprofit, and private
entities, to develop criteria for the evaluation of such
technologies and to conduct such evaluations.
(d) Report.--Not later than 180 days after the date of the
enactment of this Act, and periodically thereafter, the
Secretary shall submit to the Committee on Energy and Commerce
of the House of Representatives, and the Committee on Health,
Education, Labor, and Pensions of the Senate, a report on the
activities under this section.
SEC. 127. POTASSIUM IODIDE.
(a) In General.--Through the national stockpile under
section 121, the President, subject to subsections (b) and (c),
shall make available to State and local governments potassium
iodide tablets for stockpiling and for distribution as
appropriate to public facilities, such as schools and
hospitals, in quantities sufficient to provide adequate
protection for the population within 20 miles of a nuclear
power plant.
(b) State and Local Plans.--
(1) In general.--Subsection (a) applies with
respect to a State or local government, subject to
paragraph (2), if the government involved meets the
following conditions:
(A) Such government submits to the
President a plan for the stockpiling of
potassium iodide tablets, and for the
distribution and utilization of potassium
iodide tablets in the event of a nuclear
incident.
(B) The plan is accompanied by
certifications by such government that the
government has not already received sufficient
quantities of potassium iodide tablets from the
Federal Government.
(2) Local governments.--Subsection (a) applies with
respect to a local government only if, in addition to
the conditions described in paragraph (1), the
following conditions are met:
(A) The State in which the locality
involved is located--
(i) does not have a plan described
in paragraph (1)(A); or
(ii) has a plan described in such
paragraph, but the plan does not
address populations at a distance
greater than 10 miles from the nuclear
power plant involved.
(B) The local government has petitioned the
State to modify the State plan to address such
populations, not exceeding 20 miles from such
plant, and 60 days have elapsed without the
State modifying the State plan to address
populations at the full distance sought by the
local government through the petition.
(C) The local government has submitted its
local plan under paragraph (1)(A) to the State,
and the State has approved the plan and
certified that the plan is not inconsistent
with the State emergency plan.
(c) Guidelines.--Not later than one year after the date of
the enactment of this Act, the President, in consultation with
individuals representing appropriate Federal, State, and local
agencies, shall establish guidelines for the stockpiling of
potassium iodide tablets, and for the distribution and
utilization of potassium iodide tablets in the event of a
nuclear incident. Such tablets may not be made available under
subsection (a) until such guidelines have been established.
(d) Information.--The President shall carry out activities
to inform State and local governments of the program under this
section.
(e) Reports.--
(1) President.--Not later than six months after the
date on which the guidelines under subsection (c) are
issued, the President shall submit to the Congress a
report--
(A) on whether potassium iodide tablets
have been made available under subsection (a)
or other Federal, State, or local programs, and
the extent to which State and local governments
have established stockpiles of such tablets;
and
(B) the measures taken by the President to
implement this section.
(2) National academy of sciences.--
(A) In general.--The President shall
request the National Academy of Sciences to
enter into an agreement with the President
under which the Academy conducts a study to
determine what is the most effective and safe
way to distribute and administer potassium
iodide tablets on a mass scale. If the Academy
declines to conduct the study, the President
shall enter into an agreement with another
appropriate public or nonprofit private entity
to conduct the study.
(B) Report.--The President shall ensure
that, not later than six months after the date
of the enactment of this Act, the study
required in subparagraph (A) is completed and a
report describing the findings made in the
study is submitted to the Congress.
(f) Applicability.--Subsections (a) and (d) cease to apply
as requirements if the President determines that there is an
alternative and more effective prophylaxis or preventive
measures for adverse thyroid conditions that may result from
the release of radionuclides from nuclear power plants.
Subtitle C--Improving State, Local, and Hospital Preparedness for and
Response to Bioterrorism and Other Public Health Emergencies
SEC. 131. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL PREPAREDNESS FOR
AND RESPONSE TO BIOTERRORISM AND OTHER PUBLIC
HEALTH EMERGENCIES.
(a) In General.--Part B of title III of the Public Health
Service Act (42 U.S.C. 243 et seq.) is amended by inserting
after section 319C the following sections:
``SEC. 319C-1. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL
PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM AND
OTHER PUBLIC HEALTH EMERGENCIES.
``(a) In General.--To enhance the security of the United
States with respect to bioterrorism and other public health
emergencies, the Secretary shall make awards of grants or
cooperative agreements to eligible entities to enable such
entities to conduct the activities described in subsection (d).
``(b) Eligible Entities.--
``(1) In general.--To be eligible to receive an
award under subsection (a), an entity shall--
``(A)(i) be a State; and
``(ii) prepare and submit to the Secretary
an application at such time, and in such
manner, and containing such information as the
Secretary may require, including an assurance
that the State--
``(I) has completed an evaluation
under section 319B(a), or an evaluation
that is substantially equivalent to an
evaluation described in such section
(as determined by the Secretary);
``(II) has prepared, or will
(within 60 days of receiving an award
under this section) prepare, a
Bioterrorism and Other Public Health
Emergency Preparedness and Response
Plan in accordance with subsection (c);
``(III) has established a means by
which to obtain public comment and
input on the plan prepared under
subclause (II), and on the
implementation of such plan, that shall
include an advisory committee or other
similar mechanism for obtaining comment
from the public at large as well as
from other State and local
stakeholders;
``(IV) will use amounts received
under the award in accordance with the
plan prepared under subclause (II),
including making expenditures to carry
out the strategy contained in the plan;
and
``(V) with respect to the plan
prepared under subclause (II), will
establish reasonable criteria to
evaluate the effective performance of
entities that receive funds under the
award and include relevant benchmarks
in the plan; or
``(B)(i) be a political subdivision of a
State or a consortium of 2 or more such
subdivisions; and
``(ii) prepare and submit to the Secretary
an application at such time, and in such
manner, and containing such information as the
Secretary may require.
``(2) Coordination with statewide plans.--An award
under subsection (a) to an eligible entity described in
paragraph (1)(B) may not be made unless the application
of such entity is in coordination with, and consistent
with, applicable Statewide plans described in
subsection (d)(1).
``(c) Bioterrorism and Other Public Health Emergency
Preparedness and Response Plan.--Not later than 60 days after
receiving amounts under an award under subsection (a), an
eligible entity described in subsection (b)(1)(A) shall prepare
and submit to the Secretary a Bioterrorism and Other Public
Health Emergency Preparedness and Response Plan. Recognizing
the assessment of public health needs conducted under section
319B, such plan shall include a description of activities to be
carried out by the entity to address the needs identified in
such assessment (or an equivalent assessment).
``(d) Use of Funds.--An award under subsection (a) may be
expended for activities that may include the following and
similar activities:
``(1) To develop Statewide plans (including the
development of the Bioterrorism and Other Public Health
Emergency Preparedness and Response Plan required under
subsection (c)), and community-wide plans for
responding to bioterrorism and other public health
emergencies that are coordinated with the capacities of
applicable national, State, and local health agencies
and health care providers, including poison control
centers.
``(2) To address deficiencies identified in the
assessment conducted under section 319B.
``(3) To purchase or upgrade equipment (including
stationary or mobile communications equipment),
supplies, pharmaceuticals or other priority
countermeasures to enhance preparedness for and
response to bioterrorism or other public health
emergencies, consistent with the plan described in
subsection (c).
``(4) To conduct exercises to test the capability
and timeliness of public health emergency response
activities.
``(5) To develop and implement the trauma care and
burn center care components of the State plans for the
provision of emergency medical services.
``(6) To improve training or workforce development
to enhance public health laboratories.
``(7) To train public health and health care
personnel to enhance the ability of such personnel--
``(A) to detect, provide accurate
identification of, and recognize the symptoms
and epidemiological characteristics of exposure
to a biological agent that may cause a public
health emergency; and
``(B) to provide treatment to individuals
who are exposed to such an agent.
``(8) To develop, enhance, coordinate, or improve
participation in systems by which disease detection and
information about biological attacks and other public
health emergencies can be rapidly communicated among
national, State, and local health agencies, emergency
response personnel, and health care providers and
facilities to detect and respond to a bioterrorist
attack or other public health emergency, including
activities to improve information technology and
communications equipment available to health care and
public health officials for use in responding to a
biological threat or attack or other public health
emergency.
``(9) To enhance communication to the public of
information on bioterrorism and other public health
emergencies, including through the use of 2-1-1 call
centers.
``(10) To address the health security needs of
children and other vulnerable populations with respect
to bioterrorism and other public health emergencies.
``(11) To provide training and develop, enhance,
coordinate, or improve methods to enhance the safety of
workers and workplaces in the event of bioterrorism.
``(12) To prepare and plan for contamination
prevention efforts related to public health that may be
implemented in the event of a bioterrorist attack,
including training and planning to protect the health
and safety of workers conducting the activities
described in this paragraph.
``(13) To prepare a plan for triage and transport
management in the event of bioterrorism or other public
health emergencies.
``(14) To enhance the training of health care
professionals to recognize and treat the mental health
consequences of bioterrorism or other public health
emergencies.
``(15) To enhance the training of health care
professionals to assist in providing appropriate health
care for large numbers of individuals exposed to a
bioweapon.
``(16) To enhance training and planning to protect
the health and safety of personnel, including health
care professionals, involved in responding to a
biological attack.
``(17) To improve surveillance, detection, and
response activities to prepare for emergency response
activities including biological threats or attacks,
including training personnel in these and other
necessary functions and including early warning and
surveillance networks that use advanced information
technology to provide early detection of biological
threats or attacks.
``(18) To develop, enhance, and coordinate or
improve the ability of existing telemedicine programs
to provide health care information and advice as part
of the emergency public health response to bioterrorism
or other public health emergencies.
Nothing in this subsection may be construed as establishing new
regulatory authority or as modifying any existing regulatory
authority.
``(e) Priorities in Use of Grants.--
``(1) In general.--
``(A) Priorities.--Except as provided in
subparagraph (B), the Secretary shall, in
carrying out the activities described in this
section, address the following hazards in the
following priority:
``(i) Bioterrorism or acute
outbreaks of infectious diseases.
``(ii) Other public health threats
and emergencies.
``(B) Determination of the secretary.--In
the case of the hazard involved, the degree of
priority that would apply to the hazard based
on the categories specified in clauses (i) and
(ii) of subparagraph (A) may be modified by the
Secretary if the following conditions are met:
``(i) The Secretary determines that
the modification is appropriate on the
basis of the following factors:
``(I) The extent to which
eligible entities are
adequately prepared for
responding to hazards within
the category specified in
clause (i) of subparagraph (A).
``(II) There has been a
significant change in the
assessment of risks to the
public health posed by hazards
within the category specified
in clause (ii) of such
subparagraph.
``(ii) Prior to modifying the
priority, the Secretary notifies the
appropriate committees of the Congress
of the determination of the Secretary
under clause (i) of this subparagraph.
``(2) Areas of emphasis within categories.--The
Secretary shall determine areas of emphasis within the
category of hazards specified in clause (i) of
paragraph (1)(A), and shall determine areas of emphasis
within the category of hazards specified in clause (ii)
of such paragraph, based on an assessment of the risk
and likely consequences of such hazards and on an
evaluation of Federal, State, and local needs, and may
also take into account the extent to which receiving an
award under subsection (a) will develop capacities that
can be used for public health emergencies of varying
types.
``(f) Certain Activities.--In administering activities
under section 319C(c)(4) or similar activities, the Secretary
shall, where appropriate, give priority to activities that
include State or local government financial commitments, that
seek to incorporate multiple public health and safety services
or diagnostic databases into an integrated public health
entity, and that cover geographic areas lacking advanced
diagnostic and laboratory capabilities.
``(g) Coordination With Local Medical Response System.--An
eligible entity and local Metropolitan Medical Response Systems
shall, to the extent practicable, ensure that activities
carried out under an award under subsection (a) are coordinated
with activities that are carried out by local Metropolitan
Medical Response Systems.
``(h) Coordination of Federal Activities.--In making awards
under subsection (a), the Secretary shall--
``(1) annually notify the Director of the Federal
Emergency Management Agency, the Director of the Office
of Justice Programs, and the Director of the National
Domestic Preparedness Office, as to the amount,
activities covered under, and status of such awards;
and
``(2) coordinate such awards with other activities
conducted or supported by the Secretary to enhance
preparedness for bioterrorism and other public health
emergencies.
``(i) Definition.--For purposes of this section, the term
`eligible entity' means an entity that meets the conditions
described in subparagraph (A) or (B) of subsection (b)(1).
``(j) Funding.--
``(1) Authorizations of appropriations.--
``(A) Fiscal year 2003.--
``(i) Authorizations.--For the
purpose of carrying out this section,
there is authorized to be appropriated
$1,600,000,000 for fiscal year 2003, of
which--
``(I) $1,080,000,000 is
authorized to be appropriated
for awards pursuant to
paragraph (3) (subject to the
authority of the Secretary to
make awards pursuant to
paragraphs (4) and (5)); and
``(II) $520,000,000 is
authorized to be appropriated--
``(aa) for awards
under subsection (a) to
States, notwithstanding
the eligibility
conditions under
subsection (b), for the
purpose of enhancing
the preparedness of
hospitals (including
children's hospitals),
clinics, health
centers, and primary
care facilities for
bioterrorism and other
public health
emergencies; and
``(bb) for Federal,
State, and local
planning and
administrative
activities related to
such purpose.
``(ii) Contingent additional
authorization.--If a significant change
in circumstances warrants an increase
in the amount authorized to be
appropriated under clause (i) for
fiscal year 2003, there are authorized
to be appropriated such sums as may be
necessary for such year for carrying
out this section, in addition to the
amount authorized in clause (i).
``(B) Other fiscal years.--For the purpose
of carrying out this section, there are
authorized to be appropriated such sums as may
be necessary for each of the fiscal years 2004
through 2006.
``(2) Supplement not supplant.--Amounts
appropriated under paragraph (1) shall be used to
supplement and not supplant other State and local
public funds provided for activities under this
section.
``(3) State bioterrorism and other public health
emergency preparedness and response block grant for
fiscal year 2003.--
``(A) In general.--For fiscal year 2003,
the Secretary shall, in an amount determined in
accordance with subparagraphs (B) through (D),
make an award under subsection (a) to each
State, notwithstanding the eligibility
conditions described in subsection (b), that
submits to the Secretary an application for the
award that meets the criteria of the Secretary
for the receipt of such an award and that meets
other implementation conditions established by
the Secretary for such awards. No other awards
may be made under subsection (a) for such
fiscal year, except as provided in paragraph
(1)(A)(i)(II) and paragraphs (4) and (5).
``(B) Base amount.--In determining the
amount of an award pursuant to subparagraph (A)
for a State, the Secretary shall first
determine an amount the Secretary considers
appropriate for the State (referred to in this
paragraph as the `base amount'), except that
such amount may not be greater than the minimum
amount determined under subparagraph (D).
``(C) Increase on basis of population.--
After determining the base amount for a State
under subparagraph (B), the Secretary shall
increase the base amount by an amount equal to
the product of--
``(i) the amount appropriated under
paragraph (1)(A)(i)(I) for the fiscal
year, less an amount equal to the sum
of all base amounts determined for the
States under subparagraph (B), and less
the amount, if any, reserved by the
Secretary under paragraphs (4) and (5);
and
``(ii) subject to paragraph (4)(C),
the percentage constituted by the ratio
of an amount equal to the population of
the State over an amount equal to the
total population of the States (as
indicated by the most recent data
collected by the Bureau of the Census).
``(D) Minimum amount.--Subject to the
amount appropriated under paragraph
(1)(A)(i)(I), an award pursuant to subparagraph
(A) for a State shall be the greater of the
base amount as increased under subparagraph
(C), or the minimum amount under this
subparagraph. The minimum amount under this
subparagraph is--
``(i) in the case of each of the
several States, the District of
Columbia, and the Commonwealth of
Puerto Rico, an amount equal to the
lesser of--
``(I) $5,000,000; or
``(II) if the amount
appropriated under paragraph
(1)(A)(i)(I) is less than
$667,000,000, an amount equal
to 0.75 percent of the amount
appropriated under such
paragraph, less the amount, if
any, reserved by the Secretary
under paragraphs (4) and (5);
or
``(ii) in the case of each of
American Samoa, Guam, the Commonwealth
of the Northern Mariana Islands, and
the Virgin Islands, an amount
determined by the Secretary to be
appropriate, except that such amount
may not exceed the amount determined
under clause (i).
``(4) Certain political subdivisions.--
``(A) In general.--For fiscal year 2003,
the Secretary may, before making awards
pursuant to paragraph (3) for such year,
reserve from the amount appropriated under
paragraph (1)(A)(i)(I) for the year an amount
determined necessary by the Secretary to make
awards under subsection (a) to political
subdivisions that have a substantial number of
residents, have a substantial local
infrastructure for responding to public health
emergencies, and face a high degree of risk
from bioterrorist attacks or other public
health emergencies. Not more than three
political subdivisions may receive awards
pursuant to this subparagraph.
``(B) Coordination with statewide plans.--
An award pursuant to subparagraph (A) may not
be made unless the application of the political
subdivision involved is in coordination with,
and consistent with, applicable Statewide plans
described in subsection (c)(1).
``(C) Relationship to formula grants.--In
the case of a State that will receive an award
pursuant to paragraph (3), and in which there
is located a political subdivision that will
receive an award pursuant to subparagraph (A),
the Secretary shall, in determining the amount
under paragraph (3)(B) for the State, subtract
from the population of the State an amount
equal to the population of such political
subdivision.
``(D) Continuity of funding.--In
determining whether to make an award pursuant
to subparagraph (A) to a political subdivision,
the Secretary may consider, as a factor
indicating that the award should be made, that
the political subdivision received public
health funding from the Secretary for fiscal
year 2002.
``(5) Significant unmet needs; degree of risk.--
``(A) In general.--For fiscal year 2003,
the Secretary may, before making awards
pursuant to paragraph (3) for such year,
reserve from the amount appropriated under
paragraph (1)(A)(i)(I) for the year an amount
determined necessary by the Secretary to make
awards under subsection (a) to eligible
entities that--
``(i) have a significant need for
funds to build capacity to identify,
detect, monitor, and respond to a
bioterrorist or other threat to the
public health, which need will not be
met by awards pursuant to paragraph
(3); and
``(ii) face a particularly high
degree of risk of such a threat.
``(B) Recipients of grants.--Awards
pursuant to subparagraph (A) may be
supplemental awards to States that receive
awards pursuant to paragraph (3), or may be
awards to eligible entities described in
subsection (b)(1)(B) within such States.
``(C) Finding with respect to district of
columbia.--The Secretary shall consider the
District of Columbia to have a significant
unmet need for purposes of subparagraph (A),
and to face a particularly high degree of risk
for such purposes, on the basis of the
concentration of entities of national
significance located within the District.
``(6) Funding of local entities.--For fiscal year
2003, the Secretary shall in making awards under this
section ensure that appropriate portions of such awards
are made available to political subdivisions, local
departments of public health, hospitals (including
children's hospitals), clinics, health centers, or
primary care facilities, or consortia of such entities.
``SEC. 319C-2. PARTNERSHIPS FOR COMMUNITY AND HOSPITAL PREPAREDNESS.
``(a) Grants.--The Secretary shall make awards of grants or
cooperative agreements to eligible entities to enable such
entities to improve community and hospital preparedness for
bioterrorism and other public health emergencies.
``(b) Eligibility.--To be eligible for an award under
subsection (a), an entity shall--
``(1) be a partnership consisting of--
``(A) one or more hospitals (including
children's hospitals), clinics, health centers,
or primary care facilities; and
``(B)(i) one or more political subdivisions
of States;
``(ii) one or more States; or
``(iii) one or more States and one or more
political subdivisions of States; and
``(2) prepare, in consultation with the Chief
Executive Officer of the State, District, or territory
in which the hospital, clinic, health center, or
primary care facility described in paragraph (1)(A) is
located, and submit to the Secretary, an application at
such time, in such manner, and containing such
information as the Secretary may require.
``(c) Regional Coordination.--In making awards under
subsection (a), the Secretary shall give preference to eligible
entities that submit applications that, in the determination of
the Secretary, will--
``(1) enhance coordination--
``(A) among the entities described in
subsection (b)(1)(A); and
``(B) between such entities and the
entities described in subsection (b)(1)(B); and
``(2) serve the needs of a defined geographic area.
``(d) Consistency of Planned Activities.--An entity
described in subsection (b)(1) shall utilize amounts received
under an award under subsection (a) in a manner that is
coordinated and consistent, as determined by the Secretary,
with an applicable State Bioterrorism and Other Public Health
Emergency Preparedness and Response Plan.
``(e) Use of Funds.--An award under subsection (a) may be
expended for activities that may include the following and
similar activities--
``(1) planning and administration for such award;
``(2) preparing a plan for triage and transport
management in the event of bioterrorism or other public
health emergencies;
``(3) enhancing the training of health care
professionals to improve the ability of such
professionals to recognize the symptoms of exposure to
a potential bioweapon, to make appropriate diagnosis,
and to provide treatment to those individuals so
exposed;
``(4) enhancing the training of health care
professionals to recognize and treat the mental health
consequences of bioterrorism or other public health
emergencies;
``(5) enhancing the training of health care
professionals to assist in providing appropriate health
care for large numbers of individuals exposed to a
bioweapon;
``(6) enhancing training and planning to protect
the health and safety of personnel involved in
responding to a biological attack;
``(7) developing and implementing the trauma care
and burn center care components of the State plans for
the provision of emergency medical services; or
``(8) conducting such activities as are described
in section 319C-1(d) that are appropriate for hospitals
(including children's hospitals), clinics, health
centers, or primary care facilities.
``(f) Limitation on Awards.--A political subdivision of a
State shall not participate in more than one partnership
described in subsection (b)(1).
``(g) Priorities in Use of Grants.--
``(1) In general.--
``(A) Priorities.--Except as provided in
subparagraph (B), the Secretary shall, in
carrying out the activities described in this
section, address the following hazards in the
following priority:
``(i) Bioterrorism or acute
outbreaks of infectious diseases.
``(ii) Other public health threats
and emergencies.
``(B) Determination of the secretary.--In
the case of the hazard involved, the degree of
priority that would apply to the hazard based
on the categories specified in clauses (i) and
(ii) of subparagraph (A) may be modified by the
Secretary if the following conditions are met:
``(i) The Secretary determines that
the modification is appropriate on the
basis of the following factors:
``(I) The extent to which
eligible entities are
adequately prepared for
responding to hazards within
the category specified in
clause (i) of subparagraph (A).
``(II) There has been a
significant change in the
assessment of risks to the
public health posed by hazards
within the category specified
in clause (ii) of such
subparagraph.
``(ii) Prior to modifying the
priority, the Secretary notifies the
appropriate committees of the Congress
of the determination of the Secretary
under clause (i) of this subparagraph.
``(2) Areas of emphasis within categories.--The
Secretary shall determine areas of emphasis within the
category of hazards specified in clause (i) of
paragraph (1)(A), and shall determine areas of emphasis
within the category of hazards specified in clause (ii)
of such paragraph, based on an assessment of the risk
and likely consequences of such hazards and on an
evaluation of Federal, State, and local needs, and may
also take into account the extent to which receiving an
award under subsection (a) will develop capacities that
can be used for public health emergencies of varying
types.
``(h) Coordination With Local Medical Response System.--An
eligible entity and local Metropolitan Medical Response Systems
shall, to the extent practicable, ensure that activities
carried out under an award under subsection (a) are coordinated
with activities that are carried out by local Metropolitan
Medical Response Systems.
``(i) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of fiscal
years 2004 through 2006.''.
(b) Certain Grants.--Section 319C of the Public Health
Service Act (42 U.S.C. 247d-3) is amended by striking
subsection (f).
Subtitle D--Emergency Authorities; Additional Provisions
SEC. 141. REPORTING DEADLINES.
Section 319 of the Public Health Service Act (42 U.S.C.
247d) is amended by adding at the end the following:
``(d) Data Submittal and Reporting Deadlines.--In any case
in which the Secretary determines that, wholly or partially as
a result of a public health emergency that has been determined
pursuant to subsection (a), individuals or public or private
entities are unable to comply with deadlines for the submission
to the Secretary of data or reports required under any law
administered by the Secretary, the Secretary may,
notwithstanding any other provision of law, grant such
extensions of such deadlines as the circumstances reasonably
require, and may waive, wholly or partially, any sanctions
otherwise applicable to such failure to comply. Before or
promptly after granting such an extension or waiver, the
Secretary shall notify the Congress of such action and publish
in the Federal Register a notice of the extension or waiver.''.
SEC. 142. STREAMLINING AND CLARIFYING COMMUNICABLE DISEASE QUARANTINE
PROVISIONS.
(a) Elimination of Prerequisite for National Advisory
Health Council Recommendation Before Issuing Quarantine
Rules.--
(1) Executive orders specifying diseases subject to
individual detentions.--Section 361(b) of the Public
Health Act (42 U.S.C. 264(b)) is amended by striking
``Executive orders of the President upon the
recommendation of the National Advisory Health Council
and the Surgeon General'' and inserting ``Executive
orders of the President upon the recommendation of the
Secretary, in consultation with the Surgeon General,''.
(2) Regulations providing for apprehension of
individuals.--Section 361(d) of the Public Health Act
(42 U.S.C. 264(d)) is amended by striking ``On
recommendation of the National Advisory Health Council,
regulations'' and inserting ``Regulations''.
(3) Regulations providing for apprehension of
individuals in wartime.--Section 363 of the Public
Health Act (42 U.S.C. 266) is amended by striking ``the
Surgeon General, on recommendation of the National
Advisory Health Council,'' and inserting ``the
Secretary, in consultation with the Surgeon General,''.
(b) Apprehension Authority To Apply in Cases of Exposure to
Disease.--
(1) Regulations providing for apprehension of
individuals.--Section 361(d) of the Public Health Act
(42 U.S.C. 264(d)), as amended by subsection (a)(2), is
further amended--
(A) by striking ``(1)'' and ``(2)'' and
inserting ``(A)'' and ``(B)'', respectively;
(B) by striking ``(d)'' and inserting
``(d)(1)'';
(C) in paragraph (1) (as designated by
subparagraph (B) of this paragraph), in the
first sentence, by striking ``in a communicable
stage'' each place such term appears and
inserting ``in a qualifying stage''; and
(D) by adding at the end the following
paragraph:
``(2) For purposes of this subsection, the term `qualifying
stage', with respect to a communicable disease, means that such
disease--
``(A) is in a communicable stage; or
``(B) is in a precommunicable stage, if the disease
would be likely to cause a public health emergency if
transmitted to other individuals.''.
(2) Regulations providing for apprehension of
individuals in wartime.--Section 363 of the Public
Health Act (42 U.S.C. 266), as amended by subsection
(a)(3), is further amended by striking ``in a
communicable stage''.
(c) State Authority.--Section 361 of the Public Health Act
(42 U.S.C. 264) is amended by adding at the end the following:
``(e) Nothing in this section or section 363, or the
regulations promulgated under such sections, may be construed
as superseding any provision under State law (including
regulations and including provisions established by political
subdivisions of States), except to the extent that such a
provision conflicts with an exercise of Federal authority under
this section or section 363.''.
SEC. 143. EMERGENCY WAIVER OF MEDICARE, MEDICAID, AND SCHIP
REQUIREMENTS.
(a) Waiver Authority.--Title XI of the Social Security Act
(42 U.S.C. 1301 et seq.) is amended by inserting after section
1134 the following new section:
``authority to waive requirements during national emergencies
``Sec. 1135. (a) Purpose.--The purpose of this section is
to enable the Secretary to ensure to the maximum extent
feasible, in any emergency area and during an emergency period
(as defined in subsection (g)(1))--
``(1) that sufficient health care items and
services are available to meet the needs of individuals
in such area enrolled in the programs under titles
XVIII, XIX, and XXI; and
``(2) that health care providers (as defined in
subsection (g)(2)) that furnish such items and services
in good faith, but that are unable to comply with one
or more requirements described in subsection (b), may
be reimbursed for such items and services and exempted
from sanctions for such noncompliance, absent any
determination of fraud or abuse.
``(b) Secretarial Authority.--To the extent necessary to
accomplish the purpose specified in subsection (a), the
Secretary is authorized, subject to the provisions of this
section, to temporarily waive or modify the application of,
with respect to health care items and services furnished by a
health care provider (or classes of health care providers) in
any emergency area (or portion of such an area) during any
portion of an emergency period, the requirements of titles
XVIII, XIX, or XXI, or any regulation thereunder (and the
requirements of this title other than this section, and
regulations thereunder, insofar as they relate to such titles),
pertaining to--
``(1)(A) conditions of participation or other
certification requirements for an individual health
care provider or types of providers,
``(B) program participation and similar
requirements for an individual health care provider or
types of providers, and
``(C) pre-approval requirements;
``(2) requirements that physicians and other health
care professionals be licensed in the State in which
they provide such services, if they have equivalent
licensing in another State and are not affirmatively
excluded from practice in that State or in any State a
part of which is included in the emergency area;
``(3) sanctions under section 1867 (relating to
examination and treatment for emergency medical
conditions and women in labor) for a transfer of an
individual who has not been stabilized in violation of
subsection (c) of such section if the transfer arises
out of the circumstances of the emergency;
``(4) sanctions under section 1877(g) (relating to
limitations on physician referral);
``(5) deadlines and timetables for performance of
required activities, except that such deadlines and
timetables may only be modified, not waived; and
``(6) limitations on payments under section 1851(i)
for health care items and services furnished to
individuals enrolled in a Medicare+Choice plan by
health care professionals or facilities not included
under such plan.
Insofar as the Secretary exercises authority under paragraph
(6) with respect to individuals enrolled in a Medicare+Choice
plan, to the extent possible given the circumstances, the
Secretary shall reconcile payments made on behalf of such
enrollees to ensure that the enrollees do not pay more than
would be required had they received services from providers
within the network of the plan and may reconcile payments to
the organization offering the plan to ensure that such
organization pays for services for which payment is included in
the capitation payment it receives under part C of title XVIII.
``(c) Authority for Retroactive Waiver.--A waiver or
modification of requirements pursuant to this section may, at
the Secretary's discretion, be made retroactive to the
beginning of the emergency period or any subsequent date in
such period specified by the Secretary.
``(d) Certification to Congress.--The Secretary shall
provide a certification and advance written notice to the
Congress at least two days before exercising the authority
under this section with respect to an emergency area. Such a
certification and notice shall include--
``(1) a description of--
``(A) the specific provisions that will be
waived or modified;
``(B) the health care providers to whom the
waiver or modification will apply;
``(C) the geographic area in which the
waiver or modification will apply; and
``(D) the period of time for which the
waiver or modification will be in effect; and
``(2) a certification that the waiver or
modification is necessary to carry out the purpose
specified in subsection (a).
``(e) Duration of Waiver.--
``(1) In general.--A waiver or modification of
requirements pursuant to this section terminates upon--
``(A) the termination of the applicable
declaration of emergency or disaster described
in subsection (g)(1)(A);
``(B) the termination of the applicable
declaration of public health emergency
described in subsection (g)(1)(B); or
``(C) subject to paragraph (2), the
termination of a period of 60 days from the
date the waiver or modification is first
published (or, if applicable, the date of
extension of the waiver or modification under
paragraph (2)).
``(2) Extension of 60-day periods.--The Secretary
may, by notice, provide for an extension of a 60-day
period described in paragraph (1)(C) (or an additional
period provided under this paragraph) for additional
period or periods (not to exceed, except as
subsequently provided under this paragraph, 60 days
each), but any such extension shall not affect or
prevent the termination of a waiver or modification
under subparagraph (A) or (B) of paragraph (1).
``(f) Report to Congress.--Within one year after the end of
the emergency period in an emergency area in which the
Secretary exercised the authority provided under this section,
the Secretary shall report to the Congress regarding the
approaches used to accomplish the purposes described in
subsection (a), including an evaluation of such approaches and
recommendations for improved approaches should the need for
such emergency authority arise in the future.
``(g) Definitions.--For purposes of this section:
``(1) Emergency area; emergency period.--An
`emergency area' is a geographical area in which, and
an `emergency period' is the period during which, there
exists--
``(A) an emergency or disaster declared by
the President pursuant to the National
Emergencies Act or the Robert T. Stafford
Disaster Relief and Emergency Assistance Act;
and
``(B) a public health emergency declared by
the Secretary pursuant to section 319 of the
Public Health Service Act.
``(2) Health care provider.--The term `health care
provider' means any entity that furnishes health care
items or services, and includes a hospital or other
provider of services, a physician or other health care
practitioner or professional, a health care facility,
or a supplier of health care items or services.''.
(b) Effective Date.--The amendment made by subsection (a)
shall be effective on and after September 11, 2001.
SEC. 144. PROVISION FOR EXPIRATION OF PUBLIC HEALTH EMERGENCIES.
(a) In General.--Section 319(a) of the Public Health
Service Act (42 U.S.C. 247d(a)), is amended by adding at the
end the following new sentence: ``Any such determination of a
public health emergency terminates upon the Secretary declaring
that the emergency no longer exists, or upon the expiration of
the 90-day period beginning on the date on which the
determination is made by the Secretary, whichever occurs first.
Determinations that terminate under the preceding sentence may
be renewed by the Secretary (on the basis of the same or
additional facts), and the preceding sentence applies to each
such renewal. Not later than 48 hours after making a
determination under this subsection of a public health
emergency (including a renewal), the Secretary shall submit to
the Congress written notification of the determination.''.
(b) Applicability.--The amendment made by subsection (a)
applies to any public health emergency under section 319(a) of
the Public Health Service Act, including any such emergency
that was in effect as of the day before the date of the
enactment of this Act. In the case of such an emergency that
was in effect as of such day, the 90-day period described in
such section with respect to the termination of the emergency
is deemed to begin on such date of enactment.
Subtitle E--Additional Provisions
SEC. 151. DESIGNATED STATE PUBLIC EMERGENCY ANNOUNCEMENT PLAN.
Section 613(b) of the Robert T. Stafford Disaster Relief
and Emergency Assistance Act (42 U.S.C. 5196b(b)) is amended--
(1) in paragraph (5), by striking ``and'' at the
end;
(2) in paragraph (6), by striking the period and
inserting ``; and''; and
(3) by adding at the end the following:
``(7) include a plan for providing information to
the public in a coordinated manner.''.
SEC. 152. EXPANDED RESEARCH BY SECRETARY OF ENERGY.
(a) Detection and Identification Research.--
(1) In general.--In conjunction with the working
group under section 319F(a) of the Public Health
Service Act, the Secretary of Energy and the
Administrator of the National Nuclear Security
Administration shall expand, enhance, and intensify
research relevant to the rapid detection and
identification of pathogens likely to be used in a
bioterrorism attack or other agents that may cause a
public health emergency.
(2) Authorized activities.--Activities carried out
under paragraph (1) may include--
(A) the improvement of methods for
detecting biological agents or toxins of
potential use in a biological attack and the
testing of such methods under variable
conditions;
(B) the improvement or pursuit of methods
for testing, verifying, and calibrating new
detection and surveillance tools and
techniques; and
(C) carrying out other research activities
in relevant areas.
(3) Report.--Not later than 180 days after the date
of the enactment of this Act, the Administrator of the
National Nuclear Security Administration shall submit
to the Committee on Energy and Natural Resources and
the Committee on Armed Services of the Senate, and the
Committee on Energy and Commerce and the Committee on
Armed Services of the House of Representatives, a
report setting forth the programs and projects that
will be funded prior to the obligation of funds
appropriated under subsection (b).
(b) Authorization.--For the purpose of carrying out this
section, there are authorized to be appropriated such sums as
may be necessary in each of fiscal years 2002 through 2006.
SEC. 153. EXPANDED RESEARCH ON WORKER HEALTH AND SAFETY.
The Secretary of Health and Human Services (referred to in
this section as the ``Secretary''), acting through the Director
of the National Institute of Occupational Safety and Health,
shall enhance and expand research as deemed appropriate on the
health and safety of workers who are at risk for bioterrorist
threats or attacks in the workplace, including research on the
health effects of measures taken to treat or protect such
workers for diseases or disorders resulting from a bioterrorist
threat or attack. Nothing in this section may be construed as
establishing new regulatory authority for the Secretary or the
Director to issue or modify any occupational safety and health
rule or regulation.
SEC. 154. ENHANCEMENT OF EMERGENCY PREPAREDNESS OF DEPARTMENT OF
VETERANS AFFAIRS.
(a) Readiness of Department Medical Center.--(1) The
Secretary of Veterans Affairs shall take appropriate actions to
enhance the readiness of Department of Veterans Affairs medical
centers to protect the patients and staff of such centers from
chemical or biological attack or otherwise to respond to such
an attack and so as to enable such centers to fulfil their
obligations as part of the Federal response to public health
emegencies.
(2) Actions under paragraph (1) shall include--
(A) the provision of decontamination equipment and
personal protection equipment at Department medical
centers; and
(B) the provision of training in the use of such
equipment to staff of such centers.
(b) Security at Department Medical and Research
Facilities.--(1) Not later than 180 days after the date of the
enactment of this Act, the Secretary shall carry out an
evaluation of the security needs at Department medical centers
and research facilities. The evaluation shall address the
following needs:
(A) Needs for the protection of patients and
medical staff during emergencies, including a chemical
or biological attack or other terrorist attack.
(B) Needs, if any, for screening personnel engaged
in research relating to biological pathogens or agents,
including work associated with such research.
(C) Needs for securing laboratories or other
facilities engaged in research relating to biological
pathogens or agents.
(D) Any other needs the Secretary considers
appropriate.
(2) The Secretary shall take appropriate actions to enhance
the security of Department medical centers and research
facilities, including staff and patients at such centers and
facilities. In taking such actions, the Secretary shall take
into account the results of the evaluation required by
paragraph (1).
(c) Tracking of Pharmaceuticals and Medical Supplies and
Equipment.--The Secretary shall develop and maintain a
centralized system for tracking the current location and
availability of pharmaceuticals, medical supplies, and medical
equipment throughout the Department health care system in order
to permit the ready identification and utilization of such
pharmaceuticals, supplies, and equipment for a variety of
purposes, including response to a chemical or biological attack
or other terrorist attack.
(d) Training.--The Secretary shall ensure that the
Department medical centers, in consultation with the accredited
medical school affiliates of such medical centers, develop and
implement curricula to train resident physicians and health
care personnel in medical matters relating to biological,
chemical, or radiological attacks.
(e) Participation in National Disaster Medical System.--(1)
The Secretary shall, in consultation with the Secretary of
Defense, the Secretary of Health and Human Services, and the
Director of the Federal Emergency Management Agency, establish
and maintain a training program to facilitate the participation
of the staff of Department medical centers, and of the
community partners of such centers, in the National Disaster
Medical System.
(2) The Secretary shall establish and maintain the training
program under paragraph (1) in accordance with the
recommendations of the working group under section 319F(a) of
the Public Health Service Act.
(f) Mental Health Counseling.--(1) With respect to
activities conducted by personnel serving at Department medical
centers, the Secretary shall, in consultation with the
Secretary of Health and Human Services, the American Red Cross,
and the working group under section 319F(a) of the Public
Health Service Act, develop and maintain various strategies for
providing mental health counseling and assistance, including
counseling and assistance for post-traumatic stress disorder,
to local and community emergency response providers, veterans,
active duty military personnel, and individuals seeking care at
Department medical centers following a bioterrorist attack or
other public health emergency.
(2) The strategies under paragraph (1) shall include the
following:
(A) Training and certification of providers of
mental health counseling and assistance.
(B) Mechanisms for coordinating the provision of
mental health counseling and assistance to emergency
response providers referred to in that paragraph.
(g) Authorization of Appropriations.--There is hereby
authorized to be appropriated for the Department of Veterans
Affairs amounts as follows:
(1) To carry out activities required by subsection
(a)--
(A) $100,000,000 for fiscal year 2002; and
(B) such sums as may be necessary for each
of fiscal years 2003 through 2006.
(2) To carry out activities required by subsections
(b) through (f)--
(A) $33,000,000 for fiscal year 2002; and
(B) such sums as may be necessary for each
of fiscal years 2003 through 2006.
SEC. 155. REAUTHORIZATION OF EXISTING PROGRAM.
Section 582(f) of the Public Health Service Act (42 U.S.C.
290hh-1(f)) is amended by striking ``2002 and 2003'' and
inserting ``2003 through 2006''.
SEC. 156. SENSE OF CONGRESS.
It is the sense of the Congress that--
(1) many excellent university-based programs are
already functioning and developing important biodefense
products and solutions throughout the United States;
(2) accelerating the crucial work done at
university centers and laboratories will contribute
significantly to the United States capacity to defend
against any biological threat or attack;
(3) maximizing the effectiveness of, and extending
the mission of, established university programs would
be one appropriate use of the additional resources
provided for in this Act and the amendments made by
this Act; and
(4) the Secretary of Health and Human Services
should, as appropriate, recognize the importance of
existing public and private university-based research,
training, public awareness, and safety related
biological defense programs when the Secretary makes
awards of grants and contracts in accordance with this
Act and the amendments made by this Act.
SEC. 157. GENERAL ACCOUNTING OFFICE REPORT.
(a) In General.--The Comptroller General shall submit to
the Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate, and to the Committee
on Energy and Commerce and the Committee on Appropriations of
the House of Representatives, a report that describes--
(1) Federal activities primarily related to
research on, preparedness for, and the management of
the public health and medical consequences of a
bioterrorist attack against the civilian population;
(2) the coordination of the activities described in
paragraph (1);
(3) the effectiveness of such efforts in preparing
national, State, and local authorities to address the
public health and medical consequences of a potential
bioterrorist attack against the civilian population;
(4) the activities and costs of the Civil Support
Teams of the National Guard in responding to biological
threats or attacks against the civilian population;
(5) the activities of the working group under
subsection (a) and the efforts made by such group to
carry out the activities described in such subsection;
and
(6) the ability of private sector contractors to
enhance governmental responses to biological threats or
attacks.
SEC. 158. CERTAIN AWARDS.
Section 319(a) of the Public Health Service Act (42 U.S.C.
247d(a)) is amended in the matter after and below paragraph (2)
by striking ``grants and'' and inserting ``grants, providing
awards for expenses, and''
SEC. 159. PUBLIC ACCESS DEFIBRILLATION PROGRAMS AND PUBLIC ACCESS
DEFIBRILLATION DEMONSTRATION PROJECTS.
(a) Short Title.--This section may be cited as the
``Community Access to Emergency Defibrillation Act of 2002''.
(b) Findings.--Congress makes the following findings:
(1) Over 220,000 Americans die each year from
cardiac arrest. Every 2 minutes, an individual goes
into cardiac arrest in the United States.
(2) The chance of successfully returning to a
normal heart rhythm diminishes by 10 percent each
minute following sudden cardiac arrest.
(3) Eighty percent of cardiac arrests are caused by
ventricular fibrillation, for which defibrillation is
the only effective treatment.
(4) Sixty percent of all cardiac arrests occur
outside the hospital. The average national survival
rate for out-of-hospital cardiac arrest is only 5
percent.
(5) Communities that have established and
implemented public access defibrillation programs have
achieved average survival rates for out-of-hospital
cardiac arrest as high as 50 percent.
(6) According to the American Heart Association,
wide use of defibrillators could save as many as 50,000
lives nationally each year.
(7) Successful public access defibrillation
programs ensure that cardiac arrest victims have access
to early 911 notification, early cardiopulmonary
resuscitation, early defibrillation, and early advanced
care.
(c) Public Access Defibrillation Programs and Projects.--
Part B of title III of the Public Health Service Act (42 U.S.C.
243 et seq.), as amended by Public Law 106-310, is amended by
adding after section 311 the following:
``SEC. 312. PUBLIC ACCESS DEFIBRILLATION PROGRAMS.
``(a) In General.--The Secretary shall award grants to
States, political subdivisions of States, Indian tribes, and
tribal organizations to develop and implement public access
defibrillation programs--
``(1) by training and equipping local emergency
medical services personnel, including firefighters,
police officers, paramedics, emergency medical
technicians, and other first responders, to administer
immediate care, including cardiopulmonary resuscitation
and automated external defibrillation, to cardiac
arrest victims;
``(2) by purchasing automated external
defibrillators, placing the defibrillators in public
places where cardiac arrests are likely to occur, and
training personnel in such places to administer
cardiopulmonary resuscitation and automated external
defibrillation to cardiac arrest victims;
``(3) by setting procedures for proper maintenance
and testing of such devices, according to the
guidelines of the manufacturers of the devices;
``(4) by providing training to members of the
public in cardiopulmonary resuscitation and automated
external defibrillation;
``(5) by integrating the emergency medical services
system with the public access defibrillation programs
so that emergency medical services personnel, including
dispatchers, are informed about the location of
automated external defibrillators in their community;
and
``(6) by encouraging private companies, including
small businesses, to purchase automated external
defibrillators and provide training for their employees
to administer cardiopulmonary resuscitation and
external automated defibrillation to cardiac arrest
victims in their community.
``(b) Preference.--In awarding grants under subsection (a),
the Secretary shall give a preference to a State, political
subdivision of a State, Indian tribe, or tribal organization
that--
``(1) has a particularly low local survival rate
for cardiac arrests, or a particularly low local
response rate for cardiac arrest victims; or
``(2) demonstrates in its application the greatest
commitment to establishing and maintaining a public
access defibrillation program.
``(c) Use of Funds.--A State, political subdivision of a
State, Indian tribe, or tribal organization that receives a
grant under subsection (a) may use funds received through such
grant to--
``(1) purchase automated external defibrillators
that have been approved, or cleared for marketing, by
the Food and Drug Administration;
``(2) provide automated external defibrillation and
basic life support training in automated external
defibrillator usage through nationally recognized
courses;
``(3) provide information to community members
about the public access defibrillation program to be
funded with the grant;
``(4) provide information to the local emergency
medical services system regarding the placement of
automated external defibrillators in public places;
``(5) produce materials to encourage private
companies, including small businesses, to purchase
automated external defibrillators; and
``(6) further develop strategies to improve access
to automated external defibrillators in public places.
``(d) Application.--
``(1) In general.--To be eligible to receive a
grant under subsection (a), a State, political
subdivision of a State, Indian tribe, or tribal
organization shall prepare and submit an application to
the Secretary at such time, in such manner, and
containing such information as the Secretary may
reasonably require.
``(2) Contents.--An application submitted under
paragraph (1) shall--
``(A) describe the comprehensive public
access defibrillation program to be funded with
the grant and demonstrate how such program
would make automated external defibrillation
accessible and available to cardiac arrest
victims in the community;
``(B) contain procedures for implementing
appropriate nationally recognized training
courses in performing cardiopulmonary
resuscitation and the use of automated external
defibrillators;
``(C) contain procedures for ensuring
direct involvement of a licensed medical
professional and coordination with the local
emergency medical services system in the
oversight of training and notification of
incidents of the use of the automated external
defibrillators;
``(D) contain procedures for proper
maintenance and testing of the automated
external defibrillators, according to the
labeling of the manufacturer;
``(E) contain procedures for ensuring
notification of local emergency medical
services system personnel, including
dispatchers, of the location and type of
devices used in the public access
defibrillation program; and
``(F) provide for the collection of data
regarding the effectiveness of the public
access defibrillation program to be funded with
the grant in affecting the out-of-hospital
cardiac arrest survival rate.
``(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $25,000,000 for fiscal year 2003, and such sums as
may be necessary for each of the fiscal years 2004 through
2006. Not more than 10 percent of amounts received under a
grant awarded under this section may be used for administrative
expenses.
``SEC. 313. PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.
``(a) In General.--The Secretary shall award grants to
political subdivisions of States, Indian tribes, and tribal
organizations to develop and implement innovative,
comprehensive, community-based public access defibrillation
demonstration projects that--
``(1) provide cardiopulmonary resuscitation and
automated external defibrillation to cardiac arrest
victims in unique settings;
``(2) provide training to community members in
cardiopulmonary resuscitation and automated external
defibrillation; and
``(3) maximize community access to automated
external defibrillators.
``(b) Use of Funds.--A recipient of a grant under
subsection (a) shall use the funds provided through the grant
to--
``(1) purchase automated external defibrillators
that have been approved, or cleared for marketing, by
the Food and Drug Administration;
``(2) provide basic life training in automated
external defibrillator usage through nationally
recognized courses;
``(3) provide information to community members
about the public access defibrillation demonstration
project to be funded with the grant;
``(4) provide information to the local emergency
medical services system regarding the placement of
automated external defibrillators in the unique
settings; and
``(5) further develop strategies to improve access
to automated external defibrillators in public places.
``(c) Application.--
``(1) In general.--To be eligible to receive a
grant under subsection (a), a political subdivision of
a State, Indian tribe, or tribal organization shall
prepare and submit an application to the Secretary at
such time, in such manner, and containing such
information as the Secretary may reasonably require.
``(2) Contents.--An application submitted under
paragraph (1) may--
``(A) describe the innovative,
comprehensive, community-based public access
defibrillation demonstration project to be
funded with the grant;
``(B) explain how such public access
defibrillation demonstration project represents
innovation in providing public access to
automated external defibrillation; and
``(C) provide for the collection of data
regarding the effectiveness of the
demonstration project to be funded with the
grant in--
``(i) providing emergency
cardiopulmonary resuscitation and
automated external defibrillation to
cardiac arrest victims in the setting
served by the demonstration project;
and
``(ii) affecting the cardiac arrest
survival rate in the setting served by
the demonstration project.
``(d) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $5,000,000 for
each of fiscal years 2002 through 2006. Not more than 10
percent of amounts received under a grant awarded under this
section may be used for administrative expenses.''.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Subtitle A--Department of Health and Human Services
SEC. 201. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.
(a) Biological Agents Provisions of the Antiterrorism and
Effective Death Penalty Act of 1996; Codification in the Public
Health Service Act, With Amendments.--Subpart 1 of part F of
title III of the Public Health Service Act (42 U.S.C. 262 et
seq.) is amended by inserting after section 351 the following:
``SEC. 351A. ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS AND
TOXINS.
``(a) Regulatory Control of Certain Biological Agents and
Toxins.--
``(1) List of biological agents and toxins.--
``(A) In general.--The Secretary shall by
regulation establish and maintain a list of
each biological agent and each toxin that has
the potential to pose a severe threat to public
health and safety.
``(B) Criteria.--In determining whether to
include an agent or toxin on the list under
subparagraph (A), the Secretary shall--
``(i) consider--
``(I) the effect on human
health of exposure to the agent
or toxin;
``(II) the degree of
contagiousness of the agent or
toxin and the methods by which
the agent or toxin is
transferred to humans;
``(III) the availability
and effectiveness of
pharmacotherapies and
immunizations to treat and
prevent any illness resulting
from infection by the agent or
toxin; and
``(IV) any other criteria,
including the needs of children
and other vulnerable
populations, that the Secretary
considers appropriate; and
``(ii) consult with appropriate
Federal departments and agencies and
with scientific experts representing
appropriate professional groups,
including groups with pediatric
expertise.
``(2) Biennial review.--The Secretary shall review
and republish the list under paragraph (1) biennially,
or more often as needed, and shall by regulation revise
the list as necessary in accordance with such
paragraph.
``(b) Regulation of Transfers of Listed Agents and
Toxins.--The Secretary shall by regulation provide for--
``(1) the establishment and enforcement of safety
procedures for the transfer of listed agents and
toxins, including measures to ensure--
``(A) proper training and appropriate
skills to handle such agents and toxins; and
``(B) proper laboratory facilities to
contain and dispose of such agents and toxins;
``(2) the establishment and enforcement of
safeguard and security measures to prevent access to
such agents and toxins for use in domestic or
international terrorism or for any other criminal
purpose;
``(3) the establishment of procedures to protect
the public safety in the event of a transfer or
potential transfer of such an agent or toxin in
violation of the safety procedures established under
paragraph (1) or the safeguard and security measures
established under paragraph (2); and
``(4) appropriate availability of biological agents
and toxins for research, education, and other
legitimate purposes.
``(c) Possession and Use of Listed Agents and Toxins.--The
Secretary shall by regulation provide for the establishment and
enforcement of standards and procedures governing the
possession and use of listed agents and toxins, including the
provisions described in paragraphs (1) through (4) of
subsection (b), in order to protect the public health and
safety.
``(d) Registration; Identification; Database.--
``(1) Registration.--Regulations under subsections
(b) and (c) shall require registration with the
Secretary of the possession, use, and transfer of
listed agents and toxins, and shall include provisions
to ensure that persons seeking to register under such
regulations have a lawful purpose to possess, use, or
transfer such agents and toxins, including provisions
in accordance with subsection (e)(6).
``(2) Identification; database.--Regulations under
subsections (b) and (c) shall require that registration
include (if available to the person registering)
information regarding the characterization of listed
agents and toxins to facilitate their identification,
including their source. The Secretary shall maintain a
national database that includes the names and locations
of registered persons, the listed agents and toxins
such persons are possessing, using, or transferring,
and information regarding the characterization of such
agents and toxins.
``(e) Safeguard and Security Requirements for Registered
Persons.--
``(1) In general.--Regulations under subsections
(b) and (c) shall include appropriate safeguard and
security requirements for persons possessing, using, or
transferring a listed agent or toxin commensurate with
the risk such agent or toxin poses to public health and
safety (including the risk of use in domestic or
international terrorism). The Secretary shall establish
such requirements in consultation with the Attorney
General, and shall ensure compliance with such
requirements as part of the registration system under
such regulations.
``(2) Limiting access to listed agents and
toxins.--Requirements under paragraph (1) shall include
provisions to ensure that registered persons--
``(A) provide access to listed agents and
toxins to only those individuals whom the
registered person involved determines have a
legitimate need to handle or use such agents
and toxins;
``(B) submit the names and other
identifying information for such individuals to
the Secretary and the Attorney General,
promptly after first determining that the
individuals need access under subparagraph (A),
and periodically thereafter while the
individuals have such access, not less
frequently than once every five years;
``(C) deny access to such agents and toxins
by individuals whom the Attorney General has
identified as restricted persons; and
``(D) limit or deny access to such agents
and toxins by individuals whom the Attorney
General has identified as within any category
under paragraph (3)(B)(ii), if limiting or
denying such access by the individuals involved
is determined appropriate by the Secretary, in
consultation with the Attorney General.
``(3) Submitted names; use of databases by attorney
general.--
``(A) In general.--Upon the receipt of
names and other identifying information under
paragraph (2)(B), the Attorney General shall,
for the sole purpose of identifying whether the
individuals involved are within any of the
categories specified in subparagraph (B),
promptly use criminal, immigration, national
security, and other electronic databases that
are available to the Federal Government and are
appropriate for such purpose.
``(B) Certain individuals.--For purposes of
subparagraph (A), the categories specified in
this subparagraph regarding an individual are
that--
``(i) the individual is a
restricted person; or
``(ii) the individual is reasonably
suspected by any Federal law
enforcement or intelligence agency of--
``(I) committing a crime
set forth in section
2332b(g)(5) of title 18, United
States Code;
``(II) knowing involvement
with an organization that
engages in domestic or
international terrorism (as
defined in section 2331 of such
title 18) or with any other
organization that engages in
intentional crimes of violence;
or
``(III) being an agent of a
foreign power (as defined in
section 1801 of title 50,
United States Code).
``(C) Notification by attorney general
regarding submitted names.--After the receipt
of a name and other identifying information
under paragraph (2)(B), the Attorney General
shall promptly notify the Secretary whether the
individual is within any of the categories
specified in subparagraph (B).
``(4) Notifications by secretary.--The Secretary,
after receiving notice under paragraph (3) regarding an
individual, shall promptly notify the registered person
involved of whether the individual is granted or denied
access under paragraph (2). If the individual is denied
such access, the Secretary shall promptly notify the
individual of the denial.
``(5) Expedited review.--Regulations under
subsections (b) and (c) shall provide for a procedure
through which, upon request to the Secretary by a
registered person who submits names and other
identifying information under paragraph (2)(B) and who
demonstrates good cause, the Secretary may, as
determined appropriate by the Secretary--
``(A) request the Attorney General to
expedite the process of identification under
paragraph (3)(A) and notification of the
Secretary under paragraph (3)(C); and
``(B) expedite the notification of the
registered person by the Secretary under
paragraph (4).
``(6) Process regarding persons seeking to
register.--
``(A) Individuals.--Regulations under
subsections (b) and (c) shall provide that an
individual who seeks to register under either
of such subsections is subject to the same
processes described in paragraphs (2) through
(4) as apply to names and other identifying
information submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph.
``(B) Other persons.--Regulations under
subsections (b) and (c) shall provide that, in
determining whether to deny or revoke
registration by a person other than an
individual, the Secretary shall submit the name
of such person to the Attorney General, who
shall use criminal, immigration, national
security, and other electronic databases
available to the Federal Government, as
appropriate for the purpose of promptly
notifying the Secretary whether the person, or,
where relevant, the individual who owns or
controls such person, is a restricted person or
is reasonably suspected by any Federal law
enforcement or intelligence agency of being
within any category specified in paragraph
(3)(B)(ii) (as applied to persons, including
individuals). Such regulations shall provide
that a person who seeks to register under
either of such subsections is subject to the
same processes described in paragraphs (2) and
(4) as apply to names and other identifying
information submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph. The
Secretary may exempt Federal, State, or local
governmental agencies from the requirements of
this subparagraph.
``(7) Review.--
``(A) Administrative review.--
``(i) In general.--Regulations
under subsections (b) and (c) shall
provide for an opportunity for a review
by the Secretary--
``(I) when requested by the
individual involved, of a
determination under paragraph
(2) to deny the individual
access to listed agents and
toxins; and
``(II) when requested by
the person involved, of a
determination under paragraph
(6) to deny or revoke
registration for such person.
``(ii) Ex parte review.--During a
review under clause (i), the Secretary
may consider information relevant to
the review ex parte to the extent that
disclosure of the information could
compromise nationalsecurity or an
investigation by any law enforcement agency.
``(iii) Final agency action.--The
decision of the Secretary in a review
under clause (i) constitutes final
agency action for purposes of section
702 of title 5, United States Code.
``(B) Certain procedures.--
``(i) Submission of ex parte
materials in judicial proceedings.--
When reviewing a decision of the
Secretary under subparagraph (A), and
upon request made ex parte and in
writing by the United States, a court,
upon a sufficient showing, may review
and consider ex parte documents
containing information the disclosure
of which could compromise national
security or an investigation by any law
enforcement agency. If the court
determines that portions of the
documents considered ex parte should be
disclosed to the person involved to
allow a response, the court shall
authorize the United States to delete
from such documents specified items of
information the disclosure of which
could compromise national security or
an investigation by any law enforcement
agency, or to substitute a summary of
the information to which the person may
respond. Any order by the court
authorizing the disclosure of
information that the United States
believes could compromise national
security or an investigation by any law
enforcement agency shall be subject to
the processes set forth in
subparagraphs (A) and (B)(i) of section
2339B(f)(5) of title 18, United States
Code (relating to interlocutory appeal
and expedited consideration).
``(ii) Disclosure of information.--
In a review under subparagraph (A), and
in any judical proceeding conducted
pursuant to such review, neither the
Secretary nor the Attorney General may
be required to disclose to the public
any information that under subsection
(h) shall not be disclosed under
section 552 of title 5, United States
Code.
``(8) Notifications regarding theft or loss of
agents.--Requirements under paragraph (1) shall include
the prompt notification of the Secretary, and
appropriate Federal, State, and local law enforcement
agencies, of the theft or loss of listed agents and
toxins.
``(9) Technical assistance for registered
persons.--The Secretary, in consultation with the
Attorney General, may provide technical assistance to
registered persons to improve security of the
facilities of such persons.
``(f) Inspections.--The Secretary shall have the authority
to inspect persons subject to regulations under subsection (b)
or (c) to ensure their compliance with such regulations,
including prohibitions on restricted persons and other
provisions of subsection (e).
``(g) Exemptions.--
``(1) Clinical or diagnostic laboratories.--
Regulations under subsections (b) and (c) shall exempt
clinical or diagnostic laboratories and other persons
who possess, use, or transfer listed agents or toxins
that are contained in specimens presented for
diagnosis, verification, or proficiency testing,
provided that--
``(A) the identification of such agents or
toxins is reported to the Secretary, and when
required under Federal, State, or local law, to
other appropriate authorities; and
``(B) such agents or toxins are transferred
or destroyed in a manner set forth by the
Secretary by regulation.
``(2) Products.--
``(A) In general.--Regulations under
subsections (b) and (c) shall exempt products
that are, bear, or contain listed agents or
toxins and are cleared, approved, licensed, or
registered under any of the Acts specified in
subparagraph (B), unless the Secretary by order
determines that applying additional regulation
under subsection (b) or (c) to a specific
product is necessary to protect public health
and safety.
``(B) Relevant laws.--For purposes of
subparagraph (A), the Acts specified in this
subparagraph are the following:
``(i) The Federal Food, Drug, and
Cosmetic Act.
``(ii) Section 351 of this Act.
``(iii) The Act commonly known as
the Virus-Serum-Toxin Act (the eighth
paragraph under the heading `Bureau of
Animal Industry' in the Act of March 4,
1913; 21 U.S.C. 151-159).
``(iv) The Federal Insecticide,
Fungicide, and Rodenticide Act.
``(C) Investigational use.--
``(i) In general.--The Secretary
may exempt an investigational product
that is, bears, or contains a listed
agent or toxin from the applicability
of provisions of regulations under
subsection (b) or (c) when such product
is being used in an investigation
authorized under any Federal Act and
the Secretary determines that applying
additional regulation under subsection
(b) or (c) to such product is not
necessary to protect public health and
safety.
``(ii) Certain processes.--
Regulations under subsections (b) and
(c) shall set forth the procedures for
applying for an exemption under clause
(i). In the case of investigational
products authorized under any of the
Acts specified in subparagraph (B), the
Secretary shall make a determination
regarding a request for an exemption
not later than 14 days after the first
date on which both of the following
conditions have been met by the person
requesting the exemption:
``(I) The person has
submitted to the Secretary an
application for the exemption
meeting the requirements
established by the Secretary.
``(II) The person has
notified the Secretary that the
investigation has been
authorized under such an Act.
``(3) Public health emergencies.--The Secretary may
temporarily exempt a person from the applicability of
the requirements of this section, in whole or in part,
if the Secretary determines that such exemption is
necessary to provide for the timely participation of
the person in a response to a domestic or foreign
public health emergency (whether determined under
section 319(a) or otherwise) that involves a listed
agent or toxin. With respect to the emergency involved,
such exemption for a person may not exceed 30 days,
except that the Secretary, after review of whether such
exemption remains necessary, may provide one extension
of an additional 30 days.
``(4) Agricultural emergencies.--Upon request of
the Secretary of Agriculture, after the granting by
such Secretary of an exemption under section
212(g)(1)(D) of the Agricultural Bioterrorism
Protection Act of 2002 pursuant to a finding that there
is an agricultural emergency, the Secretary of Health
and Human Services may temporarily exempt a person from
the applicability of the requirements of this section,
in whole or in part, to provide for the timely
participation of the person in a response to the
agricultural emergency. With respect to the emergency
involved, the exemption under this paragraph for a
person may not exceed 30 days, except that upon request
of the Secretary of Agriculture, the Secretary of
Health and Human Services may, after review of whether
such exemption remains necessary, provide one extension
of an additional 30 days.
``(h) Disclosure of Information.--
``(1) Nondisclosure of certain information.--No
Federal agency specified in paragraph (2) shall
disclose under section 552 of title 5, United States
Code, any of the following:
``(A) Any registration or transfer
documentation submitted under subsections (b)
and (c) for the possession, use, or transfer of
a listed agent or toxin; or information derived
therefrom to the extent that it identifies the
listed agent or toxin possessed, used, or
transferred by a specific registered person or
discloses the identity or location of a
specific registered person.
``(B) The national database developed
pursuant to subsection (d), or any other
compilation of the registration or transfer
information submitted under subsections (b) and
(c) to the extent that such compilation
discloses site-specific registration or
transfer information.
``(C) Any portion of a record that
discloses the site-specific or transfer-
specific safeguard and security measures used
by a registered person to prevent unauthorized
access to listed agents and toxins.
``(D) Any notification of a release of a
listed agent or toxin submitted under
subsections (b) and (c), or any notification of
theft or loss submitted under such subsections.
``(E) Any portion of an evaluation or
report of an inspection of a specific
registered person conducted under subsection
(f) that identifies the listed agent or toxin
possessed by a specific registered person or
that discloses the identity or location of a
specific registered person if the agency
determines that public disclosure of the
information would endanger public health or
safety.
``(2) Covered agencies.--For purposes of paragraph
(1) only, the Federal agencies specified in this
paragraph are the following:
``(A) The Department of Health and Human
Services, the Department of Justice, the
Department of Agriculture, and the Department
of Transportation.
``(B) Any Federal agency to which
information specified in paragraph (1) is
transferred by any agency specified in
subparagraph (A) of this paragraph.
``(C) Any Federal agency that is a
registered person, or has a sub-agency
component that is a registered person.
``(D) Any Federal agency that awards grants
or enters into contracts or cooperative
agreements involving listed agents and toxins
to or with a registered person, and to which
information specified in paragraph (1) is
transferred by any such registered person.
``(3) Other exemptions.--This subsection may not be
construed as altering the application of any exemptions
to public disclosure under section 552 of title 5,
United States Code, except as to subsection 552(b)(3)
of such title, to any of the information specified in
paragraph (1).
``(4) Rule of construction.--Except as specifically
provided in paragraph (1), this subsection may not be
construed as altering the authority of any Federal
agency to withhold under section 552 of title 5, United
States Code, or the obligation of any Federal agency to
disclose under section 552 of title 5, United States
Code, any information, including information relating
to--
``(A) listed agents and toxins, or
individuals seeking access to such agents and
toxins;
``(B) registered persons, or persons
seeking to register their possession, use, or
transfer of such agents and toxins;
``(C) general safeguard and security
policies and requirements under regulations
under subsections (b) and (c); or
``(D) summary or statistical information
concerning registrations, registrants, denials
or revocations of registrations, listed agents
and toxins, inspection evaluations and reports,
or individuals seeking access to such agents
and toxins.
``(5) Disclosures to congress; other disclosures.--
This subsection may not be construed as providing any
authority--
``(A) to withhold information from the
Congress or any committee or subcommittee
thereof; or
``(B) to withhold information from any
person under any other Federal law or treaty.
``(i) Civil Money Penalty.--
``(1) In general.--In addition to any other
penalties that may apply under law, any person who
violates any provision of regulations under subsection
(b) or (c) shall be subject to the United States for a
civil money penalty in an amount not exceeding $250,000
in the case of an individual and $500,000 in the case
of any other person.
``(2) Applicability of certain provisions.--The
provisions of section 1128A of the Social Security Act
(other than subsections (a), (b), (h), and (i), the
first sentence of subsection (c), and paragraphs (1)
and (2) of subsection (f)) shall apply to a civil money
penalty under paragraph (1) in the same manner as such
provisions apply to a penalty or proceeding under
section 1128A(a) of such Act. The Secretary may
delegate authority under this subsection in the same
manner as provided in section 1128A(j)(2) of the Social
Security Act, and such authority shall include all
powers as contained in section 6 of the Inspector
General Act of 1978 (5 U.S.C. App.).
``(j) Notification in Event of Release.--Regulations under
subsections (b) and (c) shall require the prompt notification
of the Secretary by a registered person whenever a release,
meeting criteria established by the Secretary, of a listed
agent or toxin has occurred outside of the biocontainment area
of a facility of the registered person. Upon receipt of such
notification and a finding by the Secretary that the release
poses a threat to public health or safety, the Secretary shall
take appropriate action to notify relevant State and local
public health authorities, other relevant Federal authorities,
and, if necessary, other appropriate persons (including the
public). If the released listed agent or toxin is an overlap
agent or toxin (as defined in subsection (l)), the Secretary
shall promptly notify the Secretary of Agriculture upon
notification by the registered person.
``(k) Reports.--The Secretary shall report to the Congress
annually on the number and nature of notifications received
under subsection (e)(8) (relating to theft or loss) and
subsection (j) (relating to releases).
``(l) Definitions.--For purposes of this section:
``(1) The terms `biological agent' and `toxin' have
the meanings given such terms in section 178 of title
18, United States Code.
``(2) The term `listed agents and toxins' means
biological agents and toxins listed pursuant to
subsection (a)(1).
``(3) The term `listed agents or toxins' means
biological agents or toxins listed pursuant to
subsection (a)(1).
``(4) The term `overlap agents and toxins' means
biological agents and toxins that--
``(A) are listed pursuant to subsection
(a)(1); and
``(B) are listed pursuant to section
212(a)(1) of the Agricultural Bioterrorism
Protection Act of 2002.
``(5) The term `overlap agent or toxin' means a
biological agent or toxin that--
``(A) is listed pursuant to subsection
(a)(1); and
``(B) is listed pursuant to section
212(a)(1) of the Agricultural Bioterrorism
Protection Act of 2002.
``(6) The term `person' includes Federal, State,
and local governmental entities.
``(7) The term `registered person' means a person
registered under regulations under subsection (b) or
(c).
``(8) The term `restricted person' has the meaning
given such term in section 175b of title 18, United
States Code.
``(m) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2007.''.
(b) Report to Congress.--Not later than one year after the
date of the enactment of this Act, the Secretary of Health and
Human Services, after consultation with other appropriate
Federal agencies, shall submit to the Congress a report that--
(1) describes the extent to which there has been
compliance by governmental and private entities with
applicable regulations under section 351A of the Public
Health Service Act (as added by subsection (a) of this
section), including the extent of compliance before the
date of the enactment of this Act, and including the
extent of compliance with regulations promulgated after
such date of enactment;
(2) describes the actions to date and future plans
of the Secretary for updating the list of biological
agents and toxins under such section 351A;
(3) describes the actions to date and future plans
of the Secretary for determining compliance with
regulations under such section 351A and for taking
appropriate enforcement actions;
(4) evaluates the impact of such section 351A on
research on biological agents and toxins listed
pursuant to such section; and
(5) provides any recommendations of the Secretary
for administrative or legislative initiatives regarding
such section 351A.
SEC. 202. IMPLEMENTATION BY DEPARTMENT OF HEALTH AND HUMAN SERVICES.
(a) Date Certain for Notice of Possession.--Not later than
90 days after the date of the enactment of this Act, all
persons (unless exempt under subsection (g) of section 351A of
the Public Health Service Act, as added by section 201 of this
Act) in possession of biological agents or toxins listed under
such section 351A of the Public Health Service Act shall notify
the Secretary of Health and Human Services of such possession.
Not later than 30 days after such date of enactment, the
Secretary shall provide written guidance on how such notice is
to be provided to the Secretary.
(b) Date Certain for Promulgation; Effective Date Regarding
Criminal and Civil Penalties.--Not later than 180 days after
the date of the enactment of this Act, the Secretary of Health
and Human Services shall promulgate an interim final rule for
carrying out section 351A of the Public Health Service Act,
subject to subsection (c). Such interim final rule shall take
effect 60 days after the date on which such rule is
promulgated, including for purposes of--
(1) section 175b(c) of title 18, United States Code
(relating to criminal penalties), as added by section
231(a)(5) of this Act; and
(2) section 351A(i) of the Public Health Service
Act (relating to civil penalties).
(c) Transitional Provision Regarding Current Research and
Education.--The interim final rule under subsection (b) shall
include time frames for the applicability of the rule that
minimize disruption of research or educational projects that
involve biological agents and toxins listed pursuant to section
351A(a)(1) of the Public Health Service Act and that were
underway as of the effective date of such rule.
SEC. 203. EFFECTIVE DATES.
(a) In General.--Regulations promulgated by the Secretary
of Health and Human Services under section 511 of the
Antiterrorism and Effective Death Penalty Act of 1996 are
deemed to have been promulgated under section 351A of the
Public Health Service Act, as added by section 201 of this Act.
Such regulations, including the list under subsection (d)(1) of
such section 511, that were in effect on the day before the
date of the enactment of this Act remain in effect until
modified by the Secretary in accordance with such section 351A
and with section 202 of this Act.
(b) Effective Date Regarding Disclosure of Information.--
Subsection (h) of section 351A of the Public Health Service
Act, as added by section 201 of this Act, is deemed to have
taken effect on the effective date of the Antiterrorism and
Effective Death Penalty Act of 1996.
SEC. 204. CONFORMING AMENDMENT.
Subsections (d), (e), (f), and (g) of section 511 of the
Antiterrorism and Effective Death Penalty Act of 1996 (42
U.S.C. 262 note) are repealed.
Subtitle B--Department of Agriculture
SEC. 211. SHORT TITLE.
This subtitle may be cited as the ``Agricultural
Bioterrorism Protection Act of 2002''.
SEC. 212. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.
(a) Regulatory Control of Certain Biological Agents and
Toxins.--
(1) List of biological agents and toxins.--
(A) In general.--The Secretary of
Agriculture shall by regulation establish and
maintain a list of each biological agent and
each toxin that the Secretary determines has
the potential to pose a severe threat to animal
or plant health, or to animal or plant
products.
(B) Criteria.--In determining whether to
include an agent or toxin on the list under
subparagraph (A), the Secretary shall--
(i) consider--
(I) the effect of exposure
to the agent or toxin on animal
or plant health, and on the
production and marketability of
animal or plant products;
(II) the pathogenicity of
the agent or the toxicity of
the toxin and the methods by
which the agent or toxin is
transferred to animals or
plants;
(III) the availability and
effectiveness of
pharmacotherapies and
prophylaxis to treat and
prevent any illness caused by
the agent or toxin; and
(IV) any other criteria
that the Secretary considers
appropriate to protect animal
or plant health, or animal or
plant products; and
(ii) consult with appropriate
Federal departments and agencies and
with scientific experts representing
appropriate professional groups.
(2) Biennial review.--The Secretary shall review
and republish the list under paragraph (1) biennially,
or more often as needed, and shall by regulation revise
the list as necessary in accordance with such
paragraph.
(b) Regulation of Transfers of Listed Agents and Toxins.--
The Secretary shall by regulation provide for--
(1) the establishment and enforcement of safety
procedures for the transfer of listed agents and
toxins, including measures to ensure--
(A) proper training and appropriate skills
to handle such agents and toxins; and
(B) proper laboratory facilities to contain
and dispose of such agents and toxins;
(2) the establishment and enforcement of safeguard
and security measures to prevent access to such agents
and toxins for use in domestic or international
terrorism or for any other criminal purpose;
(3) the establishment of procedures to protect
animal and plant health, and animal and plant products,
in the event of a transfer or potential transfer of
such an agent or toxin in violation of the safety
procedures established under paragraph (1) or the
safeguard and security measures established under
paragraph (2); and
(4) appropriate availability of biological agents
and toxins for research, education, and other
legitimate purposes.
(c) Possession and Use of Listed Agents and Toxins.--The
Secretary shall by regulation provide for the establishment and
enforcement of standards and procedures governing the
possession and use of listed agents and toxins, including the
provisions described in paragraphs (1) through (4) of
subsection (b), in order to protect animal and plant health,
and animal and plant products.
(d) Registration; Identification; Database.--
(1) Registration.--Regulations under subsections
(b) and (c) shall require registration with the
Secretary of the possession, use, and transfer of
listed agents and toxins, and shall include provisions
to ensure that persons seeking to register under such
regulations have a lawful purpose to possess, use, or
transfer such agents and toxins, including provisions
in accordance with subsection (e)(6).
(2) Identification; database.--Regulations under
subsections (b) and (c) shall require that registration
include (if available to the person registering)
information regarding the characterization of listed
agents and toxins to facilitate their identification,
including their source. The Secretary shall maintain a
national database that includes the names and locations
of registered persons, the listed agents and toxins
such persons are possessing, using, or transferring,
and information regarding the characterization of such
agents and toxins.
(e) Safeguard and Security Requirements for Registered
Persons.--
(1) In general.--Regulations under subsections (b)
and (c) shall include appropriate safeguard and
security requirements for persons possessing, using, or
transferring a listed agent or toxin commensurate with
the risk such agent or toxin poses to animal and plant
health, and animal and plant products (including the
risk of use in domestic or international terrorism).
The Secretary shall establish such requirements in
consultation with the Attorney General, and shall
ensure compliance with such requirements as part of the
registration system under such regulations.
(2) Limiting access to listed agents and toxins.--
Requirements under paragraph (1) shall include
provisions to ensure that registered persons--
(A) provide access to listed agents and
toxins to only those individuals whom the
registered person involved determines have a
legitimate need to handle or use such agents
and toxins;
(B) submit the names and other identifying
information for such individuals to the
Secretary and the Attorney General, promptly
after first determining that the individuals
need access under subparagraph (A), and
periodically thereafter while the individuals
have such access, not less frequently than once
every five years; and
(C)(i) in the case of listed agents and
toxins that are not overlap agents and toxins
(as defined in subsection (g)(1)(A)(ii)), limit
or deny access to such agents and toxins by
individuals whom the Attorney General has
identified as within any category under
paragraph (3)(B), if limiting or denying such
access by the individuals involved is
determined appropriate by the Secretary, in
consultation with the Attorney General; and
(ii) in the case of listed agents and
toxins that are overlap agents--
(I) deny access to such
agents and toxins by
individuals whom the Attorney
General has identified as
within any category referred to
in paragraph (3)(B)(i); and
(II) limit or deny access
to such agents and toxins by
individuals whom the Attorney
General has identified as
within any category under
paragraph (3)(B)(ii), if
limiting or denying such access
by the individuals involved is
determined appropriate by the
Secretary, in consultation with
the Attorney General.
(3) Submitted names; use of databases by attorney
general.--
(A) In general.--Upon the receipt of names
and other identifying information under
paragraph (2)(B), the Attorney General shall,
for the sole purpose of identifying whether the
individuals involved are within any of the
categories specified in subparagraph (B),
promptly use criminal, immigration, national
security, and other electronic databases that
are available to the Federal Government and are
appropriate for such purpose.
(B) Certain individuals.--For purposes of
subparagraph (A), the categories specified in
this subparagraph regarding an individual are
that--
(i) the individual is within any of
the categories described in section
175b(d)(1) of title 18, United States
Code (relating to restricted persons);
or
(ii) the individual is reasonably
suspected by any Federal law
enforcement or intelligence agency of--
(I) committing a crime set
forth in section 2332b(g)(5) of
title 18, United States Code;
(II) knowing involvement
with an organization that
engages in domestic or
international terrorism (as
defined in section 2331 of such
title 18) or with any other
organization that engages in
intentional crimes of violence;
or
(III) being an agent of a
foreign power (as defined in
section 1801 of title 50,
United States Code).
(C) Notification by attorney general
regarding submitted names.--After the receipt
of a name and other identifying information
under paragraph (2)(B), the Attorney General
shall promptly notify the Secretary whether the
individual is within any of the categories
specified in subparagraph (B).
(4) Notifications by secretary.--The Secretary,
after receiving notice under paragraph (3) regarding an
individual, shall promptly notify the registered person
involved of whether the individual is granted or denied
access under paragraph (2). If the individual is denied
such access, the Secretary shall promptly notify the
individual of the denial.
(5) Expedited review.--Regulations under
subsections (b) and (c) shall provide for a procedure
through which, upon request to the Secretary by a
registered person who submits names and other
identifying information under paragraph (2)(B) and who
demonstrates good cause, the Secretary may, as
determined appropriate by the Secretary--
(A) request the Attorney General to
expedite the process of identification under
paragraph (3)(A) and notification of the
Secretary under paragraph (3)(C); and
(B) expedite the notification of the
registered person by the Secretary under
paragraph (4).
(6) Process regarding persons seeking to
register.--
(A) Individuals.--Regulations under
subsections (b) and (c) shall provide that an
individual who seeks to register under either
of such subsections is subject to the same
processes described in paragraphs (2) through
(4) as apply to names and other identifying
information submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph.
(B) Other persons.--Regulations under
subsections (b) and (c) shall provide that, in
determining whether to deny or revoke
registration by a person other than an
individual, the Secretary shall submit the name
of such person to the Attorney General, who
shall use criminal, immigration, national
security, and other electronic databases
available to the Federal Government, as
appropriate for the purpose of promptly
notifying the Secretary whether the person, or,
where relevant, the individual who owns or
controls such person, is within any of the
categories described in section 175b(d)(1) of
title 18, United States Code (relating to
restricted persons), or is reasonably suspected
by any Federal law enforcement or intelligence
agency of being within any category specified
in paragraph (3)(B)(ii) (as applied to persons,
including individuals). Such regulations shall
provide that a person who seeks to register
under either of such subsections is subject to
the same processes described in paragraphs (2)
and (4) as apply to names and other identifying
information submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph. The
Secretary may exempt Federal, State, or local
governmental agencies from the requirements of
this subparagraph.
(7) Review.--
(A) Administrative review.--
(i) In general.--Regulations under
subsections (b) and (c) shall provide
for an opportunity for a review by the
Secretary--
(I) when requested by the
individual involved, of a
determination under paragraph
(2) to deny the individual
access to listed agents and
toxins; and
(II) when requested by the
person involved, of a
determination under paragraph
(6) to deny or revoke
registration for such person.
(ii) Ex parte review.--During a
review under clause (i), the Secretary
may consider information relevant to
the review ex parte to the extent that
disclosure of the information could
compromise national security or an
investigation by any law enforcement
agency.
(iii) Final agency action.--The
decision of the Secretary in a review
under clause (i) constitutes final
agency action for purposes of section
702 of title 5, United States Code.
(B) Certain procedures.--
(i) Submission of ex parte
materials in judicial proceedings.--
When reviewing a decision of the
Secretary under subparagraph (A), and
upon request made ex parte and in
writing by the United States, a court,
upon a sufficient showing, may review
and consider ex parte documents
containing information the disclosure
of which could compromise national
security or an investigation by any law
enforcement agency. If the court
determines that portions of the
documents considered ex parte should be
disclosed to the person involved to
allow a response, the court shall
authorize the United States to delete
from such documents specified items of
information the disclosure of which
could compromise national security or
an investigation by any law enforcement
agency, or to substitute a summary of
the information to which the person may
respond. Any order by the court
authorizing the disclosure of
information that the United States
believes could compromise national
security or an investigation by any law
enforcement agency shall be subject to
the processes set forth in
subparagraphs (A) and (B)(i) of section
2339B(f)(5) of title 18, United States
Code (relating to interlocutory appeal
and expedited consideration).
(ii) Disclosure of information.--In
a review under subparagraph (A), and in
any judical proceeding conducted
pursuant to such review, neither the
Secretary nor the Attorney General may
be required to disclose to the public
any information that under subsection
(h) shall not be disclosed under
section 552 of title 5, United States
Code.
(8) Notifications regarding theft or loss of
agents.--Requirements under paragraph (1) shall include
the prompt notification of the Secretary, and
appropriate Federal, State, and local law enforcement
agencies, of the theft or loss of listed agents and
toxins.
(9) Technical assistance for registered persons.--
The Secretary, in consultation with the Attorney
General, may provide technical assistance to registered
persons to improve security of the facilities of such
persons.
(f) Inspections.--The Secretary shall have the authority to
inspect persons subject to regulations under subsection (b) or
(c) to ensure their compliance with such regulations, including
prohibitions on restricted persons and other provisions of
subsection (e).
(g) Exemptions.--
(1) Overlap agents and toxins.--
(A) In general.--
(i) Limitation.--In the case of
overlap agents and toxins, exemptions
from the applicability of provisions of
regulations under subsection (b) or (c)
may be granted only to the extent
provided in this paragraph.
(ii) Definitions.--For purposes of
this section:
(I) The term ``overlap
agents and toxins'' means
biological agents and toxins
that--
(aa) are listed
pursuant to subsection
(a)(1); and
(bb) are listed
pursuant to section
315A(a)(1) of the
Public Health Service
Act.
(II) The term ``overlap
agent or toxin'' means a
biological agent or toxin
that--
(aa) is listed
pursuant to subsection
(a)(1); and
(bb) is listed
pursuant to section
315A(a)(1) of the
Public Health Service
Act.
(B) Clinical or diagnostic laboratories.--
Regulations under subsections (b) and (c) shall
exempt clinical or diagnostic laboratories and
other persons who possess, use, or transfer
overlap agents or toxins that are contained in
specimens presented for diagnosis,
verification, or proficiency testing, provided
that--
(i) the identification of such
agents or toxins is reported to the
Secretary, and when required under
Federal, State, or local law, to other
appropriate authorities; and
(ii) such agents or toxins are
transferred or destroyed in a manner
set forth by the Secretary by
regulation.
(C) Products.--
(i) In general.--Regulations under
subsections (b) and (c) shall exempt
products that are, bear, or contain
overlap agents or toxins and are
cleared, approved, licensed, or
registered under any of the Acts
specified in clause (ii), unless the
Secretary by order determines that
applying additional regulation under
subsection (b) or (c) to a specific
product is necessary to protect animal
or plant health, or animal or plant
products.
(ii) Relevant laws.--For purposes
of clause (i), the Acts specified in
this clause are the following:
(I) The Federal Food, Drug,
and Cosmetic Act.
(II) Section 351 of the
Public Health Service Act.
(III) The Act commonly
known as the Virus-Serum-Toxin
Act (the eighth paragraph under
the heading `Bureau of Animal
Industry' in the Act of March
4, 1913; 21 U.S.C. 151-159).
(IV) The Federal
Insecticide, Fungicide, and
Rodenticide Act.
(iii) Investigational use.--
(I) In general.--The
Secretary may exempt an
investigational product that
is, bears, or contains an
overlap agent or toxin from the
applicability of provisions of
regulations under subsection
(b) or (c) when such product is
being used in an investigation
authorized under any Federal
Act and the Secretary
determines that applying
additional regulation under
subsection (b) or (c) to such
product is not necessary to
protect animal and plant
health, and animal and plant
products.
(II) Certain processes.--
Regulations under subsections
(b) and (c) shall set forth the
procedures for applying for an
exemption under subclause (I).
In the case of investigational
products authorized under any
of the Acts specified in clause
(ii), the Secretary shall make
a determination regarding a
request for an exemption not
later than 14 days after the
first date on which both of the
following conditions have been
met by the person requesting
the exemption:
(aa) The person has
submitted to the
Secretary an
application for the
exemption meeting the
requirements
established by the
Secretary.
(bb) The person has
notified the Secretary
that the investigation
has been authorized
under such an Act.
(D) Agricultural emergencies.-- The
Secretary may temporarily exempt a person from
the applicability of the requirements of this
section with respect to an overlap agent or
toxin, in whole or in part, if the Secretary
determines that such exemption is necessary to
provide for the timely participation of the
person in a response to a domestic or foreign
agricultural emergency that involves such an
agent or toxin. With respect to the emergency
involved, the exemption under this subparagraph
for a person may not exceed 30 days, except
that the Secretary, after review of whether
such exemption remains necessary, may provide
one extension of an additional 30 days.
(E) Public health emergencies.--Upon
request of the Secretary of Health and Human
Services, after the granting by such Secretary
of an exemption under 351A(g)(3) of the Public
Health Service Act pursuant to a finding that
there is a public health emergency, the
Secretary of Agriculture may temporarily exempt
a person from the applicability of the
requirements of this section with respect to an
overlap agent or toxin, in whole or in part, to
provide for the timely participation of the
person in a response to the public health
emergency. With respect to the emergency
involved, such exemption for a person may not
exceed 30 days, except that upon request of the
Secretary of Health and Human Services, the
Secretary of Agriculture may, after review of
whether such exemption remains necessary,
provide one extension of an additional 30 days.
(2) General authority for exemptions not involving
overlap agents or toxins.--In the case of listed agents
or toxins that are not overlap agents or toxins, the
Secretary may grant exemptions from the applicability
of provisions of regulations under subsection (b) or
(c) if the Secretary determines that such exemptions
are consistent with protecting animal and plant health,
and animal and plant products.
(h) Disclosure of Information.--
(1) Nondisclosure of certain information.--No
Federal agency specified in paragraph (2) shall
disclose under section 552 of title 5, United States
Code, any of the following:
(A) Any registration or transfer
documentation submitted under subsections (b)
and (c), or permits issued prior to the date of
the enactment of this Act, for the possession,
use or transfer of a listed agent or toxin; or
information derived therefrom to the extent
that it identifies the listed agent or toxin
possessed, used or transferred by a specific
person or discloses the identity or location of
a specific person.
(B) The national database developed
pursuant to subsection (d), or any other
compilation of the registration or transfer
information submitted under subsections (b) and
(c) to the extent that such compilation
discloses site-specific registration or
transfer information.
(C) Any portion of a record that discloses
the site-specific or transfer-specific
safeguard and security measures used by a
registered person to prevent unauthorized
access to listed agents and toxins.
(D) Any notification of a release of a
listed agent or toxin submitted under
subsections (b) and (c), or any notification of
theft or loss submitted under such subsections.
(E) Any portion of an evaluation or report
of an inspection of a specific registered
person conducted under subsection (f) that
identifies the listed agent or toxin possessed
by a specific registered person or that
discloses the identity or location of a
specific registered person if the agency
determines that public disclosure of the
information would endanger animal or plant
health, or animal or plant products.
(2) Covered agencies.--For purposes of paragraph
(1) only, the Federal agencies specified in this
paragraph are the following:
(A) The Department of Health and Human
Services, the Department of Justice, the
Department of Agriculture, and the Department
of Transportation.
(B) Any Federal agency to which information
specified in paragraph (1) is transferred by
any agency specified in subparagraph (A) of
this paragraph.
(C) Any Federal agency that is a registered
person, or has a sub-agency component that is a
registered person.
(D) Any Federal agency that awards grants
or enters into contracts or cooperative
agreements involving listed agents and toxins
to or with a registered person, and to which
information specified in paragraph (1) is
transferred by any such registered person.
(3) Other exemptions.--This subsection may not be
construed as altering the application of any exemptions
to public disclosure under section 552 of title 5,
United States Code, except as to subsection 552(b)(3)
of such title, to any of the information specified in
paragraph (1).
(4) Rule of construction.--Except as specifically
provided in paragraph (1), this subsection may not be
construed as altering the authority of any Federal
agency to withhold under section 552 of title 5, United
States Code, or the obligation of any Federal agency to
disclose under section 552 of title 5, United States
Code, any information, including information relating
to--
(A) listed agents and toxins, or
individuals seeking access to such agents and
toxins;
(B) registered persons, or persons seeking
to register their possession, use, or transfer
of such agents and toxins;
(C) general safeguard and security policies
and requirements under regulations under
subsections (b) and (c); or
(D) summary or statistical information
concerning registrations, registrants, denials
or revocations of registrations, listed agents
and toxins, inspection evaluations and reports,
or individuals seeking access to such agents
and toxins.
(5) Disclosures to congress; other disclosures.--
This subsection may not be construed as providing any
authority--
(A) to withhold information from the
Congress or any committee or subcommittee
thereof; or
(B) to withhold information from any person
under any other Federal law or treaty.
(i) Civil Money Penalty.--
(1) In general.--In addition to any other penalties
that may apply under law, any person who violates any
provision of regulations under subsection (b) or (c)
shall be subject to the United States for a civil money
penalty in an amount not exceeding $250,000 in the case
of an individual and $500,000 in the case of any other
person.
(2) Applicability of certain provisions.--The
provisions of sections 423 and 425(2) of the Plant
Protection Act (7 U.S.C. 7733 and 7735(2) shall apply
to a civil money penalty or activity under paragraph
(1) in the same manner as such provisions apply to a
penalty or activity under the Plant Protection Act.
(j) Notification in Event of Release.--Regulations under
subsections (b) and (c) shall require the prompt notification
of the Secretary by a registered person whenever a release,
meeting criteria established by the Secretary, of a listed
agent or toxin has occurred outside of the biocontainment area
of a facility of the registered person. Upon receipt of such
notification and a finding by the Secretary that the release
poses a threat to animal or plant health, or animal or plant
products, the Secretary shall take appropriate action to notify
relevant Federal, State, and local authorities, and, if
necessary, other appropriate persons (including the public). If
the released listed agent or toxin is an overlap agent or
toxin, the Secretary shall promptly notify the Secretary of
Health and Human Services upon notification by the registered
person.
(k) Reports.--The Secretary shall report to the Congress
annually on the number and nature of notifications received
under subsection (e)(8) (relating to theft or loss) and
subsection (j) (relating to releases).
(l) Definitions.--For purposes of this section:
(1) The terms ``biological agent'' and ``toxin''
have the meanings given such terms in section 178 of
title 18, United States Code.
(2) The term ``listed agents and toxins'' means
biological agents and toxins listed pursuant to
subsection (a)(1).
(3) The term ``listed agents or toxins'' means
biological agents or toxins listed pursuant to
subsection (a)(1).
(4) The terms ``overlap agents and toxins'' and
``overlap agent or toxin'' have the meaning given such
terms in subsection (g)(1)(A)(ii).
(5) The term ``person'' includes Federal, State,
and local governmental entities.
(6) The term ``registered person'' means a person
registered under regulations under subsection (b) or
(c).
(7) The term ```Secretary'' means the Secretary of
Agriculture.
(m) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2007, in addition to other funds that
may be available.
SEC. 213. IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE.
(a) Date Certain for Promulgation of List.--Not later than
60 days after the date of the enactment of this Act, the
Secretary of Agriculture (referred to in this section as the
``Secretary'') shall promulgate an interim final rule that
establishes the initial list under section 212(a)(1). In
promulgating such rule, the Secretary shall provide written
guidance on the manner in which the notice required in
subsection (b) is to be provided to the Secretary.
(b) Date Certain for Notice of Possession.--Not later than
60 days after the date on which the Secretary promulgates the
interim final rule under subsection (a), all persons (unless
exempt under section 212(g)) in possession of biological agents
or toxins included on the list referred to in subsection (a)
shall notify the Secretary of such possession.
(c) Date Certain for Promulgation; Effective Date Regarding
Criminal and Civil Penalties.--Not later than 180 days after
the date of the enactment of this Act, the Secretary shall
promulgate an interim final rule for carrying out section 212,
other than for the list referred to in subsection (a) of this
section (but such rule may incorporate by reference provisions
promulgated pursuant to subsection (a)). Such interim final
rule shall take effect 60 days after the date on which such
rule is promulgated, including for purposes of--
(1) section 175b(c) of title 18, United States Code
(relating to criminal penalties), as added by section
231(a)(5) of this Act; and
(2) section 212(i) of this Act (relating to civil
penalties).
(d) Transitional Provision Regarding Current Research and
Education.--The interim final rule under subsection (c) shall
include time frames for the applicability of the rule that
minimize disruption of research or educational projects that
involve biological agents and toxins listed pursuant to section
212(a)(1) and that were underway as of the effective date of
such rule.
Subtitle C--Interagency Coordination Regarding Overlap Agents and
Toxins
SEC. 221. INTERAGENCY COORDINATION.
(a) In General.--
(1) Coordination.--The Secretary of Agriculture and
the Secretary of Health and Human Services shall in
accordance with this section coordinate activities
regarding overlap agents and toxins.
(2) Overlap agents and toxins; other terms.--For
purposes of this section:
(A) The term ``overlap agent or toxin''
means a biological agent or toxin that--
(i) is listed pursuant to section
315A(a)(1) of the Public Health Service
Act, as added by section 201 of this
Act; and
(ii) is listed pursuant to section
212(a)(1) of this Act.
(B) The term ``section 351A program'' means
the program under section 351A of the Public
Health Service Act.
(C) The term ``section 212 program'' means
the program under section 212 of this Act.
(b) Certain Matters.--In carrying out the section 351A
program and the section 212 program, the Secretary of Health
and Human Services and the Secretary of Agriculture shall, to
the greatest extent practicable, coordinate activities to
achieve the following purposes:
(1) To minimize any conflicts between the
regulations issued under, and activities carried out
under, such programs.
(2) To minimize the administrative burden on
persons subject to regulation under both of such
programs.
(3) To ensure the appropriate availability of
biological agents and toxins for legitimate biomedical,
agricultural or veterinary research, education, or
other such purposes.
(4) To ensure that registration information for
overlap agents and toxins under the section 351A and
section 212 programs is contained in both the national
database under the section 351A program and the
national database under the section 212 program.
(c) Memorandum of Understanding.--
(1) In general.--Promptly after the date of the
enactment of this Act, the Secretary of Agriculture and
the Secretary of Health and Human Services shall enter
into a memorandum of understanding regarding overlap
agents and toxins that is in accordance with paragraphs
(2) through (4) and contains such additional provisions
as the Secretary of Agriculture and the Secretary of
Health and Human Services determine to be appropriate.
(2) Single registration system regarding registered
persons.--The memorandum of understanding under
paragraph (1) shall provide for the development and
implementation of a single system of registration for
persons who possess, use, or transfer overlap agents or
toxins and are required to register under both the
section 351A program and the section 212 program. For
purposes of such system, the memorandum shall provide
for the development and implementation of the
following:
(A) A single registration form through
which the person submitting the form provides
all information that is required for
registration under the section 351A program and
all information that is required for
registration under the section 212 program.
(B) A procedure through which a person may
choose to submit the single registration form
to the agency administering the section 351A
program (in the manner provided under such
program), or to the agency administering the
section 212 program (in the manner provided
under such program).
(C) A procedure through which a copy of a
single registration form received pursuant to
subparagraph (B) by the agency administering
one of such programs is promptly provided to
the agency administering the other program.
(D) A procedure through which the agency
receiving the single registration form under
one of such programs obtains the concurrence of
the agency administering the other program that
the requirements for registration under the
other program have been met.
(E) A procedure through which--
(i) the agency receiving the single
registration form under one of such
programs informs the agency
administering the other program whether
the receiving agency has denied the
registration; and
(ii) each of such agencies ensures
that registrations are entered into the
national database of registered persons
that is maintained by each such agency.
(3) Process of identification.--With respect to the
process of identification under the section 351A
program and the section 212 program for names and other
identifying information submitted to the Attorney
General (relating to certain categories of individuals
and entities), the memorandum of understanding under
paragraph (1) shall provide for the development and
implementation of the following:
(A) A procedure through which a person who
is required to submit information pursuant to
such process makes (in addition to the
submission to the Attorney General) a
submission, at the option of the person, to
either the agency administering the section
351A program or the agency administering the
section 212 program, but not both, which
submission satisfies the requirement of
submission for both of such programs.
(B) A procedure for the sharing by both of
such agencies of information received from the
Attorney General by one of such agencies
pursuant to the submission under subparagraph
(A).
(C) A procedure through which the agencies
administering such programs concur in
determinations that access to overlap agents
and toxins will be granted.
(4) Coordination of inspections and enforcement.--
The memorandum of understanding under paragraph (1)
shall provide for the development and implementation of
procedures under which Federal personnel under the
section 351A program and the section 212 program may
share responsibilities for inspections and enforcement
activities under such programs regarding overlap agents
and toxins. Activities carried out under such
procedures by one of such programs on behalf of the
other may be carried out with or without reimbursement
by the agency that administers the other program.
(5) Date certain for implementation.--The
memorandum of understanding under paragraph (1) shall
be implemented not later than 180 days after the date
of the enactment of this Act. Until the single system
of registration under paragraph (2) is implemented,
persons who possess, use, or transfer overlap agents or
toxins shall register under both the section 351A
program and the section 212 program.
(d) Joint Regulations.--Not later than 18 months after the
date on which the single system of registration under
subsection (c)(2) is implemented, the Secretary of Health and
Human Services and the Secretary of Agriculture shall jointly
issue regulations for the possession, use, and transfer of
overlap agents and toxins that meet the requirements of both
the section 351A program and the section 212 program.
Subtitle D--Criminal Penalties Regarding Certain Biological Agents and
Toxins
SEC. 231. CRIMINAL PENALTIES.
(a) In General.--Section 175b of title 18, United States
Code, as added by section 817 of Public Law 107-56, is
amended--
(1) by striking ``(a)'' and inserting ``(a)(1)'';
(2) by transferring subsection (c) from the current
placement of the subsection and inserting the
subsection before subsection (b);
(3) by striking ``(c)'' and inserting ``(2);
(4) by redesignating subsection (b) as subsection
(d); and
(5) by inserting before subsection (d) (as so
redesignated) the following subsections:
``(b) Transfer to Unregistered Person.--
``(1) Select agents.--Whoever transfers a select
agent to a person who the transferor knows or has
reasonable cause to believe is not registered as
required by regulations under subsection (b) or (c) of
section 351A of the Public Health Service Act shall be
fined under this title, or imprisoned for not more than
5 years, or both.
``(2) Certain other biological agents and toxins.--
Whoever transfers a biological agent or toxin listed
pursuant to section 212(a)(1) of the Agricultural
Bioterrorism Protection Act of 2002 to a person who the
transferor knows or has reasonable cause to believe is
not registered as required by regulations under
subsection (b) or (c) of section 212 of such Act shall
be fined under this title, or imprisoned for not more
than 5 years, or both.
``(c) Unregistered for Possession.--
``(1) Select agents.--Whoever knowingly possesses a
biological agent or toxin where such agent or toxin is
a select agent for which such person has not obtained a
registration required by regulations under section
351A(c) of the Public Health Service Act shall be fined
under this title, or imprisoned for not more than 5
years, or both.
``(2) Certain other biological agents and toxins.--
Whoever knowingly possesses a biological agent or toxin
where such agent or toxin is a biological agent or
toxin listed pursuant to section 212(a)(1) of the
Agricultural Bioterrorism Protection Act of 2002 for
which such person has not obtained a registration
required by regulations under section 212(c) of such
Act shall be fined under this title, or imprisoned for
not more than 5 years, or both.''.
(b) Conforming Amendments.--Chapter 10 of title 18, United
States Code, is amended--
(1) in section 175b (as added by section 817 of
Public Law 107-56 and amended by subsection (a) of this
section)--
(A) in subsection (d)(1), by striking ``The
term'' and all that follows through ``does not
include'' and inserting the following: ``The
term `select agent' means a biological agent or
toxin to which subsection (a) applies. Such
term (including for purposes of subsection (a))
does not include''; and
(B) in the heading for the section, by
striking ``Possession by restricted persons''
and inserting ``Select agents; certain other
agents''; and
(2) in the chapter analysis, in the item relating
to section 175b, by striking ``Possession by restricted
persons.'' and inserting ``Select agents; certain other
agents.''.
(c) Technical Corrections.--Chapter 10 of title 18, United
States Code, as amended by section 817 of Public Law 107-56 and
subsections (a) and (b) of this section, is amended--
(1) in section 175(c), by striking ``protective''
and all that follows and inserting ``protective, bona
fide research, or other peaceful purposes.'';
(2) in section 175b--
(A) in subsection (a)(1), by striking
``described in subsection (b)'' and all that
follows and inserting the following: ``shall
ship or transport in or affecting interstate or
foreign commerce, or possess in or affecting
interstate or foreign commerce, any biological
agent or toxin, or receive any biological agent
or toxin that has been shipped or transported
in interstate or foreign commerce, if the
biological agent or toxin is listed as a select
agent in Appendix A of part 72 of title 42,
Code of Federal Regulations, pursuant to
section 351A of the Public Health Service Act,
and is not exempted under subsection (h) of
section 72.6, or Appendix A of part 72, of
title 42, Code of Federal Regulations.''; and
(B) in subsection (d)(3), by striking
``section 1010(a)(3)'' and inserting ``section
101(a)(3)'';
(3) in section 176(a)(1)(A), by striking ``exists
by reason of'' and inserting ``pertains to''; and
(4) in section 178--
(A) in paragraph (1), by striking ``means
any micro-organism'' and all that follows
through ``product, capable of'' and inserting
the following: ``means any microorganism
(including, but not limited to, bacteria,
viruses, fungi, rickettsiae or protozoa), or
infectious substance, or any naturally
occurring, bioengineered or synthesized
component of any such microorganism or
infectious substance, capable of'';
(B) in paragraph (2), by striking ``means
the toxic'' and all that follows through
``including--'' and inserting the following:
``means the toxic material or product of
plants, animals, microorganisms (including, but
not limited to, bacteria, viruses, fungi,
rickettsiae or protozoa), or infectious
substances, or a recombinant or synthesized
molecule, whatever their origin and method of
production, and includes--''; and
(C) in paragraph (4), by striking
``recombinant molecule,'' and all that follows
through ``biotechnology,'' and inserting
``recombinant or synthesized molecule,''.
(d) Additional Technical Correction.--Section 2332a of
title 18, United States Code, is amended--
(1) in subsection (a), in the matter preceding
paragraph (1), by striking ``section 229F)'' and all
that follows through ``section 178)--'' and inserting
``section 229F)--''; and
(2) in subsection (c)(2)(C), by striking ``a
disease organism'' and inserting ``a biological agent,
toxin, or vector (as those terms are defined in section
178 of this title)''.
TITLE III--PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY
Subtitle A--Protection of Food Supply
SEC. 301. FOOD SAFETY AND SECURITY STRATEGY.
(a) In General.--The President's Council on Food Safety (as
established by Executive Order 13100) shall, in consultation
with the Secretary of Transportation, the Secretary of the
Treasury, other relevant Federal agencies, the food industry,
consumer and producer groups, scientific organizations, and the
States, develop a crisis communications and education strategy
with respect to bioterrorist threats to the food supply. Such
strategy shall address threat assessments; technologies and
procedures for securing food processing and manufacturing
facilities and modes of transportation; response and
notification procedures; and risk communications to the public.
(b) Authorization of Appropriations.--For the purpose of
implementing the strategy developed under subsection (a), there
are authorized to be appropriated $750,000 for fiscal year
2002, and such sums as may be necessary for each subsequent
fiscal year.
SEC. 302. PROTECTION AGAINST ADULTERATION OF FOOD.
(a) Increasing Inspections for Detection of Adulteration of
Food.--Section 801 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381) is amended by adding at the end the following
subsection:
``(h)(1) The Secretary shall give high priority to
increasing the number of inspections under this section for the
purpose of enabling the Secretary to inspect food offered for
import at ports of entry into the United States, with the
greatest priority given to inspections to detect the
intentional adulteration of food.''.
(b) Improvements to Information Management Systems.--
Section 801(h) of the Federal Food, Drug, and Cosmetic Act, as
added by subsection (a) of this section, is amended by adding
at the end the following paragraph:
``(2) The Secretary shall give high priority to making
necessary improvements to the information management systems of
the Food and Drug Administration that contain information
related to foods imported or offered for import into the United
States for purposes of improving the ability of the Secretary
to allocate resources, detect the intentional adulteration of
food, and facilitate the importation of food that is in
compliance with this Act.''.
(c) Linkages With Appropriate Public Entities.--Section
801(h) of the Federal Food, Drug, and Cosmetic Act, as amended
by subsection (b) of this section, is amended by adding at the
end the following paragraph:
``(3) The Secretary shall improve linkages with other
regulatory agencies of the Federal Government that share
responsibility for food safety, and shall with respect to such
safety improve linkages with the States and Indian tribes (as
defined in section 4(e) of the Indian Self-Determination and
Education Assistance Act (25 U.S.C. 450b(e))).''.
(d) Testing for Rapid Detection of Adulteration of Food.--
Section 801 of the Federal Food, Drug, and Cosmetic Act, as
amended by subsection (a) of this section, is amended by adding
at the end the following:
``(i)(1) For use in inspections of food under this section,
the Secretary shall provide for research on the development of
tests and sampling methodologies--
``(A) whose purpose is to test food in order to
rapidly detect the adulteration of the food, with the
greatest priority given to detect the intentional
adulteration of food; and
``(B) whose results offer significant improvements
over the available technology in terms of accuracy,
timing, or costs.
``(2) In providing for research under paragraph (1), the
Secretary shall give priority to conducting research on the
development of tests that are suitable for inspections of food
at ports of entry into the United States.
``(3) In providing for research under paragraph (1), the
Secretary shall as appropriate coordinate with the Director of
the Centers for Disease Control and Prevention, the Director of
the National Institutes of Health, the Administrator of the
Environmental Protection Agency, and the Secretary of
Agriculture.
``(4) The Secretary shall annually submit to the Committee
on Energy and Commerce of the House of Representatives, and the
Committee on Health, Education, Labor, and Pensions of the
Senate, a report describing the progress made in research under
paragraph (1), including progress regarding paragraph (2).''.
(e) Assessment of Threat of Intentional Adulteration of
Food.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall ensure that,
not later than six months after the date of the enactment of
this Act--
(1) the assessment that (as of such date of
enactment) is being conducted on the threat of the
intentional adulteration of food is completed; and
(2) a report describing the findings of the
assessment is submitted to the Committee on Energy and
Commerce of the House of Representatives and to the
Committee on Health, Education, Labor, and Pensions of
the Senate.
(f) Authorization of Appropriations.--For the purpose of
carrying out this section and the amendments made by this
section, there are authorized to be appropriated $100,000,000
for fiscal year 2002, and such sums as may be necessary for
each of the fiscal years 2003 through 2006, in addition to
other authorizations of appropriations that are available for
such purpose.
SEC. 303. ADMINISTRATIVE DETENTION.
(a) Expanded Authority.--Section 304 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 334) is amended by adding at
the end the following subsection:
``(h) Administrative Detention of Foods.--
``(1) Detention authority.--
``(A) In general.--An officer or qualified
employee of the Food and Drug Administration
may order the detention, in accordance with
this subsection, of any article of food that is
found during an inspection, examination, or
investigation under this Act conducted by such
officer or qualified employee, if the officer
or qualified employee has credible evidence or
information indicating that such article
presents a threat of serious adverse health
consequences or death to humans or animals.
``(B) Secretary's approval.--An article of
food may be ordered detained under subparagraph
(A) only if the Secretary or an official
designated by the Secretary approves the order.
An official may not be so designated unless the
official is the director of the district under
this Act in which the article involved is
located, or is an official senior to such
director.
``(2) Period of detention.--An article of food may
be detained under paragraph (1) for a reasonable
period, not to exceed 20 days, unless a greater period,
not to exceed 30 days, is necessary, to enable the
Secretary to institute an action under subsection (a)
or section 302. The Secretary shall by regulation
provide for procedures for instituting such action on
an expedited basis with respect to perishable foods.
``(3) Security of detained article.--An order under
paragraph (1) with respect to an article of food may
require that such article be labeled or marked as
detained, and shall require that the article be removed
to a secure facility, as appropriate. An article
subject to such an order shall not be transferred by
any person from the place at which the article is
ordered detained, or from the place to which the
article is so removed, as the case may be, until
released by the Secretary or until the expiration of
the detention period applicable under such order,
whichever occurs first. This subsection may not be
construed as authorizing the delivery of the article
pursuant to the execution of a bond while the article
is subject to the order, and section 801(b) does not
authorize the delivery of the article pursuant to the
execution of a bond while the article is subject to the
order.
``(4) Appeal of detention order.--
``(A) In general.--With respect to an
article of food ordered detained under
paragraph (1), any person who would be entitled
to be a claimant for such article if the
article were seized under subsection (a) may
appeal the order to the Secretary. Within five
days after such an appeal is filed, the
Secretary, after providing opportunity for an
informal hearing, shall confirm or terminate
the order involved, and such confirmation by
the Secretary shall be considered a final
agency action for purposes of section 702 of
title 5, United States Code. If during such
five-day period the Secretary fails to provide
such an opportunity, or to confirm or terminate
such order, the order is deemed to be
terminated.
``(B) Effect of instituting court action.--
The process under subparagraph (A) for the
appeal of an order under paragraph (1)
terminates if the Secretary institutes an
action under subsection (a) or section 302
regarding the article of food involved.''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331) is amended by adding at the
end the following:
``(bb) The transfer of an article of food in violation of
an order under section 304(h), or the removal or alteration of
any mark or label required by the order to identify the article
as detained.''.
(c) Temporary Holds at Ports of Entry.--Section 801 of the
Federal Food, Drug, and Cosmetic Act, as amended by section
302(d)of this Act, is amended by adding at the end the
following:
``(j)(1) If an officer or qualified employee of the Food
and Drug Administration has credible evidence or information
indicating that an article of food presents a threat of serious
adverse health consequences or death to humans or animals, and
such officer or qualified employee is unable to inspect,
examine, or investigate such article upon the article being
offered for import at a port of entry into the United States,
the officer or qualified employee shall request the Secretary
of Treasury to hold the food at the port of entry for a
reasonable period of time, not to exceed 24 hours, for the
purpose of enabling the Secretary to inspect, examine, or
investigate the article as appropriate.
``(2) The Secretary shall request the Secretary of Treasury
to remove an article held pursuant to paragraph (1) to a secure
facility, as appropriate. During the period of time that such
article is so held, the article shall not be transferred by any
person from the port of entry into the United States for the
article, or from the secure facility to which the article has
been removed, as the case may be. Subsection (b) does not
authorize the delivery of the article pursuant to the execution
of a bond while the article is so held.
``(3) An officer or qualified employee of the Food and Drug
Administration may make a request under paragraph (1) only if
the Secretary or an official designated by the Secretary
approves the request. An official may not be so designated
unless the official is the director of the district under this
Act in which the article involved is located, or is an official
senior to such director.
``(4) With respect to an article of food for which a
request under paragraph (1) is made, the Secretary, promptly
after the request is made, shall notify the State in which the
port of entry involved is located that the request has been
made, and as applicable, that such article is being held under
this subsection.''.
SEC. 304. DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT VIOLATIONS.
(a) Debarment Authority.--
(1) Permissive debarment.--Section 306(b)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
335a(b)(1)) is amended--
(A) in subparagraph (A), by striking ``or''
after the comma at the end;
(B) in subparagraph (B), by striking the
period at the end and inserting ``, or''; and
(C) by adding at the end the following
subparagraph:
``(C) a person from importing an article of
food or offering such an article for import
into the United States.'';
(2) Amendment regarding debarment grounds.--Section
306(b)) of the Federal Food,Drug, and Cosmetic Act (21
U.S.C. 335a(b)) is amended--
(A) in paragraph (2), in the matter
preceding subparagraph (A), by inserting
``subparagraph (A) or (B) of'' before
``paragraph (1)'';
(B) by redesignating paragraph (3) as
paragraph (4); and
(C) by inserting after paragraph (2) the
following paragraph:
``(3) Persons subject to permissive debarment; food
importation.--A person is subject to debarment under
paragraph (1)(C) if--
``(A) the person has been convicted of a
felony for conduct relating to the importation
into the United States of any food; or
``(B) the person has engaged in a pattern
of importing or offering for import adulterated
food that presents a threat of serious adverse
health consequences or death to humans or
animals.''.
(b) Conforming Amendments.--Section 306 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is amended--
(1) in subsection (a), in the heading for the
subsection, by striking ``Mandatory Debarment.--'' and
inserting ``Mandatory Debarment; Certain Drug
Applications.--'';
(2) in subsection (b)--
(A) in the heading for the subsection, by
striking ``Permissive Debarment.--'' and
inserting ``Permissive Debarment; Certain Drug
Applications; Food Imports.--''; and
(B) in paragraph (2), in the heading for
the paragraph, by striking ``permissive
debarment.--'' and inserting ``permissive
debarment; certain drug applications.--'';
(3) in subsection (c)(2)(A)(iii), by striking
``subsection (b)(2)'' and inserting ``paragraph (2) or
(3) of subsection (b)'';
(4) in subsection (d)(3)--
(A) in subparagraph (A)(i), by striking
``or (b)(2)(A)'' and inserting `` or paragraph
(2)(A) or (3) of subsection (b)'';
(B) in subparagraph (A)(ii)(II), by
inserting ``in applicable cases,'' before
``sufficient audits'';
(C) in subparagraph (B), in each of clauses
(i) and (ii), by inserting ``or subsection
(b)(3)'' after ``subsection (b)(2)(B)''; and
(D) in subparagraph (B)(ii), by inserting
before the period the following: ``or the food
importation process, as the case may be''.
(c) Effective Dates.--Section 306(l)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) is
amended--
(1) in the first sentence--
(A) by striking ``and'' after ``subsection
(b)(2),''; and
(B) by inserting ``, and subsection
(b)(3)(A)'' after ``subsection (b)(2)(B)''; and
(2) in the second sentence, by inserting ``,
subsection (b)(3)(B),'' after ``subsection (b)(2)(B)''.
(d) Prohibited Act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act, as amended by section 303(b) of this Act, is
amended by adding at the end the following:
``(cc) The importing or offering for import into the United
States of an article of food by, with the assistance of, or at
the direction of, a person debarred under section 306(b)(3).''.
(e) Importation by Debarred Persons.--Section 801 of the
Federal Food, Drug, and Cosmetic Act, as amended by section
303(c) of this Act, is amended by adding at the end the
following subsection:
``(k)(1) If an article of food is being imported or offered
for import into the United States, and the importer, owner, or
consignee of the article is a person who has been debarred
under section 306(b)(3), such article shall be held at the port
of entry for the article, and may not be delivered to such
person. Subsection (b) does not authorize the delivery of the
article pursuant to the execution of a bond while the article
is so held. The article shall be removed to a secure facility,
as appropriate. During the period of time that such article is
so held, the article shall not be transferred by any person
from the port of entry into the United States for the article,
or from the secure facility to which the article has been
removed, as the case may be.
``(2) An article of food held under paragraph (1) may be
delivered to a person who is not a debarred person under
section 306(b)(3) if such person affirmatively establishes, at
the expense of the person, that the article complies with the
requirements of this Act, as determined by the Secretary.''.
SEC. 305. REGISTRATION OF FOOD FACILITIES.
(a) In General.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at
the end the following:
``SEC. 415. REGISTRATION OF FOOD FACILITIES.
``(a) Registration.--
``(1) In general.--The Secretary shall by
regulation require that any facility engaged in
manufacturing, processing, packing, or holding food for
consumption in the United States be registered with the
Secretary. To be registered--
``(A) for a domestic facility, the owner,
operator, or agent in charge of the facility
shall submit a registration to the Secretary;
and
``(B) for a foreign facility, the owner,
operator, or agent in charge of the facility
shall submit a registration to the Secretary
and shall include with the registration the
name of the United States agent for the
facility.
``(2) Registration.--An entity (referred to in this
section as the `registrant') shall submit a
registration under paragraph (1) to the Secretary
containing information necessary to notify the
Secretary of the name and address of each facility at
which, and all trade names under which, the registrant
conducts business and, when determined necessary by the
Secretary through guidance, the general food category
(as identified under section 170.3 of title 21, Code of
Federal Regulations) of any food manufactured,
processed, packed, or held at such facility. The
registrant shall notify the Secretary in a timely
manner of changes to such information.
``(3) Procedure.--Upon receipt of a completed
registration described in paragraph (1), the Secretary
shall notify the registrant of the receipt of such
registration and assign a registration number to each
registered facility.
``(4) List.--The Secretary shall compile and
maintain an up-to-date list of facilities that are
registered under this section. Such list and any
registration documents submitted pursuant to this
subsection shall not be subject to disclosure under
section 552 of title 5, United States Code. Information
derived from such list or registration documents shall
not be subject to disclosure under section 552 of title
5, United States Code, to the extent that it discloses
the identity or location of a specific registered
person.
``(b) Facility.--For purposes of this section:
``(1) The term `facility' includes any factory,
warehouse, or establishment (including a factory,
warehouse, or establishment of an importer) that
manufactures, processes, packs, or holds food. Such
term does not include farms; restaurants; other retail
food establishments; nonprofit food establishments in
which food is prepared for or served directly to the
consumer; or fishing vessels (except such vessels
engaged in processing as defined in section 123.3(k) of
title 21, Code of Federal Regulations).
``(2) The term `domestic facility' means a facility
located in any of the States or Territories.
``(3)(A) The term `foreign facility' means a
facility that manufacturers, processes, packs, or holds
food, but only if food from such facility is exported
to the United States without further processing or
packaging outside the United States.
``(B) A food may not be considered to have
undergone further processing or packaging for purposes
of subparagraph (A) solely on the basis that labeling
was added or that any similar activity of a de minimis
nature was carried out with respect to the food.
``(c) Rule of Construction.--Nothing in this section shall
be construed to authorize the Secretary to require an
application, review, or licensing process.''.
(b) Prohibited Acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section
304(d) of this Act, is amended by adding at the end the
following:
``(dd) The failure to register in accordance with section
415.''.
(c) Importation; Failure to Register.--Section 801 of the
Federal Food, Drug, and Cosmetic Act, as amended by section
304(e) of this Act, is amended by adding at the end the
following subsection:
``(l)(1) If an article of food is being imported or offered
for import into the United States, and such article is from a
foreign facility for which a registration has not been
submitted to the Secretary under section 415, such article
shall be held at the port of entry for the article, and may not
be delivered to the importer, owner, or consignee of the
article, until the foreign facility is so registered.
Subsection (b) does not authorize the delivery of the article
pursuant to the execution of a bond while the article is so
held. The article shall be removed to a secure facility, as
appropriate. During the period of time that such article is so
held, the article shall not be transferred by any person from
the port of entry into the United States for the article, or
from the secure facility to which the article has been removed,
as the case may be.''.
(d) Electronic Filing.--For the purpose of reducing
paperwork and reporting burdens, the Secretary of Health and
Human Services may provide for, and encourage the use of,
electronic methods of submitting to the Secretary registrations
required pursuant to this section. In providing for the
electronic submission of such registrations, the Secretary
shall ensure adequate authentication protocols are used to
enable identification of the registrant and validation of the
data as appropriate.
(e) Rulemaking; Effective Date.--Not later than 18 months
after the date of the enactment of this Act, the Secretary of
Health and Human Services shall promulgate proposed and final
regulations for the requirement of registration under section
415 of the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a) of this section). Such requirement of
registration takes effect--
(1) upon the effective date of such final
regulations; or
(2) upon the expiration of such 18-month period if
the final regulations have not been made effective as
of the expiration of such period, subject to compliance
with the final regulations when the final regulations
are made effective.
SEC. 306. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.
(a) In General.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act, as amended by section 305 of this Act, is amended
by inserting before section 415 the following section:
``SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.
``(a) Records Inspection.--If the Secretary has a
reasonable belief that an article of food is adulterated and
presents a threat of serious adverse health consequences or
death to humans or animals, each person (excluding farms and
restaurants) who manufactures, processes, packs, distributes,
receives, holds, or imports such article shall, at the request
of an officer or employee duly designated by the Secretary,
permit such officer or employee, upon presentation of
appropriate credentials and a written notice to such person, at
reasonable times and within reasonable limits and in a
reasonable manner, to have access to and copy all records
relating to such article that are needed to assist the
Secretary in determining whether the food is adulterated and
presents a threat of serious adverse health consequences or
death to humans or animals. The requirement under the preceding
sentence applies to all records relating to the manufacture,
processing, packing, distribution, receipt, holding, or
importation of such article maintained by or on behalf of such
person in any format (including paper and electronic formats)
and at any location.
``(b) Regulations Concerning Recordkeeping.--The Secretary,
in consultation and coordination, as appropriate, with other
Federal departments and agencies with responsibilities for
regulating food safety, may by regulation establish
requirements regarding the establishment and maintenance, for
not longer than two years, of records by persons (excluding
farms and restaurants) who manufacture, process, pack,
transport, distribute, receive, hold, or import food, which
records are needed by the Secretary for inspection to allow the
Secretary to identify the immediate previous sources and the
immediate subsequent recipients of food, including its
packaging, in order to address credible threats of serious
adverse health consequences or death to humans or animals. The
Secretary shall take into account the size of a business in
promulgating regulations under this section.
``(c) Protection of Sensitive Information.--The Secretary
shall take appropriate measures to ensure that there are in
effect effective procedures to prevent the unauthorized
disclosure of any trade secret or confidential information that
is obtained by the Secretary pursuant to this section.
``(d) Limitations.--This section shall not be construed--
``(1) to limit the authority of the Secretary to
inspect records or to require establishment and
maintenance of records under any other provision of
this Act;
``(2) to authorize the Secretary to impose any
requirements with respect to a food to the extent that
it is within the exclusive jurisdiction of the
Secretary of Agriculture pursuant to the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.), or the
Egg Products Inspection Act (21 U.S.C. 1031 et seq);
``(3) to have any legal effect on section 552 of
title 5, United States Code, or section 1905 of title
18, United States Code; or
``(4) to extend to recipes for food, financial
data, pricing data, personnel data, research data, or
sales data (other than shipment data regarding
sales).''.
(b) Factory Inspection.--Section 704(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended--
(1) in paragraph (1), by inserting after the first
sentence the following new sentence: ``In the case of
any person (excluding farms and restaurants) who
manufactures, processes, packs, transports,
distributes, holds, or imports foods, the inspection
shall extend to all records and other information
described in section 414 when the Secretary has a
reasonable belief that an article of food is
adulterated and presents a threat of serious adverse
health consequences or death to humans or animals,
subject to the limitations established in section
414(d).''; and
(2) in paragraph (2), in the matter preceding
subparagraph (A), by striking ``second sentence'' and
inserting ``third sentence''.
(c) Prohibited Act.--Section 301 of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 331) is amended--
(1) in paragraph (e)--
(A) by striking ``by section 412, 504, or
703'' and inserting ``by section 412, 414, 504,
703, or 704(a)''; and
(B) by striking ``under section 412'' and
inserting ``under section 412, 414(b)''; and
(2) in paragraph (j), by inserting ``414,'' after
``412,''.
(d) Expedited Rulemaking.--Not later than 18 months after
the date of the enactment of this Act, the Secretary shall
promulgate proposed and final regulations establishing
recordkeeping requirements under subsection 414(b) of the
Federal Food, Drug, and Cosmetic Act (as added by subsection
(a)).
SEC. 307. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 305(c) of this Act, is
amended by adding at the end the following subsection:
``(m)(1) In the case of an article of food that is being
imported or offered for import into the United States, the
Secretary, after consultation with the Secretary of the
Treasury, shall by regulation require, for the purpose of
enabling such article to be inspected at ports of entry into
the United States, the submission to the Secretary of a notice
providing the identity of each of the following: The article;
the manufacturer and shipper of the article; if known within
the specified period of time that notice is required to be
provided, the grower of the article; the country from which the
article originates; the country from which the article is
shipped; and the anticipated port of entry for the article. An
article of food imported or offered for import without
submission of such notice in accordance with the requirements
under this paragraph shall be refused admission into the United
States. Nothing in this section may be construed as a
limitation on the port of entry for an article of food.
``(2)(A) Regulations under paragraph (1) shall require that
a notice under such paragraph be provided by a specified period
of time in advance of the time of the importation of the
article of food involved or the offering of the food for
import, which period shall be no less than the minimum amount
of time necessary for the Secretary to receive, review, and
appropriately respond to such notification, but may not exceed
five days. In determining the specified period of time required
under this subparagraph, the Secretary may consider, but is not
limited to consideration of, the effect on commerce of such
period of time, the locations of the various ports of entry
into the United States, the various modes of transportation,
the types of food imported into the United States, and any
other such consideration. Nothing in the preceding sentence may
be construed as a limitation on the obligation of the Secretary
to receive, review, and appropriately respond to any notice
under paragraph (1).
``(B)(i) If an article of food is being imported or offered
for import into the United States and a notice under paragraph
(1) is not provided in advance in accordance with the
requirements under paragraph (1), such article shall be held at
the port of entry for the article, and may not be delivered to
the importer, owner, or consignee of the article, until such
notice is submitted to the Secretary, and the Secretary
examines the notice and determines that the notice is in
accordance with the requirements under paragraph (1).
Subsection (b) does not authorize the delivery of the article
pursuant to the execution of a bond while the article is so
held. The article shall be removed to a secure facility, as
appropriate. During the period of time that such article is so
held, the article shall not be transferred by any person from
the port of entry into the United States for the article, or
from the secure facility to which the article has been removed,
as the case may be.
``(ii) In carrying out clause (i) with respect to an
article of food, the Secretary shall determine whether there is
in the possession of the Secretary any credible evidence or
information indicating that such article presents a threat of
serious adverse health consequences or death to humans or
animals.
``(3)(A) This subsection may not be construed as limiting
the authority of the Secretary to obtain information under any
other provision of this Act.
``(B) This subsection may not be construed as authorizing
the Secretary to impose any requirements with respect to a food
to the extent that it is within the exclusive jurisdiction of
the Secretary of Agriculture pursuant to the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products
Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products
Inspection Act (21 U.S.C. 1031 et seq).''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act, as amended by section 305(b) of this Act, is
amended by adding at the end the following:
``(ee) The importing or offering for import into the United
States of an article of food in violation of the requirements
under section 801(m).''.
(c) Rulemaking; Effective Date.--
(1) In general.--Not later than 18 months after the
date of the enactment of this Act, the Secretary of
Health and Human Services shall promulgate proposed and
final regulations for the requirement of providing
notice in accordance with section 801(m) of the Federal
Food, Drug, and Cosmetic Act (as added by subsection
(a) of this section). Such requirement of notification
takes effect--
(A) upon the effective date of such final
regulations; or
(B) upon the expiration of such 18-month
period if the final regulations have not been
made effective as of the expiration of such
period, subject to compliance with the final
regulations when the final regulations are made
effective.
(2) Default; minimum period of advance notice.--If
under paragraph (1) the requirement for providing
notice in accordance with section 801(m) of the Federal
Food, Drug, and Cosmetic Act takes effect without final
regulations having been made effective, then for
purposes of such requirement, the specified period of
time that the notice is required to be made in advance
of the time of the importation of the article of food
involved or the offering of the food for import shall
be not fewer than eight hours and not more than five
days, which shall remain in effect until the final
regulations are made effective.
SEC. 308. AUTHORITY TO MARK ARTICLES REFUSED ADMISSION INTO UNITED
STATES.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(a)), as amended by section 307(a)
of this Act, is amended by adding at the end the following:
``(n)(1) If a food has been refused admission under
subsection (a), other than such a food that is required to be
destroyed, the Secretary may require the owner or consignee of
the food to affix to the container of the food a label that
clearly and conspicuously bears the statement: `UNITED STATES:
REFUSED ENTRY'.
``(2) All expenses in connection with affixing a label
under paragraph (1) shall be paid by the owner or consignee of
the food involved, and in default of such payment, shall
constitute a lien against future importations made by such
owner or consignee.
``(3) A requirement under paragraph (1) remains in effect
until the Secretary determines that the food involved has been
brought into compliance with this Act.''.
(b) Misbranded Foods.--Section 403 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at
the end the following:
``(v) If--
``(1) it fails to bear a label required by the
Secretary under section 801(n)(1) (relating to food
refused admission into the United States);
``(2) the Secretary finds that the food presents a
threat of serious adverse health consequences or death
to humans or animals; and
``(3) upon or after notifying the owner or
consignee involved that the label is required under
section 801, the Secretary informs the owner or
consignee that the food presents such a threat.''.
(c) Rule of Construction.--With respect to articles of food
that are imported or offered for import into the United States,
nothing in this section shall be construed to limit the
authority of the Secretary of Health and Human Services or the
Secretary of the Treasury to require the marking of refused
articles of food under any other provision of law.
SEC. 309. PROHIBITION AGAINST PORT SHOPPING.
Section 402 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 342) is amended by adding at the end the following:
``(h) If it is an article of food imported or offered for
import into the United States and the article of food has
previously been refused admission under section 801(a), unless
the person reoffering the article affirmatively establishes, at
the expense of the owner or consignee of the article, that the
article complies with the applicable requirements of this Act,
as determined by the Secretary.''.
SEC. 310. NOTICES TO STATES REGARDING IMPORTED FOOD.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 391 et seq.) is amended by adding at the end the
following section:
``SEC. 908. NOTICES TO STATES REGARDING IMPORTED FOOD.
``(a) In General.--If the Secretary has credible evidence
or information indicating that a shipment of imported food or
portion thereof presents a threat of serious adverse health
consequences or death to humans or animals, the Secretary shall
provide notice regarding such threat to the States in which the
food is held or will be held, and to the States in which the
manufacturer, packer, or distributor of the food is located, to
the extent that the Secretary has knowledge of which States are
so involved. In providing notice to a State, the Secretary
shall request the State to take such action as the State
considers appropriate, if any, to protect the public health
regarding the food involved.
``(b) Rule of Construction.--Subsection (a) may not be
construed as limiting the authority of the Secretary with
respect to food under any other provision of this Act.''.
SEC. 311. GRANTS TO STATES FOR INSPECTIONS.
Chapter IX of the Federal Food, Drug and Cosmetic Act, as
amended by section 310 of this Act, is amended by adding at the
end the following section:
``SEC. 909. GRANTS TO STATES FOR INSPECTIONS.
``(a) In General.--The Secretary is authorized to make
grants to States, territories, and Indian tribes (as defined in
section 4(e) of the Indian Self-Determination and Education
Assistance Act (25 U.S.C. 450b(e))) that undertake
examinations, inspections, and investigations, and related
activities under section 702. The funds provided under such
grants shall only be available for the costs of conducting such
examinations, inspections, investigations, and related
activities.
``(b) Notices Regarding Adulterated Imported Food.--The
Secretary may make grants to the States for the purpose of
assisting the States with the costs of taking appropriate
action to protect the public health in response to notification
under section 908, including planning and otherwise preparing
to take such action.
``(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $10,000,000 for fiscal year 2002, and such sums as
may be necessary for each of the fiscal years 2003 through
2006.''.
SEC. 312. SURVEILLANCE AND INFORMATION GRANTS AND AUTHORITIES.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq.) is amended by inserting after section 317P
the following:
``SEC. 317R. FOOD SAFETY GRANTS.
``(a) In General.--The Secretary may award grants to States
and Indian tribes (as defined in section 4(e) of the Indian
Self-Determination and Education Assistance Act (25 U.S.C.
450b(e))) to expand participation in networks to enhance
Federal, State, and local food safety efforts, including
meeting the costs of establishing and maintaining the food
safety surveillance, technical, and laboratory capacity needed
for such participation.
``(b) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $19,500,000 for fiscal year 2002, and such sums as
may be necessary for each of the fiscal years 2003 through
2006.''.
SEC. 313. SURVEILLANCE OF ZOONOTIC DISEASES.
The Secretary of Health and Human Services, through the
Commissioner of Food and Drugs and the Director of the Centers
for Disease Control and Prevention, and the Secretary of
Agriculture shall coordinate the surveillance of zoonotic
diseases.
SEC. 314. AUTHORITY TO COMMISSION OTHER FEDERAL OFFICIALS TO CONDUCT
INSPECTIONS.
Section 702(a) of the Federal Food, Drug and Cosmetic Act
(21 U.S.C. 372(a)) is amended--
(1) by striking ``(a)'' and inserting ``(a)(1)'';
(2) by striking ``In the case of food packed'' and
inserting the following:
``(3) In the case of food packed'';
(3) by striking ``For the purposes of this
subsection'' and inserting the following:
``(4) For the purposes of this subsection,''; and
(4) by inserting after paragraph (1) (as designated
by paragraph (1) of this section) the following
paragraph:
``(2)(A) In addition to the authority established in
paragraph (1), the Secretary, pursuant to a memorandum of
understanding between the Secretary and the head of another
Federal department or agency, is authorized to conduct
examinations and investigations for the purposes of this Act
through the officers and employees of such other department or
agency, subject to subparagraph (B). Such a memorandum shall
include provisions to ensure adequate training of such officers
and employees to conduct the examinations and investigations.
The memorandum of understanding shall contain provisions
regarding reimbursement. Such provisions may, at the sole
discretion of the head of the other department or agency,
require reimbursement, in whole or in part, from the Secretary
for the examinations or investigations performed under this
section by the officers or employees of the other department or
agency.
``(B) A memorandum of understanding under subparagraph (A)
between the Secretary and another Federal department or agency
is effective only in the case of examinations or inspections at
facilities or other locations that are jointly regulated by the
Secretary and such department or agency.
``(C) For any fiscal year in which the Secretary and the
head of another Federal department or agency carries out one or
more examinations or inspections under a memorandum of
understanding under subparagraph (A), the Secretary and the
head of such department or agency shall with respect to their
respective departments or agencies submit to the committees of
jurisdiction (authorizing and appropriating) in the House of
Representatives and the Senate a report that provides, for such
year--
``(i) the number of officers or employees that
carried out one or more programs, projects, or
activities under such memorandum;
``(ii) the number of additional articles that were
inspected or examined as a result of such memorandum;
and
``(iii) the number of additional examinations or
investigations that were carried out pursuant to such
memorandum.''.
SEC. 315. RULE OF CONSTRUCTION.
Nothing in this title, or an amendment made by this title,
shall be construed to alter the jurisdiction between the
Secretaries of Agriculture and of Health and Human Services,
under applicable statutes and regulations.
Subtitle B--Protection of Drug Supply
SEC. 321. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS; SHIPPING
INFORMATION; DRUG AND DEVICE LISTING.
(a) Annual Registration; Listing.--Section 510 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is
amended--
(1) in subsection (i)(1)--
(A) by striking ``Any establishment'' and
inserting ``On or before December 31 of each
year, any establishment''; and
(B) by striking ``shall register'' and all
that follows and inserting the following:
``shall, through electronic means in accordance
with the criteria of the Secretary, register
with the Secretary the name and place of
business of the establishment, the name of the
United States agent for the establishment, the
name of each importer of such drug or device in
the United States that is known to the
establishment, and the name of each person who
imports or offers for import such drug or
device to the United States for purposes of
importation.''; and
(2) in subsection (j)(1), in the first sentence, by
striking ``or (d)'' and inserting ``(d), or (i)''.
(b) Importation; Statement Regarding Registration of
Manufacturer.--
(1) In general.--Section 801 of the Federal Food,
Drug, and Cosmetic Act, as amended by section 308(a) of
this Act, is amended by adding at the end the following
subsection:
``(o) If an article that is a drug or device is being
imported or offered for import into the United States, and the
importer, owner, or consignee of such article does not, at the
time of offering the article for import, submit to the
Secretary a statement that identifies the registration under
section 510(i) of each establishment that with respect to such
article is required under such section to register with the
Secretary, the article may be refused admission. If the article
is refused admission for failure to submit such a statement,
the article shall be held at the port of entry for the article,
and may not be delivered to the importer, owner, or consignee
of the article, until such a statement is submitted to the
Secretary. Subsection (b) does not authorize the delivery of
the article pursuant to the execution of a bond while the
article is so held. The article shall be removed to a secure
facility, as appropriate. During the period of time that such
article is so held, the article shall not be transferred by any
person from the port of entry into the United States for the
article, or from the secure facility to which the article has
been removed, as the case may be.''.
(2) Prohibited act.--Section 301 of the Federal
Food, Drug, and Cosmetic Act, as amended by section
307(b) of this Act, is amended by adding at the end the
following:
``(ff) The importing or offering for import into the United
States of a drug or device with respect to which there is a
failure to comply with a request of the Secretary to submit to
the Secretary a statement under section 801(o).''.
(c) Effective Date.--The amendments made by this section
take effect upon the expiration of the 180-day period beginning
on the date of the enactment of this Act.
SEC. 322. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING IMPORT
COMPONENTS INTENDED FOR USE IN EXPORT PRODUCTS.
(a) In General.--Section 801(d)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to read
as follows:
``(3)(A) Subject to subparagraph (B), no component of a
drug, no component part or accessory of a device, or other
article of device requiring further processing, which is ready
or suitable for use for health-related purposes, and no article
of a food additive, color additive, or dietary supplement,
including a product in bulk form, shall be excluded from
importation into the United States under subsection (a) if each
of the following conditions is met:
``(i) The importer of such article of a drug or
device or importer of such article of a food additive,
color additive, or dietary supplement submits to
theSecretary, at the time of initial importation, a statement in
accordance with the following:
``(I) Such statement provides that such
article is intended to be further processed by
the initial owner or consignee, or incorporated
by the initial owner or consignee, into a drug,
biological product, device, food, food
additive, color additive, or dietary supplement
that will be exported by the initial owner or
consignee from the United States in accordance
with subsection (e) or section 802, or with
section 351(h) of the Public Health Service
Act.
``(II) The statement identifies the
manufacturer of such article and each
processor, packer, distributor, or other entity
that had possession of the article in the chain
of possession of the article from the
manufacturer to such importer of the article.
``(III) The statement is accompanied by
such certificates of analysis as are necessary
to identify such article, unless the article is
a device or is an article described in
paragraph (4).
``(ii) At the time of initial importation and
before the delivery of such article to the importer or
the initial owner or consignee, such owner or consignee
executes a good and sufficient bond providing for the
payment of such liquidated damages in the event of
default as may be required pursuant to regulations of
the Secretary of the Treasury.
``(iii) Such article is used and exported by the
initial owner or consignee in accordance with the
intent described under clause (i)(I), except for any
portions of the article that are destroyed.
``(iv) The initial owner or consignee maintains
records on the use or destruction of such article or
portions thereof, as the case may be, and submits to
the Secretary any such records requested by the
Secretary.
``(v) Upon request of the Secretary, the initial
owner or consignee submits a report that provides an
accounting of the exportation or destruction of such
article or portions thereof, and the manner in which
such owner or consignee complied with the requirements
of this subparagraph.
``(B) Notwithstanding subparagraph (A), the Secretary may
refuse admission to an article that otherwise would be imported
into the United States under such subparagraph if the Secretary
determines that there is credible evidence or information
indicating that such article is not intended to be further
processed by the initial owner or consignee, or incorporated by
the initial owner or consignee, into a drug, biological
product, device, food, food additive, color additive, or
dietary supplement that will be exported by the initial owner
or consignee from the United States in accordance with
subsection (e) or section 802, or with section 351(h) of the
Public Health Service Act.
``(C) This section may not be construed as affecting the
responsibility of the Secretary to ensure that articles
imported into the United States under authority of subparagraph
(A) meet each of the conditions established in such
subparagraph for importation.''.
(b) Prohibited Act.--Section 301(w) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(w)) is amended to read as
follows:
``(w) The making of a knowingly false statement in any
statement, certificate of analysis, record, or report required
or requested under section 801(d)(3); the failure to submit a
certificate of analysis as required under such section; the
failure to maintain records or to submit records or reports as
required by such section; the release into interstate commerce
of any article or portion thereof imported into the United
States under such section or any finished product made from
such article or portion, except for export in accordance with
section 801(e) or 802, or with section 351(h) of the Public
Health Service Act; or the failure to so export or to destroy
such an article or portions thereof, or such a finished
product.''.
(c) Effective Date.--The amendments made by this section
take effect upon the expiration of the 90-day period beginning
on the date of the enactment of this Act.
Subtitle C--General Provisions Relating to Upgrade of Agricultural
Security
SEC. 331. EXPANSION OF ANIMAL AND PLANT HEALTH INSPECTION SERVICE
ACTIVITIES.
(a) In General.--The Secretary of Agriculture (referred to
in this section as the ``Secretary'') may utilize existing
authorities to give high priority to enhancing and expanding
the capacity of the Animal and Plant Health Inspection Service
to conduct activities to--
(1) increase the inspection capacity of the Service
at international points of origin;
(2) improve surveillance at ports of entry and
customs;
(3) enhance methods of protecting against the
introduction of plant and animal disease organisms by
terrorists;
(4) develop new and improve existing strategies and
technologies for dealing with intentional outbreaks of
plant and animal disease arising from acts of terrorism
or from unintentional introduction, including--
(A) establishing cooperative agreements
among Veterinary Services of the Animal and
Plant Health Inspection Service, State animal
health commissions and regulatory agencies for
livestock and poultry health, and private
veterinary practitioners to enhance the
preparedness and ability of Veterinary Services
and the commissions and agencies to respond to
outbreaks of such animal diseases; and
(B) strengthening planning and coordination
with State and local agencies, including--
(i) State animal health commissions
and regulatory agencies for livestock
and poultry health; and
(ii) State agriculture departments;
and
(5) otherwise improve the capacity of the Service
to protect against the threat of bioterrorism.
(b) Automated Recordkeeping System.--The Administrator of
the Animal and Plant Health Inspection Service may implement a
central automated recordkeeping system to provide for the
reliable tracking of the status of animal and plant shipments,
including those shipmentson hold at ports of entry and customs.
The Secretary shall ensure that such a system shall be fully accessible
to or fully integrated with the Food Safety Inspection Service.
(c) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $30,000,000 for
fiscal year 2002, and such sums as may be necessary for each
subsequent fiscal year.
SEC. 332. EXPANSION OF FOOD SAFETY INSPECTION SERVICE ACTIVITIES.
(a) In General.--The Secretary of Agriculture may utilize
existing authorities to give high priority to enhancing and
expanding the capacity of the Food Safety Inspection Service to
conduct activities to--
(1) enhance the ability of the Service to inspect
and ensure the safety and wholesomeness of meat and
poultry products;
(2) improve the capacity of the Service to inspect
international meat and meat products, poultry and
poultry products, and egg products at points of origin
and at ports of entry;
(3) strengthen the ability of the Service to
collaborate with relevant agencies within the
Department of Agriculture and with other entities in
the Federal Government, the States, and Indian tribes
(as defined in section 4(e) of the Indian Self-
Determination and Education Assistance Act (25 U.S.C.
450b(e))) through the sharing of information and
technology; and
(4) otherwise expand the capacity of the Service to
protect against the threat of bioterrorism.
(b) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $15,000,000 for
fiscal year 2002, and such sums as may be necessary for each
subsequent fiscal year.
SEC. 333. BIOSECURITY UPGRADES AT THE DEPARTMENT OF AGRICULTURE.
There is authorized to be appropriated for fiscal year
2002, $180,000,000 for the purpose of enabling the Agricultural
Research Service to conduct building upgrades to modernize
existing facilities, of which (1) $100,000,000 shall be
allocated for renovation, updating, and expansion of the
Biosafety Level 3 laboratory and animal research facilities at
the Plum Island Animal Disease Center (Greenport, New York),
and of which (2) $80,000,000 shall be allocated for the
Agricultural Research Service/Animal and Plant Health
Inspection Service facility in Ames, Iowa. There are authorized
to be appropriated such sums as may be necessary for fiscal
years 2003 through 2006 for the purpose described in the
preceding sentence, for the planning and design of an
Agricultural Research Service biocontainment laboratory for
poultry research in Athens, Georgia, and for the planning,
updating, and renovation of the Arthropod-Borne Animal Disease
Laboratory in Laramie, Wyoming.
SEC. 334. AGRICULTURAL BIOSECURITY.
(a) Security at Colleges and Universities.--
(1) Grants.--The Secretary of Agriculture (referred
to in this section as the ``Secretary'') may award
grants to covered entities to review security standards
and practices at their facilities in order to protect
against bioterrorist attacks.
(2) Covered entities.--Covered entities under this
subsection are colleges or universities that--
(A) are colleges or universities as defined
in section 1404 of the National Agricultural
Research, Extension, and Teaching Policy Act of
1977 (7 U.S.C. 3103); and
(B) have programs in food and agricultural
sciences, as defined in such section.
(3) Limitation.--Each individual covered entity may
be awarded one grant under paragraph (1), the amount of
which shall not exceed $50,000.
(4) Contract authority.--Colleges and universities
receiving grants under paragraph (1) may use such
grants to enter into contracts with independent private
organizations with established and demonstrated
security expertise to conduct the security reviews
specified in such paragraph.
(b) Guidelines for Agricultural Biosecurity.--
(1) In general.--The Secretary may award grants to
associations of food producers or consortia of such
associations for the development and implementation of
educational programs to improve biosecurity on farms in
order to ensure the security of farm facilities against
potential bioterrorist attacks.
(2) Limitation.--Each individual association
eligible under paragraph (1) may be awarded one grant
under such paragraph, the amount of which shall not
exceed $100,000. Each consortium eligible under
paragraph (1) may be awarded one grant under such
paragraph, the amount of which shall not exceed
$100,000 per association participating in the
consortium.
(3) Contract authority.--Associations of food
producers receiving grants under paragraph (1) may use
such grants to enter into contracts with independent
private organizations with established and demonstrated
expertise in biosecurity to assist in the development
and implementation of educational programs to improve
biosecurity specified in such paragraph.
(c) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each fiscal year.
SEC. 335. AGRICULTURAL BIOTERRORISM RESEARCH AND DEVELOPMENT.
(a) In General.--The Secretary of Agriculture (referred to
in this section as the ``Secretary'') may utilize existing
research authorities and research programs to protect the food
supply of the United States by conducting and supporting
research activities to--
(1) enhance the capability of the Secretary to
respond in a timely manner to emerging or existing
bioterrorist threats to the food and agricultural
system of the United States;
(2) develop new and continue partnerships with
institutions of higher education and other institutions
to help form stable, long-term programs to enhance the
biosecurity and food safety of the United States,
including the coordination of the development,
implementation, and enhancement of diverse capabilities
for addressing threats to the nation's agricultural
economy and food supply, with special emphasis on
planning, training, outreach, and research activities
related to vulnerability analyses, incident response,
detection, and prevention technologies;
(3) strengthen coordination with the intelligence
community to better identify research needs and
evaluate materials or information acquired by the
intelligence community relating to potential threats to
United States agriculture;
(4) expand the involvement of the Secretary with
international organizations dealing with plant and
animal disease control;
(5) continue research to develop rapid detection
field test kits to detect biological threats to plants
and animals and to provide such test kits to State and
local agencies preparing for or responding to
bioterrorism;
(6) develop an agricultural bioterrorism early
warning surveillance system through enhancing the
capacity of and coordination between State veterinary
diagnostic laboratories, Federal and State agricultural
research facilities, and public health agencies; and
(7) otherwise improve the capacity of the Secretary
to protect against the threat of bioterrorism.
(b) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $190,000,000 for
fiscal year 2002, and such sums as may be necessary for each
subsequent fiscal year.
SEC. 336. ANIMAL ENTERPRISE TERRORISM PENALTIES.
(a) In General.--Section 43(a) of title 18, United States
Code, is amended to read as follows:
``(a) Offense.--Whoever--
``(1) travels in interstate or foreign commerce, or
uses or causes to be used the mail or any facility in
interstate or foreign commerce for the purpose of
causing physical disruption to the functioning of an
animal enterprise; and
``(2) intentionally damages or causes the loss of
any property (including animals or records) used by the
animal enterprise, or conspires to do so,
shall be punished as provided for in subsection (b).''.
(b) Penalties.--Section 43(b) of title 18, United States
Code, is amended to read as follows:
``(b) Penalties.--
``(1) Economic damage.--Any person who, in the
course of a violation of subsection (a), causes
economic damage not exceeding $10,000 to an animal
enterprise shall be fined under this title or
imprisoned not more than 6 months, or both.
``(2) Major economic damage.--Any person who, in
the course of a violation of subsection (a), causes
economic damage exceeding $10,000 to an animal
enterprise shall be fined under this title or
imprisoned not more than 3 years, or both.
``(3) Serious bodily injury.--Any person who, in
the course of a violation of subsection (a), causes
serious bodily injury to another individual shall be
fined under this title or imprisoned not more than 20
years, or both.
``(4) Death.--Any person who, in the course of a
violation of subsection (a), causes the death of an
individual shall be fined under this title and
imprisoned for life or for any term of years.''.
(c) Restitution.--Section 43(c) of title 18, United States
Code, is amended--
(1) in paragraph (1), by striking ``and'' at the
end;
(2) in paragraph (2), by striking the period at the
end and inserting ``; and''; and
(3) by adding at the end the following:
``(3) for any other economic damage resulting from
the offense.''.
TITLE IV--DRINKING WATER SECURITY AND SAFETY
SEC. 401. TERRORIST AND OTHER INTENTIONAL ACTS.
The Safe Drinking Water Act (title XIV of the Public Health
Service Act) is amended by inserting the following new section
after section 1432:
``SEC. 1433. TERRORIST AND OTHER INTENTIONAL ACTS.
``(a) Vulnerability Assessments.--(1) Each community water
system serving a population of greater than 3,300 persons shall
conduct an assessment of the vulnerability of its system to a
terrorist attack or other intentional acts intended to
substantially disrupt the ability of the system to provide a
safe and reliable supply of drinking water. The vulnerability
assessment shall include, but not be limited to, a review of
pipes and constructed conveyances, physical barriers, water
collection, pretreatment, treatment, storage and distribution
facilities, electronic, computer or other automated systems
which are utilized by the public water system, the use,
storage, or handling of various chemicals, and the operation
and maintenance of such system. The Administrator, not later
than August 1, 2002, after consultation with appropriate
departments and agencies of the Federal Government and with
State and local governments, shall provide baseline information
to community water systems required to conduct vulnerability
assessments regarding which kinds of terrorist attacks or other
intentional acts are the probable threats to--
``(A) substantially disrupt the ability of the
system to provide a safe and reliable supply of
drinking water; or
``(B) otherwise present significant public health
concerns.
``(2) Each community water system referred to in paragraph
(1) shall certify to the Administrator that the system has
conducted an assessment complying with paragraph (1) and shall
submit to the Administrator a written copy of the assessment.
Such certification and submission shall be made prior to:
``(A) March 31, 2003, in the case of systems
serving a population of 100,000 or more.
``(B) December 31, 2003, in the case of systems
serving a population of 50,000 or more but less than
100,000.
``(C) June 30, 2004, in the case of systems serving
a population greater than 3,300 but less than 50,000.
``(3) Except for information contained in a certification
under this subsection identifying the system submitting the
certification and the date of the certification, all
information provided to the Administrator under this subsection
and all information derived therefrom shall be exempt from
disclosure under section 552 of title 5 of the United States
Code.
``(4) No community water system shall be required under
State or local law to provide an assessment described in this
section to any State, regional, or local governmental entity
solely by reason of the requirement set forth in paragraph (2)
that the system submit such assessment to the Administrator.
``(5) Not later than November 30, 2002, the Administrator,
in consultation with appropriate Federal law enforcement and
intelligence officials, shall develop such protocols as may be
necessary to protect the copies of the assessments required to
be submitted under this subsection (and the information
contained therein) from unauthorized disclosure. Such protocols
shall ensure that--
``(A) each copy of such assessment, and all
information contained in or derived from the
assessment, is kept in a secure location;
``(B) only individuals designated by the
Administrator may have access to the copies of the
assessments; and
``(C) no copy of an assessment, or part of an
assessment, or information contained in or derivedfrom
an assessment shall be available to anyone other than an individual
designated by the Administrator.
At the earliest possible time prior to November 30, 2002, the
Administrator shall complete the development of such protocols
for the purpose of having them in place prior to receiving any
vulnerability assessments from community water systems under
this subsection.
``(6)(A) Except as provided in subparagraph (B), any
individual referred to in paragraph (5)(B) who acquires the
assessment submitted under paragraph (2), or any reproduction
of such assessment, or any information derived from such
assessment, and who knowingly or recklessly reveals such
assessment, reproduction, or information other than--
``(i) to an individual designated by the
Administrator under paragraph (5),
``(ii) for purposes of section 1445 or for actions
under section 1431, or
``(iii) for use in any administrative or judicial
proceeding to impose a penalty for failure to comply
with this section,
shall upon conviction be imprisoned for not more than one year
or fined in accordance with the provisions of chapter 227 of
title 18, United States Code, applicable to class A
misdemeanors, or both, and shall be removed from Federal office
or employment.
``(B) Notwithstanding subparagraph (A), an individual
referred to in paragraph (5)(B) who is an officer or employee
of the United States may discuss the contents of a
vulnerability assessment submitted under this section with a
State or local official.
``(7) Nothing in this section authorizes any person to
withhold any information from Congress or from any committee or
subcommittee of Congress.
``(b) Emergency Response Plan.--Each community water system
serving a population greater than 3,300 shall prepare or
revise, where necessary, an emergency response plan that
incorporates the results of vulnerability assessments that have
been completed. Each such community water system shall certify
to the Administrator, as soon as reasonably possible after the
enactment of this section, but not later than 6 months after
the completion of the vulnerability assessment under subsection
(a), that the system has completed such plan. The emergency
response plan shall include, but not be limited to, plans,
procedures, and identification of equipment that can be
implemented or utilized in the event of a terrorist or other
intentional attack on the public water system. The emergency
response plan shall also include actions, procedures, and
identification of equipment which can obviate or significantly
lessen the impact of terrorist attacks or other intentional
actions on the public health and the safety and supply of
drinking water provided to communities and individuals.
Community water systems shall, to the extent possible,
coordinate with existing Local Emergency Planning Committees
established under the Emergency Planning and Community Right-
to-Know Act (42 U.S.C. 11001, et seq.) when preparing or
revising an emergency response plan under this subsection.
``(c) Record Maintenance.--Each community water system
shall maintain a copy of the emergency response plan completed
pursuant to subsection (b) for 5 years after such plan has been
certified to the Administrator under this section.
``(d) Guidance to Small Public Water Systems.--The
Administrator shall provide guidance to community water systems
serving a population of less than 3,300 persons on how to
conduct vulnerability assessments, prepare emergency response
plans, and address threats from terrorist attacks or other
intentional actions designed to disrupt the provision of safe
drinking water or significantly affect the public health or
significantly affect the safety or supply of drinking water
provided to communities and individuals.
``(e) Funding.--(1) There are authorized to be appropriated
to carry out this section not more than $160,000,000 for the
fiscal year 2002 and such sums as may be necessary for the
fiscal years 2003 through 2005.
``(2) The Administrator, in coordination with State and
local governments, may use funds made available under paragraph
(1) to provide financial assistance to community water systems
for purposes of compliance with the requirements of subsections
(a) and (b) and to community water systems for expenses and
contracts designed to address basic security enhancements of
critical importance and significant threats to public health
and the supply of drinking water as determined by a
vulnerability assessment conducted under subsection (a). Such
basic security enhancements may include, but shall not be
limited to the following:
``(A) the purchase and installation of equipment
for detection of intruders;
``(B) the purchase and installation of fencing,
gating, lighting, or security cameras;
``(C) the tamper-proofing of manhole covers, fire
hydrants, and valve boxes;
``(D) the rekeying of doors and locks;
``(E) improvements to electronic, computer, or
other automated systems and remote security systems;
``(F) participation in training programs, and the
purchase of training manuals and guidance materials,
relating to security against terrorist attacks;
``(G) improvements in the use, storage, or handling
of various chemicals; and
``(H) security screening of employees or contractor
support services.
Funding under this subsection for basic security enhancements
shall not include expenditures for personnel costs, or
monitoring, operation, or maintenance of facilities, equipment,
or systems.
``(3) The Administrator may use not more than $5,000,000
from the funds made available under paragraph (1) to make
grants to community water systems to assist in responding to
and alleviating any vulnerability to a terrorist attack or
other intentional acts intended to substantially disrupt the
ability of the system to provide a safe and reliable supply of
drinking water (including sources of water for such systems)
which the Administrator determines to present an immediate and
urgent security need.
``(4) The Administrator may use not more than $5,000,000
from the funds made available under paragraph (1) to make
grants to community water systems serving a population of less
than 3,300 persons for activities and projects undertaken in
accordance with the guidance provided to such systems under
subsection (d).
SEC. 402. OTHER SAFE DRINKING WATER ACT AMENDMENTS.
The Safe Drinking Water Act (title XIV of the Public Health
Service Act) is amended by inserting the following new sections
after section 1433 (as added by section 401 of this Act):
``SEC. 1434. CONTAMINANT PREVENTION, DETECTION AND RESPONSE.
``(a) In General.--The Administrator, in consultation with
the Centers for Disease Control and, after consultation with
appropriate departments and agencies of the Federal Government
and with State and local governments, shall review (or enter
into contracts or cooperative agreements to provide for a
review of) current and future methods to prevent, detect and
respond to the intentional introduction of chemical, biological
or radiological contaminants into community water systems and
source water for community water systems, including each of the
following:
``(1) Methods, means and equipment, including real
time monitoring systems, designed to monitor and detect
various levels of chemical, biological, and
radiological contaminants or indicators of contaminants
and reduce the likelihood that such contaminants can be
successfully introduced into public water systems and
source water intended to be used for drinking water.
``(2) Methods and means to provide sufficient
notice to operators of public water systems, and
individuals served by such systems, of the introduction
of chemical, biological or radiological contaminants
and the possible effect of such introduction on public
health and the safety and supply of drinking water.
``(3) Methods and means for developing educational
and awareness programs for community water systems.
``(4) Procedures and equipment necessary to prevent
the flow of contaminated drinking water to individuals
served by public water systems.
``(5) Methods, means, and equipment which could
negate or mitigate deleterious effects on public health
and the safety and supply caused by the introduction of
contaminants into water intended to be used for
drinking water, including an examination of the
effectiveness of various drinking water technologies in
removing, inactivating, or neutralizing biological,
chemical, and radiological contaminants.
``(6) Biomedical research into the short-term and
long-term impact on public health of various chemical,
biological and radiological contaminants that may be
introduced into public water systems through terrorist
or other intentional acts.
``(b) Funding.--For the authorization of appropriations to
carry out this section, see section 1435(e).
``SEC. 1435. SUPPLY DISRUPTION PREVENTION, DETECTION AND RESPONSE.
``(a) Disruption of Supply or Safety.--The Administrator,
in coordination with the appropriate departments and agencies
of the Federal Government, shall review (or enter into
contracts or cooperative agreements to provide for a review of)
methods and means by which terrorists or other individuals or
groups could disrupt the supply of safe drinking water or take
other actions against water collection, pretreatment,
treatment, storage and distribution facilities which could
render such water significantly less safe for human
consumption, including each of the following:
``(1) Methods and means by which pipes and other
constructed conveyances utilized in public water
systems could be destroyed or otherwise prevented from
providing adequate supplies of drinking water meeting
applicable public health standards.
``(2) Methods and means by which collection,
pretreatment, treatment, storage and distribution
facilities utilized or used in connection with public
water systems and collection and pretreatment storage
facilities used in connection with public water systems
could be destroyed or otherwise prevented from
providing adequate supplies of drinking water meeting
applicable public health standards.
``(3) Methods and means by which pipes, constructed
conveyances, collection, pretreatment, treatment,
storage and distribution systems that are utilized in
connection with public water systems could be altered
or affected so as to be subject to cross-contamination
of drinking water supplies.
``(4) Methods and means by which pipes, constructed
conveyances, collection, pretreatment, treatment,
storage and distribution systems that are utilized in
connection with public water systems could be
reasonably protected from terrorist attacks or other
acts intended to disrupt the supply or affect the
safety of drinking water.
``(5) Methods and means by which information
systems, including process controls and supervisory
control and data acquisition and cyber systems at
community water systems could be disrupted by
terrorists or other groups.
``(b) Alternative Sources.--The review under this section
shall also include a review of the methods and means by which
alternative supplies of drinking water could be provided in the
event of the destruction, impairment or contamination of public
water systems.
``(c) Requirements and Considerations.--In carrying out
this section and section 1434--
``(1) the Administrator shall ensure that reviews
carried out under this section reflect the needs of
community water systems of various sizes and various
geographic areas of the United States; and
``(2) the Administrator may consider the
vulnerability of, or potential for forced interruption
of service for, a region or service area, including
community water systems that provide service to the
National Capital area.
``(d) Information Sharing.--As soon as practicable after
reviews carried out under this section or section 1434 have
been evaluated, the Administrator shall disseminate, as
appropriate as determined by the Administrator, to community
water systems information on the results of the project through
the Information Sharing and Analysis Center, or other
appropriate means.
``(e) Funding.--There are authorized to be appropriated to
carry out this section and section 1434 not more than
$15,000,000 for the fiscal year 2002 and such sums as may be
necessary for the fiscal years 2003 through 2005.''.
SEC. 403. MISCELLANEOUS AND TECHNICAL AMENDMENTS.
The Safe Drinking Water Act is amended as follows:
(1) Section 1414(i)(1) is amended by inserting
``1433'' after ``1417''.
(2) Section 1431 is amended by inserting in the
first sentence after ``drinking water'' the following:
``, or that there is a threatened or potential
terrorist attack (or other intentional act designed to
disrupt the provision of safe drinking water or to
impact adversely the safety of drinking water supplied
to communities and individuals), which''.
(3) Section 1432 is amended as follows:
(A) By striking ``5 years'' in subsection
(a) and inserting ``20 years''.
(B) By striking ``3 years'' in subsection
(b) and inserting ``10 years''.
(C) By striking ``$50,000'' in subsection
(c) and inserting ``$1,000,000''.
(D) By striking ``$20,000'' in subsection
(c) and inserting ``$100,000''.
(4) Section 1442 is amended as follows:
(A) By striking ``this subparagraph'' in
subsection (b) and inserting ``this
subsection''.
(B) By amending subsection (d) to read as
follows:
``(d) There are authorized to be appropriated to carry out
subsection (b) not more than $35,000,000 for the fiscal year
2002 and such sums as may be necessary for each fiscal year
thereafter.''.
TITLE V--ADDITIONAL PROVISIONS
Subtitle A--Prescription Drug User Fees
SEC. 501. SHORT TITLE.
This subtitle may be cited as the ``Prescription Drug User
Fee Amendments of 2002''.
SEC. 502. FINDINGS.
The Congress finds that--
(1) prompt approval of safe and effective new drugs
and other therapies is critical to the improvement of
the public health so that patients may enjoy the
benefits provided by these therapies to treat and
prevent illness and disease;
(2) the public health will be served by making
additional funds available for the purpose of
augmenting the resources of the Food and Drug
Administration that are devoted to the process for the
review of human drug applications and the assurance of
drug safety;
(3) the provisions added by the Prescription Drug
User Fee Act of 1992, as amended by the Food and Drug
Administration Modernization Act of 1997, have been
successful in substantially reducing review times for
human drug applications and should be--
(A) reauthorized for an additional 5 years,
with certain technical improvements; and
(B) carried out by the Food and Drug
Administration with new commitments to
implement more ambitious and comprehensive
improvements in regulatory processes of the
Food and Drug Administration, including--
(i) strengthening and improving the
review and monitoring of drug safety;
(ii) considering greater
interaction between the agency and
sponsors during the review of drugs and
biologics intended to treat serious
diseases and life-threatening diseases;
and
(iii) developing principles for
improving first-cycle reviews; and
(4) the fees authorized by amendments made in this
subtitle will be dedicated towards expediting the drug
development process and the process for the review of
human drug applications as set forth in the goals
identified for purposes of part 2 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic
Act, in the letters from the Secretary of Health and
Human Services to the chairman of the Committee on
Energy and Commerce of the House of Representatives and
the chairman of the Committee on Health, Education,
Labor and Pensions of the Senate, as set forth in the
Congressional Record.
SEC. 503. DEFINITIONS.
Section 735 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379g) is amended--
(1) in paragraph (1), in the matter after and below
subparagraph (C), by striking ``licensure, as described
in subparagraph (D)'' and inserting ``licensure, as
described in subparagraph (C)'';
(2) in paragraph (3)--
(A) in subparagraph (A), by striking
``and'' at the end;
(B) in subparagraph (B), by striking the
period and inserting ``, and'';
(C) by inserting after subparagraph (B) the
following subparagraph:
``(C) which is on the list of products
described in section 505(j)(7)(A) or is on a
list created and maintained by the Secretary of
products approved under human drug applications
under section 351 of the Public Health Service
Act.''; and
(D) in the matter after and below
subparagraph (C) (as added by subparagraph (C)
of this paragraph), by striking ``Service
Act,'' and all that follows through
``biological product'' and inserting the
following: ``Service Act. Such term does not
include a biological product'';
(3) in paragraph (6), by adding at the end the
following subparagraph:
``(F) In the case of drugs approved after
October 1, 2002, under human drug applications
or supplements: collecting, developing, and
reviewing safety information on the drugs,
including adverse event reports, during a
period of time after approval of such
applications or supplements, not to exceed
three years.''; and
(4) in paragraph (8)--
(A) by striking the matter after and below
subparagraph (B);
(B) by striking subparagraph (B);
(C) by striking ``is the lower of'' and all
that follows through ``Consumer Price Index''
and inserting ``is the Consumer Price Index'';
and
(D) by striking ``1997, or'' and inserting
``1997.''.
SEC. 504. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--Section 736(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended--
(1) in the matter preceding paragraph (1), by
striking ``fiscal year 1998'' and inserting ``fiscal
year 2003'';
(2) in paragraph (1)(A)--
(A) in each of clauses (i) and (ii), by
striking ``in subsection (b)'' and inserting
``under subsection (c)(4)''; and
(B) in clause (ii), by adding at the end
the following sentence: ``Such fee shall be
half ofthe amount of the fee established under
clause (i).'';
(3) in paragraph (2)(A), in the matter after and
below clause (ii)--
(A) by striking ``in subsection (b)'' and
inserting ``under subsection (c)(4)''; and
(B) by striking ``payable on or before
January 31'' and inserting ``payable on or
before October 1''; and
(4) in paragraph (3)--
(A) by amending subparagraph (A) to read as
follows:
``(A) In general.--Except as provided in
subparagraph (B), each person who is named as
the applicant in a human drug application, and
who, after September 1, 1992, had pending
before the Secretary a human drug application
or supplement, shall pay for each such
prescription drug product the annual fee
established under subsection (c)(4). Such fee
shall be payable on or before October 1 of each
year. Such fee shall be paid only once for each
product for a fiscal year in which the fee is
payable.''; and
(B) in subparagraph (B), by striking ``The
listing'' and all that follows through ``filed
under section 505(b)(2)'' and inserting the
following: ``A prescription drug product shall
not be assessed a fee under subparagraph (A) if
such product is identified on the list compiled
under section 505(j)(7)(A) with a potency
described in terms of per 100 mL, or if such
product is the same product as another product
approved under an application filed under
section 505(b)''.
(b) Fee Amounts.--Section 736(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as
follows:
``(b) Fee Revenue Amounts.--Except as provided in
subsections (c), (d), (f), and (g), fees under subsection (a)
shall be established to generate the following revenue amounts:
----------------------------------------------------------------------------------------------------------------
Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year
``Type of Fee Revenue 2003 2004 2005 2006 2007
----------------------------------------------------------------------------------------------------------------
Application/Supplement.......... $74,300,000 $77,000,000 $84,000,000 $86,434,000 $86,434,000
Establishment................... $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000
Product......................... $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000
Total Fee Revenue............... $222,900,000 $231,000,000 $252,000,000 $259,300,000 $259,300,000
----------------------------------------------------------------------------------------------------------------
If, after the date of the enactment of the Prescription Drug
User Fee Amendments of 2002, legislation is enacted requiring
the Secretary to fund additional costs of the retirement of
Federal personnel, fee revenue amounts shall be increased in
each year by the amount necessary to fully fund the portion of
such additional costs that are attributable to the process for
the review of human drug applications.''.
(c) Adjustments.--Section 736(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(c)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph
(A), by striking ``fees and total fee
revenues'' and inserting ``revenues'';
(B) in subparagraph (A)--
(i) by striking ``during the
preceding fiscal year''; and
(ii) by striking ``, or'' and
inserting the following: ``for the 12
month period ending June 30 preceding
the fiscal year for which fees are
being established, or'';
(C) in subparagraph (B), by striking ``for
such fiscal year'' and inserting ``for the
previous fiscal year''; and
(D) in the matter after and below
subparagraph (B), by striking ``fiscal year
1997''; and inserting ``fiscal year 2003'';
(2) by redesignating paragraphs (2) and (3) as
paragraphs (4) and (5), respectively;
(3) by inserting after paragraph (1) the following
paragraphs:
``(2) Workload adjustment.--Beginning with fiscal
year 2004, after the fee revenues established in
subsection (b) are adjusted for a fiscal year for
inflation in accordance with paragraph (1), the fee
revenues shall be adjusted further for such fiscal year
to reflect changes in the workload of the Secretary for
the process for the review of human drug applications.
With respect to such adjustment:
``(A) The adjustment shall be determined by
the Secretary based on a weighted average of
the change in the total number of human drug
applications, commercial investigational new
drug applications, efficacy supplements, and
manufacturing supplements submitted to the
Secretary. The Secretary shall publish in the
Federal Register the fee revenues and fees
resulting from the adjustment and the
supporting methodologies.
``(B) Under no circumstances shall the
adjustment result in fee revenues for a fiscal
year that are less than the fee revenues for
the fiscal year established in subsection (b),
as adjusted for inflation under paragraph (1).
``(3) Final year adjustment.--For fiscal year 2007,
the Secretary may, in addition to adjustments under
paragraphs (1) and (2), further increase the fee
revenues and fees established in subsection (b) if such
an adjustment is necessary to provide for not more than
three months of operating reserves of carryover user
fees for the process for the review of human drug
applications for the first three months of fiscal year
2008. If such an adjustment is necessary, the rationale
for the amount of the increase shall be contained in
the annual notice establishing fee revenues and fees
for fiscal year 2007. If the Secretary has carryover
balances for such process in excess of three months of
such operating reserves, the adjustment under this
paragraph shall not be made.''; and
(4) in paragraph (4) (as redesignated by paragraph
(2) of this subsection), by amending such paragraph to
read as follows:
``(4) Annual fee setting.--The Secretary shall, 60
days before the start of each fiscal year that begins
after September 30, 2002, establish, for the next
fiscal year, application, product, and establishment
fees under subsection (a), based on the revenue amounts
established under subsection (b) and the adjustments
provided under this subsection.''.
(d) Fee Waiver or Reduction.--Section 736(d)) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is
amended--
(1) in paragraph (1)--
(A) in subparagraph (C), by inserting
``or'' after the comma at the end;
(B) by striking subparagraph (D); and
(C) by redesignating subparagraph (E) as
subparagraph (D); and
(2) in paragraph (3), in each of subparagraphs (A)
and (B), by striking ``paragraph (1)(E)'' each place
such term appears and inserting ``paragraph (1)(D)''.
(e) Assessment of Fees.--Section 736(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)) is amended--
(1) in the heading for the subsection, by striking
``Assessment of Fees.--'' and inserting
``Limitations.--''; and
(2) in paragraph (1), by striking the heading for
the paragraph and all that follows through ``fiscal
year beginning'' and inserting the following: ``In
general.--Fees under subsection (a) shall be refunded
for a fiscal year beginning''.
(f) Crediting and Availability of Fees.--
(1) In general.--Section 736(g)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(1)) is
amended by striking ``Fees collected for a fiscal
year'' and all that follows through ``fiscal year
limitation.'' and inserting the following: ``Fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the
amount provided in advance in appropriations Acts. Such
fees are authorized to remain available until
expended.''.
(2) Collections and appropriation acts.--Section
736(g)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379h(g)(2)) is amended--
(A) by redesignating subparagraphs (A) and
(B) as clauses (i) and (ii), respectively;
(B) by striking ``(2) Collections'' and all
that follows through ``the amount specified''
in clause (i) (as so redesignated) and
inserting the following:
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by
this section--
``(i) shall be retained in each
fiscal year in an amount not to exceed
the amount specified'';
(C) by moving clause (ii) (as so
redesignated) two ems to the right; and
(D) by adding at the end the following
subparagraph:
``(B) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated
for the process for the review of human drug
applications--
``(i) are not more than 3 percent
below the level specified in
subparagraph (A)(ii); or
``(ii)(I) are more than 3 percent
below the level specified in
subparagraph (A)(ii), and fees assessed
for the fiscal year following the
subsequent fiscal year are decreased by
the amount in excess of 3 percent by
which such costs fell below the level
specified in such subparagraph; and
``(II) such costs are not more than
5 percent below the level specified in
such subparagraph.''.
(3) Authorization of appropriations.--Section
736(g)(3) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379h(g)(3)) is amended by striking
subparagraphs (A) through (E) and inserting the
following:
``(A) $222,900,000 for fiscal year 2003;
``(B) $231,000,000 for fiscal year 2004;
``(C) $252,000,000 for fiscal year 2005;
``(D) $259,300,000 for fiscal year 2006;
and
``(E) $259,300,000 for fiscal year 2007;''.
SEC. 505. ACCOUNTABILITY AND REPORTS.
(a) Public Accountability.--
(1) Consultation.--In developing recommendations to
the Congress for the goals and plans for meeting the
goals for the process for the review of human drug
applications for the fiscal years after fiscal year
2007, and for the reauthorization of sections 735 and
736 of the Federal Food, Drug, and Cosmetic Act, the
Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall consult with
the Committee on Energy and Commerce of the House of
Representatives, the Committee on Health, Education,
Labor, and Pensions of the Senate, appropriate
scientific and academic experts, health care
professionals, representatives of patient and consumer
advocacy groups, and the regulated industry.
(2) Recommendations.--The Secretary shall publish
in the Federal Register recommendations under paragraph
(1), after negotiations with the regulated industry;
shall present such recommendations to the congressional
committees specified in such paragraph; shall hold a
meeting at which the public may present its views on
such recommendations; and shall provide for a period of
30 days for the public to provide written comments on
such recommendations.
(b) Performance Report.--Beginning with fiscal year 2003,
not later than 60 days after the end of each fiscal year during
which fees are collected under part 2 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379g et seq.), the Secretary of Health and Human
Services shall prepare and submit to the President, the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor,
and Pensions of the Senate a report concerning the progress of
the Food and Drug Administration in achieving the goals
identified in the letters described in section 502(4) during
such fiscal year and the future plans of the Food and Drug
Administration for meeting the goals.
(c) Fiscal Report.--Beginning with fiscal year 2003, not
later than 120 days after the end of each fiscal year during
which fees are collected under the part described in subsection
(b), the Secretary of Health and Human Services shall prepare
and submit to the Committee on Energy and Commerce of the House
of Representatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate, a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year for which the
report is made.
SEC. 506. REPORTS OF POSTMARKETING STUDIES.
Section 506B of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 356b) is amended by adding at the end the following
subsections:
``(d) Disclosure.--If a sponsor fails to complete an agreed
upon study required by this section by its original or
otherwise negotiated deadline, the Secretary shall publish a
statement on the Internet site of the Food and Drug
Administration stating that the study was not completed and, if
the reasons for such failure to complete the study were not
satisfactory to the Secretary, a statement that such reasons
were not satisfactory to the Secretary.
``(e) Notification.--With respect to studies of the type
required under section 506(b)(2)(A) or under section 314.510 or
601.41 of title 21, Code of Federal Regulations, as each of
such sections was in effect on the day before the effective
date of this subsection, the Secretary may require that a
sponsor who, for reasons not satisfactory to the Secretary,
fails to complete by its deadline a study under any of such
sections of such type for a drug or biological product
(including such a study conducted after such effective date)
notify practitioners who prescribe such drug or biological
product of the failure to complete such study and the questions
of clinical benefit, and, where appropriate, questions of
safety, that remain unanswered as a result of the failure to
complete such study. Nothing in this subsection shall be
construed as altering the requirements of the types of studies
required under section 506(b)(2)(A) or under section 314.510 or
601.41 of title 21, Code of Federal Regulations, as so in
effect, or as prohibiting the Secretary from modifying such
sections of title 21 of such Code to provide for studies in
addition to those of such type.''.
SEC. 507. SAVINGS CLAUSE.
Notwithstanding section 107 of the Food and Drug
Administration Modernization Act of 1997, and notwithstanding
the amendments made by this subtitle, part 2 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act, as in
effect on the day before the date of the enactment of this Act,
continues to be in effect with respect to human drug
applications and supplements (as defined in such part as of
such day) that, on or after October 1, 1997, but before October
1, 2002, were accepted by the Food and Drug Administration for
filing.
SEC. 508. EFFECTIVE DATE.
The amendments made by this subtitle shall take effect
October 1, 2002.
SEC. 509. SUNSET CLAUSE.
The amendments made by sections 503 and 504 cease to be
effective October 1, 2007, and section 505 ceases to be
effective 120 days after such date.
Subtitle B--Funding Provisions Regarding Food and Drug Administration
SEC. 521. OFFICE OF DRUG SAFETY.
Of the amounts appropriated for the Food and Drug
Administration for a fiscal year, the Secretary of Health and
Human Services shall reserve for the Office of Drug Safety
(within such Administration), the following amounts:
(1) For fiscal year 2003, an amount equal to the
sum of $5,000,000 and the amount made available under
appropriations Acts for such Office for fiscal year
2002.
(2) For fiscal year 2004, an amount equal to the
sum of $10,000,000 and the amount made available under
appropriations Acts for such Office for fiscal year
2002.
(3) For each subsequent fiscal year, an amount
equal to the sum of the amount made available under
appropriations Acts for such Office for fiscal year
2004 and an amount sufficient to offset the effects of
inflation occurring after the beginning of fiscal year
2004.
SEC. 522. DIVISION OF DRUG MARKETING, ADVERTISING, AND COMMUNICATIONS.
For the Division of Drug Marketing, Advertising, and
Communications (within the Office of Medical Policy, Food and
Drug Administration), there are authorized to be appropriated
the following amounts, stated as increases above the amount
made available under appropriations Acts for such Division for
fiscal year 2002:
(1) For fiscal year 2003, an increase of
$2,500,000.
(2) For fiscal year 2004, an increase of
$4,000,000.
(3) For fiscal year 2005, an increase of
$5,500,000.
(4) For fiscal year 2006, an increase of
$7,500,000.
(5) For fiscal year 2007, an increase of
$7,500,000.
SEC. 523. OFFICE OF GENERIC DRUGS.
For the Office of Generic Drugs (within the Food and Drug
Administration), there are authorized to be appropriated the
following amounts, stated as increases above the amount made
available under appropriations Acts for such Office for fiscal
year 2002:
(1) For fiscal year 2003, an increase of
$3,000,000.
(2) For fiscal year 2004, an increase of
$6,000,000.
(3) For fiscal year 2005, an increase of
$9,000,000.
(4) For fiscal year 2006, an increase of
$12,000,000.
(5) For fiscal year 2007, an increase of
$15,000,000.
Subtitle C--Additional Provisions
SEC. 531. TRANSITION TO DIGITAL TELEVISION.
(a) Pair Assignment Required.--In order to further promote
the orderly transition to digital television, and to promote
the equitable allocation and use of digital channels by
television broadcast permittees and licensees, the Federal
Communications Commission, at the request of an eligible
licensee or permittee, shall, within 90 days after the date of
enactment of this Act, allot, if necessary, and assign a paired
digital television channel to that licensee or permittee,
provided that--
(1) such channel can be allotted and assigned
without further modification of the tables of
allotments as set forth in sections 73.606 and 73.622
of the Commission's regulations (47 CFR 73.606,
73.622); and
(2) such allotment and assignment is otherwise
consistent with the Commission's rules (47 CFR part
73).
(b) Eligible Transition Licensee or Permittee.--For
purposes of subsection (a), the term ``eligible licensee or
permittee'' means only a full power television broadcast
licensee or permittee (or its successor in interest) that--
(1) had an application pending for an analog
television station construction permit as of October
24, 1991, which application was granted after April 3,
1997; and
(2) as of the date of enactment of this Act, is the
permittee or licensee of that station.
(c) Requirements on Licensee or Permittee.--
(1) Construction deadline.--Any licensee or
permittee receiving a paired digital channel pursuant
to this section--
(A) shall be required to construct the
digital television broadcast facility within 18
months of the date on which the Federal
Communications Commission issues a construction
permit therefore, and
(B) shall be prohibited from obtaining or
receiving an extension of time from the
Commission beyond the construction deadline
established by paragraph (1).
(2) Prohibition of analog operation using digital
pair.-- Any licensee or permittee receiving a paired
digital channel pursuant to this section shall be
prohibited from giving up its current paired analog
assignment and becoming a single-channel broadcaster
and operating in analog on such paired digital channel.
(d) Relief Restricted.--Any paired digital allotment and
assignment made under this section shall not be available to
any other applicant unless such applicant is an eligible
licensee or permittee within the meaning of subsection (b).
SEC. 532. 3-YEAR DELAY IN LOCK IN PROCEDURES FOR MEDICARE+CHOICE PLANS;
CHANGE IN CERTAIN MEDICARE+CHOICE DEADLINES AND
ANNUAL, COORDINATED ELECTION PERIOD FOR 2003, 2004,
AND 2005.
(a) Lock-In Delay.--Section 1851(e) of the Social Security
Act (42 U.S.C. 1395w-21(e)) is amended--
(1) in paragraph (2)(A), by striking ``through
2001'' and ``during 1998, 1999, 2000, and 2001'' and
inserting ``through 2004'' and ``during the period
beginning January 1, 1998, and ending on December 31,
2004'', respectively;
(2) in the heading to paragraph (2)(B), by striking
``during 2002'' and inserting ``during 2005'';
(3) in paragraphs (2)(B)(i) and (2)(C)(i), by
striking ``2002'' and inserting ``2005'' each place it
appears;
(4) in paragraph (2)(D), by striking ``2001'' and
inserting ``2004''; and
(5) in paragraph (4), by striking ``2002'' and
inserting ``2005'' each place it appears.
(b) Change in Reporting Deadline.--
(1) In general.--Section 1854(a)(1) of such Act (42
U.S.C. 1395w-24(a)(1)) is amended by striking ``Not
later than July 1 of each year'' and inserting ``Not
later than the second Monday in September of 2002,
2003, and 2004 (or July 1 of each other year)''.
(2) Effective date.--The amendment made by
paragraph (1) shall apply to information submitted for
years beginning with 2003.
(c) Delay in Annual, Coordinated Election Period.--
(1) In general.--Section 1851(e) of such Act (42
U.S.C. 1395w-21(e)) is amended--
(A) in paragraph (3)(B), by striking
``means'' and all that follows and inserting
the following: ``means, with respect to a year
before 2003 and after 2005, the month of
November before such year and with respect to
2003, 2004, and 2005, the period beginning on
November 15 and ending on December 31 of the
year before such year.''; and
(B) in paragraph (6)(A), by striking ``each
subsequent year (as provided in paragraph
(3))'' and inserting ``during the annual,
coordinated election period under paragraph (3)
for each subsequent year''.
(2) Effective date.--The amendment made by
paragraph (1) shall apply to the annual, coordinated
election period for years beginning with 2003.
(d) Change to Annual Announcement of Payment Rates.--
(1) In general.--Section 1853(b)(1) of such Act (42
U.S.C. 1395w-23(b)(1)) is amended by striking ``not
later than March 1 before the calendar year concerned''
and inserting ``for years before 2004 and after 2005
not later than March 1 before the calendar year
concerned and for 2004 and 2005 not later than the
second Monday in May before the respective calendar
year''.
(2) Effective date.--The amendment made by
paragraph (1) shall first apply to announcements for
years after 2003.
And the Senate agree to the same.
From the Committee on Energy and Commerce, for
consideration of the House bill and the Senate
amendment, and modifications committed to
conference:
Billy Tauzin,
Michael Bilirakis,
Paul E. Gillmor,
Richard Burr,
John Shimkus,
John D. Dingell,
Henry A. Waxman,
Sherrod Brown,
Provided that Mr. Pallone is appointed in lieu
of Mr. Brown of Ohio for consideration of title
IV of the House bill, and modifications
committed to conference:
Frank Pallone, Jr.,
From the Committee on Agriculture, for
consideration of title II of the House bill and
sec. 216 and title V of the Senate amendment,
and modifications committed to conference:
Larry Combest,
Frank D. Lucas,
Saxby Chambliss,
Charles Stenholm,
Tim Holden,
From the Committee on the Judiciary, for
consideration of title II of the House bill and
secs. 216 and 401 of the Senate amendment, and
modifications committed to conference:
F. James Sensenbrenner, Jr.,
Lamar Smith,
John Conyers, Jr.,
Managers on the Part of the House.
Edward Kennedy,
Chris Dodd,
Tom Harkin,
Barbara A. Mikulski,
Jim Jeffords,
Judd Gregg,
Bill Frist,
Mike Enzi,
Tim Hutchinson,
Managers on the Part of the Senate.
JOINT EXPLANATORY STATEMENT OF THE COMMITTEE OF CONFERENCE
The managers on the part of the House and the Senate at the
conference on the disagreeing votes of the two Houses on the
amendment of the Senate to the bill (H.R. 3448), to improve the
ability of the United States to prevent, prepare for, and
respond to bioterrorism and other public health emergencies,
submit the following joint statement to the House and the
Senate in explanation of the effect of the action agreed upon
by the managers and recommended in the accompanying conference
report:
The Senate amendment struck all of the House bill after the
enacting clause and inserted a substitute text.
The House recedes from its disagreement to the amendment of
the Senate with an amendment that is a substitute for the House
bill and the Senate amendment. The differences between the
House bill, the Senate amendment, and the substitute agreed to
in conference are noted below, except for clerical corrections,
conforming changes made necessary by agreements reached by the
conferees, and minor drafting and clerical changes.
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
As approved by the conference Managers, Title I addresses
core public health concerns associated with preparedness for
and effective response to bioterrorism and other public health
emergencies in a number of different ways. First Title I
improves communications between and among all levels of
government, public health officials, first responders, and
health care providers and facilities during emergencies. The
Managers have authorized substantial sums in FY 2002 and beyond
in grants to States, local governments, and other public and
private health care facilities and other entities to improve
planning and preparedness activities, and educate and train
health care personnel. Under Title I, the Department of Health
and Human Services (HHS) will have a new focus, and improved
coordination and accountability, through a new Assistant
Secretary for Public Health Emergency Preparedness. The
legislation also authorizes the National Disaster Medical
System, new planning and reporting provisions, training
exercises, and improved communications strategies and networks.
The Managers also believe that the provisions of Title I will
ensure that the nation has sufficient drugs, vaccines, and
other supplies for our emergency health security. The Managers
intend for activities under Title I to enhance the Nation's
public health infrastructure at the national, state, and local
levels. The Managers believe that an effective public health
system is essential to responding effectively to bioterrorism
and other public health emergencies.
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
Section 101. National Preparedness and Response
House provision: The House provision requires the
Secretary of HHS to continue the process of developing and
implementing a coordinated strategy, including the preparation
of a national plan for carrying out health-related activities
to prepare for and respond effectively to bioterrorism and
other public health emergencies. The plan would be in
consultation with other Federal agencies and other appropriate
public and private entities. The plan also would be coordinated
with activities of State and local governments to meet
preparedness goals set out under the Act. National preparedness
goals include providing effective assistance to State and local
governments to ensure that they and their health care
facilities have adequate capacity and properly trained response
personnel; a coordinated plan, effective communications
networks, and laboratory readiness, training and surveillance;
developing and maintaining medical countermeasures against
biological agents; and effective coordination at all levels of
government. There would be evaluations and reports of progress.
Senate amendment: The Senate amendment contains similar
provisions.
Conference substitute: The Conference adopts the House
provisions with certain modifications to clarify the provision
does not expand regulatory or other authority, and to
incorporate various advisory committee and study provisions. A
study to emergency response services and their use during
public health emergencies, formerly located in section 114 of
the House bill, is now located in this section.
Section 102. Assistant Secretary for Public Health Emergency
Preparedness; National Disaster Medical System
House provision: The House provision establishes the new
position of Assistant Secretary for Emergency Preparedness to
coordinate HHS activities under the new Act. The provision also
would authorize the National Disaster Medical System, under the
new Assistant Secretary to provide for further National
capacity during public health emergencies.
Senate amendment: The Senate amendment contains a similar
provision in section 211 of the Senate amendment.
Conference substitute: The Conference substitute uses the
House language with modification. The Managers believe that
there is a need to increase coordination of the Department of
Health and Human Services' efforts in responding to
bioterrorism and other public health emergencies, and thus has
provided for the creation of an Assistant Secretary for Public
Health Emergency Preparedness. The substitute also formally
establishes the National Disaster Medical System (NDMS),
recognizing the important role already played by the NDMS in
the Federal government's response to all types of emergencies
and disasters. The substitute also addresses a number of
critical personnel issues within the NDMS, including liability
protections, employment rights, and compensation for work
injuries. In addition, the Secretary shall take into account
the role and expertise of the Agency for Toxic Substances and
Disease Registry.
Section 103. Improving Ability of Centers for Disease Control and
Prevention
House provision: The House bill provides authorization
and multi-year contracting authority for the renovation,
development and security at facilities for the Centers for
Disease Control and Prevention (CDC). The House bill also
enhances training and nationwide laboratory capacity, and the
establishment of integrated, national public health
communications and surveillance networks.
Senate amendment: The Senate amendment, in section 202,
also contains provisions for upgrading CDC's activities and
facilities.
Conference substitute: The Conference substitute adopts
the House provision with modifications. The substitute
recognizes the critical role played by CDC in the nation's
efforts to defend against bioterrorism and other public health
emergencies. The Managers are concerned by extreme disrepair at
many CDC laboratories and believe that repair and modernization
funds are desperately needed. To that end, the substitute has
provided multi-year contracting authority for CDC and has
authorized an accelerated program of facilities funding. The
substitute also recognizes the central role played by CDC in
maintaining robust public health alert communications and
surveillance networks, and has provided for grants, contracts,
and cooperative agreements to further strengthen a national
network that includes public health laboratories and other
health care facilities. Provisions concerning priorities for
public health lab enhancements have been moved to the general
grants section, section 131, of the Conference substitute.
Section 104. Advisory Committees and Communications; Study Regarding
Communications Abilities of Public Health Agencies
House provision: Section 104 of the House bill
establishes an advisory committee on children and terrorism and
also one on emergency public information and communications.
The provision also requires a coordinated strategy on public
health communications during a bioterrorism attack. Section 111
also contains a provision for a study regarding the
communications ability of public health agencies and to improve
telecommunications infrastructure and connectivity during
public health emergencies.
Senate amendment: Section 213 of the Senate amendment
contains similar provisions. Section 214 of the Senate
amendment also contains a provision establishing the official
Federal Internet Site on Bioterrorism.
Conference substitute: The Conference substitute adopts,
with minor modification, the provisions from the House and
Senate establishing an advisory committee on children and
terrorism; an advisory committee on emergency public
information and communications; acoordinated strategy on public
health communications during a bioterrorism attack; and the official
Federal Internet Site on Bioterrorism.
Section 105. Education of Health Care Personnel; Training Regarding
Pediatric Issues
House provision: The House bill requires the
establishment of core curriculum materials for public health
emergencies, for the purpose of education and training of
health care personnel.
Senate amendment: Section 105 of the Senate amendment
contains a similar provision.
Conference substitute: The Conference substitute adopts
the House provision with minor modification. The Managers
intend that the eligible entity phrase ``other appropriate
educational entities'' includes medical schools that have
established departments of medical education.
Section 106. Grants Regarding Shortages of Certain Health Professionals
House provision: The House bill provides grants for
training and education to certain categories of health care
professionals for which there exist shortages impacting the
ability to respond to bioterrorism and other public health
emergencies.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference adopts the House
provision without modification.
Section 107. Emergency System for Advance Registration of Health
Professions Volunteers
House provision: The House bill establishes a national
system to help verify the licenses, credentials and hospital
privileges of health professionals who volunteer to respond
during public health emergencies.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference adopts the House
provision with modifications to make clear that use of the
verification database is entirely voluntary, and that nothing
in the section changes the roles of States in licensing or
hospitals in establishing privileging requirements.
Section 108. Working Groups
House provision: House section 108 makes modifications to
the existing working groups in section 319 of the Public Health
Service Act (PHSA).
Senate amendment: The Senate amendment also makes
modifications and additions to the working group provisions.
The Senate amendment also consolidates the two existing working
groups in sections 319F of the Public Health Service Act.
Conference substitute: The Conference substitute adopts a
single working group, but allows for subcommittees to represent
the working group with respect to particular matters. The
authority of the working group is limited through various
savings clauses. The primary purposes of the working group are
consultation, assisting in coordination, and making
recommendations on a variety of topics related to preparedness
for and response to bioterrorism and other public health
emergencies. The Managers expect the working group to take into
account the role and expertise of the Agency for Toxic
Substances and Disease Registry. Additionally, the Managers
encourage the working group to recognize the role of private
ambulance services, especially when they may be the only
ambulance services in the area.
Section 109. Antimicrobial Resistance
House provision: The House bill authorizes further
research and DNA analysis of priority pathogens that may be
used by bioterrorists, and contains other provisions concerning
antimicrobial resistance.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House provision on antimicrobial resistance. The provision
concerning priority pathogens has been moved to section 125 of
the Conference substitute.
Section 110. Supplies and Services in Lieu of Award Funds
House provision: The House bill provides flexibility to
allow the Secretary of HHS to supply actual supplies,
equipment, or services instead of, or in conjunction with,
grants.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House provision.
Section 111. Additional Amendments
House provision: The House bill makes revisions to time
frames to accelerate preparedness planning.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House provision.
Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures
Section 121. Strategic National Stockpile
House provision: The House bill authorizes a national
stockpile or stockpiles of drugs, vaccines, biologic products,
medical devices and supplies to meet the health security needs
of the United States. It requires enhanced procedures for
coordination, maintenance, delivery, and distribution. House
authorization language in section 151 of the House bill
specifies specific sums for smallpox vaccines.
Senate amendment: Section 201 of the Senate amendment
also authorizes a national stockpile, and separately has a
provision under section 402 for authorizing smallpox vaccines
for the stockpile.
Conference substitute: The Conference substitute adopts
the House provision with modifications and inclusion of a
specific provision on smallpox vaccines. The Managers believe
that antiviral products may be appropriate for the strategic
national stockpile and may include antiviral products reviewed
by the Food and Drug Administration (FDA) or National
Institutes of Health (NIH).
Section 122. Accelerated Approval of Priority Countermeasures
House provision: The House bill clarifies certain fast-
track authority for drug priority countermeasures under the
Federal Food, Drug, and Cosmetic Act.
Senate amendment: Section 405 of the Senate amendment
contains a similar provision.
Conference substitute: The Conference substitute adopts
the Senate provision with modification.
Section 123. Issuance of Rule on Animal Trials
House provision: The House bill requires the FDA to issue
a final rule within six months allowing reliance on animal
trials for certain priority countermeasures for public health
emergencies.
Senate amendment: The Senate amendment contains a similar
requirement with a 30-day time frame.
Conference substitute: The Conference substitute adopts
the House provision with modifications to provide the rule
within 90 days of the date of enactment.
Section 124. Security for Countermeasure Development and Production
House provision: The House bill authorizes the Secretary,
in consultation with the Attorney General and Secretary of
Defense, to provide technical or other assistance to enhance
security at facilities that conduct development, production,
distribution, or storage of priority countermeasures.
Senate amendment: Section 402 of the Senate amendment
contains a similar provision and also provides for best
practices guidelines.
Conference substitute: The Conference substitute adopts
the House provisions without a requirement for best practices
guidelines.
Section 125. Accelerated Countermeasure Research and Development
House provision: The House bill directs the Secretary to
conduct an accelerated countermeasure development program, and
to award grants for biomedical research, development of
vaccines, and diagnostic tests for priority countermeasures.
Senate amendment: Section 404 of the Senate amendment
contains similar provisions.
Conference substitute: The Conference substitute adopts
the Senate provisions with modifications. The House provision
concerning priority pathogens is included. The Managers
encourage the Secretary to consider novel methods for detecting
and identifying viral and bacterial pathogens, and developing
and manufacturing effective therapeutic responses, including
both vaccines and antibiotics. The Managers also encourage the
Secretary to consider the use of emerging biophysical and
biomanufacturing technologies that hold the promise of
producing rapid detection/response programs that can achieve
accelerated responses to bioterrist attacks or threats. In
addition, the Managers encourage the Secretary, in coordination
with the Administrator of the Environmental Protection Agency,
to develop protocols for and enhance facilities for testing
technologies used to decontaminate facilities contaminated as a
result of bioterrorism.
Section 126. Evaluation of New and Emerging Technologies Regarding
Bioterrist Attack and Other Public Health Emergencies
House provision: The House bill requires the Secretary to
evaluate new and emerging technologies to help detect,
identify, diagnose, or conduct public health surveillance
activities for public health emergencies, and prioritize
development and deployment where warranted.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House provision with limiting modifications.
Section 127. Potassium Iodide
House provision: The House bill requires the Secretary to
make potassium iodide available to States and local governments
that submit a plan for local stockpile and distribution for the
population within 20 miles of a nuclear power plant.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House provision with modifications that include authority
provided to the President; additional restrictions on the
eligibility of local governments; and a different schedule for
effective dates, and other modifications.
Subtitle C--Improving State, Local, and Hospital Preparedness for and
Response to Bioterrorism and Other Public Health Emergencies
Section 131. Grants to Improve State, Local, and Hospital Preparedness
for and Response to Bioterrorism and Other Public Health
Emergencies
House provision: The House bill modifies current
authorities under section 319 of the PHSA and otherwise
authorized grant funding to improve State, local, and hospital
preparedness for and response tobioterrorism and other public
health emergencies through the existing mechanisms of the PHSA.
Authorization was provided from FY 2002-2006.
Senate amendment: The Senate amendment contains a
provision for State block grants for fiscal years 2002-2003 for
bioterrorism activities only, and the authorization would not
continue past FY 2003. It also provides an authorization for
bioterrorism medical centers with authorization from FY 2002-
2006, limited to bioterrorism activities. Finally, the Senate
amendment maintains and authorizes a portion of funding under
section 319 for a broader list of purposes and eligible
entities.
Conference substitute: The Conference substitute reflects
a compromise between House and Senate approaches. For FY 2003,
there is a modified State block grant provision. Beyond FY
2003, greater flexibility is provided to the Secretary to
either continue the same approach or modify the approach
without the restrictions of the FY 2003 formulas. The
substitute also provides authorization for the purpose of
enhancing the preparedness of hospitals (including children's
hospitals), clinics, health centers, and primary care
facilities, and for planning and administrative purposes
relating to such authorizations. For FY 2004-2006, there is a
new section 319 C-2.
The Managers want to ensure that section 131 does not
delay or disrupt the current grants and cooperative agreements
that the Administration has been using in FY 2002, including
those programs administered by CDC and the Health Resources and
Services Administration (HRSA). It is the Managers' intent to
allow the Administration to continue this approach. The
Managers expect the Administration to evaluate the
effectiveness of the program and make revisions where necessary
to improve effectiveness and accountability.
The Managers intend that a permissible use of funds under
this section includes grants to one or more centers of
excellence to develop appropriate innovative technology
projects--for example, the development of a web-based
computerized planning application that incorporates
standardized language and utilizes wireless mobile technology.
The Managers intend that training programs pursuant to this
section could include the use of virtual reality training
methods, human patient simulators, computer-assisted training
modalities, and internet-based training and modeling
capabilities. One or more centers of excellence could be
established to develop, deploy, and evaluate virtual and
augmented reality-based, internet-ready training capabilities.
Subtitle D--Emergency Authorities; Additional Provisions
Section 141. Reporting Deadlines
House provision: The House bill provides extensions for
certain reporting deadlines during a public health emergency,
and for transfer authority for funds during a public health
emergency.
Senate amendment: The Senate amendment contains an
analogous provision on reporting deadlines and no new transfer
authority.
Conference substitute: The Conference substitute adopts
the Senate provision on reporting deadlines with minor
modifications.
Section 142. Streamlining and Clarifying Communicable Disease
Quarantine Provisions
House provision: The House bill changes existing law to
expand the authority of the Secretary, in consultation with the
Surgeon General, and under certain conditions, to specify
diseases that are subject to individual detention orders.
Senate amendment: The senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House provision with modifications to the standards
required before the Secretary may exercise this authority.
Section 143. Emergency Waiver of Medicare, Medicaid, and SCHIP
Requirements
House provision: Section 143 allows the Secretary of
Health and Human Services to waive certain requirements (and
related regulations) inof titles XVIII, XIX, and XXI of the
Social Security Act (as well as requirements and regulations under
title XI of the Social Security Act, only as necessary to effectuate
the waiver of the enumerated requirements of titles XVIII, XIX, and XXI
to meet the purposes of this section) in the event of an emergency or
disaster in order to: (1) facilitate the provision of health services
in the emergency or disaster area, and (2) ensure that health care
providers who furnish care in good faith to individuals enrolled in
these programs during an emergency or disaster may be reimbursed
without penalty. The Secretary can waive requirements pertaining to:
conditions of participation for providers; provider licensing
requirements; sanctions for physician self-referral; sanctions relating
to transferring patients in an emergency; and deadlines for filing
reports for periods of up to 90 days.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House provision with modifications. The Managers agree that
the Secretary shall provide written notice to Congress,
including a certification that a waiver is necessary. This
notice shall be issued before the waiver authority is
exercised. Additionally, the Secretary must report to Congress
within a year evaluating the effectiveness of the approaches
used during the operation of the waiver. The time frame for
such waivers shall be 60 days.
Section 144. Provision for Expiration of Public Health Emergencies
House provision: The House bill provides that public
health emergencies expire by announcement of the Secretary, or
after 90 days. The Secretary may renew emergency declarations
at his or her discretion.
Senate amendment: Section 212 of the Senate Amendment
contains a similar provision, but with a 180-day expiration
period.
Conference substitute: The Conference substitute adopts
the House provision with amendments, including clarifying the
status of any existing declaration of public health
emergencies.
Subtitle--Additional Provisions
Section 151. Designated State Public Emergency Announcement Plan
House provision: Section 135 of the House bill amends the
Stafford Act to provide for coordinated communications
response.
Senate amendment: Section 312 of the Senate amendment
contains an identical provision.
Conference substitute: The Conference substitute adopts
the identical House and Senate provisions.
Section 152. Expanded Research by Secretary of Energy
House provision: The House bill expands current research
at the Department of Energy (DOE) and the National Nuclear
Security Administration (NNSA) on rapid detection of pathogens
likely to be used in bioterrorist attacks or other agents that
may cause a public health emergency.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House provision.
Section 153. Expanded Research on Worker Health and Safety
House provision: The House bill authorizes the National
Institutes of Occupational Safety and Health (NIOSH) to expand
research on health and safety of workers who are at risk for
bioterrorist threats or attacks in the workplace.
Senate amendment: The Senate amendment contains an
analogous provision.
Conference substitute: The Conference substitute adopts
the Senate Amendment with minor modification.
Section 154. Enhancement of Emergency Preparedness of Department of
Veterans Affairs
House provision: The House bill has no analogous
provision.
Senate amendment: The Senate amendment has no analogous
provision.
Conference substitute: The Conference substitute
instructs the Secretary of Veterans Affairs to take appropriate
actions to enhance the readiness of the Department's medical
centers and research facilities for a chemical or biological
attack, based on the results of an evaluation to be conducted
by the Secretary on the security needs at these facilities.
Section 155. Reauthorization of Existing Program
House provision: The House bill has no analogous
provision.
Senate amendment: The Senate amendment has no analogous
provision.
Conference substitute: The Conference substitute amends
section 582(f) of the Public Health Service Act by
reauthorizing a grant program through 2006 that provides awards
to public and private entities, as well as Indian tribes and
tribal organizations, that develop programs focusing on the
behavioral and biological aspects of psychological trauma
response and research that will help treat psychiatric
disorders of children and youth resulting from witnessing or
experiencing a traumatic event.
Section 156. Sense of Congress
House provision: The House bill has no analogous
provision.
Senate amendment: The Senate amendment states that
Congress recognizes that many university-based programs are
already functioning and developing important biodefense
products and solutions. Congress should recognize the
importance of supporting work done at university centers and
laboratories. In addition, Congress should recognize the
importance of existing public and private university-based
research, training, public awareness, and safety-related
biological defense programs in the awarding of grants and
contracts made in accordance with this Act.
Conference substitute: The Conference substitute contains
one modification to the Senate amendment, which clarifies that
the Secretary of Health and Human Services may recognize the
importance of existing public and private university-based
efforts in grants and cooperative agreements.
Section 157. General Accounting Office Report
House provision: The House bill has no analogous
provision.
Senate amendment: The Senate amendment requires a General
Accounting Office (GAO) report to Congress on Federal
bioterrorism-related activities.
Conference substitute: The Conference substitute amends
section 319F of the Public Health Service Act to require GAO to
report on Federal bioterrorism-related activities, including
research, preparedness, and response, to the following
committees: Senate Health, Education, Labor, and Pensions;
Senate Appropriations; House Energy and Commerce; and House
Appropriations.
Section 158. Certain Awards
House provision: The House bill has no analogous
provision.
Senate amendment: The Senate amendment has no analogous
provision.
Conference substitute: The Conference substitute amends
section 319(a) of the Public Health Service Act by inserting
after ``grants,'' ``providing awards for expenses, and.''
Section 159. Public Access Defibrillation Programs and Public Access
Defibrillation Demonstration Projects
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute amends
section 243 of title 42, United States Code, to enact the
``Community Access to Emergency Defibrillation Act of 2002.''
The Conference substitute directs the Secretary to establish a
new grant program for States, political subdivisions of States,
Indian tribes, and tribal organizations to develop and
implement public access defibrillation programs. These grants
may be used to purchase automated external defibrillators
(AEDs), to provide automated external defibrillation and basic
life support training in AED usage, to provide information to
community members about the public access defibrillation
program, to provide information to the local emergency medical
system regarding the placement of AEDs, and to produce
materials to encourage private companies to purchase AEDs. For
this new grant program, the Conference substitute authorizes
the appropriation of $25 million in fiscal year 2002, and such
sums as may be necessary for each of the fiscal years 2004
through 2006. The Conference substitute also establishes a new
grant program for political divisions of States, Indian tribes,
and tribal organizations to develop and implement innovative,
comprehensive, community-based public access defibrillation
demonstration projects. These grants may be used to purchase
AEDs, to provide basic life training in automated external
defibrillator usage, to provide information to community
members about the public access defibrillation demonstration
project, and to provide information to the local emergency
medical services system regarding the placement of AEDs. For
these demonstration projects, the Conference substitute
authorizes the appropriation of $5 million for fiscal years
2003 through 2006. The Managers intend that the ``Good
Samaritan'' protections regarding emergency use of AEDs
outlined in section 238(q) of title 42, United States Code will
apply to this section. It is the intent of the Managers that
this new program coordinates its activities with the Rural AED
program and avoid duplication of effort.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Subtitle A--Department of Health and Human Services
Section 201. Regulation of Certain Biological Agents and Toxins
House provision: The House bill requires all persons who
possess, use or transfer ``select agents''--the 36 biological
agents or toxins currently determined by the Secretary of the
Department of Health and Human Services (HHS) to pose ``a
severe threat to public health and safety''--to register with
the Secretary and be subject to reasonable safety and security
requirements and inspections. Current law requires registration
only of those entities transferring such agents. The House bill
also directs that the Secretary maintain a national database of
all such agents, with sufficient information to facilitate
their identification and traceability. The Secretary, in
consultation with the Attorney General, must establish specific
security requirements for registered facilities and a personnel
screening protocol to ensure that access to such agents is not
permitted by individuals who are ``restricted persons'' under
the USA PATRIOT Act (18 U.S.C. 175b), are named in a warrant
for violent criminal or terrorist activity, are under
investigation for involvement in domestic or international
terrorist or criminal organizations, or suspected of spying for
the military or intelligence operations of a foreign nation.
The Secretary is granted authority to assist public and
nonprofit private entities in meeting such security
requirements. The House bill also imposes civil penalties for
those who violate the regulations, up to $500,000.
The House bill grants the Secretary discretion to make
exemptions to the registration requirements only where those
exemptions are consistent with protecting the public health and
safety--for example, with respect to inactivated or attenuated
strains of select agents used in vaccines or other products for
legitimate medical research or use--or when the agent is
presented for diagnosis, verification or proficiency testing
purposes at a clinical laboratory and is promptly destroyed or
transferred to a registered facility after such identification.
The House bill also exempts from mandatory disclosure under the
Freedom of Information Act (FOIA) site-specific or identifying
information submitted under these regulations concerning
registered persons, select agents, and security mechanisms.
Senate amendment: The Senate amendment is substantially
similar to the House bill but differs in a few respects. First,
in developing the list of select agents, the Secretary is
directed to consider the needs of children and other vulnerable
populations. Second, individuals who seek access to select
agents are screened only to identify if they are ``restricted
persons'' under the USA PATRIOT Act, or are named in a warrant
for participation in a domestic or international act of
terrorism. Third, the Secretary is permitted to exempt certain
attenuated or inactive biological agents or toxins and certain
approved medical products from the list of select agents.
Conference substitute: The Conference substitute adopts
provisions of both bills, with significant modifications. The
primary goals of this subtitle are to ensure the prompt
reporting to the Federal government of possession of select
agents (including by those who were in possession prior to
April 15, 1997, the effective date for reporting transfers of
select agents), to increase the security over such agents
(including access controls and screening of personnel), and to
establish a comprehensive and detailed national database of the
location and characterization of such agents and the identities
of those in possession of them. To effectuate these goals, the
substitute requires that, at a minimum, all possession of
select agents (unless exempt under the provisions of this
subtitle) must be registered with the Secretary. The Managers
expect that most ``persons'' who register under this subtitle
will be public and private entities, rather than individuals.
But these provisions also will cover individuals possessing,
using or transferring select agents who have not been granted
authority to do so by registered persons. If an individual has
not been granted such authority, then that individual would be
a person required to register under this subtitle. If an
individual has been granted such authority without proper
authorization from the Secretary, as required by this subtitle,
then the registered person is subject to any penalties provided
for violation of such regulations. The Managers emphasize that
the primary responsibility for registration and the screening
of employees working with select agents is with the entity or
employer, not the individual employee. The Secretary also is
required to promulgate regulations establishing safety
requirements for the possession, use, and transfer of select
agents. These regulations must include procedures to protect
the public safety in the event the safety requirements for
possession, use or transfer are violated.
The Managers recognize that some select agents may pose a
greater threat to the public health and safety than others.
Accordingly, the Conference substitute amends the security
requirements of both bills by adding the phrase ``commensurate
with the risk such agent or toxin poses to public health and
safety (including the risk of use in domestic or international
terrorism).'' The Secretary will have flexibility to impose
different levels of security requirements on different select
agents based on his or her evaluation of the level of threat to
the public, as is currently done with respect to laboratory
biosafety levels. Because an agent must pose a severe threat to
human health to be placed on the select agent list, the
Secretary may not decide that security requirements or
registration of possession are unnecessary for a particular
select agent.
The substitute also modifies the existing statutory
requirements for the transfer regulations by adding ``and
security measures'' after ``safeguards'' in the term
``safeguards to prevent access . . . for use in domestic or
international terrorism or for any other criminal purposes'' to
clarify that such regulations include the imposition of
security requirements. The substitute also requires that
registered persons promptly notify the Secretary whenever a
select agent is lost, stolen, or released outside of a
biocontainment area of a facility. Current HHS regulations do
not mandate such notifications.
The Conference substitute adds new provisions regarding
the screening of entities and individuals seeking to register
their possession, use or transfer of select agents. While both
the House and Senate bills mandate screening of individuals
seeking access to agents through a registered person, neither
bill required screening of the registered persons themselves.
The substitute provides for such screening in a similar manner
to that performed for individuals working at the facilities of
registered persons. Further with respect to screening, the
substitute drops the provision in both bills relating to
outstanding warrants, as duplicative of the fugitive provision
in the restricted person categories of the USA PATRIOT Act, and
adds a screening category that was in neither bill--those
reasonably suspected of committing Federal crimes of terrorism.
The substitute includes but makes revisions to the two
additional screening categories contained in the House bill to
ensure an objective basis for governmental suspicion of
involvement with terrorist or criminal organizations, or with
foreign powers. In the case of restricted persons, the
substitute mandates that access to select agents be denied,
because of the criminal prohibition on possession by such
persons. In the case ofpersons falling within the other three
specified categories, the substitute grants the Secretary and Attorney
General discretion in determining how to proceed, given the law
enforcement sensitivity of such situations. By making this distinction
between the handling of restricted persons and other screening
categories, the Managers do not intend that potential terrorists or
foreign agents should be subject to a less strict screening standard
than restricted persons. The substitute also clarifies that the
screening performed by the Attorney General is for the sole purpose of
identifying--through the use of official, electronic databases
available to the Federal government--whether an individual or entity
falls within any of the specified categories, and for notifying the HHS
Secretary of such identification. It is the Managers' intent that the
term ``electronic databases'' is not meant to preclude the use of other
databases or files by the Attorney General to clarify or confirm
information obtained during the electronic database search.
To address concerns within the academic and research
communities about the timeliness and accuracy of the background
screening process, the Conference substitute amends both bills
by requiring ``prompt'' action by the Attorney General and the
Secretary with respect to screening of and notification to
affected individuals, and by providing for an expedited review
process where good cause has been demonstrated by the
registered person. The substitute also provides for a review of
denials by the Secretary based on the screening process, and
subsequent judicial review--with provisions to ensure that
classified or sensitive law enforcement information is not
compromised during such reviews. Specifically, the substitute
allows for ex parte review by the Secretary in administrative
proceedings, and the court during judicial review, whenever a
denial is challenged. In providing the right for ex parte
review, the Managers intend to protect classified and law
enforcement sensitive information, including through the use of
in camera proceedings. Moreover, the Managers intend that a
reviewing court should not order the disclosure of any
information that the United States believes may compromise
national security or an ongoing law enforcement investigation
without affording the United States an opportunity for further
review in accordance with this subtitle. It is the Managers'
overall expectation that the screening process be conducted in
a timely and fair manner, and that the Secretary and the
Attorney General will work closely together to effectuate such
intent.
With respect to the national database of select agents
that the Secretary must develop pursuant to this section, the
Conference substitute slightly alters the language used in both
bills with respect to the database's purpose. The object of the
registration and database requirements is to provide
information about all persons possessing, using or transferring
select agents, and to collect sufficiently detailed
characterization information on the registered select agents so
that the database can differentiate between and within strains
of a given agent or toxin. Such information should be in a
format that public health and law enforcement officials can use
to identify the origin or source of an agent or toxin that is
used to cause harm to the public. Because of concerns over the
potential for misconstruction, the term ``traceability''--which
could imply a chain of custody or tracking requirement--was
eliminated, and was replaced with the concept of ``source.''
Significant modifications were made to both bills with
respect to exemptions from the statutory and regulatory
requirements governing select agents. The Conference substitute
establishes several exemptions from the regulatory regime for
select agents, most of which are consistent with the
Secretary's current regulations and practices. First, the
Conference substitute adopts, with modifications, the Senate
amendment's language with respect to product exemptions. The
substitute directs the Secretary to exempt from such
regulations products that are, bear or contain a select agent
and are licensed or approved under several specified Federal
laws, unless the Secretary determines that additional
regulation is necessary for a specific product to ensure
protection of public health and safety. The Managers intend
that the Secretary will exempt by regulation categories of
products, consistent with current regulations, and will act to
regulate a specific product, or a particular application of a
specific product, only when existing regulation under other
Federal laws is inadequate. For example, HHS currently exempts
the FDA-approved medical product Botox, which is the select
agent botulinum toxin, when it is used by licensed physicians
in the treatment of patients. However, when it is used in
purely research settings or as part of early-stage clinical
trials, HHS has chosen not to exempt Botox from current
regulations. The Managers do not intend to alter this
flexibility.
Second, the Conference substitute adds a provision
granting the Secretary discretionary authority to exempt, on a
case-by-case basis, investigational products when they are
being used in investigational or clinical trials authorized
under other Federal laws, such as the Federal Food, Drug, and
Cosmetic Act. Given the time sensitivity of such trials, the
substitute also includes a provision mandating a prompt
determinationby the Secretary of such an exemption request--
within 14 days after the applicant has submitted a complete exemption
request and has notified the Secretary that the investigation may
proceed as authorized under Federal law.
Third, with respect to clinical or diagnostic
laboratories that may come into possession of select agents
when conducting specimen diagnosis, verification or proficiency
testing, the substitute adopts with minor changes the
comparable provisions in the House and Senate bills. The
Secretary shall exempt such laboratories from registration
requirements, but only if they report the identification of
select agents to the Secretary and either promptly transfer the
agent to a registered person or destroy the agent on site, in
accordance with regulations established by the Secretary. While
HHS currently exempts such laboratories, existing regulations
permit them to transfer, destroy, or store the agent on site
for reference purposes. The Conference substitute expressly
rejects that regulatory approach, as it is inconsistent with
the fundamental premise of this title--that all those who
maintain possession of a select agent must register and be
subject to appropriate security and safety requirements. The
Secretary may not exempt laboratories that possess select
agents for reference purposes, or any other clinical or
diagnostic laboratories that do not qualify for an exemption
under the terms of this title. In addition, the Conference
substitute creates two temporary exemption authorities to deal
with public health emergencies and agricultural emergencies,
whether domestic or foreign.
With respect to funding, the Conference substitute
authorizes such sums as may be necessary to carry out these new
and expanded functions. The Managers note that, historically,
HHS has had insufficient resources to properly run the existing
select agent transfer program. While current regulations permit
inspections, only 20 percent of all registered facilities have
been inspected since the inception of the program in 1997, and
virtually none of these inspections were conducted prior to
registration. The Managers also note that HHS received a large
increase in funding for this program in the Fiscal Year 2002
supplemental appropriations bill. Given the broader, but
uncertain scope of the new regulatory regime, it is unclear
whether additional funds beyond current appropriations will be
necessary for Fiscal Year 2003. Once all persons possessing
select agents notify the Secretary of such possession 90 days
after enactment of this title, the appropriations level may
need to be re-evaluated.
Section 202. Implementation by Department of Health and Human Services
House provision: The House bill requires notification to
the Secretary by all persons possessing select agents within 60
days of enactment, and an interim final rule establishing a
regulatory structure to be issued within 120 days of enactment.
Senate amendment: The Senate amendment requires the
Secretary to issue an interim final rule within 180 days of
enactment, and requires all persons possessing select agents to
register within 60 days of issuance of the rule.
Conference substitute: The Conference substitute adopts
the House bill with modifications. The substitute requires
notification to the Secretary by all persons possessing select
agents within 90 days of enactment, based on guidance issued by
the Secretary within 30 days of enactment, and the issuance of
an interim final rule within 180 days of enactment. The
substitute also provides that the interim final rule shall
include time frames for applicability of the rule that minimize
disruption of research or educational projects that involve
select agents and that were underway as of the effective date
of such rule. The Managers note that the interim final rule and
effective date provisions will result in these new regulations
going into effect at approximately the same time as the
National Institutes of Health (NIH) begins to award Fiscal Year
2003 grants for research, some of which will be in the select
agent area. The Managers expect that the Secretary will
encourage those seeking such grants to begin the registration
and screening process under this title concurrently with the
NIH grant process, and that the Secretary will ensure the
timely registration and screening of such grantees, so as not
to delay this important research.
Section 203. Effective Dates
House provision and Senate amendment: Both the House bill
and the Senate amendment provide that regulations promulgated
by the Secretary under section 511 of the Antiterrorism and
Effective Death Penalty Act of 1996 are deemed to have been
promulgated under section 351A of the Public Health Service
Act, as added by this Act. They bothalso provide that the FOIA
exemptions apply retroactively to the effective date of the
Antiterrorism and Effective Death Penalty Act of 1996.
Conference substitute: The Conference substitute adopts
the same provisions.
Section 204. Conforming Amendment
House provision and Senate amendment: Both the House bill
and the Senate amendment repeal those provisions of the
Antiterrorism and Effective Death Penalty Act of 1996 that have
been codified in section 351A of the Public Health Service Act
by this Act.
Conference substitute: The Conference substitute adopts
the same provisions.
Subtitle B--Department of Agriculture
Section 211. Short Title
House provision and Senate amendment: Neither the House
bill nor the Senate amendment contain any analogous provision.
Conference substitute: The Conference substitute includes
a new subtitle, with its own short title--the Agricultural
Bioterrorism Protection Act of 2002.
Section 212. Regulation of Certain Biological Agents and Toxins
House provision and Senate amendment: Neither the House
bill nor the Senate amendment contain any analogous provision.
Conference substitute: The Conference substitute adopts
provisions that would grant comparable regulatory authorities
to the U.S. Department of Agriculture (USDA) as those granted
to HHS under subtitle A of this title for the regulation of
possession, use or transfer of listed biological agents and
toxins that present a severe threat to plant or animal health,
or animal or plant products. In an effort to minimize
regulatory duplication and burden, the substitute seeks to
ensure, to the greatest extent practicable, uniformity in the
statutory authority that the two departments will administer.
Exceptions exist in the criteria to be used by the Secretary of
Agriculture in developing a list of agriculturally significant
biological agents and toxins; considerations to be made in
granting exemptions from regulation under the statute;
procedures related to civil monetary penalties; and the time
frames for promulgation of a biological agents and toxins list
and the accompanying requirement that individuals who possess
these agents notify the Secretary of such possession. In
addition, with respect to the screening of persons registering
or accessing listed agents, the substitute uses the same
screening categories as are in subtitle A, but does not mandate
any denials of access, given that possession of USDA-listed
agents by restricted persons is not a Federal crime. Instead,
the Secretary and Attorney General are granted discretion as to
how to proceed in such situations.
The Managers recognize that, under provisions of current
law, biologics manufacturers have had to register, maintain
associated paperwork, and be subject to inspections and
requirements from both USDA and HHS. Likewise, the Managers are
aware that the inadequacy of the penalty provisions of the
Virus-Serum-Toxin Act--enacted in 1913 and under which USDA
currently regulates these dangerous agents--as well as the lack
of authority for the Secretary of Agriculture to regulate
possession of biological agents and toxins that pose a severe
threat to plant or animal health may expose the United States
to potential acts of bioterrorism that could have a devastating
impact on animal and plant health, or the domestic agricultural
economy.
The Managers intend that, in developing the list of
agents and toxins to be regulated under this subtitle, the USDA
Secretary shall consult with other appropriate Federal
agencies. With regard to zoonotic agents, which pose a threat
to both animals and humans, the Managers expect that the USDA
Secretary will consult with the HHS Secretary in developing
such a list. The Managers also intend that the USDA Secretary
will develop the list of regulated agents and toxins based
solely on the risk to animals or plants, or to animal or plant
products, including consideration of the effect of exposure on
the production and marketability of such products. The Managers
do not intend that the USDA Secretary will include an agent or
toxin on the USDA list because of the effect of that agent or
toxin on human health, which is governed by the statutory
provisions of section 351A of the Public Health Service Act, as
amended by this title.
The Managers expect that most ``persons'' who register
under this subtitle will be public and private entities, rather
than individuals. But these provisions also will cover
individuals possessing, using or transferring listed agents who
have not been granted authority to do so by registered persons.
If an individual has not been granted such authority, then that
individual would be a person required to register under this
subtitle. If an individual has been granted such authority
without proper authorization from the Secretary, as required by
this subtitle, then the registered person is subject to any
penalties provided for violation of such regulations. The
Managers emphasize that the primary responsibility for
registration and the screening of employees working with listed
agents is with the entity or employer, not the individual
employee.
Procedures for the registration of persons, review of
individuals, and inspection of facilities have been described
in the statutory language in some detail. Of equal importance
to the Managers are the regulations, to be established by the
Secretary, which, to ensure compliance with this subtitle,
shall include provisions for the revocation and suspension of
registrations for failure to maintain safe and secure
facilities.
Section 213. Implementation by the Department of Agriculture
House provision and Senate amendment: Neither the House
bill nor the Senate amendment contain any analagous provision.
Conference substitute: The Conference substitute provides
that, within 60 days of enactment, the Secretary of Agriculture
shall promulgate an interim final rule that establishes an
initial list of agents and toxins meeting the statutory
criteria for enhanced regulation. Within 60 days of the
publishing of the interim final rule, all persons (unless
exempt) must notify the Secretary of such possession. Within
180 days of enactment, the Secretary shall promulgate an
interim final rule for carrying out the remainder of section
212, which such rule shall include time frames that minimize
disruption of ongoing research and education with listed agents
and toxins.
Subtitle C--Interagency Coordination Regarding Overlap Agents and
Toxins
Section 221. Interagency Coordination
House provision: The House bill requires that the HHS
Secretary ensure that select agent regulations are coordinated
with the existing regulations of USDA governing certain of the
select agents that are used in the development of vaccines or
other products for the treatment of domestic animals. The
purpose of such coordination is to minimize conflict and
duplication of administrative burdens of registered persons.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute, in adding
new USDA regulatory authority comparable to that given HHS in
subtitle A of this title, also adopts provisions that would
facilitate coordination and cooperation between USDA and HHS
with respect to the regulation of those ``overlap'' agents or
toxins that are regulated by both such agencies.
In the case of zoonotic agents that appear on both the USDA
and HHS lists of dangerous biological agents and toxins
developed under this title, the Managers intend that the two
Secretaries shall work cooperatively to develop a streamlined,
joint registration whereby the registrant shall be permitted to
submit a single registration document to either USDA or HHS.
Upon receipt of the registration document, the receiving agency
shall review the application and transfer it to the other
agency in order that the second agency may conduct an
independent review. Upon completion of the individual reviews
by both agencies, and if both agencies concur that the
registration should not be denied, the receiving agency shall
notify the prospective registrant of this determination. In the
absence of concurrence, the receiving agency shall notify the
prospective registrant of the denial of the application.
The Managers intend that this system of joint registration
should be implemented through the development of a
comprehensive Memorandum of Understanding between the two
agencies no later than six months after the date of enactment
of this act, which will coincide with the issuance by each
Secretary of an interim final rule requiring the registration
of listed agents and toxins. Until such time as the Memorandum
of Understanding is implemented, the separate regulatory
systems of USDA and HHS shall remain in effect.
It is the Managers' intent that the two Secretaries will
coordinate closely with respect to exemptions from these new
regulatory regimes for overlap agents, so as to create a
uniform and consistent approach. The Managers also intend that,
under the Memorandum of Understanding, a regulated party will
interact with one agency with respect to all matters--including
registration, screening, and inspections--so as to avoid
confusion and forum shopping. The Managers also expect that the
two Departments will coordinate and consult with respect to
overlap agent registration, screening, and exemptions in a
timely manner, particularly in situations of public health or
agricultural emergencies.
Within 18 months of the implementation of a Memorandum of
Understanding between USDA and HHS, the Managers intend that a
formal, joint regulatory system shall be implemented by the two
Departments for agents and toxins that appear on both the USDA
and HHS lists. Once implemented, the Managers intend that these
joint regulations shall supercede the Memorandum of
Understanding with respect to matters covered by such
regulations.
Subtitle D--Criminal Penalties Regarding Certain Biological Agents and
Toxins
Section 231. Criminal Penalties
House provision: The House bill authorizes amendments to
current law to require all persons who possess, use or transfer
biological agents or toxins that have been listed as select
agents by the HHS Secretary to register with the Secretary. To
enforce these new regulatory provisions, subsection (a) of
section 231 of the House bill provides that any person who
knowingly transfers a select agent to any person without first
verifying such registration with the Secretary could be fined
or imprisoned up to five years, or both. The subsection also
provides that any person who knowingly possesses a biological
agent or toxin, where such agent or toxin is a select agent for
which such person has not obtained a registration required by
the Secretary, could be fined or imprisoned for up to five
years, or both.
The House bill makes technical changes to 18 U.S.C. 175b
to renumber current subsection (a) as (a)(1), and to
redesignate subsection (c) as (a)(2). This change will result
in the description of the possible penalties being placed
immediately following the description of the unlawful conduct.
The House bill also redesignates subsection (b) as subsection
(d). The two new criminal provisions added under this bill are
designated subsections (b) and (c) of section 175b. The House
bill also makes conforming amendments to clarify the definition
of the term ``select agent.'' The House bill also changes the
title of section 175b from ``Possession by restricted persons''
to ``Select Agents.''
Senate amendment: The Senate amendment includes the same
criminal provision relating to those who possess select agents
without being registered, but differs with respect to the
criminal penalty for unauthorized transfers. The Senate
amendment criminalizes transfers to unregistered persons when
the transferor has reason to believe that the recipient is not
registered. The Senate amendment also differs by including the
unlawful conduct in 18 U.S.C. 175, rather than 175b. The Senate
amendment makes conforming changes to 18 U.S.C. 175 to make the
sections technically correct and to eliminate a definition that
is already provided in another section. The Senate amendment
provides that current 18 U.S.C. 175(b) and (c) are redesignated
as (c) and (d). New subsection (b) creates the criminal
penalties referenced above. New subsection (d), which contains
the definitions, amends current law to provide new definitions
for the following terms: ``biological agent,'' ``for use as a
weapon,'' and ``select agent.''
Conference substitute: The Conference substitute adopts
the House language with regard to technical changes to 18
U.S.C. 175b, but adopts the Senate language with respect to new
criminal penalties with modifications. The Conference
substitute adopts the common language dealing with unlawful
possession. However, the Conference substitute amends the
Senate language regarding transfers to provide that any person
who transfers a select agent to any person one knows or has
reasonable cause to believe has not registered with the HHS
Secretary could be fined or imprisoned up to five years, or
both.
The Conference substitute also amends both bills by
adding language that requires all persons who possess, use or
transfer biological agents that have been listed as agents that
pose a threat to agriculture by the Secretary of Agriculture to
register with such Secretary. The Conference substitute
provides that knowing possession of a biological agent or
toxin, where such agent or toxin is listed by the Secretary of
Agriculture under this Act and for which a required
registration has notbeen obtained, is punishable by a fine or
up to five years imprisonment, or both. Similarly, transfer of a
biological agent or toxin listed by the Secretary of Agriculture to a
person one knows or has reasonable cause to believe has not registered
with the Secretary is punishable by a fine or up to five years
imprisonment, or both.
The Conference substitute also makes additional
conforming and technical amendments to title 18, including
providing a comma in 18 U.S.C. 175(c); specifically describing
what activities restricted persons are prohibited from engaging
in under this section; referring to the correct code section
for the definition of ``alien''; replacing legislative language
in 176(a)(1)(A); modifying the definitions in 18 U.S.C. 178 for
``biological agent'', ``toxin'', and ``vector'' to make each
more accurate; and modifying 18 U.S.C. 2332a regarding use of
weapons of mass destruction to make it clear it refers to use
of biological agents or toxins.
The Managers expect that most ``persons'' who register
under this title will be public and private entities, rather
than individuals. When an entity fails to register as required,
the new criminal possession statutes will apply to that entity.
These provisions also will cover individuals possessing select
or listed agents who are unregistered and who have not been
granted access to such agents by registered persons. If an
individual has not been granted access by a registered person,
then that individual would be a person required to register
under this title for purposes of these criminal possession
provisions. If an individual is granted access to a select or
listed agent by a registered person without proper
authorization from the Secretary, as required by this title,
then the registered person is subject to any penalties provided
for violation of such regulations. The Managers emphasize that
the primary responsibility for registration and the screening
of employees working with select or listed agents is with the
entity or employer, not the individual employee. This same
analysis applies to the criminal transfer provisions set forth
in this section.
TITLE III--PROTECTING THE SAFETY AND SECURITY OF THE FOOD AND DRUG
SUPPLY
Subtitle A--Protection of Food Supply
For purposes of this Title, the term ``Secretary'' refers
to the Secretary of Health and Human Services, unless otherwise
indicated.
Section 301. Food Safety and Security Strategy
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment expands the
responsibilities of the President's Council on Food and Safety
(established by Executive Order 13100) by directing the
Council, with the Secretary of Commerce and the Secretary of
Treasury to develop a crisis communications and education
strategy with respect to bioterrorist threats to the food
supply. The Senate amendment authorizes to be appropriated
$500,000 to develop such a strategy.
Conference substitute: The Conference substitute adopts
the Senate amendment with modification. The Conference
substitute expands the scope of consultation between the
President's Council on Food Safety and other entities to
include any other relevant Federal agencies, including law
enforcement and intelligence related agencies, and scientific
organizations. The Conference substitute also expands the scope
of the food safety and security strategy to address
technologies, threat assessments, risk communication, and
procedures for securing food processing and manufacturing
facilities and modes of transportation. The Conference
substitute increases the amount of funds that are authorized to
be appropriated for fiscal year 2002 to $750,000 to develop
such a strategy.
Section 302. Protection Against Adulteration of Food
House provision: The House bill authorizes to be
appropriated $100,000,000 for fiscal year 2002, and such sums
as may be necessary for each year from fiscal year 2003 thorugh
fiscal year 2006, for the Secretary to carry out increased
activities to ensure the safety of the food supply.
Specifically, the House bill amends section 801 of the Federal
Food Drug and Cosmetic Act (FFDCA) directing the Secretary to
give high priority to increasing the number of food safety
inspections at ports of entry, with highest priority on
inspections to detect intentional adulteration of food.The
House bill also directs the Secretary to give a high priority to
improving the information management systems that support food safety
inspection programs for the purpose of improving the ability of the
Secretary to detect intentional adulteration of food and to facilitate
the importation of food that is in compliance with the Act. Further,
the House bill directs the Secretary to give high priority to
researching and developing improved tests and sampling methods for the
purpose of rapidly detecting adulterated foods, with highest priority
on detection of intentional adulteration. Finally, the House bill
directs the Secretary to complete an assessment of potential threats to
the food supply posed by efforts to intentionally adulterate food, and
to report the findings on such assessment to Congress within six
months.
Senate amendment: The Senate amendment authorizes to be
appropriated $59,000,000 for fiscal year 2002 and such sums as
may be necessary for each year thereafter to expand the
capacity of the Food and Drug Administration (FDA) to increase
inspections to ensure the safety of the food supply and to
improve linkages between the FDA and other Federal regulatory
agencies, the States, and Indian tribes.
Conference substitute: The Conference substitute adopts
the House bill with modification. The Conference substitute
directs the Secretary to improve linkages with other Federal
regulatory agencies that share responsibility for food safety,
and directs the Secretary to improve linkages with the States
and Indian tribes with respect to food safety. The Managers
intend that the Secretary in making improvements to the
information management systems that support food safety
inspection programs, including the OASIS system, may include
improvements that assist food importers and filers in providing
accurate and timely information on entries filed on food import
shipments. The Managers also intend that in conducting research
to develop improved tests and sampling methods for the purpose
of rapidly detecting adulterated foods, the Secretary may
involve institutions of higher education, including such
institutions that receive Federal funding to operate
consortiums within the food industries, for the purpose of
conducting research and development in food safety and food
security. Finally, it is the understanding of the Managers that
FDA already has underway (under agreement with Battelle
Laboratories) an assessment of potential threats to the food
supply posed by efforts to intentionally adulterate food. For
purposes of this section, the requirement to conduct an
assessment of potential threats to the food supply posed by
efforts to intentionally adulterate food refers to such threat
assessment that is already underway or very recently completed.
Section 303. Administrative Detention
House provision: The House bill amends section 304 of the
FFDCA by authorizing the Secretary to administratively detain
an article of food that is found during an inspection,
examination or investigation under this Act if the Secretary
has credible evidence or information indicating that the
article presents a threat of serious adverse health
consequences or death to humans or animals. Such food may be
detained for a reasonable period of up to 20 days, and where
needed up to 30 days, for the purpose of enabling the Secretary
to institute a seizure action under section 304(a) or
injunctive relief under section 302, as warranted. The House
bill authorizes the Secretary to move detained food from the
place at which it has been detained to a secured facility, as
appropriate, for the period of detention or until released by
the Secretary. The House bill also authorizes a claimant of an
article of food that has been detained under this section to
appeal the detention of the article. In addition, where the
Secretary already has credible evidence or information
indicating that an imported article of food presents a threat
of serious adverse health consequences or death to humans or
animals, this section also requires the Secretary to request
the Secretary of Treasury to temporarily hold imported food at
a port of entry for up to 24 hours to enable the Secretary to
inspect, examine or investigate the food. For an article of
food temporarily held under this section, the Secretary is also
required to notify the State in which the port of entry is
located about such request or that such food is being
temporarily held.
Senate amendment: The Senate amendment provides authority
to administratively detain food that is similar to the House
bill. The Senate amendment allows the Secretary to detain food
that violates the FFDCA and that presents a threat of serious
adverse health consequences or death, and requires that the
Secretary provide an opportunity for a hearing (and to confirm
or to revoke) a detention order within 15 days of the filing of
an appeal by a claimant. Unlike the House bill, the Senate
amendment does not include additional authority to temporarily
hold food, nor does itrequire the Secretary to notify a State
regarding the port of entry within such State at which food is being
temporarily held.
Conference substitute: The Conference substitute adopts
the House bill with modification. The Conference substitute
clarifies that food that is detained under this section may not
be delivered pursuant to an execution of a bond in accordance
with section 801 of the FFDCA (if the detained food is
imported) or otherwise (if the detained food is domestically
produced), while the food is subject to the detention order,
unless released by the Secretary. The Conference substitute
requires the Secretary in response to an appeal filed by a
claimant challenging the detention of an article of food to
conduct an informal hearing and confirm or terminate a
detention order within five days after an appeal is filed, at
which time the Secretary's determination is subject to judicial
review in accordance with section 702 of title 5, United States
Code. The Conference substitute amends section 304 of the FFDCA
by authorizing the Secretary to detain an article of food for
the purpose of enabling the Secretary to institute a seizure
action under section 304(a) or to seek injunctive relief under
section 302 of the Act. This section provides a claimant of the
food the right to appeal a detention order, but that right of
appeal terminates if the Secretary institutes either a seizure
action under section 304(a) or injunctive relief under section
302 of the Act. The Managers do not intend to terminate the
claimant's right to appeal a detention order under paragraph
4(B) of such subsection, unless the basis for the seizure
action instituted under section 304(a) or the injunctive relief
sought under section 302 is related to the original basis for
detention under this section.
The Conference substitute provides that an article of
food subject to detention shall be held in a secure facility,
as appropriate. Under this title, in instances where the
Secretary moves food that has been refused admission to a
secure facility, the Secretary should ensure that such food
will be held under appropriate conditions of cleanliness,
temperature, humidity and other such considerations that are
necessary so as not to erode the safety and wholesomeness of
the detained article.
The Managers recognize that perishable foods may be
detained under this section. As a result, the Secretary is
required to promulgate a rule to establish expedited procedures
for instituting an action under section 304(a) or section 302
of the FFDCA for perishable foods, such as fresh produce, fresh
fish and fresh seafood products. The Secretary should promptly
complete such rule making.
The Conference substitute requires the Secretary to
temporarily hold food for not longer than 24 hours, where the
Secretary has credible evidence or information indicating that
such article of food presents a threat of serious adverse
health consequences or death to humans or animals. The period
of temporary hold is intended to allow the Secretary time to
dispatch an inspector to the port of entry in order to conduct
the needed inspection, examination or investigation.
Section 304. Debarment for Repeated or Serious Food Import Violations
House provision: The House bill provides authority to the
Secretary to debar from importing articles of food, any person
that is convicted of a felony relating to food importation or
any person that repeatedly imports food and who knew, or should
have known, that such food was adulterated. The House bill
treats the importation or offer for importation of an article
of food by a debarred person as a prohibited act under section
301 of the FFDCA.
Senate amendment: The Senate amendment includes
permissive debarment authority for food importers that is
similar to the permissive debarment authority of the House
bill, but replaces the standard in the House bill, allowing
debarment for repeatedly importing unsafe food, with a
different standard allowing debarment of food importers for
engaging in a pattern of importing unsafe food. Unlike the
House bill, the Senate amendment treats food that is imported
by a debarred person as adulterated.
Conference substitute: The Conference substitute adopts
the Senate amendment with modification. Unlike the Senate
amendment, the Conference substitute does not treat food that
is imported by a debarred person as adulterated solely on the
basis of its importation by a debarred person. Rather the
Conference substitute treats the importation or offering for
importation into the United States of an article of food by,
and with the assistance of, or at the direction of, a debarred
person as a prohibited act under section 301 of the FFDCA. In
addition, the Conference substitute requires food imported by a
debarred person to berefused admission and held in a secure
facility, as appropriate, unless a person, other than a debarred
person, affirmatively establishes that such food complies with the
requirements of the FFDCA. The Conference substitute also clarifies
that imported food that is refused admission may not be delivered
pursuant to the execution of a bond under subsection (b) of section 801
of the FFDCA. For purposes of this section, the person other than the
debarred person who may established that food, which has been refused
admission under this section, is in compliance with this Act is
intended to be an innocent purchaser of food, not a person that is
engaged in the improper importation of food with a debarred person. In
addition, the classification as a prohibited act (under section 301 of
the FFDCA) of the importation or offer for importation of food ``with
the assistance of'' a debarred person is not intended to include an
innocent purchaser who did not have knowledge, actual or constructive,
of the importer's debarred status. Finally, the Conference substitute
clarifies that the Secretary has the authority to terminate the
debarment of corporations or persons under this subsection.
Section 305. Registration of Food Facilities
House provision: The House bill requires facilities
(excluding farms) that manufacture, process, pack or hold food
for consumption in the United States to file with the
Secretary, and keep up to date, a registration that contains
the identity and address of the facility and, when the
Secretary determines appropriate the general category of food
manufactured, processed, packed or held at the facility. The
House bill also authorizes the Secretary to exempt certain
retail establishments only if the Secretary determines that the
registration of such facilities is not needed for effective
enforcement. Enforcement of this section is delayed one hundred
and eighty days from the date of enactment, and this section
requires the Secretary to notify and issue guidance within
sixty days identifying facilities that are required to register
under this section.
Senate amendment: The Senate amendment includes a
requirement for certain food facilities to register with the
Secretary that is similar to the registration requirement for
food facilities that is contained in the House bill. The Senate
amendment exempts types of farms or retail establishments but,
unlike the House bill, farms can be exempted only if the
Secretary determines that the registration of such facilities
is not needed for effective enforcement of the FFDCA. The
Senate amendment also lacks the requirements of the House bill
relating to notice to those who must register and relating to
electronic registration.
Conference substitute: The Conference substitute adopts
the Senate amendment with modification. The Conference
substitute requires the Secretary to establish registration
requirements for specified food facilities by regulation not
later than eighteen months after the date of enactment of this
Act. If such regulations are not effective prior to the
conclusion of such eighteen-month period, the requirements of
this section are self-executing and enter into effect at such
time and remain in effect unless superseded by such final
regulations. The Managers strongly encourage the Secretary to
complete this rule making in a timely manner in order to enable
the efficient operation of these registration requirements.
The Conference substitute treats the failure of a
specified facility to register under this section as a
prohibited act under section 301 of the FFDCA. The Conference
substitute requires the Secretary to refuse admission to food
imported from foreign facilities that have failed to register
in accordance with this section until such facility is
registered, and requires the Secretary to remove such food to a
secure facility, as appropriate. The Conference substitute
clarifies that imported food that is refused admission under
this section shall not be delivered pursuant to the execution
of a bond under subsection (b) of section 801 of the FFDCA.
The Conference substitute exempts from the requirements
of registration farms, restaurants, other retail food
establishments, non-profit food establishments in which food is
prepared for, or served directly to, the consumer, and fishing
vessels not engaged in processing, as defined in section
123.3(k) of title 21, Code of Federal Regulations. The Managers
intend that, for purposes of this section, the term ``retail
food establishments'' includes establishments that store,
prepare, package, serve or otherwise provide articles of food
directly to the retail consumer for human consumption, such as
grocery stores, convenience stores, cafeterias, lunch rooms,
food stands, saloons, taverns, bars, lounges, catering or
vending facilities, or other similar establishments that
provide food directly to a retail consumer. The term does not
include a warehouse that does not provide articles of food
directly to a retail consumer as its primary function. The
Managers intend that, for purposes of this section,the term
``non-profit food establishments'' includes not-for-profit
establishments in which food is prepared for, or served directly to the
consumer, such as food banks, soup kitchens, homebound food delivery
services, or other similar charitable organizations that provide food
or meals for human consumption. In addition, the Managers intend that,
for purposes of this section, ``facility'' does not include trucks or
other motor carriers, by reason of their receipt, carriage, holding, or
delivery of food in the usual course of business as carriers. In
addition, nothing in this section shall be construed to alter or amend
the treatment of carriers under section 703 of the FFDCA.
Finally, the Conference substitute calls for one-time
registration of covered facilities, rather than annual
registration of such facilities. Once a facility is registered
it should amend its original registration in a timely manner to
reflect any changes. The Conference substitute encourages
electronic registration to help reduce paperwork and reporting
burden, but registration is also permitted using a paper form.
Section 306. Maintenance and Inspection of Records for Foods
House provision: The House bill provides the Secretary
with authority to inspect and copy all records relating to an
article of food if the Secretary has credible evidence or
information indicating that an article of food presents a
threat of serious health consequences or death to humans or
animals. The House bill contains certain limitations on the
Secretary's authority, including limitations to ensure the
protection of trade secrets and confidential information. The
House bill provides the Secretary with the discretion to issue
a regulation requiring maintenance of additional records that
are needed to identify the source and chain of distribution of
food, in order to address credible threats of serious adverse
health consequences or death to humans or animals. The House
bill excludes restaurants and farms, and the Secretary is
provided the authority to take into account the size of the
business when imposing any record keeping requirements.
Senate amendment: The Senate amendment includes records
access authority that is similar to the records access
authority granted to the Secretary in the House bill. The
Senate amendment authorizes the Secretary to inspect and copy
records relating to the violation when he has a reason to
believe that an article of food is adulterated or misbranded
and presents a threat of serious adverse health consequences or
death. The Senate amendment also includes record keeping
authority that is similar to the record keeping authority in
the House bill. The Senate amendment requires the Secretary to
issue a regulation to require the maintenance and retention of
records to trace the chain and distribution of food within 18
months of enactment of the Act. In addition, the Senate
amendment allows the Secretary to require maintenance and
retention of records necessary to determine if a food may be
adulterated or misbranded to the extent that it presents a
threat of serious adverse health consequences or death. The
Senate amendment limits the Secretary's authority to require
the retention of either type of records for not longer than two
years. The Senate amendment also criminalizes the release of
trade secret information obtained by inspection of records
under this section.
Conference substitute: The Conference substitute adopts
the House bill with modification. The Conference substitute
replaces the standard for records acccess in the House bill
with a different standard that grants the Secretary records
access if the Secretary has a reasonable belief that an article
of food is adulterated and presents a threat of serious adverse
health consequences or death to humans or animals. The
Conference substitute limits access to those records relating
to such article of food that are needed to assist the Secretary
in determining whether food is adulterated and presents a
threat of serious adverse health consequences or death to
humans or animals.
The Conference substitute amends the scope of record
keeping authority contained in the House bill by clarifying
that the authority under this section applies to both the
establishment and maintenance of records that meet the standard
under this section and by limiting the record retention
requirement to a period of not longer than 2 years. The
Conference substitute also adopts the requirement of the Senate
amendment to criminalize the disclosure of trade secrets
obtained under this section.
The Conference substitute authorizes the issuance of
regulations to require establishment and maintenance of chain
of distribution records. This authority should not be used to
require a business to maintain records regarding transactions
or activities to which it was not a party. The Managers intend
that those records that document the person from whom food was
directly received, and to whom food was directlydelivered, are
adequate to enable identification of the source and distribution of
food. As a result, for purposes of this section, the terms ``immediate
previous sources'' and ``immediate subsequent recipients'' refer to the
person from whom the food was received and the person to whom the food
was delivered, respectively.
The Managers did not adopt a Senate proposal to authorize
the Secretary to require the maintenance and retention of other
records for inspection relating to food safety, because the
Secretary has authority under section 701(a) of the FFDCA to
issue regulations for the ``efficient enforcement of this Act''
and this authority, in combination with other provisions (such
as section 402), gives the Secretary the authority to require
appropriate record keeping in food safety regulations.
Section 307. Prior Notice of Imported Food Shipments
House provision: The House bill directs the Secretary by
regulation to require importers of articles of food to provide
up to seventy-two hours, but not less than twenty-four hours,
prior notice that food will be imported or offered for import
into the United States. The House bill requires that the notice
contain the following information: a description of food to be
imported; the identity of the manufacturer and shipper; and, if
known within the specified period of time that notice is
required to be provided, the identity of the grower; the
country of origin of the article; the country from which the
food is being shipped; and the anticipated port of entry into
the United States. In the event notice is not provided in
advance of importation in accordance with the Secretary's
regulation, the food shall be held at the port of entry until
notice is properly provided and the Secretary determines
whether there is credible evidence or information in his
possession indicating that the article presents a threat of
serious adverse health consequences or death to humans or
animals.
Senate amendment: The Senate amendment, like the House
bill, includes a requirement that food importers provide prior
notice to the Secretary of incoming food imports. The Senate
amendment differs from the requirement in the House bill,
because the prior notice requirement in the Senate amendment is
self-effectuating upon enactment of the Act and requires at
least four hours minimum prior notice and no limitation on the
maximum notice allowable. The Senate amendment requires that
the notification contain the identity of the food, the food's
country of origin, the quantity imported, and other information
that the Secretary may require by regulation. Finally, if an
importer fails to provide the required prior notice, under the
Senate amendment the Secretary is provided with discretion to
refuse admission into the United States of the food.
Conference substitute: The Conference substitute adopts
the House amendment with modification. The Conference
substitute requires the Secretary to establish by regulation
the period of time for prior notice, that must be no less than
the minimum amount of time necessary for the Secretary to
receive, review, and appropriately respond to the notice, but
that may not exceed five days. In determining the specified
period of time for prior notice, by regulation, the Conference
substitute identified several factors the Secretary may take
into account, including the effect on commerce, the locations
of various ports of entry, the various modes of transportation,
the types of food imported into the United States, and other
such considerations. Nothing in the preceding sentence may be
construed as a limitation on the obligation of the Secretary to
receive, review, and appropriately respond to any notice under
this section.
The Conference substitute treats the failure to provide
adequate prior notice under this section as a prohibited act
under section 301 of the FFDCA. The Conference substitute
requires the Secretary to refuse admission to food imported
without properly providing prior notice in accordance with this
section until such prior notice is properly provided. In
addition, the Conference substitute requires the Secretary to
remove such food to a secure facility, as appropriate and
clarifies that imported food that is refused admission under
this section shall not be delivered pursuant to the execution
of a bond under subsection (b) of section 801 of the FFDCA.
The Conference substitute directs the Secretary to
establish prior notice requirements for imported foods by
regulation not later than eighteen months after the date of
enactment of this Act. If such regulations are not effective
prior to the conclusion of such eighteen-month period, the
requirements of this section are self-executing and enter into
effect at such time and remain in effect unless superseded by
such final regulations. In addition, at the conclusion of the
eighteen-month period, if such final regulations are not
effective, the Conference substitute establishes a default
period of time for prior notice of not less than 8 hours and
not more than 5 days that remains in effect unless superseded
by such final regulations. The Managers strongly encouragethe
Secretary to complete this rule making in a timely manner in order to
enable the efficient operation of these requirements.
The Managers intend that the requirements of this section
should not be construed to apply to packaging materials if, at
the time of importation, such materials will not be used for,
or in contact with, food as defined under section 201 of the
FFDCA. Nothing in this section shall be construed to alter or
amend the regulatory treatment of food packaging materials or
food contact substances under the FFDCA. Also, the Conference
substitute requires the importer of an article of food to
provide information about the grower of the article of food,
but this provision only requires the importer to provide the
identity of the grower of the article of food if known during
the period of time in which prior notice is required to be
provided. Finally, the Secretary shall consult and coordinate
with the Secretary of Treasury in developing the prior notice
regulation. This section of the Conference substitute contains
prior notice requirements for imported food and is not intended
as a limitation on the port of entry for an article of food.
Section 308. Authority to Mark Articles Refused Admission into United
States
House provision: The House bill requires that food that
has been refused admission to the United States, but has not
been ordered destroyed, may have a label affixed to its
container at the expense of the owner or consignee indicating
that it has been refused admission.
Senate amendment: The Senate amendment, similar to the
House bill, includes authority regarding the marking of food
that has been refused admission into the United States. Unlike
the House bill, the Senate amendment provides the Secretary
with a broader authority than the House bill to mark foods as
refused admission, including foods that have not been
determined to present a threat of serious adverse health
consequences or death to humans or animals. The Senate contains
an enforcement provision under which food that has been refused
admission but that has not been properly marked as refused
admission is treated as misbranded if it is determined that it
presents a threat of serious adverse health consequences or
death to humans or animals.
Conference substitute: The Conference substitute adopts
the House bill with modification. The Conference substitute
provides the Secretary with discretionary authority to require
that items that have been refused admission to the United
States under section 801 of the FFDCA shall be so marked. The
Conference substitute clarifies that the marking of such items
may be applied to the container of the food. The Conference
substitute also requires the Secretary to notify the owner or
consignee of an article of food that has been refused admission
and that has been required to be so marked under this section,
if at some time subsequent to requirement to mark the food, the
Secretary determines that the food is misbranded and presents a
threat of serious adverse health consequences or death to
humans or animals.
Nothing in this section shall be construed to alter or
amend the authority of the Secretary to authorize the admission
of an article of food that has been relabeled, reconditioned or
otherwise brought into compliance with the Act in accordance
with subsection (b) of section 801 of the Act.
Section 309. Prohibition Against Port Shopping
House provision: The House bill requires any person
attempting to re-offer for admission an article of food at a
port of entry into the United States, after it has been
previously refused admission at another port of entry into the
United States, to affirmatively establish that the food is not
adulterated.
Senate amendment: The Senate amendment contains a
prohibition against port shopping that is comparable to the
prohibition contained in the House bill. The Senate amendment
prohibits a person from port shopping with respect to food that
has been refused admission, by requiring that the person show
that food that has been refused admission previously, has been
brought into compliance with the applicable requirements of the
FFDCA.
Conference substitute: The Conference substitute adopts
the Senate amendment without modification.
Section 310. Notice to States Regarding Imported Food
House provision: The House bill requires that where the
Secretary has credible evidence or information indicating that
an article of food presents a threat of serious adverse health
consequences or death to humans or animals, the Secretary shall
provide notice regarding the threat posed by such food to those
States in which the food is held or will be held and shall
request that such States take appropriate remedial action.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House bill with modification. The Conference substitute
clarifies the scope of the rule of construction included in
subsection (b) of this section.
Section 311. Grants to States for Inspections
House provision: The House bill authorizes the Secretary
to make grants for increased food safety inspections,
examinations, investigations and related activities and to
assist States in taking appropriate actions to respond to any
Federal notice received pursuant to section 309 (governing
notice to States) of the House bill. The House bill authorizes
to be appropriated such sums as may be necessary for fiscal
year 2002 through fiscal year 2006 to establish and carry out
the grants under the section.
Senate amendment: The Senate amendment authorizes the
Secretary to make grants to States, territories, and Federally
recognized tribes to cover the cost of food safety
examinations, inspections, investigations, and related
activities under section 702 of the FFDCA, and it authorizes to
be appropriated $10 million in fiscal year 2002 and such sums
as may be necessary for each year thereafter for such purpose.
Conference substitute: The Conference substitute adopts
the House bill with modification. The Conference substitute
extends the grants made available under this section to Indian
tribes to the extent they undertake inspections, investigations
or examinations under section 702 of the FFDCA. The Conference
substitute authorizes to be appropriated $10 million in fiscal
year 2002 and such sums as may be necessary for each fiscal
year 2003-2006 for such purpose.
Section 312. Surveillance and Information Grants and Authorities
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment authorizes the
Secretary to award grants to States to increase participation
in Pulsenet, the Foodborne Diseases Active Surveillance
Network, and other such networks, and authorizes to be
appropriated $19.5 million in fiscal year 2002, and such sums
as may be necessary each year for such purpose from fiscal year
2003 through fiscal year 2006.
Conference substitute: The Conference substitute adopts
the Senate amendment with modification. The Managers intend
that funds awarded under this section shall be used by States
and Indian tribes to assist in meeting the costs of
establishing and maintaining the food safety surveillance,
technical and laboratory capacity needed to participate in
programs, including Pulsenet, Foodborne Diseases Active
Surveillance Network, and other networks to enhance Federal,
State, and local food safety efforts.
Section 313. Surveillance of Zoonotic Disease
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment requires the
Secretary of Health and Human Services and the Secretary of
Agriculture to develop and implement a plan for the
surveillance of zoonotic and human disease.
Conference substitute: The Conference substitute adopts
the Senate amendment with modification. The Conference
substitute directsthe Secretary, through the Commissioner of
FDA and the Director of the Centers for Disease Control and Prevention
(CDC), and the Secretary of Agriculture to coordinate the surveillance
of zoonotic diseases.
Section 314. Authority to Commission Other Federal Officials to Conduct
Inspections
House provision: The House bill does contain no analogous
provision.
Senate amendment: The Senate amendment includes authority
that is not included in the House bill that allows the
Secretary to commission officers and qualified employees of
other Federal Departments or Federal agencies to conduct
examinations and inspections for the Secretary under section
702 of the FFDCA.
Conference substitute: The Conference substitute adopts
the Senate amendment with modification. The Conference
substitute clarifies that the authority of the Secretary to
commission other Federal officials to conduct inspections,
examinations and investigations under section 702 of the FFDCA
shall be carried out pursuant to a memorandum of understanding
between the Secretary and the head of the Department or agency
of such other Federal employees.
Section 315. Rule of Construction
House provision: The House bill does contain no analogous
provision.
Senate amendment: The Senate amendment includes a rule of
construction that applies to the amendments made in Title V of
the Senate amendment that provides that such amendments do not
provide the FDA with additional authority over meat, poultry,
and egg products, nor do such amendments limit the authority of
the Department of Agriculture over such products.
Conference substitute: The Conference substitute adopts
the Senate amendment with modification. The Conference
substitute clarifies that nothing in this Title, or an
amendment made by this Title, shall be construed to alter the
jurisdiction between the Secretary and the Secretary of
Agriculture, under applicable statutes and regulations.
Subtitle B--Protection of Drug Supply
Section 321. Annual Registration of Foreign Manufacturers; Shipping
Information; Drug and Device Listing
House provision: The House bill mandates annual
registration of foreign manufacturers engaged in the import of
drug and device products into United States. The House bill
also requires that the annual registration include information
on each importer or carrier transporting the foreign
manufacturer's drug or device products. The House bill also
directs that the registration and listing numbers be included
in the declaration for the products when offered for import.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House bill with modification. The conference substitute
requires registration through electronic means. The Conference
substitute deletes carrier in the annual registration and
replaces with ``person who imports or offers for import.'' The
Conference substitute makes non-registration a prohibited act
rather than deeming it misbranded. Non-registration is a
failure to comply with the Secretary's request to submit
registration information. The Conference substitute provides
for a non-registered drug or device to be removed to a secure
facility until non-registration is cured. For purposes of this
section, the Managers intend ``person who imports or offers for
import'' to capture import brokers and other persons who file
import-related paperwork with the U.S. Customs Service or the
FDA.
Section 322. Requirement of Additional Information Regarding Import
Components Intended for Use in Export Products
House provision: The House bill mandates a chain of
possession identification and a customs bond for those firms
that seek to importcomponents of drugs, devices, food
additives, color additives, or dietary supplements for further
processing and export. The House bill requires certificates of analysis
for components containing any chemical substance or biological
substance intended for export.
Senate provision: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House bill with modification. The Conference substitute
deletes reference to carriers in chain of possession
identification. The Conference substitute exempts devices and
products covered by section 801(d)(4) of the FFDCA from the
certificate of analysis requirement. The Conference substitute
clarifies that the provisions permitting import-for-export do
not apply to articles for which the Secretary of Health and
Human Services determines that there is credible evidence or
information indicating the article is not intended to be
imported for export.
The Managers understand this section does not change any
definitions of regulated articles or the scope of regulation of
those articles as set forth in the FFDCA and its implementing
regulations.
The Managers intend that this section shall not be
construed to restrict or facilitate the entry of articles
imported for research and development or quality assurance
purposes under subsection 801(d)(3) of the FFDCA beyond the
existing authority.
For the purposes of articles subject to subsection
801(d)(4) of the FFDCA, the Managers understand that the
collection agency would be considered the first manufacturer
under subsection 801(d)(3)(A)(i)(II) of the FFDCA, relating to
the chain-of-possession.
The Managers agree that certificates of analysis are not
required if the only chemical or biological component of the
article imported under subsection 801(d)(3) of the FFDCA is de
minimis, incidental and poses no danger to human or animal
health. Further, the Managers expect that the Secretary will
understand that ``certificate of analysis'' is a widely
understood and utilized document to assure the identity of the
substance and its components in the chemical and drug
industries. However, the Secretary in consultation with other
affected industries may accept documents that convey equivalent
assurance as to the identity of the article and its components
or substances. For example, the Secretary may determine that
for an article of food additive or color additive, a document
indicating specification of purity serves as the functional
equivalent of a certificate of analysis and meets the
requirement of a certificate analysis for purposes of this
section. This section exempts devices and blood and blood
products covered under subsection 801(d)(4) of the FFDCA from
the certificate of analysis requirement.
The Managers do not intend the Secretary of the Treasury
to engage in a new rulemaking to specify the requirement for
the bonding of goods imported under subsection 801(d)(3) of
FFDCA. Existing requirements for the bonding of goods imported
for further processing and export should be applied.
The Managers agree that articles imported for export
under this section 322 which otherwise meet the requirements of
this section should be permitted entry unless the Secretary
determines there is credible evidence or information that an
article offered for import is not intended to be imported for
export. In this regard, the Managers believe that refusal of
entry should not involve shipments between known shippers and
known recipients unless the Secretary has received credible
evidence or information that suggests such shipments may not be
legitimate. The Managers intend to permit the Secretary to
refuse admission of articles if the Secretary determines there
is credible evidence or information that the articles may be
used as instruments of terror. Such evidence might include
highly toxic or otherwise exceptionally dangerous products
going to recipients unknown to the Secretary or to recipients
believed to lack the capacity to further process such dangerous
articles, for example, nitroglycerin imported under this
section for delivery to a business other than a pharmaceutical
manufacturer. Such standard may also include, for example,
presentation for entry of articles not consistent with the
accompanying documentation.
Subtitle C--General Provisions Relating to Upgrading of Agricultural
Security
Section 331. Expansion of Animal and Plant Health Inspection Service
Activities
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment requires the
Secretary of Agriculture to enhance and expand the capacity of
theAnimal and Plant Health Inspection Service (APHIS) to
protect against the threat of bioterrorism, including through increased
inspection capacity internationally, improved surveillance at ports of
entry, and enhanced protections against terrorist use of plant and
animal disease organisms. The Senate amendment also requires the
Secretary of Agriculture to implement and then expand a high-tech
agriculture early warning and emergency response system, as well as an
automated record keeping system to track animal and plant shipments.
The Senate amendment authorizes the appropriation of $30 million in
fiscal year 2002 and such sums in each year thereafter, as may be
necessary for such purposes.
Conference substitute: The Conference substitute adopts
the Senate amendment with modification. The Conference
substitute clarifies that this section provides additional
authorization of appropriations to the Secretary of Agriculture
to utilize existing authorities to give high priority to
enhancing and expanding the capacity of APHIS to conduct the
specified activities and to otherwise improve the capacity of
APHIS to protect against the threat of bioterrorism. The
Conference substitute authorizes to be appropriated $30 million
for fiscal year 2002, and such sums as may be necessary for
each subsequent fiscal year.
Section 332. Expansion of Food Safety Inspection Service Activities
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment requires the
Secretary of Agriculture to enhance and expand the capacity of
the Food Safety Inspection Service (FSIS) to protect against
the threat of bioterrorism, including through enhanced ability
to inspect meat and poultry products and increased inspections
of meat and meat products, poultry and poultry products, and
egg products at ports of entry. The Senate amendment authorizes
the appropriation of $15 million in fiscal year 2002 and such
sums in each year thereafter, as may be necessary for such
purposes.
Conference substitute: The Conference substitute adopts
the Senate amendment with modification. The Conference
substitute authorizes to be appropriated $15 million in fiscal
year 2002 and such sums in each year thereafter, as may be
necessary for the the purpose of providing additional
authorization to the Secretary of Agriculture to utilize
existing authorities to give high priority to enhancing and
expanding the capacity of FSIS to conduct the specified
activities and to otherwise improve the capacity of FSIS to
protect against the threat of bioterrorism.
Section 333. Biosecurity Upgrades at the Department of Agriculture
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment authorizes to be
appropriated $180 million in fiscal year 2002 to update,
renovate, and expand the Department of Agriculture laboratory
and research facilities at Plum Island Animal Disease Center
and the Agricultural Research Service and Animal and Plant
Health Inspection Service facility in Ames, Iowa, and also
authorizes such sums as may be necessary in each year from
fiscal year 2003 through fiscal year 2006, for those
facilities, and for similar improvements at two other
Department of Agriculture facilities, one in Athens, Georgia,
and the other in Laramie, Wyoming.
Conference substitute: The Conference substitute adopts
the Senate amendment without modification. In addition to the
biosecurity upgrades at the Department of Agriculture
authorized in this section, the Managers intend that the
Secretary of Health and Human Services shall also continue to
take such actions as may be necessary to secure existing
facilities of the Department of Health and Human Services where
potential animal and plant pathogens are housed and researched.
Section 334. Agricultural Biosecurity
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment requires the
Secretary of Agriculture to establish minimum security
standards andaward grants of up to $50,000 to land grant
universities to assess security needs and plan upgrades of both
security of facilities where hazardous biological agents or toxins are
stored or used, and communication networks about such agents or toxins,
as well as to develop a national inventory of such agents and toxins.
The Senate amendment also requires the Secretary of Agriculture to
provide for screening of personnel who require access at agricultural
research facilities, and to develop and implement educational programs
directed at biosecurity at agricultural facilities, including farms,
livestock confinement operations, and crop producers, handlers,
processors, and transporters, as well as educational programs related
to animal quarantine and testing. The Senate amendment authorizes to be
appropriated $20 million in fiscal year 2002 and such sums in each year
thereafter, as may be necessary for such purposes.
Conference substitute: The Conference substitute adopts
the Senate amendment with modification. The Conference
substitute authorizes to be appropriated such sums as may be
necessary for the Secretary of Agriculture to award grants of
up to $50,000 each, to colleges and universities that have food
and agricultural science programs to review security standards
and practices at their facilities in order to protect against
bioterrorist threats. The Conference substitute also authorizes
the Secretary of Agriculture to award grants, of up to $100,000
per association, to associations of food producers or consortia
of such associations for the development and implementation of
educational programs to improve bio-security on farms against
bioterrorist attacks.
Section 335. Agricultural Bioterrorism Research and Development
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment requires the
Secretary of Agriculture, to the maximum extent practicable, to
expand research and development programs of the Agricultural
Research Service and the Cooperative State Research Education
and Extension Service to protect the nation's food supply from
bioterrorism, including by enhancing their capability to
respond to the needs of other food and agricultural regulatory
agencies, continuing existing partnerships with institutions of
higher education with programs related to agricultural
biosecurity, and by strengthening linkages with the
intelligence community. The Senate amendment authorizes the
appropriation of $190 million in fiscal year 2002 and such sums
in each year thereafter, as may be necessary for such purposes.
Conference substitute: The Conference substitute adopts
the Senate amendment with modification. The Conference
substitute authorizes to be appropriated $190 million in fiscal
year 2002 and such sums in each year thereafter, as may be
necessary for the Secretary of Agriculture to utilize existing
research authorities and programs to protect the food supply of
the United States by conducting various research activities,
including developing new and continuing partnerships with
institutions of higher education and other institutions to
establish and enhance bio-security and food safety programs,
with special emphasis on vulnerability analyses, incident
response, detection and prevention technologies. The Conference
substitute also authorizes the Secretary of Agriculture to
continue research to develop improved rapid detection field
test kits to detect biological threats to plants and animals
for use in responding to bioterrorism, and to develop an
agriculture bioterrorism early warning surveillance system by
enhancing the capacity of and coordination between State
veterinary diagnostic laboratories, Federal and State
agricultural research facilities, and public health agencies.
Section 336. Animal Enterprise Terrorism Penalties
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute amends
section 43(a) of title 18, United States Code, establishing a
Federal criminal offense against a person traveling in
interstate or foreign commerce for intentionally damaging or
causing the loss of any property used by the animal enterprise,
or conspiring to do such activities. The Conference substitute
establishes penalties for such criminal offense and authorizes
restitution for economic damage resulting from the loss.
TITLE IV--DRINKING WATER SECURITY AND SAFETY
The conference agreement builds upon title IV of the
House bill to ensure that drinking water systems across the
country assess their vulnerability to terrorist attack and
develop emergency plans to prepare for and respond to such
attacks. Americans deserve to know that the water they drink
everyday is safe. The legislation will lay the groundwork for
developing the necessary information, and emergency planning
and response efforts that are needed to address potential
terrorist attacks at drinking water systems.
Section 401. Terrorist and Other Intentional Acts
House provision: The House bill requires community water
systems serving over 3,300 persons to conduct vulnerability
assessments. These requirements are phased-in, depending on the
size of the community water system. Community water systems
serving over 100,000 persons must complete a vulnerability
assessment by December 31, 2002; community water systems
serving over 50,000 persons must complete a vulnerability
assessment by June 30, 2003; community water systems serving
over 3,300 persons must complete a vulnerability assessment by
December 31, 2003. Each community water system must certify to
the Administrator of the Environmental Protection Agency (EPA)
that they have conducted a vulnerability assessment. The
Administrator of EPA is also required to provide baseline
information by June 1, 2002 regarding which kinds of terrorist
attacks or other intentional acts are probable threats.
The House bill also requires community water systems to
prepare or revise emergency response plans that incorporate the
results of the vulnerability assessments. Community water
systems must certify to the Administrator of the Environmental
Protection Agency within 6 months of the completion of a
vulnerability assessment that they have completed an emergency
response plan. To the extent possible, community water systems
are to coordinate with Local Emergency Planning Committees when
preparing or revising an emergency response plan. The House
bill additionally requires EPA to provide guidance to community
water systems serving under 3,300 persons on how to conduct
vulnerability assessments and prepare emergency response plans.
In order to carry out the provisions of the section, the
House bill authorized $120 million in Fiscal Year 2002 and such
sums as necessary in Fiscal Years 2003 and 2004. The funds are
made available for purposes of complying with vulnerability
assessment and emergency response plan requirements and to
address basic security enhancements of critical importance and
significant threats to public health as determined by a
vulnerability assessment.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House provision with modifications. The Conference
substitute extends dates for certifying that systems have
completed a vulnerability assessment by three months for
systems serving over 100,000 persons and by six months for all
other systems. The substitute also extends the time for EPA
baseline information to August 1, 2002 to reflect the passage
of time between House action and conference agreement.
The Conference substitute also adds the requirement that
community water systems provide a copy of their vulnerability
assessment to the Administrator of the EPA. Under the
conference substitute, however, information that is provided by
a community water system to EPA and information that is derived
thereof is exempt from disclosure under the Freedom of
Information Act except for information that identifies the
community water system and the date on which a community water
system certifies to EPA that it has completed a vulnerability
assessment. In addition, no community water system shall be
required under State or local law to provide an assessment to
any State, regional or local governmental authority solely by
reason of the requirements to submit such assessment to the
Administrator of EPA.
The Administrator of the EPA is also required, by
November 30, 2002 to develop protocols to protect the
assessments from unauthorized disclosure. These protocols shall
ensure that all assessments and information are kept in a
secure location, only individuals designated by the
Administrator have access and that assessment in whole or in
part or information contained or derived from such assessments
shall not be available to anyone other than individuals
designated by the Administrator.
The Conference substitute also provides that any
individual designated by the Administrator who acquires
assessments or information derived from assessments and who
knowingly or recklessly reveals such information other than to
an individual designated by the Administrator shall be subject
to up to 1 year imprisonment, or a fine in accordance with 16
U.S.C. 227 and shall be removed from Federal office or
employment unless the information is revealed for purposes of
section 1445 of the Act, or actions taken under section 1431 of
the Act, or for use in any administrative or judicial
proceeding to impose a penalty for failure to comply with
section 1433 of the bill. The substitute further provides that
an individual designated by the Administrator who is an
employee or officer of the United States may discuss the
content of a vulnerability assessment submitted under this
section with a State or local official. The Conference
substitute provides that nothing authorizes any person to
withhold any information from Congress.
The Conference substitute adds the requirement that each
community water system maintain a copy of the emergency
response plan it has completed for 5 years after it certifies
to the Administrator of the EPA that it has completed such
plan. The Conference agreement also increases authorized
funding for Fiscal Year 2002 to $160 million and adds
additional specification of basic security enhancements. The
Conference Agreement also extends authorizations in this
section through Fiscal Year 2005. Finally, the Conference
agreement provides that not more than $5,000,000 of the funds
made available under the section may be used by the
Administrator of EPA for immediate and urgent security needs
and for grants for community water systems under 3,300 in
accordance with the guidance provided by EPA under the section.
Section 402. Other Safe Drinking Water Act Amendments
House provision: The House bill provides for a review of
current and future methods to prevent, detect and respond to
the intentional introduction of chemical, biological and
radiological contaminants into community water systems and
source water for community water systems. This review is to
encompass methods and means to detect contaminants, to provide
sufficient notice of contamination, to prevent the flow of
contaminated drinking water, to negate or mitigate deleterious
effects on public health and to conduct biomedical research.
The House bill also provides for a review of methods and
means by which terrorists or other individuals or groups could
disrupt the supply of safe drinking water or render a public
water system significantly less safe for human consumption. The
House bill required a review of the methods and means by which
pipes, constructed conveyances, collection, pretreatment,
storage or distribution facilities could be destroyed or
otherwise prevented from providing adequate supplies of
drinking water and methods and means by which they could be
protected. The House bill also required a review of methods and
means by which such items could be subjected to cross-
contamination and a review of methods and means by which
alternative supplies of water could be provided in the event of
destruction, impairment or contamination of public water
systems. The House bill authorized $15,000,000 in Fiscal Year
2002 to carry out sections 1434 and 1435 and such sums as may
be necessary for Fiscal Years 2003 and 2004.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts
the House provision with modifications. The Conference
substitute includes further specification in section 1434 as to
the detection of various levels of contaminants and indicators
of contaminants using methods, means and equipment that include
real time monitoring systems. The Conference substitute
additionally requires methods and means for developing
education and awareness programs for community water systems.
The conference substitute also adds additional
specification to the reviews undertaken under section 1435 to
include methods and means by which information systems,
including process controls, supervisory control and data
acquisition and syber systems could be disrupted by terrorists
or other groups. The Conference substitute also includes
additional requirements and considerations that are applicable
in the implementation of sections 1434 and 1435. These
requirements and considerations include the assurance that
reviews reflect the needs of various community water system
sizes and geographical locations, the vulnerability of regions
or service areas, including the National Capital area, and that
the Administrator of EPA disseminate certain information
through the Information Sharing and Analysis Center. The
Conference substitute also provides such sums as may be
necessary in Fiscal Year2005.
Section 403. Miscellaneous and Technical Amendments
House provision: The House bill provides that section
1433 be included as a cross-reference in section 1414(i)(1) on
the Safe Drinking Water Act (SDWA), that section 1431 of the
SDWA be amended, that existing penalties for tampering with
drinking water systems under section 1432 be increased and that
section 1442 of the SDWA be amended to provide authorization
for $35 million in Fiscal Year 2002 and such sums as may be
necessary in fiscal years thereafter.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The conference substitute adopts
the House provisions. The conferees encourage the committees of
jurisdiction in the House and Senate to develop comparable
legislation covering publicly owned treatment works in this
legislative session. The conferees encourage EPA to work
closely with organizations representing small and rural water
systems to implement the provisions of this Title.
TITLE V--ADDITIONAL PROVISIONS
The Managers agree to the following provisions.
Subtitle A--Prescription Drug User Fees
Section 501. Short Title
Designates the name of this title as the ``Prescription
Drug User Fee Amendments of 2002.''
Section 502. Findings
Declares the findings of Congress related to the
reauthorization of prescription drug user fees.
Section 503. Definitions
The following terms in section 735 of the Federal Food,
Drug, and Cosmetic Act (FFD&C Act) (21 U.S.C. 379g) are
modified by this section: human drug application, prescription
drug product, process for the review of human drug
applications, and adjustment factor. These modifications are
necessary to give effect to the changes instituted by the
reauthorization of the Prescription Drug User Fee Act (PDUFA).
The term ``human drug application'' is modified to make a
technical correction.
The term ``prescription drug product'' is modified to
allow the Secretary to use the Prescription Drug Product List
(the active portion) in the ``Approved Drug Products with
Therapeutic Equivalence Evaluations,'' (the Orange Book) as the
basis for identifying which products should be considered to be
prescription drug products for fee assessment purposes. The
Managers expect that these proposed changes will lead to a more
efficient, less burdensome, billing procedure. Under current
law, any prescription drug product eligible for drug listing is
subject to product fees. Determining eligibility for listing is
administratively complex and sometimes resource intensive. In
addition, listing is often controlled by a re-packer or
distributor rather than by the sponsor, but the sponsor must
nonetheless pay the product fee. The Managers expect that the
use of the Orange Book, which is found on FDA's Internet site,
as the basis to identify products for user fee assessment
purposes will not be construed to affect the legal status of
the book or the products in the book. The purpose of using this
method is merely a tool for the Secretary to provide a public,
efficient billing process. It also provides sponsors an easier
way to remove products from the list that is the basis for
billing.
Also, the addition of the reference to the list of
products approved under human drug applications under section
351 of the Public Health Service Act created and maintained by
the Secretary refers to the current FDA method of identifying
biological products considered to be prescription drug products
for fee assessment determinations. The Managers do not intend
this to be a change in practice; rather it documents FDA's
current practice. The list is to be provided on FDA's Internet
site.
A further change to the term ``prescription drug
product'' deletes the clause ``does not include a large volume
parenteral drug product approved before September 1, 1992.'' As
a result, any large volume parenteral (LVP) product is treated
as a prescription drug product and issubject to a fee. However,
when coupled with a corresponding change proposed to section
736(a)(3)(B), all LVP's would be exempt from product fees in this
reauthorization, including products approved after September 1, 1992.
The Managers intend this change to decrease FDA's administrative burden
in determining which products should be billed.
The term ``process for the review of human drug
applications'' is modified to allow the use of funds, for a
period of up to three years after approval, to cover risk
management activities for products approved after October 1,
2002. This change is highly important to the Managers, as
improving drug and biological product safety is a goal shared
by all.
The term ``adjustment factor'' is modified to eliminate
obsolete provisions.
Section 504. Authority to Assess and Use Drug Fees
Subsection (a) of this section allows fees authorized by
the Act to be assessed beginning on October 1, 2002. With
respect to prescription drug establishment fees and
prescription drug product fees, the subsection advances the
date by which fees are payable to October 1 of each year.
Under the second Prescription Drug User Fee Act (PDUFA),
prescription drug establishment and product fees, which
represent two-thirds of PDUFA fees were due January 31, four
months into the fiscal year. This necessitated carrying forward
funds from a previous year to sustain operations for the first
four months of each new fiscal year. By advancing the date for
annual fees to be paid to FDA, the necessity of carrying
forward these large cash surpluses from year to year is
eliminated. Also, by making this change effective for FY 2003,
FDA will have access to revenue as early in FY 2003 as invoices
can be issued and fees collected rather than having to wait
until January 31 to collect funds. This is especially important
for FDA operations in FY 2003 because the agency does not
expect to have any appreciable carryover funds at the end of FY
2002.
Making the fee due and payable on October 1 necessitates
other changes to the FFD&C Act that are executed in subsection
(e) and (f) of this section.
This section sets forth a table containing the
application, establishment, and product fee revenues, and total
fee revenue, for fiscal years 2003 through 2007. The subsection
further authorizes an increase in fee revenue amounts to fully
fund the portion of additional costs attributable to the cost
of the retirement of Federal personnel. This provision would go
into effect, if, after the enactment of the Prescription Drug
User Fee Amendments of 2002, legislation is enacted requiring
the Secretary to fund additional costs of the retirement of
Federal personnel.
This section also authorizes inflation adjustments,
workload adjustments, and a final year adjustment. Under
present law, annual inflation adjustments were based on the
higher of the federal pay raise applicable for employees in the
fiscal year for which the fees were set or the CPI for the
previous year. In order to collect fees on October 1, FDA will
have to set fees and issue invoices in August of each year well
before the pay-raise determination for the next fiscal year is
made. For this reason the inflation adjustment factors have
been changed to the Federal pay raise for employees in the
Washington, D.C., area for the previous fiscal year or the
change in the CPI for the 12 month period ending June 30,
whichever is higher. Both of these figures will be available in
August when fees must be set. As has been the case in the past,
these inflationary changes will continue to be cumulative and
compounded.
Under the workload adjustment, annual revenue adjustments
are made that reflect changes in review workload, after
inflation adjustments. the workload adjustment is to be
determined by the Secretary based on a weighted average of the
changes in the total number of (1) human drug applications, (2)
commercial investigational new drug applications, (3) efficacy
supplements, and (4) manufacturing supplements. The subsection
provides that the Secretary shall publish in the Federal
Register the fees resulting from this adjustment and the
supporting methodologies. Each of the 4 components used to
develop the workload adjustment is a defined category of
applications that FDA currently counts. Each component will be
given a weighting factor that corresponds to its percent of FDA
review workload.
The workload adjustment envisioned for each component has
as its base the average number of applications of each
particular type that FDA received over the five-year period of
current law. It requires that a rolling average of submissions
also be calculated each year for the latest five-year period
that ends on June 30 before the end of each fiscal year
beginning on or after October 1, 2002. The percent change in
the latest five-year average, compared to the base year is then
multiplied by the weighting factor for that component. Then all
four components of the workload adjuster are added together and
the total percent that results is the workload adjuster that
will be used to further adjust the inflation-adjustedstatutory
revenue levels each year after FY 2003. Use of five year rolling
averages in this process dampens the impact of revenue fluctuations--
both up and down.
Under this section, the revenue adjuster will never
result in lower revenues than the inflation-adjusted statutory
revenue levels. Nonetheless, in years when fee-paying
applications fall below projections, FDA will automatically
experience a shortfall in revenues due to the shortfall in fee-
paying applications. Further downward adjustment of the
revenues would over-compensate for such a decline in workload
and is not authorized under the subsection. This is a lesson
learned from experience during 1998 through 2002. If such a
model had been in place for the past five years, revenues
during PDUFA II would have been much more predictable year to
year rather than exhibiting the volatility FDA experienced.
Also under this section, FDA is allowed to make a one-
time increase in fees in FY 2007, if necessary, to assure that
the agency will have no less than three months of operating
reserves on hand at the end of FY 2007, when this legislation
will expire. This final year adjustment will allow the agency
sufficient fees to operate for up to 3 months in FY 2008 if
there is any delay in the reauthorization of PDUFA at the end
of FY 2007. Further, delaying this payment from industry until
FY 2007 minimizes the need for FDA to carry large balances over
from year to year, reducing industry outlays until they are
necessary to support operations.
Finally, this section provides that application, product,
and establishment fees are to be established 60 days before the
start of the fiscal year based on the revenue amounts
previously established in this section.
Under subsection (d), the waiver or fee reduction for
supplements filed under section 505(b)(1) of the FFD&C Act is
eliminated.
In this section the word ``assessed'' in section 736(f)
of the FFD&C Act has been changed to ``retained.'' This change
is part of a series of changes made to permit FDA to issue
invoices and collect fees before an appropriation is actually
made for the fiscal year. The change maintains the original
intent of this and related provisions, however, by providing
that the conditions originally specified in these sections must
be fulfilled once all appropriations for the fiscal year,
including any supplemental appropriations, are enacted. If the
conditions are not fulfilled, FDA may not retain the fees it
collects. Further, under this section, the word ``collected''
in section 736(g)(2)(A) of the FFD&C Act is changed to
``retained.'' Once again, this change is part of a series of
changes made to permit FDA to issue invoices and collect fees
before an appropriation is actually made for the fiscal year.
The change maintains the original intent of this and related
provisions by asserting that the conditions originally
specified in these sections must be fulfilled once all
appropriations for the fiscal year, including any supplemental
appropriations, are enacted.
This section also responds to the problems associated
with FDA's inability under the FFD&C Act to collect and spend
fees in any year that FDA fails to spend from appropriations as
much as it spent in FY 1997, adjusted for inflation. Failing to
meet this obligation by as little as one dollar causes FDA to
lose the authority to collect application, product and
establishment fees for a given fiscal year. The consequence of
failing to meet this ``trigger'' would be catastrophic. Since
the trigger is based on the amount FDA spends, the agency can
never identify exactly how much it has actually spent until
after the end of the fiscal year. As a result, FDA consistently
overspends by a substantial amount to be certain that FDA
expenditures do not fall below the trigger amount and thereby
cause the agency to lose the authority to collect fees.
Modifications to section 736(g)(2)(B) are proposed to
provide FDA a margin of error in its effort to meet this
requirement of the law. This section is being modified so that
if FDA's spending is within five percent of the amount required
by this section of the Act, the requirement of this section is
considered to be satisfied. If FDA under-spends by three
percent or less, there are no consequences. If FDA under-spends
by more than three percent but not more than five percent, FDA
will be required to reduce collections in the fiscal year
following the subsequent fiscal year by the amount in excess of
three percent by which FDA under-spent from appropriations. The
intent is to relieve FDA of the need to overspend from
appropriations each year, as it has done consistently since
1993 to assure that this trigger is met. Spending from
appropriations on the drug review process each year is still
expected to be at or very close to the amount specified by this
trigger, and may never be more than five percent below the
trigger amount.
This section also authorizes appropriations for fiscal
years 2003 through 2007 in amounts consistent with the total
fee revenue amounts set forth in subsection (b).
Section 505. Accountability and Annual Reports
This section for the first time requires the agency to
meet with interested public and private stakeholders when
considering the reauthorization of this program before its
expiration. The Managers believe that the agency will be in the
best position to recognize what best serves the public health
by meeting with representatives of consumer and patient
advocacy groups, industry, the Congress, health care
professionals, and academic experts prior to the next
reauthorization of PDUFA. Further, the Managers believe that it
is very important for the agency to make any recommendations to
the Congress public, so this section requires that the FDA both
publish the recommendations, as well as hold a public hearing
at which time the agency can receive public feedback.
This section also requires an annual Performance Report
and a Financial Report.
Section 506. Reports of Postmarketing Studies
Under this section, the Managers intend that in instances
wherein a study subject to the reporting requirements of
Section 130 is not completed by the original or otherwise
negotiated deadline agreed upon by the sponsor and if the
reasons for such failure to complete the study were not
satisfactory to the Secretary, the Secretary shall so note on
the agency website. The Managers intend that the Secretary
would not find the delay or termination of a study
unsatisfactory if the Secretary determined that the delay or
termination occurred through no fault of the sponsor (such as
ethical concerns, or the study is no longer needed).
This section also empowers the Secretary to require a
sponsor of a study required under section 505(b)(2)(A) or
sections 314.510 or 601.41 of Title 21, Code of Federal
Regulations, to notify health care practitioners who prescribe
such drugs or biological products of the sponsor's failure to
complete the study, and the questions of clinical benefit and,
where appropriate, questions of safety, that remain unanswered
as a result of such failure. The Managers intend that this
authority not be utilized in cases where, through no fault of
the sponsor (such as ethical concerns, or the study is no
longer needed), the study has been delayed or terminated.
Section 507. Savings Clause
This section authorizes user fees to be assessed and
collected after October 1, 2002 for human drug applications and
supplements accepted for filing prior to October 1, 2002. For
example, in the event that application fees are owed but have
not been collected prior to the expiration date for PDUFA II
established by section 107 of the Food and Drug Administration
Modernization Act (FDAMA), the section will allow these fees to
be collected after October 1, 2002. The section further
authorizes assessment and collection of product and
establishment fees after October 1, 2002 that are owed but have
not been collected.
Section 508. Effective Date
Section 508 provides that the Prescription Drug User Fee
Amendments of 2002 shall take effect October 1, 2002.
Section 509. Sunset Clause
Section 509 provides that the amendments made by sections
503 (relating to definitions) and 504 (relating to the
authority to assess and use drug fees) shall cease to be
effective on October 1, 2007.
The section further provides that the amendments made by
section 505 (relating to annual reports) shall cease to be
effective 120 days after October 1, 2007. The additional 120
days will allow the prescription drug user fee reports for
fiscal year 2007 to be prepared and submitted.
Subtitle B--Additional Authorizations of Appropriations Regarding Food
and Drug Administration
Section 521. Office of Drug Safety
This section will help the FDA fulfill its vitally
important role of ensuring drug safety. The Managers are highly
supportive of the postmarket surveillance activities conducted
by the Office of Drug Safety (ODS), and to that end other
provisions in this legislation ensure for the first time that
user fee monies will be available for postmarket purposes.This
section complements those efforts by ensuring that not only will new
user fee monies be available for this very important purpose, but so
will new appropriated monies.
Section 522. Division of Drug Marketing, Advertising, and
Communications
This section provides an increased authorization for the
Division of Drug Marketing, Advertising, and Communications
(DDMAC) within the Office of Medical Policy, Center for Drug
Evaluation and Research at the FDA. DDMAC plays a vital role in
ensuring that promotional drug material is not false or
misleading, and they do so on a limited budget. The authorized
amounts will better ensure that DDMAC can perform its mission.
Section 523. Office of Generic Drugs
This section provides an increased authorization for the
Office of Generic Drugs (OGD) within the Center for Drug
Evaluation and Research at the FDA. OGD is vitally important to
ensuring that Americans have access to safe, effective generic
drugs. This Office needs increased funding, however, due to the
fact that it presently takes OGD nearly 18 months to review the
typical ANDA. This section will lead to increased funding, so
that these review times can be decreased without compromising
health and safety.
Subtitle C--Additional Provisions
Section 531. Transition to Digital Television
In an effort to further promote the orderly transition to
digital television, and to promote the equitable allocation and
use of digital channels by television broadcast permittees and
licensees, the Managers direct the Federal Communications
Commission, at the request of an eligible licensee or
permittee, to, within 90 days after the date of enactment of
this Act, allot, if necessary, and assign a requested and
identified paired digital television channel to that licensee
or permittee. In order to avoid any undue burden to the
Commission, which is required to allot and assign the paired
digital television channel within a short timeframe, the
Managers expect all eligible applicants to file their
applications as soon as practicable after the date of
enactment. The FCC shall only do this if such channel can be
allotted and assigned without further modification of the
tables of allotments as set forth in sections 73.606 and 73.622
of the Commission's regulations (47 CFR 73.606, 73.622) and
such allotment and assignment is consistent with the
Commission's technical rules (47 CFR part 73). The only
licensees or permittees eligible for this digital allotment are
those that are full power television broadcast licensee or
permittees (or their successors in interest) that had an
application pending for an analog television station
construction permit as of October 24, 1991, which application
was granted after April 3, 1997; and as of the date of
enactment of this Act, is the permittee or licensee of that
station. This provision enables such licensees or permittees an
opportunity to realize their expectations created by prior FCC
action to foster a digital audience during the transition
period to digital television without having to terminate
abruptly analog service now enjoyed by their viewers. Without
this change, those broadcast licensees or permittees would be
denied the flexibility to operate an analog and a digital
facility simultaneously in the near term, especially in a major
market. This is contrary to the Congressional goals of
increasing competition and accelerating the digital television
transition. The Managers are ensuring that eligible licensees
or permittees will meet the intended objectives by doing two
important things. First, the Managers impose an unequivocally
hard 18-month deadline for the construction of the digital
facility from the time of the FCC's issuance of the
construction permit for the new digital channel. In this
regard, eligible licensees are absolutely prohibited from
obtaining or receiving an extension of time from the Commission
pursuant to 47 C.F.R. 73.624(d)(3). Second, the Managers
safeguard against eligible licensees from using the newly
granted ``in-core'' digital channel allotment and assignment to
provide analog service.
Section 532. 3-Year Delay in Lock-in Procedures for Medicare+Choice
Plans; Change in Medicare+Choice Reporting Deadlines and
Annual, Coordinated Election Period for 2003, 2004, and 2005
This section changes the deadline for Medicare+Choice
plans to submit information to the Secretary on Medicare
benefits, premiums, cost sharing, supplemental benefits, and
actuarial values of such coveragefrom July 1 to the second
Monday in September for the years 2002, 2003, and 2004. It would also
delay the annual election period for Medicare enrollees to select a M+C
plan to the period of time beginning on November 15 and ending on
December 31 in 2002, 2003, and 2004. This section also delays the
phase-in of the limitation on Medicare beneficiaries changing health
plans more than once a year (the ``lock-in''). This requirement,
enacted in the Balanced Budget Act of 1997, was scheduled to phase in
incrementally beginning in 2002. The substitute would postpone the
lock-in requirements until 2005.
From the Committee on Energy and Commerce, for
consideration of the House bill and the Senate
amendment, and modifications committed to
conference:
Billy Tauzin,
Michael Bilirakis,
Paul E. Gillmor,
Richard Burr,
John Shimkus,
John D. Dingell,
Henry A. Waxman,
Sherrod Brown,
Provided that Mr. Pallone is appointed in lieu
of Mr. Brown of Ohio for consideration of title
IV of the House bill, and modifications
committed to conference:
Frank Pallone, Jr.,
From the Committee on Agriculture, for
consideration of title II of the House bill and
sec. 216 and title V of the Senate amendment,
and modifications committed to conference:
Larry Combest,
Frank D. Lucas,
Saxby Chambliss,
Charles Stenholm,
Tim Holden,
From the Committee on the Judiciary, for
consideration of title II of the House bill and
secs. 216 and 401 of the Senate amendment, and
modifications committed to conference:
F. James Sensenbrenner, Jr.,
Lamar Smith,
John Conyers, Jr.,
Managers on the Part of the House.
Edward Kennedy,
Chris Dodd,
Tom Harkin,
Barbara A. Mikulski,
Jim Jeffords,
Judd Gregg,
Bill Frist,
Mike Enzi,
Tim Hutchinson,
Managers on the Part of the Senate.