[House Report 108-608]
[From the U.S. Government Publishing Office]
108th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 108-608
======================================================================
MINOR USE AND MINOR SPECIES ANIMAL HEALTH ACT OF 2004; FOOD ALLERGEN
LABELING AND CONSUMER PROTECTION ACT OF 2004
_______
July 15, 2004.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Barton of Texas, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany S. 741]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (S. 741) to amend the Federal Food, Drug, and Cosmetic
Act with regard to new animal drugs, and for other purposes,
having considered the same, report favorably thereon without
amendment and recommend that the bill do pass.
CONTENTS
Page
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 2
Hearings......................................................... 3
Committee Consideration.......................................... 3
Committee Votes.................................................. 3
Committee Oversight Findings..................................... 3
Statement of General Performance Goals and Objectives............ 3
New Budget Authority, Entitlement Authority, and Tax Expenditures 4
Committee Cost Estimate.......................................... 4
Congressional Budget Office Estimate............................. 4
Federal Mandates Statement....................................... 9
Advisory Committee Statement..................................... 10
Constitutional Authority Statement............................... 10
Applicability to Legislative Branch.............................. 10
Section-by-Section Analysis of the Legislation................... 10
Changes in Existing Law Made by the Bill, as Reported............ 19
Purpose and Summary
Title I of S. 741 addresses the critical shortage of animal
drugs available for minor species, which are defined as animals
other than humans that are not major species (cattle, horses,
swine, chickens, turkeys, dogs, and cats), and for minor uses
for major species, which are defined as the use of a drug in a
major species for a disease that occurs infrequently in a small
number of animals, or in limited geographic areas in a small
number of animals annually. The bill does so by creating new
ways for animal drugs to be legally marketed.
Title II of S. 741 is the Food Allergen Labeling and
Consumer Protection Act. It lays out a number of new
requirements for the labeling of food in order to protect
consumers with food allergies. Specifically, food that contains
one of the eight major food allergens (milk, eggs, fish,
Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans)
must list the food source from which the major food allergen is
derived either immediately after the list of ingredients or in
parentheses following an ingredient that contains a food
allergen.
Background and Need for Legislation
TITLE I
Congress has recognized for some time that there are not
adequate market incentives for manufacturers to produce animal
drugs for minor species and for minor uses in major species.
Therefore veterinarians, animal owners, and livestock producers
may have limited options for treating these animals if they
become ill. Veterinarians are often forced to treat these
animals with unapproved drugs, or to treat these animals with
the off-label use of an approved animal drug.
Congress approved the Animal Medicinal Drug Use
Clarification Act (AMDUCA) of 1994 (Public Law 103-396), which
expanded the ability of veterinarians to use approved animal
drugs for unapprovedpurposes. However, this legislation did not
create new avenues for FDA approval of new animal drugs for minor uses
and minor species.
Congress responded to this shortage by approving the Animal
Drug Availability Act (ADAA) of 1996 (Public Law 104-250).
Section 2(f) of ADAA directed the Secretary of Health and Human
Services to ``consider legislative and regulatory options for
facilitating the approval under section 512 of the Federal
Food, Drug, and Cosmetic Act of animal drugs intended for minor
species and for minor uses and, within 18 months after the date
of enactment of this Act, announce proposals for legislative or
regulatory change to the approval process under such section
for animal drugs intended for use in minor species or for minor
uses.'' The FDA responded to this directive by forming the ADAA
Minor Use/Minor Species Working Group, which issued a report
entitled ``Proposals to Increase the Legal Availability of
Animal Drugs for Minor Species and Minor Uses.'' This report
was made available through a Federal Register notice on October
29, 1998 (63 FR 58058). Included in the report's
recommendations were proposals to create a conditional approval
process for new animal drugs and a mechanism to index legally
marketed, unapproved new animal drugs. Both of these proposals
are contained in S. 741.
TITLE II
Currently, approximately 2 percent of adults and 5 percent
of children are allergic to various types of foods. Eight major
food allergens (fish, Crustacean shellfish, milk, eggs,
peanuts, tree nuts, soybeans, and wheat) cause over percent of
food allergies in the United States. Since there is currently
no cure for food allergies, consumers need to be empowered to
know whether or not food allergies are present in the food they
consume. There are no labeling standards currently in place for
food allergies. S. 741 fills this gap by ensuring that the food
source from which a major food allergen is derived is clearly
labeled in plain English.
The Committee expects, consistent with the November 30,
1987 Memorandum of Understanding, that the Alcohol and Tobacco
Tax and Trade Bureau (TTB) of the Department of Treasury will
pursuant to the Federal Alcohol Administration Act determine
how, as appropriate, to apply allergen labeling of beverage
alcohol products and the labeling requirements for those
products. The Committee expects that the TTB and the FDA will
work together in promulgation of allergen regulations, with
respect to those products.
Hearings
The Committee on Energy and Commerce has not held hearings
on the legislation.
Committee Consideration
On Tuesday, June 15, 2004, the Subcommittee on Health met
in open markup session and approved S. 741 for Full Committee
consideration by a voice vote, a quorum being present. On
Thursday, June 24, 2004, the Full Committee met in open markup
session and favorably ordered S. 741 reported by a voice vote,
a quorum being present.
Committee Votes
There were no record votes taken in connection with
ordering S. 741 reported. A motion by Mr. Pickering to order S.
741 reported to the House, as amended, was agreed to by a voice
vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held oversight
or legislative hearings on this legislation.
Statement of General Performance Goals and Objectives
The first goal of S. 741 is to address the critical
shortage of animal drugs available for minor species, and drugs
for minor uses for major species. The second goal is to protect
consumers with food allergies by implementing new requirements
for the labeling of food.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that S.
741, Minor Use and Minor Species Animal Health Act, would
result in no new or increased budget authority, entitlement
authority, or tax expenditures or revenues.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, July 2, 2004.
Hon. Joe Barton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 741, an act to amend
the Federal Food, Drug, and Cosmetic Act with regard to new
animal drugs, and for the other purposes.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Julia
Christensen (for animal drugs) and Niall Brennan (for food
allergens).
Sincerely,
Elizabeth M. Robinson
(For Douglas Holtz-Eakin).
Enclosure.
S. 741--An act to amend the Federal Food, Drug, and Cosmetic Act with
regard to new animal drugs, and for other purposes
Summary: S. 741 aims to increase the market availability of
new animal drugs for minor species and for minor uses in major
species of animals. It would amend the Federal Food, Drug, and
Cosmetic Act (FFDCA) to authorize the Food and Drug
Administration (FDA) to establish a conditional approval
process for such drugs and to create an index of legally
marketed unapproved drugs to treat certain minor species. It
also would authorize grants to help defray a portion of the
cost associated with the development of designated drugs and
would award seven years of marketing exclusivity to products
meeting certain criteria.
S. 741 also would require that labels for food products
indicate in plain English the presence of any of the eight
major food allergens, and would direct the Secretary of Health
and Human Services to engage in a number of activities to
increase scientific and public understanding of issues related
to food allergies.
CBO estimates that implementing S. 741 would cost $6
million in 2006 and $60 million over the 2005-2009 period,
assuming appropriation of the necessary funds.
The legislation would not affect direct spending. There
would be potential for higher revenues through penalties
imposed on sponsors of misbranded or illegally marketed drugs
or of mislabeled food products. However, the FDA generally
issues warning letters to violators and works with them to
correct the violation. For chronic violators or for serious
offenses, the FDA generally pursues injunctions or seizes
products; prosecution, which can involve penalties, generally
is a last resort. Therefore, CBO expects that revenues from
such penalties would be negligible.
S. 741 contains no intergovernmental mandates as defined in
the Unfunded Mandates Reform Act (UMRA). The act's provisions
would increase the availability and broaden the potential uses
of certain drugs used to treat minor species animals and also
to treat minorconditions in major species. State and local
conservation programs, zoos, and animal shelters could take advantage
of those new drugs or uses, and the impact on their budgets would
likely be positive.
S. 741 would impose a private-sector mandate on the
manufacturers, packagers, and labelers of processed foods by
requiring them to display on the label the names of the major
food allergens from which the ingredients are derived. It also
would impose mandates on some manufacturers of generic animal
drugs for minor uses or use in minor species by potentially
delaying the time at which their products could enter the
market. CBO estimates that the direct cost of these mandates
would not exceed the threshold established by UMRA ($120
million in 2004, adjusted annually for inflation) in any of the
first five years the mandates would be effective.
Estimated cost to the Federal Government: The estimated
budgetary impact of S. 741 is shown in the following table. The
costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
--------------------------------------------
2005 2006 2007 2008 2009
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Title I: Minor Use and Minor Species Animal Health Act of 2004:
Estimated Authorization Level.................................. 1 1 2 3 4
Estimated Outlays.............................................. 1 1 2 3 3
Title II: Food Allergen Labeling and Consumer Protection Act of
2004:
Estimated Authorization Level.................................. 12 12 12 12 12
Estimated Outlays.............................................. 5 10 11 12 12
Net Effect on Spending by the Food and Drug Administration \1\:
Estimated Authorization Level.................................. 13 13 14 15 16
Estimated Outlays.............................................. 6 11 13 15 15
----------------------------------------------------------------------------------------------------------------
\1\ CBO assumes that a portion of the costs associated with the conditional approval process proposed under S.
741 would be covered by user fees collected from sponsors seeking approval to market animal drugs. (User fees
are collected and made available for obligation only to the extent, and in the amount, provided in advance in
appropriation acts.) We estimate that additional collections associated with activities required by the act
would total less than $500,000 annually.
Basis of Estimate: For this estimate, CBO assumes that S.
741 will be enacted this fall and that the amounts necessary to
implement the act will be appropriated for each year.
Spending subject to appropriation
S. 741 would increase the availability of approved or
legally marketed animal drugs for minor species and for minor
uses in major species and would modify food labeling
requirements regarding food allergens. CBO estimates that
implementing S. 741 would cost the FDA $6 million in 2005 and
$60 million over the 2005-2009 period, subject to the
availability of appropriated funds.
Title I: Minor Use and Minor Species Animal Health Act of
2004. S. 741 would create two procedures within the FDA to
allow sponsors to lawfully market animal drugs without final
approval for use in minor species and for minor uses in major
species. (Minor species are species other than cattle, horses,
swine, chickens, turkey, dogs, and cats. A minor use in a major
species refers to the intended use of a drug in a major species
for a disease that occurs in a small number of animals and
occurs either infrequently or in limited geographic areas.) The
act also would authorize grants and award market exclusivity to
encourage the development of new drugs for animals, and it
would establish a new office within the FDA to administer
activities related to regulating animal drugs for minor uses
and minor species.
New procedures for legal marketing of animal drugs. Under
current law, the FDA will approve drugs for marketing only
after the sponsor has demonstrated that the drug is both safe
and effective. S. 741 would require the Secretary of the Health
and Human Services to establish a process for granting
conditional approval of new animal drugs intended for minor
uses and for use in minor species. Conditional approval would
be granted for one year at a time, and could be renewed for a
total of five years.
S. 741 also would require the Secretary to establish a
process for listing on an index unapproved drugs that may be
marketed legally for use in certain minor species. Eligibility
for listing on the index would apply to drugs for animals that
are not consumed by humans or food-producing animals, or for
use in a non-food life stage of a minor species (such as the
larval form of shellfish) in a contained man-made structure
(such as a hatchery pond or tank). The Secretary could place a
drug on the index if the sponsor demonstrates that the drug
meets certain safety criteria and if an expert panel concludes
that the benefits of using the drug outweigh it risks to the
target animal.
Based on information from the FDA, CBO anticipates that the
cost to the FDA associated with implementing those procedures
to allow sponsors to lawfully market animal drugs without final
approval would total less than $500,000 annually. CBO assumes a
portion of the costs associated with the conditional approval
process would be covered by higher user fees collected from
sponsors seeking approval to market animal drugs, but we
estimate that additional collections associated with activities
required under S. 741 would be negligible.
Incentives to develop new drugs for animals. The act would
provide two incentives to encourage development of new animal
drugs for minor uses and for minor species through the awarding
of grants and of market exclusivity to qualifying sponsors of
designated drugs.
First, the act would direct the FDA to award market
exclusivity for seven years on the approved indication of
certain designated drugs. As a result, a sponsor could sell its
product without competition in the market and recover a portion
of the research and development costs. CBO anticipates that the
cost to the FDA associated with implementing this provision
would be negligible.
Second, S. 741 would authorize the appropriation of
specific amounts for making grants to sponsors of designated
drugs in the two fiscal years following the issuance of final
regulations for the new program and would authorize the
appropriation of such sums as necessary in later years. Grants
awarded under the program would defray some of the costs for
qualified safety and effectiveness testing and for certain
manufacturing expenses associated with developing the
qualifying drug. Based on the time frame outlined in the act,
CBO assumes that funding for grants would not be authorized
until fiscal year 2007. We estimate that outlays for the new
grant program would total $4 million over the 2007-2009 period,
assuming the availability of appropriated funds.
New Office. S. 741 would establish a new Office of Minor
Use and Minor Species Animal Drug Development within the Center
for Veterinary Medicine at the FDA. The office would designate
minor use and minor species drugs, administer grants authorized
under the act, and review requests for listing of drugs on the
newly created index. S. 741 would authorize the appropriation
of $1.2 million in 2004 and such sums as necessary in later
years. Assuming the appropriation of the necessary amounts, CBO
estimates that creating and funding the new office would cost
$1 million in 2005 and $6 million over the 2005-2009 period.
Title II: Food Allergen Labeling and Consumer Protection
Act of 2004. Title II of the act would direct the Secretary to
engage in a number of activities to increase scientific and
public understanding of issues related to food allergies. CBO
estimates that implementing title II would cost $5 million in
2005 and $50 million over the 2005-2009 period, assuming the
appropriation of the necessary amounts.
S. 741 would amend the FFDCA to require that any food that
contains a major food allergen be labeled in such a way that
the presence of the food allergen is easily visible to
consumers. Major food allergens are defined as ``milk, egg,
fish, crustacean shellfish, tree nuts, wheat, peanuts, and
soybeans.'' Section 203 also would provide for an appeal
process whereby an individual or company could petition the
Secretary to exempt a food ingredient from that labeling
requirement. The Secretary would be required to approve or deny
the petition within 180 days of receiving such an appeal. Based
on information from the FDA, CBO estimates that spending by the
FDA to carry out those responsibilities would amount to $1
million in 2005 and $5 million over the 2005-2009 period,
assuming appropriation of the necessary funds.
The act also would direct the Secretary, through the
Centers for Disease Control and Prevention (CDC), to engage in
the collection of, and publication of data on the prevalence of
food allergies, the incidence of serious adverse events related
to food allergies, and the treatment and prevention of food
allergies. Because true food allergy events are relatively rare
(in contrast to food poisoning events), CBO expects that the
CDC would engage in multiple strategies to identify and collect
useful data, such as:
Analyzing existing data, including questions
recently added to the National Health Interview Survey
(NHIS) to better assess the prevalence of known food
allergies.
Adding laboratory tests to the National
Health and Nutrition Examination Survey (NHANES) to
identify conditions that may be unknown to the survey
participant.
Testing stored blood specimens that were
collected in a previous cycle of the NHANES, and stored
for future analysis, to estimate the prevalence of food
allergy reactivity in the U.S. population.
Improving the ability of the nation's vital
statistics system to monitor food allergy-related
deaths by using intelligent automated systems to help
physicians more accurately record cause of death, and
by working with physicians' organizations to improve
education on recording cause of death.
Increasing the precision of surveys of
health care providers, and improving the quality of
information recorded by providers, so that
comparatively small numbers of events could be better
detected.
Based on information from the FDA and CDC, CBO estimates
that federal spending to develop and operate the system for
collecting data on food allergies would total $3 million in
2005 and $41 million over the 2005-2009 period, subject to
appropriation of the necessary amounts.
S. 741 would require the Secretary to submit a report to
the Congress within 18 months of enactment. That report should
analyze the extent to which foods are unintentionally
contaminated with major food allergens during the manufacturing
process, recommend manufacturing practices that would reduce
the incidence of such contamination, and describe the types of
advisory labeling currently being used by food producers, the
extent to which such labeling is being used, and the
preferences of those likely to be affected by food allergies
regarding labeling information. Assuming the availability of
appropriated funds, CBO estimates that the FDA would spend less
than $500,000 in 2005 and a total of $1 million over the 2005-
2009 period to produce that report.
S. 741 would require the Secretary to conduct inspections
of food and manufacturing, processing, and packing facilities
to ensure that such entities are engaging in efforts to reduce
the possibility of food allergen contamination and to ensure
that food allergens are being appropriately labeled. Based on
information provided by the FDA, CBO expects those tasks would
be accomplished without increasing the number of inspections of
food facilities and without having a significant effect on the
cost of those inspections.
The act also would require the Secretary to develop
guidelines for preparing allergen-free foods in food
establishments (such as restaurants, bakeries, delicatessens,
and cafeterias), and to issue regulations to define and permit
the use of the term ``gluten-free'' on the labeling of foods.
Based on information from the FDA about the cost of similar
activities, CBO estimates that spending by the FDA to carry out
those responsibilities would total $1 million in 2005 and $3
million over the 2005-2009 period.
Estimated impact on state, local, and tribal governments:
S. 741 contains no intergovernmental mandates ad defined in
UMRA. The act's provisions would increase the availability and
broaden the potential uses of certain drugs used to treat minor
species animals and also to treat minor conditions in major
species. State and local conservation programs, zoos, and
animal shelters could take advantage of those new drugs or
uses, and the impact on their budgets would likely be positive.
Estimated impact on the private sector: S. 741 would impose
private-sector mandates, as defined in UMRA, on the
manufacturers, packagers and labelers of processed foods
regulated by the Food and Drug Administration and on the
manufacturers of certain animal drugs. CBO estimates that the
direct cost of these mandates would not exceed the threshold
established by UMRA ($120 million in 2004, adjusted annually
for inflation) in any of the first five years the mandates
would be effective.
Section 203 would require the labels of processed foods
containing major food allergens to display the names of those
allergens from which ingredients are derived. According to
industry sources, the majority of the approximately 300,000
food labels regulated by the FDA are currently in compliance
with the requirement of S. 741. Moreover, the requirement would
not become effective until January 1, 2006, allowing many food
processors to incorporate the required changes during planned
label revisions, further decreasing the cost of the mandate.
This compliance period also would provide food processors with
sufficient time to exhaust most label inventories, resulting in
small costs due to lost inventories. Based on information
provided by the FDA and industry sources, CBO estimates that
the administrative, printing, analytical, and label inventory
costs associated with this mandate would total less than $75
million through fiscal year 2006, and would be negligible in
later years.
Section 102 also would impose private-sector mandates, as
defined in UMRA, on some manufacturers of generic animal drugs
for minor uses or use in minor species by providing additional
market exclusivity to innovators. This additional exclusivity
would potentially delay the time at which the generic products
of some animal drug manufacturers could enter the market. Based
on information provided by the FDA and the Department of
Agriculture, CBO estimates the cost of these mandates to be
small.
Previous CBO estimate: On July 1, 2004, CBO transmitted a
cost estimate for S. 741 as passed by the Senate on March 8,
2004. The two versions of the legislation are identical, as are
CBO's two estimates.
Estimate prepared by: Federal Costs: Niall Brennan and
Julia Christensen; Impact on State, Local, and Tribal
Governments: Leo Lex; and Impact on the Private Sector: Daniel
Wilmoth.
Estimate approved by: Peter H. Fontaine, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
TITLE I
Section 101. Short title
Section 101 designates the short title of Title I of this
bill as the ``Minor Use and Minor Species Animal Health Act of
2004.''
Section 102(a). Findings
Section 102(a) includes a number of Congressional findings
regarding the need for new procedures to increase the number of
new animal drugs available for minor species and for minor uses
for major species.
Section 102(b). Amendments to the Federal Food, Drug, and Cosmetic Act
Section (b)(1) amends section 201 of the Federal Food,
Drug, and Cosmetic Act (FFDCA) to include definitions for major
species, minor species, and minor use. Section (b)(2) amends
sections 512(c)(2)(F)(ii), (iii), and (v) to create a new
exclusivity provision. Residue depletion studies will be
considered ``significant new data'' for granting three years of
market exclusivity for minor species or minor use approvals.
Currently, only effectiveness and target animal safety studies
qualify to get this marketing exclusivity. Subsection (b)(3)
creates a new subsection (d)(5) to clarify that in reviewing an
application to add an intended use for a minor use or a minor
species, the Secretary of Health and Human Services shall
reevaluate only the information needed to determine whether the
application can be approved. This review of only the
information relevant to whether the application can be approved
should not be construed to constitute reaffirmation of the
original new drug application.
Subsection (b)(4) adds new sections 571, 572, and 573 to
FFDCA.
New Section 571. Conditional approval of new animal drugs for minor use
and minor species
Subsection (a)(1) permits any person to file an application
for conditional approval of a new animal drug intended for a
minor use or a minor species.
Subsection (a)(2) describes the information an applicant is
required to submit to the Secretary as part of an application
for conditional approval of a new animal drug. Included as part
of an application is a commitment that an applicant will
perform the research necessary to secure approval as a new
animal drug under section 512(d) within five years of the
Secretary's original conditional approval.
Subsection (a)(3) lists a number of reasons that would
prevent a person from submitting an application for conditional
approval of a new animal drug under section 571. Conditional
approval of a new animal drug that is contained in, or is a
product of, a transgenic animal is prohibited under this
subsection.
Subsection (b) directs the Secretary to either approve an
application for conditional approval of a new animal drug
within 180 days of the filing of an application (or after a
period of time agreed to by both the Secretary and the
applicant) or notify the applicant of the opportunity for an
informal hearing on the question of whether or not the
conditional approval should be granted.
Subsection (c) lists circumstances under which the
Secretary should refuse to conditionally approve an application
submitted under subsection (a). If the application fails to
meet the criteria established under sections 512(d)(1)(A)
through (D) or (F) through (I), then the Secretary is directed
to refuse to conditionally approve the application.
Additionally, the Secretary may not conditionally approve an
application if the applicant presents insufficient evidence to
show that there is a reasonable expectation that the drug will
be effective. Finally, an application may not be conditionally
approved if another application has been approved under section
512 for the same drug, for the same dosage, for the same
intended use, and there are sufficient quantities of the drug
available. If none of these categories apply, then the
Secretary is directed to conditionally approve the new animal
drug and publish a notice in the Federal Register indicating as
much.
Subsection (d) states that a conditional approval is
effective for one year, renewable for up to four additional
years. The Secretary may granta 90-day extension to review the
renewal request. The request shall be deemed to be approved unless the
applicant failed to submit a timely application; the application fails
to demonstrate that the applicant is making sufficient progress towards
gaining full approval under section 512(d), that there is a large
enough quantity of the drug available, or that the same drug in the
same dosage form for the same intended use has not received approval
under section 512; and the applicant is not able to prove that the drug
does not violate sections 512(e)(1)(A) through (B) or (D) through (F).
If the Secretary declines to renew the conditional approval, then the
Secretary shall provide an opportunity for the applicant to engage in
an informal hearing to discuss whether the conditional approval should
be reinstated.
Subsection (e)(1) directs the Secretary to withdraw any
conditional approval if the Secretary finds that another
applicant has received approval for the same drug in the same
dosage form for the same intended use and there is sufficient
quantity of the drug to meet the needs for which the drug is
intended. Under subsection (e)(2), the Secretary is required to
withdraw the conditional approval of an application if the
Secretary finds that any of the provisions of section
512(e)(1)(A) through (B) or (D) through (F) or if the Secretary
believes that there is not a reasonable expectation that the
drug will have the effect for which it was originally approved.
Subsection (f) describes labeling requirements for
conditionally approved new animal drugs. A label on a
conditionally approved new animal drug must read
``conditionally approved by FDA pending a full demonstration of
effectiveness under application ___'' and must include other
information specified by the Secretary. Additionally, an
intended use that is the subject of a conditional approval is
not to be included as part of a product label under section
512.
Subsection (g) states that a new animal drug that has been
conditionally approved may not be amended or supplemented to
add a new indication for use.
Subsection (h) states that 180 days prior to the
termination date established for a conditionally approved
animal drug the applicant should have all materials submitted
to the Secretary to make a decision whether or not to fully
approve the drug under section 512(d).
Subsection (i) establishes that the decision of the
Secretary to refuse or withdraw conditional approval of an
application constitutes final agency action subject to judicial
review.
Subsection (j) defines the term ``transgenic animal.''
New Section 572. Index of legally marketed unapproved new animal drugs
for minor species
New subsection (a) directs the Secretary to establish an
index of legally marketed, unapproved new animal drugs for new
animal drugs intended for use in a minor species for which
there is a reasonable certainty that the animal or edible
products from the animal will not be consumed by humans or
food-producing animals (new subsection (a)(1)(A)), and for new
animal drugs intended for use only in a hatchery, tank, pond,
or other similar contained man-made structure in an early, non-
food life stage of a food-producing minor species (new
subsection (a)(1)(B)). In the latter case, the law requires
that safety for humans is demonstrated in accordance with
section 512(d) of the FFDCA. New animal drugs that are
contained in, or are a product of, a transgenic animal are not
eligible for inclusion in the index.
New subsection (b) states that any entity intending to file
a request under this new section 572 shall be entitled to one
or more conferences to discuss the requirements for indexing a
new animal drug.
New subsection (c) provides for a mechanism whereby an
entity can request that the Secretary make a decision regarding
the eligibility of a particular new animal drug for inclusion
in the index. After submitting a request to the Secretary, the
Secretary will make a determination of eligibility within 90
days for new animal drugs requesting inclusion in the index
under new subsection (a)(1)(A) and 180 days for new animal
drugs requesting inclusion in the index under new subsection
(a)(1)(B). The Secretary may approve the eligibility request
if: the same drug in the same dosage form for the same intended
use is not approved under section 512 or conditionally approved
under section 571; the proposed use of the drug meets the
conditions of subsections (a)(1)(A) or (a)(1)(B), as
appropriate; the person requesting the determination has
established appropriate specifications for the manufacture and
control of the new animal drug and has demonstrated an
understanding of the requirements of current good manufacturing
practices; the new animal drug will not significantly affect
the human environment; and the new animal drug is safe with
respect to individuals exposed to the new animal drug through
its manufacture or use. If the Secretary denies the request,
the Secretary shall thereafter provide due notice and an
opportunity for an informal conference. A decision of the
Secretary to deny an eligibility request following an informal
conference shall constitute final agency action subject to
judicial review.
New subsection (d) provides for a mechanism whereby an
entity may request that the Secretary add a new animal drug to
the index of legally marketed unapproved new animal drugs for
minor species. The entity requesting inclusion in the index
must provide the Secretary with a number of items that are
described in subsection (d)(1). Among those items is a report
described in subsection (d)(2), which must be authored by a
qualified expert panel as defined in subsection (d)(3).
Included in the report is an evaluation of all available target
animal safety and effectiveness information, including
anecdotal information. The report must state the expert panel's
opinion regarding whether the benefits of using the new animal
drug for the proposed use in a minor species outweigh its risks
to the target animal, taking into account the harm caused by
the absence of an approved or conditionally approved new animal
drug for the minor species in question. The Committee notes
that while the focus of the expert panel is on the benefits and
risks to the target animal, the Secretary will have already
determined that the new animal drug in question is either not
going to be used on animals that humans or food-producing
animals will consume, or is in full compliance with the human
safety standards described in section 512(d) of the FFDCA. The
report must also include information from which labeling can be
written and a recommendation regarding whether the new
animaldrug should be limited to use under the professional supervision
of a licensed veterinarian. Subsection (d)(3) describes the
requirements for a ``qualified expert panel.'' The panel must operate
external to the FDA and be composed of experts qualified by scientific
training and experience to evaluate the target animal safety and
effectiveness of the new animal drug under consideration. Qualified
expert panels are not subject to the Federal Advisory Committee Act, 5
U.S.C. App. 2. The Secretary by regulation shall define the criteria
for selection of a qualified expert panel and the procedures for the
operation of the panel.
Subsection (d)(4) requires the Secretary to grant or deny a
request for inclusion in the index of legally marketed
unapproved new animal drugs for minor species within 180 days
of receipt of the information required in subsection (d)(2).
The Secretary shall grant the request if the request for
indexing continues to meet the eligibility criteria in
subsection (a) and the Secretary finds, on the basis of the
report of the qualified expert panel and other information
available to the Secretary, that the benefits of using the new
animal drug for the proposed use in a minor species outweigh
its risks to the target animal, taking into account the harm
caused by the absence of an approved or conditionally-approved
new animal drug for the minor species in question. If the
Secretary denies the request, the Secretary shall provide the
entity with the opportunity for an informal conference. The
decision of the Secretary following an informal conference
shall constitute final agency action subject to judicial
review.
New subsection (e) describes the information that must be
included for each new animal drug listed under the index. This
includes the name and address of the person who holds the index
listing; the name of the drug and the intended use and
conditions of use for which it is being indexed; product
labeling; and conditions and any limitations that the Secretary
deems necessary regarding use of the drug. The Secretary is
directed to publish the index, and revise it periodically;
additionally, the Secretary may establish a process for
reporting changes in the conditions of manufacturing or
labeling of indexed products.
New subsection (f) lists a number of circumstances whereby
the Secretary may remove a new animal drug from the index. New
subsection (f)(1) provides the Secretary with a number of
justifications for removing a new animal drug from the index.
New subsection (f)(2) provides the Secretary with additional
authority to remove a new animal drug from the index. Under new
subsection (f)(2), the Secretary must only find that there is a
reasonable probability that the use of the drug would present a
risk to the health of humans or other animals. The Secretary
must give the entity listed in the index the opportunity for an
informal conference if he or she uses the authority available
under new subsections (f)(1) and (f)(2) to remove a new animal
drug from the index. The decision of the Secretary following an
informal conference shall constitute final agency action
subject to judicial review.
New subsection (g) directs the Secretary to promulgate
regulations (to the extent consistent with the public health)
to exempt new animal drugs and animal feeds bearing or
containing new animal drugs intended solely for investigational
use by experts qualified by scientific training and experience
to investigate the safety and effectiveness of minor species
animal drugs from the safety and effectiveness standards
described in section 512 of the FFDCA.
New subsection (h) describes labeling requirements for new
animal drugs included in the index of legally marketed
unapproved new animal drugs for minor species. Specifically,
the labeling of such a drug shall read ``NOT APPROVED BY FDA.--
Legally marketed as an FDA indexed product. Extra-label use is
prohibited.'' Additionally, the labeling shall include the
following statement except in the case of new animal drugs
indexed for use in an early life stage of a food-producing
animal, ``This product is not to be used in animals intended
for use as food for humans or other animals.'' The Secretary
may require other information in the index listing.
New subsection (i) requires that the entity who has a new
animal drug included in the index shall establish and maintain
such records, and make such reports to the Secretary that he or
she determines, either through regulation or by order with
respect to a particular listing, is needed to determine whether
there is or may be ground for using new subsection (f) to
remove a new animal drug from the index.
Finally, new subsection (j) requires that safety and
effectiveness data and information which has been submitted in
support of a request for a new animal drug to be indexed under
this section be made available to the public under certain
circumstances.
New Section 573. Designated new animal drugs for minor use or minor
species
New section 573(a) provides the Secretary with the
authority to declare a new animal drug to be a ``designated new
animal drug.'' A designated new animal drug is eligible for two
different kinds of incentives to encourage the development of
new animal drugs for minor use or minor species. Under new
section 573(b), the Secretary may award grants and enter into
contracts with public and private entities to subsidize the
costs incurred by qualified safety and effectiveness testing
and manufacturing expenses. Qualified safety and effectiveness
testing is defined as testing that occurs after a new animal
drug is declared to be a designated new animal drug and is
carried out under an investigational exemption under section
512(j) of the FFDCA. Manufacturing expenses are defined as
expenses incurred in developing processes and procedures
associated with manufacture of the designated new animal drug
which occur after the new animal drug is declared to be a
designated new animal drug and before the sponsor files an
application for approval under section 512 or conditional
approval under new section 571. Under new section 573(c), if
the Secretary approves an application for approval under
section 512 or for conditional approval under new section 571,
the sponsor of the new animal drug will receive seven years of
marketing exclusivity. During this time, the Secretary may not
approve or conditionally approve another application for a new
animal drug with the same intended use as the designated new
animal drug unless the Secretary finds that the holder of the
approved application cannot assure the availability of
sufficient quantities of the drug or the holder provides
written consent to the Secretary for the approval or
conditional approvalof a new animal drug. The Secretary may
terminate the designation of a new animal drug if the sponsor of the
drug in question discontinues active pursuit of a full approval under
section 512 or conditional approval under section 571. In addition, the
Secretary may also terminate designation if the Secretary independently
determines that the sponsor is not actively pursuing approval under
section 512 or 571 with due diligence. The sponsor of an approved
designated new animal drug shall notify the Secretary of any
discontinuance of the manufacture of such new animal drug at least one
year before discontinuance.
Subsection (b)(5) makes a number of technical and
conforming changes to the FFDCA.
Subsection (b)(6) lists the timelines for implementing
regulations for new sections 571, 572, and 573.
Subsection (b)(7) creates an Office of Minor Use and Minor
Species Animal Drug Development at the Center for Veterinary
Medicine at the Food and Drug Administration. $1.2 million is
authorized to be appropriated for the office in fiscal year
2004, and such sums as may be necessary for each fiscal year
thereafter.
Subsection (b)(8) authorizes $1 million for the grants for
designated new animal drugs for the fiscal year following
publication of the final regulations implementing section
573(b), $2 million for the subsequent fiscal year, and such
sums as may be necessary for each fiscal year thereafter.
TITLE II
Section 201. Short title
Section 201 designates the short title of Title II of this
bill as the ``Food Allergen Labeling and Consumer Protection
Act of 2004.''
Section 202. Findings
Section 202 makes a number of findings regarding the
prevalence of food allergies. Specifically, approximately 2
percent of adults and 5 percent of children suffer from food
allergies--further, eight major foods or food groups account
for 90 percent of food allergies. These eight are milk, eggs,
fish, Crustacean shellfish, tree nuts, peanuts, wheat, and
soybeans.
Section 203. Food labeling; requirement of information regarding
allergenic substances
Section 203(a) creates a new section 403(w) in the FFDCA.
New section 403(w)(1) states that a food shall be deemed to be
misbranded if it, or one of its ingredients, is a major food
allergen, unless the food allergen is properly labeled. First,
under new section 403(w)(1)(A), the manufacturer may include a
list, either immediately after or adjacent to the list of
ingredients, which identifies the food source from which the
major food allergen is derived. Second, under new section
403(w)(1)(B), the manufacturer may include the common or usual
name of the major food allergen in the list of ingredients
followed in parentheses by the name of the food source from
which the major food allergen is derived. There are two
exceptions to this provision. The manufacturer is not required
to include the food source from which the major food allergen
is derived if the common or usual name of the ingredient uses
the name of the food source from which the major food allergen
is derived. For example, if ``milk casing'' is included in the
list of ingredients, it is not necessary for the manufacturer
to include the word ``milk'' in parentheses following this
ingredient. Additionally, the manufacturer is not required to
include the name of the food source from which the major food
allergen is derived if the name of the food source appears
elsewhere in the list of ingredients. For example, if the list
of ingredients includes ``milk casing,'' then it is not
necessary to include the word ``milk'' in parentheses after
``whey.'' However, this exception does not hold when the name
of the food source that appears elsewhere in the list of
ingredients is not a major food allergen. For example, peanut
oil is a highly refined oil and does not cause food allergies.
In this case, the list of ingredients would have to include
``peanuts'' in parentheses after an ingredient that includes
peanuts.
Under new section 403(w)(2), the definition of ``major food
allergen,'' which is defined under new section 201(q)(q) of the
FFDCA, means that in the case of a tree nut, fish, or
Crustacean shellfish, the specific tree nut (pecans), fish
(salmon), or Crustacean shellfish (lobster) must be listed.
New section 403(w)(3) holds that this labeling information
required under new section 403(w) may appear in labeling in
lieu of appearing on the label only if the Secretary finds that
such other labeling is sufficient to protect the public health.
The Secretary must publish any such finding in the Federal
Register as a notice. The finding will be effective as of the
date the notice is published.
New section 403(w)(4) states that notwithstanding the
provision in current law for flavorings, coloring, or
incidental additives that exempts them from other food labeling
requirements, a flavoring, coloring, or incidental additive
that is or contains a major food allergen shall be subject to
the labeling requirements 403(w)(1).
New section 403(w)(5) gives the Secretary the authority to
modify the food labeling requirements of subparagraph (A) or
(B) of new section 403(w)(1), or eliminate either the
requirement of subparagraph (A) or the requirements of
subparagraph (B) of paragraph (1), if the Secretary determines
that the modification or elimination of one of the new food
labeling requirements is necessary to protect the public
health.
New section 403(w)(6) creates a procedure by which any
entity may petition the Secretary to exempt a food ingredient
from the new food allergen labeling requirements created under
section 403(w)(1). Within 180 days, the Secretary will be
required to approve or deny such petition or the petition shall
be deemed denied, unless the Secretary and the petitioner
mutually agree upon an extension of time. The burden is on the
entity filing the petition to provide scientific evidence that
the food ingredient does not cause an allergic response that
poses a risk to human health.
New section 403(w)(7) provides industry with a different
process for securing an exemption from the food allergen
labeling requirements. An entity may file a notification with
the Secretary stating that scientific evidence demonstrates
that the food ingredient does not contain allergenic protein or
that the ingredient does not cause an allergic response that
poses a risk to human health. An entity filing a notification
may use the food ingredient in question as a food ingredient
that is not a major food allergen 90 days after the date of
receipt of the notification by the Secretary, unless the
Secretary decides to not approve the notification. Note that in
the case of a petition, the petition is deemed denied unless
the Secretary affirmatively approves the petition; in the case
of a notification, the burden is on the Secretary to explicitly
deny the notification request. While the Committee recognizes
that thresholds for the eight major allergens have not yet been
established by the scientific community, if they are
established, ingredients containing allergenic proteins below
the established threshold would be eligible for the
notification procedure.
New section 403(x) states that the exemption from current
law food labeling requirements for spices, flavorings,
colorings, or incidental additives does not apply in cases
where these ingredients contain a food allergen that is not a
major food allergen. In such a case, the food allergen shall be
disclosed in a manner specified by the Secretary by regulation.
Section 203(b) states that the labeling requirements
established under new section 403(w) do not prevent the
Secretary from requiring labels or labeling changes for other
food allergens that are not major food allergens.
Section 203(c) adds a new section 201qq to the FFDCA. New
section 201qq defines a ``major food allergen'' to be milk,
egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and
soybeans. Included in the definition are food ingredients that
contain proteins derived from one of the eight major food
allergens, with two exceptions. First, any highly refined oil
or ingredient derived from a highly refined oil is exempted
from the food allergy labeling requirements. Second, any food
ingredient that is exempted through either the petition or
notification procedures is not included in the definition of
major food allergens.
The requirements of section 203 will take effect on January
1, 2006.
Section 204. Report on food allergies
Section 204 directs the Secretary to produce a report on a
number of issues related to food allergies within 18 months of
enactment of S. 741. In reference to paragraph 4, it is the
Committee's intention that the Secretary focus on which types
of advisory labeling are effective in alerting consumers with
food allergies or their caregivers about the risk of cross-
contact. Appropriate survey mechanisms would be a particularly
useful way to gather this information.
Section 205. Inspections relating to food allergens
Section 205 directs the Secretary to continue conducting
inspections under section 704 of the FFDCA to ensure that
manufacturers, processors, and packagers are taking appropriate
steps to reduce or eliminate cross-contact between food
ingredients that are major food allergens and food ingredients
that are not major food allergens. In addition, the Secretary
is to use these inspections to ensure that major food allergens
are properly labeled.
Section 206. Gluten labeling
Section 206 directs the Secretary to issue a proposed rule
to define, and permit use of the term ``gluten-free'' on the
labeling of foods within two years of enactment of S. 741. The
Secretary is required to consult with appropriate experts and
stakeholders before promulgating this proposed rule. The
Secretary shall issue a final rule to define, and permit the
use of, the term ``gluten-free'' on the labeling of foods
within four years of the enactment of S. 741. Given the
devastating nature of celiac disease, the Committee urges the
Secretary to move expeditiously in implementing the
requirements of this section.
Section 207. Improvement and publication of data on food-related
allergic responses
Section 207 directs the Secretary, acting through the
Centers for Disease Control and Prevention and in consultation
with the Food and Drug Administration, to improve the national
data on the prevalence of food allergies; the incidence of
clinically significant or serious adverse events related to
food allergies; and the use of different modes of treatment for
and prevention of allergic responses to foods. There are
authorized such sums as may be necessary to carry out this
section.
Section 208. Food allergies research
Section 208 directs the Secretary, acting through the
Director of the National Institutes of Health, to convene an ad
hoc panel of nationally recognized experts in allergy and
immunology to review current basic and clinical research
efforts related to food allergies. The Committee encourages the
panel to review existing scientific data on food allergy
reaction thresholds for each of the major food allergens. It is
the Committee's hope that this information will be helpful to
the FDA as it continues to review scientific data on food
allergy reaction thresholds. The panel shall make
recommendations to the Secretary for enhancing and coordinating
research activities concerning food allergies not later than
one year after the enactment of S. 741. The Secretary shall
make these recommendations public.
Section 209. Food allergies in the food code
Section 209 directs the Secretary, in the Conference for
Food Protection, to pursue revision of the Food Code to provide
guidelines for preparing allergen-free foods in food
establishments, including in restaurants, grocery store
delicatessens and bakeries, and elementary and secondary school
cafeterias. The Secretary is directed to consider guidelines
and recommendations developed by public and private entities
for public and private food establishments for preparing
allergen-free foods in pursuing this revision, including
guidelines and recommendations preventing unintentional cross-
contact with major food allergens.
Section 210. Recommendation regarding responding to food-related
allergic responses
Section 210 directs the Secretary to include technical
assistance relating to the use of different modes of treatment
for and prevention of allergic responses to foods when
providing technical assistance relating to trauma care and
emergency medical services to State and local agencies.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, existing law in which no change
is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER II--DEFINITIONS
Sec. 201. For the purposes of this Act--
(a) * * *
* * * * * * *
(u) The term ``safe,'' as used in paragraph (s) of this
section and in sections 409, 512, 571, and 721, has reference
to the health of man or animal.
(v) The term ``new animal drug'' means any drug intended for
use for animals other than man, including any drug intended for
use in animal feed but not including such animal feed--
(1) * * *
* * * * * * *
Provided that any drug intended for minor use or use in a minor
species that is not the subject of a final regulation published
by the Secretary through notice and comment rulemaking finding
that the criteria of paragraphs (1) and (2) have not been met
(or that the exception to the criterion in paragraph (1) has
been met) is a new animal drug.
* * * * * * *
(nn) The term ``major species'' means cattle, horses, swine,
chickens, turkeys, dogs, and cats, except that the Secretary
may add species to this definition by regulation.
(oo) The term ``minor species'' means animals other than
humans that are not major species.
(pp) The term ``minor use'' means the intended use of a drug
in a major species for an indication that occurs infrequently
and in only a small number of animals or in limited
geographical areas and in only a small number of animals
annually.
(qq) The term ``major food allergen'' means any of the
following:
(1) Milk, egg, fish (e.g., bass, flounder, or cod),
Crustacean shellfish (e.g., crab, lobster, or shrimp),
tree nuts (e.g., almonds, pecans, or walnuts), wheat,
peanuts, and soybeans.
(2) A food ingredient that contains protein derived
from a food specified in paragraph (1), except the
following:
(A) Any highly refined oil derived from a
food specified in paragraph (1) and any
ingredient derived from such highly refined
oil.
(B) A food ingredient that is exempt under
paragraph (6) or (7) of section 403(w).
CHAPTER III--PROHIBITED ACTS AND PENALTIES
prohibited acts
Sec. 301. The following acts and the causing thereof are
hereby prohibited:
(a) * * *
* * * * * * *
(e) The refusal to permit access to or copying of any record
as required by section 412, 414, 504, 564, 703, or 704(a); or
the failure to establish or maintain any record, or make any
report, required under section 412, 414(b), 504, 505 (i) or
(k), [512(a)(4)(C), 512 (j), (l) or (m)] 512(a)(4)(C), 512 (j),
(l) or (m), 572(i)., 515(f), 519, or 564 or the refusal to
permit access to or verification or copying of any such
required record.
* * * * * * *
(j) The using by any person to his own advantage, or
revealing, other than to the Secretary or officers or employees
of the Department, or to the courts when relevant in any
judicial proceeding under this Act, any information acquired
under authority of section 404, 409, 412, 414, 505, 510, 512,
513, 514, 515, 516, 518, 519, 520, 571, 572, 573., 704, 708, or
721 concerning any method or process which as a trade secret is
entitled to protection; or the violating of section 408(i)(2)
or any regulation issued under that section. This paragraph
does not authorize the withholding of information from either
House of Congress or from, to the extent of matter within its
jurisdiction, any committee or subcommittee of such committee
or any joint committee of Congress or any subcommittee of such
joint committee.
* * * * * * *
CHAPTER IV--FOOD
* * * * * * *
MISBRANDED FOOD
Sec. 403. A food shall be deemed to be misbranded--
(a) * * *
* * * * * * *
(w)(1) If it is not a raw agricultural commodity and it is,
or it contains an ingredient that bears or contains, a major
food allergen, unless either--
(A) the word ``Contains'', followed by the name of
the food source from which the major food allergen is
derived, is printed immediately after or is adjacent to
the list of ingredients (in a type size no smaller than
the type size used in the list of ingredients) required
under subsections (g) and (i); or
(B) the common or usual name of the major food
allergen in the list of ingredients required under
subsections (g) and (i) is followed in parentheses by
the name of the food source from which the major food
allergen is derived, except that the name of the food
source is not required when--
(i) the common or usual name of the
ingredient uses the name of the food source
from which the major food allergen is derived;
or
(ii) the name of the food source from which
the major food allergen is derived appears
elsewhere in the ingredient list, unless the
name of the food source that appears elsewhere
in the ingredient list appears as part of the
name of a food ingredient that is not a major
food allergen under section 201(qq)(2)(A) or
(B).
(2) As used in this subsection, the term ``name of the food
source from which the major food allergen is derived'' means
the name described in section 201(qq)(1); provided that in the
case of a tree nut, fish, or Crustacean shellfish, the term
``name of the food source from which the major food allergen is
derived'' means the name of the specific type of nut or species
of fish or Crustacean shellfish.
(3) The information required under this subsection may appear
in labeling in lieu of appearing on the label only if the
Secretary finds that such other labeling is sufficient to
protect the public health. A finding by the Secretary under
this paragraph (including any change in an earlier finding
under this paragraph) is effective upon publication in the
Federal Register as a notice.
(4) Notwithstanding subsection (g), (i), or (k), or any other
law, a flavoring, coloring, or incidental additive that is, or
that bears or contains, a major food allergen shall be subject
to the labeling requirements of this subsection.
(5) The Secretary may by regulation modify the requirements
of subparagraph (A) or (B) of paragraph (1), or eliminate
either the requirement of subparagraph (A) or the requirements
of subparagraph (B) of paragraph (1), if the Secretary
determines that the modification or elimination of the
requirement of subparagraph (A) or the requirements of
subparagraph (B) is necessary to protect the public health.
(6)(A) Any person may petition the Secretary to exempt a food
ingredient described in section 201(qq)(2) from the allergen
labeling requirements of this subsection.
(B) The Secretary shall approve or deny such petition within
180 days of receipt of the petition or the petition shall be
deemed denied, unless an extension of time is mutually agreed
upon by the Secretary and the petitioner.
(C) The burden shall be on the petitioner to provide
scientific evidence (including the analytical method used to
produce the evidence) that demonstrates that such food
ingredient, as derived by the method specified in the petition,
does not cause an allergic response that poses a risk to human
health.
(D) A determination regarding a petition under this paragraph
shall constitute final agency action.
(E) The Secretary shall promptly post to a public site all
petitions received under this paragraph within 14 days of
receipt and the Secretary shall promptly post the Secretary's
response to each.
(7)(A) A person need not file a petition under paragraph (6)
to exempt a food ingredient described in section 201(qq)(2)
from the allergen labeling requirements of this subsection, if
the person files with the Secretary a notification containing--
(i) scientific evidence (including the analytical
method used) that demonstrates that the food ingredient
(as derived by the method specified in the
notification, where applicable) does not contain
allergenic protein; or
(ii) a determination by the Secretary that the
ingredient does not cause an allergic response that
poses a risk to human health under a premarket approval
or notification program under section 409.
(B) The food ingredient may be introduced or delivered for
introduction into interstate commerce as a food ingredient that
is not a major food allergen 90 days after the date of receipt
of the notification by the Secretary, unless the Secretary
determines within the 90-day period that the notification does
not meet the requirements of this paragraph, or there is
insufficient scientific evidence to determine that the food
ingredient does not contain allergenic protein or does not
cause an allergenic response that poses a risk to human health.
(C) The Secretary shall promptly post to a public site all
notifications received under this subparagraph within 14 days
of receipt and promptly post any objections thereto by the
Secretary.
(x) Notwithstanding subsection (g), (i), or (k), or any other
law, a spice, flavoring, coloring, or incidental additive that
is, or that bears or contains, a food allergen (other than a
major food allergen), as determined by the Secretary by
regulation, shall be disclosed in a manner specified by the
Secretary by regulation.
Sec. 403A. (a) Except as provided in subsection (b), no State
or political subdivision of a State may directly or indirectly
establish under any authority or continue in effect as to any
food in interstate commerce--
(1) * * *
(2) any requirement for the labeling of food of the
type required by section 403(c), 403(e), [or 403(i)(2)]
403(i)(2), 403(w), or 403(x) that is not identical to
the requirement of such section, except that this
paragraph does not apply to a requirement of a State or
political subdivision of a State that is of the type
required by section 403(c) and that is applicable to
maple syrup,
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
MISBRANDED DRUGS AND DEVICES
Sec. 502. A drug or device shall be deemed to be misbranded--
(a) * * *
* * * * * * *
(w) If it is a new animal drug--
(1) that is conditionally approved under section 571
and its labeling does not conform with the approved
application or section 571(f), or that is not
conditionally approved under section 571 and its label
bears the statement set forth in section 571(f)(1)(A);
or
(2) that is indexed under section 572 and its
labeling does not conform with the index listing under
section 572(e) or 572(h), or that has not been indexed
under section 572 and its label bears the statement set
forth in section 572(h).
EXEMPTIONS AND CONSIDERATION FOR CERTAIN DRUGS, DEVICES, AND BIOLOGICAL
PRODUCTS
Sec. 503. (a) * * *
* * * * * * *
(f)(1)(A) A drug intended for use by animals other than man,
other than a veterinary feed directive drug intended for use in
animal feed or an animal feed bearing or containing a
veterinary feed directive drug, which--
(i) * * *
(ii) is limited by an approved application under
subsection (b) of section 512, a conditionally-approved
application under section 571, or an index listing
under section 572 to use under the professional
supervision of a licensed veterinarian,
* * * * * * *
(3) The Secretary may by regulation exempt drugs for animals
other than man subject to section 512, 571, or 572 from the
requirements of paragraph (1) when such requirements are not
necessary for the protection of the public health.
* * * * * * *
VETERINARY FEED DIRECTIVE DRUGS
Sec. 504. (a)(1) A drug intended for use in or on animal feed
which is limited by an approved application filed pursuant to
section 512(b), a conditionally-approved application filed
pursuant to section 571, or an index listing pursuant to
section 572 to use under the professional supervision of a
licensed veterinarian is a veterinary feed directive drug. Any
animal feed bearing or containing a veterinary feed directive
drug shall be fed to animals only by or upon a lawful
veterinary feed directive issued by a licensed veterinarian in
the course of the veterinarian's professional practice. When
labeled, distributed, held, and used in accordance with this
section, a veterinary feed directive drug and any animal feed
bearing or containing a veterinary feed directive drug shall be
exempt from section 502(f).
(2) A veterinary feed directive is lawful if it--
(A) * * *
(B) is in compliance with the conditions and
indications for use of the drug set forth in the notice
published pursuant to section 512(i), or the index
listing pursuant to section 572(e).
* * * * * * *
(b) A veterinary feed directive drug and any feed bearing or
containing a veterinary feed directive drug shall be deemed to
be misbranded if their labeling fails to bear such cautionary
statement and such other information as the Secretary may by
general regulation or by order prescribe, or their advertising
fails to conform to the conditions and indications for use
published pursuant to section 512(i), or the index listing
pursuant to section 572(e) or fails to contain the general
cautionary statement prescribed by the Secretary.
* * * * * * *
NEW ANIMAL DRUGS
Sec. 512. (a)[(1) A new animal drug shall, with respect to
any particular use or intended use of such drug, be deemed
unsafe for the purposes of section 501(a)(5) and section
402(a)(2)(D) unless--
[(A) there is in effect an approval of an application
filed pursuant to subsection (b) with respect to such
use or intended use of such drug, and
[(B) such drug, its labeling, and such use conform to
such approved application.
A new animal drug shall also be deemed unsafe for such purposes
in the event of removal from the establishment of a
manufacturer, packer, or distributor of such drug for use in
the manufacture of animal feed in any State unless at the time
of such removal such manufacturer, packer, or distributor has
an unrevoked written statement from the consignee of such drug,
or notice from the Secretary, to the effect that, with respect
to the use of such drug in animal feed, such consignee (i)
holds a license issued under subsection (m) and has in its
possession current approved labeling for such drug in animal
feed; or (ii) will, if the consignee is not a user of the drug,
ship such drug only to a holder of a license issued under
subsection (m).
[(2) An animal feed bearing or containing a new animal drug
shall, with respect to any particular use or intended use of
such animal feed be deemed unsafe for the purposes of section
501(a)(6) unless--
[(A) there is in effect an approval of an application
filed pursuant to subsection (b) with respect to such
drug, as used in such animal feed,
[(B) such animal feed is manufactured at a site for
which there is in effect a license issued pursuant to
subsection (m)(1) to manufacture such animal feed, and
[(C) such animal feed and its labeling, distribution,
holding, and use conform to the conditions and
indications of use published pursuant to subsection
(i).] (1) A new animal drug shall, with respect to any
particular use or intended use of such drug, be deemed
unsafe for purposes of section 501(a)(5) and section
402(a)(2)(C)(ii) unless--
(A) there is in effect an approval of an application
filed pursuant to subsection (b) with respect to such
use or intended use of such drug, and such drug, its
labeling, and such use conform to such approved
application;
(B) there is in effect a conditional approval of an
application filed pursuant to section 571 with respect
to such use or intended use of such drug, and such
drug, its labeling, and such use conform to such
conditionally approved application; or
(C) there is in effect an index listing pursuant to
section 572 with respect to such use or intended use of
such drug in a minor species, and such drug, its
labeling, and such use conform to such index listing.
A new animal drug shall also be deemed unsafe for such purposes
in the event of removal from the establishment of a
manufacturer, packer, or distributor of such drug for use in
the manufacture of animal feed in any State unless at the time
of such removal such manufacturer, packer, or distributor has
an unrevoked written statement from the consignee of such drug,
or notice from the Secretary, to the effect that, with respect
to the use of such drug in animal feed, such consignee (i)
holds a license issued under subsection (m) and has in its
possession current approved labeling for such drug in animal
feed; or (ii) will, if the consignee is not a user of the drug,
ship such drug only to a holder of a license issued under
subsection (m).
(2) An animal feed bearing or containing a new animal drug
shall, with respect to any particular use or intended use of
such animal feed be deemed unsafe for purposes of section
501(a)(6) unless--
(A) there is in effect--
(i) an approval of an application filed
pursuant to subsection (b) with respect to such
drug, as used in such animal feed, and such
animal feed and its labeling, distribution,
holding, and use conform to such approved
application;
(ii) a conditional approval of an application
filed pursuant to section 571 with respect to
such drug, as used in such animal feed, and
such animal feed and its labeling,
distribution, holding, and use conform to such
conditionally approved application; or
(iii) an index listing pursuant to section
572 with respect to such drug, as used in such
animal feed, and such animal feed and its
labeling, distribution, holding, and use
conform to such index listing; and
(B) such animal feed is manufactured at a site for
which there is in effect a license issued pursuant to
subsection (m)(1) to manufacture such animal feed.
* * * * * * *
(b)(1) * * *
* * * * * * *
(3) Any person intending to file an application [under
paragraph (1) or a request for an investigational exemption
under subsection (j)] under paragraph (1), section 571, or a
request for an investigational exemption under subsection (j)
shall be entitled to one or more conferences prior to such
submission to reach an agreement acceptable to the Secretary
establishing a submission or an investigational requirement,
which may include a requirement for a field investigation. A
decision establishing a submission or an investigational
requirement shall bind the Secretary and the applicant or
requestor unless (A) the Secretary and the applicant or
requestor mutually agree to modify the requirement, or (B) the
Secretary by written order determines that a substantiated
scientific requirement essential to the determination of safety
or effectiveness of the animal drug involved has appeared after
the conference. No later than 25 calendar days after each such
conference, the Secretary shall provide a written order setting
forth a scientific justification specific to the animal drug
and intended uses under consideration if the agreement referred
to in the first sentence requires more than one field
investigation as being essential to provide substantial
evidence of effectiveness for the intended uses of the drug.
Nothing in this paragraph shall be construed as compelling the
Secretary to require a field investigation.
(c)(1) * * *
(2)(A) * * *
* * * * * * *
(F)(i) * * *
(ii) If an application submitted under subsection (b)(1) for
a drug, which includes an active ingredient (including any
ester or salt of the active ingredient) that has been approved
in another application approved under such subsection, is
approved after the date of enactment of this paragraph and if
such application contains substantial evidence of the
effectiveness of the drug involved, any studies of animal
safety, or, in the case of food producing animals, human food
safety studies [(other than bioequivalence or residue studies)]
(other than bioequivalence studies or residue depletion
studies, except residue depletion studies for minor uses or
minor species) required for the approval of the application and
conducted or sponsored by the applicant, the Secretary may not
make the approval of an application submitted under subsection
(b)(2) for the conditions of approval of such drug in the
subsection (b)(1) application effective before the expiration
of 3 years from the date of the approval of the application
under subsection (b)(1) for such drug.
(iii) If a supplement to an application approved under
subsection (b)(1) is approved after the date of enactment of
this paragraph and the supplement contains substantial evidence
of the effectiveness of the drug involved, any studies of
animal safety, or, in the case of food producing animals, human
food safety studies [(other than bioequivalence or residue
studies)] (other than bioequivalence studies or residue
depletion studies, except residue depletion studies for minor
uses or minor species) required for the approval of the
supplement and conducted or sponsored by the person submitting
the supplement, the Secretary may not make the approval of an
application submitted under subsection (b)(2) for a change
approved in the supplement effective before the expiration of 3
years from the date of the approval of the supplement.
* * * * * * *
(v) If an application (including any supplement to a new
animal drug application) submitted under subsection (b)(1) for
a new animal drug for a food-producing animal use, which
includes an active ingredient (including any ester or salt of
the active ingredient) which has been the subject of a waiver
under clause (iv) is approved after the date of enactment of
this paragraph, and if the application contains substantial
evidence of the effectiveness of the drug involved, any studies
of animal safety, or human food safety studies [(other than
bioequivalence or residue studies)] (other than bioequivalence
studies or residue depletion studies, except residue depletion
studies for minor uses or minor species) required for the new
approval of the application and conducted or sponsored by the
applicant, the Secretary may not make the approval of an
application (including any supplement to such application)
submitted under subsection (b)(2) for the new conditions of
approval of such drug in the subsection (b)(1) application
effective before the expiration of five years from the date of
approval of the application under subsection (b)(1) for such
drug. The provisions of this paragraph shall apply only to the
first approval for a food-producing animal use for the same
applicant after the waiver under clause (iv).
* * * * * * *
(d)(1) * * *
* * * * * * *
(4) In a case in which an animal drug contains more than one
active ingredient, or the labeling of the drug prescribes,
recommends, or suggests use of the drug in combination with one
or more other animal drugs, and the active ingredients or drugs
intended for use in the combination [have previously been
separately approved] have previously been separately approved
pursuant to an application submitted under section 512(b)(1)
for particular uses and conditions of use for which they are
intended for use in the combination--
(A) * * *
* * * * * * *
(5) In reviewing an application that proposes a
change to add an intended use for a minor use or a
minor species to an approved new animal drug
application, the Secretary shall reevaluate only the
relevant information in the approved application to
determine whether the application for the minor use or
minor species can be approved. A decision to approve
the application for the minor use or minor species is
not, implicitly or explicitly, a reaffirmation of the
approval of the original application.
* * * * * * *
(f) Whenever the Secretary finds that the facts so require,
he shall revoke any previous order under [subsection (d), (e),
or (m)] subsection (d), (e), or (m), or section 571 (c), (d),
or (e) refusing, withdrawing, or suspending approval of an
application and shall approve such application or reinstate
such approval, as may be appropriate.
(g) Orders of the Secretary issued under this section, or
section 571 (other than orders issuing, amending, or repealing
regulations) shall be served (1) in person by any officer or
employee of the department designated by the Secretary or (2)
by mailing the order by registered mail or by certified mail
addressed to the applicant or respondent at his last known
address in the records of the Secretary.
* * * * * * *
(i) When a new animal drug application filed pursuant to
subsection (b) or section 571 is approved, the Secretary shall
by notice, which upon publication shall be effective as a
regulation, publish in the Federal Register the name and
address of the applicant and the conditions and indications of
use of the new animal drug covered by such application,
including any tolerance and withdrawal period or other use
restrictions and, if such new animal drug is intended for use
in animal feed, appropriate purposes and conditions of use
(including special labeling requirements and any requirement
that an animal feed bearing or containing the new animal drug
be limited to use under the professional supervision of a
licensed veterinarian) applicable to any animal feed for use in
which such drug is approved, and such other information, upon
the basis of which such application was approved, as the
Secretary deems necessary to assure the safe and effective use
of such drug. Upon withdrawal of approval of such new animal
drug application or upon its suspension or upon failure to
renew a conditional approval under section 571, the Secretary
shall forthwith revoke or suspend, as the case may be, the
regulation published pursuant to this subsection (i) insofar as
it is based on the approval of such application.
* * * * * * *
(l)(1) In the case of any new animal drug for which an
approval of an application filed pursuant to subsection (b) or
section 571 is in effect, the applicant shall establish and
maintain such records, and make such reports to the Secretary,
of data relating to experience, including experience with uses
authorized under subsection (a)(4)(A), and other data or
information, received or otherwise obtained by such applicant
with respect to such drug, or with respect to animal feeds
bearing or containing such drug, as the Secretary may by
general regulation, or by order with respect to such
application, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination, whether
there is or may be ground for invoking subsection (e) or
subsection (m)(4) of this section. Such regulation or order
shall provide, where the Secretary deems it to be appropriate,
for the examination, upon request, by the persons to whom such
regulation or order is applicable, of similar information
received or otherwise obtained by the Secretary.
* * * * * * *
(m)(1) Any person may file with the Secretary an application
for a license to manufacture animal feeds bearing or containing
new animal drugs. Such person shall submit to the Secretary as
part of the application (A) a full statement of the business
name and address of the specific facility at which the
manufacturing is to take place and the facility's registration
number, (B) the name and signature of the responsible
individual or individuals for that facility, (C) a
certification that the animal feeds bearing or containing new
animal drugs are manufactured and labeled in accordance with
the [applicable regulations published pursuant to subsection
(i)] applicable regulations published pursuant to subsection
(i) or for indexed new animal drugs in accordance with the
index listing published pursuant to section 572(e)(2) and the
labeling requirements set forth in section 572(h), and (D) a
certification that the methods used in, and the facilities and
controls used for, manufacturing, processing, packaging, and
holding such animal feeds are in conformity with current good
manufacturing practice as described in section 501(a)(2)(B).
* * * * * * *
(3) If the Secretary, after due notice to the applicant in
accordance with paragraph (2) and giving the applicant an
opportunity for a hearing in accordance with such paragraph,
finds, on the basis of information submitted to the Secretary
as part of the application, on the basis of a preapproval
inspection, or on the basis of any other information before the
Secretary--
(A) * * *
* * * * * * *
(C) that the facility manufactures animal feeds
bearing or containing new animal drugs in a manner that
does not accord with the specifications for manufacture
or labels animal feeds bearing or containing new animal
drugs in a manner that does not accord with the
conditions or indications of use that are published
pursuant to subsection (i) or an index listing pursuant
to section 572(e),
the Secretary shall issue an order refusing to approve the
application. If, after such notice and opportunity for hearing,
the Secretary finds that subparagraphs (A) through (C) do not
apply, the Secretary shall issue an order approving the
application. An order under this subsection approving an
application for a license to manufacture animal feeds bearing
or containing new animal drugs shall permit a facility to
manufacture only those animal feeds bearing or containing new
animal drugs for which there are in effect regulations pursuant
to subsection (i) or an index listing pursuant to section
572(e) relating to the use of such drugs in or on such animal
feed.
* * * * * * *
(p)(1) Safety and effectiveness data and information which
has been submitted in an application filed under subsection
(b)(1) or section 571(a) for a drug and which has not
previously been disclosed to the public shall be made available
to the public, upon request, unless extraordinary circumstances
are shown--
(A) * * *
* * * * * * *
(2) Any request for data and information pursuant to
paragraph (1) shall include a verified statement by the person
making the request that any data or information received under
such paragraph shall not be disclosed by such person to any
other person--
(A) for the purpose of, or as part of a plan, scheme,
or device for, obtaining the right to make, use, or
market, or making, using, or marketing, outside the
United States, the drug identified in the application
filed under subsection (b)(1) or section 571(a), and
* * * * * * *
Subchapter F--New Animal Drugs for Minor Use and Minor Species
SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS FOR MINOR USE AND
MINOR SPECIES.
(a)(1) Except as provided in paragraph (3) of this section,
any person may file with the Secretary an application for
conditional approval of a new animal drug intended for a minor
use or a minor species. Such an application may not be a
supplement to an application approved under section 512. Such
application must comply in all respects with the provisions of
section 512 of this Act except sections 512(a)(4), 512(b)(2),
512(c)(1), 512(c)(2), 512(c)(3), 512(d)(1), 512(e), 512(h), and
512(n) unless otherwise stated in this section, and any
additional provisions of this section. New animal drugs are
subject to application of the same safety standards that would
be applied to such drugs under section 512(d) (including, for
antimicrobial new animal drugs, with respect to antimicrobial
resistance).
(2) The applicant shall submit to the Secretary as part of an
application for the conditional approval of a new animal drug--
(A) all information necessary to meet the
requirements of section 512(b)(1) except section
512(b)(1)(A);
(B) full reports of investigations which have been
made to show whether or not such drug is safe under
section 512(d) (including, for an antimicrobial new
animal drug, with respect to antimicrobial resistance)
and there is a reasonable expectation of effectiveness
for use;
(C) data for establishing a conditional dose;
(D) projections of expected need and the
justification for that expectation based on the best
information available;
(E) information regarding the quantity of drug
expected to be distributed on an annual basis to meet
the expected need; and
(F) a commitment that the applicant will conduct
additional investigations to meet the requirements for
the full demonstration of effectiveness under section
512(d)(1)(E) within 5 years.
(3) A person may not file an application under paragraph (1)
if--
(A) the application seeks conditional approval of a
new animal drug that is contained in, or is a product
of, a transgenic animal.
(B) the person has previously filed an application
for conditional approval under paragraph (1) for the
same drug in the same dosage form for the same intended
use whether or not subsequently conditionally approved
by the Secretary under subsection (b), or
(C) the person obtained the application, or data or
other information contained therein, directly or
indirectly from the person who filed for conditional
approval under paragraph (1) for the same drug in the
same dosage form for the same intended use whether or
not subsequently conditionally approved by the
Secretary under subsection (b).
(b) Within 180 days after the filing of an application
pursuant to subsection (a), or such additional period as may be
agreed upon by the Secretary and the applicant, the Secretary
shall either--
(1) issue an order, effective for one year,
conditionally approving the application if the
Secretary finds that none of the grounds for denying
conditional approval, specified in subsection (c) of
this section applies and publish a Federal Register
notice of the conditional approval, or
(2) give the applicant notice of an opportunity for
an informal hearing on the question whether such
application can be conditionally approved.
(c) If the Secretary finds, after giving the applicant notice
and an opportunity for an informal hearing, that--
(1) any of the provisions of section 512(d)(1) (A)
through (D) or (F) through (I) are applicable;
(2) the information submitted to the Secretary as
part of the application and any other information
before the Secretary with respect to such drug, is
insufficient to show that there is a reasonable
expectation that the drug will have the effect it
purports or is represented to have under the conditions
of use prescribed, recommended, or suggested in the
proposed labeling thereof; or
(3) another person has received approval under
section 512 for the same drug in the same dosage form
for the same intended use, and that person is able to
assure the availability of sufficient quantities of the
drug to meet the needs for which the drug is intended;
the Secretary shall issue an order refusing to conditionally
approve the application. If, after such notice and opportunity
for an informal hearing, the Secretary finds that paragraphs
(1) through (3) do not apply, the Secretary shall issue an
order conditionally approving the application effective for one
year and publish a Federal Register notice of the conditional
approval. Any order issued under this subsection refusing to
conditionally approve an application shall state the findings
upon which it is based.
(d) A conditional approval under this section is effective
for a 1-year period and is thereafter renewable by the
Secretary annually for up to 4 additional 1-year terms. A
conditional approval shall be in effect for no more than 5
years from the date of approval under subsection (b)(1) or (c)
of this section unless extended as provided for in subsection
(h) of this section. The following shall also apply:
(1) No later than 90 days from the end of the 1-year
period for which the original or renewed conditional
approval is effective, the applicant may submit a
request to renew a conditional approval for an
additional 1-year term.
(2) A conditional approval shall be deemed renewed at
the end of the 1-year period, or at the end of a 90-day
extension that the Secretary may, at the Secretary's
discretion, grant by letter in order to complete review
of the renewal request, unless the Secretary determines
before the expiration of the 1-year period or the 90-
day extension that--
(A) the applicant failed to submit a timely
renewal request;
(B) the request fails to contain sufficient
information to show that--
(i) the applicant is making
sufficient progress toward meeting
approval requirements under section
512(d)(1)(E), and is likely to be able
to fulfill those requirements and
obtain an approval under section 512
before the expiration of the 5-year
maximum term of the conditional
approval;
(ii) the quantity of the drug that
has been distributed is consistent with
the conditionally approved intended use
and conditions of use, unless there is
adequate explanation that ensures that
the drug is only used for its intended
purpose; or
(iii) the same drug in the same
dosage form for the same intended use
has not received approval under section
512, or if such a drug has been
approved, that the holder of the
approved application is unable to
assure the availability of sufficient
quantities of the drug to meet the
needs for which the drug is intended;
or
(C) any of the provisions of section
512(e)(1) (A) through (B) or (D) through (F)
are applicable.
(3) If the Secretary determines before the end of the
1-year period or the 90-day extension, if granted, that
a conditional approval should not be renewed, the
Secretary shall issue an order refusing to renew the
conditional approval, and such conditional approval
shall be deemed withdrawn and no longer in effect. The
Secretary shall thereafter provide an opportunity for
an informal hearing to the applicant on the issue
whether the conditional approval shall be reinstated.
(e)(1) The Secretary shall issue an order withdrawing
conditional approval of an application filed pursuant to
subsection (a) if the Secretary finds that another person has
received approval under section 512 for the same drug in the
same dosage form for the same intended use and that person is
able to assure the availability of sufficient quantities of the
drug to meet the needs for which the drug is intended.
(2) The Secretary shall, after due notice and opportunity for
an informal hearing to the applicant, issue an order
withdrawing conditional approval of an application filed
pursuant to subsection (a) if the Secretary finds that--
(A) any of the provisions of section 512(e)(1) (A)
through (B) or (D) through (F) are applicable; or
(B) on the basis of new information before the
Secretary with respect to such drug, evaluated together
with the evidence available to the Secretary when the
application was conditionally approved, that there is
not a reasonable expectation that such drug will have
the effect it purports or is represented to have under
the conditions of use prescribed, recommended, or
suggested in the labeling thereof.
(3) The Secretary may also, after due notice and opportunity
for an informal hearing to the applicant, issue an order
withdrawing conditional approval of an application filed
pursuant to subsection (a) if the Secretary finds that any of
the provisions of section 512(e)(2) are applicable.
(f)(1) The label and labeling of a new animal drug with a
conditional approval under this section shall--
(A) bear the statement, ``conditionally approved by
FDA pending a full demonstration of effectiveness under
application number''; and
(B) contain such other information as prescribed by
the Secretary.
(2) An intended use that is the subject of a conditional
approval under this section shall not be included in the same
product label with any intended use approved under section 512.
(g) A conditionally approved new animal drug application may
not be amended or supplemented to add indications for use.
(h) 180 days prior to the termination date established under
subsection (d) of this section, an applicant shall have
submitted all the information necessary to support a complete
new animal drug application in accordance with section
512(b)(1) or the conditional approval issued under this section
is no longer in effect. Following review of this information,
the Secretary shall either--
(1) issue an order approving the application under
section 512(c) if the Secretary finds that none of the
grounds for denying approval specified in section
512(d)(1) applies, or
(2) give the applicant an opportunity for a hearing
before the Secretary under section 512(d) on the
question whether such application can be approved.
Upon issuance of an order approving the application, product
labeling and administrative records of approval shall be
modified accordingly. If the Secretary has not issued an order
under section 512(c) approving such application prior to the
termination date established under subsection (d) of this
section, the conditional approval issued under this section is
no longer in effect unless the Secretary grants an extension of
an additional 180-day period so that the Secretary can complete
review of the application. The decision to grant an extension
is committed to the discretion of the Secretary and not subject
to judicial review.
(i) The decision of the Secretary under subsection (c), (d),
or (e) of this section refusing or withdrawing conditional
approval of an application shall constitute final agency action
subject to judicial review.
(j) In this section and section 572, the term ``transgenic
animal'' means an animal whose genome contains a nucleotide
sequence that has been intentionally modified in vitro, and the
progeny of such an animal; Provided that the term ``transgenic
animal'' does not include an animal of which the nucleotide
sequence of the genome has been modified solely by selective
breeding.
SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR
MINOR SPECIES.
(a)(1) The Secretary shall establish an index limited to--
(A) new animal drugs intended for use in a minor
species for which there is a reasonable certainty that
the animal or edible products from the animal will not
be consumed by humans or food-producing animals; and
(B) new animal drugs intended for use only in a
hatchery, tank, pond, or other similar contained man-
made structure in an early, non-food life stage of a
food-producing minor species, where safety for humans
is demonstrated in accordance with the standard of
section 512(d) (including, for an antimicrobial new
animal drug, with respect to antimicrobial resistance).
(2) The index shall not include a new animal drug that is
contained in or a product of a transgenic animal.
(b) Any person intending to file a request under this section
shall be entitled to one or more conferences to discuss the
requirements for indexing a new animal drug.
(c)(1) Any person may submit a request to the Secretary for a
determination whether a new animal drug may be eligible for
inclusion in the index. Such a request shall include--
(A) information regarding the need for the new animal
drug, the species for which the new animal drug is
intended, the proposed intended use and conditions of
use, and anticipated annual distribution;
(B) information to support the conclusion that the
proposed use meets the conditions of subparagraph (A)
or (B) of subsection (a)(1) of this section;
(C) information regarding the components and
composition of the new animal drug;
(D) a description of the methods used in, and the
facilities and controls used for, the manufacture,
processing, and packing of such new animal drug;
(E) an environmental assessment that meets the
requirements of the National Environmental Policy Act
of 1969, as amended, and as defined in 21 CFR Part 25,
as it appears on the date of enactment of this
provision and amended thereafter or information to
support a categorical exclusion from the requirement to
prepare an environmental assessment;
(F) information sufficient to support the conclusion
that the proposed use of the new animal drug is safe
under section 512(d) with respect to individuals
exposed to the new animal drug through its manufacture
or use; and
(G) such other information as the Secretary may deem
necessary to make this eligibility determination.
(2) Within 90 days after the submission of a request for a
determination of eligibility for indexing based on subsection
(a)(1)(A) of this section, or 180 days for a request submitted
based on subsection (a)(1)(B) of this section, the Secretary
shall grant or deny the request, and notify the person who
requested such determination of the Secretary's decision. The
Secretary shall grant the request if the Secretary finds that--
(A) the same drug in the same dosage form for the
same intended use is not approved or conditionally
approved;
(B) the proposed use of the drug meets the conditions
of subparagraph (A) or (B) of subsection (a)(1), as
appropriate;
(C) the person requesting the determination has
established appropriate specifications for the
manufacture and control of the new animal drug and has
demonstrated an understanding of the requirements of
current good manufacturing practices;
(D) the new animal drug will not significantly affect
the human environment; and
(E) the new animal drug is safe with respect to
individuals exposed to the new animal drug through its
manufacture or use.
If the Secretary denies the request, the Secretary shall
thereafter provide due notice and an opportunity for an
informal conference. A decision of the Secretary to deny an
eligibility request following an informal conference shall
constitute final agency action subject to judicial review.
(d)(1) With respect to a new animal drug for which the
Secretary has made a determination of eligibility under
subsection (c), the person who made such a request may ask that
the Secretary add the new animal drug to the index established
under subsection (a). The request for addition to the index
shall include--
(A) a copy of the Secretary's determination of
eligibility issued under subsection (c);
(B) a written report that meets the requirements in
subsection (d)(2) of this section;
(C) a proposed index entry;
(D) facsimile labeling;
(E) anticipated annual distribution of the new animal
drug;
(F) a written commitment to manufacture the new
animal drug and animal feeds bearing or containing such
new animal drug according to current good manufacturing
practices;
(G) a written commitment to label, distribute, and
promote the new animal drug only in accordance with the
index entry;
(H) upon specific request of the Secretary,
information submitted to the expert panel described in
paragraph (3); and
(I) any additional requirements that the Secretary
may prescribe by general regulation or specific order.
(2) The report required in paragraph (1) shall--
(A) be authored by a qualified expert panel;
(B) include an evaluation of all available target
animal safety and effectiveness information, including
anecdotal information;
(C) state the expert panel's opinion regarding
whether the benefits of using the new animal drug for
the proposed use in a minor species outweigh its risks
to the target animal, taking into account the harm
being caused by the absence of an approved or
conditionally approved new animal drug for the minor
species in question;
(D) include information from which labeling can be
written; and
(E) include a recommendation regarding whether the
new animal drug should be limited to use under the
professional supervision of a licensed veterinarian.
(3) A qualified expert panel, as used in this section, is a
panel that--
(A) is composed of experts qualified by scientific
training and experience to evaluate the target animal
safety and effectiveness of the new animal drug under
consideration;
(B) operates external to FDA; and
(C) is not subject to the Federal Advisory Committee
Act, 5 U.S.C. App. 2.
The Secretary shall define the criteria for selection of a
qualified expert panel and the procedures for the operation of
the panel by regulation.
(4) Within 180 days after the receipt of a request for
listing a new animal drug in the index, the Secretary shall
grant or deny the request. The Secretary shall grant the
request if the request for indexing continues to meet the
eligibility criteria in subsection (a) and the Secretary finds,
on the basis of the report of the qualified expert panel and
other information available to the Secretary, that the benefits
of using the new animal drug for the proposed use in a minor
species outweigh its risks to the target animal, taking into
account the harm caused by the absence of an approved or
conditionally-approved new animal drug for the minor species in
question. If the Secretary denies the request, the Secretary
shall thereafter provide due notice and the opportunity for an
informal conference. The decision of the Secretary following an
informal conference shall constitute final agency action
subject to judicial review.
(e)(1) The index established under subsection (a) shall
include the following information for each listed drug--
(A) the name and address of the person who holds the
index listing;
(B) the name of the drug and the intended use and
conditions of use for which it is being indexed;
(C) product labeling; and
(D) conditions and any limitations that the Secretary
deems necessary regarding use of the drug.
(2) The Secretary shall publish the index, and revise it
periodically.
(3) The Secretary may establish by regulation a process for
reporting changes in the conditions of manufacturing or
labeling of indexed products.
(f)(1) If the Secretary finds, after due notice to the person
who requested the index listing and an opportunity for an
informal conference, that--
(A) the expert panel failed to meet the requirements
as set forth by the Secretary by regulation;
(B) on the basis of new information before the
Secretary, evaluated together with the evidence
available to the Secretary when the new animal drug was
listed in the index, the benefits of using the new
animal drug for the indexed use do not outweigh its
risks to the target animal;
(C) the conditions of subsection (c)(2) of this
section are no longer satisfied;
(D) the manufacture of the new animal drug is not in
accordance with current good manufacturing practices;
(E) the labeling, distribution, or promotion of the
new animal drug is not in accordance with the index
entry;
(F) the conditions and limitations of use associated
with the index listing have not been followed; or
(G) the request for indexing contains any untrue
statement of material fact,
the Secretary shall remove the new animal drug from the index.
The decision of the Secretary following an informal conference
shall constitute final agency action subject to judicial
review.
(2) If the Secretary finds that there is a reasonable
probability that the use of the drug would present a risk to
the health of humans or other animals, the Secretary may--
(A) suspend the listing of such drug immediately;
(B) give the person listed in the index prompt notice
of the Secretary's action; and
(C) afford that person the opportunity for an
informal conference.
The decision of the Secretary following an informal conference
shall constitute final agency action subject to judicial
review.
(g) For purposes of indexing new animal drugs under this
section, to the extent consistent with the public health, the
Secretary shall promulgate regulations for exempting from the
operation of section 512 minor species new animal drugs and
animal feeds bearing or containing new animal drugs intended
solely for investigational use by experts qualified by
scientific training and experience to investigate the safety
and effectiveness of minor species animal drugs. Such
regulations may, at the discretion of the Secretary, among
other conditions relating to the protection of the public
health, provide for conditioning such exemption upon the
establishment and maintenance of such records, and the making
of such reports to the Secretary, by the manufacturer or the
sponsor of the investigation of such article, of data
(including but not limited to analytical reports by
investigators) obtained as a result of such investigational use
of such article, as the Secretary finds will enable the
Secretary to evaluate the safety and effectiveness of such
article in the event of the filing of a request for an index
listing pursuant to this section.
(h) The labeling of a new animal drug that is the subject of
an index listing shall state, prominently and conspicuously--
(1) ``Not approved by fda.--Legally marketed as an
FDA indexed product. Extra-label use is prohibited.'';
(2) except in the case of new animal drugs indexed
for use in an early life stage of a food-producing
animal, ``This product is not to be used in animals
intended for use as food for humans or other
animals.''; and
(3) such other information as may be prescribed by
the Secretary in the index listing.
(i)(1) In the case of any new animal drug for which an index
listing pursuant to subsection (a) is in effect, the person who
has an index listing shall establish and maintain such records,
and make such reports to the Secretary, of data relating to
experience, and other data or information, received or
otherwise obtained by such person with respect to such drug, or
with respect to animal feeds bearing or containing such drug,
as the Secretary may by general regulation, or by order with
respect to such listing, prescribe on the basis of a finding
that such records and reports are necessary in order to enable
the Secretary to determine, or facilitate a determination,
whether there is or may be ground for invoking subsection (f).
Such regulation or order shall provide, where the Secretary
deems it to be appropriate, for the examination, upon request,
by the persons to whom such regulation or order is applicable,
of similar information received or otherwise obtained by the
Secretary.
(2) Every person required under this subsection to maintain
records, and every person in charge or custody thereof, shall,
upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable
times to have access to and copy and verify such records.
(j)(1) Safety and effectiveness data and information which
has been submitted in support of a request for a new animal
drug to be indexed under this section and which has not been
previously disclosed to the public shall be made available to
the public, upon request, unless extraordinary circumstances
are shown--
(A) if no work is being or will be undertaken to have
the drug indexed in accordance with the request,
(B) if the Secretary has determined that such drug
cannot be indexed and all legal appeals have been
exhausted,
(C) if the indexing of such drug is terminated and
all legal appeals have been exhausted, or
(D) if the Secretary has determined that such drug is
not a new animal drug.
(2) Any request for data and information pursuant to
paragraph (1) shall include a verified statement by the person
making the request that any data or information received under
such paragraph shall not be disclosed by such person to any
other person--
(A) for the purpose of, or as part of a plan, scheme,
or device for, obtaining the right to make, use, or
market, or making, using, or marketing, outside the
United States, the drug identified in the request for
indexing; and
(B) without obtaining from any person to whom the
data and information are disclosed an identical
verified statement, a copy of which is to be provided
by such person to the Secretary, which meets the
requirements of this paragraph.
SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR USE OR MINOR SPECIES.
(a) Designation.--
(1) The manufacturer or the sponsor of a new animal
drug for a minor use or use in a minor species may
request that the Secretary declare that drug a
``designated new animal drug''. A request for
designation of a new animal drug shall be made before
the submission of an application under section 512(b)
or section 571 for the new animal drug.
(2) The Secretary may declare a new animal drug a
``designated new animal drug'' if--
(A) it is intended for a minor use or use in
a minor species; and
(B) the same drug in the same dosage form for
the same intended use is not approved under
section 512 or 571 or designated under this
section at the time the request is made.
(3) Regarding the termination of a designation--
(A) the sponsor of a new animal drug shall
notify the Secretary of any decision to
discontinue active pursuit of approval under
section 512 or 571 of an application for a
designated new animal drug. The Secretary shall
terminate the designation upon such
notification;
(B) the Secretary may also terminate
designation if the Secretary independently
determines that the sponsor is not actively
pursuing approval under section 512 or 571 with
due diligence;
(C) the sponsor of an approved designated new
animal drug shall notify the Secretary of any
discontinuance of the manufacture of such new
animal drug at least one year before
discontinuance. The Secretary shall terminate
the designation upon such notification; and
(D) the designation shall terminate upon the
expiration of any applicable exclusivity period
under subsection (c).
(4) Notice respecting the designation or termination
of designation of a new animal drug shall be made
available to the public.
(b) Grants and Contracts for Development of Designated New
Animal Drugs.--
(1) The Secretary may make grants to and enter into
contracts with public and private entities and
individuals to assist in defraying the costs of
qualified safety and effectiveness testing expenses and
manufacturing expenses incurred in connection with the
development of designated new animal drugs.
(2) For purposes of paragraph (1) of this section--
(A) The term ``qualified safety and
effectiveness testing'' means testing--
(i) which occurs after the date such
new animal drug is designated under
this section and before the date on
which an application with respect to
such drug is submitted under section
512; and
(ii) which is carried out under an
investigational exemption under section
512(j).
(B) The term ``manufacturing expenses'' means
expenses incurred in developing processes and
procedures associated with manufacture of the
designated new animal drug which occur after
the new animal drug is designated under this
section and before the date on which an
application with respect to such new animal
drug is submitted under section 512 or 571.
(c) Exclusivity for Designated New Animal Drugs.--
(1) Except as provided in subsection (c)(2), if the
Secretary approves or conditionally approves an
application for a designated new animal drug, the
Secretary may not approve or conditionally approve
another application submitted for such new animal drug
with the same intended use as the designated new animal
drug for another applicant before the expiration of
seven years from the date of approval or conditional
approval of the application.
(2) If an application filed pursuant to section 512
or section 571 is approved for a designated new animal
drug, the Secretary may, during the 7-year exclusivity
period beginning on the date of the application
approval or conditional approval, approve or
conditionally approve another application under section
512 or section 571 for such drug for such minor use or
minor species for another applicant if--
(A) the Secretary finds, after providing the
holder of such an approved application notice
and opportunity for the submission of views,
that in the granted exclusivity period the
holder of the approved application cannot
assure the availability of sufficient
quantities of the drug to meet the needs for
which the drug was designated; or
(B) such holder provides written consent to
the Secretary for the approval or conditional
approval of other applications before the
expiration of such exclusivity period.
* * * * * * *
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SECTION 108 OF THE ANIMAL DRUG AMENDMENTS OF 1968
(Public Law 90-399)
EFFECTIVE DATE AND TRANSITIONAL PROVISIONS
Sec. 108. (a) * * *
(b)(1) * * *
* * * * * * *
(3) In the case of any drug (other than a drug subject to
section 512(n) of the basic Act as amended by this Act)
intended for use in animals other than man which, on October 9,
1962, (A) was commercially used or sold in the United States,
(B) was not a new drug as defined by section 201(p) of the
basic Act as then in force, and (C) was not covered by an
effective application under section 505 of that Act, the words
``effectiveness'' and ``effective'' contained in [section
201(w) as added by this Act] section 201(v) to the basic Act
shall not apply to such drug when intended solely for use under
conditions prescribed, recommended, or suggested in labeling
with respect to such drug on that day.
* * * * * * *