[Senate Report 110-329]
[From the U.S. Government Publishing Office]
Calendar No. 549
110th Congress Report
SENATE
2d Session 110-329
======================================================================
COMPREHENSIVE TUBERCULOSIS ELIMINATION ACT OF 2007
_______
April 22, 2008.--Ordered to be printed
_______
Mr. Kennedy, from the Committee on Health, Education, Labor, and
Pensions, submitted the following
R E P O R T
[To accompany S. 1551]
The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 1551) to amend the Public
Health Service Act with respect to making progress toward the
goal of eliminating tuberculosis, and for other purposes,
having considered the same, reports favorably thereon with an
amendment in the nature of a substitute and recommends that the
bill (as amended) do pass.
CONTENTS
Page
I. Purpose and Summary..............................................1
II. Background and Need for Legislation..............................2
III. Legislative History and Committee Action.........................5
IV. Committee Views..................................................5
V. Cost Estimate...................................................11
VI. Regulatory Impact Statement.....................................13
VII. Application of Law to the Legislative Branch....................13
VIII.Section-by-Section Analysis.....................................14
IX. Changes in Existing Law.........................................17
I. Purpose and Summary
The Comprehensive Tuberculosis Elimination Act of 2007
addresses the role of the Department of Health and Human
Services in the development and implementation of a national
strategy to eliminate tuberculosis (TB) in the United States.
In order to attain this goal, the act mandates expansion,
intensification, and coordination of the ongoing activities of
the Centers for Disease Control and Prevention (CDC) and the
National Institutes of Health (NIH). The act enhances research,
education, training, and international efforts to eliminate TB
through the CDC and expands basic research through the NIH. The
act includes the following provisions:
1. The legislation calls for expanding and intensifying the
CDC's TB prevention, control, and elimination activities.
The CDC will award grants to public or nonprofit entities
for the purposes of prevention, control, and elimination of TB,
under section 317. The agency will support State public health
activities including TB case finding, prevention and treatment
utilizing directly observed therapy; research into the
diagnosis and treatment of latent TB, drug-resistant TB, and
cases of TB in high-risk populations. Additionally, the CDC
will conduct demonstration projects; education and training of
health care professionals; and public education projects. These
grants are authorized at $300 million in fiscal year 2008 and
such sums as may be necessary in fiscal years 2009 through
2012.
2. The legislation mandates the creation of a national
strategy.
The Advisory Council for the Elimination of Tuberculosis
(ACET) will develop a national strategy to eliminate
tuberculosis from the United States. While constructing the
national plan, ACET will review the recommendations of the
Institute of Medicine (IOM) report Ending Neglect: The
Elimination of Tuberculosis in the United States. Not only will
ACET's recommendations guide U.S. domestic TB programs, but
they will provide counsel on U.S. involvement in global TB-
control activities.
3. The act calls for the development of new tools for the
elimination of tuberculosis.
The Secretary may expand, intensify, and coordinate
research for the development of new tools for the elimination
of tuberculosis, including drugs, diagnostics, vaccines, and
public health interventions, such as directly observed therapy
and non-pharmaceutical interventions. The Federal Tuberculosis
Task Force will make recommendations on the development of a
comprehensive plan for the creation of new tools. These efforts
are authorized at $100 million in fiscal year 2008, and such
sums as may be necessary in fiscal years 2009 through 2012.
4. The act calls for the evaluation of public health
authorities related to tuberculosis.
The Secretary will submit a report to Congress that
evaluates and provides recommendations on Federal and State
disease-containment challenges, including an evaluation of the
effectiveness of policies to detain patients with active
tuberculosis, an evaluation of whether Federal policies should
be strengthened to address the movement of infected
individuals, and any other legislative recommendations for
changes to Federal laws. The Secretary must also promulgate
regulations within 8 months to update interstate and foreign
quarantine regulations.
5. The act calls for increased basic and clinical research
regarding TB at the National Institutes of Health.
The Director of the National Institutes of Health will
enhance basic and clinical research and development related to
tuberculosis.
II. Background and Need for Legislation
Tuberculosis (TB) is a preventable and treatable disease
that continues to infect thousands of Americans each year.
Recent cases of drug-resistant TB have served as timely
warnings that TB, particularly drug-resistant TB, is a real and
present public health threat to the United States. It is
critical to recognize that drug-resistant TB is a human-made
disaster caused by the world's failure to properly treat the
disease and develop new, more effective tools to fight TB.
Although drugs, diagnostics and vaccines for TB exist, these
technologies are 40-100 years old and are increasingly
inadequate for controlling the global epidemic.
The widespread global utilization of the BCG vaccine and
antibiotics, in addition to generally improved public health,
led to a dramatic reduction in the global TB deaths and disease
burden between 1940 and 1980. But the short-term success of
these tools led to complacency and a lessening interest on the
part of governments and pharmaceutical companies in TB research
and development.
What resulted in the late 1980s in the United States,
spurred by the spread of HIV and the increases in homelessness,
incarceration, and injection drug use, was a 20 percent
increase in TB case rates and the emergence of drug-resistant
strains of TB. The TB outbreaks were difficult to control and
extremely costly, given that the health infrastructure for
dealing with the infection had been allowed to deteriorate due
to a lack of funding. In New York City alone, more than $1
billion were needed to regain control of TB.
The Advisory Council for the Elimination of Tuberculosis
was established in 1987 to provide recommendations regarding
the elimination of TB to the Secretary and Assistant Secretary
of Health and Human Services and the Director of the Centers
for Disease Control and Prevention (CDC). In 1989, ACET and the
CDC issued A Strategic Plan for the Elimination of TB in the
United States, which described actions necessary to eliminate
TB by 2010. In 1991, a Federal TB Task Force was created to
combat the resurgence of TB.
Commissioned by the CDC, the Institute of Medicine (IOM)
released a report in 2000, entitled, ``Ending Neglect: the
Elimination of Tuberculosis in the United States.'' This report
reviewed the current status of TB prevention and control in the
United States and outlined a comprehensive framework for a
national campaign to eliminate TB. The committee recognizes the
value of the expert recommendations contained within the IOM
report and believes that these recommendations should be
carefully evaluated in planning our efforts to eliminate TB
from the United States.
TB has retreated into high-risk populations and isolated
communities across the United States. These populations include
minorities, those co-infected with the human immunodeficiency
virus (HIV), inmates and staff of correctional facilities, and
those born in foreign countries, as previously discussed. For
instance, TB is more than eight times as prevalent among
African-Americans compared to Caucasians. Greater staffing,
outreach, education, and followup are urgently needed in order
to effectively prevent and treat TB in these populations.
Today, the United States faces four significant challenges
to the elimination of TB. First, our progress in reducing the
TB case rate in the United States has stalled. Between 1993 and
2000, the Nation's TB rate fell by 7.3 percent, but from 2000
to 2006, the rate of decline slowed to 3.8 percent. Although
the number of TB cases in the United States continues to fall,
with 13,779 cases reported in 2006, our progress against the
disease should be measured by annual decreases of at least 7
percent in the number of active TB cases. This is occurring at
a time when domestic TB control categorical funding has been
stagnant for a decade. As we have learned from the history of
TB in this country, complacency and neglect of TB control
programs can lead to costly resurgences of the disease.
Second, the emergence of multidrug-resistant, and
extensively drug-resistant strains of TB poses a major
challenge to current methods of treating TB. Twenty-seven
States reported cases of multidrug-resistant TB in 2006.
Treatment failure with any of these cases could lead to the
development of extensively drug-resistant strains. Multidrug-
resistant TB requires treatment with toxic, expensive, and less
effective drugs and even then, is often fatal. The number of
multidrug-resistant TB cases among the foreign-born population
in the United States has increased significantly since the
early 1990s from approximately 26 percent of multidrug-
resistant cases in 1993 to approximately 76 percent of cases
between 1999 and 2006.
Extensively drug-resistant TB is characterized by very
high, and among immunocompromised persons, very rapid fatality
rates. According to the CDC, about 30 percent of extensively
drug-resistant TB patients can be cured, but more than half
will die within 5 years of diagnosis. Between 1993 and 2006,
there were 49 cases of extensively drug-resistant TB in the
United States.
Third, the global TB epidemic endangers TB control efforts
in the United States. Approximately one-third of the world's
population is infected with latent TB and about 1.6 million
people die of the disease every year. If current trends
continue, by 2020, nearly 1 billion more people will become
infected and 35 million people will die from TB. TB case rates
in the United States reflect the global situation. The
proportion of TB cases in foreign-born people has increased
steadily in the last decade, from 27 percent of all cases in
1992 to 57 percent of all cases in 2006. To eliminate TB from
the United States, targeted efforts are needed to prevent and
treat TB among foreign-born individuals residing in the United
States.
Finally, TB will never be defeated without new and more
effective tools for preventing the disease in people of all
ages. The most commonly used TB diagnostic in the world, sputum
microscopy, is more than 100 years old and lacks sensitivity to
detect TB in most HIV/AIDS patients and in children. The
standard TB skin test, developed over a century ago, needs to
be replaced by promising single-visit blood tests but extensive
field testing will be needed to ensure the proper use and
interpretation of these newer tests. The TB vaccine, Baccillus
Calmette-Guerin (BCG), provides some protection against TB to
infants and children but it has little or no efficacy in
preventing pulmonary TB in adolescents and adults.
Improved testing for drug susceptibility is critical to
combating the spread of drug-resistant TB. Current drug
susceptibility tests take at least 1 month to complete. Faster
drug susceptibility tests must be developed to stop the spread
of drug-resistant TB.
There is an urgent need for new anti-TB drugs, particularly
for a shorter regimen. The current TB drug regimen requires 6
to 9 months of treatment and patients with multidrug-resistant
TB require treatment for 18-24 months, creating difficulties in
completing therapy, further promoting the development of drug-
resistant strains of TB. A shorter drug regimen with new
classes of drugs active against susceptible and drug-resistant
strains would increase compliance and prevent the development
of more extensive drug resistance. There is also a critical
need for drugs that can safely be taken concurrently with
antiretroviral therapy for HIV.
By unanimously supporting this legislation, the committee
recognizes that, given the rising threat of drug-resistant TB
and the expertise of public health officials and promise of new
tools to more effectively fight TB, we now have a historic
opportunity to eradicate TB from the United States. At this
critical time, with the expert recommendations of the IOM in
hand, the committee is committed to effectively targeting and
eliminating TB from our country through renewed and expanded
efforts in research, vaccine development, TB case finding,
prevention, and treatment via directly observed therapy,
education, and international collaboration.
III. Legislative History and Committee Action
S. 1551 was introduced on June 5, 2007 by Senator Sherrod
Brown for himself, Senator Hutchison, Senator Kennedy, Senator
Clinton and Senator Murray. The bill is cosponsored by Senator
Bingaman, Senator Boxer, Senator Cantwell, Senator Feinstein,
Senator Harkin, Senator Landrieu, Senator Menendez, Senator
Murkowski, Senator Sanders, Senator Lautenberg, and Senator
Johnson. S. 1551 was referred to the Committee on Health,
Education, Labor, and Pensions. On November 14, 2007 the Senate
Committee on Health, Education, Labor, and Pensions held an
executive session to consider a substitute for S. 1551 in the
nature of an amendment. S. 1551 was ordered reported favorably
by a unanimous voice vote.
IV. Committee Views
The committee recognizes that tuberculosis (TB), a
preventable and treatable disease that continues to claim
thousands of American lives, can be eliminated from the United
States with the proper level of commitment and resources. The
act also builds on a longstanding recognition by the public
health community that an aggressive, sustained commitment and
new investment into new diagnostic, treatment and prevention
tools are needed to eradicate TB from the United States.
The committee further wishes to clarify its views regarding
the act.
TITLE I--DEPARTMENT OF HEALTH AND HUMAN SERVICES IN COORDINATION WITH
THE CENTERS FOR DISEASE CONTROL AND PREVENTION AND OTHER APPROPRIATE
AGENCIES
The Department of Health and Human Services including the
Centers for Disease Control and Prevention currently supports
research, demonstration projects, education, and training
related to the prevention, control, and elimination of TB. The
scientific community, including Stop TB USA, has estimated that
$528 million is needed annually to implement strategies that
will advance us toward the goal of TB elimination, such as
those outlined in the IOM report. The act increases the
authorization level for grants to $300 million in fiscal year
2008 and such sums as may be necessary for fiscal years 2009
through 2012.
Given the prevalence of TB in certain high risk and often
isolated populations, the committee would emphasize that
special priority be given to research concerning TB in these
populations, including individuals infected with HIV, foreign-
born persons from high incidence countries, minority
populations with high TB rates, homeless persons, intravenous
drug users, and incarcerated persons. The committee also
understands the necessity for developing improved methods of
diagnosing and treating drug-resistant TB and latent TB that
would increase screening and patient compliance with therapy,
when therapy is indicated, and encourages the CDC to award
grants for research in this area.
The act reauthorizes the Department's (including the
Centers for Disease Control and Prevention and the National
Institutes of Health) priority research on TB including
clinical trials to evaluate the safety and effectiveness of new
drugs, diagnostics and vaccines for latent and active TB,
including drug-resistant TB, through the Tuberculosis Trials
Consortium, epidemiological studies through the Tuberculosis
Epidemiologic Studies Consortium and field studies to evaluate
the effectiveness of new drugs, diagnostics, and vaccines and
assess the prevalence of drug-resistant TB.
The act amends current authority to provide four new
examples of demonstration projects that may be funded. The
committee does not intend for funding to be limited to these
specific demonstration projects.
Based on the IOM report, this act recommends evaluating the
possible regionalization of TB elimination activities on a
multistate level in areas of the country with a low incidence
of TB. Projects in these low incidence regions should aim to
maintain access to clinical, epidemiological, and other TB
services in a cost-effective and efficient manner and to ensure
the presence of sufficient public health staff to educate
health care providers and to identify an outbreak or emergency
situation.
In new subsection 317E(b)(2)(B), the committee authorizes
the Secretary, acting through the Director of the Centers for
Disease Control and Prevention, to fund demonstration project
activities to reduce health disparities in the incidence of TB.
The committee understands that disparities among racial and
ethnic minorities, including African-Americans, Hispanic-
Americans, and Asian-Americans, persists and that additional
targeted efforts are needed to eliminate these disparities.
This act recommends the expansion of programs to identify
immigrants with latent and active TB infection and offer
treatment, when indicated. The committee intends to encourage
increased screening and treatment, when appropriate, of
immigrants from countries with a high incidence of TB. These
activities may benefit from collaboration with the Immigration
and Customs Enforcement (ICE) whose expertise in immigration
policy and the feasibility of altering current practices will
be useful in determining the best approach to the high
incidence of TB among immigrants. It should be noted that the
committee does not necessarily endorse mandated latent TB
testing for immigrant visa and permanent residency applicants.
The committee encourages the CDC to work with the ICE to
develop targeted screening programs that are effective in
screening and treating latent TB without endangering the rights
of all immigrants and refugees in the United States.
In new subsection 317E(b)(2)(C), the committee authorizes
the CDC to fund demonstration project activities for the
intensification of efforts to control TB along the United
States-Mexico border and among binational populations,
including expanding the scope and number of programs to detect
and treat binational cases of TB and high risk cases referred
from Mexican health departments.
The committee understands that foreign-born individuals
comprise an increasing proportion of TB cases in the United
States and encourages the funding of immigrant outreach
programs to increase the effectiveness of TB screening and
prevention services among new refugees and immigrants. In King
County, Washington, for example, two-thirds of TB cases occur
among foreign-born individuals. A pilot program in this county
utilizing bilingual-bicultural community members, interviews,
and focus groups in a culturally sensitive manner, achieved a
96 percent completion rate for those being treated for TB, far
exceeding the 70 percent completion rates obtained by other
programs. The success of this pilot demonstrates the
effectiveness of culturally and linguistically sensitive
programs to eliminate TB among high risk foreign born
populations, and is a commendable model for future
demonstration projects and public outreach efforts.
In new subsection 317E(b)(2)(D), the committee authorizes
the CDC to fund demonstration project activities for the
intensification of efforts to prevent, detect, and treat TB
among foreign-born persons who are in the United States.
In new subsection 317E(b)(2)(E), the committee authorizes
the CDC to fund demonstration project activities for the
intensification of efforts to prevent, detect, and treat TB
among high-risk populations and settings documented as having a
high risk for TB.
In new subsection 317E(b)(2)(F), the committee authorizes
the CDC to fund demonstration project activities for TB
detection, control and prevention. This additional
prioritization is granted to facilitate CDC's capacity for
enhanced TB detection, control and prevention in general.
The act reauthorizes CDC's authority to award grants for
education, training, and clinical skills improvement activities
for health professionals. The agency's implementation of these
education and training programs should take into consideration
appropriate recommendations in the Strategic Plan for TB
Training and Education 2004-2008 as a joint project of the
National Tuberculosis Centers and the Centers for Disease
Control and Prevention's Division of TB Elimination (DTBE). The
plan provides a blueprint for creating a strong, coordinated,
and effective system for TB training and education.
In subsection 317E(b)(5), the committee does not intend to
limit support of ``Centers'' to the four Regional Training and
Medical Consultation Centers that are currently in operation in
New York City, San Francisco, CA, and San Antonio, TX, and
Gainesville, FL. Rather, the committee intends that support for
these continue and that the development of additional centers,
particularly in areas of high incidence, commences.
The committee further understands that the elimination of
TB from the United States cannot be achieved without
cooperation between the United States and Mexico and
collaboration with international organizations. In 2006, Mexico
was the country of origin for 25 percent of all foreign-born
persons infected with TB. Of TB cases among Mexican-born
persons living in the United States, three-fourths were
reported by the four States bordering Mexico. The CDC should
support the development of coordinated binational TB control
projects at the national, State, and local levels in
coordination with the United States Agency for International
Development.
In new subsection 317E(b)(7), the committee authorizes the
CDC to fund activities to develop, enhance, and expand TB
control surveillance and database management systems with
cross-jurisdictional capabilities, which shall conform to the
standards and implementation specifications for information
technologies as recommended by the Secretary.
In new subsection 317(E)(d)(3), the committee authorizes
the Secretary to give highest priority to grant applicants that
provide non-Federal funds, which may be provided directly or
through donations from public or private entities and may be
cash or in kind, including equipment or services. Amounts
provided by the government or services assisted or subsidized
to any significant extent by the Federal Government may not be
included in determining the amount of non-Federal
contributions.
Subtitle B--Interagency collaboration
The ACET works closely with the DTBE in developing and
evaluating guidelines for prevention, control, and treatment
and addressing issues related to TB elimination in the United
States.
The committee recognizes the value of ACET's expertise in
advising and evaluating Federal, State, and local efforts to
eliminate TB. With this legislation, the committee authorizes
ACET to create or update a national plan for the elimination of
TB from the United States. In developing this plan, ACET should
carefully evaluate and incorporate, as appropriate, the
recommendations of the Institute of Medicine. The committee
also intends for ACET to continuously modify this plan as new
insights, data, or technology become available.
The committee understands that TB case rates in the United
States are heavily impacted by the global TB burden and that
elimination of TB from the United States is difficult, if not
impossible, without addressing TB control in foreign countries.
ACET should expand its scope of interest and provide
recommendations to guide U.S. involvement in fighting the
global TB epidemic. The World Health Organization (WHO) has
identified a total of 22 high incidence countries that account
for 80 percent of all new cases worldwide. ACET's
recommendations should be concerned with countries where the
high incidence of TB may contribute to TB case rates in the
United States. For instance, Mexico, the Philippines, Vietnam
and India are the countries of origin for over half the
foreign-born residents of the United States infected with TB.
ACET should specify goals and strategies for how the United
States can assist these countries in reducing their TB rates
and focus on implementing proven control measures, such as the
WHO's directly observed treatment, short course strategy
(DOTS).
ACET currently is composed of representatives from diverse
Federal and non-Federal agencies, public health departments,
and local groups that are concerned with TB. The United States-
Mexico Border Health Commission should also be represented on
the Council given the high TB case rates and difficulty
controlling TB in communities near the U.S.-Mexico border. The
expertise of the Health Resources and Services Administration
(HRSA) and the Agency for Healthcare Research and Quality
(AHRQ) should also be included in ACET because of the agencies'
work with professionals in rural areas and on quality of care
respectively. The committee reaffirms a commitment to address
TB prevention, control, and treatment issues in this high-risk
region.
In new subsection 317E(f)(2)(B), the committee authorizes
ACET to provide the Secretary and other appropriate Federal
officials advice on responding rapidly and effectively to
emerging issues in TB.
In new subsection 317E(f)(3)(B), the committee authorizes
ACET to consult with appropriate public and private entities,
subject to the discretion of the Secretary that may include
scientists, physicians, laboratorians, and other health
professionals who represent the disciplines relevant to TB
elimination; members of public-private partnerships established
to address the elimination of TB; members of national and
international nongovernmental organizations established to
address TB elimination; and members of the general public who
are knowledgeable with respect to TB elimination including
individuals who have or have had TB.
In new subsection 317E(f)(4)(A), the committee charges ACET
to submit an annual report to the Secretary on the activities
carried under this section. The annual report will also include
the opinion of the Council on the extent to which its
recommendations regarding the elimination of TB have been
implemented. In new subsection 317E(f)(4)(B), the committee
authorizes the Secretary to make ACET's annual report public.
In new subsection 317E(f)(5)(B), the committee authorizes
the composition of ACET to include State and local TB control
and public health officials; individuals who are scientists,
physicians, laboratorians, and other health professionals who
represent disciplines relevant to TB elimination; members of
national and international nongovernmental organizations
established to address the elimination of TB; and members from
the general public who are knowledgeable with respect to the
elimination of TB, including individuals who have or have had
TB.
In new subsection 317E(b) Rule of Construction Regarding
Current Membership--the amendments made to the act may not be
construed as terminating the membership on ACET of any
individual serving as such a member as of the day before the
date of the enactment of the act.
Subtitle C--New tools for tuberculosis elimination
The act creates a new authorization through the Secretary
of the Department of Health and Human Services to fund grants,
cooperative agreements and contracts for research and
development on drugs, diagnostics, vaccines and public health
interventions for the elimination of TB. The act authorizes
$100 million in fiscal year 2008 and such sums as necessary for
fiscal years 2009 through 2012.
The act will provide a first step in providing the U.S.
contribution toward an urgently needed global reinvestment into
new TB diagnostic, treatment and prevention tools research. The
committee recognizes that the clinical trials and field studies
needed to bring new TB diagnostics, drugs and vaccines into
practice are ongoing through the CDC's DTBE, including the
multisite TB Trials Consortium, the TB Epidemiologic Studies
Consortium; and this research is often derived from research
conducted by the National Institute of Allergy and Infectious
Disease's Division of Microbiology and Infectious Diseases,
Division of AIDS and the Division of Intramural Research. The
committee recommends that these activities be expanded and
intensified and encourages collaboration between the CDC and
the NIH in the area of TB research.
New subsection 317E(g)(1) authorizes the Secretary to
expand, intensify and coordinate research and development and
related activities to develop new TB elimination tools,
including drugs, diagnostics, vaccines and public health
interventions, including methods to enhance detection and
response to outbreaks of drug resistant TB.
New subsection 317E(g)(2) authorizes the Federal TB Task
Force. The Federal TB Task Force works closely with the CDC's
DTBE and the NIH in developing a comprehensive plan for the
creation of new tools for the elimination of tuberculosis,
including drugs, diagnostics, vaccines and public health
interventions. The committee intends for the Task Force to
continuously modify the plan for new TB tools development as
new research or technology become available.
The Task Force currently is composed of representatives
from diverse Federal and non-Federal agencies, public health
departments, and local groups that are concerned with TB
research.
In new subsection 317E(g)(2)(C), the committee authorizes
the Task Force to consult with appropriate public and private
entities that may include scientists, physicians,
laboratorians, and other health professionals who represent the
disciplines relevant to TB research; members of public-private
partnerships engaged in TB research; members of national and
international nongovernmental organizations established to
address TB elimination; members of the general public who are
knowledgeable with respect to TB elimination including
individuals who have or have had TB; and health professionals
from other countries with a substantial incidence of TB, and
who represent the specialties and disciplines relevant to TB
research.
In new subsection 317E(g)(3), the committee authorizes the
Secretary to award grants, cooperative agreements and contracts
to public and private entities for the provision of the
research activities described in section 317E(g)(1).
New subtitle D--Evaluation of public health authorities
In new subsection 131, the committee requests that the
Secretary submit a report to the appropriate congressional
committees that evaluates the effectiveness of Federal and
State public health authorities to address disease containment
challenges and provides recommendations for improvement,
including: an evaluation of the effectiveness of policies to
detain patients with active TB; an evaluation of the need for
Federal laws to be strengthened to address the movement of
infected individuals; and specific legislative recommendations
for Federal law changes. This section also requires the
Secretary to promulgate regulations within 8 months to update
interstate and foreign quarantine regulations
TITLE III--NATIONAL INSTITUTES OF HEALTH
The committee recommends that the National Institutes of
Health expand and intensify its TB research and development
activities including basic and clinical research on TB. Given
the global health emergency of drug-resistant TB and the strong
co-occurrence between TB and HIV, the committee would emphasize
that special priority be given to research concerning drug-
resistant TB and the relationship between TB and HIV.
V. Cost Estimate
U.S. Congress,
Congressional Budget Office,
Washington, DC, April 17, 2008.
Hon. Edward M. Kennedy,
Chairman, Committee on Health, Education, Labor, and Pensions,
U.S. Senate, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 1551, the
Comprehensive Tuberculosis Elimination Act of 2007.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Tim
Gronniger and Sarah Evans.
Sincerely,
Robert A. Sunshine
(For Peter R. Orszag, Director).
Enclosure.
S. 1551--Comprehensive Tuberculosis Elimination Act of 2007
Summary: S. 1551 would amend the Public Health Service Act
to authorize funding for grants to States and local
governments, research on treatment and prevention, and other
activities intended to eliminate tuberculosis in the United
States. CBO estimates that implementing S. 1551 would cost $11
million in 2008 and $2.2 billion over the 2009-2013 period,
assuming appropriation of the authorized amounts.
S. 1551 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA),
and would have no effect on direct spending or revenues of the
Federal Government.
Estimated cost to the Federal Government: The estimated
budgetary impact of S. 1551 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------
2008 2009 2010 2011 2012 2013
----------------------------------------------------------------------------------------------------------------
SPENDING SUBJECT TO APPROPRIATION
Spending Under Current Law:
CDC:
Budget Authority\1\..................................... 140 0 0 0 0 0
Estimated Outlays....................................... 135 86 50 5 1 0
NIH:
Budget Authority\2\..................................... 165 0 0 0 0 0
Estimated Outlays....................................... 159 118 40 15 5 0
Total Spending:
Budget Authority.................................... 305 0 0 0 0 0
Estimated Outlays................................... 294 204 90 20 6 0
Proposed Changes:
CDC:
Estimated Authorization Level........................... 290 440 448 457 468 0
Estimated Outlays....................................... 11 343 460 438 453 288
NIH:
Estimated Authorization Level........................... 0 168 0 0 0 0
Estimated Outlays....................................... 0 44 79 26 10 5
Total Changes:
Estimated Authorization Level....................... 290 608 448 457 468 0
Estimated Outlays................................... 11 387 539 464 463 293
Spending Under S. 1551:
CDC:
Estimated Authorization Level........................... 430 440 448 457 468 0
Estimated Outlays....................................... 146 429 510 443 454 288
NIH:
Estimated Authorization Level........................... 165 168 0 0 0 0
Estimated Outlays....................................... 159 162 119 41 15 5
Total Spending Under S. 1551:
Estimated Authorization Level....................... 595 608 448 457 468 0
Estimated Outlays................................... 305 591 629 484 469 293
----------------------------------------------------------------------------------------------------------------
\1\The 2008 level is the amount appropriated for that year for tuberculosis control activities at CDC.
\2\The 2008 level is the amount appropriated for that year for tuberculosis research at NIH.
Note: CDC = Centers for Disease Control and Prevention, NIH = National Institutes of Health.
Basis of estimate: S. 1551 would modify the Public Health
Service Act to authorize programs to detect, prevent, and treat
tuberculosis. The bill also would authorize research on new
vaccines, treatment interventions, tests, and other tools to
help eliminate tuberculosis in the United States. Those
activities would be administered by the Centers for Disease
Control and Prevention (CDC) and the National Institutes of
Health (NIH). CDC's activities would be authorized for fiscal
years 2008 through 2012, and NIH's activities would be
authorized for fiscal years 2008 and 2009. This estimate
assumes that the authorized amounts would be provided in a
supplemental appropriation for 2008 and near the start of
subsequent fiscal years, and that outlays would follow
historical patterns for similar activities. CBO estimates that
implementing S. 1551 would cost $11 million in 2008 and $2.2
billion over the 2009-2013 period.
CDC's Activities. The bill would authorize CDC to
administer grant programs, research and demonstration programs,
and research activities related to tuberculosis. Based on
information provided by CDC, CBO estimates that the agency will
spend $135 million of its 2008 appropriation for activities
specified by the bill. In total, CBO estimates that the
additional cost for CDC to implement S. 1551 would amount to
$11 million in fiscal year 2008 and $2.0 billion over the 2008-
2013 period.
The bill would authorize the appropriation of $300 million
for 2008 and such sums as may be necessary for the 2009-2012
period to provide grants to States, local governments, and
other public entities for the prevention, control, and
elimination of tuberculosis in the United States. CBO estimates
that implementing that provision would cost $8 million in 2008
and $1.4 billion over the 2008-2013 period, assuming
appropriation of the authorized amounts.
In addition, S. 1551 would authorize the appropriation of
such sums as are necessary for research and demonstration
programs that promote the elimination of tuberculosis in the
United States. CBO estimates that the CDC would require the
appropriation of an additional $7 million for such activities
in 2008 and $134 million over the 2008-2012 period. Assuming
the appropriation of the necessary amounts, CBO estimates that
implementing that provision would cost less than $500,000 in
2008 and $126 million over the 2008-2013 period.
The bill also would authorize appropriation of $100 million
for 2008 and such sums as are necessary for the 2009-2012
period for research on new tools to help eliminate tuberculosis
in the United States. The tools include vaccines, treatment,
interventions, and diagnostic tests. That authorization would
apply only for years in which the appropriated amount for other
activities relating to the elimination of tuberculosis in the
United States exceeds its level in 2007. (For 2008, the amount
appropriated for those activities was $6 million more than the
amount appropriated for 2007.) Assuming that the 2007 level
continues to be surpassed for those other activities, CBO
estimates that implementing that provision would cost $3
million in 2008 and $467 million over the 2009-2013 period.
NIH Activities. NIH estimates that it will spend $159
million on tuberculosis research in fiscal year 2008. S. 1551
would modify Title IV of the Public Health Service Act to
direct the Director of the NIH to conduct research on
tuberculosis, particularly with regard to drug-resistant
tuberculosis and the relationship between tuberculosis and the
human immunodeficiency virus. Activities under title IV are
authorized through fiscal year 2009, so this estimate reflects
an authorization of funding only for that year. Based on
information provided by NIH, CBO expects that implementing S.
1551 would not have a significant effect on tuberculosis-
related research or spending at NIH in fiscal year 2008, and
would cost $164 million over the 2009-2013 period.
Intergovernmental and private-sector impact: S. 1551
contains no intergovernmental or private-sector mandates as
defined in the UMRA.
Estimate prepared by: Federal Costs: Sarah Evans, Tim
Gronniger; Impact on State, Local, and Tribal Governments: Lisa
Ramirez-Branum; Impact on the Private Sector: Patrick
Bernhardt.
Estimate approved by: Keith J. Fontenot, Deputy Assistant
Director for Health and Human Resources, Budget Analysis
Division.
VI. Regulatory Impact Statement
The committee has determined that there is no legislative
impact.
VII. Application of Law to the Legislative Branch
The committee has determined that there will be minimal
increases in the regulatory burden imposed by this bill.
VIII. Section-by-Section Analysis
Note on References: Except as otherwise specified, as used
in the summary--
``The Act'' means the Public Health Service Act
(PHSA), and references to provisions of law are
provisions of the PHSA;
``CDC'' means the Centers for Disease Control and
Prevention;
``ACET'' means the Advisory Council for the
Elimination of Tuberculosis;
``Task Force'' means the Federal Tuberculosis Task
Force;
``Secretary'' means the Secretary of Health and Human
Services.
Section 1. Short title
This legislation is titled the ``Comprehensive Tuberculosis
Elimination Act of 2007.''
TITLE I--DEPARTMENT OF HEALTH AND HUMAN SERVICES IN COORDINATION WITH
THE CENTERS FOR DISEASE CONTROL AND PREVENTION AND OTHER
APPROPRIATE AGENCIES
Subtitle A--Section 101, National Strategy for Combating and
Eliminating Tuberculosis, amends Section 317E of the PHSA
The heading for the section is changed to the ``National
Strategy for Combating and Eliminating Tuberculosis.''
Section 317E(b)(2) is amended to refocus the activities of
regional capabilities on the prevention of multidrug-resistant
and extensively drug-resistant strains of TB in addition to the
prevention, control and elimination of TB.
Section 317E(b)(2)(B) is added to provide an example of a
demonstration project that would be appropriate for the CDC to
conduct under this section to reduce health disparities in the
incidence of TB.
Section 317E(b)(2)(C) is added to provide an example of a
demonstration project that would be appropriate for the CDC to
conduct under this section. It calls for the intensification of
efforts to control TB along the United States-Mexico border and
among binational populations, including expanding the scope and
number of programs to detect and treat binational cases of TB
and high risk cases referred from Mexican health departments.
Section 317E(b)(2)(D) is added to provide an example of a
demonstration project that would be appropriate for the CDC to
conduct under this section to intensify efforts to prevent,
detect, and treat TB among foreign-born persons who are in the
United States.
Section 317E(b)(2)(E) is added to provide an example of a
demonstration project that would be appropriate for the CDC to
conduct under this section to intensify efforts to prevent,
detect, and treat TB among high-risk populations and settings
documented as having a high risk for TB.
Section 317E(b)(2)(F) is added to clarify that TB
detection, control and prevention activities are appropriate
demonstration project activities.
Section 317E(b)(7) is added to clarify that support should
be provided for the development, enhancement and expansion of
TB control surveillance and database management systems with
cross-jurisdictional capabilities, and to clarify that such
systems should conform to the standards and implementation
specifications for information technologies as recommended by
the Secretary.
Section 317E(3)(A)(B) is amended such to allow priority to
be given grant applicants that contribute non-Federal
contributions to carry out activities under this section, which
may be provided directly or through donations from public or
private entities and may be in cash or in kind, including
equipment or services.
Section 317E(3)(A)(B), is added to allow grant applicants
to provide non-Federal funds, which may be provided directly or
through donations from public or private entities and may be
cash or in kind, including equipment or services. (B) is added
to clarify that amounts or services assisted or subsidized to
any significant extent by the Federal Government may not be
included in determining the amount of non-Federal
contributions.
Subtitle B--Interagency Collaboration
Section 111--Advisory Council for the Elimination of
Tuberculosis
Section 317E(f)(2)(B) is amended to direct ACET to provide
the Secretary and other appropriate Federal officials advice on
responding rapidly and effectively to emerging issues in TB.
Section 317E(f)(3)(B) is amended to direct ACET to consult
with appropriate public and private entities, subject to the
discretion of the Secretary, that may include: scientists,
physicians, laboratorians, and other health professionals who
represent the disciplines relevant to TB elimination; members
of public-private partnerships established to address the
elimination of TB; members of national and international
nongovernmental organizations established to address TB
elimination; and members of the general public who are
knowledgeable with respect to TB elimination including
individuals who have or have had TB.
Section 317E(f)(4)(A), is amended to require ACET to submit
a bienniel report to the Secretary on the activities carried
under this section. The report will also include the opinion of
the Council on the extent to which its recommendations
regarding the elimination of TB have been implemented.
Section 317E(f)(4)(B) is amended to require the Secretary
to make ACET's annual report public.
Section 317E(f)(5)(B) is revised to specify that ACET shall
include in its composition State and local TB control and
public health officials; individuals who are scientists,
physicians, laboratorians, and other health professionals who
represent disciplines relevant to TB elimination; members of
national and international nongovernmental organizations
established to address the elimination of TB; and members from
the general public who are knowledgeable with respect to the
elimination of TB, including individuals who have or have had
TB.
Section 317E(b) is added to specify that the amendments to
this section should not be construed as terminating the
membership on ACET of any individual serving as such a member
as of the day before the date of the enactment of the act.
New Subtitle C--New tools for tuberculosis elimination
Section 317E(g)(1) authorizes the Secretary to expand,
intensify and coordinate research and development and related
activities to develop new TB elimination tools including drugs,
diagnostics, vaccines and public health interventions, as well
as methods to enhance detection and response to outbreaks of
drug resistant TB.
Section 317E(g)(2) establishes a Federal TB Task Force to
advise the Secretary and other Federal officials on the
development of new TB elimination tools including drugs,
diagnostics, vaccines and public health interventions.
Section 317E(g)(B) is added to direct the Task Force to
make recommendations on the development of a comprehensive plan
for the elimination of TB. Section 317E(g)(2)(C) is added to
direct the Task Force to consult with appropriate public and
private entities that may include: scientists, physicians,
laboratorians, and other health professionals who represent the
disciplines relevant to TB research; members of public-private
partnerships engaged in TB research; members of national and
international nongovernmental organizations established to
address TB elimination; members of the general public who are
knowledgeable with respect to TB elimination including
individuals who have or have had TB; and health professionals
from other countries with a substantial incidence of TB, and
who represent the specialties and disciplines relevant to TB
research.
Section 317E(g)(3) is added to authorize the Secretary to
award grants, cooperative agreements, and contracts to public
and private entities for the provision of the research
activities described in section 317E(g)(1).
New Subtitle D--Evaluation of public health authorities
Section 131 is added to direct the Secretary to submit a
report to the appropriate congressional committees that
evaluates the effectiveness of Federal and State public health
authorities to address disease containment challenges and
provides recommendations for improvement, including an
evaluation of the effectiveness of policies to detain patients
with active TB; an evaluation of the need for Federal laws to
be strengthened to address the movement of infected
individuals; and specific legislative recommendations for
Federal law changes. This section also requires the Secretary
to promulgate regulations within 8 months to update interstate
and foreign quarantine regulations.
Subtitle E--Authorization of appropriations
Section 317E(h)(1)(A) authorizes $300 million in fiscal
year 2008 and such sums as may be necessary for fiscal years
2009 through 2012 for a National Strategy for Combating and
Eliminating Tuberculosis under Title I.
Section 317E(h)(1)(B) is added to direct the Secretary to
reserve no more than 25 percent of funds for emergency grants
for geographic areas, States, political subdivisions of States
or other public entities under the National Strategy for
Combating and Eliminating Tuberculosis under Title 1.
Section 317E(h)(1)(C) is added to authorize such sums as
necessary for fiscal years 2008 through 2012 for research,
education and training activities under the National Strategy
for Combating and Eliminating Tuberculosis under Title I.
Section 317E(h)(1)(D) is added to direct the Secretary to
distribute grants under section 317E(h)(1)(B) on the basis of a
formula that takes into account the level of TB morbidity and
case complexity in respective geographic areas and
consideration of other factors. This section also clarifies
that the Secretary may use the existing formula from fiscal
year 2007.
Section 317E(h)(2) authorizes $100 million for fiscal year
2008 and such sums as necessary for fiscal years 2009 through
2012 for new tools for tuberculosis elimination, section
317E(g).
TITLE III--NATIONAL INSTITUTES OF HEALTH
Section 201 amends subpart 2 of part C of title IV of the
PHSA by adding section 424C after section 424B.
Section 424C authorizes the Director of the National
Institute of Health to expand and intensify its TB research and
development activities, including basic and clinical research
on TB. Given the global health emergency of drug-resistant TB
and the strong co-occurrence between TB and HIV, the committee
would emphasize that special priority be given to research
concerning drug-resistant TB and the relationship between TB
and HIV.
IX. Changes in Existing Law
In compliance with rule XXVI paragraph 12 of the Standing
Rules of the Senate, the following provides a print of the
statute or the part or section thereof to be amended or
replaced (existing law proposed to be omitted is enclosed in
black brackets, new matter is printed in italic, existing law
in which no change is proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
[PREVENTIVE HEALTH SERVICES REGARDING TUBERCULOSIS] NATIONAL STRATEGY
FOR COMBATING AND ELIMINATING TUBERCULOSIS
Sec. 317E. [247b-6] (a) In General.--* * *
* * * * * * *
[(b) Research, Demonstration Projects, Education, and
Training.--With respect to the prevention, control, and
elimination of tuberculosis, the Secretary may, directly or
through grants to public or nonprofit private entities, carry
out the following:
[(1) Research, with priority given to research
concerning strains of tuberculosis resistant to drugs
and research concerning cases of tuberculosis that
affect certain populations.
[(2) Demonstration projects.
[(3) Public information and education programs.
[(4) Education, training, and clinical skills
improvement activities for health professionals,
including allied health personnel and emergency
response employees.
[(5) Support of centers to carry out activities under
paragraphs (1) through (4).
[(6) Collaboration with international organizations
and foreign countries in carrying out such activities.]
(b) Research and Development; Demonstration Projects;
Education and Training.--With respect to the prevention,
treatment, control, and elimination of tuberculosis, the
Secretary may, directly or through grants to public or
nonprofit private entities, carry out the following:
(1) Research, with priority given to research and
development concerning latent tuberculosis infection,
strains of tuberculosis resistant to drugs, and
research concerning cases of tuberculosis that affect
certain populations at risk for tuberculosis.
(2) Demonstration projects for--
(A) the development of regional capabilities
to prevent, control and eliminate tuberculosis
and prevent multidrug resistant and extensively
drug resistant strains of tuberculosis;
(B) the intensification of efforts to reduce
health disparities in the incidence of
tuberculosis;
(C) the intensification of efforts to control
tuberculosis along the United States-Mexico
border and among United States-Mexico
binational populations, including through
expansion of the scope and number of programs
that--
(i) detect and treat binational cases
of tuberculosis; and
(ii) treat high-risk cases of
tuberculosis referred from Mexican
health departments;
(D) the intensification of efforts to
prevent, detect, and treat tuberculosis among
foreign-born persons who are in the United
States;
(E) the intensification of efforts to
prevent, detect, and treat tuberculosis among
populations and settings documented as having a
high risk for tuberculosis; and
(F) tuberculosis detection, control, and
prevention.
(3) Public information and education activities.
(4) Education, training, clinical skills improvement
activities, and workplace exposure prevention for
health professionals, including allied health personnel
and emergency response employees.
(5) Support of Centers to carry out activities under
paragraphs (1) through (4).
(6) Collaboration with international organizations
and foreign countries in carrying out such activities.
(7) Develop, enhance, and expand information
technologies that support tuberculosis control
including surveillance and database management systems
with cross-jurisdictional capabilities, which shall
conform to the standards and implementation
specifications for such information technologies as
recommended by the Secretary.
* * * * * * *
(d) Application for Grant.--
(1) In general.--* * *
* * * * * * *
(3) Determination of amount of non-federal
contributions.--
(A) Priority.--In awarding grants under
subsection (a) or (b), the Secretary shall give
highest priority to an applicant that provides
assurances that the applicant will contribute
non-Federal funds to carry out activities under
this section, which may be provided directly or
through donations from public or private
entities and may be in cash or in kind,
including equipment or services.
(B) Federal amounts not to be included as
contributions.--Amounts provided by the Federal
Government, or services assisted or subsidized
to any significant extent by the Federal
Government, may not be included in determining
the amount of non-Federal contributions as
described in subparagraph (A).
* * * * * * *
(f) Advisory Council.--
(1) In general.--* * *
* * * * * * *
[(2) General duties.--The Council shall provide
advice and recommendations regarding the elimination of
tuberculosis to the Secretary, the Assistant Secretary
for Health, and the Director of the Centers for Disease
Control and Prevention.
[(3) Certain activities.--With respect to the
elimination of tuberculosis, the Council shall--
[(A) in making recommendations under
paragraph (2), make recommendations regarding
policies, strategies, objectives, and
priorities;
[(B) address the development and application
of new technologies; and
[(C) review the extent to which progress has
been made toward eliminating tuberculosis.
[(4) Composition.--The Secretary shall determine the
size and composition of the Council, and the frequency
and scope of official meetings of the Council.]
(2) Duties.--The Council shall provide advice and
recommendations regarding the elimination of
tuberculosis to the Secretary. In addition, the Council
shall, with respect to eliminating such disease,
provide to the Secretary and other appropriate Federal
officials advice on--
(A) coordinating the activities of the
Department of Health and Human Services and
other Federal agencies that relate to the
disease, including activities under subsection
(b);
(B) responding rapidly and effectively to
emerging issues in tuberculosis; and
(C) efficiently utilizing the Federal
resources involved.
(3) Comprehensive plan.--
(A) In general.--In carrying out paragraph
(2), the Council shall make or update
recommendations on the development, revision,
and implementation of a comprehensive plan to
eliminate tuberculosis in the United States.
(B) Consultation.--In carrying out
subparagraph (A), the Council may consult with
appropriate public and private entities, which
may, subject to the direction or discretion of
the Secretary, include--
(i) individuals who are scientists,
physicians, laboratorians, and other
health professionals, who are not
officers or employees of the Federal
Government and who represent the
disciplines relevant to tuberculosis
elimination;
(ii) members of public-private
partnerships or private entities
established to address the elimination
of tuberculosis;
(iii) members of national and
international nongovernmental
organizations whose purpose is to
eliminate tuberculosis; and
(iv) members from the general public
who are knowledgeable with respect to
tuberculosis elimination including
individuals who have or have had
tuberculosis.
(C) Certain components of plan.--In carrying
out subparagraph (A), the Council shall,
subject to the direction or discretion of the
Secretary--
(i) consider recommendations for the
involvement of the United States in
continuing global and cross-border
tuberculosis control activities in
countries where a high incidence of
tuberculosis directly affects the
United States; and
(ii) review the extent to which
progress has been made toward
eliminating tuberculosis.
(4) Biennial report.--
(A) In general.--The Council shall submit a
biennial report to the Secretary, as determined
necessary by the Secretary, on the activities
carried under this section, other than
subsection (g). Each such report shall include
the opinion of the Council on the extent to
which its recommendations regarding the
elimination of tuberculosis have been
implemented, including with respect to--
(i) activities under subsection (b);
and
(ii) the national plan referred to in
paragraph (3).
(B) Public.--The Secretary shall make a
report submitted under subparagraph (A) public.
(5) Composition.--The Council shall be composed of--
(A) ex officio representatives from the
Centers for Disease Control and Prevention, the
National Institutes of Health, the United
States Agency for International Development,
the Agency for Healthcare Research and Quality,
the Health Resources and Services
Administration, the United States-Mexico Border
Health Commission, and other Federal
departments and agencies that carry out
significant activities related to tuberculosis;
(B) State and local tuberculosis control and
public health officials;
(C) individuals who are scientists,
physicians, laboratorians, and other health
professionals who represent disciplines
relevant to tuberculosis elimination; and
(D) members of national and international
nongovernmental organizations established to
address the elimination of tuberculosis.
[(5)] (6) Staff, information, and other assistance.--
* * *
* * * * * * *
(g) New Tools for Elimination of Tuberculosis.--
(1) Research and development on drugs, diagnostics,
vaccines, and public health interventions.--The
Secretary may expand, intensify, and coordinate
research and development and related activities to
develop new tools for the elimination of tuberculosis,
including drugs, diagnostics, vaccines, and public
health interventions, such, as directly observed
therapy and non-pharmaceutical intervention, and
methods to enhance detection and response to outbreaks
of tuberculosis, including multidrug resistant
tuberculosis. The Secretary shall give priority to
programmatically relevant research so that new tools
can be utilized in public health practice.
(2) Federal tuberculosis task force.--
(A) Duties.--The Federal Tuberculosis Task
Force (in this subsection referred to as the
Task Force) shall provide to the Secretary and
other appropriate Federal officials advice on
the implementation of paragraph (1), including
advice regarding the efficient utilization of
the Federal resources involved.
(B) Comprehensive plan for new tools
development.--In carrying out paragraph (1),
the Task Force shall make recommendations on
the development of a comprehensive plan for the
creation of new tools for the elimination of
tuberculosis, including drugs, diagnostics, and
vaccines.
(C) Consultation.--In developing the
comprehensive plan under paragraph (1), the
Task Force shall consult with external parties
including representatives from groups such as--
(i) scientists, physicians,
laboratorians, and other health
professionals who represent the
specialties and disciplines relevant to
the research under consideration;
(ii) members from public-private
partnerships, private entities, or
foundations (or both) engaged in
activities relevant to research under
consideration;
(iii) members of national and
international nongovernmental
organizations established to address
tuberculosis elimination;
(iv) members from the general public
who are knowledgeable with respect to
tuberculosis including individuals who
have or have had tuberculosis; and
(v) scientists, physicians,
laboratorians, and other health
professionals who reside in a foreign
country with a substantial incidence or
prevalence of tuberculosis, and who
represent the specialties and
disciplines relevant to the research
under consideration.
(3) Grants and contracts.--The Secretary may carry
out paragraph (1) directly and through awards of
grants, cooperative agreements, and contracts to public
and private entities, including--
(A) public-private partnerships;
(B) academic institutions, including
institutions of higher education;
(C) research institutions; and
(D) nonprofit entities established and
dedicated to tuberculosis vaccine and treatment
product development.
* * * * * * *
[(g) Funding.--
[(1) In general; allocation for emergency grants.--
[(A) For the purpose of making grants under
subsection (a), there are authorized to be
appropriated $200,000,000 for fiscal year 1994,
and such sums as may be necessary for each of
the fiscal years 1995 through 2002.
[(B) Of the amounts appropriated under
subparagraph (A) for a fiscal year, the
Secretary may reserve not more than 25 percent
for emergency grants under subsection (a) for
any geographic area in which there is, relative
to other areas, a substantial number of cases
of tuberculosis or a substantial rate of
increase in such cases.
[(2) Research, demonstration projects, education, and
training.--For the purpose of carrying out subsection
(b), there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 1994
through 2002.]
(h) Authorization of Appropriations.--
(1) General program.--
(A) In general.--For the purpose of carrying
out this section, other than subsections (b)
and (g), there are authorized to be
appropriated $300,000,000 for fiscal year 2008,
and such sums as may be necessary for each of
the fiscal years 2009 through 2012.
(B) Reservation for emergency grants.--Of the
amounts appropriated under subparagraph (A) for
a fiscal year, the Secretary may reserve not
More than 25 percent for emergency grants under
subsection (a) for any geographic area, State,
political subdivision of a State, or other
public entity in which there is, relative to
other areas, a substantial number of cases of
tuberculosis, multidrug resistant tuberculosis,
or extensively drug resistant tuberculosis or a
substantial rate of increase in such cases.
(C) Research, demonstration projects,
education, and training.--For the purpose of
carrying out subsection (b), there are
authorized to be appropriated such sums as may
be necessary for each of fiscal years 2008
through 2012.
(D) Priority.--In allocating amounts
appropriated under subparagraph (A) and not
reserved under subparagraph (B), the Secretary
shall give priority to allocating such amounts
for grants under subsection (a).
(E) Allocation of funds.--
(i) Requirement of formula.--Of the
amounts appropriated under subparagraph
(A), not reserved under subparagraph
(B), and allocated by the Secretary for
grants under subsection (a), the
Secretary shall distribute a portion of
such amounts to grantees under
subsection (a) on the basis of a
formula.
(ii) Relevant factors.--The formula
developed by the Secretary under clause
(i) shall take into account the level
of tuberculosis morbidity and case
complexity in the respective geographic
area and may consider other factors
relevant to tuberculosis in such area.
(iii) No change to formula
required.--This subparagraph does not
require the Secretary to modify the
formula that was used by the Secretary
to distribute funds to grantees under
subsection (a) for fiscal year 2007.
(2) New tools.--
(A) In general.--For the purpose of carrying
out subsection (g), there are authorized to be
appropriated $100,000,000 for fiscal year 2008,
and such sums as may be necessary for each of
the fiscal years 2009 through 2012.
(B) Limitation.--The authorization of
appropriations established in subparagraph (A)
for a fiscal year is effective only if the
amount appropriated under paragraph (1) for
such year equals or exceeds the amount
appropriated to carry out this section for
fiscal year 2007.
* * * * * * *
TITLE IV--NATIONAL RESEARCH INSTITUTES
Part A--National Institutes of Health
* * * * * * *
Part C--Specific Provisions Respecting National Research Institutes
Subpart 1--National Cancer Institute
* * * * * * *
Subpart 2--National Heart, Lung, and Blood Institute
PURPOSE OF THE INSTITUTE
Sec. 418. [285b] * * *
* * * * * * *
COORDINATION OF FEDERAL ASTHMA ACTIVITIES
Sec. 424B. [285b-7b] (a) In General.--* * *
* * * * * * *
SEC. 424C. TUBERCULOSIS.
(a) In General.--The Director of the National Institutes of
Health may expand, intensify, and coordinate research and
development and related activities of the Institute with
respect to tuberculosis including activities toward the goal of
eliminating such disease.
(b) Certain Activities.--Activities under subsection (a)
may include--
(1) enhancing basic and clinical research on
tuberculosis, including drug resistant tuberculosis;
and
(2) expanding research on the relationship between
such disease and the human immunodeficiency virus.
* * * * * * *