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                                                       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

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  Part C--Specific Provisions Respecting National Research Institutes


Subpart 1--National Cancer Institute

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          Subpart 2--National Heart, Lung, and Blood Institute


                        PURPOSE OF THE INSTITUTE

    Sec. 418. [285b] * * *

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               COORDINATION OF FEDERAL ASTHMA ACTIVITIES

    Sec. 424B. [285b-7b] (a) In General.--* * *

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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.

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