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                                                       Calendar No. 526

107th Congress                                                   Report
                                 SENATE
 2d Session                                                     107-227

======================================================================



 
           COMPREHENSIVE TUBERCULOSIS ELIMINATION ACT OF 2001

                                _______
                                

                 July 26, 2002.--Ordered to be printed

                                _______
                                

   Mr. Kennedy, from the Committee on Health, Education, Labor, and 
                   Pensions, submitted the following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                         [To accompany S. 1115]

    The Committee on Health, Education, Labor, and Pensions, to 
which was referred the bill (S. 1115) 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..............................................2
 II. Background and Need for Legislation..............................3
III. Legislative History and Committee Action.........................5
 IV. Committee Views..................................................5
  V. Cost Estimate....................................................9
 VI. Application of Law to the Legislative Branch....................11
VII. Regulatory Impact Statement.....................................11
VIII.Section-by-Section Analysis.....................................11

 IX. Additional Views................................................15
  X. Changes in Existing Law.........................................16

                         I. Purpose and Summary

    The Comprehensive Tuberculosis Elimination Act of 2001 
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, clinical training, 
and vaccine-related research through the NIH. The act includes 
the following provisions:
    1. The legislation mandates the creation of a national 
plan.
    The Advisory Council for the Elimination of Tuberculosis 
(ACET) will develop a national plan 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 council on U.S. involvement in global TB-control 
activities.
    2. 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; and clinical trials. 
Additionally, the CDC will conduct demonstration projects; 
education and training of health care professionals; and public 
education projects. These grants are authorized at $235 million 
in fiscal year 2003 and such sums as may be necessary in fiscal 
years 2004 through 2007.
    3. The act calls for increased basic and clinical research 
regarding TB, its diagnosis and its treatment.
    The activities of the National Heart, Lung, and Blood 
Institute at NIH are reauthorized with an enhanced emphasis on 
basic and clinical research into TB as well as its relationship 
to the human immunodeficiency virus (HIV). The Institute will 
grant TB Academic Awards in order to enable institutions to 
improve the clinical training of health care professionals in 
the prevention and management of tuberculosis. The Institute 
will grant TB/Pulmonary Infection Awards to support basic 
research into the biological processes involved in TB, as well 
as new diagnostic techniques and treatments.
    4. The act calls for renewed focus on the development of a 
safe and effective TB vaccine.
    The National Institute of Allergy and Infectious Diseases 
(NIAID) at NIH, under section 447, will pursue development of a 
vaccine to be used in the efforts to eliminate TB. In the 
process of establishing a vaccine development strategy, NIAID 
shall take into consideration the Blueprint for Tuberculosis 
Vaccine Development, published by NIH in 1998. These efforts 
are authorized at $136 million in FY 2003, $162 million in FY 
2004, and such sums as may be necessary in fiscal years 2004 
through 2007.
    5. The legislation highlights the role of the Fogarty 
Center in global TB control efforts.
    The John E. Fogarty International Center for Advanced Study 
in the Health Sciences (Fogarty Center) at NIH promotes 
international cooperation and collaboration in the life 
sciences. In such a capacity, the Fogarty Center has a crucial 
role in expanding and intensifying global TB activities. This 
legislation clarifies the function that the Fogarty Center 
serves in providing international training programs and support 
for clinical, operational, and health services research.

                II. Background and Need for Legislation

    Tuberculosis (TB) is a preventable and treatable disease 
that continues to infect thousands of Americans each year. 
After years of fighting TB, the Institute of Medicine (IOM) has 
determined that the incidence of TB has declined to the point 
where it is feasible to mobilize the expertise and the 
resources of the Federal, State, and local government and the 
public health community to fully eradicate the disease from the 
United States.
    TB has been a public health threat in the United States for 
centuries. In the nineteenth century, the rise in European 
immigration to American cities led to overcrowded living 
conditions and unhealthy workplaces. TB became one of the 
leading causes of death in America. Early in the twentieth 
century, however, TB rates began to decline as social and 
economic conditions and our scientific knowledge of infectious 
diseases improved. Under these conditions, experts gradually 
began to consider the possibility of eliminating TB from the 
United States. In the 1950's, the first effective 
antimicrobials to treat TB were introduced, followed by the 
closing of many TB hospitals and sanatoriums in the 1960s. The 
elimination of TB appeared to be close at hand.
    Unfortunately, our country failed to seize upon the 
opportunity to mount an aggressive campaign to eliminate the 
disease. Instead, the declining incidence of TB resulted in 
complacency and neglect. Federal categorical funding for TB 
control and prevention was discontinued from 1972 to 1981, and 
control efforts broke down in many parts of the country.
    What resulted in the late 1980's, 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. The Task Force estimated that a Federal TB 
budget of $610 million, with $484 million allocated to CDC, was 
needed to adequately fight TB. Federal funding increased, but 
not to the level that was required. The public health community 
successfully mobilized to control the resurgence and in 1999, 
ACET reassessed its plans in light of the changed nature of the 
disease and the public health environment in the U.S. and 
issued a new report entitled, TB Elimination Revisited: 
Obstacles, Opportunities, and a Renewed Commitment.
    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 U.S. 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.
    Today, the United States faces three significant challenges 
to the elimination of TB. First, 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 100 million people have active cases. If 
current trends continue, by 2020, nearly onebillion 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 50 percent of all cases 
in 2001. To eliminate TB from the United States, targeted efforts are 
needed to prevent and treat TB among foreign-born individuals resident 
in the United States.
    Second, the emergence of multidrug-resistant strains of TB 
poses a major challenge to current methods of treating TB. 
Cases involving variants of TB that are resistant to all major 
anti-TB drugs have been documented in 45 States and the 
District of Columbia. Multidrug-resistant strains often result 
from inconsistent or partial treatment-patients who do not take 
their required drugs or health care workers who prescribe 
ineffective treatments. Multidrug-resistant TB requires 
treatment with toxic, expensive, and less effective drugs and 
even then, is often fatal.
    Finally, TB has retreated into high-risk populations and 
isolated communities across the United States. These 
populations include those co-infected with the human 
immunodeficiency virus (HIV), minorities, inmates and staff of 
correctional facilities, and those born in foreign countries, 
as previously discussed. For instance, in 2000, TB was eight 
times as prevalent among African Americans compared to 
Caucasians. Greater staffing, outreach, education, and follow-
up are urgently needed in order to effectively prevent and 
treat TB in these populations.
    By unanimously supporting this legislation, the committee 
shares a determination with the public health community to 
prevent the mistakes of the past from recurring. The committee 
believes that now, given the low incidence of TB and the 
expertise and awareness of public health officials, we 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 tuberculosis 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. 1115 was introduced on June 27, 2001 by Senator Edward 
M. Kennedy for himself, Senator Stevens, Senator Inouye, and 
Senator Hutchison. The bill is cosponsored by Senator Bingaman, 
Senator Corzine, Senator Murray, and Senator Torricelli. S. 
1115 was referred to the Committee on Health, Education, Labor, 
and Pensions. On June 19, 2002, the Senate Committee on Health, 
Education, Labor, and Pensions held an executive session to 
consider a substitute for S. 1115 in the nature of an 
amendment. S. 1115 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 is 
needed to eradicate TB from the U.S.
    The committee further wishes to clarify its views regarding 
the act.

                  TITLE I--PREVENTIVE HEALTH SERVICES

    The ACET works closely with the Centers for Disease Control 
and Prevention Division of TB Elimination (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 23 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 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 withTB. The U.S.-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.

          TITLE II--CENTERS FOR DISEASE CONTROL AND PREVENTION

    The CDC is currently authorized $200 million for fiscal 
year 2002 to support research, demonstration projects, 
education, and training related to the prevention, control, and 
elimination of TB. The scientific community, including the 
National Coalition for the Elimination of Tuberculosis, has 
estimated that $528 million will be needed annually to 
implement strategies that will advance us toward the goal of TB 
elimination, such as those outlined in the IOM report. The 
committee intends that the CDC reach the goal of $528 million 
annually for TB elimination as quickly as possible, but 
recognizes the value of an incremental expansion of TB 
prevention and control efforts. Thus, the Act increases CDC's 
authorization for grants to $235 million in FY 2003 and such 
sums as may be necessary for fiscal years 2004 through 2007.
    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 by the HIV/AIDS, 
foreign-born persons from high incidence countries, minority 
populations with high TB rates compared to the general 
population, intravenous drug users, and incarcerated persons. 
The committee also understands the necessity for developing 
improved methods of diagnosing and treating 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 amends current authority to provide two examples of 
demonstration projects that may be funded through the CDC. 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 
multi-state 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 education 
health care providers and to identify an outbreak or emergency 
situation.
    This act also recommends investigation into the 
applicability of programs to identify immigrants with latent 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 
INS 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 INS 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.
    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)(1) the committee authorizes the 
CDC to prioritize funding for research concerning the diagnosis 
and treatment of latent TB infection, TB associated with the 
human immunodeficiency virus (HIV), and for clinical trials, 
especially those conducted through the Tuberculosis Trials 
Consortium; and, to prioritize funding for research concerning 
TB epidemiology, behavioral science, infection control, and 
field testing of laboratory methods, including those studies 
conducted through the Tuberculosis Epidemiologic Studies 
Consortium.
    In new subsection 317E(b)(4), the committee authorizes the 
CDC 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 released in January 1999 as a joint project of the 
National Tuberculosis Centers and DTBE. The plan provides a 
blueprint for creating a strong, coordinated, and effective 
system for TB training and education.
    In new subsection 317E(b)(5), the committee does not want 
to limit support of ``model centers'' to the three Model 
Tuberculosis Centers that are currently in operation in New 
York City, Newark, NJ, and San Francisco, CA. Rather, the 
committee intends that support for these continue and that the 
development of additional centers, particularly in areas of 
high incidence, commences.
    Section 317E(b)(6) is amended to specify that to properly 
address TB elimination in the United States, the CDC, in 
coordination with USAID, should support collaboration with 
international organizations and foreign countries, including 
Mexico, the Philippines, Vietnam, other WHO-designated high TB 
burden countries; countries with high burden multidrug 
resistant TB; and countries with high rates of HIV.
    The committee further understands that the elimination of 
TB from the United States cannot be achieved without 
cooperation between the U.S. and Mexico. In 1999, Mexico was 
the country of origin for 23 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. Programs should aim to reduce the racial and 
ethnic disparities of TB by preventing, diagnosing, and 
treating infected persons along both sides of the U.S.-Mexico 
border.
    On a biennial basis, the committee requests that the 
Secretary report to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives on activities 
regarding the act. Within that report, the Secretary will 
evaluate the effectiveness of the programs, areas for 
improvement and plans for appropriate changes, and the extent 
to which the recommendations of both the IOM and ACET have been 
addressed.

                TITLE III--NATIONAL INSTITUTES OF HEALTH

    The act authorizes the Tuberculosis Academic Awards 
currently administered through the National Heart, Lung, and 
Blood Institute (NHLBI) at the National Institutes of Health.
    The act also authorizes Tuberculosis/Pulmonary Infection 
Awards to fund basic science and clinical research through the 
NHLBI on the processes of active and latent TB infection as 
they occur in the lung and other organ systems. The awards may 
also support research into the development of more efficient 
and effective treatments and diagnostic techniques.
    The committee intends for the National Institute of Allergy 
and Infectious Diseases to intensify its TB research efforts 
and to focus on the development of a safe and effective TB 
vaccine. The scientific community has estimated, based on the 
development process outlined in the Blueprint for TB Vaccine 
Development, that $240 million annually will be required to 
develop an effective TB vaccine. The Act authorizes $136 
million for FY 2003, $162 million for FY 2004, and such sums 
for fiscal years 2005 through 2007, with the goal of reaching 
$240 million and developing a TB vaccine as quickly as 
possible.
    The NIAID should carefully consider the recommendations 
contained in the Blueprint for TB Vaccine Development, but not 
to the exclusion of evolving scientific discoveries that may 
enhance progress toward a TB vaccine, or of subsequent, 
similarly comprehensive planning by the NIAID and relevant 
stakeholders to achieve this important public health goal.
    The John E. Fogarty Center has specialized expertise in the 
development and implementation of international training and 
research programs. The committee requests that they incorporate 
TB programs into their activities, as appropriate, in order to 
enhance and support global TB initiatives carried out by the 
United States Government.

                            V. Cost Estimate

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, July 23, 2002.
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. 1115, the 
Comprehensive Tuberculosis Elimination Act of 2002.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Jeanne De 
Sa, Hallie Torrell, and Christopher Topoleski.
            Sincerely,
                                        Steven M. Lieberman
                                    (For Dan L. Crippen, Director).
    Enclosure.

S. 1115--Comprehensive Tuberculosis Elimination Act of 2002

    Summary: S. 1115 would amend the Public Health Service Act 
to increase the Department of Health and Human Services' 
responsibilities in the area of tuberculosis elimination. The 
bill would broaden the role of the department's Advisory 
Council for the Elimination of Tuberculosis. The bill also 
would expand the role at the Centers for Disease Control and 
Prevention (CDC) in the implementation of a national plan to 
eliminate tuberculosis.
    Additionally, S. 1115 would require the National Institutes 
of Health (NIH) to award funds to educational institutions for 
education and training programs, and for research on pulmonary 
infection. The bill would authorize appropriations for the 
development of a tuberculosis vaccine and direct the John E. 
Fogarty International Center for Advanced Study in the Health 
Sciences at the NIH to carry out an international training 
program regarding tuberculosis.
    Assuming the appropriation of necessary amounts (including 
annual adjustments for anticipated inflation), CBO estimates 
that implementing S. 1115 would cost $117 million in 2003 and 
$1.6 billion over the 2003-2007 period. The legislation would 
not affect direct spending or receipts; therefore, pay-as-you-
go procedures would not apply.
    S. 1115 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA) 
and would impose no costs on state, local, or tribal 
governments.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of S. 1115 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                    By fiscal year, in millions of dollars--
                                                               -------------------------------------------------
                                                                  2003      2004      2005      2006      2007
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Estimated authorization level:
    Centers for Disease Control and Prevention \1\............       235       241       246       252       258
    National Institutes of Health \2\.........................       146       172       176       180       184
                                                               -------------------------------------------------
      Total...................................................       381       413       422       432       442
                                                               =================================================
Estimated outlays:
    Centers for Disease Control and Prevention................        82       190       227       240       252
    National Institutes of Health.............................        35       117       149       164       175
                                                               -------------------------------------------------
      Total...................................................       117       307       377       404       427
----------------------------------------------------------------------------------------------------------------
\1\ The 2003 level for the Centers for Disease Control and Prevention is the amount authorized for that year
  under the bill. The 2004 through 2007 levels reflect adjustments for anticipated inflation.
\2\ The 2003 level for the National Institutes of Health is the combined amount the bill would authorize for the
  National Heart, Lung, and Blood Institute and the National Institute of Allergy and Infectious Diseases in
  2003. The 2004 level is the amount authorized for the National Institute of Allergy and Infectious Diseases in
  2004 and anticipated inflation for proposed activities in the National Heart, Lung, and Blood Institute. The
  2005 through 2007 levels reflect adjustments for anticipated inflation.

Basis of estimate

    CBO estimates that S. 1115 would authorize the 
appropriation of $381 million in 2003 and approximately $2.1 
billion over the 2003-2007 period. CBO estimates that outlays 
would total $117 million in fiscal year 2003 and approximately 
$1.6 billion over the 2003-2007 period, assuming that the 
necessary amounts are appropriated.
            Title I--Preventive Health Services
    The bill would require the Advisory Council for the 
Elimination of Tuberculosis to make recommendations for 
developing, revising, and implementing a national plan to 
eliminate tuberculosis and global plans to control 
tuberculosis. S. 1115 does not specify an authorization of 
appropriations for those activities, but based on discussions 
with officials at the Department of Health and Human Services, 
CBO estimates that this proposal would not have significant 
costs.
            Title II--Centers for Disease Control and Prevention
    S. 1115 would authorize the creation of the National 
Program for Tuberculosis Elimination at the CDC, which would 
include current CDC efforts aimed at eliminating tuberculosis. 
(In fiscal year 2002, $134 million was appropriated for those 
activities.) The program also would include a broadened set of 
responsibilities related to research, demonstration projects, 
and collaboration with international organizations and foreign 
countries on tuberculosis elimination and control efforts.
    The bill would authorize the appropriation of $235 million 
in fiscal year 2003 for the continuation and expansion of CDC 
tuberculosis elimination activities and such sums as necessary 
for the 2004-2007 period. Assuming that the 2003 level is 
increased annually to reflect anticipated inflation, CBO 
estimates that implementing this title would require the 
appropriation of $1,232 million over the 2003-2007 period. 
Based on historical spending patterns for similar activities, 
CBO estimates that outlays would total $82 million in fiscal 
year 2003 and $991 million over the 2003-2007 period, assuming 
that the necessary amounts are appropriated.
            Title III--National Institutes of Health
    S. 1115 would authorize the Director of the National Heart, 
Lung, and Blood Institute to award grants to educational 
institutions to educate and train clinicians and medical, 
nursing, or osteopathic students about preventing, managing, 
and controlling tuberculosis and to support pulmonary infection 
research. To support those purposes, the bill would authorize 
the appropriation of $10 million in fiscal year 2003 and such 
sums as may be necessary for 2004 through 2007.
    The bill would authorize the appropriation of $136 million 
for fiscal year 2003, $162 million for 2004, and such sums as 
may be necessary for 2005 through 2007 for the National 
Institute of Allergy and Infectious Diseases of NIH to develop 
a tuberculosis vaccine. The bill also would create statutory 
authority for an existing international training program 
regarding tuberculosis at the John E. Fogarty International 
Center for Advanced Study in the Health Sciences of the NIH. 
(Hence, that provision would have no significant impact on 
spending.)
    CBO estimates that implementing title III would require the 
appropriation of $146 million for fiscal year 2003 and $858 
million over the 2003-2007 period. Based on historical spending 
patterns for similar activities, CBO estimates that outlays 
would total $35 million in 2003 and $640 million over the 2003-
2007 period, assuming that the necessary amounts are 
appropriated.
    Pay-as-you-go consideration: None.
    Intergovernmental and private-sector impact: S. 1115 
contains no intergovernmental or private-sector mandates as 
defined in UMRA and would impose no costs on state, local, or 
tribal governments.
    Estimate prepared by: Federal costs: Jeanne De Sa, Hallie 
Torrell, and Christopher Topoleski; impact on state, local, and 
tribal governments: Leo Lex; impact on the private sector: 
Jennifer Bowman.
    Estimate approved by: Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

            VI. Application of Law to the Legislative Branch

    The committee finds that the legislation has no application 
to the legislative branch.

                    VII. Regulatory Impact Statement

    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;
          ``ACET'' means the Advisory Council for the 
        Elimination of Tuberculosis;
          ``CDC'' means the Centers for Disease Control and 
        Prevention;
          ``Secretary'' means the Secretary of Health and Human 
        Services.

Section 1. Short title

    This legislation is titled the ``Comprehensive Tuberculosis 
Elimination Act of 2001.''

                  TITLE I--PREVENTIVE HEALTH SERVICES

Section 101, Advisory Council for the Elimination of Tuberculosis, 
        amends section 317E(f) of the PHSA

    Section 317E(f)(2) is amended to direct ACET to advise the 
Secretary and other Federal officials on how best to coordinate 
the activities of the Public Health Service and other Federal 
agencies and how to efficiently utilize Federal resources in 
order to eliminate tuberculosis.
    Section 317E(f)(3) is amended to require ACET to develop 
and update a national plan to eliminate TB in the U.S., taking 
into consideration the recommendations of the Institute of 
Medicine.
    Section 317E(f)(4) is amended to require ACET to make 
recommendations for U.S. participation in global and cross 
border TB control activities.
    Section 317E(f)(5) is redesignated as Section 317E(f)(6).
    Section 317E(f)(5) is revised to specify that ACET shall 
include among its membership, representatives from the CDC, 
National Institutes of Health, Agency for Healthcare Research 
and Quality, Health Resources and Services Administration, the 
U.S.-Mexico Border Health Commission, and any other Federal 
departments or agencies active in TB activities, as well as 
individuals who are officers or employees of the Federal 
Government.

          TITLE II--CENTERS FOR DISEASE CONTROL AND PREVENTION

Section 201, National Program for TB Elimination, amends Section 317E 
        of the PHSA

    The heading for Section 317E is changed to the ``National 
Program for Tuberculosis Elimination.''
    Section 317E(b)(1) is amended to refocus activities within 
the scope of the CDC's research program, on research concerning 
the diagnosis and treatment of latent TB infection; drug-
resistant TB; cases of TB that affect certain high-risk 
populations; and clinical trials, especially those conducted 
through the Tuberculosis Trials Consortium.
    Section 317E(b)(2)(A) 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 development of 
regional, multi-state capabilities for TB prevention, control, 
and treatment in low incidence areas of the United States.
    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 improve screening and treatment, 
when necessary, of high risk immigrant groups.
    Section 317E(b)(5) is amended to clarify that support 
should go to model centers to implement tuberculosis activities 
outlined under paragraphs (2) through (4).
    Section 317E(b)(6) is amended to specify the need for 
collaboration with Mexico, in particular, the necessity for 
coordination with the United States Agency for International 
Development, and the role of ACET.
    Section 317E(g) is amended to require the Secretary to 
prepare a biennial report regarding the activities described 
under section 317E and submit it to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives. The 
report shall include the opinion of the Council on the extent 
to which its recommendations under section 317E(f)(3) have been 
implemented.
    Section 317E(h) authorizes $235 million for fiscal year 
2003, and such sums as may be necessary for fiscal years 2004 
through 2007, for the Secretary to award grants as described in 
this section.

                TITLE III--NATIONAL INSTITUTES OF HEALTH

Section 301 amends subpart 2 of part C of title IV of the PHSA by 
        adding section 424C after section 424B

    Section 424C(a) authorizes the Director of the National 
Heart, Lung, and Blood Institute to expand, intensify, and 
coordinate basic and clinical research regarding TB prevention, 
diagnosis, and treatment, and the relationship between 
tuberculosis and the human immunodeficiency virus.
    Section 424C(b)(1) establishes the Tuberculosis Academic 
Awards for the development and support of clinical curricular 
programs in TB prevention, management, and control in patients 
for health professionals in training.
    Section 424C(b)(2) establishes the Tuberculosis/Pulmonary 
Infection Awards to support basic science research into the 
pathophysiology of TB infection, as well as research in the 
development of new diagnostic techniques and treatments.
    Section 424C(b)(3) authorizes $10 million for fiscal year 
2003 and such sums as may be necessary for fiscal years 2004 
through 2007 for the TB Academic Awards and the TB/Pulmonary 
Infection Awards.

Section 302, Activities of the National Institute of Allergy and 
        Infectious Diseases, amends section 447A of the PHS Act

    Section 447A(b) is redesignated Section 447A(c).
    Section 447A(b) is amended to include specific reference to 
the development of a TB vaccine, taking into consideration the 
recommendations contained in the Blueprint for TB Vaccine 
Development.
    Section 447A(c) is amended to increase the authorization 
for the Institute to pursue the activities described in Section 
447A(a)-(b) to $136 million for fiscal year 2003, $162 million 
for fiscal year 2004, and such sums as may be necessary for 
fiscal years 2005 through 2007.

Section 303, John E. Fogarty International Center for Advanced Study in 
        the Health Sciences, does not amend the PHS Act

    This section authorizes the Center to expand, intensify, 
and coordinate international activities for research and 
training on tuberculosis. The Center will provide support for 
clinical, operational, and health services research and 
training. The Center shall model these activities on the 
international HIV training program currently administered by 
the Center.

                          IX. Additional Views

    Tuberculosis in the U.S., unlike some other health 
conditions, responds quite well to careful and adequately-
funded prevention and control programs. When neglect of these 
programs occurred in the past, particularly at the State and 
local levels, tuberculosis rates increased. When State and 
local Governments, in partnership with the Federal Government, 
invested appropriately in tuberculosis prevention and control, 
incidence of latent and active disease decreased. Accordingly, 
we support on-going, appropriate investments in TB prevention 
and control efforts.
    We believe that report language should accurately reflect 
the content of the reported bill. In describing the committee 
views on authorization levels for CDC and NIH, the majority 
views appear to deviate from this principle. Though the report 
implies otherwise, the bill authorizes $235 million at CDC for 
FY 2003 and $136 million at NIH for FY 2003 and $162 million 
for FY 2005 for efforts at TB prevention and control. The bill, 
as reported, can not be interpreted to authorize more than the 
authorized amounts for 2003 and 2004 and such sums thereafter. 
The committee is, of course, aware of the recommendation by 
some members of the public health advocacy community (the 
National Coalition for the Elimination of Tuberculosis) that 
certain levels of funding are needed at CDC ($528 million) and 
NIH ($240 million) in order to eliminate TB. But the express 
intention of the committee for authorizations at CDC and NIH 
from FYS 2003-2007 is reflected in what is explicitly stated in 
the bill language itself.

                                                        Judd Gregg.

                       X. 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

           *       *       *       *       *       *       *


    Section 1.* * *

           *       *       *       *       *       *       *


          [PREVENTIVE HEALTH SERVICES REGARDING TUBERCULOSIS]

NATIONAL PROGRAM FOR TUBERCULOSIS ELIMINATION

           *       *       *       *       *       *       *


    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 detain 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, 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--
                  (A) diagnosis and treatment of latent 
                infection of tuberculosis;
                  (B) strains of tuberculosis resistant to 
                drugs.
                  (C) cases of tuberculosis that affect certain 
                high-risk populations; and
                  (D) clinical trials, including those 
                conducted through the Tuberculosis Trails 
                Consortium.
          (2) Demonstration projects, including for--
                  (A) the development of regional capabilities 
                for the prevention control, and elimination of 
                tuberculosis particularly in low-incidence 
                regions; and
                  (B) collaboration with the Immigration and 
                Naturalization Service to identify and treat 
                immigrants with active or latent tuberculosis 
                infection.
          (3) Public information and education programs.
          (4) Education, training and clinical skills 
        improvement activities for health professionals, 
        including allied health personnel.
          (5) Support of model centers to carry out activities 
        under paragraphs (2) through (4).
          (6) Collaboration with international organizations 
        and foreign countries, including Mexico, in 
        coordination with the United States Agency for 
        International Development, in carrying out such 
        activities, including coordinating activities through 
        the Advisory Council for the Elimination of 
        Tuberculosis.

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        (f) Advisory Council.--
          (1) In general.--The Secretary shall establish an 
        advisory council to be known as the Advisory Council 
        for the Elimination of Tuberculosis (in this subsection 
        referred to as the ``Council'').
          [(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.--For the purpose of making progress 
        toward the goal of eliminating tuberculosis from the 
        United States, the Council shall provide to the 
        Secretary and other appropriate Federal officials 
        advice on coordinating the activities of the Public 
        Health Service and other Federal agencies tat relate to 
        such disease and on efficiently utilizing the Federal 
        resources involved.
          (3) National plan.--In carrying out paragraph (2), 
        the Council, in consultation with appropriate public 
        and private entities, shall make recommendations on the 
        development, revision, and implementation of a national 
        plan to eliminate tuberculosis in the United States. In 
        carrying out this paragraph, the Council shall--
                  (A) consider the recommendations of the 
                Institute of Medicine regarding the elimination 
                of tuberculosis;
                  (B) address the development and application 
                of new technologies; and
                  (C) review the extent to which progress has 
                been made toward eliminating tuberculosis.
          (4) Global activities.--In carrying out paragraph 
        (2), the Council, in consultation with appropriate 
        public and private entities, shall make recommendations 
        for the development and implementation of a plan to 
        guide the involvement of the United States in global 
        and cross border tuberculosis-control activities, 
        including recommendations regarding policies, 
        strategies, objectives, and priorities. Such 
        recommendations for the plan shall have a focus on 
        countries where a high incidence of tuberculosis 
        directly affects the United States, such as Mexico, and 
        on access to a comprehensive package of tuberculosis 
        control measurers, as defined by the World Health 
        Organization directly observed treatment, short course 
        strategy (commonly known as DOTS).
          (5) Composition.--The Council shall be composed of--
                  (A) representatives from the Centers for 
                Disease Control and Prevention, the National 
                Institutes of Health, the Agency for Healthcare 
                Research and Quality, the Health Resources and 
                Services Administration, the U.S.-Mexico Border 
                Health Commission, and other Federal 
                departments and agencies that carry out 
                significant activities relating to 
                tuberculosis; and
                  (B) members appointed from among individuals 
                who are not officers or employees of the 
                Federal Government.
          [5](6) Staff, information and other assistance.--The 
        Secretary shall provide to the Council such staff, 
        information, and other assistance as may be necessary 
        to carry out the duties of the Council.
     [(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.]
     (g) Reports.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention and in 
consultation with the Advisory Council for the Elimination of 
Tuberculosis, shall biennially prepare and submit to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives, a report on the activities carried out under 
this section. Each report shall include the opinion of the 
Council on the extent to which its recommendations under 
section 317E(f)(3) regarding tuberculosis have been 
implemented.
     (h) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $235,000,000 for fiscal year 2003, and such sums 
as may be necessary for each of the fiscal years 2004 through 
2007.

           *       *       *       *       *       *       *

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

           *       *       *       *       *       *       *


                              TUBERCULOSIS

    Sec. 424C. (a) In General.--The Director of the Institute 
shall expand, intensify, and coordinate research and related 
activities of the Institute with respect to the treatment, 
diagnosis, and prevention of tuberculosis, including--
          (1) basic and clinical research on tuberculosis; and
          (2) research on the relationship between tuberculosis 
        and the human immunodeficiency virus.
    (b) Research Education.--
          (1) Tuberculosis academic awards.--The Director of 
        the Institute may award grants to institutions for the 
        development and support of programs of core curricula 
        for training clinical investigators, including medical, 
        nursing, or osteopathic students, in the principles and 
        practices of preventing, managing, and controlling 
        tuberculosis in patients.
          (2) Tuberculosis/pulmonary infection awards.--The 
        Director of the Institute may provide awards to support 
        the research of trained professionals into the basic 
        biological processes and mechanisms involved in 
        tuberculosis, as well as research into the development 
        of new diagnostic techniques and treatments.
          (3) Authorization of appropriations.--For the purpose 
        of carrying out this subsection, there are authorized 
        to be appropriated $10,000,000 for fiscal year 2003, 
        and such sums as may be necessary for each of the 
        fiscal years 2004 through 2007.

           *       *       *       *       *       *       *

    Sec. 447A. [285f-2] (a) * * *

           *       *       *       *       *       *       *

    (b) Activities under subsection (a) may include activities 
to develop a tuberculosis vaccine. The recommendations 
contained within the Blueprint for Tuberculosis Vaccine 
Development, described in the report prepared pursuant to the 
workshop convened in March 1998 by the Director of the 
Institute, shall be taken into consideration.
    [(b)] (c) For the purpose of carrying out subsection (a), 
there are authorized to be appropriated $50,000,000 for fiscal 
year 1994, such sums as may be necessary for each of the fiscal 
years 1995 through 1998, $136,000,000 for fiscal year 2003, 
$162,000,000 for fiscal year 2004, and such sums as may be 
necessary for each of the fiscal years 2005 through 2007. Such 
authorization is in addition to any other authorization of 
appropriations that is available for such purpose.

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