[Senate Report 107-227]
[From the U.S. Government Publishing Office]
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.
* * * * * * *
(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.
* * * * * * *