99–010

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 

2

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 

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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. 

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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 

one billion more people will become infected, and 35 million people 

will die from TB. TB case rates in the United States reflect the 

global situation. The proportion of TB cases in foreign-born people 

has increased steadily in the last decade, from 27 percent of all 

cases in 1992 to 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 opporVerDate Jul 25 2002 06:33 Jul 29, 2002 Jkt 099010 PO 00000 Frm 00004 Fmt 6659 Sfmt 6602 E:\HR\OC\SR227.XXX pfrm17 PsN: SR227
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tunity 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 

6

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 with TB. 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 multistate level in areas of the country with a low incidence of TB. 

Projects in these low incidence regions should aim to maintain access to clinical, epidemiological, and other TB services in a cost efVerDate Jul 25 2002 06:33 Jul 29, 2002 Jkt 099010 PO 00000 Frm 00006 Fmt 6659 Sfmt 6602 E:\HR\OC\SR227.XXX pfrm17 PsN: SR227
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fective 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 

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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 comVerDate Jul 25 2002 06:33 Jul 29, 2002 Jkt 099010 PO 00000 Frm 00008 Fmt 6659 Sfmt 6602 E:\HR\OC\SR227.XXX pfrm17 PsN: SR227
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prehensive 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. 

10

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 

11

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 fis- cal 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; 

12

‘‘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. 

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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. 

14

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.

(15)

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.

(16)

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.* * *

* * * * * * *

øPREVENTIVE HEALTH SERVICES REGARDING TUBERCULOSIS¿

NATIONAL PROGRAM FOR TUBERCULOSIS ELIMINATION

* * * * * * *

SEC. 317E. ø247b–6¿ (a) IN GENERAL.—***

* * * * * * *

ø(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: 

ø(1) Research, with priority given to research concerning 

strains of tuberculosis resistant to drugs and research concerning cases of tuberculosis that affect detain populations. 

ø(2) Demonstration projects. 

ø(3) Public information and education programs. 

ø(4) Education, training, and clinical skills improvement activities for health professionals, including allied health personnel and emergency response employees. 

ø(5) Support of centers to carry out activities under paragraphs (1) through (4). 

ø(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 

17

(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’’). 

ø(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. 

ø(3) CERTAIN ACTIVITIES.—With respect to the elimination of 

tuberculosis, the Council shall— ø(A) in making recommendations under paragraph (2) 

make recommendations regarding policies, strategies, objectives, and priorities; 

ø(B) address the development and application of new 

technologies; and 

ø(C) review the extent to which progress has been made 

toward eliminating tuberculosis. 

ø(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 tuberVerDate Jul 25 2002 06:33 Jul 29, 2002 Jkt 099010 PO 00000 Frm 00017 Fmt 6604 Sfmt 6603 E:\HR\OC\SR227.XXX pfrm17 PsN: SR227
18

culosis 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.

ø5¿(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. 

ø(g) FUNDING.— ø(1) IN GENERAL; ALLOCATION FOR EMERGENCY GRANTS.— ø(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. 

ø(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. 

ø(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, EduVerDate Jul 25 2002 06:33 Jul 29, 2002 Jkt 099010 PO 00000 Frm 00018 Fmt 6604 Sfmt 6603 E:\HR\OC\SR227.XXX pfrm17 PsN: SR227
19

cation, 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 ø285b–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. ø285f–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.

ø(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 

20

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. 

* * * * * * *

Æ