69–010 

Calendar No. 549 

110TH CONGRESS REPORT " ! SENATE 2d Session 110–329 

COMPREHENSIVE TUBERCULOSIS ELIMINATION ACT OF 

2007 

APRIL 22, 2008.—Ordered to be printed 

Mr. KENNEDY, from the Committee on Health, Education, Labor, 

and Pensions, submitted the following 

R E P O R T 

[To accompany S. 1551] 

The Committee on Health, Education, Labor, and Pensions, to 

which was referred the bill (S. 1551) to amend the Public Health 

Service Act with respect to making progress toward the goal of 

eliminating tuberculosis, and for other purposes, having considered 

the same, reports favorably thereon with an amendment in the nature of a substitute and recommends that the bill (as amended) do 

pass. 

CONTENTS 

Page 

I. Purpose and Summary .................................................................................. 1 

II. Background and Need for Legislation .......................................................... 2 

III. Legislative History and Committee Action .................................................. 5 

IV. Committee Views ........................................................................................... 5 

V. Cost Estimate ................................................................................................. 11 

VI. Regulatory Impact Statement ....................................................................... 13 

VII. Application of Law to the Legislative Branch ............................................. 13 

VIII. Section-by-Section Analysis .......................................................................... 14 

IX. Changes in Existing Law .............................................................................. 17 

I. PURPOSE AND SUMMARY

The Comprehensive Tuberculosis Elimination Act of 2007 addresses the role of the Department of Health and Human Services 

in the development and implementation of a national strategy to 

eliminate tuberculosis (TB) in the United States. In order to attain 

this goal, the act mandates expansion, intensification, and coordination of the ongoing activities of the Centers for Disease Control 

and Prevention (CDC) and the National Institutes of Health (NIH). 


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The act enhances research, education, training, and international 

efforts to eliminate TB through the CDC and expands basic research through the NIH. The act includes the following provisions: 

1. The legislation calls for expanding and intensifying the CDC’s 

TB prevention, control, and elimination activities. 

The CDC will award grants to public or nonprofit entities for the 

purposes of prevention, control, and elimination of TB, under section 317. The agency will support State public health activities including TB case finding, prevention and treatment utilizing directly 

observed therapy; research into the diagnosis and treatment of latent TB, drug-resistant TB, and cases of TB in high-risk populations. Additionally, the CDC will conduct demonstration projects; 

education and training of health care professionals; and public education projects. These grants are authorized at $300 million in fiscal year 2008 and such sums as may be necessary in fiscal years 

2009 through 2012. 

2. The legislation mandates the creation of a national strategy. 

The Advisory Council for the Elimination of Tuberculosis (ACET) 

will develop a national strategy to eliminate tuberculosis from the 

United States. While constructing the national plan, ACET will review the recommendations of the Institute of Medicine (IOM) report Ending Neglect: The Elimination of Tuberculosis in the United 

States. Not only will ACET’s recommendations guide U.S. domestic 

TB programs, but they will provide counsel on U.S. involvement in 

global TB-control activities. 

3. The act calls for the development of new tools for the elimination of tuberculosis. 

The Secretary may expand, intensify, and coordinate research for 

the development of new tools for the elimination of tuberculosis, including drugs, diagnostics, vaccines, and public health interventions, such as directly observed therapy and non-pharmaceutical 

interventions. The Federal Tuberculosis Task Force will make recommendations on the development of a comprehensive plan for the 

creation of new tools. These efforts are authorized at $100 million 

in fiscal year 2008, and such sums as may be necessary in fiscal 

years 2009 through 2012. 

4. The act calls for the evaluation of public health authorities related to tuberculosis. 

The Secretary will submit a report to Congress that evaluates 

and provides recommendations on Federal and State disease-containment challenges, including an evaluation of the effectiveness of 

policies to detain patients with active tuberculosis, an evaluation of 

whether Federal policies should be strengthened to address the 

movement of infected individuals, and any other legislative recommendations for changes to Federal laws. The Secretary must 

also promulgate regulations within 8 months to update interstate 

and foreign quarantine regulations. 

5. The act calls for increased basic and clinical research regarding TB at the National Institutes of Health. 

The Director of the National Institutes of Health will enhance 

basic and clinical research and development related to tuberculosis. 

II. BACKGROUND AND NEED FOR LEGISLATION

Tuberculosis (TB) is a preventable and treatable disease that 

continues to infect thousands of Americans each year. Recent cases 


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of drug-resistant TB have served as timely warnings that TB, particularly drug-resistant TB, is a real and present public health 

threat to the United States. It is critical to recognize that drug-resistant TB is a human-made disaster caused by the world’s failure 

to properly treat the disease and develop new, more effective tools 

to fight TB. Although drugs, diagnostics and vaccines for TB exist, 

these technologies are 40–100 years old and are increasingly inadequate for controlling the global epidemic. 

The widespread global utilization of the BCG vaccine and antibiotics, in addition to generally improved public health, led to a 

dramatic reduction in the global TB deaths and disease burden between 1940 and 1980. But the short-term success of these tools led 

to complacency and a lessening interest on the part of governments 

and pharmaceutical companies in TB research and development. 

What resulted in the late 1980s in the United States, spurred by 

the spread of HIV and the increases in homelessness, incarceration, 

and injection drug use, was a 20 percent increase in TB case rates 

and the emergence of drug-resistant strains of TB. The TB outbreaks were difficult to control and extremely costly, given that the 

health infrastructure for dealing with the infection had been allowed to deteriorate due to a lack of funding. In New York City 

alone, more than $1 billion were needed to regain control of TB. 

The Advisory Council for the Elimination of Tuberculosis was established in 1987 to provide recommendations regarding the elimination of TB to the Secretary and Assistant Secretary of Health 

and Human Services and the Director of the Centers for Disease 

Control and Prevention (CDC). In 1989, ACET and the CDC issued 

A Strategic Plan for the Elimination of TB in the United States, 

which described actions necessary to eliminate TB by 2010. In 

1991, a Federal TB Task Force was created to combat the resurgence of TB. 

Commissioned by the CDC, the Institute of Medicine (IOM) released a report in 2000, entitled, ‘‘Ending Neglect: the Elimination 

of Tuberculosis in the United States.’’ This report reviewed the current status of TB prevention and control in the United States and 

outlined a comprehensive framework for a national campaign to 

eliminate TB. The committee recognizes the value of the expert recommendations contained within the IOM report and believes that 

these recommendations should be carefully evaluated in planning 

our efforts to eliminate TB from the United States. 

TB has retreated into high-risk populations and isolated communities across the United States. These populations include minorities, those co-infected with the human immunodeficiency virus 

(HIV), inmates and staff of correctional facilities, and those born in 

foreign countries, as previously discussed. For instance, TB is more 

than eight times as prevalent among African-Americans compared 

to Caucasians. Greater staffing, outreach, education, and followup 

are urgently needed in order to effectively prevent and treat TB in 

these populations. 

Today, the United States faces four significant challenges to the 

elimination of TB. First, our progress in reducing the TB case rate 

in the United States has stalled. Between 1993 and 2000, the Nation’s TB rate fell by 7.3 percent, but from 2000 to 2006, the rate 

of decline slowed to 3.8 percent. Although the number of TB cases 

in the United States continues to fall, with 13,779 cases reported 


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in 2006, our progress against the disease should be measured by 

annual decreases of at least 7 percent in the number of active TB 

cases. This is occurring at a time when domestic TB control categorical funding has been stagnant for a decade. As we have 

learned from the history of TB in this country, complacency and neglect of TB control programs can lead to costly resurgences of the 

disease. 

Second, the emergence of multidrug-resistant, and extensively 

drug-resistant strains of TB poses a major challenge to current 

methods of treating TB. Twenty-seven States reported cases of 

multidrug-resistant TB in 2006. Treatment failure with any of 

these cases could lead to the development of extensively drug-resistant strains. Multidrug-resistant TB requires treatment with 

toxic, expensive, and less effective drugs and even then, is often 

fatal. The number of multidrug-resistant TB cases among the foreign-born population in the United States has increased significantly since the early 1990s from approximately 26 percent of 

multidrug-resistant cases in 1993 to approximately 76 percent of 

cases between 1999 and 2006. 

Extensively drug-resistant TB is characterized by very high, and 

among immunocompromised persons, very rapid fatality rates. According to the CDC, about 30 percent of extensively drug-resistant 

TB patients can be cured, but more than half will die within 5 

years of diagnosis. Between 1993 and 2006, there were 49 cases of 

extensively drug-resistant TB in the United States. 

Third, the global TB epidemic endangers TB control efforts in the 

United States. Approximately one-third of the world’s population is 

infected with latent TB and about 1.6 million people die of the disease every year. If current trends continue, by 2020, nearly 1 billion more people will become infected and 35 million people will die 

from TB. TB case rates in the United States reflect the global situation. The proportion of TB cases in foreign-born people has increased steadily in the last decade, from 27 percent of all cases in 

1992 to 57 percent of all cases in 2006. To eliminate TB from the 

United States, targeted efforts are needed to prevent and treat TB 

among foreign-born individuals residing in the United States. 

Finally, TB will never be defeated without new and more effective tools for preventing the disease in people of all ages. The most 

commonly used TB diagnostic in the world, sputum microscopy, is 

more than 100 years old and lacks sensitivity to detect TB in most 

HIV/AIDS patients and in children. The standard TB skin test, developed over a century ago, needs to be replaced by promising single-visit blood tests but extensive field testing will be needed to ensure the proper use and interpretation of these newer tests. The 

TB vaccine, Baccillus Calmette-Guerin (BCG), provides some protection against TB to infants and children but it has little or no efficacy in preventing pulmonary TB in adolescents and adults. 

Improved testing for drug susceptibility is critical to combating 

the spread of drug-resistant TB. Current drug susceptibility tests 

take at least 1 month to complete. Faster drug susceptibility tests 

must be developed to stop the spread of drug-resistant TB. 

There is an urgent need for new anti-TB drugs, particularly for 

a shorter regimen. The current TB drug regimen requires 6 to 9 

months of treatment and patients with multidrug-resistant TB require treatment for 18–24 months, creating difficulties in comVerDate Aug 31 2005 23:01 Apr 23, 2008 Jkt 069010 PO 00000 Frm 00004 Fmt 6659 Sfmt 6602 E:\HR\OC\SR329.XXX SR329

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pleting therapy, further promoting the development of drug-resistant strains of TB. A shorter drug regimen with new classes of 

drugs active against susceptible and drug-resistant strains would 

increase compliance and prevent the development of more extensive drug resistance. There is also a critical need for drugs that can 

safely be taken concurrently with antiretroviral therapy for HIV. 

By unanimously supporting this legislation, the committee recognizes that, given the rising threat of drug-resistant TB and the expertise of public health officials and promise of new tools to more 

effectively fight TB, we now have a historic opportunity to eradicate TB from the United States. At this critical time, with the expert recommendations of the IOM in hand, the committee is committed to effectively targeting and eliminating TB from our country 

through renewed and expanded efforts in research, vaccine development, TB case finding, prevention, and treatment via directly observed therapy, education, and international collaboration. 

III. LEGISLATIVE HISTORY AND COMMITTEE ACTION

S. 1551 was introduced on June 5, 2007 by Senator Sherrod 

Brown for himself, Senator Hutchison, Senator Kennedy, Senator 

Clinton and Senator Murray. The bill is cosponsored by Senator 

Bingaman, Senator Boxer, Senator Cantwell, Senator Feinstein, 

Senator Harkin, Senator Landrieu, Senator Menendez, Senator 

Murkowski, Senator Sanders, Senator Lautenberg, and Senator 

Johnson. S. 1551 was referred to the Committee on Health, Education, Labor, and Pensions. On November 14, 2007 the Senate 

Committee on Health, Education, Labor, and Pensions held an executive session to consider a substitute for S. 1551 in the nature 

of an amendment. S. 1551 was ordered reported favorably by a 

unanimous voice vote. 

IV. COMMITTEE VIEWS

The committee recognizes that tuberculosis (TB), a preventable 

and treatable disease that continues to claim thousands of American lives, can be eliminated from the United States with the proper level of commitment and resources. The act also builds on a 

longstanding recognition by the public health community that an 

aggressive, sustained commitment and new investment into new 

diagnostic, treatment and prevention tools are needed to eradicate 

TB from the United States. 

The committee further wishes to clarify its views regarding the 

act. 

TITLE I—DEPARTMENT OF HEALTH AND HUMAN SERVICES IN COORDINATION WITH THE CENTERS FOR DISEASE CONTROL AND PREVENTION AND OTHER APPROPRIATE AGENCIES

The Department of Health and Human Services including the 

Centers for Disease Control and Prevention currently supports research, demonstration projects, education, and training related to 

the prevention, control, and elimination of TB. The scientific community, including Stop TB USA, has estimated that $528 million 

is needed annually to implement strategies that will advance us toward the goal of TB elimination, such as those outlined in the IOM 

report. The act increases the authorization level for grants to $300 


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million in fiscal year 2008 and such sums as may be necessary for 

fiscal years 2009 through 2012. 

Given the prevalence of TB in certain high risk and often isolated populations, the committee would emphasize that special priority be given to research concerning TB in these populations, including individuals infected with HIV, foreign-born persons from 

high incidence countries, minority populations with high TB rates, 

homeless persons, intravenous drug users, and incarcerated persons. The committee also understands the necessity for developing 

improved methods of diagnosing and treating drug-resistant TB 

and latent TB that would increase screening and patient compliance with therapy, when therapy is indicated, and encourages the 

CDC to award grants for research in this area. 

The act reauthorizes the Department’s (including the Centers for 

Disease Control and Prevention and the National Institutes of 

Health) priority research on TB including clinical trials to evaluate 

the safety and effectiveness of new drugs, diagnostics and vaccines 

for latent and active TB, including drug-resistant TB, through the 

Tuberculosis Trials Consortium, epidemiological studies through 

the Tuberculosis Epidemiologic Studies Consortium and field studies to evaluate the effectiveness of new drugs, diagnostics, and vaccines and assess the prevalence of drug-resistant TB. 

The act amends current authority to provide four new examples 

of demonstration projects that may be funded. The committee does 

not intend for funding to be limited to these specific demonstration 

projects. 

Based on the IOM report, this act recommends evaluating the 

possible regionalization of TB elimination activities on a multistate 

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

in these low incidence regions should aim to maintain access to 

clinical, epidemiological, and other TB services in a cost-effective 

and efficient manner and to ensure the presence of sufficient public 

health staff to educate health care providers and to identify an outbreak or emergency situation. 

In new subsection 317E(b)(2)(B), the committee authorizes the 

Secretary, acting through the Director of the Centers for Disease 

Control and Prevention, to fund demonstration project activities to 

reduce health disparities in the incidence of TB. The committee understands that disparities among racial and ethnic minorities, including African-Americans, Hispanic-Americans, and Asian-Americans, persists and that additional targeted efforts are needed to 

eliminate these disparities. 

This act recommends the expansion of programs to identify immigrants with latent and active TB infection and offer treatment, 

when indicated. The committee intends to encourage increased 

screening and treatment, when appropriate, of immigrants from 

countries with a high incidence of TB. These activities may benefit 

from collaboration with the Immigration and Customs Enforcement 

(ICE) whose expertise in immigration policy and the feasibility of 

altering current practices will be useful in determining the best approach to the high incidence of TB among immigrants. It should be 

noted that the committee does not necessarily endorse mandated 

latent TB testing for immigrant visa and permanent residency applicants. The committee encourages the CDC to work with the ICE 

to develop targeted screening programs that are effective in screenVerDate Aug 31 2005 23:01 Apr 23, 2008 Jkt 069010 PO 00000 Frm 00006 Fmt 6659 Sfmt 6602 E:\HR\OC\SR329.XXX SR329

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ing and treating latent TB without endangering the rights of all 

immigrants and refugees in the United States. 

In new subsection 317E(b)(2)(C), the committee authorizes the 

CDC to fund demonstration project activities for the intensification 

of efforts to control TB along the United States-Mexico border and 

among binational populations, including expanding the scope and 

number of programs to detect and treat binational cases of TB and 

high risk cases referred from Mexican health departments. 

The committee understands that foreign-born individuals comprise an increasing proportion of TB cases in the United States and 

encourages the funding of immigrant outreach programs to increase the effectiveness of TB screening and prevention services 

among new refugees and immigrants. In King County, Washington, 

for example, two-thirds of TB cases occur among foreign-born individuals. A pilot program in this county utilizing bilingual-bicultural 

community members, interviews, and focus groups in a culturally 

sensitive manner, achieved a 96 percent completion rate for those 

being treated for TB, far exceeding the 70 percent completion rates 

obtained by other programs. The success of this pilot demonstrates 

the effectiveness of culturally and linguistically sensitive programs 

to eliminate TB among high risk foreign born populations, and is 

a commendable model for future demonstration projects and public 

outreach efforts. 

In new subsection 317E(b)(2)(D), the committee authorizes the 

CDC to fund demonstration project activities for the intensification 

of efforts to prevent, detect, and treat TB among foreign-born persons who are in the United States. 

In new subsection 317E(b)(2)(E), the committee authorizes the 

CDC to fund demonstration project activities for the intensification 

of efforts to prevent, detect, and treat TB among high-risk populations and settings documented as having a high risk for TB. 

In new subsection 317E(b)(2)(F), the committee authorizes the 

CDC to fund demonstration project activities for TB detection, control and prevention. This additional prioritization is granted to facilitate CDC’s capacity for enhanced TB detection, control and prevention in general. 

The act reauthorizes CDC’s authority to award grants for education, training, and clinical skills improvement activities for 

health professionals. The agency’s implementation of these education and training programs should take into consideration appropriate recommendations in the Strategic Plan for TB Training and 

Education 2004–2008 as a joint project of the National Tuberculosis Centers and the Centers for Disease Control and Prevention’s Division of TB Elimination (DTBE). The plan provides a 

blueprint for creating a strong, coordinated, and effective system 

for TB training and education. 

In subsection 317E(b)(5), the committee does not intend to limit 

support of ‘‘Centers’’ to the four Regional Training and Medical 

Consultation Centers that are currently in operation in New York 

City, San Francisco, CA, and San Antonio, TX, and Gainesville, FL. 

Rather, the committee intends that support for these continue and 

that the development of additional centers, particularly in areas of 

high incidence, commences. 

The committee further understands that the elimination of TB 

from the United States cannot be achieved without cooperation beVerDate Aug 31 2005 23:01 Apr 23, 2008 Jkt 069010 PO 00000 Frm 00007 Fmt 6659 Sfmt 6602 E:\HR\OC\SR329.XXX SR329

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tween the United States and Mexico and collaboration with international organizations. In 2006, Mexico was the country of origin 

for 25 percent of all foreign-born persons infected with TB. Of TB 

cases among Mexican-born persons living in the United States, 

three-fourths were reported by the four States bordering Mexico. 

The CDC should support the development of coordinated binational 

TB control projects at the national, State, and local levels in coordination with the United States Agency for International Development. 

In new subsection 317E(b)(7), the committee authorizes the CDC 

to fund activities to develop, enhance, and expand TB control surveillance and database management systems with cross-jurisdictional capabilities, which shall conform to the standards and implementation specifications for information technologies as recommended by the Secretary. 

In new subsection 317(E)(d)(3), the committee authorizes the Secretary to give highest priority to grant applicants that provide nonFederal funds, which may be provided directly or through donations from public or private entities and may be cash or in kind, 

including equipment or services. Amounts provided by the government or services assisted or subsidized to any significant extent by 

the Federal Government may not be included in determining the 

amount of non-Federal contributions. 

Subtitle B—Interagency collaboration 

The ACET works closely with the DTBE in developing and evaluating guidelines for prevention, control, and treatment and addressing issues related to TB elimination in the United States. 

The committee recognizes the value of ACET’s expertise in advising and evaluating Federal, State, and local efforts to eliminate TB. 

With this legislation, the committee authorizes ACET to create or 

update a national plan for the elimination of TB from the United 

States. In developing this plan, ACET should carefully evaluate 

and incorporate, as appropriate, the recommendations of the Institute of Medicine. The committee also intends for ACET to continuously modify this plan as new insights, data, or technology become 

available. 

The committee understands that TB case rates in the United 

States are heavily impacted by the global TB burden and that 

elimination of TB from the United States is difficult, if not impossible, without addressing TB control in foreign countries. ACET 

should expand its scope of interest and provide recommendations 

to guide U.S. involvement in fighting the global TB epidemic. The 

World Health Organization (WHO) has identified a total of 22 high 

incidence countries that account for 80 percent of all new cases 

worldwide. ACET’s recommendations should be concerned with 

countries where the high incidence of TB may contribute to TB 

case rates in the United States. For instance, Mexico, the Philippines, Vietnam and India are the countries of origin for over half 

the foreign-born residents of the United States infected with TB. 

ACET should specify goals and strategies for how the United 

States can assist these countries in reducing their TB rates and 

focus on implementing proven control measures, such as the 

WHO’s directly observed treatment, short course strategy (DOTS). 


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ACET currently is composed of representatives from diverse Federal and non-Federal agencies, public health departments, and 

local groups that are concerned with TB. The United States-Mexico 

Border Health Commission should also be represented on the 

Council given the high TB case rates and difficulty controlling TB 

in communities near the U.S.-Mexico border. The expertise of the 

Health Resources and Services Administration (HRSA) and the 

Agency for Healthcare Research and Quality (AHRQ) should also 

be included in ACET because of the agencies’ work with professionals in rural areas and on quality of care respectively. The committee reaffirms a commitment to address TB prevention, control, 

and treatment issues in this high-risk region. 

In new subsection 317E(f)(2)(B), the committee authorizes ACET 

to provide the Secretary and other appropriate Federal officials advice on responding rapidly and effectively to emerging issues in TB. 

In new subsection 317E(f)(3)(B), the committee authorizes ACET 

to consult with appropriate public and private entities, subject to 

the discretion of the Secretary that may include scientists, physicians, laboratorians, and other health professionals who represent 

the disciplines relevant to TB elimination; members of public-private partnerships established to address the elimination of TB; 

members of national and international nongovernmental organizations established to address TB elimination; and members of the 

general public who are knowledgeable with respect to TB elimination including individuals who have or have had TB. 

In new subsection 317E(f)(4)(A), the committee charges ACET to 

submit an annual report to the Secretary on the activities carried 

under this section. The annual report will also include the opinion 

of the Council on the extent to which its recommendations regarding the elimination of TB have been implemented. In new subsection 317E(f)(4)(B), the committee authorizes the Secretary to 

make ACET’s annual report public. 

In new subsection 317E(f)(5)(B), the committee authorizes the 

composition of ACET to include State and local TB control and public health officials; individuals who are scientists, physicians, 

laboratorians, and other health professionals who represent disciplines relevant to TB elimination; members of national and international nongovernmental organizations established to address the 

elimination of TB; and members from the general public who are 

knowledgeable with respect to the elimination of TB, including individuals who have or have had TB. 

In new subsection 317E(b) Rule of Construction Regarding Current Membership—the amendments made to the act may not be 

construed as terminating the membership on ACET of any individual serving as such a member as of the day before the date of 

the enactment of the act. 

Subtitle C—New tools for tuberculosis elimination 

The act creates a new authorization through the Secretary of the 

Department of Health and Human Services to fund grants, cooperative agreements and contracts for research and development on 

drugs, diagnostics, vaccines and public health interventions for the 

elimination of TB. The act authorizes $100 million in fiscal year 

2008 and such sums as necessary for fiscal years 2009 through 

2012. 


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The act will provide a first step in providing the U.S. contribution toward an urgently needed global reinvestment into new TB 

diagnostic, treatment and prevention tools research. The committee 

recognizes that the clinical trials and field studies needed to bring 

new TB diagnostics, drugs and vaccines into practice are ongoing 

through the CDC’s DTBE, including the multisite TB Trials Consortium, the TB Epidemiologic Studies Consortium; and this research is often derived from research conducted by the National Institute of Allergy and Infectious Disease’s Division of Microbiology 

and Infectious Diseases, Division of AIDS and the Division of Intramural Research. The committee recommends that these activities 

be expanded and intensified and encourages collaboration between 

the CDC and the NIH in the area of TB research. 

New subsection 317E(g)(1) authorizes the Secretary to expand, 

intensify and coordinate research and development and related activities to develop new TB elimination tools, including drugs, 

diagnostics, vaccines and public health interventions, including 

methods to enhance detection and response to outbreaks of drug resistant TB. 

New subsection 317E(g)(2) authorizes the Federal TB Task 

Force. The Federal TB Task Force works closely with the CDC’s 

DTBE and the NIH in developing a comprehensive plan for the creation of new tools for the elimination of tuberculosis, including 

drugs, diagnostics, vaccines and public health interventions. The 

committee intends for the Task Force to continuously modify the 

plan for new TB tools development as new research or technology 

become available. 

The Task Force currently is composed of representatives from diverse Federal and non-Federal agencies, public health departments, and local groups that are concerned with TB research. 

In new subsection 317E(g)(2)(C), the committee authorizes the 

Task Force to consult with appropriate public and private entities 

that may include scientists, physicians, laboratorians, and other 

health professionals who represent the disciplines relevant to TB 

research; members of public-private partnerships engaged in TB research; members of national and international nongovernmental organizations established to address TB elimination; members of the 

general public who are knowledgeable with respect to TB elimination including individuals who have or have had TB; and health 

professionals from other countries with a substantial incidence of 

TB, and who represent the specialties and disciplines relevant to 

TB research. 

In new subsection 317E(g)(3), the committee authorizes the Secretary to award grants, cooperative agreements and contracts to 

public and private entities for the provision of the research activities described in section 317E(g)(1). 

New subtitle D—Evaluation of public health authorities 

In new subsection 131, the committee requests that the Secretary submit a report to the appropriate congressional committees 

that evaluates the effectiveness of Federal and State public health 

authorities to address disease containment challenges and provides 

recommendations for improvement, including: an evaluation of the 

effectiveness of policies to detain patients with active TB; an evaluation of the need for Federal laws to be strengthened to address 


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the movement of infected individuals; and specific legislative recommendations for Federal law changes. This section also requires 

the Secretary to promulgate regulations within 8 months to update 

interstate and foreign quarantine regulations 

TITLE III—NATIONAL INSTITUTES OF HEALTH

The committee recommends that the National Institutes of 

Health expand and intensify its TB research and development activities including basic and clinical research on TB. Given the global health emergency of drug-resistant TB and the strong co-occurrence between TB and HIV, the committee would emphasize that 

special priority be given to research concerning drug-resistant TB 

and the relationship between TB and HIV. 

V. COST ESTIMATE

U.S. CONGRESS, 

CONGRESSIONAL BUDGET OFFICE, 

Washington, DC, April 17, 2008. 

Hon. EDWARD M. KENNEDY, 

Chairman, Committee on Health, Education, Labor, and Pensions, 

U.S. Senate, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for S. 1551, the Comprehensive 

Tuberculosis Elimination Act of 2007. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contacts are Tim Gronniger and 

Sarah Evans. 

Sincerely, 

ROBERT A. SUNSHINE

(For Peter R. Orszag, Director). 

Enclosure. 

S. 1551—Comprehensive Tuberculosis Elimination Act of 2007 

Summary: S. 1551 would amend the Public Health Service Act 

to authorize funding for grants to States and local governments, research on treatment and prevention, and other activities intended 

to eliminate tuberculosis in the United States. CBO estimates that 

implementing S. 1551 would cost $11 million in 2008 and $2.2 billion over the 2009–2013 period, assuming appropriation of the authorized amounts. 

S. 1551 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA), 

and would have no effect on direct spending or revenues of the Federal Government. 

Estimated cost to the Federal Government: The estimated budgetary impact of S. 1551 is shown in the following table. The costs 

of this legislation fall within budget function 550 (health). 

By fiscal year, in millions of dollars— 

2008 2009 2010 2011 2012 2013 

SPENDING SUBJECT TO APPROPRIATION 

Spending Under Current Law: 

CDC: 

Budget Authority 1 .................................................................. 140 0 0 0 0 0 


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By fiscal year, in millions of dollars—

2008 2009 2010 2011 2012 2013 

Estimated Outlays .................................................................. 135 86 50 5 1 0 

NIH: 

Budget Authority 2 .................................................................. 165 0 0 0 0 0 

Estimated Outlays .................................................................. 159 118 40 15 5 0 

Total Spending: 

Budget Authority ............................................................ 305 0 0 0 0 0 

Estimated Outlays ......................................................... 294 204 90 20 6 0 

Proposed Changes: 

CDC: 

Estimated Authorization Level ................................................ 290 440 448 457 468 0 

Estimated Outlays .................................................................. 11 343 460 438 453 288 

NIH: 

Estimated Authorization Level ................................................ 0 168 0 0 0 0 

Estimated Outlays .................................................................. 0 44 79 26 10 5 

Total Changes: 

Estimated Authorization Level ....................................... 290 608 448 457 468 0 

Estimated Outlays ......................................................... 11 387 539 464 463 293 

Spending Under S. 1551: 

CDC: 

Estimated Authorization Level ................................................ 430 440 448 457 468 0 

Estimated Outlays .................................................................. 146 429 510 443 454 288 

NIH: 

Estimated Authorization Level ................................................ 165 168 0 0 0 0 

Estimated Outlays .................................................................. 159 162 119 41 15 5 

Total Spending Under S. 1551: 

Estimated Authorization Level ....................................... 595 608 448 457 468 0 

Estimated Outlays ......................................................... 305 591 629 484 469 293 

1 The 2008 level is the amount appropriated for that year for tuberculosis control activities at CDC. 

2 The 2008 level is the amount appropriated for that year for tuberculosis research at NIH. 

Note: CDC = Centers for Disease Control and Prevention, NIH = National Institutes of Health. 

Basis of estimate: S. 1551 would modify the Public Health Service Act to authorize programs to detect, prevent, and treat tuberculosis. The bill also would authorize research on new vaccines, 

treatment interventions, tests, and other tools to help eliminate tuberculosis in the United States. Those activities would be administered by the Centers for Disease Control and Prevention (CDC) and 

the National Institutes of Health (NIH). CDC’s activities would be 

authorized for fiscal years 2008 through 2012, and NIH’s activities 

would be authorized for fiscal years 2008 and 2009. This estimate 

assumes that the authorized amounts would be provided in a supplemental appropriation for 2008 and near the start of subsequent 

fiscal years, and that outlays would follow historical patterns for 

similar activities. CBO estimates that implementing S. 1551 would 

cost $11 million in 2008 and $2.2 billion over the 2009–2013 period. 

CDC’s Activities. The bill would authorize CDC to administer 

grant programs, research and demonstration programs, and research activities related to tuberculosis. Based on information provided by CDC, CBO estimates that the agency will spend $135 million of its 2008 appropriation for activities specified by the bill. In 

total, CBO estimates that the additional cost for CDC to implement 

S. 1551 would amount to $11 million in fiscal year 2008 and $2.0 

billion over the 2008–2013 period. 

The bill would authorize the appropriation of $300 million for 

2008 and such sums as may be necessary for the 2009–2012 period 

to provide grants to States, local governments, and other public entities for the prevention, control, and elimination of tuberculosis in 

the United States. CBO estimates that implementing that proviVerDate Aug 31 2005 23:01 Apr 23, 2008 Jkt 069010 PO 00000 Frm 00012 Fmt 6659 Sfmt 6602 E:\HR\OC\SR329.XXX SR329

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sion would cost $8 million in 2008 and $1.4 billion over the 2008–

2013 period, assuming appropriation of the authorized amounts. 

In addition, S. 1551 would authorize the appropriation of such 

sums as are necessary for research and demonstration programs 

that promote the elimination of tuberculosis in the United States. 

CBO estimates that the CDC would require the appropriation of an 

additional $7 million for such activities in 2008 and $134 million 

over the 2008–2012 period. Assuming the appropriation of the necessary amounts, CBO estimates that implementing that provision 

would cost less than $500,000 in 2008 and $126 million over the 

2008–2013 period. 

The bill also would authorize appropriation of $100 million for 

2008 and such sums as are necessary for the 2009–2012 period for 

research on new tools to help eliminate tuberculosis in the United 

States. The tools include vaccines, treatment, interventions, and diagnostic tests. That authorization would apply only for years in 

which the appropriated amount for other activities relating to the 

elimination of tuberculosis in the United States exceeds its level in 

2007. (For 2008, the amount appropriated for those activities was 

$6 million more than the amount appropriated for 2007.) Assuming 

that the 2007 level continues to be surpassed for those other activities, CBO estimates that implementing that provision would cost 

$3 million in 2008 and $467 million over the 2009–2013 period. 

NIH Activities. NIH estimates that it will spend $159 million on 

tuberculosis research in fiscal year 2008. S. 1551 would modify 

Title IV of the Public Health Service Act to direct the Director of 

the NIH to conduct research on tuberculosis, particularly with regard to drug-resistant tuberculosis and the relationship between 

tuberculosis and the human immunodeficiency virus. Activities 

under title IV are authorized through fiscal year 2009, so this estimate reflects an authorization of funding only for that year. Based 

on information provided by NIH, CBO expects that implementing 

S. 1551 would not have a significant effect on tuberculosis-related 

research or spending at NIH in fiscal year 2008, and would cost 

$164 million over the 2009–2013 period. 

Intergovernmental and private-sector impact: S. 1551 contains no 

intergovernmental or private-sector mandates as defined in the 

UMRA. 

Estimate prepared by: Federal Costs: Sarah Evans, Tim 

Gronniger; Impact on State, Local, and Tribal Governments: Lisa 

Ramirez-Branum; Impact on the Private Sector: Patrick Bernhardt. 

Estimate approved by: Keith J. Fontenot, Deputy Assistant Director for Health and Human Resources, Budget Analysis Division. 

VI. REGULATORY IMPACT STATEMENT

The committee has determined that there is no legislative impact. 

VII. APPLICATION OF LAW TO THE LEGISLATIVE BRANCH

The committee has determined that there will be minimal increases in the regulatory burden imposed by this bill. 


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VIII. SECTION-BY-SECTION ANALYSIS

Note on References: Except as otherwise specified, as used in the 

summary— ‘‘The Act’’ means the Public Health Service Act (PHSA), and 

references to provisions of law are provisions of the PHSA; ‘‘CDC’’ means the Centers for Disease Control and Prevention; ‘‘ACET’’ means the Advisory Council for the Elimination of 

Tuberculosis; ‘‘Task Force’’ means the Federal Tuberculosis Task Force; ‘‘Secretary’’ means the Secretary of Health and Human Services. 

Section 1. Short title 

This legislation is titled the ‘‘Comprehensive Tuberculosis Elimination Act of 2007.’’

TITLE I—DEPARTMENT OF HEALTH AND HUMAN SERVICES 

IN COORDINATION WITH THE CENTERS FOR DISEASE 

CONTROL AND PREVENTION AND OTHER APPROPRIATE 

AGENCIES 

Subtitle A—Section 101, National Strategy for Combating and 

Eliminating Tuberculosis, amends Section 317E of the PHSA 

The heading for the section is changed to the ‘‘National Strategy 

for Combating and Eliminating Tuberculosis.’’ Section 317E(b)(2) is amended to refocus the activities of regional 

capabilities on the prevention of multidrug-resistant and extensively drug-resistant strains of TB in addition to the prevention, 

control and elimination of TB. 

Section 317E(b)(2)(B) is added to provide an example of a demonstration project that would be appropriate for the CDC to conduct under this section to reduce health disparities in the incidence 

of TB. 

Section 317E(b)(2)(C) is added to provide an example of a demonstration project that would be appropriate for the CDC to conduct under this section. It calls for the intensification of efforts to 

control TB along the United States-Mexico border and among binational populations, including expanding the scope and number of 

programs to detect and treat binational cases of TB and high risk 

cases referred from Mexican health departments. 

Section 317E(b)(2)(D) is added to provide an example of a demonstration project that would be appropriate for the CDC to conduct under this section to intensify efforts to prevent, detect, and 

treat TB among foreign-born persons who are in the United States. 

Section 317E(b)(2)(E) is added to provide an example of a demonstration project that would be appropriate for the CDC to conduct under this section to intensify efforts to prevent, detect, and 

treat TB among high-risk populations and settings documented as 

having a high risk for TB. 

Section 317E(b)(2)(F) is added to clarify that TB detection, control and prevention activities are appropriate demonstration project 

activities. 

Section 317E(b)(7) is added to clarify that support should be provided for the development, enhancement and expansion of TB conVerDate Aug 31 2005 23:01 Apr 23, 2008 Jkt 069010 PO 00000 Frm 00014 Fmt 6659 Sfmt 6602 E:\HR\OC\SR329.XXX SR329

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trol surveillance and database management systems with cross-jurisdictional capabilities, and to clarify that such systems should 

conform to the standards and implementation specifications for information technologies as recommended by the Secretary. 

Section 317E(3)(A)(B) is amended such to allow priority to be 

given grant applicants that contribute non-Federal contributions to 

carry out activities under this section, which may be provided directly or through donations from public or private entities and may 

be in cash or in kind, including equipment or services. 

Section 317E(3)(A)(B), is added to allow grant applicants to provide non-Federal funds, which may be provided directly or through 

donations from public or private entities and may be cash or in 

kind, including equipment or services. (B) is added to clarify that 

amounts or services assisted or subsidized to any significant extent 

by the Federal Government may not be included in determining the 

amount of non-Federal contributions. 

Subtitle B—Interagency Collaboration 

Section 111—Advisory Council for the Elimination of Tuberculosis 

Section 317E(f)(2)(B) is amended to direct ACET to provide the 

Secretary and other appropriate Federal officials advice on responding rapidly and effectively to emerging issues in TB. 

Section 317E(f)(3)(B) is amended to direct ACET to consult with 

appropriate public and private entities, subject to the discretion of 

the Secretary, that may include: scientists, physicians, 

laboratorians, and other health professionals who represent the 

disciplines relevant to TB elimination; members of public-private 

partnerships established to address the elimination of TB; members of national and international nongovernmental organizations 

established to address TB elimination; and members of the general 

public who are knowledgeable with respect to TB elimination including individuals who have or have had TB. 

Section 317E(f)(4)(A), is amended to require ACET to submit a 

bienniel report to the Secretary on the activities carried under this 

section. The report will also include the opinion of the Council on 

the extent to which its recommendations regarding the elimination 

of TB have been implemented. 

Section 317E(f)(4)(B) is amended to require the Secretary to 

make ACET’s annual report public. 

Section 317E(f)(5)(B) is revised to specify that ACET shall include in its composition State and local TB control and public 

health officials; individuals who are scientists, physicians, 

laboratorians, and other health professionals who represent disciplines relevant to TB elimination; members of national and international nongovernmental organizations established to address the 

elimination of TB; and members from the general public who are 

knowledgeable with respect to the elimination of TB, including individuals who have or have had TB. 

Section 317E(b) is added to specify that the amendments to this 

section should not be construed as terminating the membership on 

ACET of any individual serving as such a member as of the day 

before the date of the enactment of the act. 


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New Subtitle C—New tools for tuberculosis elimination 

Section 317E(g)(1) authorizes the Secretary to expand, intensify 

and coordinate research and development and related activities to 

develop new TB elimination tools including drugs, diagnostics, vaccines and public health interventions, as well as methods to enhance detection and response to outbreaks of drug resistant TB. 

Section 317E(g)(2) establishes a Federal TB Task Force to advise 

the Secretary and other Federal officials on the development of new 

TB elimination tools including drugs, diagnostics, vaccines and 

public health interventions. 

Section 317E(g)(B) is added to direct the Task Force to make recommendations on the development of a comprehensive plan for the 

elimination of TB. Section 317E(g)(2)(C) is added to direct the Task 

Force to consult with appropriate public and private entities that 

may include: scientists, physicians, laboratorians, and other health 

professionals who represent the disciplines relevant to TB research; 

members of public-private partnerships engaged in TB research; 

members of national and international nongovernmental organizations established to address TB elimination; members of the general public who are knowledgeable with respect to TB elimination 

including individuals who have or have had TB; and health professionals from other countries with a substantial incidence of TB, 

and who represent the specialties and disciplines relevant to TB research. 

Section 317E(g)(3) is added to authorize the Secretary to award 

grants, cooperative agreements, and contracts to public and private 

entities for the provision of the research activities described in section 317E(g)(1). 

New Subtitle D—Evaluation of public health authorities 

Section 131 is added to direct the Secretary to submit a report 

to the appropriate congressional committees that evaluates the effectiveness of Federal and State public health authorities to address disease containment challenges and provides recommendations for improvement, including an evaluation of the effectiveness 

of policies to detain patients with active TB; an evaluation of the 

need for Federal laws to be strengthened to address the movement 

of infected individuals; and specific legislative recommendations for 

Federal law changes. This section also requires the Secretary to 

promulgate regulations within 8 months to update interstate and 

foreign quarantine regulations. 

Subtitle E—Authorization of appropriations 

Section 317E(h)(1)(A) authorizes $300 million in fiscal year 2008 

and such sums as may be necessary for fiscal years 2009 through 

2012 for a National Strategy for Combating and Eliminating Tuberculosis under Title I. 

Section 317E(h)(1)(B) is added to direct the Secretary to reserve 

no more than 25 percent of funds for emergency grants for geographic areas, States, political subdivisions of States or other public entities under the National Strategy for Combating and Eliminating Tuberculosis under Title 1. 

Section 317E(h)(1)(C) is added to authorize such sums as necessary for fiscal years 2008 through 2012 for research, education 


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and training activities under the National Strategy for Combating 

and Eliminating Tuberculosis under Title I. 

Section 317E(h)(1)(D) is added to direct the Secretary to distribute grants under section 317E(h)(1)(B) on the basis of a formula 

that takes into account the level of TB morbidity and case complexity in respective geographic areas and consideration of other 

factors. This section also clarifies that the Secretary may use the 

existing formula from fiscal year 2007. Section 317E(h)(2) authorizes $100 million for fiscal year 2008 

and such sums as necessary for fiscal years 2009 through 2012 for 

new tools for tuberculosis elimination, section 317E(g). 

TITLE III—NATIONAL INSTITUTES OF HEALTH 

Section 201 amends subpart 2 of part C of title IV of the PHSA 

by adding section 424C after section 424B. 

Section 424C authorizes the Director of the National Institute of 

Health to expand and intensify its TB research and development 

activities, including basic and clinical research on TB. Given the 

global health emergency of drug-resistant TB and the strong co-occurrence between TB and HIV, the committee would emphasize 

that special priority be given to research concerning drug-resistant 

TB and the relationship between TB and HIV. 

IX. CHANGES IN EXISTING LAW

In compliance with rule XXVI paragraph 12 of the Standing 

Rules of the Senate, the following provides a print of the statute 

or the part or section thereof to be amended or replaced (existing 

law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed 

is shown in roman): 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

øPREVENTIVE HEALTH SERVICES REGARDING TUBERCULOSIS¿ NA- TIONAL STRATEGY FOR COMBATING AND ELIMINATING TUBER- CULOSIS

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 certain 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). 


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ø(6) Collaboration with international organizations and foreign countries in carrying out such activities.¿ 

(b) RESEARCH AND DEVELOPMENT; DEMONSTRATION PROJECTS; 

EDUCATION AND TRAINING.—With respect to the prevention, treatment, control, and elimination of tuberculosis, the Secretary may, 

directly or through grants to public or nonprofit private entities, 

carry out the following: 

(1) Research, with priority given to research and development 

concerning latent tuberculosis infection, strains of tuberculosis 

resistant to drugs, and research concerning cases of tuberculosis 

that affect certain populations at risk for tuberculosis. 

(2) Demonstration projects for— (A) the development of regional capabilities to prevent, 

control and eliminate tuberculosis and prevent multidrug 

resistant and extensively drug resistant strains of tuberculosis; 

(B) the intensification of efforts to reduce health disparities in the incidence of tuberculosis; 

(C) the intensification of efforts to control tuberculosis 

along the United States-Mexico border and among United 

States-Mexico binational populations, including through 

expansion of the scope and number of programs that—

(i) detect and treat binational cases of tuberculosis; 

and 

(ii) treat high-risk cases of tuberculosis referred from 

Mexican health departments; 

(D) the intensification of efforts to prevent, detect, and 

treat tuberculosis among foreign-born persons who are in 

the United States; 

(E) the intensification of efforts to prevent, detect, and 

treat tuberculosis among populations and settings documented as having a high risk for tuberculosis; and 

(F) tuberculosis detection, control, and prevention. 

(3) Public information and education activities. 

(4) Education, training, clinical skills improvement activities, 

and workplace exposure prevention for health professionals, including allied health personnel and emergency response employees. 

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

(6) Collaboration with international organizations and foreign countries in carrying out such activities. 

(7) Develop, enhance, and expand information technologies 

that support tuberculosis control including surveillance and 

database management systems with cross-jurisdictional capabilities, which shall conform to the standards and implementation specifications for such information technologies as recommended by the Secretary. 

* * * * * * * 

(d) APPLICATION FOR GRANT.—

(1) IN GENERAL.—* * * 

* * * * * * * 

(3) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTIONS.—


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(A) PRIORITY.—In awarding grants under subsection (a) 

or (b), the Secretary shall give highest priority to an applicant that provides assurances that the applicant will contribute non-Federal funds to carry out activities under this 

section, which may be provided directly or through donations from public or private entities and may be in cash or 

in kind, including equipment or services. 

(B) FEDERAL AMOUNTS NOT TO BE INCLUDED AS CON- TRIBUTIONS.—Amounts provided by the Federal Government, or services assisted or subsidized to any significant 

extent by the Federal Government, may not be included in 

determining the amount of non-Federal contributions as described in subparagraph (A). 

* * * * * * * 

(f) ADVISORY COUNCIL.— (1) IN GENERAL.— * * * 

* * * * * * * 

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.—The Council shall provide advice and recommendations regarding the elimination of tuberculosis to the 

Secretary. In addition, the Council shall, with respect to eliminating such disease, provide to the Secretary and other appropriate Federal officials advice on—

(A) coordinating the activities of the Department of 

Health and Human Services and other Federal agencies 

that relate to the disease, including activities under subsection (b); 

(B) responding rapidly and effectively to emerging issues 

in tuberculosis; and 

(C) efficiently utilizing the Federal resources involved. 

(3) COMPREHENSIVE PLAN.—

(A) IN GENERAL.—In carrying out paragraph (2), the 

Council shall make or update recommendations on the development, revision, and implementation of a comprehensive plan to eliminate tuberculosis in the United States. 

(B) CONSULTATION.—In carrying out subparagraph (A), 

the Council may consult with appropriate public and private entities, which may, subject to the direction or discretion of the Secretary, include—


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(i) individuals who are scientists, physicians, 

laboratorians, and other health professionals, who are 

not officers or employees of the Federal Government 

and who represent the disciplines relevant to tuberculosis elimination; 

(ii) members of public-private partnerships or private 

entities established to address the elimination of tuberculosis; 

(iii) members of national and international nongovernmental organizations whose purpose is to eliminate tuberculosis; and 

(iv) members from the general public who are knowledgeable with respect to tuberculosis elimination including individuals who have or have had tuberculosis. 

(C) CERTAIN COMPONENTS OF PLAN.—In carrying out subparagraph (A), the Council shall, subject to the direction or 

discretion of the Secretary—

(i) consider recommendations for the involvement of 

the United States in continuing global and cross-border tuberculosis control activities in countries where a 

high incidence of tuberculosis directly affects the 

United States; and 

(ii) review the extent to which progress has been 

made toward eliminating tuberculosis. 

(4) BIENNIAL REPORT.—

(A) IN GENERAL.—The Council shall submit a biennial 

report to the Secretary, as determined necessary by the Secretary, on the activities carried under this section, other 

than subsection (g). Each such report shall include the 

opinion of the Council on the extent to which its recommendations regarding the elimination of tuberculosis 

have been implemented, including with respect to—

(i) activities under subsection (b); and 

(ii) the national plan referred to in paragraph (3). 

(B) PUBLIC.—The Secretary shall make a report submitted under subparagraph (A) public. 

(5) COMPOSITION.—The Council shall be composed of—

(A) ex officio representatives from the Centers for Disease 

Control and Prevention, the National Institutes of Health, 

the United States Agency for International Development, 

the Agency for Healthcare Research and Quality, the 

Health Resources and Services Administration, the United 

States-Mexico Border Health Commission, and other Federal departments and agencies that carry out significant 

activities related to tuberculosis; 

(B) State and local tuberculosis control and public health 

officials; 

(C) individuals who are scientists, physicians, 

laboratorians, and other health professionals who represent 

disciplines relevant to tuberculosis elimination; and 

(D) members of national and international nongovernmental organizations established to address the elimination 

of tuberculosis. 


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ø(5)¿ (6) STAFF, INFORMATION, AND OTHER ASSISTANCE.—

* * * 

* * * * * * * 

(g) NEW TOOLS FOR ELIMINATION OF TUBERCULOSIS.—

(1) RESEARCH AND DEVELOPMENT ON DRUGS, DIAGNOSTICS, 

VACCINES, AND PUBLIC HEALTH INTERVENTIONS.—The Secretary 

may expand, intensify, and coordinate research and development and related activities to develop new tools for the elimination of tuberculosis, including drugs, diagnostics, vaccines, 

and public health interventions, such, as directly observed therapy and non-pharmaceutical intervention, and methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis. The Secretary shall 

give priority to programmatically relevant research so that new 

tools can be utilized in public health practice. 

(2) FEDERAL TUBERCULOSIS TASK FORCE.—

(A) DUTIES.—The Federal Tuberculosis Task Force (in 

this subsection referred to as the Task Force) shall provide 

to the Secretary and other appropriate Federal officials advice on the implementation of paragraph (1), including advice regarding the efficient utilization of the Federal resources involved. 

(B) COMPREHENSIVE PLAN FOR NEW TOOLS DEVELOPMENT.—In carrying out paragraph (1), the Task Force shall 

make recommendations on the development of a comprehensive plan for the creation of new tools for the elimination 

of tuberculosis, including drugs, diagnostics, and vaccines. 

(C) CONSULTATION.—In developing the comprehensive 

plan under paragraph (1), the Task Force shall consult 

with external parties including representatives from groups 

such as—

(i) scientists, physicians, laboratorians, and other 

health professionals who represent the specialties and 

disciplines relevant to the research under consideration; 

(ii) members from public-private partnerships, private entities, or foundations (or both) engaged in activities relevant to research under consideration; 

(iii) members of national and international nongovernmental organizations established to address tuberculosis elimination; 

(iv) members from the general public who are knowledgeable with respect to tuberculosis including individuals who have or have had tuberculosis; and 

(v) scientists, physicians, laboratorians, and other 

health professionals who reside in a foreign country 

with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and disciplines relevant to the research under consideration. 

(3) GRANTS AND CONTRACTS.—The Secretary may carry out 

paragraph (1) directly and through awards of grants, cooperative agreements, and contracts to public and private entities, including—

(A) public-private partnerships; 


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(B) academic institutions, including institutions of higher 

education; 

(C) research institutions; and 

(D) nonprofit entities established and dedicated to tuberculosis vaccine and treatment product development. 

* * * * * * * 

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.¿ 

(h) AUTHORIZATION OF APPROPRIATIONS.—

(1) GENERAL PROGRAM.—

(A) IN GENERAL.—For the purpose of carrying out this 

section, other than subsections (b) and (g), there are authorized to be appropriated $300,000,000 for fiscal year 2008, 

and such sums as may be necessary for each of the fiscal 

years 2009 through 2012. 

(B) RESERVATION FOR EMERGENCY GRANTS.—Of the 

amounts appropriated under subparagraph (A) for a fiscal 

year, the Secretary may reserve not More than 25 percent 

for emergency grants under subsection (a) for any geographic area, State, political subdivision of a State, or 

other public entity in which there is, relative to other areas, 

a substantial number of cases of tuberculosis, multidrug resistant tuberculosis, or extensively drug resistant tuberculosis or a substantial rate of increase in such cases. 

(C) RESEARCH, DEMONSTRATION PROJECTS, EDUCATION, and TRAINING.—For the purpose of carrying out subsection 

(b), there are authorized to be appropriated such sums as 

may be necessary for each of fiscal years 2008 through 

2012. 

(D) PRIORITY.—In allocating amounts appropriated 

under subparagraph (A) and not reserved under subparagraph (B), the Secretary shall give priority to allocating 

such amounts for grants under subsection (a). 

(E) ALLOCATION OF FUNDS.—

(i) REQUIREMENT OF FORMULA.—Of the amounts appropriated under subparagraph (A), not reserved under 

subparagraph (B), and allocated by the Secretary for 

grants under subsection (a), the Secretary shall distribute a portion of such amounts to grantees under 

subsection (a) on the basis of a formula. 


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(ii) RELEVANT FACTORS.—The formula developed by 

the Secretary under clause (i) shall take into account 

the level of tuberculosis morbidity and case complexity 

in the respective geographic area and may consider 

other factors relevant to tuberculosis in such area. 

(iii) NO CHANGE TO FORMULA REQUIRED.—This subparagraph does not require the Secretary to modify the 

formula that was used by the Secretary to distribute 

funds to grantees under subsection (a) for fiscal year 

2007. 

(2) NEW TOOLS.— (A) IN GENERAL.—For the purpose of carrying out subsection (g), there are authorized to be appropriated 

$100,000,000 for fiscal year 2008, and such sums as may 

be necessary for each of the fiscal years 2009 through 2012. 

(B) LIMITATION.—The authorization of appropriations established in subparagraph (A) for a fiscal year is effective 

only if the amount appropriated under paragraph (1) for 

such year equals or exceeds the amount appropriated to 

carry out this section for fiscal year 2007. 

* * * * * * * 

TITLE IV—NATIONAL RESEARCH INSTITUTES 

PART A—NATIONAL INSTITUTES OF HEALTH

* * * * * * * 

PART C—SPECIFIC PROVISIONS RESPECTING NATIONAL RESEARCH

INSTITUTES

Subpart 1—National Cancer Institute 

* * * * * * * 

Subpart 2—National Heart, Lung, and Blood Institute 

PURPOSE OF THE INSTITUTE

SEC. 418. ø285b¿ * * * 

* * * * * * * 

COORDINATION OF FEDERAL ASTHMA ACTIVITIES

SEC. 424B. ø285b–7b¿ (a) IN GENERAL.—* * * 

* * * * * * * 

SEC. 424C. TUBERCULOSIS. 

(a) IN GENERAL.—The Director of the National Institutes of 

Health may expand, intensify, and coordinate research and development and related activities of the Institute with respect to tuberculosis including activities toward the goal of eliminating such disease. 

(b) CERTAIN ACTIVITIES.—Activities under subsection (a) may include—

(1) enhancing basic and clinical research on tuberculosis, including drug resistant tuberculosis; and 


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(2) expanding research on the relationship between such disease and the human immunodeficiency virus. 

* * * * * * * 

Æ 


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