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69-006

110TH CONGRESS

REPORT

HOUSE OF REPRESENTATIVES

2d Session

110-873

--COMPREHENSIVE TUBERCULOSIS ELIMINATION ACT OF 2008

SEPTEMBER 23, 2008- Committed to the Committee of the Whole House on the State of the Union and ordered to be printed

Mr. DINGELL, from the Committee on Energy and Commerce, submitted the following

R E P O R T

[To accompany H.R. 1532]

[Including cost estimate of the Congressional Budget Office]

The Committee on Energy and Commerce, to whom was referred the bill (H.R. 1532) 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, report favorably thereon with an amendment and recommend that the bill as amended do pass.

CONTENTS Page
Amendment 2
Purpose and Summary 6
Background and Need for Legislation 6
Hearings 7
Committee Consideration 7
Committee Votes 7
Committee Oversight Findings 7
Statement of General Performance Goals and Objectives 7
New Budget Authority, Entitlement Authority, and Tax Expenditures 8
Earmarks and Tax and Tariff Benefits 8
Committee Cost Estimate 8
Congressional Budget Office Estimate 8
Federal Mandates Statement 9
Advisory Committee Statement 9
Constitutional Authority Statement 9
Applicability to Legislative Branch 9
Section-by-Section Analysis of the Legislation 9
Changes in Existing Law Made by the Bill, as Reported 12

AMENDMENT

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

Sec. 1. Short title; table of contents.
TITLE I--DEPARTMENT OF HEALTH AND HUMAN SERVICES IN COORDINATION WITH THE CENTERS FOR DISEASE CONTROL AND PREVENTION AND OTHER APPROPRIATE AGENCIES
Subtitle A--National Strategy for Combating and Eliminating Tuberculosis
Sec. 101. National strategy.
Subtitle B--Interagency Collaboration
Sec. 111. Advisory Council for Elimination of Tuberculosis and the Federal Tuberculosis Task Force .
Subtitle C--Evaluation of Public Health Authorities
Sec. 121. Evaluation of public health authorities.
Subtitle D--Authorization of Appropriations
Sec. 131. Authorizations of appropriations.
TITLE II--NATIONAL INSTITUTES OF HEALTH
Sec. 201. Research and development concerning tuberculosis.

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

Subtitle A--National Strategy for Combating and Eliminating Tuberculosis

SEC. 101. NATIONAL STRATEGY.

Subtitle B--Interagency Collaboration

SEC. 111. ADVISORY COUNCIL FOR ELIMINATION OF TUBERCULOSIS AND THE FEDERAL TUBERCULOSIS TASK FORCE.

Subtitle C--Evaluation of Public Health Authorities

SEC. 121. EVALUATION OF PUBLIC HEALTH AUTHORITIES.

Subtitle D--Authorization of Appropriations

SEC. 131. AUTHORIZATIONS OF APPROPRIATIONS.

TITLE II--NATIONAL INSTITUTES OF HEALTH

SEC. 201. RESEARCH AND DEVELOPMENT CONCERNING TUBERCULOSIS.

`SEC. 424C. TUBERCULOSIS.

PURPOSE AND SUMMARY

The purpose of H.R. 1532, the Comprehensive Tuberculosis Elimination Act of 2008, is to amend the Public Health Service Act with respect to making progress toward the goal of eliminating tuberculosis, and for other purposes.

BACKGROUND AND NEED FOR LEGISLATION

Tuberculosis (TB), a chronic bacterial infection, continues to be a worldwide problem. Tuberculosis is spread through the air when an infected person coughs, sneezes, or speaks. It usually infects the lungs; however, it can also damage other parts of the body. Nearly 2 billion people, including 10 to 15 million in the United States, are infected and approximately 8 million new cases and 1.6 million tuberculosis deaths are reported globally each year. Tuberculosis causes more deaths than any other infectious disease caused by a single microorganism. Tuberculosis is the leading cause of death among the 40 million people living with human immunodeficiency virus (HIV), approximately one-third of whom are co-infected with TB.

An emerging public health concern is the increase in the number of cases of multidrug-resistant tuberculosis, a form of the disease that is resistant to several of the standard therapeutic drugs. Recently, there has also been an increase in the number of cases of extensively drug-resistant tuberculosis, which is resistant to four or more standard drugs.

A May 2000 Institute for Medicine (IOM) report entitled `Ending Neglect: The Elimination of Tuberculosis in the U.S.' found that the resurgence of tuberculosis in the late 1980s and early 1990s was largely due to Federal funding reductions. According to the Centers for Disease Control and Prevention (CDC), however, intensive efforts brought the disease under control again and the Nation is back on track toward its goal of eliminating tuberculosis. In 2006, the lowest number of U.S. cases (13,779) was reported. Since the 1992 TB resurgence peak in the United States, the number of TB cases reported annually has decreased by 48 percent. In addition, the case rate is the lowest ever, at 4.6 cases per 100,000 people. Yet, the high global burden of disease, coupled with continued problems of drug-resistant strains and a failure to develop better tools for TB control, threaten our ability to eliminate TB in the U.S. and hamper efforts to control TB globally as the decreasing trend in the annual case rate has slowed from an annual average decline of 6.6 percent for 1993 through 2002 to an annual average decline of 3.1 percent for 2003 through 2006.

The IOM report also stated that proper funding, the organization of prevention and control activities, and the research and development of new tools could eliminate tuberculosis as a public health problem in the U.S. As a result, research aimed at the diagnosis, treatment, and prevention of all forms of tuberculosis and the care of infected individuals continues to be of interest to Congress.

HEARINGS

No hearings were held in connection with H.R. 1532.

COMMITTEE CONSIDERATION

On Wednesday, September 17, 2008, the full Committee met in open markup session and ordered H.R. 1532 favorably reported to the House, amended, by a voice vote.

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion to report legislation and amendments thereto. No record votes were taken on amendments or in connection with ordering H.R. 1532 reported to the House. A motion by Mr. Dingell to order H.R. 1532 favorably reported to the House, amended, was agreed to by a voice vote.

COMMITTEE OVERSIGHT FINDINGS

Regarding clause 3(c)(1) of rule XIII of the Rules of the House of Representatives, the oversight findings of the Committee regarding H.R. 1532 are reflected in this report.

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

The objective of H.R. 1532 is to amend the Public Health Service Act to (1) reauthorize and modify a grant program for the prevention, treatment, control, and elimination of tuberculosis; (2) create a new Federal Tuberculosis Task Force; and (3) encourage the Director of the National Institutes of Health (NIH) to expand, intensify, and coordinate research and development and related activities with respect to tuberculosis, including activities related to the goal of eliminating the disease.

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX EXPENDITURES

Regarding compliance with clause 3(c)(2) of rule XIII of the Rules of the House of Representatives, the Committee finds that H.R. 1532 would result in no new or increased budget authority, entitlement authority, or tax expenditures or revenues.

EARMARKS AND TAX AND TARIFF BENEFITS

Regarding compliance with clause 9 of rule XXI of the Rules of the House of Representatives, H.R. 1532 does not contain any congressional earmarks, limited tax benefits, or limited tariff benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate on H.R. 1532 prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974.

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House of Representatives, the following is the cost estimate on H.R. 1532 provided by the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974:

U.S. Congress,

Congressional Budget Office,

Washington, DC, September 22, 2008.

Hon. JOHN D. DINGELL,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 1532, the Comprehensive Tuberculosis Elimination Act of 2008.

If you wish further details on this estimate, we will be pleased to provide them. The CBO staff contact is Jamease Kowalczyk.

Sincerely,

Robert A. Sunshine

(For Peter R. Orszag, Director).

Enclosure.

H.R. 1532--Comprehensive Tuberculosis Elimination Act of 2008

H.R. 1532 would authorize the Secretary of Health and Human Services to conduct planning, research, and development activities to detect, treat, and eliminate tuberculosis, and to provide grants to public or nonprofit entities to carry out related research and development activities. The bill also would direct the Secretary to issue updated regulations regarding quarantine for communicable diseases.

The bill would authorize the appropriation of $300 million for fiscal year 2009 and about $1.7 billion for the 2009-2013 period. Based on past spending for similar activities, CBO estimates that implementing H.R. 1532 would cost $111 million in 2009 and about $1.3 billion over the 2009-2013 period, assuming the appropriation of authorized amounts. Enacting H.R. 1532 would have no effect on direct spending or receipts. Costs of the legislation fall within budget function 550 (health). 



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                                             By fiscal year, in millions of dollars--                               


                                                                                 2009 2010 2011 2012 2013 2009-2013 


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CHANGES IN SPENDING SUBJECT TO APPROPRIATION                                                                        


Authorization Level                                                               300  315  331  347  365     1,658 


Estimated Outlays                                                                 111  253  302  327  347     1,340 


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H.R. 1532 contains no intergovernmental or private-sector mandates as defined in Unfunded Mandates Reform Act.

The CBO staff contact for this estimate is Jamease Kowalczyk, who can be reached at 226-9010. This estimate was approved by Keith J. Fontenot, Deputy Assistant Director for Health and Human Resources, Budget Analysis Division.

FEDERAL MANDATES STATEMENT


The Committee adopts as its own the estimate of Federal mandates regarding H.R. 1532 prepared by the Director of the Congressional Budget Office pursuant to section 423 of the Unfunded Mandates Reform Act.

ADVISORY COMMITTEE STATEMENT


No advisory committees within the meaning of section 5(b) of the Federal Advisory Committee Act would be created by H.R. 1532.

CONSTITUTIONAL AUTHORITY STATEMENT


Pursuant to clause 3(d)(1) of rule XIII of the Rules of the House of Representatives, the Committee finds that the Constitutional authority for H.R. 1532 is provided in the provisions of Article I, section 8, clause 1, that relate to expending funds to provide for the general welfare of the United States.

APPLICABILITY TO LEGISLATIVE BRANCH


The Committee finds that H.R. 1532 does not relate to the terms and conditions of employment or access to public services or accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act of 1995.

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION


Section 1. Short title; table of contents

Section establishes the short title of the bill as the `Comprehensive Tuberculosis Elimination Act of 2008', and also provides the table of contents.

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


SUBTITLE A--NATIONAL STRATEGY FOR COMBATING AND ELIMINATING TUBERCULOSIS


Section 101. National strategy

Section 101 amends Section 317E of the Public Health Service Act (42 U.S.C. 247b-6) to strike the existing title and replace it with, `National Strategy for Combating and Eliminating Tuberculosis.'

In addition, section 101 states that, 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 additional activities including (1) research and development, with priority given to projects concerning latent tuberculosis infection, strains of tuberculosis resistant to drugs, and cases of tuberculosis that affect certain at-risk populations and (2) research and development and related activities concerning the development of new tools for the elimination of tuberculosis, such as directly observed therapy and non-pharmaceutical intervention and methods to enhance detection and response to outbreaks of tuberculosis. In doing so, the Secretary is encouraged to give priority to programmatically relevant research.

Section 101 states that demonstration projects shall be for the development of regional capabilities to prevent, control, and eliminate tuberculosis and prevent multidrug-resistant and extensively drug-resistant strains of tuberculosis. In addition, demonstration projects shall be for the intensification of efforts to reduce disparities in the incidence of tuberculosis among United States-Mexico bi-national populations and to control tuberculosis along the United States-Mexico border. Demonstration projects shall also be for the intensification of efforts to prevent, detect, and treat tuberculosis among foreign-born persons who are living in the United States and among other high-risk populations and settings.

Section 101 also requires that, with respect to the prevention, treatment, control, and elimination of tuberculosis, the Secretary may carry out activities relating to workplace exposure prevention for health professionals. The Secretary may also develop, enhance, and expand information technologies that support tuberculosis control such as surveillance and database management systems with cross-jurisdictional capabilities.

In awarding grants in this section, the Secretary shall give highest priority to an applicant that provides assurances that they will contribute non-Federal funds to carry out the activities. These non-Federal funds may be provided directly or through donations from public or private entities and may be in cash or in kind, including equipment and services. Finally, section 101 clarifies that 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.

SUBTITLE B--INTERAGENCY COLLABORATION


Section 111. Advisory Council for Elimination of Tuberculosis and the Federal Tuberculosis Task Force

Section 111 amends section 317E(f) of the Public Health Service Act (42 U.S.C. 247b-6(f)) by modifying the structure and duties of the Advisory Council for the Elimination of Tuberculosis. Section 111 establishes both the composition of the Advisory Council and the specific duties for the Advisory Council, which include providing advice and recommendations regarding the elimination of tuberculosis to the Secretary. In addition, the Advisory Council shall provide advice on coordinating the activities of Federal agencies that relate to tuberculosis, respond rapidly and effectively to emerging issues relating to tuberculosis, and efficiently utilize the Federal resources involved.

Section 111 establishes a Comprehensive Plan which requires the Advisory Council to make or update recommendations on the development, revision, and implementation of a strategy to eliminate tuberculosis in the United States. In carrying out this task, the Advisory Council may consult with appropriate public and private entities, subject to the direction or discretion of the Secretary. In addition, the Advisory Council shall, subject to the discretion of the Secretary, consider recommendations for continuing the involvement of the United States in global and cross-border tuberculosis control activities in countries where a high incidence of tuberculosis directly affects the United States. The Advisory Council shall review the extent to which progress has been made toward eliminating tuberculosis with regard to these cross-border control activities.

Section 111 requires the Advisory Council to submit a biennial report to the Secretary, if the Secretary determines it necessary, on the activities carried out under this section. The report shall include the opinion of the Advisory Council on the extent to which its recommendations regarding the elimination of tuberculosis have been implemented. The Secretary shall make this report public.

Section 111 creates a Federal Tuberculosis Task Force. The Task Force is required to provide the Secretary, and other appropriate Federal officials, advice on research into new tools for the elimination of tuberculosis, including advice regarding the efficient utilization of the Federal resources involved. In carrying out these activities, 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. In developing this comprehensive plan, the Task Force shall consult with external parties.

SUBTITLE C--EVALUATION OF PUBLIC HEALTH AUTHORITIES


Section 121. Evaluation of public health authorities

Section 121 requires the HHS Secretary to prepare and submit a report to Congress, which evaluates and provides recommendations on changes needed to Federal and State public health authorities to address current disease containment challenges such as isolation and quarantine. The report shall include an evaluation of the effectiveness of current policies to detain patients with active tuberculosis, an evaluation of whether Federal laws should be strengthened to expressly address the movement of individuals with active tuberculosis, and specific legislative recommendations for changes to Federal laws, if any. This report shall be submitted to Congress no later than 180 days after the date of enactment of this Act.

In addition, Section 121 requires the Secretary of HHS to promulgate regulations to update current interstate and foreign quarantine regulations within 240 days of the date of enactment of this Act.

SUBTITLE D--AUTHORIZATION OF APPROPRIATIONS


Section 131. Authorization of appropriations

Section 131 amends section 317E of the Public Health Service Act to provide updated and modified authorization of appropriations. Section 131 authorizes to be appropriated $300,000,000 for fiscal year 2009 with 5 percent increases per year for each of fiscal years 2010 through 2013. Of amounts appropriated for a fiscal year, the Secretary may reserve not more than 25 percent for emergency grants.

TITLE II--NATIONAL INSTITUTES OF HEALTH


Section 201. Research and development concerning tuberculosis

Section 201 amends Subpart 2 of part C of title IV of the Public Health Service Act (42 U.S.C. 285b et seq.) to include a new section which states that the Director of the National Institutes of Health (NIH) may expand, intensify, and coordinate research and development and related activities of the Institutes with respect to tuberculosis, including activities related to the goal of eliminating the disease. Such activities may include enhancing basic and clinical research on tuberculosis, expanding research on the relationship between tuberculosis and the human immunodeficiency virus, and developing new tools for the elimination of tuberculosis, including public health interventions and methods to enhance detection and response to outbreaks of tuberculosis.

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED




PUBLIC HEALTH SERVICE ACT


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TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE


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PART B--FEDERAL-STATE COOPERATION


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 [Struck out->][ PREVENTIVE HEALTH SERVICES REGARDING TUBERCULOSIS ][<-Struck out]


NATIONAL STRATEGY FOR COMBATING AND ELIMINATING TUBERCULOSIS




















































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TITLE IV--NATIONAL RESEARCH INSTITUTES


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PART C--SPECIFIC PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES


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SEC. 424C. TUBERCULOSIS.












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