[House Report 110-873]
[From the U.S. Government Publishing Office]






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

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

  (a) Short Title.--This Act may be cited as the ``Comprehensive 
Tuberculosis Elimination Act of 2008''.
  (b) Table of Contents.--The table of contents for this Act is as 
follows:

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.

  Section 317E of the Public Health Service Act (42 U.S.C. 247b-6) is 
amended--
          (1) by striking the heading for the section and inserting the 
        following: ``national strategy for combating and eliminating 
        tuberculosis'';
          (2) by amending subsection (b) to read as follows:
  ``(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) 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 is encouraged to give 
        priority to programmatically relevant research so that new 
        tools can be utilized in public health practice.
          ``(3) 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.
          ``(4) Public information and education activities.
          ``(5) Education, training, clinical skills improvement 
        activities, and workplace exposure prevention for health 
        professionals, including allied health personnel and emergency 
        response employees.
          ``(6) Support of Centers to carry out activities under 
        paragraphs (1) through (4).
          ``(7) Collaboration with international organizations and 
        foreign countries in carrying out such activities.
          ``(8) 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.''; and
          (3) in subsection (d), by adding at the end the following:
          ``(3) Determination of amount of nonfederal contributions.--
                  ``(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 
                contributions.--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).''.

                 Subtitle B--Interagency Collaboration

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

  (a) In General.--Section 317E(f) of the Public Health Service Act (42 
U.S.C. 247b-6(f)) is amended--
          (1) by redesignating paragraph (5) as paragraph (6); and
          (2) by striking paragraphs (2) through (4), and inserting the 
        following:
          ``(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--
                          ``(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;
                          ``(iv) members from the general public who 
                        are knowledgeable with respect to tuberculosis 
                        elimination 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.
                  ``(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. 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.''.
  (b) Rule of Construction Regarding Current Membership.--With respect 
to the advisory council under section 317E(f) of the Public Health 
Service Act, the amendments made by subsection (a) may not be construed 
as terminating the membership on such council of any individual serving 
as such a member as of the day before the date of the enactment of this 
Act.
  (c) Federal Tuberculosis Task Force.--Section 317E of the Public 
Health Service Act (42 U.S.C. 247b-6) is amended--
          (1) by redesignating subsection (g) as subsection (h); and
          (2) by inserting after subsection (f) the following 
        subsection:
  ``(g) Federal Tuberculosis Task Force.--
          ``(1) 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 
        research into new tools under subsection (b)(2), including 
        advice regarding the efficient utilization of the Federal 
        resources involved.
          ``(2) 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.
          ``(3) Consultation.--In developing the comprehensive plan 
        under paragraph (1), the Task Force shall consult with external 
        parties including representatives from groups such as--
                  ``(A) scientists, physicians, laboratorians, and 
                other health professionals who represent the 
                specialties and disciplines relevant to the research 
                under consideration;
                  ``(B) members from public-private partnerships, 
                private entities, or foundations (or both) engaged in 
                activities relevant to research under consideration;
                  ``(C) members of national and international 
                nongovernmental organizations established to address 
                tuberculosis elimination;
                  ``(D) members from the general public who are 
                knowledgeable with respect to tuberculosis including 
                individuals who have or have had tuberculosis; and
                  ``(E) 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.''.

          Subtitle C--Evaluation of Public Health Authorities

SEC. 121. EVALUATION OF PUBLIC HEALTH AUTHORITIES.

  (a) In General.--Not later than 180 days after the date of enactment 
of the Comprehensive Tuberculosis Elimination Act of 2008, the 
Secretary of Health and Human Services shall prepare and submit to the 
appropriate committees of Congress a report that 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.
  (b) Contents of Evaluation.--The report described in subsection (a) 
shall include--
          (1) an evaluation of the effectiveness of current policies to 
        detain patients with active tuberculosis;
          (2) an evaluation of whether Federal laws should be 
        strengthened to expressly address the movement of individuals 
        with active tuberculosis; and
          (3) specific legislative recommendations for changes to 
        Federal laws, if any.
  (c) Update of Quarantine Regulations.--Not later than 240 days after 
the date of enactment of this Act, the Secretary of Health and Human 
Services shall promulgate regulations to update the current interstate 
and foreign quarantine regulations found in parts 70 and 71 of title 
42, Code of Federal Regulations.

              Subtitle D--Authorization of Appropriations

SEC. 131. AUTHORIZATIONS OF APPROPRIATIONS.

  Section 317E of the Public Health Service Act, as amended by section 
111(c) of this Act, is amended by striking subsection (h) and inserting 
the following:
  ``(h) Authorization of Appropriations.--
          ``(1) General program.--
                  ``(A) In general.--For the purpose of carrying out 
                this section, there are authorized to be appropriated 
                $300,000,000 for fiscal year 2009, $315,000,000 for 
                fiscal year 2010, $330,750,000 for fiscal year 2011, 
                $347,287,500 for fiscal year 2012, and $364,651,900 for 
                fiscal year 2013.
                  ``(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) Priority.--In allocating amounts appropriated 
                under subparagraph (A), the Secretary shall give 
                priority to allocating such amounts for grants under 
                subsection (a).
                  ``(D) 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.
                          ``(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 2009.
          ``(2) Limitation.--The authorization of appropriations 
        established in paragraph (1) for a fiscal year is effective 
        only if the amount appropriated under such paragraph for such 
        year equals or exceeds the amount appropriated to carry out 
        this section for fiscal year 2009.''.

                TITLE II--NATIONAL INSTITUTES OF HEALTH

SEC. 201. RESEARCH AND DEVELOPMENT CONCERNING TUBERCULOSIS.

  Subpart 2 of part C of title IV of the Public Health Service Act (42 
U.S.C. 285b et seq.) is amended by inserting after section 424B the 
following section:

``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 Institutes 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;
          ``(2) expanding research on the relationship between such 
        disease and the human immunodeficiency virus; and
          ``(3) developing new tools for the elimination of 
        tuberculosis, including public health interventions and methods 
        to enhance detection and response to outbreaks of tuberculosis, 
        including multidrug resistant 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).

----------------------------------------------------------------------------------------------------------------
                                                                    By fiscal year, in millions of dollars--
                                                              --------------------------------------------------
                                                                2009    2010    2011    2012    2013   2009-2013
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Authorization Level..........................................     300     315     331     347     365      1,658
Estimated Outlays............................................     111     253     302     327     347      1,340
----------------------------------------------------------------------------------------------------------------

    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

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (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




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

           *       *       *       *       *       *       *



Part B--Federal-State Cooperation

           *       *       *       *       *       *       *



          [PREVENTIVE HEALTH SERVICES REGARDING TUBERCULOSIS]

      NATIONAL STRATEGY FOR COMBATING AND ELIMINATING TUBERCULOSIS

  Sec. 317E. (a) * * *
  [(b) Research, Demonstration Projects, Education, and 
Training.--With respect to the prevention, control, and 
elimination of tuberculosis, the Secretary may, directly or 
through grants to public or nonprofit private entities, carry 
out the following:
          [(1) Research, with priority given to research 
        concerning strains of tuberculosis resistant to drugs 
        and research concerning cases of tuberculosis that 
        affect certain populations.
          [(2) Demonstration projects.
          [(3) Public information and education programs.
          [(4) Education, training, and clinical skills 
        improvement activities for health professionals, 
        including allied health personnel and emergency 
        response employees.
          [(5) Support of centers to carry out activities under 
        paragraphs (1) through (4).
          [(6) Collaboration with international organizations 
        and foreign countries in carrying out such activities.]
  (b) Research 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) 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 is encouraged to 
        give priority to programmatically relevant research so 
        that new tools can be utilized in public health 
        practice.
          (3) 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.
          (4) Public information and education activities.
          (5) Education, training, clinical skills improvement 
        activities, and workplace exposure prevention for 
        health professionals, including allied health personnel 
        and emergency response employees.
          (6) Support of Centers to carry out activities under 
        paragraphs (1) through (4).
          (7) Collaboration with international organizations 
        and foreign countries in carrying out such activities.
          (8) 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) * * *

           *       *       *       *       *       *       *

          (3) Determination of amount of nonfederal 
        contributions.--
                  (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 
                contributions.--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) * * *
          [(2) General duties.--The Council shall provide 
        advice and recommendations regarding the elimination of 
        tuberculosis to the Secretary, the Assistant Secretary 
        for Health, and the Director of the Centers for Disease 
        Control and Prevention.
          [(3) Certain activities.--With respect to the 
        elimination of tuberculosis, the Council shall--
                  [(A) in making recommendations under 
                paragraph (2), make recommendations regarding 
                policies, strategies, objectives, and 
                priorities;
                  [(B) address the development and application 
                of new technologies; and
                  [(C) review the extent to which progress has 
                been made toward eliminating tuberculosis.
          [(4) Composition.--The Secretary shall determine the 
        size and composition of the Council, and the frequency 
        and scope of official meetings of the Council.]
          (2) Duties.--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--
                          (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;
                          (iv) members from the general public 
                        who are knowledgeable with respect to 
                        tuberculosis elimination 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.
                  (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. 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.
          [(5)] (6) Staff, information, and other assistance.--
        The Secretary shall provide to the Council such staff, 
        information, and other assistance as may be necessary 
        to carry out the duties of the Council.
  [(g) Funding.--
          [(1) In general; allocation for emergency grants.--
                  [(A) For the purpose of making grants under 
                subsection (a), there are authorized to be 
                appropriated $200,000,000 for fiscal year 1994, 
                and such sums as may be necessary for each of 
                the fiscal years 1995 through 2002.
                  [(B) Of the amounts appropriated under 
                subparagraph (A) for a fiscal year, the 
                Secretary may reserve not more than 25 percent 
                for emergency grants under subsection (a) for 
                any geographic area in which there is, relative 
                to other areas, a substantial number of cases 
                of tuberculosis or a substantial rate of 
                increase in such cases.
          [(2) Research, demonstration projects, education, and 
        training.--For the purpose of carrying out subsection 
        (b), there are authorized to be appropriated such sums 
        as may be necessary for each of the fiscal years 1994 
        through 2002.]
  (g) Federal Tuberculosis Task Force.--
          (1) 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 research into new tools 
        under subsection (b)(2), including advice regarding the 
        efficient utilization of the Federal resources 
        involved.
          (2) 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.
          (3) Consultation.--In developing the comprehensive 
        plan under paragraph (1), the Task Force shall consult 
        with external parties including representatives from 
        groups such as--
                  (A) scientists, physicians, laboratorians, 
                and other health professionals who represent 
                the specialties and disciplines relevant to the 
                research under consideration;
                  (B) members from public-private partnerships, 
                private entities, or foundations (or both) 
                engaged in activities relevant to research 
                under consideration;
                  (C) members of national and international 
                nongovernmental organizations established to 
                address tuberculosis elimination;
                  (D) members from the general public who are 
                knowledgeable with respect to tuberculosis 
                including individuals who have or have had 
                tuberculosis; and
                  (E) 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.
  (h) Authorization of Appropriations.--
          (1) General program.--
                  (A) In general.--For the purpose of carrying 
                out this section, there are authorized to be 
                appropriated $300,000,000 for fiscal year 2009, 
                $315,000,000 for fiscal year 2010, $330,750,000 
                for fiscal year 2011, $347,287,500 for fiscal 
                year 2012, and $364,651,900 for fiscal year 
                2013.
                  (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) Priority.--In allocating amounts 
                appropriated under subparagraph (A), the 
                Secretary shall give priority to allocating 
                such amounts for grants under subsection (a).
                  (D) 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.
                          (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 2009.
          (2) Limitation.--The authorization of appropriations 
        established in paragraph (1) for a fiscal year is 
        effective only if the amount appropriated under such 
        paragraph for such year equals or exceeds the amount 
        appropriated to carry out this section for fiscal year 
        2009.

           *       *       *       *       *       *       *


TITLE IV--NATIONAL RESEARCH INSTITUTES

           *       *       *       *       *       *       *


Part C--Specific Provisions Respecting National Research Institutes

           *       *       *       *       *       *       *


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 Institutes 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;
          (2) expanding research on the relationship between 
        such disease and the human immunodeficiency virus; and
          (3) developing new tools for the elimination of 
        tuberculosis, including public health interventions and 
        methods to enhance detection and response to outbreaks 
        of tuberculosis, including multidrug resistant 
        tuberculosis.

           *       *       *       *       *       *       *


                                  
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