[110th Congress Public Law 392]
[From the U.S. Government Printing Office]


[DOCID: f:publ392.110]

[[Page 122 STAT. 4195]]

Public Law 110-392
110th Congress

                                 An Act


 
 To amend the Public Health Service Act with respect to making progress 
       toward the goal of eliminating tuberculosis, and for other 
            purposes. <<NOTE: Oct. 13, 2008 -  [H.R. 1532]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress 
assembled, <<NOTE: Comprehensive Tuberculosis Elimination Act of 
2008.>> 
SECTION 1. SHORT TITLE; <<NOTE: 42 USC 201 note.>> 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.

[[Page 122 STAT. 4196]]

 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;

[[Page 122 STAT. 4197]]

                    ``(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

[[Page 122 STAT. 4198]]

                    ``(C) efficiently utilizing the Federal resources 
                involved.
            ``(3) Comprehensive plan.--
                    ``(A) In general.--In <<NOTE: Recommen- 
                dations.>> 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

[[Page 122 STAT. 4199]]

                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 <<NOTE: 42 USC 247b-6 note.>> 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 <<NOTE: Recommen- dations.>> 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.''.

[[Page 122 STAT. 4200]]

           Subtitle C--Evaluation of Public Health Authorities

SEC. 121. <<NOTE: 42 USC 264 note.>> EVALUATION OF PUBLIC HEALTH 
                        AUTHORITIES.

    (a) In General.--Not <<NOTE: Deadline. Reports.>> 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 <<NOTE: Deadline.>> 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 
                $200,000,000 for fiscal year 2009, $210,000,000 for 
                fiscal year 2010, $220,500,000 for fiscal year 2011, 
                $231,525,000 for fiscal year 2012, and $243,101,250 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).

[[Page 122 STAT. 4201]]

                    ``(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. <<NOTE: 42 USC 285b-7c.>> 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

[[Page 122 STAT. 4202]]

        detection and response to outbreaks of tuberculosis, including 
        multidrug resistant tuberculosis.''.

    Approved October 13, 2008.

LEGISLATIVE HISTORY--H.R. 1532 (S. 1551):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 110-873 (Comm. on Energy and Commerce).
SENATE REPORTS: No. 110-329 accompanying S. 1551 (Comm. on Health, 
Education, Labor, and Pensions).
CONGRESSIONAL RECORD, Vol. 154 (2008):
            Sept. 23, 24, considered and passed House.
            Sept. 27, considered and passed Senate.

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