[United States Statutes at Large, Volume 122, 110th Congress, 2nd Session] [From the U.S. Government Publishing Office, www.gpo.gov] 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 4196]] 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 4197]] 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 4198]] 122 STAT. 4198 ``(C) efficiently utilizing the Federal resources involved. ``(3) Comprehensive plan.-- ``(A) In general.--In [NOTE: Recommenda- tions. 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 4199]] 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: Recommenda- tions. 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 4200]] 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 4201]] 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 4202]] 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.