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S 1551 ISRSCommentsClose CommentsPermalink

110th CONGRESS 1st Session S. 1551

To amend the Public Health Service Act with respect to making progress toward the goal of eliminating tuberculosis, and for other purposes.CommentsClose CommentsPermalink

IN THE SENATE OF THE UNITED STATES

June 5, 2007

Mr. BROWN (for himself, Mrs. HUTCHISON, Mr. KENNEDY, Mrs. CLINTON, and Mrs. MURRAY, Mrs. FEINSTEIN, Mr. SANDERS, Mr. BINGAMAN, Mr. MENENDEZ, Mr. HARKIN, Mrs. BOXER, Ms. LANDRIEU, Ms. CANTWELL, Ms. MURKOWSKI, and Mr. LAUTENBERG) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsCommentsClose CommentsPermalink

A BILL

To amend the Public Health Service Act with respect to making progress toward the goal of eliminating tuberculosis, and for other purposes.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title- This Act may be cited as the `Comprehensive Tuberculosis Elimination Act of 2007'. CommentsClose CommentsPermalink





(b) Table of Contents- The table of contents for this Act is as follows: CommentsClose CommentsPermalink





Sec. 1. Short title; table of contents. CommentsClose CommentsPermalink

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 Program for Elimination ofStrategy for Combating and Eliminating Tuberculosis

Sec. 101. National programstrategy. CommentsClose CommentsPermalink

Subtitle B--Interagency Collaboration

Sec. 111. Advisory council for elimination of tuberculosis. CommentsClose CommentsPermalink

Subtitle C--New Tools for Tuberculosis Elimination

Sec. 121. New tools. CommentsClose CommentsPermalink

Subtitle D--Authorizations of AppropriationEvaluation of Public Health Authorities

Sec. 131. Evaluation of public health authorities. CommentsClose CommentsPermalink

Sec. 141. Authorizations of appropriations. CommentsClose CommentsPermalink

TITLE II--NATIONAL INSTITUTES OF HEALTH

Sec. 201. Research and development concerning tuberculosis. CommentsClose CommentsPermalink

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 Program for Elimination ofStrategy for Combating and Eliminating Tuberculosis

SEC. 101. NATIONAL PROGRAMSTRATEGY.

Section 317E of the Public Health Service Act (42 U.S.C. 247b-6) is amended-- CommentsClose CommentsPermalink





(1) by striking the heading for the section and inserting the following: `NATIONAL PROGRAMSTRATEGY FOR ELIMINATION OFCOMBATING AND ELIMINATING TUBERCULOSIS'; CommentsClose CommentsPermalink





and(2) by amending subsection (b) to read as follows: CommentsClose CommentsPermalink





`(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: CommentsClose CommentsPermalink





`(1) Research, with priority given to research and development concerning --`(A) clinical trials to evaluate the safety and effectiveness of new drugs, diagnostics, and vaccines for latent tuberculosis infection and active tuberculosis, including drug-resistant tuberculosis, that are suitable for use by patients with HIV/AIDS;`(B) epidemiological studies of, strains of tuberculosis resistant to drugs, and research concerning cases of tuberculosis that affect certain populations at risk for tuberculosis; and`(C) field studies to evaluate the effectiveness of new drugs, diagnostics, and vaccines, to assess the incidence and prevalence of multidrug resistant and extensively drug resistant strains of tuberculosis. CommentsClose CommentsPermalink





`(2) Demonstration projects for-- CommentsClose CommentsPermalink





`(A) the development of regional capabilities to prevent, control and eliminate tuberculosis and prevent multidrug resistant and extensively drug resistant strains of tuberculosis; CommentsClose CommentsPermalink





`(B) the intensification of efforts--`(i) to prevent, detect, and treat tuberculosis among African Americans, Hispanic Americans, Asian Americans, and other United States-born populations with documented health disparities; and`(ii) to reduce or eliminate racial to reduce health disparities in the incidence of tuberculosis in these populations; CommentsClose CommentsPermalink





`(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-- CommentsClose CommentsPermalink





`(i) detect and treat binational cases of tuberculosis; and CommentsClose CommentsPermalink





`(ii) treat high-risk cases of tuberculosis referred from Mexican health departments; CommentsClose CommentsPermalink





`(D) the intensification of efforts to prevent, detect, and treat tuberculosis among foreign-born persons who are in the United States; CommentsClose CommentsPermalink





`(E) providing guidance to Immigration and Customs Enforcement in developing risk-based screening procedures based on current epidemiological data;`(F) the intensification of efforts to increase targeted testing and treatment of latent tuberculosis infection and drug-resistant tuberculosis; and`(G) the intensification of efforts to prevent, detect, and treat tuberculosis among other high risk populations and settings, including among children and adolescents, homeless persons, detainees and prisoners, HIV-infected persons, and within health care settings.`(3) A public information and education program to include components that raise awareness regarding tuberculosis among the general population as well as those that target populationpopulations and settings documented as having a high risk for tuberculosis; and CommentsClose CommentsPermalink





`(F) tuberculosis detection, control, and prevention. CommentsClose CommentsPermalink





`(3) Public information and education activities. CommentsClose CommentsPermalink





`(4) Education, training and, clinical skills improvement activities, and workplace exposure prevention for health professionals, including allied health personnel and emergency response employees. CommentsClose CommentsPermalink





`(5) Provide support for the Tuberculosis Trials Consortium, the Tuberculosis Epidemiologic Studies Consortium, the National Laboratory Training Network, and Regional Training and Medical ConsultationSupport of Centers to carry out activities under paragraphs (1) through (4). CommentsClose CommentsPermalink





`(6) Collaboration with international organizations and foreign countries in intensifying efforts to prevent, treat, control, and eliminate tuberculosis, including efforts that address risks associated with international travel.`(7) carrying out such activities. CommentsClose CommentsPermalink





`(7) Develop, enhance, and expand information technologies that support tuberculosis control, including surveillance and database management systems with cross-jurisdictional capabilities, which shall conform to the standards and implementation specifications for such information technologies as recommended by the Secretary.'; and CommentsClose CommentsPermalink





(3) in subsection (d), by adding at the end the following: CommentsClose CommentsPermalink





`(3) DETERMINATION OF AMOUNT OF NONFEDERAL CONTRIBUTIONS- CommentsClose CommentsPermalink





`(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. CommentsClose CommentsPermalink





`(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).'. CommentsClose CommentsPermalink

Subtitle B--Interagency Collaboration

SEC. 111. ADVISORY COUNCIL FOR ELIMINATION OF TUBERCULOSIS.

(a) In General- Section 317E(f) of the Public Health Service Act (42 U.S.C. 247b-6(f)) is amended-- CommentsClose CommentsPermalink





(1) by redesignating paragraph (5) as paragraph (6); and CommentsClose CommentsPermalink





(2) by striking paragraphs (2) through (4), and inserting the following: CommentsClose CommentsPermalink





`(2) 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. In addition, the Council shall, with respect to eliminating such disease, provide to the Secretary and other appropriate Federal officials advice on-- CommentsClose CommentsPermalink





`(A) coordinating the activities of the Public Health Service and other Federal Department of Health and Human Services and other Federal agencies that relate to the disease, including activities under subsection (b); CommentsClose CommentsPermalink





`(B) responding rapidly and effectively to cases of extensively drug resistant strains ofemerging issues in tuberculosis; and CommentsClose CommentsPermalink





`(C) efficiently utilizing the Federal resources involved. CommentsClose CommentsPermalink





`(3) COMPREHENSIVE PLAN- CommentsClose CommentsPermalink





`(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. CommentsClose CommentsPermalink





`(B) CONSULTATION- In carrying out subparagraph (A), the Council shall consult withmay consult with appropriate public and private entities, includingwhich may, subject to the direction or discretion of the Secretary, include-- CommentsClose CommentsPermalink





`(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; CommentsClose CommentsPermalink





`(ii) members of public-private partnerships or private entities established to address the elimination of tuberculosis; CommentsClose CommentsPermalink





`(iii) members of national and international nongovernmental organizations established to address tuberculosis eliminationwhose purpose is to eliminate tuberculosis; and CommentsClose CommentsPermalink





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





`(C) CERTAIN COMPONENTS OF PLAN- In carrying out subparagraph (A), the Council shall, subject to the direction or discretion of the Secretary-- CommentsClose CommentsPermalink





`(i) consider the recommendations of the Institute of Medicine regarding the elimination of tuberculosis;`(ii) 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 such as Mexico; and`(i; and CommentsClose CommentsPermalink





`(ii) review the extent to which progress has been made toward eliminating tuberculosis. CommentsClose CommentsPermalink





`(4) ANNUAL REPORTBIENNIAL REPORT- CommentsClose CommentsPermalink





`(A) IN GENERAL- The Council shall annually submit to Congress and the Secretary a reportsubmit a biennial report to the Secretary, as determined necessary by the Secretary, on the activities carried under this section, other than subsection (g). Each such report shall include the opinion of the Council on the extent to which its recommendations regarding the elimination of tuberculosis have been implemented, including with respect to-- CommentsClose CommentsPermalink





`(Ai) activities under subsection (b); and CommentsClose CommentsPermalink





`(Bii) the national plan referred to in paragraph (3). CommentsClose CommentsPermalink





`(B) PUBLIC- The Secretary shall make a report submitted under subparagraph (A) public. CommentsClose CommentsPermalink





`(5) COMPOSITION- The Council shall be composed of-- CommentsClose CommentsPermalink





`(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; CommentsClose CommentsPermalink





`(B) State and local tuberculosis control and public health officials; CommentsClose CommentsPermalink





`(C) individuals who are scientists, physicians, laboratorians, and other health professionals who represent disciplines relevant to tuberculosis elimination; and CommentsClose CommentsPermalink





`(D) members of national and international nongovernmental organizations established to address the elimination of tuberculosis; and`(E) members from the general public who are knowledgeable with respect to the elimination of tuberculosis, including individuals who have or have had tuberculosis.'. CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink

Subtitle C--New Tools for Tuberculosis Elimination

SEC. 121. NEW TOOLS.

Section 317E of the Public Health Service Act (42 U.S.C. 247b-6) is amended-- CommentsClose CommentsPermalink





(1) by redesignating subsection (g) as subsection (h); and CommentsClose CommentsPermalink





(2) by inserting after subsection (f) the following subsection: CommentsClose CommentsPermalink





`(g) New Tools for Elimination of Tuberculosis- CommentsClose CommentsPermalink





`(1) RESEARCH AND DEVELOPMENT ON DRUGS, DIAGNOSTICS, VACCINES, AND PUBLIC HEALTH INTERVENTIONS- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall may expand, intensify, and coordinate research and development and related activities of such Centers to develop new tools for the elimination of tuberculosis, including drugs, diagnostics, vaccines, and public health interventions, such as directly observed therapy and non-pharmaceutical intervention, and methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis. The Secretary shall give priority to programmatically relevant research so that new tools can be utilized in public health practice. CommentsClose CommentsPermalink





`(2) FEDERAL TUBERCULOSIS TASK FORCE- CommentsClose CommentsPermalink





`(A) DUTIES- The Federal Tuberculosis Task Force (established in December 2001 as part of the Centers for Disease Control and Prevention) (in this subsection referred to as the `Task Force') shall provide to the Secretary and other appropriate Federal officials advice on the implementation of paragraph (1), including advice regarding the efficient utilization of the Federal resources involved. CommentsClose CommentsPermalink





`(B) COMPREHENSIVE PLAN FOR NEW TOOLS DEVELOPMENT- In carrying out paragraph (1), the Task Force shall make recommendations on the development of a comprehensive plan for the creation of new tools for the elimination of tuberculosis, including drugs, diagnostics, and vaccines. CommentsClose CommentsPermalink





`(C) CONSULTATION- In developing the comprehensive plan under paragraph (1), the Task Force shall consult with external parties including representatives from groups such as-- CommentsClose CommentsPermalink





`(i) scientists, physicians, laboratorians, and other health professionals and who represent the specialties and disciplines relevant to the research under consideration; CommentsClose CommentsPermalink





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





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





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





`(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. CommentsClose CommentsPermalink





`(3) GRANTS AND CONTRACTS- The Secretary shallmay carry out paragraph (1) directly and through awards of grants, cooperative agreements, and contracts to public and private entities, including-- CommentsClose CommentsPermalink





`(A) public-private partnerships; CommentsClose CommentsPermalink





`(B) academic institutions, including institutions of higher education; CommentsClose CommentsPermalink





`(C) research institutions; and CommentsClose CommentsPermalink





`(D) the Tuberculosis Trials Consortium and the Tuberculosis Epidemiologic Studies Consortiumnonprofit entities established and dedicated to tuberculosis vaccine and treatment product development.'. CommentsClose CommentsPermalink

Subtitle D--Authorizations of AppropriationEvaluation of Public Health Authorities

SEC. 131. EVALUATION OF PUBLIC HEALTH AUTHORITIES.

SEC. 141. AUTHORIZATIONS OF APPROPRIATIONS.

Section 317E of the Public Health Service Act, as amended by section 121(1) of this Act, is amended by striking subsection (h) and inserting the following: CommentsClose CommentsPermalink





`(h) Authorization of Appropriations- CommentsClose CommentsPermalink





`(1) GENERAL PROGRAM- CommentsClose CommentsPermalink





`(A) IN GENERAL- For the purpose of carrying out this section, other than subsections (b) and (g), there are authorized to be appropriated $300,000,000 for fiscal year 2008, and such sums as may be necessary for each of the fiscal years 2009 through 2012. CommentsClose CommentsPermalink





`(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 States, 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. CommentsClose CommentsPermalink





`(C) RESEARCH, DEMONSTRATION PROJECTS, EDUCATION, AND TRAINING- For the purpose of carrying out subsection (b), there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2008 through 2012. CommentsClose CommentsPermalink





`(D) PRIORITY- In allocating amounts appropriated under subparagraph (A) and not reserved under subparagraph (B), the Secretary shall give priority to allocating such amounts for grants under subsection (a). CommentsClose CommentsPermalink





`(E) ALLOCATION OF FUNDS- CommentsClose CommentsPermalink





`(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. CommentsClose CommentsPermalink





`(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. CommentsClose CommentsPermalink





`(iii) NO CHANGE TO FORMULA REQUIRED- This subparagraph does not require the Secretary to modify the formula that was used by the Secretary to distribute funds to grantees under subsection (a) for fiscal year 2007. CommentsClose CommentsPermalink





`(2) NEW TOOLS- CommentsClose CommentsPermalink





`(A) IN GENERAL- For the purpose of carrying out subsection (g), there are authorized to be appropriated $100,000,000 for fiscal year 2008, and such sums as may be necessary for each of the fiscal years 2009 through 2012. CommentsClose CommentsPermalink





`(B) LIMITATION- The authorization of appropriations established in subparagraph (A) for a fiscal year is effective only if the amount appropriated under paragraph (1) for such year equals or exceeds the amount appropriated to carry out this section for fiscal year 2007.'. CommentsClose CommentsPermalink

TITLE II--NATIONAL INSTITUTES OF HEALTH

SEC. 201. RESEARCH AND DEVELOPMENT CONCERNING TUBERCULOSIS.

(a) In General- 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: CommentsClose CommentsPermalink

`SEC. 424C. TUBERCULOSIS.

`(a) In General- The Director of the National Institutes of Health shallmay expand, intensify, and coordinate research and development and related activities of the Institute with respect to tuberculosis, including activities toward the goal of eliminating such disease. CommentsClose CommentsPermalink





`(b) Certain Activities- Activities under subsection (a) shallmay include-- CommentsClose CommentsPermalink





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





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

(b) Research Education- Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following:`SEC. 404I. TUBERCULOSIS ACADEMIC AWARDS.`(a) Tuberculosis Academic Awards- The Director of the National Institutes of Health may provide awards to faculty of schools of medicine, osteopathic medicine, nursing, public health, or related fields to assist such faculty in developing high quality curricula in such schools designed to significantly increase the opportunities for interested individuals, including students of the school and practicing physicians and nurses, to learn the principles and practices of preventing, managing, and controlling tuberculosis.`(b) Tuberculosis/pulmonary Infection Awards- The Director of the National Institutes of Health may provide awards to support the career development of clinically trained professionals who are committed to research regarding pulmonary infections and tuberculosis by providing for supervised study and research.'.SEC. 202. ACTIVITIES OF NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES.Section 447A of the Public Health Service Act (42 U.S.C. 285f-2) is amended--(1) by striking `In carrying out section 446' and inserting `(a) In carrying out section 446'; and(2) by inserting at the end the following:`(b) Activities under subsection (a) shall include activities to develop a tuberculosis vaccine. Such activities shall be carried out in accordance with the blueprint for tuberculosis vaccine development described in the report prepared pursuant to the workshop convened in March 1998 by the Advisory Council for Elimination of Tuberculosis, the Director of the National Vaccine Program, and the Director of the Institute.'.SEC. 203. JOHN E. FOGARTY INTERNATIONAL CENTER FOR ADVANCED STUDY IN THE HEALTH SCIENCES.Section 482 of the Public Health Service Act (42 U.S.C. 287b) is amended--(1) by inserting `(a) In General- ' before `The general purpose';(2) in subsection (a) (as so designated), by inserting after `Health Sciences' the following: `(in this subpart referred to as the `Center')'; and(3) by adding at the end the following subsection:`(b) Tuberculosis-`(1) IN GENERAL- In carrying out subsection (a) with respect to tuberculosis, the Center shall expand, intensify, and coordinate international activities of the Center for research and training.`(2) INTERNATIONAL TRAINING PROGRAM- In carrying out paragraph (1), the Center shall carry out Calendar No. 549 CommentsClose CommentsPermalink

Reported with

an

international training program regarding tuberculosis. Such program shall be modeled after the international training program carried out by the Center with respect to the human immunodeficiency virus.'.

SEC. 204. LOAN REPAYMENT PROGRAMS REGARDING RESEARCH ON TUBERCULOSIS.

Part G of title IV of the Public Health Service Act (42 U.S.C. 288 et seq.) is amended--

(1) by redesignating the second section 487F as section 487G; and

(2) by inserting after section 487G (as so redesignated) the following section:

`LOAN REPAYMENTS REGARDING RESEARCH ON TUBERCULOSIS

`Sec. 487H. In carrying out sections 487C, 487E, and 487F, the Secretary shall seek to ensure that, for fiscal year 2008 and subsequent fiscal years, a portion of amounts appropriated to carry out such sections is reserved for the purpose of entering into contracts under which (in accordance with the section involved) individuals will conduct research on tuberculosis. The Secretary shall have sole discretion for the administration of activities under this section.'.

SEC. 205. AUTHORIZATION OF APPROPRIATIONS.

For the purpose of carrying out this title and the amendments made by this title, there are authorized to be appropriated such sums as may be necessary. Such authorization of appropriations shall be in addition to the authorization of appropriations established by section 402A(a) of the Public Health Service Act and any other authorization of appropriations available for such purpose.

amendment