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S 1551 ISRS

Calendar No. 549

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.

IN THE SENATE OF THE UNITED STATES

June 5, 2007

Mr. BROWN (for himself, Mrs. HUTCHISON, Mr. KENNEDY, Mrs. and CLINTON, 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 Pensions

December 18, 2007

Reported by Mr. KENNEDY, with an amendment

[Strike out all after the enacting clause and insert the part printed in italic]

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A BILL

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

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

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

Sec. 1. Short title; table of Sec. 2. Findings.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 ProgramStrategy for Elimination ofCombating and Eliminating Tuberculosis

Sec. 101. National programstrategy.

Subtitle B--Interagency Collaboration

Sec. 111. Advisory council for elimination of tuberculosis.

Subtitle C--New Tools for Tuberculosis Elimination

Sec. 121. New tools.

Subtitle D--AuthorizationsEvaluation of AppropriationPublic Health Authorities

Sec. 131. Evaluation of public health authorities.

Subtitle E--Authorization of Appropriations

Sec. 141. Authorizations of appropriations.

TITLE II--NATIONAL INSTITUTES OF HEALTH

Sec. 201. Research and development concerning Sec. 202. Activities of National institute of Allergy and Infectious Diseases.Sec. 203. John E. Fogarty International Center for Advanced Study in the Health Sciences.Sec. 204. Loan repayment programs regarding research on tuberculosis.Sec. 205. Authorization of appropriations.SEC. 2. FINDINGS.The Congress finds as follows:(1) Each year approximately 9,000,000 people become ill with active tuberculosis ( referred to in this section as `TB'), and it is estimated that 1,600,000 of those people die, a result of critical underinvestment in quality TB control and the research and development of new TB drugs, diagnostics and a vaccine, as well as the comorbid relationship between TB and HIV/AIDS. Such levels of morbidity and mortality are complicated by the disease having the ability to develop resistance to treatments and to travel easily across borders.(2) In 2006, there were 13,767 cases of active TB reported in the United States. The average annual decline in the national TB rate slowed from 7.3 percent per year in the period of 1993 to 2000 to 3.8 percent per year in the period of 2000 to 2006.(3) In addition to those with active TB, an estimated 10,000,000 to 15,000,000 people in the United States have latent TB infection.(4) The increasing occurrence of multidrug resistant (`MDR') TB, including extensively drug resistant (`XDR') TB--which is resistant to at least almost all drugs used to treat TB, including the two recommended first-line drugs and the recommended second-line medications, raises concerns of a future epidemic of virtually untreatable TB.(5) To prevent the spread of extensively drug resistant TB, the immediate strengthening of TB control systems must be a priority. This includes improved case detection, strengthened laboratory capacity, rapid implementation of infection control measures, enhanced treatment programs, and immediate support to existing public sector infrastructure.(6) The Centers for Disease Control and Prevention is increasingly relied upon globally for its expertise and technical assistance in global tuberculosis preparedness and outbreak response capacity to identify and investigate outbreaks of multidrug resistant and extensively drug resistant TB.(7) New tools are needed to more effectively prevent, diagnose, and treat TB. The standard method of diagnosing TB is over 100 years old, and fails to adequately detect TB, especially in children and those co-infected with HIV/AIDS. The newest class of anti-TB drug is over 40 years old, while rates of multidrug resistant TB are rising globally. The existing vaccine confers no protection to adolescents and adults, protecting only against severe forms of TB in infants and young children.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 ProgramStrategy for Elimination ofCombating and Eliminating Tuberculosis

SEC. 101. NATIONAL PROGRAM.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 PROGRAMSTRATEGY FOR ELIMINATION OFCOMBATING AND ELIMINATING TUBERCULOSIS';

and(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, strain`(A) clinical trials to evaluate the safety and effectiveness of newtuberculosis resistant to diagnostics, drugs, and vaccines for latentresearch concerning cases of infection and active tuberculosis, including drug-resistant tuberculosis, tuberculosis that are suitable for use by patients with HIV/AIDS;ffect certain`(B) epidemiological studies of 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.`(2) 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--`(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 racialhealth disparities in the incidence of tuberculosis in these populations;;

`(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;

`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) (E) the intensification of efforts to prevent, detect, and treat tuberculosis other high risk among 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 populations documented as having a high risk for tuberculosis.; and

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

`(3) Public information and education activities.

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

`(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).

`(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.carrying out such activities.

`(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

(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.

(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, 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--

`(A) coordinating the activities of the PublicDepartment of Health Serviceand Human Services and other Federal agencies that relate to the disease, including activities under subsection (b);

`(B) responding rapidly and effectively to cases of extensively drug resistant strains ofemerging 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 shallmay consult with appropriate public and private entities, including--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 establishedwhose purpose is to address tuberculosis elimination; andeliminate tuberculosis; and

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

`(C) CERTAIN COMPONENTS OF PLAN- In carrying out subparagraph (A), the Council shall--, subject to`(i) consider the recommendations of the Institutedirection or discretion Medicine regarding of the elimination of tuberculosis;Secretary--

`(i `(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 such as Mexico; and; and

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

`(4) ANNUAL REPORTBIENNIAL REPORT-

`(A) IN GENERAL- The Council annually shall to Congress and the Secretary submit 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--

`(A `(i) activities under subsection (b); and

`(B `(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; 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.'.(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.

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--

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

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

`(g) New Tools for Elimination of Tuberculosis-

`(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 of such Centers 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 shall give priority to programmatically relevant research so that new tools can be utilized in public health practice.

`(2) FEDERAL TUBERCULOSIS TASK FORCE-

`(A) DUTIES- The Federal Tuberculosis Task (established in December 2001 as part of the Centers for Disease Control and Prevention) Force (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.

`(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.

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

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

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

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

`(iv) members from the general public who are knowledgeable with respect to tuberculosis, 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.

`(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--

`(A) public-private partnerships;

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

`(C) research institutions; and

`(D) nonprofit entities established and dedicated to tuberculosis vaccine and treatment product development.'.

Subtitle D--Evaluation of Public Health Authorities

SEC. 131. EVALUATION OF PUBLIC HEALTH AUTHORITIES.

(a) In General- Not later than 180 days after the date of enactment of the Comprehensive Tuberculosis Trials ConsortiumElimination Act of 2007, the Secretary of Health and Human Services shall prepare and submit to the Tuberculosis Epidemiologic Studies Consortium.'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--AuthorizationsE--Authorization of Appropriations

SEC. 1341. 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:

`(h) Authorization of Appropriations-

`(1) GENERAL PROGRAM-

`(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.

`(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.

`(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.

`(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).

`(E) 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 2007.

`(2) NEW TOOLS-

`(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.

`(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.'.

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:

`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.

`(b) Certain Activities- Activities under subsection (a) shall include--may include--

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

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

(b) Research Education- Part A of title IV of the Public Health Service Act ( Calendar No. 549

42 U.S.C. 281 110th CONGRESS

et seq.) is amended by adding at the end the following: 1st Session

`SEC. 404I. TUBERCULOSIS ACADEMIC AWARDS. S. 1551

`(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. A BILL

`(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.'.To amendSEC. 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 (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 an international training program regarding tuberculosis. Such program shall be modeled after the international training program carried out by the Center Act with respect to making progress toward the human immunodeficiency virus.'.goalSEC. 204. LOAN REPAYMENT PROGRAMS REGARDING RESEARCH ON TUBERCULOSIS.Part G of title IV of the Public Health Service Act (eliminating tuberculosis,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 subsequent fiscal years, a portion of amounts appropriated to carry out such sections is reserved and 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 for other authorization of appropriations available for such purpose.purposes.

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December 18, 2007

Reported with an amendment