H.R. 4261 — Introduced in House

I 113th CONGRESS 2d Session H. R. 4261 IN THE HOUSE OF REPRESENTATIVES March 14, 2014 Mr. Coffman (for himself, Mrs. Kirkpatrick, and Mr. Michaud) introduced the following bill; which was referred to the Committee on Veterans’ Affairs A BILL To improve the research of Gulf War Illness, the Research Advisory Committee on Gulf War Veterans’ Illnesses, and for other purposes. 1. Short title This Act may be cited as the Gulf War Health Research Reform Act of 2014. 2. Improvements to Research Advisory Committee on Gulf War Veterans' Illnesses (a) Independence of Committee Subsection (b) of section 707 of the Veterans Health Care Act of 1992 (Public Law 102–585; 38 U.S.C. 527 note) is amended— (1) by striking Not later than and inserting (1) Establishment.—Not later than; and (2) by adding at the end the following new paragraphs: (2) Independence (A) The Committee established under paragraph (1) shall be an independent advisory committee which shall provide advice and counsel to the congressional veterans committees and to the Secretary of Veterans Affairs (as the head of the department designated under subsection (a) that established the Committee under paragraph (1)). (B) In carrying out the functions, powers, and duties of the Committee, the Committee shall be independent of the Secretary of Veterans Affairs. The Committee shall exert independent control of the budget allocations, staffing levels and expenditures, personnel decisions and processes, procurements, and other administrative and management functions of the Committee. The administration and management of the Committee shall be subject to the usual and customary Federal audit procedures. (3) Duties (A) The Committee shall provide to Congress, the Secretary of Veterans Affairs, and the heads of other departments and agencies of the Federal Government that conduct research on illnesses in Gulf War veterans advice with respect to proposed research studies, research plans, or research strategies relating to the health consequences of military service in the Southwest Asia theater of operations during the Gulf War. (B) The Committee may not conduct scientific research or review research proposals submitted to the Secretary of Veterans Affairs prior to funding. The Secretary shall appoint three members from the Committee who have appropriate scientific expertise to the committee designated to review such research proposals relating to illnesses in Gulf War veterans. (C) The guiding principle for the Committee shall be the premise that the fundamental goal of Gulf War health-related research, either basic or applied, conducted by the Federal Government is to ultimately improve the health of ill Gulf War veterans, and that the choice and success of research efforts shall be judged accordingly. The Committee shall assess the overall effectiveness of such research conducted by the Federal Government to answer central questions on the nature, causes, and treatments for health consequences of military service in the Southwest Asia theater of operations during the Gulf War. (D) The Committee shall meet in public session to review research funded by the Department of Veterans Affairs relevant to understanding and treating the health consequences of military service in the Gulf War, and the processes conducted to solicit, review, and select such funded research to assess methods, results, and implications of such research. The Committee may review research plans, initiatives, and activities from other departments and agencies of the Federal Government supporting research relating to the health consequences of military service in the Southwest Asia theater of operations during the Gulf War. (4) Reports and recommendations (A) Not later than December 1 of each year, the Committee shall submit to the congressional veterans committees and the Secretary of Veterans Affairs an annual report summarizing the activities of the Committee during the period covered by the report. (B) The Committee shall submit to the congressional veterans committees, the Secretary of Veterans Affairs, and the head of any other department or agency of the Federal Government that conducts research on illnesses in Gulf War veterans any other reports and recommendations of the Committee regarding Gulf War-related research. (C) Reports, recommendations, publications, and other documents of the Committee shall not be subject to review or approval by the Secretary of Veterans Affairs. (D) The Committee may submit to the Secretary of Veterans Affairs proposed recommendations of the Committee for comment for a period not to exceed 30 days. (E) Each report submitted by the Committee shall be approved by the Committee meeting in public session prior to such submission. (5) Membership (A) The Committee shall be composed of 12 members appointed as follows: (i) One member appointed jointly by the chairman of the congressional veterans committees, who shall serve as chairman of the Committee. (ii) Two members appointed by the chairman of the Committee on Veterans’ Affairs of the House of Representatives. (iii) Two members appointed by the chairman of the Committee on Veterans’ Affairs of the Senate. (iv) Two members appointed by the ranking member of the Committee on Veterans’ Affairs of the House of Representatives. (v) Two members appointed by the ranking member of the Committee on Veterans’ Affairs of the Senate. (vi) Three members appointed by the Secretary of Veterans Affairs, of whom not less than one shall be a veteran. (B) (i) The first 11 vacancies from among the members of the Committee (not including a member serving as chairman of the Committee) occurring on or after the date of the enactment of the Gulf War Health Research Reform Act of 2014 shall be filled by— (I) the chairman of the Committee on Veterans’ Affairs of the House of Representatives appointing a member for the first and sixth vacancy; (II) the chairman of the Committee on Veterans’ Affairs of the Senate appointing a member for the second and seventh vacancy; (III) the ranking member of the Committee on Veterans’ Affairs of the House of Representatives appointing a member for the third and eighth vacancy; (IV) the ranking member of the Committee on Veterans’ Affairs of the Senate appointing a member for the fourth and ninth vacancy; and (V) the Secretary of Veterans Affairs appointing a member for the fifth, tenth, and eleventh vacancy. (ii) A vacancy in the Committee of a member serving as chairman shall be filled jointly by the chairmen of the congressional veterans committees. (iii) Except as provided by clause (i) or (ii), a vacancy in the Committee of a member shall be filled in the manner in which the appointment of such member was made. A member appointed to fill a vacancy occurring before the expiration of the term for which the member’s predecessor was appointed shall be appointed only for the remainder of that term. (C) Of the members of the Committee who are appointed on or after the date of the enactment of the Gulf War Health Research Reform Act of 2014— (i) not fewer than three members shall be veterans; (ii) not fewer than eight members shall be scientists or physicians who have experience in biomedicine, epidemiology, immunology, environmental health, neurology, toxicology, or other appropriate disciplines; and (iii) the chairman shall be a veteran or an expert described in clause (ii), or both. (D) Each member of the Committee who is appointed on or after the date of the enactment of the Gulf War Health Research Reform Act of 2014 shall be appointed for a three-year term. Except as provided by section 2(c)(3) of such Act, a member may be reappointed once (not including the initial appointment of a member made before the date of the enactment of such Act). (6) Meetings (A) The Committee shall meet at the call of the chairman, but not less than twice annually. (B) A majority of the members of the Committee shall constitute a quorum, but a lesser number of members may hold hearings. (C) (i) The Secretary of Veterans Affairs, the head of the Office of Research and Development of the Department of Veterans Affairs, and the head of the Office of Public Health of the Department shall attend each meeting of the Committee. (ii) The Secretary of Veterans Affairs may delegate the attendance of the Secretary under clause (i) to a level not below the Deputy Under Secretary for Health of the Department of Veterans Affairs, but the Secretary shall attend at least one meeting each year without making such delegation. (D) Each meeting of the Committee shall be open to the public. (7) Compensation and staff (A) Except with respect to a member who serves a scientific director under subparagraph (C)(ii) and is treated as staff for purposes of compensation, each member of the Committee shall be paid at the daily rate provided for temporary and intermittent services under section 3109(b) of title 5, United States Code, for each day during which the member attends meetings of the Committee. (B) The members of the Committee shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for employees of agencies under subchapter I of chapter 57 of title 5, United States Code, while away from their homes or regular places of business in the performance of service of the Committee. (C) (i) The chairman of the Committee may appoint a staff of not more than four employees to provide the Committee scientific and administrative support. Such employees may be— (I) detailees of the Department of Veterans Affairs or other departments or agencies of the Federal Government; (II) individuals employed as temporary employees of the Federal Government; or (III) at the request of the chairman of the Committee, provided under a contract entered into by the Secretary of Veterans Affairs and a medical school or other medical research institution selected by the chairman of the Committee. (ii) The chairman of the Committee may appoint, from the members of the Committee, a scientific director to supervise the operations of the Committee. Such director shall count as one of the four employees authorized under clause (i). (iii) At the request of the chairman of the Committee, the Secretary of Veterans Affairs shall procure services from nongovernmental consultants to assist the Committee in preparing reports, background papers, and other material for consideration by the Committee. Such services may be procured under the contract described in clause (i)(III). (8) Application of Federal Advisory Committee Act (A) Except as otherwise provided by this subsection, the Committee shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.). (B) The Secretary of Veterans Affairs shall consult with the chairman of the congressional veterans committees in designating an officer or employee of the Department under section 10 of the Federal Advisory Committee Act (5 U.S.C. App.). (C) Notwithstanding such section 10, such designated officer or employee may not have authority— (i) over the agenda or conduct of a meeting; (ii) to adjourn a meeting of the Committee; or (iii) to take any other action that is inconsistent with the independence of the Committee under paragraph (2). (9) Funding Amounts for the activities of the Committee shall be derived from amounts appropriated to the Department of Veterans Affairs for purposes of this subsection. (10) Termination (A) Except as provided by subparagraph (B), the Committee shall terminate on the date that is two years after the date on which the Committee submits to the congressional veterans committees, the Secretary of Defense, and the Secretary of Veterans Affairs a report (signed by not less than nine concurring members) explaining that each Secretary is carrying out an effective research program relating to the health consequences of military service in the Southwest Asia theater of operations during the Gulf War. (B) If during the two-year period described in subparagraph (A) the Committee notifies the congressional veterans committees, the Secretary of Defense, and the Secretary of Veterans Affairs that the information contained in the report submitted under subparagraph (A) is no longer applicable, the two-year period shall toll until the date on which the Committee submits a new report described in subparagraph (A). . (b) Definitions; redesignation; conforming amendments (1) Definitions Such section 707 is further amended by adding at the end the following new subsection: (f) Definitions In this section: (1) The term congressional veterans committees means the Committees on Veterans’ Affairs of the House of Representatives and the Senate. (2) The term Gulf War means the Southwest Asia theater of operations from August 2, 1990, to July 31, 1991. (3) The term Gulf War veteran means an individual who served as a member of the Armed Forces in the Gulf War. . (2) Redesignation Subsection (a) of such section 707 is amended by striking , and may redesignate from time to time,. (3) Conforming amendments Such section 707 is further amended— (A) in paragraph (1) of subsection (b), as designated by subsection (a)(1) and amended by paragraph (2)— (i) by inserting (in this subsection referred to as the Committee) after an advisory committee; and (ii) by striking and representatives of such veterans and inserting representatives of such veterans, and individuals from the scientific and medical community; (B) by striking Persian Gulf theater of operations during the Persian Gulf War each place it appears and inserting Gulf War; (C) by striking Persian Gulf War veterans each place it appears and inserting Gulf War veterans; and (D) by striking during the Persian Gulf War each place it appears and inserting during the Gulf War. (c) Members currently serving (1) Membership Notwithstanding paragraph (5)(A) of subsection (b) of such section 707, as amended by subsection (a)(2), the chairmen and ranking members of the congressional veterans committees shall jointly designate 10 members of the Research Advisory Committee on Gulf War Veterans' Illnesses established pursuant to such subsection (b) who are serving as members as of the date of the enactment of this Act to continue to serve as members for periods determined pursuant to paragraph (2) rather than for the term for which the members were appointed before such date of enactment. (2) Period of service The chairmen and ranking members of the congressional veterans committees shall jointly determine the period of service of each member specified in paragraph (1) in a manner that staggers the periods of such members in periods of one, two, or three years beginning on the date of the enactment of this Act. In determining such staggered periods, the chairmen and ranking members shall take into account the order of filling vacancies pursuant to subsection (b)(5)(B) of such section 707, as amended by subsection (a)(2). Any vacancies occurring of such members shall be filled in accordance with such subsection. (3) New members Upon designating members under paragraph (1), the chairmen of the congressional veterans committees shall each appoint one additional member to the committee from among individuals who have not served on the Research Advisory Committee on Gulf War Veterans' Illnesses. Such appointments shall be treated as the first and second vacancies described in subclauses (I) and (II) of subsection (b)(5)(B)(i) of such section 707, as amended by subsection (a)(2), respectively. (4) Reappointment A member of the Committee specified in paragraph (1) who has served more than three years may not be reappointed after the period for the member specified in paragraph (2) expires. 3. Research case definition of Gulf War Illness (a) Standard definition Except as provided by subsection (b), the Secretary of Veterans Affairs shall ensure that any research conducted or funded by the Secretary on the chronic multisymptom illness that afflicts approximately 25 percent of Gulf War veterans— (1) refers to the illness as Gulf War Illness; and (2) uses the research case definition of such illness that is recommended from time to time by the Research Advisory Committee on Gulf War Veterans' Illnesses established by section 707 of the Veterans Health Care Act of 1992 (Public Law 102–585; 38 U.S.C. 527 note). (b) Alternative definition During any period in which the Research Advisory Committee on Gulf War Veterans' Illnesses has not recommended a research case definition for Gulf War Illness, the Secretary of Veterans Affairs shall ensure that any research on such illness conducted or funded by the Secretary uses a research case definition that is consistent with the definition of the term chronic multisymptom illness in Persian Gulf War veterans provided by section 805(e) of the Veterans' Benefits Act of 2010 (Public Law 111–275; 124 Stat. 2890). (c) Advice The Research Advisory Committee on Gulf War Veterans' Illnesses shall submit to the Secretary of Defense advice regarding the best type of organization and process for the Gulf War Illness Research Program of the Congressionally Directed Medical Research Program to use to develop a research case definition of Gulf War Illness. 4. Studies and reports on Gulf War Illness (a) Conduct of new studies (1) Evaluation of animal studies In conducting or funding any study relating to illnesses of Gulf War veterans on or after the date of the enactment of this Act, the Secretary of Veterans Affairs shall ensure that such study is conducted in a manner such that animal studies are considered to the same extent in all respects as human studies. (2) Sufficient evidence of association In conducting or funding any study relating to illnesses of Gulf War veterans, or other health matters of veterans, on or after the date of the enactment of this Act, the Institute of Medicine of the National Academies shall ensure that such study is conducted in a manner that defines sufficient evidence of an association in the categories of association used in the study as the following: Evidence is sufficient to conclude that there is a positive association. That is, a positive association has been observed between an exposure to a specific agent and a health outcome in human or animal studies in which chance, bias, and confounding could be ruled out with reasonable confidence.. (b) Sense of Congress on national cohort study It is the sense of Congress that the Secretary of Veterans Affairs should conduct an additional follow-up study of a national cohort of Gulf War and Gulf-War-Era veterans that includes questions described in the Symptom Inventory Required to Ascertain Case Status for Gulf War Multisymptom Illness, as Defined by both the Fukuda and Kansas criteria published by the Research Advisory Committee on Gulf War Veterans’ Illnesses on June 9, 2012, in appendix F of the document titled Research Advisory Committee on Gulf War Veterans’ Illnesses Findings and Recommendations. (c) Sense of Congress on study on risk of developing multiple sclerosis, multiple sclerosis, Parkinson's disease, brain cancers, and other conditions It is the sense of Congress that the Secretary of Veterans Affairs should submit to the congressional veterans committees each report required by section 804 of the Veterans' Benefits Improvement Act of 2008 (Public Law 110–389; 122 Stat. 4187). (d) Sense of Congress on previously conducted studies It is the sense of Congress that the Secretary of Veterans Affairs should— (1) seek to enter into an agreement with the Institute of Medicine of the National Academies to carry out the review described in section 805 of the Veterans' Benefits Act of 2010 (Public Law 111–275; 124 Stat. 2890), regardless of any previous review conducted under such section, in a manner that ensures that the Institute of Medicine convenes to conduct the review a group of medical professionals who are experienced in treating individuals who served as members of the Armed Forces in the Southwest Asia Theater of Operations of the Persian Gulf War during 1990 or 1991 and who have been diagnosed with Gulf War illness, chronic multisymptom illness, or another health condition related to chemical and environmental exposure that may have occurred during such service; (2) seek to enter into an agreement with the Institute of Medicine to carry out the review described in section 1603 of the Persian Gulf War Veterans Act of 1998 (Public Law 105–277; 38 U.S.C. 1117 note), regardless of any previous review conducted under such section, addressing the matters originally reviewed by the Institute of Medicine in the reports titled Gulf War and Health: Volume 1. Depleted Uranium, Sarin, Pyridostigmine Bromide, and Vaccines, Gulf War and Health: Volume 2. Insecticides and Solvents, and Gulf War and Health: Volume 3. Fuels, Combustion Products, and Propellants; and (3) not disseminate or use for research, clinical care, benefits, or any other purpose the results of the report of the Institute of Medicine titled Gulf War and Health Report: Volume 9. Treatment for Chronic Multisymptom Illness. (e) Sense of Congress on consultation It is the sense of Congress that the Secretary of Veterans Affairs should, prior to entering into a contract or agreement with the Institute of Medicine of the National Academies with respect to research or studies on the health of Gulf War veterans, obtain the advice of the Research Advisory Committee on Gulf War Veterans' Illnesses established by section 707 of the Veterans Health Care Act of 1992 (Public Law 102–585; 38 U.S.C. 527 note) regarding the scope of work and the charge to be given to the Institute of Medicine. (f) Sense of Congress on inclusion of certain professionals in scientific or medical groups It is the sense of Congress that, in any contract requiring the Institute of Medicine of the National Academies to convene a committee to study the health of Gulf War veterans, the Secretary of Veterans Affairs should ensure that any such committee convened should contain not less than three members of the Research Advisory Committee on Gulf War Veterans' Illnesses established by section 707 of the Veterans Health Care Act of 1992 (Public Law 102–585; 38 U.S.C. 527 note). (g) Sense of Congress on notification of undue influence It is the sense of Congress that the Secretary of Veterans Affairs should promptly notify the congressional veterans committees of any employee or contractor of the Federal Government whom the Secretary believes influenced, or attempted to influence, the outcome of a report or study on the health of Gulf War veterans conducted by the Department of Veterans Affairs or the Institute of Medicine of the National Academies if such influence was not related to a scientifically objective outcome. 5. Definitions In this Act: (1) The term congressional veterans committees means the Committees on Veterans’ Affairs of the House of Representatives and the Senate. (2) The term Gulf War means the Southwest Asia theater of operations from August 2, 1990, to July 31, 1991. (3) The term Gulf War veteran means an individual who served as a member of the Armed Forces in the Gulf War.