II 114th CONGRESS 2d Session S. 2700 IN THE SENATE OF THE UNITED STATES March 17, 2016 Mr. Alexander (for himself and Mrs. Murray ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To update the authorizing provisions relating to the workforces of the National Institutes of Health and the Food and Drug Administration, and for other purposes.

1. Short title This Act may be cited as the FDA and NIH Workforce Authorities Modernization Act . 2. Silvio O. Conte senior biomedical research service (a) Hiring and retention authority Section 228 of the Public Health Service Act ( 42 U.S.C. 237 ) is amended— (1) in the section heading, by inserting and Biomedical Product Assessment after Research ; (2) in subsection (a)— (A) in paragraph (1), by striking Silvio O. Conte Senior Biomedical Research Service, not to exceed 500 members and inserting Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (in this section referred to as the Service ), not to exceed 2,000 members, the purpose of which is to recruit and retain outstanding and qualified scientific and technical experts in the fields of biomedical research, clinical research evaluation, and biomedical product assessment ; (B) by amending paragraph (2) to read as follows: (2) The authority established in paragraph (1) may not be construed to require the Secretary to reduce the number of employees serving under any other employment system in order to offset the number of members serving in the Service. ; and (C) by adding at the end the following: (3) The Secretary shall assign experts under this section to agencies within the Department of Health and Human Services taking into account the need for the expertise of such expert. ; (3) in subsection (b)— (A) in the matter preceding paragraph (1), by striking or clinical research evaluation and inserting , clinical research evaluation, or biomedical product assessment ; and (B) in paragraph (1), by inserting or a doctoral or master's level degree in engineering, bioinformatics, or a related or emerging field, after the comma; (4) in subsection (d)(2), by striking and shall not exceed the rate payable for level I of the Executive Schedule unless approved by the President under section 5377(d)(2) of title 5, United States Code and inserting and shall not exceed the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code ; (5) by striking subsection (e); and (6) by redesignating subsections (f) and (g) as subsections (e) and (f), respectively. (b) GAO study (1) In general The Comptroller General of the United States shall conduct a study of the effectiveness of the amendments to section 228 of the Public Health Service Act ( 42 U.S.C. 237 ) made by subsection (a) and the impact of such amendments, if any, on all agencies or departments of the Department of Health and Human Services, and, not later than 4 years after the date of enactment of this Act, shall submit a report based on such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. (2) Content of study and report The study and report under paragraph (1) shall include an examination of the extent to which recruitment and retention of outstanding and qualified scientific, medical, or technical experts in the fields of biomedical research, clinical research evaluation, and biomedical product assessment has improved or otherwise has been affected by the amendments to section 228 of the Public Health Service Act ( 42 U.S.C. 237 ) made by subsection (a), including by determining, during the period between the date of enactment of this Act and the completion of the study— (A) the total number of members recruited and retained under the Senior Biomedical Research and Biomedical Product Assessment Service under such section 228, and the effect of increasing the number of members eligible for such Service; (B) the number of members of such Senior Biomedical Research and Biomedical Product Assessment Service hired with a doctoral level degree in biomedicine or a related field, or doctoral or master's level degree in engineering, bioinformatics, or a related or emerging field; and (C) how many Senior Biomedical Research and Biomedical Product Assessment Service members have been hired by each agency or department of the Department of Health and Human Services, and how such Department assigns such members to each agency or department. 3. Hiring authority for scientific, technical, and professional personnel (a) In general The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 714 ( 21 U.S.C. 379d–3 ) the following: 714A. Hiring authority for scientific, technical, and professional personnel (a) In general The Secretary may, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service, appoint outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products. Such positions shall be within the competitive service. (b) Compensation (1) In general Notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of chapter 53 of title 5, United States Code, and consistent with the requirements of paragraph (2), the Commissioner of Food and Drugs may determine and fix— (A) the annual rate of pay of any individual appointed under subsection (a); and (B) for purposes of retaining qualified employees, the annual rate of pay for any qualified scientific, technical, or professional personnel appointed to a position described in subsection (a) before the date of enactment of this section. (2) Limitation The annual rate of pay established pursuant to paragraph (1) may not exceed the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code. (3) Public availability The annual rate of pay provided to an individual in accordance with this section shall be publicly available information. (c) Rule of construction The authorities under this section shall not be construed to affect the authority provided under section 714. (d) Report on workforce planning (1) In general Not later than 18 months after the date of enactment of the FDA and NIH Workforce Authorities Modernization Act , the Secretary shall submit a report on workforce planning to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that examines the extent to which the Food and Drug Administration has a critical need for qualified individuals for scientific, technical, or professional positions, including— (A) an analysis of the workforce needs at the Food and Drug Administration and the Secretary’s strategic plan for addressing such needs, including through use of the authority under this section; and (B) a recruitment and retention plan for hiring qualified scientific, technical, and professional candidates, which may include the use of— (i) recruitment through non-governmental recruitment or placement agencies; (ii) recruitment through academic institutions; (iii) recruitment or hiring bonuses, if applicable; (iv) recruitment using targeted direct hiring authorities; and (v) retention of qualified scientific, technical, and professional employees using the authority under this section, or other applicable authorities of the Secretary. (2) Recommendations The report under paragraph (1) may include the recommendations of the Commissioner of Food and Drugs that would help the Food and Drug Administration to better recruit and retain qualified individuals for scientific, technical, or professional positions at the agency. . (b) GAO study and report (1) In general The Comptroller General of the United States shall conduct a study of the ability of the Food and Drug Administration to hire, train, and retain qualified scientific, technical, and professional staff, not including contractors, necessary to fulfill the mission of the Food and Drug Administration to protect and promote public health. Not later than January 1, 2022, the Comptroller General shall submit a report on such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. (2) Contents of study The Comptroller General shall include in the study and report under paragraph (1)— (A) information about the progress of the Food and Drug Administration in recruiting and retaining qualified scientific, technical, and professional staff outstanding in the field of biomedical research, clinical research evaluation, and biomedical product assessment; (B) the extent to which critical staffing needs exist at the Food and Drug Administration, and barriers to hiring, training, and retaining qualified staff, if any; (C) an examination of the recruitment and retention strategies of the Food and Drug Administration, including examining any strategic workforce plan, focused on improving scientific, technical, and professional staff recruitment and retention; and (D) recommendations for potential improvements that would address staffing needs of the Food and Drug Administration. 4. Establishment of food and drug administration intercenter institutes (a) In general Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq. ) is amended by adding at the end the following: 1014. Food and Drug Administration Intercenter Institutes (a) In general The Secretary shall establish one or more Intercenter Institutes within the Food and Drug Administration (referred to in this section as an Institute ) for a major disease area or areas. With respect to the major disease area of focus of an Institute, such Institute shall develop and implement processes for coordination of activities, as applicable to such major disease area or areas, between the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health (for the purposes of this section, referred to as the Centers ). Such activities may include— (1) coordination of staff from the Centers with diverse product expertise in the diagnosis, cure, mitigation, treatment, or prevention of the specific diseases relevant to the major disease area of focus of the Institute; (2) streamlining, where appropriate, the review of medical products to diagnose, cure, mitigate, treat, or prevent the major disease area of focus of the Institute, applying relevant standards under sections 505, 510(k), and 515 of this Act and section 351 of the Public Health Service Act, and other applicable authorities; (3) promotion of scientific programs within the Centers related to the major disease area of focus of the Institute; (4) development of programs and enhancement of strategies to recruit, train, and provide continuing education opportunities for the personnel of the Centers with expertise related to the major disease area of focus of the Institute; (5) enhancement of the interactions of the Centers with patients, sponsors, and the external biomedical community regarding the major disease area of focus of the Institute; and (6) facilitation of the collaborative relationships of the Centers with other agencies within the Department of Health and Human Services regarding the major disease area of focus of the Institute. (b) Implementation plan Prior to establishing an Institute under subsection (a), and not later than 1 year after the date of enactment of the FDA and NIH Workforce Authorities Modernization Act , the Secretary shall publish a draft implementation plan for such Institute, and provide for not less than 60 calendar days for public comment on such plan. (c) Timing The Secretary shall establish at least one Institute under subsection (a) within 1 year of the closing of the public comment period under subsection (b), unless the Secretary determines that establishing such Institute would not be feasible or would not benefit the public health, and publishes such determination on the public Internet website of the Food and Drug Administration. (d) Termination of institutes The Secretary may terminate any Institute established pursuant to this section if the Secretary determines such Institute is no longer benefitting the public health. Not less than 60 days prior to so terminating an Institute, the Secretary shall provide public notice, including the rationale for such termination. . (b) Technical amendments Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq. ) is amended— (1) by redesignating section 1012 as section 1013; and (2) by redesignating the second section 1011 (with respect to improving the training of State, local, territorial, and tribal food safety officials), as added by section 209(a) of the FDA Food Safety Modernization Act ( Public Law 111–353 ), as section 1012. 5. Scientific meetings (a) In general Scientific meetings that are attended by scientific or medical personnel, or other professionals, of the Department of Health and Human Services for whom attendance at such meeting is directly related to their professional duties and the mission of the Department— (1) shall not be considered conferences for the purposes of complying with Federal reporting requirements contained in annual appropriations Acts or in this section; and (2) shall not be considered conferences for purposes of a restriction contained in an annual appropriations Act, based on Office of Management and Budget Memorandum M–12–12 or any other regulation restricting such travel. (b) Limitation Nothing in this section shall be construed to exempt travel for scientific meetings from Federal regulations relating to travel. (c) Reports Each operating division of the Department of Health and Human Services shall prepare, and post on an Internet website of the operating division, an annual report on scientific meeting attendance and related travel spending for each fiscal year. Such report shall include— (1) general information concerning the scientific meeting activities involved; (2) information concerning the total amount expended for such meetings; (3) a description of all such meetings that were attended by scientific or medical personnel, or other professionals, of each such operating division where the total amount expended by the operating division associated with each such meeting are in excess of $30,000, including— (A) the total amount of meeting expenses incurred by the operating division for such meeting; (B) the location of such meeting; (C) the date of such meeting; (D) a brief explanation on how such meeting advanced the mission of the operating division; and (E) the total number of individuals whose travel expenses or other scientific meeting expenses were paid by the operating division; and (4) with respect to any such meeting where the total expenses to the operating division exceeded $150,000, a description of the exceptional circumstances that necessitated the expenditure of such amounts. 6. Reagan-Udall Foundation for the Food and Drug Administration (a) Board of Directors (1) Composition and size Section 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379dd(d)(1)(C) ) is amended— (A) by redesignating clause (ii) as clause (iii); (B) by inserting after clause (i) the following: (ii) Additional members The Board, through amendments to the bylaws of the Foundation, may provide that the number of voting members of the Board shall be a number (to be specified in such amendment) greater than 14. Any Board positions that are established by any such amendment shall be appointed (by majority vote) by the individuals who, as of the date of such amendment, are voting members of the Board and persons so appointed may represent any of the categories specified in subclauses (I) through (V) of clause (i), so long as no more than 30 percent of the total voting members of the Board (including members whose positions are established by such amendment) are representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries. ; and (C) in clause (iii)(I), as redesignated by subparagraph (A), by striking The ex officio members shall ensure and inserting The ex officio members, acting pursuant to clause (i), and the Board, acting pursuant to clause (ii), shall ensure . (2) Federal employees allowed to serve on Board Clause (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379dd(d)(1)(C) ), as redesignated by paragraph (1)(A), is amended by adding at the end the following: For purposes of this section, the term employee of the Federal Government does not include a special Government employee , as that term is defined in section 202(a) of title 18, United States Code. . (3) Staggered terms Subparagraph (A) of section 770(d)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379dd(d)(3) ) is amended to read as follows: (A) Term The term of office of each member of the Board appointed under paragraph (1)(C)(i), and the term of office of any member of the Board whose position is established pursuant to paragraph (1)(C)(ii), shall be 4 years, except that— (i) the terms of offices for the members of the Board initially appointed under paragraph (1)(C)(i) shall expire on a staggered basis as determined by the ex officio members; and (ii) the terms of office for the persons initially appointed to positions established pursuant to paragraph (1)(C)(ii) may be made to expire on a staggered basis, as determined by the individuals who, as of the date of the amendment establishing such positions, are members of the Board. . (b) Executive Director compensation Section 770(g)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379dd(g)(2) ) is amended by striking but shall not be greater than the compensation of the Commissioner . (c) Separation of Funds Section 770(m) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379dd(m) ) is amended by striking are held in separate accounts from funds received from entities under subsection (i) and inserting are managed as individual programmatic funds under subsection (i), according to best accounting practices . 7. NIH research information collection exempted from Paperwork Reduction Act Section 301 of the Public Health Service Act ( 42 U.S.C. 241 ) is amended by adding to the end the following: (f) Paperwork reduction Subchapter I of chapter 35 of title 44, United States Code, shall not apply to the collection of information during the conduct of research by the National Institutes of Health. . 8. Studies The Federal Food, Drug, and Cosmetic Act is amended— (1) in section 505(k)(5) ( 21 U.S.C. 355(k)(5) )— (A) in subparagraph (A), by inserting and after the semicolon; (B) by striking subparagraph (B); and (C) by redesignating subparagraph (C) as subparagraph (B); (2) in section 505A ( 21 U.S.C. 355a ), by striking subsection (p); (3) in section 505B ( 21 U.S.C. 355c )— (A) by striking subsection (l); and (B) by redesignating subsection (m) as subsection (l); and (4) in section 523 ( 21 U.S.C. 360m ), by striking subsection (d).