FDA and NIH Workforce Authorities Modernization Act

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 (1) in the section heading, by inserting and Biomedical Product Assessment Research (2) in subsection (a)— (A) in paragraph (1), by striking Silvio O. Conte Senior Biomedical Research Service, not to exceed 500 members Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (in this section referred to as the Service (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 , clinical research evaluation, or biomedical product assessment (B) in paragraph (1), by inserting or a doctoral or master's level degree in engineering, bioinformatics, or a related or emerging field, (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 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 (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 (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 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 (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 (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. 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 Centers (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 (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. (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 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) (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 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) For purposes of this section, the term employee of the Federal Government special Government employee (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) (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) 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) are held in separate accounts from funds received from entities under subsection (i) 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 (f) Paperwork reduction Subchapter I of chapter 35 . 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 (B) by striking subparagraph (B); and (C) by redesignating subparagraph (C) as subparagraph (B); (2) in section 505A ( 21 U.S.C. 355a (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

Summary: FDA and NIH Workforce Authorities Modernization Act (Sec. 2) This bill amends the Public Health Service Act to revise the Silvio O. Conte Senior Biomedical Research Service to: (1) increase the limit on the number of members, (2) expand eligibility for appointment, (3) set a maximum pay rate, and (4) remove the option for members to contribute to the retirement system of an institution of higher education. The Government Accountability Office (GAO) must report on these amendments. (Sec. 3) This bill amends the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration (FDA) additional hiring authority for scientific, technical, or professional positions that support the development, review, and regulation of medical products. The FDA must report on its need for qualified individuals for such positions and must include a recruitment and retention plan. The GAO must report on the FDA&rsquo;s ability to hire, train, and retain qualified staff. (Sec. 4) The FDA must establish one or more Intercenter Institutes. Each institute must coordinate activities applicable to a major disease area among the FDA centers that review products. Activities may include coordinating staff with relevant expertise, streamlining product review, and enhancing interactions with patients, sponsors, and the biomedical community. (Sec. 5) Scientific meetings directly related to the duties of a Department of Health and Human Services (HHS) professional must not be considered conferences for purposes of certain reporting requirements and restrictions on conference travel. Each division of HHS must report on scientific meeting attendance and related travel spending. (Sec. 6) The bill revises Board of Directors membership, Executive Director compensation, and accounting for the Reagan-Udall Foundation for the FDA. (Sec. 7) The Paperwork Reduction Act does not apply to National Institutes of Health research. (Sec. 9) For certain indications, the FDA may rely upon a summary of clinical data to approve a supplemental application for a drug. (Sec. 10) The bill revises provisions regarding: (1) FDA screening of the Adverse Event Reporting System, and (2) evaluation of elements to assure safe use of drugs. The FDA must publish: (1) best practices for using the Adverse Event Reporting System, (2) criteria for publishing adverse event information, and (3) best practices for drug safety surveillance activities for newly approved medications. The FDA no longer must prepare a summary analysis of adverse drug reaction reports for recently approved drugs. (Sec. 11) Biological products are not subject to provisions that refer to an official compendium of drug information. (Sec. 12) The manufacturer or distributor of an investigational drug for a serious condition must publish a policy for compassionate use of the drug. (Sec. 13) HHS must finalize the guidance entitled &ldquo;Expanded Access to Investigational Drugs for Treatment Use--Qs &amp; As.&rdquo; The guidance must explain how HHS uses adverse drug event data from compassionate use. (Sec. 14) This bill amends the Orphan Drug Act to authorize HHS to defray all the costs of development of orphan drugs (drugs for rare conditions), instead of only certain testing expenses. (Sec. 15) HHS must facilitate the development of standards to support development and review of regenerative medicine and advanced therapies. (Sec. 16) FDA guidance must include specified information, including the statutory provisions or regulations that are the basis for policy decisions. (Sec. 17) The Paperwork Reduction Act does not apply to voluntary collection of information during a public health emergency or while determining whether there is a public health emergency. (Sec. 18) The bill revises provisions regarding: movement of impounded drugs, pediatric study plans, reporting on drug shortages, reporting on inspections of establishments manufacturing drugs or medical devices, requests to classify medical devices, priority review of qualified infectious disease products, use of clinical investigation data from outside the United States, and medical gasses. The bill makes technical changes to various provisions regarding medical products.