[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2700 Introduced in Senate (IS)]

<DOC>






114th CONGRESS
  2d Session
                                S. 2700

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.


_______________________________________________________________________


                   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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA and NIH Workforce Authorities 
Modernization Act''.

SEC. 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.

SEC. 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:

``SEC. 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.

SEC. 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:

``SEC. 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.

SEC. 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.

SEC. 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''.

SEC. 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.''.

SEC. 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).
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