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

<DOC>





                                                       Calendar No. 427
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

                             April 18, 2016

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

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

<DELETED>SEC. 2. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH 
              SERVICE.</DELETED>

<DELETED>    (a) Hiring and Retention Authority.--Section 228 of the 
Public Health Service Act (42 U.S.C. 237) is amended--</DELETED>
        <DELETED>    (1) in the section heading, by inserting ``and 
        biomedical product assessment'' after ``research'';</DELETED>
        <DELETED>    (2) in subsection (a)--</DELETED>
                <DELETED>    (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'';</DELETED>
                <DELETED>    (B) by amending paragraph (2) to read as 
                follows:</DELETED>
<DELETED>    ``(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</DELETED>
                <DELETED>    (C) by adding at the end the 
                following:</DELETED>
<DELETED>    ``(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.'';</DELETED>
        <DELETED>    (3) in subsection (b)--</DELETED>
                <DELETED>    (A) in the matter preceding paragraph (1), 
                by striking ``or clinical research evaluation'' and 
                inserting ``, clinical research evaluation, or 
                biomedical product assessment''; and</DELETED>
                <DELETED>    (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;</DELETED>
        <DELETED>    (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'';</DELETED>
        <DELETED>    (5) by striking subsection (e); and</DELETED>
        <DELETED>    (6) by redesignating subsections (f) and (g) as 
        subsections (e) and (f), respectively.</DELETED>
<DELETED>    (b) GAO Study.--</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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--
        </DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (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.</DELETED>

<DELETED>SEC. 3. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 
              PROFESSIONAL PERSONNEL.</DELETED>

<DELETED>    (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:</DELETED>

<DELETED>``SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 
              PROFESSIONAL PERSONNEL.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Compensation.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) the annual rate of pay of any 
                individual appointed under subsection (a); 
                and</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Public availability.--The annual rate of pay 
        provided to an individual in accordance with this section shall 
        be publicly available information.</DELETED>
<DELETED>    ``(c) Rule of Construction.--The authorities under this 
section shall not be construed to affect the authority provided under 
section 714.</DELETED>
<DELETED>    ``(d) Report on Workforce Planning.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) a recruitment and retention plan for 
                hiring qualified scientific, technical, and 
                professional candidates, which may include the use of--
                </DELETED>
                        <DELETED>    ``(i) recruitment through non-
                        governmental recruitment or placement 
                        agencies;</DELETED>
                        <DELETED>    ``(ii) recruitment through 
                        academic institutions;</DELETED>
                        <DELETED>    ``(iii) recruitment or hiring 
                        bonuses, if applicable;</DELETED>
                        <DELETED>    ``(iv) recruitment using targeted 
                        direct hiring authorities; and</DELETED>
                        <DELETED>    ``(v) retention of qualified 
                        scientific, technical, and professional 
                        employees using the authority under this 
                        section, or other applicable authorities of the 
                        Secretary.</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (b) GAO Study and Report.--</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (2) Contents of study.--The Comptroller General 
        shall include in the study and report under paragraph (1)--
        </DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (D) recommendations for potential 
                improvements that would address staffing needs of the 
                Food and Drug Administration.</DELETED>

<DELETED>SEC. 4. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRATION 
              INTERCENTER INSTITUTES.</DELETED>

<DELETED>    (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:</DELETED>

<DELETED>``SEC. 1014. FOOD AND DRUG ADMINISTRATION INTERCENTER 
              INSTITUTES.</DELETED>

<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(3) promotion of scientific programs within the 
        Centers related to the major disease area of focus of the 
        Institute;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>
<DELETED>    (b) Technical Amendments.--Chapter X of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended--</DELETED>
        <DELETED>    (1) by redesignating section 1012 as section 1013; 
        and</DELETED>
        <DELETED>    (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.</DELETED>

<DELETED>SEC. 5. SCIENTIFIC MEETINGS.</DELETED>

<DELETED>    (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--</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (b) Limitation.--Nothing in this section shall be 
construed to exempt travel for scientific meetings from Federal 
regulations relating to travel.</DELETED>
<DELETED>    (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--</DELETED>
        <DELETED>    (1) general information concerning the scientific 
        meeting activities involved;</DELETED>
        <DELETED>    (2) information concerning the total amount 
        expended for such meetings;</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) the total amount of meeting expenses 
                incurred by the operating division for such 
                meeting;</DELETED>
                <DELETED>    (B) the location of such 
                meeting;</DELETED>
                <DELETED>    (C) the date of such meeting;</DELETED>
                <DELETED>    (D) a brief explanation on how such 
                meeting advanced the mission of the operating division; 
                and</DELETED>
                <DELETED>    (E) the total number of individuals whose 
                travel expenses or other scientific meeting expenses 
                were paid by the operating division; and</DELETED>
        <DELETED>    (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.</DELETED>

<DELETED>SEC. 6. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
              ADMINISTRATION.</DELETED>

<DELETED>    (a) Board of Directors.--</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) by redesignating clause (ii) as clause 
                (iii);</DELETED>
                <DELETED>    (B) by inserting after clause (i) the 
                following:</DELETED>
                        <DELETED>    ``(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</DELETED>
                <DELETED>    (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''.</DELETED>
        <DELETED>    (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.''.</DELETED>
        <DELETED>    (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:</DELETED>
                <DELETED>    ``(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--
                </DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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''.</DELETED>
<DELETED>    (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''.</DELETED>

<DELETED>SEC. 7. NIH RESEARCH INFORMATION COLLECTION EXEMPTED FROM 
              PAPERWORK REDUCTION ACT.</DELETED>

<DELETED>    Section 301 of the Public Health Service Act (42 U.S.C. 
241) is amended by adding to the end the following:</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 8. STUDIES.</DELETED>

<DELETED>    The Federal Food, Drug, and Cosmetic Act is amended--
</DELETED>
        <DELETED>    (1) in section 505(k)(5) (21 U.S.C. 355(k)(5))--
        </DELETED>
                <DELETED>    (A) in subparagraph (A), by inserting 
                ``and'' after the semicolon;</DELETED>
                <DELETED>    (B) by striking subparagraph (B); 
                and</DELETED>
                <DELETED>    (C) by redesignating subparagraph (C) as 
                subparagraph (B);</DELETED>
        <DELETED>    (2) in section 505A (21 U.S.C. 355a), by striking 
        subsection (p);</DELETED>
        <DELETED>    (3) in section 505B (21 U.S.C. 355c)--</DELETED>
                <DELETED>    (A) by striking subsection (l); 
                and</DELETED>
                <DELETED>    (B) by redesignating subsection (m) as 
                subsection (l); and</DELETED>
        <DELETED>    (4) in section 523 (21 U.S.C. 360m), by striking 
        subsection (d).</DELETED>

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), 513(f)(2), 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) Public Process.--The Secretary shall provide a period for 
public comment during the time that each Institute is being 
implemented.
    ``(c) Timing.--The Secretary shall establish at least one Institute 
under subsection (a) before the date that is 1 year after the date of 
enactment of the FDA and NIH Workforce Authorities Modernization Act.
    ``(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).

SEC. 9. SUMMARY LEVEL REVIEW.

    Section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(c)) is amended by adding at the end the following:
            ``(5)(A) The Secretary may rely upon qualified data 
        summaries to support the approval of a supplemental 
        application, with respect to a qualified indication for a drug, 
        submitted under subsection (b) or section 351(a) of the Public 
        Health Service Act, if such supplemental application complies 
        with subparagraph (B).
            ``(B) A supplemental application is eligible for review as 
        described in subparagraph (A) only if--
                    ``(i) there is existing data available and 
                acceptable to the Secretary demonstrating the safety of 
                the drug; and
                    ``(ii) all data used to develop the qualified data 
                summaries are submitted to the Secretary as part of the 
                supplemental application.
            ``(C) In this paragraph--
                    ``(i) the term `qualified indication' means an 
                indication for a drug that the Secretary determines to 
                be appropriate for summary level review under this 
                paragraph; and
                    ``(ii) the term `qualified data summary' means a 
                summary of clinical data that demonstrates the safety 
                and effectiveness of a drug with respect to a qualified 
                indication.''.

SEC. 10. DRUG SURVEILLANCE.

    (a) New Drugs.--Section 505(k)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by section 8, is further 
amended--
            (1) in subparagraph (A), by striking ``, bi-weekly 
        screening'' and inserting ``screenings'';
            (2) in subparagraph (B), as redesignated by section 
        8(1)(C), by striking the period at the end and inserting ``; 
        and''; and
            (3) by adding at the end the following:
                    ``(C) make available on the Internet website of the 
                Food and Drug Administration--
                            ``(i) guidelines, developed with input from 
                        experts qualified by scientific training and 
                        experience to evaluate the safety and 
                        effectiveness of drugs, that detail best 
                        practices for drug safety surveillance using 
                        the FDA Adverse Event Reporting Systems; and
                            ``(ii) criteria for public posting of 
                        adverse event signals.''.
    (b) FAERS Revision.--Section 505(r)(2)(D) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is amended by striking 
``, by 18 months'' and all that follows through the semicolon at the 
end of the subparagraph and inserting ``and making publicly available 
on the Internet Web site established under paragraph (1) best practices 
for drug safety surveillance activities for drugs newly approved under 
this section or section 351 of the Public Health Service Act;''.
    (c) Risk Evaluation and Mitigation Strategies.--Section 505-1(f)(5) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f)(5)) is 
amended--
            (1) in the matter preceding subparagraph (A), by inserting 
        ``or other advisory committee'' after ``(or successor 
        committee)''; and
            (2) in subparagraph (B), by striking ``at least annually,'' 
        and inserting ``periodically''.

SEC. 11. BIOLOGICAL PRODUCT INNOVATION.

    Section 351(j) of the Public Health Service Act (42 U.S.C. 262(j)) 
is amended by striking ``except that'' and all that follows through the 
period at the end and inserting ``except that--
            ``(1) a product for which a license has been approved under 
        this section shall not be required to have an approved 
        application under section 505 of such Act; and
            ``(2) those provisions of the Federal Food, Drug, and 
        Cosmetic Act that refer to an official compendium as defined 
        under section 201(j) of such Act shall not apply to a 
        biological product subject to regulation under this section.''.

SEC. 12. EXPANDED ACCESS POLICY.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 561 (21 U.S.C. 360bbb) the following:

``SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR INVESTIGATIONAL DRUGS.

    ``(a) In General.--The manufacturer or distributor of one or more 
investigational drugs for the diagnosis, cure, mitigation, treatment, 
or prevention of one or more serious diseases or conditions shall make 
available the policy of the manufacturer or distributor on evaluating 
and responding to requests submitted under section 561(b) for provision 
of such a drug.
    ``(b) Public Availability of Expanded Access Policy.--The policies 
under subsection (a) shall be made public and readily available, such 
as by posting such policies on a publicly available Internet website. 
Such policies may be generally applicable to all investigational drugs 
of such manufacturer or distributor.
    ``(c) Content of Policy.--A policy described in subsection (a) 
shall include--
            ``(1) contact information for the manufacturer or 
        distributor to facilitate communication about requests 
        described in subsection (a);
            ``(2) procedures for making such requests;
            ``(3) the general criteria the manufacturer or distributor 
        will use to evaluate such requests for individual patients, and 
        for responses to such requests; and
            ``(4) the length of time the manufacturer or distributor 
        anticipates will be necessary to acknowledge receipt of such 
        requests.
    ``(d) No Guarantee of Access.--The posting of policies by 
manufacturers and distributors under subsection (a) shall not serve as 
a guarantee of access to any specific investigational drug by any 
individual patient.
    ``(e) Revised Policy.--Nothing in this section shall prevent a 
manufacturer or distributor from revising a policy required under this 
section at any time.
    ``(f) Application.--This section shall apply to a manufacturer or 
distributor with respect to an investigational drug beginning on the 
later of--
            ``(1) the date that is 60 calendar days after the date of 
        enactment of the FDA and NIH Workforce Authorities 
        Modernization Act; or
            ``(2) the first initiation of a phase 2 or phase 3 study 
        (as such terms are defined in section 312.21(b) and (c) of 
        title 21, Code of Federal Regulations (or any successor 
        regulations)) with respect to such investigational drug.''.

SEC. 13. FINALIZING DRAFT GUIDANCE ON EXPANDED ACCESS.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services shall finalize 
the draft guidance entitled ``Expanded Access to Investigational Drugs 
for Treatment Use--Qs & As'', dated May 2013.
    (b) Contents.--The final guidance described in subsection (a) shall 
explain how the Secretary of Health and Human Services considers and 
uses adverse drug event data reported by investigators in the case of 
data reported from use under a request submitted under section 561(b) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)).

SEC. 14. AMENDMENTS TO THE ORPHAN DRUG ACT.

    Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended--
            (1) in subsection (a), by striking paragraph (1) and 
        inserting the following: ``(1) defraying the costs of 
        developing drugs for rare diseases or conditions, including 
        qualified testing expenses,''; and
            (2) in subsection (b)(1)--
                    (A) in subparagraph (A)(ii), by striking ``and'' 
                after the semicolon;
                    (B) in subparagraph (B), by striking the period and 
                inserting ``; and''; and
                    (C) by adding at the end the following:
                    ``(C) prospectively planned and designed 
                observational studies and other analyses conducted to 
                assist in the understanding of the natural history of a 
                rare disease or condition and in the development of a 
                therapy, including studies and analyses to--
                            ``(i) develop or validate a drug 
                        development tool related to a rare disease or 
                        condition; or
                            ``(ii) understand the full spectrum of the 
                        disease manifestations, including describing 
                        genotypic and phenotypic variability and 
                        identifying and defining distinct 
                        subpopulations affected by a rare disease or 
                        condition.''.

SEC. 15. STANDARDS FOR REGENERATIVE MEDICINE AND ADVANCED THERAPIES.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F 
the following:

``SEC. 506G. STANDARDS FOR REGENERATIVE MEDICINE AND ADVANCED 
              THERAPIES.

    ``(a) In General.--The Secretary, in consultation with the National 
Institute of Standards and Technology and stakeholders (including 
regenerative medicine and advanced therapies manufacturers and clinical 
trial sponsors, contract manufacturers, academic institutions, 
practicing clinicians, regenerative medicine and advanced therapies 
industry organizations, and standard setting organizations), shall 
facilitate an effort to coordinate and prioritize the development of 
standards, through a transparent public process, that will help support 
product development, evaluation, and review, with respect to 
regenerative medicine and advanced therapies, through regulatory 
predictability, including with regard to manufacturing processes and 
controls for regenerative medicine and advanced therapies products.
    ``(b) Activities.--
            ``(1) In general.--In carrying out this section, the 
        Secretary shall continue to--
                    ``(A) identify opportunities to help advance the 
                development of regenerative medicine and advanced 
                therapies;
                    ``(B) identify opportunities for the development of 
                laboratory regulatory science research and documentary 
                standards that the Secretary determines would help 
                support the development, evaluation, and review of 
                regenerative medicine and advanced therapies through 
                regulatory predictability; and
                    ``(C) work with stakeholders, such as those 
                described in subsection (a), as appropriate, in the 
                development of such standards.
            ``(2) Regulations and guidance.--After the development of 
        standards as described in subsection (a), the Secretary shall 
        review relevant regulations and guidance and, through a 
        transparent public process, update such regulations and 
        guidance as the Secretary determines appropriate.
    ``(c) Definition.--For purposes of this section, the term 
`regenerative medicine and advanced therapies' includes cell therapy, 
gene therapy, gene-modified cell therapy, therapeutic tissue 
engineering products, human cell and tissue products, and combination 
products using any such therapies or products.''.

SEC. 16. GOOD GUIDANCE PRACTICES.

    (a) In General.--Section 701(h)(1)(C) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 371(h)(1)(C)) is amended--
            (1) by moving the margin of clause (ii) 2 ems to the left; 
        and
            (2) by adding at the end the following:
                            ``(iii) When proposing or finalizing any 
                        guidance document under this subparagraph, the 
                        Secretary shall include in the guidance 
                        document a statement, the contents of which are 
                        committed to the discretion of the Secretary--
                                    ``(I) explaining why the 
                                interpretation or policy set forth in 
                                such guidance document is being 
                                provided in a nonbinding guidance 
                                document and not established through 
                                rulemaking; and
                                    ``(II) identifying each specific 
                                statutory provision or regulation being 
                                interpreted in the guidance document or 
                                authorizing a policy decision described 
                                in the guidance document.''.
    (b) Effective Date.--The amendment made under subsection (a)(2) 
shall take effect with respect to any applicable guidance documents 
that are issued on or after the date that is 3 months after the date of 
enactment of this Act.

SEC. 17. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC HEALTH 
              EMERGENCY.

    Section 319 of the Public Health Service Act (42 U.S.C. 247d) is 
amended by adding at the end the following:
    ``(f) Determination With Respect to Paperwork Reduction Act Waiver 
During a Public Health Emergency.--
            ``(1) Determination.--If the Secretary determines, after 
        consultation with such public health officials as may be 
        necessary, that--
                    ``(A)(i) the criteria set forth for a public health 
                emergency under paragraph (1) or (2) of subsection (a) 
                has been met; or
                    ``(ii) a disease or disorder, including a novel and 
                emerging public health threat, is significantly likely 
                to become a public health emergency; and
                    ``(B) the circumstances of such public health 
                emergency, or potential for such significantly likely 
                public health emergency, including the specific 
                preparation for and response to such public health 
                emergency or threat, necessitate a waiver from the 
                requirements of subchapter I of chapter 35 of title 44, 
                United States Code (commonly referred to as the 
                Paperwork Reduction Act);
        then the requirements of such subchapter I with respect to 
        voluntary collection of information shall not be applicable 
        during the immediate investigation of, and response to, such 
        public health emergency during the period of such public health 
        emergency or the period of time necessary to determine if a 
        disease or disorder, including a novel and emerging public 
        health threat, will become a public health emergency as 
        provided for in this paragraph. The requirements of such 
        subchapter I with respect to voluntary collection of 
        information shall not be applicable during the immediate post-
        response review regarding such public health emergency if such 
        immediate post-response review does not exceed a reasonable 
        length of time.
            ``(2) Transparency.--If the Secretary determines that a 
        waiver is necessary under paragraph (1), the Secretary shall 
        promptly post on the Internet website of the Department of 
        Health and Human Services a brief justification for such 
        waiver, the anticipated period of time such waiver will be in 
        effect, and the agencies and offices within the Department of 
        Health and Human Services to which such waiver shall apply, and 
        update such information posted on the Internet website of the 
        Department of Health and Human Services, as applicable.
            ``(3) Effectiveness of waiver.--Any waiver under this 
        subsection shall take effect on the date on which the Secretary 
        posts information on the Internet website as provided for in 
        this subsection.
            ``(4) Termination of waiver.--Upon determining that the 
        circumstances necessitating a waiver under paragraph (1) no 
        longer exist, the Secretary shall promptly update the Internet 
        website of the Department of Health and Human Services to 
        reflect the termination of such waiver.
            ``(5) Limitations.--
                    ``(A) Period of waiver.--The period of a waiver 
                under paragraph (1) shall not exceed the period of time 
                for the related public health emergency, including a 
                public health emergency declared pursuant to subsection 
                (a), and any immediate post-response review regarding 
                the public health emergency consistent with the 
                requirements of this subsection.
                    ``(B) Subsequent compliance.--An initiative subject 
                to a waiver under paragraph (1) that is ongoing after 
                the date on which the waiver expires, shall be subject 
                to the requirements of subchapter I of chapter 35 of 
                title 44, United States Code, and the Secretary shall 
                ensure that compliance with such requirements occurs in 
                as timely a manner as possible based on the applicable 
                circumstances, but not to exceed 30 calendar days after 
                the expiration of the applicable waiver.''.

SEC. 18. TECHNICAL CORRECTIONS.

    (a) References.--Except as otherwise expressly provided, whenever 
in this subsection an amendment is expressed in terms of an amendment 
to a section or other provision, the reference shall be considered to 
be made to that section or other provision of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.).
    (b) Amendments.--
            (1) Prohibited acts.--Section 301(r) of the Act (21 U.S.C. 
        331(r)) is amended by inserting ``, drug,'' after ``device'' 
        each place the term appears.
            (2) New drugs.--Section 505 of the Act (21 U.S.C. 355) is 
        amended--
                    (A) in subsection (d), in the last sentence, by 
                striking ``premarket approval'' and inserting 
                ``marketing approval''; and
                    (B) in subsection (q)(5)(A), by striking 
                ``subsection (b)(2) or (j) of the Act or 351(k)'' and 
                inserting ``subsection (b)(2) or (j) of this section or 
                section 351(k)''.
            (3) Risk evaluation and mitigation strategies.--Section 
        505-1(h) of the Act (21 U.S.C. 355-1(h)) is amended--
                    (A) in paragraph (2)(A)(iii)--
                            (i) in the clause heading, by striking 
                        ``label'' and inserting ``labeling'';
                            (ii) by striking ``label'' each place the 
                        term appears and inserting ``labeling''; and
                            (iii) by striking ``sponsor'' and inserting 
                        ``responsible person''; and
                    (B) in paragraph (8), by striking ``and (7).'' and 
                inserting ``and (7)''.
            (4) Pediatric study plans.--Section 505B of the Act (21 
        U.S.C. 355c) is amended--
                    (A) in subsection (e)--
                            (i) in paragraph (2)--
                                    (I) in subparagraph (A), in the 
                                matter preceding clause (i), by 
                                inserting ``study'' after ``initial 
                                pediatric'' each place the term 
                                appears; and
                                    (II) in subparagraph (B), in the 
                                subparagraph heading, by striking 
                                ``initial plan'' and inserting 
                                ``initial pediatric study plan'';
                            (ii) in paragraph (5), by inserting 
                        ``agreed initial pediatric study'' before 
                        ``plan'' in the paragraph heading; and
                            (iii) in paragraph (6), by striking 
                        ``agreed initial pediatric plan'' and inserting 
                        ``agreed initial pediatric study plan''; and
                    (B) in subsection (f)(1), by inserting ``and any 
                significant amendments to such plans,'' after ``agreed 
                initial pediatric study plans,''.
            (5) Discontinuance or interruption in the production of 
        live-saving drugs.--Section 506C of the Act (21 U.S.C. 356c) is 
        amended--
                    (A) in subsection (c), by striking 
                ``discontinuation'' and inserting ``discontinuance''; 
                and
                    (B) in subsection (g)(1), by striking ``section 
                505(j) that could help'' and inserting ``section 
                505(j), that could help''.
            (6) Annual reporting on drug shortages.--Section 506C-1(a) 
        of the Act (21 U.S.C. 331(a)) is amended, in the matter before 
        paragraph (1)--
                    (A) by striking ``Not later than the end of 
                calendar year 2013, and not later than the end of each 
                calendar year thereafter,'' and inserting ``Not later 
                than March 31 of each calendar year,''; and
                    (B) by inserting ``, with respect to the preceding 
                calendar year,'' after ``a report''.
            (7) Drug shortage list.--Section 506E(b)(3)(E) of the Act 
        (21 U.S.C. 356e(b)(3)(E)) is amended by striking 
        ``discontinuation'' and inserting ``discontinuance''.
            (8) Inspections of establishments.--Section 510(h) of the 
        Act (21 U.S.C. 360(h)) is amended--
                    (A) in paragraph (4), in the matter preceding 
                subparagraph (A), by striking ``establishing the risk-
                based scheduled'' and inserting ``establishing a risk-
                based schedule''; and
                    (B) in paragraph (6)--
                            (i) in subparagraph (A), by striking 
                        ``fiscal'' and inserting ``calendar'' each 
                        place the term appears; and
                            (ii) in subparagraph (B), by striking ``an 
                        active ingredient of a drug, a finished drug 
                        product, or an excipient of a drug'' and 
                        inserting ``an active ingredient of a drug or a 
                        finished drug product''.
            (9) Classification of devices intended for human use.--
        Section 513(f)(2)(A) of the Act (21 U.S.C. 360c(f)(2)(A)) is 
        amended--
                    (A) in clause (i), by striking ``within 30 days''; 
                and
                    (B) in clause (iv), by striking ``low-moderate'' 
                and inserting ``low to moderate''.
            (10) Premarket approval.--Section 515(a)(1) of the Act (21 
        U.S.C. 360e(a)(1)) is amended by striking ``subject to a an 
        order'' and inserting ``subject to an order''.
            (11) Program to improve the device recall system.--Section 
        518A of the Act (21 U.S.C. 360h-1) is amended--
                    (A) by striking subsection (c); and
                    (B) by redesignating subsection (d) as subsection 
                (c).
            (12) Unique device identifier.--Section 519(f) of the Act 
        (21 U.S.C. 360i(f)) is amended by striking ``and life 
        sustaining'' and inserting ``or life sustaining''.
            (13) Priority review for qualified infectious disease 
        products.--Section 524A of the Act (21 U.S.C. 360n-1) is 
        amended--
                    (A) by striking ``If the Secretary'' and inserting 
                the following:
    ``(a) In General.--If the Secretary'';
                    (B) by striking ``any'' and inserting ``the 
                first''; and
                    (C) by adding at the end the following:
    ``(b) Construction.--Nothing in this section shall prohibit the 
Secretary from giving priority review to a human drug application or 
efficacy supplement submitted for approval under section 505(b) that 
otherwise meets the criteria for the Secretary to grant priority 
review.''.
            (14) Consultation with external experts on rare diseases, 
        targeted therapies, and genetic targeting of treatments.--
        Section 569(a)(2)(A) of the Act (21 U.S.C. 360bbb-8(a)(2)(A)) 
        is amended, in the first sentence, by striking ``subsection 
        (c)'' and inserting ``subsection (b)''.
            (15) Optimizing global clinical trials.--Section 569A(c) of 
        the Act (21 U.S.C. 360bbb-8a(c)) is amended by inserting ``or 
        under the Public Health Service Act'' after ``this Act''.
            (16) Use of clinical investigation data from outside the 
        united states.--Section 569B of the Act (21 U.S.C. 360bbb-8b) 
        is amended by striking ``drug or device'' and inserting ``drug, 
        biological product, or device'' each place the term appears.
            (17) Medical gases definitions.--Section 575(1)(H) of the 
        Act (21 U.S.C. 360ddd(1)(H)) is amended--
                    (A) by inserting ``for a new drug'' after ``any 
                period of exclusivity''; and
                    (B) by inserting ``or any period of exclusivity for 
                a new animal drug under section 512(c)(2)(F),'' after 
                ``section 505A,''.
            (18) Regulation of medical gases.--Section 576(a) of the 
        Act (21 U.S.C. 360ddd-1(a)) is amended--
                    (A) in the matter preceding subparagraph (A) of 
                paragraph (1), by inserting ``who seeks to initially 
                introduce or deliver for introduction a designated 
                medical gas into interstate commerce'' after ``any 
                person''; and
                    (B) in paragraph (3)--
                            (i) in subparagraph (A)--
                                    (I) in clause (i)(VIII), by 
                                inserting ``for a new drug'' after 
                                ``any period of exclusivity''; and
                                    (II) in clause (ii), in the matter 
                                preceding subclause (I), by inserting 
                                ``the'' before ``final use''; and
                            (ii) in subparagraph (B)--
                                    (I) in clause (i), by inserting 
                                ``for a new drug'' after ``any period 
                                of exclusivity''; and
                                    (II) in clause (ii), by inserting a 
                                comma after ``drug product''.
            (19) Inapplicability of drug fees to designated medical 
        gases.--Section 577 of this Act (21 U.S.C. 360ddd-2) is amended 
        by inserting ``or 740(a)'' after ``section 736(a)''.
            (20) Conflicts of interest.--Section 712(e)(1)(B) of the 
        Act (21 U.S.C. 379d-1(e)(1)(B)) is amended by striking 
        ``services'' and inserting ``service''.
            (21) Authority to assess and use biosimilar biological 
        product fees.--Section 744H(a) of the Act (21 U.S.C. 379j-
        52(a)) is amended--
                    (A) in paragraph (1)(A)(v), by striking 
                ``Biosimilars User Fee Act of 2012'' and inserting 
                ``Biosimilar User Fee Act of 2012''; and
                    (B) in paragraph (2)(B), by striking ``Biosimilars 
                User Fee Act of 2012'' and inserting ``Biosimilar User 
                Fee Act of 2012''.
            (22) Registration of commercial importers.--
                    (A) Amendment.--Section 801(s)(2) of the Act (21 
                U.S.C. 381(s)(2)) is amended by adding at the end the 
                following:
                    ``(D) Effective date.--In establishing the 
                effective date of the regulations under subparagraph 
                (A), the Secretary shall, in consultation with the 
                Secretary of Homeland Security acting through U.S. 
                Customs and Border Protection, as determined 
                appropriate by the Secretary of Health and Human 
                Services, provide a reasonable period of time for an 
                importer of a drug to comply with good importer 
                practices, taking into account differences among 
                importers and types of imports, including based on the 
                level of risk posed by the imported product.''.
                    (B) Conforming amendment.--Section 714 of the Food 
                and Drug Administration Safety and Innovation Act 
                (Public Law 112-144; 126 Stat. 1074) is amended by 
                striking subsection (d).
            (23) Recognition of foreign government inspections.--
        Section 809(a)(2) of the Act (21 U.S.C. 384e(a)(2)) is amended 
        by striking ``conduction'' and inserting ``conducting''.
            (24) Findings relating to drug approval.--Section 
        901(a)(1)(A) of the Food and Drug Administration Safety and 
        Innovation Act (Public Law 112-144; 21 U.S.C. 356 note) is 
        amended by striking ``serious and life-threatening diseases'' 
        and inserting ``serious or life-threatening diseases''.
            (25) Reporting of inclusion of demographic subgroups.--
        Section 907 of the Food and Drug Administration Safety and 
        Innovation Act (Public Law 112-144; 126 Stat. 1092, 1093) is 
        amended--
                    (A) in the section heading, by striking 
                ``biologics'' in the heading and inserting ``biological 
                products''; and
                    (B) in subsection (a)(2)(B), by striking 
                ``applications for new drug applications'' and 
                inserting ``new drug applications''.
            (26) Combating prescription drug abuse.--Section 1122 of 
        the Food and Drug Administration Safety and Innovation Act 
        (Public Law 112-144; 126 Stat. 1112, 1113) is amended--
                    (A) in subsection (a)(2), by striking 
                ``dependance'' and inserting ``dependence''; and
                    (B) in subsection (c), by striking ``promulgate'' 
                and inserting ``issue''.
                                                       Calendar No. 427

114th CONGRESS

  2d Session

                                S. 2700

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                             April 18, 2016

                       Reported with an amendment