[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