221 
serves a single institution as well as a lead in-
stitutional review board. 
SEC. 2262. USE OF NON-LOCAL INSTITUTIONAL REVIEW 
BOARDS FOR REVIEW OF INVESTIGATIONAL 
DEVICE EXEMPTIONS AND HUMAN DEVICE 
EXEMPTIONS. 
(a) IN GENERAL.—Section 520 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(j)) is amended— 
(1) in subsection (g)(3)— 
(A) by striking ‘‘local’’ each place it ap-
pears; and 
(B) in subparagraph (A)(i), by striking 
‘‘which has been’’; and 
(2) in subsection (m)(4)— 
(A) by striking ‘‘local’’ each place it ap-
pears; and 
(B) by striking subparagraph (A) and in-
serting the following new subparagraph: 
‘‘(A) in facilities in which clinical testing of de-
vices is supervised by an institutional review com-
mittee established in accordance with the regulations 
of the Secretary, and’’. 
(b) REGULATIONS.—Not later than 12 months after 
the date of the enactment of this Act, the Secretary of 
Health and Human Services shall revise or issue such reg-
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222 
ulations or guidance as may be necessary to carry out the 
amendments made by subsection (a). 
SEC. 2263. ALTERATION OR WAIVER OF INFORMED CON-
SENT FOR CLINICAL INVESTIGATIONS. 
(a) DEVICES.—Section 520(g)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)) is 
amended— 
(1) in subparagraph (D), by striking ‘‘except 
where subject to such conditions as the Secretary 
may prescribe, the investigator’’ and inserting the 
following: ‘‘except where, subject to such conditions 
as the Secretary may prescribe— 
‘‘(i) the proposed clinical testing poses 
no more than minimal risk to the human 
subject and includes appropriate safe-
guards to protect the rights, safety, and 
welfare of the human subject; or 
‘‘(ii) the investigator’’; and 
(2) in the matter following subparagraph (D), 
by striking ‘‘subparagraph (D)’’ and inserting ‘‘sub-
paragraph (D)(ii)’’. 
(b) DRUGS.—Section 505(i)(4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended 
by striking ‘‘except where it is not feasible or it is contrary 
to the best interests of such human beings’’ and inserting 
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‘‘except where it is not feasible, it is contrary to the best 
interests of such human beings, or the proposed clinical 
testing poses no more than minimal risk to such human 
beings and includes appropriate safeguards as prescribed 
to protect the rights, safety, and welfare of such human 
beings’’. 
Subtitle P—Improving Scientific 
Expertise and Outreach at FDA 
SEC. 2281. SILVIO O. CONTE SENIOR BIOMEDICAL RE-
SEARCH 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 ‘‘RE-
SEARCH’’; 
(2) in subsection (a)(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’), the purpose of which is to recruit and re-
tain competitive and qualified scientific and tech-
nical experts outstanding in the field of biomedical 
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224 
research, clinical research evaluation, and biomedical 
product assessment’’; 
(3) by amending subsection (a)(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.’’; 
(4) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘or clinical research evaluation’’ and 
inserting ‘‘, clinical research evaluation or bio-
medical product assessment’’ after ‘‘evalua-
tion’’; and 
(B) in paragraph (1), by inserting ‘‘or a 
master’s 
level 
degree 
in 
engineering, 
bioinformatics, or a related or emerging field,’’ 
after the comma; 
(5) in subsection (d), 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 rate payable 
for the President’’; 
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(6) by striking subsection (e); and 
(7) by redesignating subsections (f) and (g) as 
subsections (e) and (f), respectively. 
(b) REPORT.—Not later than 3 years after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall submit, and publish on the website 
of the Department of Health and Human Services a report 
on the implementation of the amendments made by sub-
section (a), including whether the amendments have im-
proved the ability of the Food and Drug Administration 
to hire and retain qualified experts to fulfill obligations 
specified under user fee agreements. 
SEC. 2282. ENABLING FDA SCIENTIFIC ENGAGEMENT. 
It is the sense of Congress that participation in or 
sponsorship of scientific conferences and meetings is es-
sential to the mission of the Food and Drug Administra-
tion. 
SEC. 2283. 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 Cos-
metic Act (21 U.S.C. 379dd(d)(1)(C)) is amended— 
(A) by redesignating clause (ii) as clause 
(iii); 
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(B) by inserting after clause (i) the fol-
lowing: 
‘‘(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 (includ-
ing members whose positions are estab-
lished by such amendment) are representa-
tives of the general pharmaceutical, device, 
food, cosmetic, and biotechnology indus-
tries.’’; and 
(C) in clause (iii)(I), as redesignated by 
subparagraph (A), by striking ‘‘The ex officio 
members shall ensure’’ and inserting ‘‘The ex 
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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 para-
graph (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 in-
clude 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 para-
graph (1)(C)(i), and the term of office of any 
member of the Board whose position is estab-
lished pursuant to paragraph (1)(C)(ii), shall be 
4 years, except that— 
‘‘(i) the terms of offices for the mem-
bers of the Board initially appointed under 
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228 
paragraph (1)(C)(i) shall expire on a stag-
gered basis as determined by the ex officio 
members; and 
‘‘(ii) the terms of office for the per-
sons initially appointed to positions estab-
lished 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 es-
tablishing 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 Commis-
sioner’’. 
(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 sub-
section (i)’’ and inserting ‘‘are managed as individual pro-
grammatic funds under subsection (i), according to best 
accounting practices’’. 
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229 
SEC. 2284. COLLECTION OF CERTAIN VOLUNTARY INFOR-
MATION EXEMPTED FROM PAPERWORK RE-
DUCTION ACT. 
Chapter VII of the Federal Food, Drug, and Cos-
metic Act is amended by inserting after section 708 of 
such Act (21 U.S.C. 379) the following: 
‘‘SEC. 708A. COLLECTION OF CERTAIN VOLUNTARY INFOR-
MATION EXEMPTED FROM PAPERWORK RE-
DUCTION ACT. 
‘‘Chapter 35 of title 44, United States Code, shall 
not apply to the collection from patients, industry, aca-
demia, and other stakeholders, of voluntary information 
such as through voluntary surveys or questionnaires, initi-
ated by the Secretary.’’. 
TITLE III—DELIVERY 
Subtitle A—Interoperability 
SEC. 3001. ENSURING INTEROPERABILITY OF HEALTH IN-
FORMATION TECHNOLOGY. 
(a) INTEROPERABILITY STANDARDS.— 
(1) IN GENERAL.—Subtitle A of title XXX of 
the Public Health Service Act (42 U.S.C. 300jj–11 
et seq.) is amended by adding at the end the fol-
lowing new section: 
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230 
‘‘SEC. 3010. ENSURING INTEROPERABILITY OF HEALTH IN-
FORMATION TECHNOLOGY. 
‘‘(a) INTEROPERABILITY.—In order for health infor-
mation technology to be considered interoperable, such 
technology must satisfy the following criteria: 
‘‘(1) SECURE TRANSFER.—The technology al-
lows the secure transfer of the entirety of a patient’s 
data from any and all health information technology 
for authorized use under applicable law. 
‘‘(2) COMPLETE ACCESS TO HEALTH DATA.— 
The technology allows access to the entirety of a pa-
tient’s available data for authorized use under appli-
cable law without special effort, as defined by rec-
ommendations adopted in accordance with this sec-
tion, by the requestor of such data unless such data 
is not disclosable under applicable law. 
‘‘(3) NO INFORMATION BLOCKING.—The tech-
nology is not configured, set up, or implemented to 
engage in information blocking, as defined in section 
3010A(f). 
‘‘(b) CATEGORIES FOR INTEROPERABILITY STAND-
ARDS.—The categories described in this subsection, with 
respect to standards for determining if health information 
technology is interoperable, consistent with the criteria de-
scribed in subsection (a), include the following categories 
of standards: 
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‘‘(1) Standards with respect to vocabulary and 
terminology. 
‘‘(2) Standards with respect to content and 
structure. 
‘‘(3) Standards with respect to transport of in-
formation. 
‘‘(4) Security standards. 
‘‘(5) Service standards.’’. 
(2) GUIDANCE.—Not later than January 1, 
2017, the Secretary of Health and Human Services, 
through the National Coordinator of the Office of 
the National Coordinator for Health Information 
Technology, shall issue guidance with respect to the 
implementation of section 3010 of the Public Health 
Service Act, as added by paragraph (1), including 
with respect to defining and providing examples of 
authorized use of health information technology, as 
described in such section. 
(b) IMPROVEMENTS
TO RECOMMENDATION PROC-
ESS.— 
(1) HIT POLICY COMMITTEE TO INCORPORATE 
POLICIES
FOR
UPDATES
TO
INTEROPERABILITY 
STANDARDS.—Section 3002 of the Public Health 
Service Act (42 U.S.C. 300jj–12) is amended— 
(A) in subsection (a)— 
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(i) by striking ‘‘National Coordinator’’ 
and inserting ‘‘Secretary, in consultation 
with the National Coordinator,’’; and 
(ii) by adding at the end the following 
new sentence: ‘‘The HIT Policy Committee 
is authorized only to provide policy and 
priority recommendations to the Secretary 
and not authorized to otherwise affect the 
development or modification of any stand-
ard, implementation specification, or cer-
tification criterion under this title.’’; and 
(B) in subsection (b)(2)— 
(i) in subparagraph (A), in the first 
sentence— 
(I) by striking ‘‘The HIT Policy 
Committee’’ and inserting ‘‘Subject to 
subparagraph (D), the HIT Policy 
Committee’’; and 
(II) by inserting ‘‘(including the 
areas in which modifications and addi-
tions to interoperability standards 
under section 3010 are needed for the 
electronic exchange and use of health 
information for purposes of adoption 
of such modifications and additions 
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under section 3004)’’ after ‘‘section 
3004’’. 
(ii) by adding at the end the following 
new subparagraph: 
‘‘(D) SPECIAL RULE RELATED TO INTER-
OPERABILITY.—Any recommendation made by 
the HIT Policy Committee on or after the date 
of the enactment of this subparagraph with re-
spect to interoperability of health information 
technology shall be consistent with the criteria 
described in subsection (a) of section 3010.’’. 
(2) SUNSET OF HIT STANDARDS COMMITTEE.— 
Section 3003 of the Public Health Service Act (42 
U.S.C. 300jj–13) is amended by adding at the end 
the following new subsection: 
‘‘(f) TERMINATION.—The HIT Standards Committee 
shall terminate on the date that is 90 days after the date 
of the enactment of this subsection.’’. 
(3) 
STANDARDS
DEVELOPMENT
ORGANIZA-
TIONS.—Title XXX of the Public Health Service Act 
is amended by inserting after section 3003 the fol-
lowing new section: 
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‘‘SEC. 
3003A. 
RECOMMENDATIONS 
FOR 
STANDARDS 
THROUGH CONTRACT WITH STANDARDS DE-
VELOPMENT ORGANIZATIONS. 
‘‘(a) CONTRACT.— 
‘‘(1) IN GENERAL.—For purposes of activities 
conducted under this title, the Secretary shall enter 
into contracts with health care standards develop-
ment organizations accredited by the American Na-
tional Standards Institute to carry out the duties de-
scribed in subsection (b), as applicable. 
‘‘(2) TIMING FOR FIRST CONTRACT.—As soon 
as practicable after the date of the enactment of this 
section, the Secretary shall enter into the first con-
tract under paragraph (1). 
‘‘(3) PERIOD
OF
CONTRACT.—Each contract 
under paragraph (1) shall be for a period deter-
mined necessary by the Secretary, in consultation 
with the National Coordinator, to carry out the ap-
plicable duties described in subsection (b). 
‘‘(4) APPROPRIATE ORGANIZATIONS.—The Sec-
retary shall ensure the most appropriate organiza-
tions described in paragraph (1) are selected for 
each contract under paragraph (1). 
‘‘(b) DUTIES.— 
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‘‘(1) INITIAL
CONTRACT.—Under the initial 
contract under subsection (a)(1), the standards de-
velopment organizations— 
‘‘(A) shall provide to the Secretary, in con-
sultation with the National Coordinator, for 
adoption under section 3004, recommendations, 
in accordance with section 3010, for interoper-
ability standards consistent with the criteria de-
scribed in subsection (a) of such section and 
with respect to the categories described in sub-
section (b)(1) of such section; and 
‘‘(B) may provide to the Secretary, in con-
sultation with the National Coordinator, rec-
ommendations described in paragraph (2). 
‘‘(2) SUBSEQUENT
CONTRACTS.—Under each 
subsequent contract, the organizations shall provide 
to the Secretary, in consultation with the National 
Coordinator, for adoption under section 3004 rec-
ommendations for any standards (including inter-
operability criteria), implementation specifications, 
and certification criteria (and modifications, includ-
ing additions to such standards, specifications, and 
criteria), which are in accordance with the policies 
and priorities developed by the Secretary, in con-
sultation with the National Coordinator. 
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‘‘(c) 
MODIFICATIONS
AND
SUBSEQUENT
CON-
TRACTS.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with the National Coordinator, shall periodically 
conduct hearings to evaluate and review the stand-
ards, implementation specification, and certification 
criteria adopted under section 3004 for purposes of 
determining if modifications, including any addi-
tions, are needed with respect to such standards, 
specifications, and criteria. 
‘‘(2) CONTRACT TRIGGER.—Based on the needs 
for standards, implementation specifications, and 
certification criteria (and modifications, including 
additions to such standards, specifications, and cri-
teria) under this title, as determined by the Sec-
retary, in consultation with the National Coordi-
nator, the Secretary shall, as needed, enter into con-
tracts under subsection (a) in addition to the initial 
contract. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated $10,000,000 for contracts 
under subsection (a), to remain available until expended.’’. 
(4) MODIFICATIONS
TO
ROLE
OF
ONCHIT.— 
Section 3001(c)(1)(A) of the Public Health Service 
Act (42 U.S.C. 300jj–11(c)(1)(A)) is amended by in-
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237 
serting ‘‘for recommendations made before the date 
of the enactment of the 21st Century Cures Act,’’ 
before ‘‘review and determine’’. 
(c) ADOPTION.—Section 3004 of the Public Health 
Service Act (42 U.S.C. 300jj–14) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1), by inserting after 
‘‘section 3001(c)’’ the following: ‘‘(or, subject to 
subsection (c), in the case of a standard, speci-
fication, or criterion recommended on or after 
the date of the enactment of the 21st Century 
Cures Act, after the date of submission of the 
recommendation to the Secretary under section 
3003A)’’; and 
(B) in paragraph (2), by striking ‘‘and the 
HIT Standards Committee’’; 
(2) in subsection (b), by adding at the end the 
following new paragraph: 
‘‘(4) LIMITATION.—The Secretary may not 
adopt any standards, implementation specifications, 
or certification criteria under this subsection or sub-
section (a) that are inconsistent with or duplicative 
of an interoperability standard adopted under this 
section, in accordance with section 3010. In the case 
of a standard, specification, or criterion that has 
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been adopted under this section and is inconsistent 
or duplicative of such an interoperability standard 
that is subsequently adopted under this section, such 
interoperability standard shall supercede such other 
standard, specification, or criterion and such other 
standard, specification, or criterion shall no longer 
be considered adopted under this section beginning 
on the date that such interoperability standard be-
comes effective.’’; and 
(3) by adding at the end the following new sub-
sections: 
‘‘(c) ADOPTION
OF
INITIAL
INTEROPERABILITY 
STANDARDS.—Notwithstanding the previous subsections 
of this section, the following shall apply in the case of the 
initial set of interoperability standards recommended 
under section 3003A: 
‘‘(1) REVIEW OF STANDARDS.—Not later than 
90 days after the date of receipt of recommendations 
for such interoperability standards, the Secretary, in 
consultation with the National Coordinator and rep-
resentatives of other relevant Federal agencies, shall 
jointly review such standards and shall determine 
whether or not to propose adoption of such stand-
ards. 
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