(1) by amending the section heading to read as 
follows: ‘‘INTRAMURAL LOAN REPAYMENT PRO-
GRAM’’; 
(2) in subsection (a)— 
(A) by striking ‘‘The Secretary shall carry 
out a program’’ and inserting ‘‘The Director of 
the National Institutes of Health shall, as appro-
priate and based on workforce and scientific pri-
orities, carry out a program through the subcat-
egories listed in subsection (b)(1) (or modified 
subcategories as provided for in subsection 
(b)(2))’’; 
(B) by striking ‘‘conduct’’ and inserting 
‘‘conduct research’’; 
(C) by striking ‘‘research with respect to ac-
quired immune deficiency syndrome’’; and 
(D) by striking ‘‘$35,000’’ and inserting 
‘‘$50,000’’; 
(3) by redesignating subsection (b) as subsection 
(d); 
(4) by inserting after subsection (a), the fol-
lowing: 
‘‘(b) SUBCATEGORIES OF RESEARCH.—
‘‘(1) IN GENERAL.—In carrying out the program 
under subsection (a), the Director of the National In-
stitutes of Health— 
‘‘(A) shall continue to focus on— 
‘‘(i) general research; 
‘‘(ii) research on acquired immune de-
ficiency syndrome; and 
‘‘(iii) clinical research conducted by 
appropriately qualified health professional 
who are from disadvantaged backgrounds; 
and 
‘‘(B) may focus on an area of emerging sci-
entific or workforce need. 
‘‘(2) ELIMINATION OR ESTABLISHMENT OF SUB-
CATEGORIES.—The Director of the National Institutes 
of Health may eliminate one or more subcategories 
provided for in paragraph (1) due to changes in 
workforce or scientific needs related to biomedical re-
search. The Director may establish other subcategory 
areas based on workforce and scientific priorities if 
the total number of subcategories does not exceed the 
number of subcategories listed in paragraph (1). 
‘‘(c) LIMITATION.—The Director of the National Insti-
tutes of Health may not enter into a contract with a health 
professional pursuant to subsection (a) unless such profes-
sional has a substantial amount of education loans relative 
to income (as determined pursuant to guidelines issued by 
the Director).’’; and 
(5) by adding at the end the following: 
‘‘(e) AVAILABILITY
OF APPROPRIATIONS.—Amounts 
available for carrying out this section shall remain avail-
able until the expiration of the second fiscal year beginning 
after the fiscal year for which such amounts are made avail-
able.’’. 
(b) EXTRAMURAL LOAN REPAYMENT PROGRAM.—Sec-
tion 487B of the Public Health Service Act (42 U.S.C. 288– 
2) is amended— 
(1) by amending the section heading to read as 
follows: ‘‘EXTRAMURAL LOAN REPAYMENT PRO-
GRAM’’; 
(2) in subsection (a)— 
(A) by striking ‘‘The Secretary, in consulta-
tion with the Director of the Eunice Kennedy 
Shriver National Institute of Child Health and 
Human Development, shall establish a program’’ 
and inserting ‘‘IN GENERAL.—The Director of 
the National Institutes of Health shall, as appro-
priate and based on workforce and scientific pri-
orities, carry out a program through the subcat-
egories listed in subsection (b)(1) (or modified
subcategories as provided for in subsection 
(b)(2)),’’; 
(B) by striking ‘‘(including graduate stu-
dents)’’; 
(C) by striking ‘‘with respect to contracep-
tion, or with respect to infertility,’’; and 
(D) by striking ‘‘service, not more than 
$35,000’’ and inserting ‘‘research, not more than 
$50,000’’; 
(3) by redesignating subsections (b) and (c) as 
subsections (d) and (e), respectively; 
(4) by inserting after subsection (a), the fol-
lowing: 
‘‘(b) SUBCATEGORIES OF RESEARCH.— 
‘‘(1) IN GENERAL.—In carrying out the program 
under subsection (a), the Director of the National In-
stitutes of Health— 
‘‘(A) shall continue to focus on— 
‘‘(i) contraception or infertility re-
search; 
‘‘(ii) pediatric research, including pe-
diatric pharmacological research; 
‘‘(iii) minority health disparities re-
search; 
‘‘(iv) clinical research; and
‘‘(v) clinical research conducted by ap-
propriately qualified health professional 
who are from disadvantaged backgrounds; 
and 
‘‘(B) may focus on an area of emerging sci-
entific or workforce need. 
‘‘(2) ELIMINATION OR ESTABLISHMENT OF SUB-
CATEGORIES.—The Director of the National Institutes 
of Health may eliminate one or more subcategories 
provided for in paragraph (1) due to changes in 
workforce or scientific needs related to biomedical re-
search. The Director may establish other subcategory 
areas based on workforce and scientific priorities if 
the total number of subcategories does not exceed the 
number of subcategories listed in paragraph (1). 
‘‘(c) LIMITATION.—The Director of the National Insti-
tutes of Health may not enter into a contract with a health 
professional pursuant to subsection (a) unless such profes-
sional has a substantial amount of education loans relative 
to income (as determined pursuant to guidelines issued by 
the Director).’’; 
(5) in subsection (d) (as so redesignated), by 
striking ‘‘The provisions’’ and inserting ‘‘APPLICA-
BILITY OF CERTAIN PROVISIONS REGARDING OBLI-
GATED SERVICE.—The provisions’’; and
(6) in subsection (e) (as so redesignated), by 
striking ‘‘Amounts’’ and inserting ‘‘AVAILABILITY OF 
APPROPRIATIONS.—Amounts’’. 
(c) TECHNICAL
AND CONFORMING AMENDMENTS.— 
Title IV of the Public Health Service Act is amended— 
(1) by striking section 464z–5 (42 U.S.C. 285t– 
2); 
(2) by striking section 487C (42 U.S.C. 288–3); 
(3) by striking section 487E (42 U.S.C. 288–5); 
(4) by striking section 487F (42 U.S.C. 288–5a), 
as added by section 205 of Public Law 106–505, re-
lating to loan repayment for clinical researchers; and 
(5) by striking section 487F (42 U.S.C. 288–6), 
as added by section 1002(b) of Public Law 106–310 
relating to pediatric research loan repayment. 
(d) GAO REPORT.—Not later than 18 months after the 
date of enactment of this Act, the Comptroller General of 
the United States shall submit to Congress a report on the 
efforts of the National Institutes of Health to attract, retain, 
and develop emerging scientists, including underrepresented 
individuals in the sciences, such as women, racial and eth-
nic minorities, and other groups. Such report shall include 
an analysis of the impact of the additional authority pro-
vided to the Secretary of Health and Human Services under 
this Act to address workforce shortages and gaps in priority
research areas, including which centers and research areas 
offered loan repayment program participants the increased 
award amount. 
Subtitle D—National Institutes of 
Health Planning and Adminis-
tration 
SEC. 2031. NATIONAL INSTITUTES OF HEALTH STRATEGIC 
PLAN. 
(a) STRATEGIC PLAN.—Section 402 of the Public 
Health Service Act (42 U.S.C. 282) is amended— 
(1) in subsection (b)(5), by inserting before the 
semicolon the following: ‘‘, and through the develop-
ment, implementation, and updating of the strategic 
plan developed under subsection (m)’’; and 
(2) by adding at the end the following: 
‘‘(m) NATIONAL INSTITUTES OF HEALTH STRATEGIC 
PLAN.— 
‘‘(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of the 21st Century Cures Act, 
and at least every 6 years thereafter, the Director of 
the National Institutes of Health shall develop and 
submit to the appropriate committees of Congress and 
post on the Internet website of the National Institutes 
of Health, a coordinated strategy (to be known as the 
‘National Institutes of Health Strategic Plan’) to pro-
vide direction to the biomedical research investments 
made by the National Institutes of Health, to facili-
tate collaboration across the institutes and centers, to 
leverage scientific opportunity, and to advance bio-
medicine. 
‘‘(2) REQUIREMENTS.—The strategy under para-
graph (1) shall— 
‘‘(A) identify strategic research priorities 
and objectives across biomedical research, includ-
ing— 
‘‘(i) an assessment of the state of bio-
medical and behavioral research, including 
areas of opportunity with respect to basic, 
clinical, and translational research; 
‘‘(ii) priorities and objectives to ad-
vance the treatment, cure, and prevention of 
health conditions; 
‘‘(iii) emerging scientific opportunities, 
rising public health challenges, and sci-
entific knowledge gaps; and 
‘‘(iv) the identification of near-, mid-, 
and long-term scientific needs; 
‘‘(B) consider, in carrying out subpara-
graph (A)—
‘‘(i) disease burden in the United 
States and the potential for return on in-
vestment to the United States; 
‘‘(ii) rare diseases and conditions; 
‘‘(iii) biological, social, and other de-
terminants of health that contribute to 
health disparities; and 
‘‘(iv) other factors the Director of Na-
tional Institutes of Health determines ap-
propriate; 
‘‘(C) include multi-institute priorities, in-
cluding coordination of research among insti-
tutes and centers; 
‘‘(D) include strategic priorities for funding 
research through the Common Fund, in accord-
ance with section 402A(c)(1)(C); 
‘‘(E) address the National Institutes of 
Health’s proposed and ongoing activities related 
to training and the biomedical workforce; and 
‘‘(F) describe opportunities for collaboration 
with other agencies and departments, as appro-
priate. 
‘‘(3) USE OF PLANS.—Strategic plans developed 
and updated by the national research institutes and 
national centers of the National Institutes of Health
shall be prepared regularly and in such a manner 
that such plans will be informed by the strategic 
plans developed and updated under this subsection. 
Such plans developed by and updated by the national 
research institutes and national centers shall have a 
common template. 
‘‘(4) CONSULTATION.—The Director of National 
Institutes of Health shall develop the strategic plan 
under paragraph (1) in consultation with the direc-
tors of the national research institutes and national 
centers, researchers, patient advocacy groups, and in-
dustry leaders.’’. 
(b) 
CONFORMING
AMENDMENT.—Section 
402A(c)(1)(C) of the Public Health Service Act (42 U.S.C. 
282a(c)(1)(C)) is amended by striking ‘‘Not later than June 
1, 2007, and every 2 years thereafter,’’ and inserting ‘‘As 
part of the National Institutes of Health Strategic Plan re-
quired under section 402(m),’’. 
(c) STRATEGIC PLAN.—Section 492B(a) of the Public 
Health Service Act (42 U.S.C. 289a–2(a)) is amended by 
adding at the end the following: 
‘‘(3) STRATEGIC PLANNING.— 
‘‘(A) IN GENERAL.—The directors of the na-
tional institutes and national centers shall con-
sult at least once annually with the Director of
the National Institute on Minority Health and 
Health Disparities and the Director of the Office 
of Research on Women’s Health regarding objec-
tives of the national institutes and national cen-
ters to ensure that future activities by such insti-
tutes and centers take into account women and 
minorities and are focused on reducing health 
disparities. 
‘‘(B) STRATEGIC
PLANS.—Any strategic 
plan issued by a national institute or national 
center shall include details on the objectives de-
scribed in subparagraph (A).’’. 
SEC. 2032. TRIENNIAL REPORTS. 
Section 403 of the Public Health Service Act (42 
U.S.C. 283) is amended— 
(1) in the section heading, by striking ‘‘BIEN-
NIAL’’ and inserting ‘‘TRIENNIAL’’ ; and 
(2) in subsection (a)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘biennial’’ and inserting ‘‘triennial’’; 
(B) by amending paragraph (3) to read as 
follows: 
‘‘(3) A description of intra-National Institutes of 
Health activities, including—
‘‘(A) identification of the percentage of 
funds made available by each national research 
institute and national center with respect to each 
applicable fiscal year for conducting or sup-
porting research that involves collaboration be-
tween the institute or center and 1 or more other 
national research institutes or national centers; 
and 
‘‘(B) recommendations for promoting co-
ordination of information among the centers of 
excellence.’’; 
(C) in paragraph (4)— 
(i) in subparagraph (B), by striking 
‘‘demographic variables and other vari-
ables’’ and inserting ‘‘demographic vari-
ables, including biological and social vari-
ables and relevant age categories (such as 
pediatric subgroups), and determinants of 
health,’’; and 
(ii) in subparagraph (C)(v)— 
(I) 
by 
striking 
‘‘demographic 
variables and such’’ and inserting ‘‘de-
mographic variables, including rel-
evant age categories (such as pediatric 
subgroups), information submitted by
each national research institute and 
national center to the Director of Na-
tional Institutes of Health under sec-
tion 492B(f), and such’’; and 
(II) by striking ‘‘(regarding inclu-
sion of women and minorities in clin-
ical research)’’ and inserting ‘‘and 
other applicable requirements regard-
ing inclusion of demographic groups’’; 
and 
(D) in paragraph (6)— 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘the following:’’ and 
inserting ‘‘the following—’’; 
(ii) in subparagraph (A)— 
(I) by striking ‘‘An evaluation’’ 
and inserting ‘‘an evaluation’’; and 
(II) by striking the period and in-
serting ‘‘; and’’; 
(iii) by striking subparagraphs (B) 
and (D); 
(iv) by redesignating subparagraph (C) 
as subparagraph (B); and 
(v) in subparagraph (B), as redesig-
nated by clause (iv), by striking ‘‘Rec-
ommendations’’ 
and 
inserting 
‘‘rec-
ommendations’’. 
SEC. 2033. INCREASING ACCOUNTABILITY AT THE NA-
TIONAL INSTITUTES OF HEALTH. 
(a) APPOINTMENT AND TERMS OF DIRECTORS OF NA-
TIONAL
RESEARCH
INSTITUTES
AND
NATIONAL
CEN-
TERS.—Subsection (a) of section 405 of the Public Health 
Service Act (42 U.S.C. 284) is amended to read as follows: 
‘‘(a) APPOINTMENT.— 
‘‘(1) IN GENERAL.—The Director of the National 
Cancer Institute shall be appointed by the President, 
and the Directors of the other national research insti-
tutes and national centers shall be appointed by the 
Secretary, acting through the Director of National In-
stitutes of Health. Each Director of a national re-
search institute or national center shall report di-
rectly to the Director of National Institutes of Health. 
‘‘(2) APPOINTMENT.— 
‘‘(A) TERM.—A Director of a national re-
search institute or national center who is ap-
pointed by the Secretary, acting through the Di-
rector of National Institutes of Health, shall be 
appointed for 5 years. 
‘‘(B) REAPPOINTMENT.—At the end of the 
term of a Director of a national research insti-
tute or national center, the Director may be re-
appointed in accordance with standards applica-
ble to the relevant appointment mechanism. 
There shall be no limit on the number of terms 
that a Director may serve. 
‘‘(C) VACANCIES.—If the office of a Director 
of a national research institute or national cen-
ter becomes vacant before the end of such Direc-
tor’s term, the Director appointed to fill the va-
cancy shall be appointed for a 5-year term start-
ing on the date of such appointment. 
‘‘(D) CURRENT DIRECTORS.—Each Director 
of a national research institute or national cen-
ter who is serving on the date of enactment of the 
21st Century Cures Act shall be deemed to be ap-
pointed for a 5-year term under this subsection 
beginning on such date of enactment. 
‘‘(E) RULE OF CONSTRUCTION.—Nothing in 
this subsection shall be construed to limit the au-
thority of the Secretary or the Director of Na-
tional Institutes of Health to terminate the ap-
pointment of a director referred to in subpara-
graph (A) before the expiration of such director’s 
5-year term.
‘‘(F) NATURE OF APPOINTMENT.—Appoint-
ments and reappointments under this subsection 
shall be made on the basis of ability and experi-
ence as it relates to the mission of the National 
Institutes of Health and its components, includ-
ing compliance with any legal requirement that 
the Secretary or Director of National Institutes 
of Health determines relevant. 
‘‘(3) NONAPPLICATION OF CERTAIN PROVISION.— 
The restrictions contained in section 202 of the De-
partments of Labor, Health and Human Services, 
and Education, and Related Agencies Appropriations 
Act, 1993 (Public Law 102–394; 42 U.S.C. 238f note) 
related to consultants and individual scientists ap-
pointed for limited periods of time shall not apply to 
Directors appointed under this subsection.’’. 
(b) REVIEW OF CERTAIN AWARDS BY DIRECTORS.— 
Section 405(b) of the Public Health Service Act (42 U.S.C. 
284(b)) is amended by adding at the end the following: 
‘‘(3) Before an award is made by a national research 
institute or by a national center for a grant for a research 
program or project (commonly referred to as an ‘R-series 
grant’), other than an award constituting a noncompetitive 
renewal of such a grant, or a noncompetitive administrative 
supplement to such a grant, the Director of such national
research institute or national center shall, consistent with 
the peer review process— 
‘‘(A) review and make the final decision with re-
spect to making the award; and 
‘‘(B) take into consideration, as appropriate— 
‘‘(i) the mission of the national research in-
stitute or national center and the scientific pri-
orities identified in the strategic plan under sec-
tion 402(m); 
‘‘(ii) programs or projects funded by other 
agencies on similar research topics; and 
‘‘(iii) advice by staff and the advisory coun-
cil or board of such national research institute or 
national center.’’. 
(c) REPORT
ON DUPLICATION
IN FEDERAL BIO-
MEDICAL
RESEARCH.—The Secretary of Health and 
Human Services (referred to in this subsection as the ‘‘Sec-
retary’’), shall, not later than 2 years after the date of en-
actment of this Act, submit a report to Congress on efforts 
to prevent and eliminate duplicative biomedical research 
that is not necessary for scientific purposes. Such report 
shall— 
(1) describe the procedures in place to identify 
such duplicative research, including procedures for
monitoring research applications and funded research 
awards to prevent unnecessary duplication; 
(2) describe the steps taken to improve the proce-
dures described in paragraph (1), in response to rel-
evant recommendations made by the Comptroller Gen-
eral of the United States; 
(3) describe how the Secretary operationally dis-
tinguishes necessary and appropriate scientific rep-
lication from unnecessary duplication; and 
(4) provide examples of instances where the Sec-
retary has identified unnecessarily duplicative re-
search and the steps taken to eliminate the unneces-
sary duplication. 
SEC. 2034. REDUCING ADMINISTRATIVE BURDEN FOR RE-
SEARCHERS. 
(a) PLAN PREPARATION
AND IMPLEMENTATION
OF 
MEASURES TO REDUCE ADMINISTRATIVE BURDENS.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of this Act, the Secretary of 
Health and Human Services (referred to in this sec-
tion as the ‘‘Secretary’’) shall— 
(A) lead a review by research funding agen-
cies of all regulations and policies related to the 
disclosure of financial conflicts of interest, in-
cluding the minimum threshold for reporting fi-
nancial conflicts of interest; 
(B) make revisions, as appropriate, to har-
monize existing policies and reduce administra-
tive burden on researchers while maintaining the 
integrity and credibility of research findings and 
protections of human participants; and 
(C) confer with the Office of the Inspector 
General about the activities of such office related 
to financial conflicts of interest involving re-
search funding agencies. 
(2) CONSIDERATIONS.—In updating policies 
under paragraph (1)(B), the Secretary shall con-
sider— 
(A) modifying the timelines for the report-
ing of financial conflicts of interest to just-in- 
time information by institutions receiving grant 
or cooperative agreement funding from the Na-
tional Institutes of Health; 
(B) ensuring that financial interest disclo-
sure reporting requirements are appropriate for, 
and relevant to, awards that will directly fund 
research, which may include modification of the 
definition of the term ‘‘investigator’’ for purposes
of the regulations and policies described in sub-
paragraphs (A) and (B) of paragraph (1); and 
(C) updating any applicable training mod-
ules of the National Institutes of Health related 
to Federal financial interest disclosure. 
(b) MONITORING
OF SUBRECIPIENTS
OF FUNDING 
FROM THE NATIONAL INSTITUTES OF HEALTH.—The Di-
rector of the National Institutes of Health (referred to in 
this section as the ‘‘Director of National Institutes of 
Health’’) shall implement measures to reduce the adminis-
trative burdens related to monitoring of subrecipients of 
grants by primary awardees of funding from the National 
Institutes of Health, which may incorporate findings and 
recommendations from existing and ongoing activities. 
Such measures may include, as appropriate— 
(1) an exemption from subrecipient monitoring 
requirements, upon request from the primary award-
ees, provided that— 
(A) the subrecipient is subject to Federal 
audit requirements pursuant to the Uniform 
Guidance of the Office of Management and 
Budget; 
(B) the primary awardee conducts, pursu-
ant to guidance of the National Institutes of 
Health, a pre-award evaluation of each sub-
recipient’s risk of noncompliance with Federal 
statutes and regulations, the conditions of the 
subaward, and any recurring audit findings; 
and 
(C) such exemption does not absolve the pri-
mary awardee of liability for misconduct by sub-
recipients; and 
(2) the implementation of alternative grant 
structures that obviate the need for subrecipient moni-
toring, which may include collaborative grant models 
allowing for multiple primary awardees. 
(c) REPORTING OF FINANCIAL EXPENDITURES.—The 
Secretary, in consultation with the Director of National In-
stitutes of Health, shall evaluate financial expenditure re-
porting procedures and requirements for recipients of fund-
ing from the National Institutes of Health and take action, 
as appropriate, to avoid duplication between department 
and agency procedures and requirements and minimize 
burden to funding recipients. 
(d) ANIMAL CARE AND USE IN RESEARCH.—Not later 
than 2 years after the date of enactment of this Act, the 
Director of National Institutes of Health, in collaboration 
with the Secretary of Agriculture and the Commissioner of 
Food and Drugs, shall complete a review of applicable regu-
lations and policies for the care and use of laboratory ani-
mals and make revisions, as appropriate, to reduce admin-
istrative burden on investigators while maintaining the in-
tegrity and credibility of research findings and protection 
of research animals. In carrying out this effort, the Director 
of the National Institutes of Health shall seek the input of 
experts, as appropriate. The Director of the National Insti-
tutes of Health shall— 
(1) identify ways to ensure such regulations and 
policies are not inconsistent, overlapping, or unneces-
sarily duplicative, including with respect to inspec-
tion and review requirements by Federal agencies and 
accrediting associations; 
(2) take steps to eliminate or reduce identified 
inconsistencies, overlap, or duplication among such 
regulations and policies; and 
(3) take other actions, as appropriate, to im-
prove the coordination of regulations and policies 
with respect to research with laboratory animals. 
(e) DOCUMENTATION OF PERSONNEL EXPENSES.—The 
Secretary shall clarify the applicability of the requirements 
under the Office of Management and Budget Uniform Guid-
ance for management and certification systems adopted by 
entities receiving Federal research grants through the De-
partment of Health and Human Services regarding docu-
mentation of personnel expenses, including clarification of
the extent to which any flexibility to such requirements 
specified in such Uniform Guidance applies to entities re-
ceiving grants through the Department of Health and 
Human Services. 
(f) RESEARCH POLICY BOARD.— 
(1) ESTABLISHMENT.—Not later than 1 year 
after the date of enactment of this Act, the Director 
of the Office of Management and Budget shall estab-
lish an advisory committee, to be known as the ‘‘Re-
search Policy Board’’ (referred to in this subsection as 
the ‘‘Board’’), to provide Federal Government officials 
with information on the effects of regulations related 
to Federal research requirements. 
(2) MEMBERSHIP.— 
(A) IN GENERAL.—The Board shall include 
not more than 10 Federal members, including 
each of the following Federal members or their 
designees: 
(i) The Administrator of the Office of 
Information and Regulatory Affairs of the 
Office of Management and Budget. 
(ii) The Director of the Office of 
Science and Technology Policy. 
(iii) The Secretary of Health and 
Human Services.
(iv) The Director of the National 
Science Foundation. 
(v) The secretaries and directors of 
other departments and agencies that sup-
port or regulate scientific research, as deter-
mined by the Director of the Office of Man-
agement and Budget. 
(B) NON-FEDERAL MEMBERS.—The Board 
shall be comprised of not less than 9 and not 
more than 12 representatives of academic re-
search institutions, other private, nonprofit re-
search institutions, or other nonprofit organiza-
tions with relevant expertise. Such members shall 
be appointed by a formal process, to be estab-
lished by the Director of the Office of Manage-
ment and Budget, in consultation with the Fed-
eral membership, and that incorporates— 
(i) nomination by members of the non-
profit scientific research community, in-
cluding academic research institutions; and 
(ii) procedures to fill membership posi-
tions vacated before the end of a member’s 
term. 
(3) 
PURPOSE
AND
RESPONSIBILITIES.—The 
Board shall make recommendations regarding the
modification and harmonization of regulations and 
policies having similar purposes across research fund-
ing agencies to ensure that the administrative burden 
of such research policy and regulation is minimized 
to the greatest extent possible and consistent with 
maintaining responsible oversight of federally funded 
research. Activities of the Board may include— 
(A) providing thorough and informed anal-
ysis of regulations and policies; 
(B) identifying negative or adverse con-
sequences of existing policies and making action-
able recommendations regarding possible im-
provement of such policies; 
(C) making recommendations with respect 
to efforts within the Federal Government to im-
prove coordination of regulation and policy re-
lated to research; 
(D) creating a forum for the discussion of 
research policy or regulatory gaps, challenges, 
clarification, or harmonization of such policies 
or regulation, and best practices; and 
(E) conducting ongoing assessment and 
evaluation of regulatory burden, including devel-
opment of metrics, periodic measurement, and
identification of process improvements and pol-
icy changes. 
(4) EXPERT SUBCOMMITTEES.—The Board may 
form temporary expert subcommittees, as appropriate, 
to develop timely analysis on pressing issues and as-
sist the Board in anticipating future regulatory chal-
lenges, including challenges emerging from new sci-
entific advances. 
(5) REPORTING REQUIREMENTS.—Not later than 
2 years after the date of enactment of this Act, and 
once thereafter, the Board shall submit a report to the 
Director of the Office of Management and Budget, the 
Administrator of the Office of Information and Regu-
latory Affairs of the Office of Management and Budg-
et, the Director of the Office of Science and Tech-
nology Policy, the heads of relevant Federal depart-
ments and agencies, the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate, and the 
Committee on Energy and Commerce of the House of 
Representatives containing formal recommendations 
on the conceptualization, development, harmonization, 
and reconsideration of scientific research policy, in-
cluding the regulatory benefits and burdens. 
(6) SUNSET.—The Board shall terminate on 
September 30, 2021.
(7) GAO REPORT.—Not later than 4 years after 
the date of enactment of this Act, the Comptroller 
General of the United States shall conduct an inde-
pendent evaluation of the activities carried out by the 
Board pursuant to this subsection and submit to the 
appropriate committees of Congress a report regard-
ing the results of the independent evaluation. Such re-
port shall review and assess the Board’s activities 
with respect to the responsibilities described in para-
graph (3). 
SEC. 2035. EXEMPTION FOR THE NATIONAL INSTITUTES OF 
HEALTH FROM THE PAPERWORK REDUCTION 
ACT REQUIREMENTS. 
Section 301 of the Public Health Service Act (42 
U.S.C. 241), as amended by section 2013, is further amend-
ed by adding at the end the following: 
‘‘(g) Subchapter I of chapter 35 of title 44, United 
States Code, shall not apply to the voluntary collection of 
information during the conduct of research by the National 
Institutes of Health.’’. 
SEC. 2036. HIGH-RISK, HIGH-REWARD RESEARCH. 
(a) IN GENERAL.—Section 402 of the Public Health 
Service Act (42 U.S.C. 282), as amended by section 2031, 
is further amended by adding at the end the following: 
‘‘(n) UNIQUE RESEARCH INITIATIVES.—
‘‘(1) IN GENERAL.—The Director of NIH may 
approve, after consideration of a proposal under 
paragraph (2)(A), requests by the national research 
institutes and centers, or program officers within the 
Office of the Director to engage in transactions other 
than a contract, grant, or cooperative agreement with 
respect to projects that carry out— 
‘‘(A) the Precision Medicine Initiative 
under section 498E; or 
‘‘(B) section 402(b)(7), except that not more 
than 50 percent of the funds available for a fiscal 
year through the Common Fund under section 
402A(c)(1) for purposes of carrying out such sec-
tion 402(b)(7) may be used to engage in such 
other transactions. 
‘‘(2) REQUIREMENTS.—The authority provided 
under this subsection may be used to conduct or sup-
port high impact cutting-edge research described in 
paragraph (1) using the other transactions authority 
described in such paragraph if the institute, center, or 
office— 
‘‘(A) submits a proposal to the Director of 
NIH for the use of such authority before con-
ducting or supporting the research, including
why the use of such authority is essential to pro-
moting the success of the project; 
‘‘(B) receives approval for the use of such 
authority from the Director of NIH; and 
‘‘(C) for each year in which the institute, 
center, or office has used such authority in ac-
cordance with this subsection, submits a report 
to the Director of NIH on the activities of the in-
stitute, center, or office relating to such re-
search.’’. 
(b) REPORT TO CONGRESS.—Not later than September 
30, 2020, the Secretary of Health and Human Services, act-
ing through the Director of the National Institutes of 
Health, shall conduct an evaluation of the activities under 
subsection (n) of section 402 of the Public Health Service 
Act (42 U.S.C. 282), as added by subsection (a), and submit 
a report to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives on the re-
sults of such evaluation. 
(c) DUTIES OF DIRECTORS OF INSTITUTES.—Section 
405(b)(1) of the Public Health Service Act (42 U.S.C. 
284(b)(1)) is amended—
(1) by redesignating subparagraphs (C) through 
(L) as subparagraphs (D) through (M), respectively; 
and 
(2) by inserting after subparagraph (B), the fol-
lowing: 
‘‘(C) shall, as appropriate, conduct and support 
research that has the potential to transform the sci-
entific field, has inherently higher risk, and that seeks 
to address major current challenges;’’. 
SEC. 
2037. 
NATIONAL 
CENTER 
FOR 
ADVANCING 
TRANSLATIONAL SCIENCES. 
(a) IN GENERAL.—Section 479(b) of the Public Health 
Service Act (42 U.S.C. 287(b)) is amended— 
(1) in paragraph (1), by striking ‘‘phase IIA’’ 
and inserting ‘‘phase IIB’’; and 
(2) in paragraph (2)— 
(A) in the matter preceding subparagraph 
(A), by striking ‘‘phase IIB’’ and inserting 
‘‘phase III’’; 
(B) in subparagraph (A), by striking 
‘‘phase IIB’’ and inserting ‘‘phase III’’; 
(C) in subparagraph (B), by striking 
‘‘phase IIA’’ and inserting ‘‘phase IIB’’; and 
(D) in subparagraph (C), by striking 
‘‘phase IIB’’ and inserting ‘‘phase III’’.
(b) INCREASED TRANSPARENCY.—Section 479 of the 
Public Health Service Act (42 U.S.C. 287) is amended— 
(1) in subsection (c)— 
(A) in paragraph (4)(D), by striking ‘‘and’’ 
at the end; 
(B) in paragraph (5), by striking the period 
and inserting a semicolon; and 
(C) by adding at the end the following: 
‘‘(6) the methods and tools, if any, that have 
been developed since the last biennial report was pre-
pared; and 
‘‘(7) the methods and tools, if any, that have 
been developed and are being utilized by the Food and 
Drug Administration to support medical product re-
views.’’; and 
(2) by adding at the end the following: 
‘‘(d) INCLUSION OF LIST.—The first biennial report 
submitted under this section after the date of enactment of 
the 21st Century Cures Act shall include a complete list 
of all of the methods and tools, if any, which have been 
developed by research supported by the Center. 
‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as authorizing the Secretary to dis-
close any information that is a trade secret, or other privi-
leged or confidential information subject to section
552(b)(4) of title 5, United States Code, or section 1905 
of title 18, United States Code.’’. 
SEC. 2038. COLLABORATION AND COORDINATION TO EN-
HANCE RESEARCH. 
(a) RESEARCH
PRIORITIES; COLLABORATIVE
RE-
SEARCH PROJECTS.—Section 402(b) of the Public Health 
Service Act (42 U.S.C. 282(b)) is amended— 
(1) by amending paragraph (4) to read as fol-
lows: 
‘‘(4) shall assemble accurate data to be used to 
assess research priorities, including— 
‘‘(A) information to better evaluate sci-
entific opportunity, public health burdens, and 
progress in reducing health disparities; and 
‘‘(B) data on study populations of clinical 
research, funded by or conducted at each na-
tional research institute and national center, 
which— 
‘‘(i) specifies the inclusion of— 
‘‘(I) women; 
‘‘(II) members of minority groups; 
‘‘(III) relevant age categories, in-
cluding pediatric subgroups; and
‘‘(IV) other demographic variables 
as the Director of the National Insti-
tutes of Health determines appropriate; 
‘‘(ii) is disaggregated by research area, 
condition, and disease categories; and 
‘‘(iii) is to be made publicly available 
on the Internet website of the National In-
stitutes of Health;’’; and 
(2) in paragraph (8)— 
(A) in subparagraph (A), by striking ‘‘and’’ 
at the end; and 
(B) by adding at the end the following: 
‘‘(C) foster collaboration between clinical re-
search projects funded by the respective national 
research institutes and national centers that— 
‘‘(i) conduct research involving human 
subjects; and 
‘‘(ii) collect similar data; and 
‘‘(D) encourage the collaboration described 
in subparagraph (C) to— 
‘‘(i) allow for an increase in the num-
ber of subjects studied; and 
‘‘(ii) utilize diverse study populations, 
with special consideration to biological, so-
cial, and other determinants of health that 
contribute to health disparities;’’. 
(b) REPORTING.—Section 492B(f) of the Public Health 
Service Act (42 U.S.C. 289a–2(f)) is amended— 
(1) by striking ‘‘biennial’’ each place such term 
appears and inserting ‘‘triennial’’; 
(2) by striking ‘‘The advisory council’’ and in-
serting the following: 
‘‘(1) IN GENERAL.—The advisory council’’; and 
(3) by adding at the end the following: 
‘‘(2) CONTENTS.—Each triennial report pre-
pared by an advisory council of each national re-
search institute as described in paragraph (1) shall 
include each of the following: 
‘‘(A) The number of women included as sub-
jects, and the proportion of subjects that are 
women, in any project of clinical research con-
ducted during the applicable reporting period, 
disaggregated by categories of research area, con-
dition, or disease, and accounting for single-sex 
studies. 
‘‘(B) The number of members of minority 
groups included as subjects, and the proportion 
of subjects that are members of minority groups, 
in any project of clinical research conducted dur-
ing 
the 
applicable 
reporting 
period, 
disaggregated by categories of research area, con-
dition, or disease and accounting for single-race 
and single-ethnicity studies. 
‘‘(C) For the applicable reporting period, 
the number of projects of clinical research that 
include women and members of minority groups 
and that— 
‘‘(i) have been completed during such 
reporting period; and 
‘‘(ii) are being carried out during such 
reporting period and have not been com-
pleted. 
‘‘(D) The number of studies completed dur-
ing the applicable reporting period for which re-
porting has been submitted in accordance with 
subsection (c)(2)(A).’’. 
(c) COORDINATION.—Section 486(c)(2) of the Public 
Health Service Act (42 U.S.C. 287d(c)(2)) is amended by 
striking ‘‘designees’’ and inserting ‘‘senior-level staff des-
ignees’’. 
(d) IN GENERAL.—Part A of title IV of the Public 
Health Service Act (42 U.S.C. 281 et seq.), as amended by 
section 2021, is further amended by adding at the end the 
following:
‘‘SEC. 404N. POPULATION FOCUSED RESEARCH. 
‘‘The Director of the National Institutes of Health 
shall, as appropriate, encourage efforts to improve research 
related to the health of sexual and gender minority popu-
lations, including by— 
‘‘(1) facilitating increased participation of sex-
ual and gender minority populations in clinical re-
search supported by the National Institutes of Health, 
and reporting on such participation, as applicable; 
‘‘(2) facilitating the development of valid and re-
liable methods for research relevant to sexual and gen-
der minority populations; and 
‘‘(3) addressing methodological challenges.’’. 
(e) REPORTING.— 
(1) IN GENERAL.—The Secretary, in collabora-
tion with the Director of the National Institutes of 
Health, shall as appropriate— 
(A) continue to support research for the de-
velopment of appropriate measures related to re-
porting health information about sexual and 
gender minority populations; and 
(B) not later than 2 years after the date of 
enactment of this Act, disseminate and make 
public such measures. 
(2) NATIONAL
ACADEMY
OF
MEDICINE
REC-
OMMENDATIONS.—In developing the measures de-
and national centers and may encourage the 
funding of collaborative research projects to 
achieve the goals of the National Institutes of 
Health that are related to minority health and 
health disparities.’’. 
(g) BASIC RESEARCH.— 
(1) DEVELOPING
POLICIES.—Not later than 2 
years after the date of enactment of this Act, the Di-
rector of the National Institutes of Health (referred to 
in this section as the ‘‘Director of the National Insti-
tutes of Health’’), taking into consideration the rec-
ommendations developed under section 2039, shall de-
velop policies for projects of basic research funded by 
National Institutes of Health to assess— 
(A) relevant biological variables including 
sex, as appropriate; and 
(B) how differences between male and fe-
male cells, tissues, or animals may be examined 
and analyzed. 
(2) REVISING
POLICIES.—The Director of the 
National Institutes of Health may update or revise 
the policies developed under paragraph (1) as appro-
priate. 
(3) CONSULTATION AND OUTREACH.—In devel-
oping, updating, or revising the policies under this
section, the Director of the National Institutes of 
Health shall— 
(A) consult with— 
(i) the Office of Research on Women’s 
Health; 
(ii) the Office of Laboratory Animal 
Welfare; and 
(iii) appropriate members of the sci-
entific and academic communities; and 
(B) conduct outreach to solicit feedback 
from members of the scientific and academic 
communities on the influence of sex as a variable 
in basic research, including feedback on when it 
is appropriate for projects of basic research in-
volving cells, tissues, or animals to include both 
male and female cells, tissues, or animals. 
(4) ADDITIONAL REQUIREMENTS.—The Director 
of the National Institutes of Health shall— 
(A) ensure that projects of basic research 
funded by the National Institutes of Health are 
conducted in accordance with the policies devel-
oped, updated, or revised under this section, as 
applicable; and 
(B) encourage that the results of such re-
search, 
when 
published 
or 
reported, 
be
disaggregated as appropriate with respect to the 
analysis of any sex differences. 
(h) CLINICAL RESEARCH.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Director of the 
National Institutes of Health, in consultation with 
the Director of the Office of Research on Women’s 
Health and the Director of the National Institute on 
Minority Health and Health Disparities, shall update 
the guidelines established under section 492B(d) of 
Public Health Service Act (42 U.S.C. 289a–2(d)) in 
accordance with paragraph (2). 
(2) REQUIREMENTS.—The updated guidelines 
described in paragraph (1) shall— 
(A) reflect the science regarding sex dif-
ferences; 
(B) improve adherence to the requirements 
under section 492B of the Public Health Service 
Act (42 U.S.C. 289a–2), including the reporting 
requirements under subsection (f) of such section; 
and 
(C) clarify the circumstances under which 
studies should be designed to support the conduct 
of analyses to detect significant differences in the 
intervention effect due to demographic factors re-
lated to section 492B of the Public Health Serv-
ice Act, including in the absence of prior studies 
that demonstrate a difference in study outcomes 
on the basis of such factors and considering the 
effects of the absence of such analyses on the 
availability of data related to demographic dif-
ferences. 
(i) APPROPRIATE AGE GROUPINGS IN CLINICAL RE-
SEARCH.— 
(1) INPUT FROM EXPERTS.—Not later than 180 
days after the date of enactment of this Act, the Di-
rector of the National Institutes of Health shall con-
vene a workshop of experts on pediatric and older 
populations to provide input on— 
(A) appropriate age groups to be included 
in research studies involving human subjects; 
and 
(B) acceptable justifications for excluding 
participants from a range of age groups from 
human subjects research studies. 
(2) POLICY UPDATES.—Not later than 180 days 
after the conclusion of the workshop under paragraph 
(1), the Director of the National Institutes of Health 
shall make a determination with respect to whether 
the policies of the National Institutes of Health on the
inclusion of relevant age groups in clinical studies 
need to be updated, and shall update such policies as 
appropriate. In making the determination, the Direc-
tor of the National Institutes of Health shall take into 
consideration whether such policies— 
(A) address the consideration of age as an 
inclusion variable in research involving human 
subjects; and 
(B) identify the criteria for justification for 
any age-related exclusions in such research. 
(3) PUBLIC AVAILABILITY OF FINDINGS AND CON-
CLUSIONS.—The Director of the National Institutes of 
Health shall— 
(A) make the findings and conclusions re-
sulting from the workshop under paragraph (1) 
and updates to policies in accordance with para-
graph (2), as applicable, available to the public 
on the Internet website of the National Institutes 
of Health; and 
(B) ensure that age-related data reported in 
the triennial report under section 403 of the 
Public Health Service Act (42 U.S.C. 283) (as 
amended by section 2032) are made available to 
the public on the Internet website of the National 
Institutes of Health.
SEC. 2039. ENHANCING THE RIGOR AND REPRODUCIBILITY 
OF SCIENTIFIC RESEARCH. 
(a) ESTABLISHMENT.—Not later than 1 year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Director of the Na-
tional Institutes of Health, shall convene a working group 
under the Advisory Committee to the Director of the Na-
tional Institutes of Health (referred to in this section as 
the ‘‘Advisory Committee’’), appointed under section 222 of 
the Public Health Service Act (42 U.S.C. 217a), to develop 
and issue recommendations through the Advisory Com-
mittee for a formal policy, which may incorporate or be 
informed by relevant existing and ongoing activities, to en-
hance rigor and reproducibility of scientific research funded 
by the National Institutes of Health. 
(b) CONSIDERATIONS.—In developing and issuing rec-
ommendations through the Advisory Committee under sub-
section (a), the working group established under such sub-
section shall consider, as appropriate— 
(1) preclinical experiment design, including 
analysis of sex as a biological variable; 
(2) clinical experiment design, including— 
(A) the diversity of populations studied for 
clinical research, with respect to biological, so-
cial, and other determinants of health that con-
tribute to health disparities;
(B) the circumstances under which sum-
mary information regarding biological, social, 
and other factors that contribute to health dis-
parities should be reported; and 
(C) the circumstances under which clinical 
studies, including clinical trials, should conduct 
an analysis of the data collected during the 
study on the basis of biological, social, and other 
factors that contribute to health disparities; 
(3) applicable levels of rigor in statistical meth-
ods, methodology, and analysis; 
(4) data and information sharing in accordance 
with applicable privacy laws and regulations; and 
(5) any other matter the working group deter-
mines relevant. 
(c) POLICIES.—Not later than 18 months after the date 
of enactment of this Act, the Director of the National Insti-
tutes of Health shall consider the recommendations devel-
oped by the working group and issued by the Advisory Com-
mittee under subsection (a) and develop or update policies 
as appropriate. 
(d) REPORT.—Not later than 2 years after the date 
of enactment of this Act, the Director of the National Insti-
tutes of Health shall issue a report to the Secretary of 
Health and Human Services, the Committee on Health,
Education, Labor, and Pensions of the Senate, and the 
Committee on Energy and Commerce of the House of Rep-
resentatives regarding recommendations developed under 
subsection (a) and any subsequent policy changes imple-
mented, to enhance rigor and reproducibility in scientific 
research funded by the National Institutes of Health. 
(e) CONFIDENTIALITY.—Nothing in this section au-
thorizes the Secretary of Health and Human Services to 
disclose any information that is a trade secret, or other 
privileged or confidential information, described in section 
552(b)(4) of title 5, United States Code, or section 1905 
of title 18, United States Code. 
SEC. 2040. IMPROVING MEDICAL REHABILITATION RE-
SEARCH AT THE NATIONAL INSTITUTES OF 
HEALTH. 
(a) IN GENERAL.—Section 452 of the Public Health 
Service Act (42 U.S.C. 285g–4) is amended— 
(1) in subsection (b), by striking ‘‘conduct and 
support’’ and inserting ‘‘conduct, support, and co-
ordination’’; 
(2) in subsection (c)(1)(C), by striking ‘‘of the 
Center’’ and inserting ‘‘within the Center’’; 
(3) in subsection (d)—
(A) by striking ‘‘(d)(1) In consultation’’ 
and all that follows through the end of para-
graph (1) and inserting the following: 
‘‘(d)(1) The Director of the Center, in consultation 
with the Director of the Institute, the coordinating com-
mittee established under subsection (e), and the advisory 
board established under subsection (f), shall develop a com-
prehensive plan (referred to in this section as the ‘Research 
Plan’) for the conduct, support, and coordination of medical 
rehabilitation research.’’; 
(B) in paragraph (2)— 
(i) in subparagraph (A), by striking ‘‘; 
and’’ and inserting a semicolon; 
(ii) in subparagraph (B), by striking 
the period and inserting ‘‘; and’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(C) include goals and objectives for conducting, 
supporting, and coordinating medical rehabilitation 
research, consistent with the purpose described in sub-
section (b).’’; 
(C) by striking paragraph (4) and inserting 
the following: 
‘‘(4) The Director of the Center, in consultation with 
the Director of the Institute, the coordinating committee es-
tablished under subsection (e), and the advisory board es-
tablished under subsection (f), shall revise and update the 
Research Plan periodically, as appropriate, or not less than 
every 5 years. Not later than 30 days after the Research 
Plan is so revised and updated, the Director of the Center 
shall transmit the revised and updated Research Plan to 
the President, the Committee on Health, Education, Labor, 
and Pensions of the Senate, and the Committee on Energy 
and Commerce of the House of Representatives.’’; and 
(D) by adding at the end the following: 
‘‘(5) The Director of the Center, in consultation with 
the Director of the Institute, shall, prior to revising and 
updating the Research Plan, prepare a report for the co-
ordinating committee established under subsection (e) and 
the advisory board established under subsection (f) that de-
scribes and analyzes the progress during the preceding fiscal 
year in achieving the goals and objectives described in para-
graph (2)(C) and includes expenditures for rehabilitation 
research at the National Institutes of Health. The report 
shall include recommendations for revising and updating 
the Research Plan, and such initiatives as the Director of 
the Center and the Director of the Institute determine ap-
propriate. In preparing the report, the Director of the Cen-
ter and the Director of the Institute shall consult with the 
Director of the National Institutes of Health.’’;
(4) in subsection (e)— 
(A) in paragraph (2), by inserting ‘‘peri-
odically host a scientific conference or workshop 
on medical rehabilitation research and’’ after 
‘‘The Coordinating Committee shall’’; and 
(B) in paragraph (3), by inserting ‘‘the Di-
rector of the Division of Program Coordination, 
Planning, and Strategic Initiatives within the 
Office of the Director of the National Institutes 
of Health,’’ after ‘‘shall be composed of’’; 
(5) in subsection (f)(3)(B)— 
(A) by redesignating clauses (ix) through 
(xi) as clauses (x) through (xii), respectively; and 
(B) by inserting after clause (viii) the fol-
lowing: 
‘‘(ix) The Director of the Division of Program 
Coordination, Planning, and Strategic Initiatives.’’; 
and 
(6) by adding at the end the following: 
‘‘(g)(1) The Secretary and the heads of other Federal 
agencies shall jointly review the programs carried out (or 
proposed to be carried out) by each such official with respect 
to medical rehabilitation research and, as appropriate, 
enter into agreements preventing duplication among such 
programs.
‘‘(2) The Secretary shall, as appropriate, enter into 
interagency agreements relating to the coordination of med-
ical rehabilitation research conducted by agencies of the Na-
tional Institutes of Health and other agencies of the Federal 
Government. 
‘‘(h) For purposes of this section, the term ‘medical re-
habilitation research’ means the science of mechanisms and 
interventions that prevent, improve, restore, or replace lost, 
underdeveloped, or deteriorating function.’’. 
(b) CONFORMING AMENDMENT.—Section 3 of the Na-
tional Institutes of Health Amendments of 1990 (42 U.S.C. 
285g–4 note) is amended— 
(1) in subsection (a), by striking ‘‘IN GEN-
ERAL.—’’; and 
(2) by striking subsection (b). 
SEC. 2041. TASK FORCE ON RESEARCH SPECIFIC TO PREG-
NANT WOMEN AND LACTATING WOMEN. 
(a) TASK FORCE ON RESEARCH SPECIFIC TO PREG-
NANT WOMEN AND LACTATING WOMEN.— 
(1) ESTABLISHMENT.—Not later than 90 days 
after the date of enactment of this Act, the Secretary 
of Health and Human Services (referred to in this 
section as the ‘‘Secretary’’) shall establish a task force, 
in accordance with the Federal Advisory Committee 
Act (5 U.S.C. App.), to be known as the ‘‘Task Force
on Research Specific to Pregnant Women and Lac-
tating Women’’ (in this section referred to as the 
‘‘Task Force’’). 
(2) DUTIES.—The Task Force shall provide ad-
vice and guidance to the Secretary regarding Federal 
activities related to identifying and addressing gaps 
in knowledge and research regarding safe and effective 
therapies for pregnant women and lactating women, 
including the development of such therapies and the 
collaboration on and coordination of such activities. 
(3) MEMBERSHIP.— 
(A) FEDERAL MEMBERS.—The Task Force 
shall be composed of each of the following Federal 
members, or the designees of such members: 
(i) The Director of the Centers for Dis-
ease Control and Prevention. 
(ii) The Director of the National Insti-
tutes of Health, the Director of the Eunice 
Kennedy Shriver National Institute of 
Child Health and Human Development, 
and the directors of such other appropriate 
national research institutes. 
(iii) The Commissioner of Food and 
Drugs.
(iv) The Director of the Office on 
Women’s Health. 
(v) The Director of the National Vac-
cine Program Office. 
(vi) The head of any other research-re-
lated agency or department not described in 
clauses (i) through (v) that the Secretary 
determines appropriate, which may include 
the Department of Veterans Affairs and the 
Department of Defense. 
(B) NON-FEDERAL
MEMBERS.—The Task 
Force shall be composed of each of the following 
non-Federal members, including— 
(i) representatives from relevant med-
ical societies with subject matter expertise 
on pregnant women, lactating women, or 
children; 
(ii) nonprofit organizations with ex-
pertise related to the health of women and 
children; 
(iii) relevant industry representatives; 
and 
(iv) other representatives, as appro-
priate.
(C) LIMITATIONS.—The non-Federal mem-
bers described in subparagraph (B) shall— 
(i) compose not more than one-half, 
and not less than one-third, of the total 
membership of the Task Force; and 
(ii) be appointed by the Secretary. 
(4) TERMINATION.— 
(A) IN GENERAL.—Subject to subparagraph 
(B), the Task Force shall terminate on the date 
that is 2 years after the date on which the Task 
Force is established under paragraph (1). 
(B) EXTENSION.—The Secretary may ex-
tend the operation of the Task Force for one ad-
ditional 2-year period following the 2-year pe-
riod described in subparagraph (A), if the Sec-
retary determines that the extension is appro-
priate for carrying out the purpose of this sec-
tion. 
(5) MEETINGS.—The Task Force shall meet not 
less than 2 times each year and shall convene public 
meetings, as appropriate, to fulfill its duties under 
paragraph (2). 
(6) TASK FORCE REPORT TO CONGRESS.—Not 
later than 18 months after the date on which the Task 
Force is established under paragraph (1), the Task
Force shall prepare and submit to the Secretary, the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate, and the Committee on Energy 
and Commerce of the House of Representatives a re-
port that includes each of the following: 
(A) A plan to identify and address gaps in 
knowledge and research regarding safe and effec-
tive therapies for pregnant women and lactating 
women, including the development of such thera-
pies. 
(B) Ethical issues surrounding the inclu-
sion of pregnant women and lactating women in 
clinical research. 
(C) Effective communication strategies with 
health care providers and the public on informa-
tion relevant to pregnant women and lactating 
women. 
(D) Identification of Federal activities, in-
cluding— 
(i) the state of research on pregnancy 
and lactation; 
(ii) recommendations for the coordina-
tion of, and collaboration on research re-
lated to pregnant women and lactating 
women;
(iii) dissemination of research findings 
and information relevant to pregnant 
women and lactating women to providers 
and the public; and 
(iv) existing Federal efforts and pro-
grams to improve the scientific under-
standing of the health impacts on pregnant 
women, lactating women, and related birth 
and pediatric outcomes, including with re-
spect 
to 
pharmacokinetics, 
pharmacodynamics, and toxicities. 
(E) Recommendations to improve the devel-
opment of safe and effective therapies for preg-
nant women and lactating women. 
(b) CONFIDENTIALITY.—Nothing in this section shall 
authorize the Secretary of Health and Human Services to 
disclose any information that is a trade secret, or other 
privileged or confidential information, described in section 
552(b)(4) of title 5, United States Code, or section 1905 
of title 18, United States Code. 
(c) UPDATING PROTECTIONS FOR PREGNANT WOMEN 
AND LACTATING WOMEN IN RESEARCH.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of this Act, the Secretary, con-
sidering any recommendations of the Task Force
available at such time and in consultation with the 
heads of relevant agencies of the Department of 
Health and Human Services, shall, as appropriate, 
update regulations and guidance, as applicable, re-
garding the inclusion of pregnant women and lac-
tating women in clinical research. 
(2) CRITERIA
FOR
EXCLUDING
PREGNANT
OR 
LACTATING WOMEN.—In updating any regulations or 
guidance described in paragraph (1), the Secretary 
shall consider any appropriate criteria to be used by 
institutional review boards and individuals reviewing 
grant proposals for excluding pregnant women or lac-
tating women as a study population requiring addi-
tional protections from participating in human sub-
ject research. 
SEC. 
2042. 
STREAMLINING 
NATIONAL 
INSTITUTES 
OF 
HEALTH REPORTING REQUIREMENTS. 
(a) TRANS-NATIONAL INSTITUTES OF HEALTH RE-
SEARCH REPORTING.—Section 402A(c)(2) of the Public 
Health Service Act (42 U.S.C. 282a(c)(2)) is amended— 
(1) by amending subparagraph (B) to read as 
follows: 
‘‘(B) REPORTING.—Not later than 2 years 
after the date of enactment of 21st Century Cures 
Act, the head of each national research institute
100 
or national center shall submit to the Director of 
the National Institutes of Health a report, to be 
included in the triennial report under section 
403, on the amount made available by the insti-
tute or center for conducting or supporting re-
search that involves collaboration between the in-
stitute or center and 1 or more other national re-
search institutes or national centers.’’; and 
(2) in subparagraphs (D) and (E) by striking 
‘‘(B)(i)’’ each place it appears and inserting ‘‘(B)’’. 
(b) FRAUD AND ABUSE REPORTING.—Section 403B of 
the Public Health Service Act (42 U.S.C. 283a–1) is amend-
ed— 
(1) by striking subsection (b); 
(2) by redesignating subsection (c) as subsection 
(b); and 
(3) in subsection (b) (as so redesignated), by 
striking ‘‘subsections (a) and (b)’’ and inserting ‘‘sub-
section (a)’’. 
(c) 
DOCTORAL
DEGREES
REPORTING.—Section 
403C(a)(2) of the Public Health Service Act (42 U.S.C. 
283a–2(a)(2)) is amended by striking ‘‘(not including any 
leaves of absence)’’. 
(d) VACCINE REPORTING.—Section 404B of the Public 
Health Service Act (42 U.S.C. 283d) is amended—
102 
(h) NATIONAL INSTITUTE OF NURSING RESEARCH.— 
(1) REPEAL.—Section 464Y of the Public Health 
Service Act (42 U.S.C. 285q–3) is repealed. 
(2) CONFORMING AMENDMENT.—Section 464X(g) 
of the Public Health Service Act (42 U.S.C. 285q– 
2(g)) is amended by striking ‘‘biennial report made 
under section 464Y,’’ and inserting ‘‘triennial report 
made under section 403’’. 
SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES 
AND LIVING ORGANISMS. 
Section 301 of the Public Health Service Act (42 
U.S.C. 241), as amended by section 2035, is further amend-
ed— 
(1) in the flush matter at the end of subsection 
(a)— 
(A) by redesignating such matter as sub-
section (h)(1); and 
(B) by moving such matter so as to appear 
at the end of such section; and 
(2) in subsection (h) (as so redesignated), by 
adding at the end the following: 
‘‘(2) Where research substances and living organisms 
are made available under paragraph (1) through contrac-
tors, the Secretary may direct such contractors to collect 
payments on behalf of the Secretary for the costs incurred
103 
to make available such substances and organisms and to 
forward amounts so collected to the Secretary, in the time 
and manner specified by the Secretary. 
‘‘(3) Amounts collected under paragraph (2) shall be 
credited to the appropriations accounts that incurred the 
costs to make available the research substances and living 
organisms involved, and shall remain available until ex-
pended for carrying out activities under such accounts.’’. 
SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION 
OF UNDERREPRESENTED POPULATIONS IN 
CLINICAL TRIALS. 
It is the sense of Congress that the National Institute 
on Minority Health and Health Disparities should include 
within its strategic plan under section 402(m) of the Public 
Health Service Act (42 U.S.C. 282(m)) ways to increase 
representation of underrepresented populations in clinical 
trials. 
Subtitle E—Advancement of the Na-
tional Institutes of Health Re-
search and Data Access 
SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS 
DATABASE. 
Section 402(j)(2)(D) of the Public Health Service Act 
(42 U.S.C. 282(j)(2)(D)) is amended—
104 
(1) in clause (ii)(I), by inserting before the semi-
colon ‘‘, unless the responsible party affirmatively re-
quests that the Director of the National Institutes of 
Health publicly post such clinical trial information 
for an applicable device clinical trial prior to such 
date of clearance or approval’’; and 
(2) by adding at the end the following: 
‘‘(iii) OPTION TO MAKE CERTAIN CLIN-
ICAL TRIAL INFORMATION AVAILABLE EAR-
LIER.—The Director of the National Insti-
tutes of Health shall inform responsible par-
ties of the option to request that clinical 
trial information for an applicable device 
clinical trial be publicly posted prior to the 
date of clearance or approval, in accordance 
with clause (ii)(I). 
‘‘(iv) COMBINATION
PRODUCTS.—An 
applicable clinical trial for a product that 
is a combination of drug, device, or biologi-
cal product shall be considered— 
‘‘(I) an applicable drug clinical 
trial, if the Secretary determines under 
section 503(g) of the Federal Food, 
Drug, and Cosmetic Act that the pri-
105 
mary mode of action of such product is 
that of a drug or biological product; or 
‘‘(II) an applicable device clinical 
trial, if the Secretary determines under 
such section that the primary mode of 
action of such product is that of a de-
vice.’’. 
SEC. 2052. COMPLIANCE ACTIVITIES REPORTS. 
(a) DEFINITIONS.—In this section: 
(1) APPLICABLE
CLINICAL
TRIAL.—The term 
‘‘applicable clinical trial’’ has the meaning given the 
term in section 402(j) of the Public Health Service 
Act (42 U.S.C. 282(j)). 
(2) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
(b) REPORT ON ACTIVITIES TO ENCOURAGE COMPLI-
ANCE.—Not later than 2 years after the date of enactment 
of this Act, the Secretary, acting through the Director of 
the National Institutes of Health and in collaboration with 
the Commissioner of Food and Drugs, shall submit to the 
Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce 
of the House of Representatives, a report that describes edu-
cation and outreach, guidance, enforcement, and other ac-
106 
tivities undertaken to encourage compliance with section 
402(j) of the Public Health Service Act (42 U.S.C. 282(j)). 
(c) REPORTS ON CLINICAL TRIALS.— 
(1) IN GENERAL.—Not later than 2 years after 
the final compliance date under the final rule imple-
menting section 402(j) of the Public Health Service 
Act, and every 2 years thereafter for the next 4 years, 
the Secretary, acting through the Director of the Na-
tional Institutes of Health and in collaboration with 
the Commissioner of Food and Drugs, shall submit to 
the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives, a re-
port describing— 
(A) the total number of applicable clinical 
trials with complete data bank registration in-
formation registered during the period for which 
the report is being prepared (broken down by 
each year of such reporting period); 
(B) the total number of applicable clinical 
trials registered during the period for which the 
report is being prepared for which results have 
been submitted to the data bank (broken down by 
each year of such reporting period);
107 
(C) the activities undertaken by the Sec-
retary to educate responsible persons about data 
bank registration and results submission require-
ments, including through issuance of guidance 
documents, informational meetings, and training 
sessions; and 
(D) the activities described in the report 
submitted under subsection (b). 
(2) ACTIONS TO ENFORCE COMPLIANCE.—After 
the Secretary has undertaken the educational activi-
ties described in paragraph (1)(C), the Secretary shall 
include in subsequent reports submitted under para-
graph (1) the number of actions taken by the Sec-
retary during the period for which the report is being 
prepared to enforce compliance with data bank reg-
istration and results submission requirements. 
SEC. 2053. UPDATES TO POLICIES TO IMPROVE DATA. 
Section 492B(c) of the Public Health Service Act (42 
U.S.C. 289a–2(c)) is amended— 
(1) by striking ‘‘In the case’’ and inserting the 
following: 
‘‘(1) IN GENERAL.—In the case’’; and 
(2) by adding at the end the following: 
‘‘(2) REPORTING REQUIREMENTS.—For any new 
and competing project of clinical research subject to
108 
the requirements under this section that receives a 
grant award 1 year after the date of enactment of the 
21st Century Cures Act, or any date thereafter, for 
which a valid analysis is provided under paragraph 
(1)— 
‘‘(A) and which is an applicable clinical 
trial as defined in section 402(j), the entity con-
ducting such clinical research shall submit the 
results of such valid analysis to the clinical trial 
registry data bank expanded under section 
402(j)(3), and the Director of the National Insti-
tutes of Health shall, as appropriate, consider 
whether such entity has complied with the re-
porting requirement described in this subpara-
graph in awarding any future grant to such en-
tity, 
including 
pursuant 
to 
section 
402(j)(5)(A)(ii) when applicable; and 
‘‘(B) the Director of the National Institutes 
of Health shall encourage the reporting of the re-
sults of such valid analysis described in para-
graph (1) through any additional means deter-
mined appropriate by the Director.’’. 
SEC. 2054. CONSULTATION. 
Not later than 90 days after the date of enactment of 
this Act, the Secretary of Health and Human Services shall
109 
consult with relevant Federal agencies, including the Food 
and Drug Administration, the Office of the National Coor-
dinator for Health Information Technology, and the Na-
tional Institutes of Health, as well as other stakeholders (in-
cluding patients, researchers, physicians, industry rep-
resentatives, and developers of health information tech-
nology) to receive recommendations with respect to enhance-
ments to the clinical trial registry data bank under section 
402(j) of the Public Health Service Act (42 U.S.C. 282(j)), 
including with respect to usability, functionality, and 
search capability. 
Subtitle F—Facilitating 
Collaborative Research 
SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SUR-
VEILLANCE SYSTEM. 
Part P of title III of the Public Health Service Act 
(42 U.S.C. 280g et seq.) is amended by inserting after sec-
tion 399S the following: 
‘‘SEC. 399S–1. SURVEILLANCE OF NEUROLOGICAL DISEASES. 
‘‘(a) IN GENERAL.—The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention 
and in coordination with other agencies as the Secretary 
determines, shall, as appropriate—
110 
‘‘(1) enhance and expand infrastructure and ac-
tivities to track the epidemiology of neurological dis-
eases; and 
‘‘(2) incorporate information obtained through 
such activities into an integrated surveillance system, 
which may consist of or include a registry, to be 
known as the National Neurological Conditions Sur-
veillance System. 
‘‘(b) RESEARCH.—The Secretary shall ensure that the 
National Neurological Conditions Surveillance System is 
designed in a manner that facilitates further research on 
neurological diseases. 
‘‘(c) CONTENT.—In carrying out subsection (a), the 
Secretary— 
‘‘(1) shall provide for the collection and storage 
of information on the incidence and prevalence of 
neurological diseases in the United States; 
‘‘(2) to the extent practicable, shall provide for 
the collection and storage of other available informa-
tion on neurological diseases, including information 
related to persons living with neurological diseases 
who choose to participate, such as— 
‘‘(A) demographics, such as age, race, eth-
nicity, sex, geographic location, family history, 
and other information, as appropriate;
111 
‘‘(B) risk factors that may be associated 
with neurological diseases, such as genetic and 
environmental risk factors and other informa-
tion, as appropriate; and 
‘‘(C) diagnosis and progression markers; 
‘‘(3) may provide for the collection and storage 
of information relevant to analysis on neurological 
diseases, such as information concerning— 
‘‘(A) the natural history of the diseases; 
‘‘(B) the prevention of the diseases; 
‘‘(C) the detection, management, and treat-
ment approaches for the diseases; and 
‘‘(D) the development of outcomes measures; 
‘‘(4) may address issues identified during the 
consultation process under subsection (d); and 
‘‘(5) initially may address a limited number of 
neurological diseases. 
‘‘(d) CONSULTATION.—In carrying out this section, the 
Secretary shall consult with individuals with appropriate 
expertise, which may include— 
‘‘(1) epidemiologists with experience in disease 
surveillance or registries; 
‘‘(2) representatives of national voluntary health 
associations that— 
‘‘(A) focus on neurological diseases; and
112 
‘‘(B) have demonstrated experience in re-
search, care, or patient services; 
‘‘(3) health information technology experts or 
other information management specialists; 
‘‘(4) clinicians with expertise in neurological 
diseases; and 
‘‘(5) research scientists with experience con-
ducting translational research or utilizing surveil-
lance systems for scientific research purposes. 
‘‘(e) GRANTS.—The Secretary may award grants to, 
or enter into contracts or cooperative agreements with, pub-
lic or private nonprofit entities to carry out activities under 
this section. 
‘‘(f) COORDINATION WITH OTHER FEDERAL, STATE, 
AND LOCAL AGENCIES.—Subject to subsection (h), the Sec-
retary shall— 
‘‘(1) make information and analysis in the Na-
tional Neurological Conditions Surveillance System 
available, as appropriate— 
‘‘(A) to Federal departments and agencies, 
such as the National Institutes of Health and the 
Department of Veterans Affairs; and 
‘‘(B) to State and local agencies; and 
‘‘(2) identify, build upon, leverage, and coordi-
nate among existing data and surveillance systems,
113 
surveys, registries, and other Federal public health in-
frastructure, wherever practicable. 
‘‘(g) PUBLIC ACCESS.—Subject to subsection (h), the 
Secretary shall ensure that information and analysis in the 
National Neurological Conditions Surveillance System are 
available, as appropriate, to the public, including research-
ers. 
‘‘(h) PRIVACY.—The Secretary shall ensure that infor-
mation and analysis in the National Neurological Condi-
tions Surveillance System are made available only to the 
extent permitted by applicable Federal and State law, and 
in a manner that protects personal privacy, to the extent 
required by applicable Federal and State privacy law, at 
a minimum. 
‘‘(i) REPORTS.— 
‘‘(1) REPORT ON INFORMATION AND ANALYSES.— 
Not later than 1 year after the date on which any sys-
tem is established under this section, the Secretary 
shall submit an interim report to the Committee on 
Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the 
House of Representatives regarding aggregate infor-
mation collected pursuant to this section and epide-
miological analyses, as appropriate. Such report shall 
be posted on the Internet website of the Department
114 
of Health and Human Services and shall be updated 
biennially. 
‘‘(2) IMPLEMENTATION REPORT.—Not later than 
4 years after the date of the enactment of this section, 
the Secretary shall submit a report to the Congress 
concerning the implementation of this section. Such 
report shall include information on— 
‘‘(A) the development and maintenance of 
the National Neurological Conditions Surveil-
lance System; 
‘‘(B) the type of information collected and 
stored in the surveillance system; 
‘‘(C) the use and availability of such infor-
mation, including guidelines for such use; and 
‘‘(D) the use and coordination of databases 
that collect or maintain information on neuro-
logical diseases. 
‘‘(j) DEFINITION.—In this section, the term ‘national 
voluntary health association’ means a national nonprofit 
organization with chapters, other affiliated organizations, 
or networks in States throughout the United States with 
experience serving the population of individuals with neu-
rological disease and have demonstrated experience in neu-
rological disease research, care, and patient services.
115 
‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$5,000,000 for each of fiscal years 2018 through 2022.’’. 
SEC. 2062. TICK-BORNE DISEASES. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as ‘‘the Sec-
retary’’) shall continue to conduct or support epidemiolog-
ical, basic, translational, and clinical research related to 
vector-borne diseases, including tick-borne diseases. 
(b) REPORTS.—The Secretary shall ensure that each 
triennial report under section 403 of the Public Health 
Service Act (42 U.S.C. 283) (as amended by section 2032) 
includes information on actions undertaken by the National 
Institutes of Health to carry out subsection (a) with respect 
to tick-borne diseases. 
(c) TICK-BORNE DISEASES WORKING GROUP.— 
(1) ESTABLISHMENT.—The Secretary shall estab-
lish a working group, to be known as the Tick-Borne 
Disease Working Group (referred to in this section as 
the ‘‘Working Group’’), comprised of representatives of 
appropriate Federal agencies and other non-Federal 
entities, to provide expertise and to review all efforts 
within the Department of Health and Human Serv-
ices related to all tick-borne diseases, to help ensure
116 
interagency coordination and minimize overlap, and 
to examine research priorities. 
(2) RESPONSIBILITIES.—The working group 
shall— 
(A) not later than 2 years after the date of 
enactment of this Act, develop or update a sum-
mary of— 
(i) ongoing tick-borne disease research, 
including research related to causes, preven-
tion, treatment, surveillance, diagnosis, 
diagnostics, duration of illness, and inter-
vention for individuals with tick-borne dis-
eases; 
(ii) advances made pursuant to such 
research; 
(iii) Federal activities related to tick- 
borne diseases, including— 
(I) epidemiological activities re-
lated to tick-borne diseases; and 
(II) 
basic, 
clinical, 
and 
translational tick-borne disease re-
search related to the pathogenesis, pre-
vention, diagnosis, and treatment of 
tick-borne diseases;
117 
(iv) gaps in tick-borne disease research 
described in clause (iii)(II); 
(v) the Working Group’s meetings re-
quired under paragraph (4); and 
(vi) the comments received by the 
Working Group; 
(B) make recommendations to the Secretary 
regarding any appropriate changes or improve-
ments to such activities and research; and 
(C) solicit input from States, localities, and 
nongovernmental entities, including organiza-
tions representing patients, health care pro-
viders, researchers, and industry regarding sci-
entific advances, research questions, surveillance 
activities, and emerging strains in species of 
pathogenic organisms. 
(3) MEMBERSHIP.—The members of the working 
group shall represent a diversity of scientific dis-
ciplines and views and shall be composed of the fol-
lowing members: 
(A) FEDERAL
MEMBERS.—Seven Federal 
members, consisting of one or more representa-
tives of each of the following: 
(i) The Office of the Assistant Sec-
retary for Health.
118 
(ii) The Food and Drug Administra-
tion. 
(iii) The Centers for Disease Control 
and Prevention. 
(iv) The National Institutes of Health. 
(v) Such other agencies and offices of 
the Department of Health and Human 
Services as the Secretary determines appro-
priate. 
(B) NON–FEDERAL
PUBLIC
MEMBERS.— 
Seven non–Federal public members, consisting of 
representatives of the following categories: 
(i) Physicians and other medical pro-
viders with experience in diagnosing and 
treating tick-borne diseases. 
(ii) Scientists or researchers with ex-
pertise. 
(iii) Patients and their family mem-
bers. 
(iv) Nonprofit organizations that advo-
cate for patients with respect to tick-borne 
diseases. 
(v) Other individuals whose expertise 
is determined by the Secretary to be bene-
119 
ficial to the functioning of the Working 
Group. 
(4) MEETINGS.—The Working Group shall meet 
not less than twice each year. 
(5) REPORTING.—Not later than 2 years after 
the date of enactment of this Act, and every 2 years 
thereafter until termination of the Working Group 
pursuant to paragraph (7), the Working Group 
shall— 
(A) submit a report on its activities under 
paragraph (2)(A) and any recommendations 
under paragraph (2)(B) to the Secretary, the 
Committee on Energy and Commerce of the 
House of Representatives, and the Committee on 
Health, Education, Labor, and Pensions of the 
Senate; and 
(B) make such report publicly available on 
the Internet website of the Department of Health 
and Human Services. 
(6) APPLICABILITY
OF
FACA.—The Working 
Group shall be treated as an advisory committee sub-
ject to the Federal Advisory Committee Act (5 U.S.C. 
App.).
120 
(7) SUNSET.—The Working Group under this 
section shall terminate 6 years after the date of enact-
ment of this Act. 
SEC. 2063. ACCESSING, SHARING, AND USING HEALTH DATA 
FOR RESEARCH PURPOSES. 
(a) GUIDANCE RELATED TO REMOTE ACCESS.—Not 
later than 1 year after the date of enactment of this Act, 
the Secretary of Health and Human Services (referred to 
in this section as the ‘‘Secretary’’) shall issue guidance 
clarifying 
that 
subparagraph 
(B) 
of 
section 
164.512(i)(1)(ii) of part 164 of the Rule (prohibiting the 
removal of protected health information by a researcher) 
does not prohibit remote access to health information by a 
researcher for such purposes as described in section 
164.512(i)(1)(ii) of part 164 of the Rule so long as— 
(1) at a minimum, security and privacy safe-
guards, consistent with the requirements of the Rule, 
are maintained by the covered entity and the re-
searcher; and 
(2) the protected health information is not copied 
or otherwise retained by the researcher. 
(b) GUIDANCE RELATED TO STREAMLINING AUTHOR-
IZATION.—Not later than 1 year after the date of enactment 
of this Act, the Secretary shall issue guidance on the fol-
lowing:
121 
(1) AUTHORIZATION FOR USE AND DISCLOSURE 
OF HEALTH INFORMATION.—Clarification of the cir-
cumstances under which the authorization for the use 
or disclosure of protected health information, with re-
spect to an individual, for future research purposes 
contains a sufficient description of the purpose of the 
use or disclosure, such as if the authorization— 
(A) sufficiently describes the purposes such 
that it would be reasonable for the individual to 
expect that the protected health information 
could be used or disclosed for such future re-
search; 
(B) either— 
(i) states that the authorization will 
expire on a particular date or on the occur-
rence of a particular event; or 
(ii) states that the authorization will 
remain valid unless and until it is revoked 
by the individual; and 
(C) provides instruction to the individual 
on how to revoke such authorization at any time. 
(2) REMINDER OF THE RIGHT TO REVOKE.— 
Clarification of the circumstances under which it is 
appropriate to provide an individual with an annual
122 
notice or reminder that the individual has the right 
to revoke such authorization. 
(3) REVOCATION OF AUTHORIZATION.—Clarifica-
tion of appropriate mechanisms by which an indi-
vidual may revoke an authorization for future re-
search purposes, such as described in paragraph 
(1)(C). 
(c) WORKING GROUP ON PROTECTED HEALTH INFOR-
MATION FOR RESEARCH.— 
(1) ESTABLISHMENT.—Not later than 1 year 
after the date of enactment of this Act, the Secretary 
shall convene a working group to study and report on 
the uses and disclosures of protected health informa-
tion for research purposes, under the Health Insur-
ance Portability and Accountability Act of 1996 
(Public Law 104–191). 
(2) MEMBERS.—The working group shall include 
representatives of— 
(A) relevant Federal agencies, including the 
National Institutes of Health, the Centers for 
Disease Control and Prevention, the Food and 
Drug Administration, and the Office for Civil 
Rights; 
(B) the research community; 
(C) patients;
123 
(D) experts in civil rights, such as privacy 
rights; 
(E) developers of health information tech-
nology; 
(F) experts in data privacy and security; 
(G) health care providers; 
(H) bioethicists; and 
(I) other experts and entities, as the Sec-
retary determines appropriate. 
(3) REPORT.—Not later than 1 year after the 
date on which the working group is convened under 
paragraph (1), the working group shall conduct a re-
view and submit a report to the Secretary containing 
recommendations on whether the uses and disclosures 
of protected health information for research purposes 
should be modified to allow protected health informa-
tion to be available, as appropriate, for research pur-
poses, including studies to obtain generalizable knowl-
edge, while protecting individuals’ privacy rights. In 
conducting the review and making recommendations, 
the working group shall— 
(A) address, at a minimum— 
(i) the appropriate manner and timing 
of authorization, including whether addi-
tional notification to the individual should
124 
be required when the individual’s protected 
health information will be used or disclosed 
for such research; 
(ii) opportunities for individuals to set 
preferences on the manner in which their 
protected health information is used in re-
search; 
(iii) opportunities for patients to re-
voke authorization; 
(iv) notification to individuals of a 
breach in privacy; 
(v) existing gaps in statute, regulation, 
or policy related to protecting the privacy of 
individuals, and 
(vi) existing barriers to research re-
lated to the current restrictions on the uses 
and disclosures of protected health informa-
tion; and 
(B) consider, at a minimum— 
(i) expectations and preferences on how 
an individual’s protected health informa-
tion is shared and used; 
(ii) issues related to specific subgroups 
of people, such as children, incarcerated in-
dividuals, and individuals with a cognitive
125 
or intellectual disability impacting capacity 
to consent; 
(iii) relevant Federal and State laws; 
(iv) models of facilitating data access 
and levels of data access, including data 
segmentation, where applicable; 
(v) potential impacts of disclosure and 
non-disclosure of protected health informa-
tion on access to health care services; and 
(vi) the potential uses of such data. 
(4) REPORT SUBMISSION.—The Secretary shall 
submit the report under paragraph (3) to the Com-
mittee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Com-
merce of the House of Representatives, and shall post 
such report on the appropriate Internet website of the 
Department of Health and Human Services. 
(5) TERMINATION.—The working group convened 
under paragraph (1) shall terminate the day after the 
report under paragraph (3) is submitted to Congress 
and made public in accordance with paragraph (4). 
(d) DEFINITIONS.—In this section: 
(1) THE RULE.—References to ‘‘the Rule’’ refer 
to part 160 or part 164, as appropriate, of title 45,
126 
Code of Federal Regulations (or any successor regula-
tion). 
(2) PART 164.—References to a specified section 
of ‘‘part 164’’, refer to such specified section of part 
164 of title 45, Code of Federal Regulations (or any 
successor section). 
Subtitle G—Promoting Pediatric 
Research 
SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK. 
Section 409D(d) of the Public Health Service Act (42 
U.S.C. 284h(d)) is amended— 
(1) in paragraph (1), by striking ‘‘in consulta-
tion with the Director of the Eunice Kennedy Shriver 
National Institute of Child Health and Human De-
velopment and in collaboration with other appro-
priate national research institutes and national cen-
ters that carry out activities involving pediatric re-
search, may provide for the establishment of’’ and in-
serting ‘‘in collaboration with the national research 
institutes and national centers that carry out activi-
ties involving pediatric research, shall support’’; and 
(2) in paragraph (2)(A) and the first sentence of 
paragraph (2)(E), by striking ‘‘may’’ each place such 
term appears and inserting ‘‘shall’’.
127 
SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK. 
It is the sense of Congress that— 
(1) the National Institutes of Health should en-
courage a global pediatric clinical study network by 
providing grants, contracts, or cooperative agreements 
to support new and early stage investigators who par-
ticipate in the global pediatric clinical study network; 
(2) the Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’) should 
engage with clinical investigators and appropriate 
authorities outside of the United States, including au-
thorities in the European Union, during the forma-
tion of the global pediatric clinical study network to 
encourage the participation of such investigator and 
authorities; and 
(3) once a global pediatric clinical study network 
is established and becomes operational, the Secretary 
should continue to encourage and facilitate the par-
ticipation of clinical investigators and appropriate 
authorities outside of the United States, including in 
the European Union, to participate in the network 
with the goal of enhancing the global reach of the net-
work.
128 
TITLE III—DEVELOPMENT 
Subtitle A—Patient-Focused Drug 
Development 
SEC. 3001. PATIENT EXPERIENCE DATA. 
Section 569C of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–8c) is amended— 
(1) in subsection (a)— 
(A) in the subsection heading, by striking 
‘‘IN GENERAL’’ and inserting ‘‘PATIENT EN-
GAGEMENT IN DRUGS AND DEVICES’’; 
(B) by redesignating paragraphs (1) and 
(2) as subparagraphs (A) and (B), respectively, 
and moving such subparagraphs 2 ems to the 
right; and 
(C) by striking ‘‘The Secretary’’ and insert-
ing the following: 
‘‘(1) IN GENERAL.—The Secretary’’; 
(2) by redesignating subsections (b) through (e) 
as paragraphs (2) through (5), respectively, and mov-
ing such paragraphs 2 ems to the right; and 
(3) by adding at the end the following: 
‘‘(b) STATEMENT OF PATIENT EXPERIENCE.— 
‘‘(1) IN GENERAL.—Following the approval of an 
application that was submitted under section 505(b) 
of this Act or section 351(a) of the Public Health
129 
Service Act at least 180 days after the date of enact-
ment of the 21st Century Cures Act, the Secretary 
shall make public a brief statement regarding the pa-
tient experience data and related information, if any, 
submitted and reviewed as part of such application. 
‘‘(2) DATA AND INFORMATION.—The data and 
information referred to in paragraph (1) are— 
‘‘(A) patient experience data; 
‘‘(B) information on patient-focused drug 
development tools; and 
‘‘(C) other relevant information, as deter-
mined by the Secretary. 
‘‘(c) PATIENT EXPERIENCE DATA.—For purposes of 
this section, the term ‘patient experience data’ includes data 
that— 
‘‘(1) are collected by any persons (including pa-
tients, family members and caregivers of patients, pa-
tient advocacy organizations, disease research founda-
tions, researchers, and drug manufacturers); and 
‘‘(2) are intended to provide information about 
patients’ experiences with a disease or condition, in-
cluding— 
‘‘(A) the impact of such disease or condi-
tion, or a related therapy, on patients’ lives; and
130 
‘‘(B) patient preferences with respect to 
treatment of such disease or condition.’’. 
SEC. 3002. PATIENT-FOCUSED DRUG DEVELOPMENT GUID-
ANCE. 
(a) PUBLICATION OF GUIDANCE DOCUMENTS.—Not 
later than 180 days after the date of enactment of this Act, 
the Secretary of Health and Human Services (referred to 
in this section as the ‘‘Secretary’’), acting through the Com-
missioner of Food and Drugs, shall develop a plan to issue 
draft and final versions of one or more guidance documents, 
over a period of 5 years, regarding the collection of patient 
experience data, and the use of such data and related infor-
mation in drug development. Not later than 18 months after 
the date of enactment of this Act, the Secretary shall issue 
a draft version of at least one such guidance document. Not 
later than 18 months after the public comment period on 
the draft guidance ends, the Secretary shall issue a revised 
draft guidance or final guidance. 
(b) PATIENT EXPERIENCE DATA.—For purposes of 
this section, the term ‘‘patient experience data’’ has the 
meaning given such term in section 569C of the Federal 
Food, Drug, and Cosmetic Act (as added by section 3001). 
(c) CONTENTS.—The guidance documents described in 
subsection (a) shall address—
131 
(1) methodological approaches that a person 
seeking to collect patient experience data for submis-
sion to, and proposed use by, the Secretary in regu-
latory decisionmaking may use, that are relevant and 
objective and ensure that such data are accurate and 
representative of the intended population, including 
methods to collect meaningful patient input through-
out the drug development process and methodological 
considerations for data collection, reporting, manage-
ment, and analysis; 
(2) methodological approaches that may be used 
to develop and identify what is most important to pa-
tients with respect to burden of disease, burden of 
treatment, and the benefits and risks in the manage-
ment of the patient’s disease; 
(3) approaches to identifying and developing 
methods to measure impacts to patients that will help 
facilitate collection of patient experience data in clin-
ical trials; 
(4) methodologies, standards, and technologies to 
collect and analyze clinical outcome assessments for 
purposes of regulatory decisionmaking; 
(5) how a person seeking to develop and submit 
proposed draft guidance relating to patient experience
132 
data for consideration by the Secretary may submit 
such proposed draft guidance to the Secretary; 
(6) the format and content required for submis-
sions under this section to the Secretary, including 
with respect to the information described in para-
graph (1); 
(7) how the Secretary intends to respond to sub-
missions of information described in paragraph (1), 
if applicable, including any timeframe for response 
when such submission is not part of a regulatory ap-
plication or other submission that has an associated 
timeframe for response; and 
(8) how the Secretary, if appropriate, antici-
pates using relevant patient experience data and re-
lated information, including with respect to the struc-
tured risk-benefit assessment framework described in 
section 505(d) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(d)), to inform regulatory 
decisionmaking. 
SEC. 3003. STREAMLINING PATIENT INPUT. 
Chapter 35 of title 44, United States Code, shall not 
apply to the collection of information to which a response 
is voluntary, that is initiated by the Secretary under sec-
tion 569C of the Federal Food, Drug, and Cosmetic Act (21
133 
U.S.C. 360bbb–8c) (as amended by section 3001) or section 
3002. 
SEC. 3004. REPORT ON PATIENT EXPERIENCE DRUG DEVEL-
OPMENT. 
Not later than June 1 of 2021, 2026, and 2031, the 
Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall prepare and 
publish on the Internet website of the Food and Drug Ad-
ministration a report assessing the use of patient experience 
data in regulatory decisionmaking, in particular with re-
spect to the review of patient experience data and informa-
tion on patient-focused drug development tools as part of 
applications approved under section 505(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) or section 
351(a) of the Public Health Service Act (42 U.S.C. 262(a)). 
Subtitle B—Advancing New Drug 
Therapies 
SEC. 3011. QUALIFICATION OF DRUG DEVELOPMENT TOOLS. 
(a) IN GENERAL.—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 new section: 
‘‘SEC. 507. QUALIFICATION OF DRUG DEVELOPMENT TOOLS. 
‘‘(a) PROCESS FOR QUALIFICATION.—
134 
‘‘(1) IN GENERAL.—The Secretary shall establish 
a process for the qualification of drug development 
tools for a proposed context of use under which— 
‘‘(A)(i) a requestor initiates such process by 
submitting a letter of intent to the Secretary; 
and 
‘‘(ii) the Secretary accepts or declines to ac-
cept such letter of intent; 
‘‘(B)(i) if the Secretary accepts the letter of 
intent, a requestor submits a qualification plan 
to the Secretary; and 
‘‘(ii) the Secretary accepts or declines to ac-
cept the qualification plan; and 
‘‘(C)(i) if the Secretary accepts the quali-
fication plan, the requestor submits to the Sec-
retary a full qualification package; 
‘‘(ii) the Secretary determines whether to 
accept such qualification package for review; and 
‘‘(iii) if the Secretary accepts such quali-
fication package for review, the Secretary con-
ducts such review in accordance with this sec-
tion. 
‘‘(2) ACCEPTANCE
AND
REVIEW
OF
SUBMIS-
SIONS.—
135 
‘‘(A) IN
GENERAL.—Subparagraphs (B), 
(C), and (D) shall apply with respect to the 
treatment of a letter of intent, a qualification 
plan, or a full qualification package submitted 
under paragraph (1) (referred to in this para-
graph as ‘qualification submissions’). 
‘‘(B) ACCEPTANCE
FACTORS; NONACCEPT-
ANCE.—The Secretary shall determine whether to 
accept a qualification submission based on fac-
tors which may include the scientific merit of the 
qualification submission. A determination not to 
accept a submission under paragraph (1) shall 
not be construed as a final determination by the 
Secretary under this section regarding the quali-
fication of a drug development tool for its pro-
posed context of use. 
‘‘(C) PRIORITIZATION
OF
QUALIFICATION 
REVIEW.—The Secretary may prioritize the re-
view of a full qualification package submitted 
under paragraph (1) with respect to a drug de-
velopment tool, based on factors determined ap-
propriate by the Secretary, including— 
‘‘(i) as applicable, the severity, rarity, 
or prevalence of the disease or condition 
targeted by the drug development tool and
136 
the availability or lack of alternative treat-
ments for such disease or condition; and 
‘‘(ii) the identification, by the Sec-
retary or by biomedical research consortia 
and other expert stakeholders, of such a 
drug development tool and its proposed con-
text of use as a public health priority. 
‘‘(D) ENGAGEMENT
OF
EXTERNAL
EX-
PERTS.—The Secretary may, for purposes of the 
review of qualification submissions, through the 
use of cooperative agreements, grants, or other 
appropriate mechanisms, consult with bio-
medical research consortia and may consider the 
recommendations of such consortia with respect 
to the review of any qualification plan submitted 
under paragraph (1) or the review of any full 
qualification package under paragraph (3). 
‘‘(3) REVIEW
OF
FULL
QUALIFICATION
PACK-
AGE.—The Secretary shall— 
‘‘(A) conduct a comprehensive review of a 
full qualification package accepted under para-
graph (1)(C); and 
‘‘(B) determine whether the drug develop-
ment tool at issue is qualified for its proposed 
context of use.
137 
‘‘(4) QUALIFICATION.—The Secretary shall deter-
mine whether a drug development tool is qualified for 
a proposed context of use based on the scientific merit 
of a full qualification package reviewed under para-
graph (3). 
‘‘(b) EFFECT OF QUALIFICATION.— 
‘‘(1) IN GENERAL.—A drug development tool de-
termined to be qualified under subsection (a)(4) for a 
proposed context of use specified by the requestor may 
be used by any person in such context of use for the 
purposes described in paragraph (2). 
‘‘(2) USE OF A DRUG DEVELOPMENT TOOL.— 
Subject to paragraph (3), a drug development tool 
qualified under this section may be used for— 
‘‘(A) supporting or obtaining approval or 
licensure (as applicable) of a drug or biological 
product (including in accordance with section 
506(c)) under section 505 of this Act or section 
351 of the Public Health Service Act; or 
‘‘(B) supporting the investigational use of a 
drug or biological product under section 505(i) 
of this Act or section 351(a)(3) of the Public 
Health Service Act. 
‘‘(3) RESCISSION OR MODIFICATION.—
138 
‘‘(A) IN GENERAL.—The Secretary may re-
scind or modify a determination under this sec-
tion to qualify a drug development tool if the 
Secretary determines that the drug development 
tool is not appropriate for the proposed context 
of use specified by the requestor. Such a deter-
mination may be based on new information that 
calls into question the basis for such qualifica-
tion. 
‘‘(B) MEETING FOR REVIEW.—If the Sec-
retary rescinds or modifies under subparagraph 
(A) a determination to qualify a drug develop-
ment tool, the requestor involved shall, on re-
quest, be granted a meeting with the Secretary to 
discuss the basis of the Secretary’s decision to re-
scind or modify the determination before the ef-
fective date of the rescission or modification. 
‘‘(c) TRANSPARENCY.— 
‘‘(1) IN GENERAL.—Subject to paragraph (3), the 
Secretary shall make publicly available, and update 
on at least a biannual basis, on the Internet website 
of the Food and Drug Administration the following: 
‘‘(A) Information with respect to each qual-
ification submission under the qualification 
process under subsection (a), including—
139 
‘‘(i) the stage of the review process ap-
plicable to the submission; 
‘‘(ii) the date of the most recent change 
in stage status; 
‘‘(iii) whether external scientific ex-
perts were utilized in the development of a 
qualification plan or the review of a full 
qualification package; and 
‘‘(iv) 
submissions 
from 
requestors 
under the qualification process under sub-
section (a), including any data and evi-
dence contained in such submissions, and 
any updates to such submissions. 
‘‘(B) The Secretary’s formal written deter-
minations in response to such qualification sub-
missions. 
‘‘(C) Any rescissions or modifications under 
subsection (b)(3) of a determination to qualify a 
drug development tool. 
‘‘(D) Summary reviews that document con-
clusions and recommendations for determina-
tions to qualify drug development tools under 
subsection (a). 
‘‘(E) A comprehensive list of—
140 
‘‘(i) all drug development tools quali-
fied under subsection (a); and 
‘‘(ii) all surrogate endpoints which 
were the basis of approval or licensure (as 
applicable) of a drug or biological product 
(including in accordance with section 
506(c)) under section 505 of this Act or sec-
tion 351 of the Public Health Service Act. 
‘‘(2) RELATION TO TRADE SECRETS ACT.—Infor-
mation made publicly available by the Secretary 
under paragraph (1) shall be considered a disclosure 
authorized by law for purposes of section 1905 of title 
18, United States Code. 
‘‘(3) APPLICABILITY.—Nothing in this section 
shall be construed as authorizing the Secretary to dis-
close any information contained in an application 
submitted under section 505 of this Act or section 351 
of the Public Health Service Act that is confidential 
commercial or trade secret information subject to sec-
tion 552(b)(4) of title 5, United States Code, or sec-
tion 1905 of title 18, United States Code. 
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed— 
‘‘(1) to alter the standards of evidence under sub-
section (c) or (d) of section 505, including the sub-
141 
stantial evidence standard in such subsection (d), or 
under section 351 of the Public Health Service Act (as 
applicable); or 
‘‘(2) to limit the authority of the Secretary to 
approve or license products under this Act or the Pub-
lic Health Service Act, as applicable (as in effect be-
fore the date of the enactment of the 21st Century 
Cures Act). 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) BIOMARKER.—The term ‘biomarker’— 
‘‘(A) means a characteristic (such as a 
physiologic, 
pathologic, 
or 
anatomic 
char-
acteristic or measurement) that is objectively 
measured and evaluated as an indicator of nor-
mal biologic processes, pathologic processes, or 
biological responses to a therapeutic intervention; 
and 
‘‘(B) includes a surrogate endpoint. 
‘‘(2) BIOMEDICAL RESEARCH CONSORTIA.—The 
term ‘biomedical research consortia’ means collabo-
rative groups that may take the form of public-pri-
vate partnerships and may include government agen-
cies, institutions of higher education (as defined in 
section 101(a) of the Higher Education Act of 1965), 
patient advocacy groups, industry representatives,
142 
clinical and scientific experts, and other relevant enti-
ties and individuals. 
‘‘(3) CLINICAL
OUTCOME
ASSESSMENT.—The 
term ‘clinical outcome assessment’ means— 
‘‘(A) a measurement of a patient’s symp-
toms, overall mental state, or the effects of a dis-
ease or condition on how the patient functions; 
and 
‘‘(B) includes a patient-reported outcome. 
‘‘(4) CONTEXT OF USE.—The term ‘context of 
use’ means, with respect to a drug development tool, 
the circumstances under which the drug development 
tool is to be used in drug development and regulatory 
review. 
‘‘(5) DRUG
DEVELOPMENT
TOOL.—The term 
‘drug development tool’ includes— 
‘‘(A) a biomarker; 
‘‘(B) a clinical outcome assessment; and 
‘‘(C) any other method, material, or meas-
ure that the Secretary determines aids drug de-
velopment and regulatory review for purposes of 
this section. 
‘‘(6) PATIENT-REPORTED OUTCOME.—The term 
‘patient-reported outcome’ means a measurement 
based on a report from a patient regarding the status
143 
of the patient’s health condition without amendment 
or interpretation of the patient’s report by a clinician 
or any other person. 
‘‘(7) QUALIFICATION.—The terms ‘qualification’ 
and ‘qualified’ mean a determination by the Sec-
retary that a drug development tool and its proposed 
context of use can be relied upon to have a specific 
interpretation and application in drug development 
and regulatory review under this Act. 
‘‘(8) REQUESTOR.—The term ‘requestor’ means 
an entity or entities, including a drug sponsor or a 
biomedical research consortia, seeking to qualify a 
drug development tool for a proposed context of use 
under this section. 
‘‘(9) SURROGATE ENDPOINT.—The term ‘surro-
gate endpoint’ means a marker, such as a laboratory 
measurement, radiographic image, physical sign, or 
other measure, that is not itself a direct measurement 
of clinical benefit, and— 
‘‘(A) is known to predict clinical benefit 
and could be used to support traditional ap-
proval of a drug or biological product; or 
‘‘(B) is reasonably likely to predict clinical 
benefit and could be used to support the acceler-
144 
ated approval of a drug or biological product in 
accordance with section 506(c).’’. 
(b) GUIDANCE.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the 
‘‘Secretary’’) shall, in consultation with biomedical 
research consortia (as defined in subsection (e) of sec-
tion 507 of the Federal Food, Drug, and Cosmetic Act 
(as added by subsection (a)) and other interested par-
ties through a collaborative public process, issue guid-
ance to implement such section 507 that— 
(A) provides a conceptual framework de-
scribing appropriate standards and scientific 
approaches to support the development of bio-
markers delineated under the taxonomy estab-
lished under paragraph (3); 
(B) with respect to the qualification process 
under such section 507— 
(i) describes the requirements that enti-
ties seeking to qualify a drug development 
tool under such section shall observe when 
engaging in such process; 
(ii) outlines reasonable timeframes for 
the Secretary’s review of letters, qualifica-
145 
tion plans, or full qualification packages 
submitted under such process; and 
(iii) establishes a process by which 
such entities or the Secretary may consult 
with biomedical research consortia and 
other individuals and entities with expert 
knowledge and insights that may assist the 
Secretary in the review of qualification 
plans and full qualification submissions 
under such section; and 
(C) includes such other information as the 
Secretary determines appropriate. 
(2) TIMING.—Not later than 3 years after the 
date of the enactment of this Act, the Secretary shall 
issue draft guidance under paragraph (1) on the im-
plementation of section 507 of the Federal Food, 
Drug, and Cosmetic Act (as added by subsection (a)). 
The Secretary shall issue final guidance on the imple-
mentation of such section not later than 6 months 
after the date on which the comment period for the 
draft guidance closes. 
(3) TAXONOMY.— 
(A) IN GENERAL.—For purposes of inform-
ing guidance under this subsection, the Secretary 
shall, in consultation with biomedical research
146 
consortia and other interested parties through a 
collaborative public process, establish a tax-
onomy for the classification of biomarkers (and 
related scientific concepts) for use in drug devel-
opment. 
(B) PUBLIC AVAILABILITY.—Not later than 
2 years after the date of the enactment of this 
Act, the Secretary shall make such taxonomy 
publicly available in draft form for public com-
ment. The Secretary shall finalize the taxonomy 
not later than 1 year after the close of the public 
comment period. 
(c) MEETING AND REPORT.— 
(1) MEETING.—Not later than 2 years after the 
date of the enactment of this Act, the Secretary shall 
convene a public meeting to describe and solicit pub-
lic input regarding the qualification process under 
section 507 of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a). 
(2) REPORT.—Not later than 5 years after the 
date of the enactment of this Act, the Secretary shall 
make publicly available on the Internet website of the 
Food and Drug Administration a report. Such report 
shall include, with respect to the qualification process 
under section 507 of the Federal Food, Drug, and
147 
Cosmetic Act, as added by subsection (a), information 
on— 
(A) the number of requests submitted, as a 
letter of intent, for qualification of a drug devel-
opment tool (as defined in subsection (e) of such 
section 507); 
(B) the number of such requests accepted 
and determined to be eligible for submission of a 
qualification plan or full qualification package 
(as such terms are defined in subsection (e) of 
such section 507), respectively; 
(C) the number of such requests for which 
external scientific experts were utilized in the de-
velopment of a qualification plan or review of a 
full qualification package; 
(D) the number of qualification plans and 
full qualification packages, respectively, sub-
mitted to the Secretary; and 
(E) the drug development tools qualified 
through such qualification process, specified by 
type of tool, such as a biomarker or clinical out-
come assessment (as such terms are defined in 
subsection (e) of such section 507).
148 
SEC. 3012. TARGETED DRUGS FOR RARE DISEASES. 
Subchapter B of chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360aa et seq.) is amended by 
inserting after section 529 the following: 
‘‘SEC. 529A. TARGETED DRUGS FOR RARE DISEASES. 
‘‘(a) PURPOSE.—The purpose of this section, through 
the approach provided for in subsection (b), is to— 
‘‘(1) facilitate the development, review, and ap-
proval of genetically targeted drugs and variant pro-
tein targeted drugs to address an unmet medical need 
in one or more patient subgroups, including sub-
groups of patients with different mutations of a gene, 
with respect to rare diseases or conditions that are se-
rious or life-threatening; and 
‘‘(2) maximize the use of scientific tools or meth-
ods, including surrogate endpoints and other bio-
markers, for such purposes. 
‘‘(b) LEVERAGING OF DATA FROM PREVIOUSLY AP-
PROVED DRUG APPLICATION OR APPLICATIONS.—The Sec-
retary may, consistent with applicable standards for ap-
proval under this Act or section 351(a) of the Public Health 
Service Act, allow the sponsor of an application under sec-
tion 505(b)(1) of this Act or section 351(a) of the Public 
Health Service Act for a genetically targeted drug or a vari-
ant protein targeted drug to rely upon data and informa-
tion—
149 
‘‘(1) previously developed by the same sponsor 
(or another sponsor that has provided the sponsor 
with a contractual right of reference to such data and 
information); and 
‘‘(2) submitted by a sponsor described in para-
graph (1) in support of one or more previously ap-
proved applications that were submitted under section 
505(b)(1) of this Act or section 351(a) of the Public 
Health Service Act, 
for a drug that incorporates or utilizes the same or similar 
genetically targeted technology as the drug or drugs that 
are the subject of an application or applications described 
in paragraph (2) or for a variant protein targeted drug 
that is the same or incorporates or utilizes the same variant 
protein targeted drug, as the drug or drugs that are the 
subject of an application or applications described in para-
graph (2). 
‘‘(c) DEFINITIONS.—For purposes of this section— 
‘‘(1) the term ‘genetically targeted drug’ means a 
drug that— 
‘‘(A) is the subject of an application under 
section 505(b)(1) of this Act or section 351(a) of 
the Public Health Service Act for the treatment 
of a rare disease or condition (as such term is
150 
defined in section 526) that is serious or life- 
threatening; 
‘‘(B) may result in the modulation (includ-
ing suppression, up-regulation, or activation) of 
the function of a gene or its associated gene 
product; and 
‘‘(C) incorporates or utilizes a genetically 
targeted technology; 
‘‘(2) the term ‘genetically targeted technology’ 
means a technology comprising non-replicating nu-
cleic acid or analogous compounds with a common or 
similar chemistry that is intended to treat one or 
more patient subgroups, including subgroups of pa-
tients with different mutations of a gene, with the 
same disease or condition, including a disease or con-
dition due to other variants in the same gene; and 
‘‘(3) the term ‘variant protein targeted drug’ 
means a drug that— 
‘‘(A) is the subject of an application under 
section 505(b)(1) of this Act or section 351(a) of 
the Public Health Service Act for the treatment 
of a rare disease or condition (as such term is 
defined in section 526) that is serious or life- 
threatening;
151 
‘‘(B) modulates the function of a product of 
a mutated gene where such mutation is respon-
sible in whole or in part for a given disease or 
condition; and 
‘‘(C) is intended to treat one or more pa-
tient subgroups, including subgroups of patients 
with different mutations of a gene, with the same 
disease or condition. 
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to— 
‘‘(1) alter the authority of the Secretary to ap-
prove drugs pursuant to this Act or section 351 of the 
Public Health Service Act (as authorized prior to the 
date of enactment of the 21st Century Cures Act), in-
cluding the standards of evidence, and applicable con-
ditions, for approval under such applicable Act; or 
‘‘(2) confer any new rights, beyond those author-
ized under this Act or the Public Health Service Act 
prior to enactment of this section, with respect to the 
permissibility of a sponsor referencing information 
contained in another application submitted under sec-
tion 505(b)(1) of this Act or section 351(a) of the 
Public Health Service Act.’’.
152 
SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOUR-
AGE TREATMENTS FOR RARE PEDIATRIC DIS-
EASES. 
(a) IN GENERAL.—Section 529(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended 
by striking paragraph (5) and inserting the following: 
‘‘(5) TERMINATION
OF
AUTHORITY.—The Sec-
retary may not award any priority review vouchers 
under paragraph (1) after September 30, 2020, unless 
the rare pediatric disease product application— 
‘‘(A) is for a drug that, not later than Sep-
tember 30, 2020, is designated under subsection 
(d) as a drug for a rare pediatric disease; and 
‘‘(B) is, not later than September 30, 2022, 
approved under section 505(b)(1) of this Act or 
section 351(a) of the Public Health Service Act.’’. 
(b) REPORT.—The Advancing Hope Act of 2016 (Pub-
lic Law 114–229) is amended by striking section 3. 
SEC. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PRO-
GRAMS. 
(a) STUDY.—The Comptroller General of the United 
States (referred to in this section as the ‘‘Comptroller Gen-
eral’’) shall conduct a study addressing the effectiveness and 
overall impact of the following priority review voucher pro-
grams, including any such programs amended or estab-
lished by this Act:
153 
(1) The neglected tropical disease priority review 
voucher program under section 524 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360n). 
(2) The rare pediatric disease priority review 
voucher program under section 529 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360ff). 
(3) The medical countermeasure priority review 
voucher program under section 565A of the Federal 
Food, Drug, and Cosmetic Act, as added by section 
3086. 
(b) ISSUANCE OF REPORT.—Not later than January 
31, 2020, the Comptroller General shall submit to the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the 
House of Representatives a report containing the results of 
the study under subsection (a). 
(c) CONTENTS OF REPORTS.—The report submitted 
under subsection (b) shall address— 
(1) for each drug for which a priority review 
voucher has been awarded as of initiation of the 
study— 
(A) the indications for which the drug is 
approved under section 505(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355(c)), pursuant to an application under sec-
154 
tion 505(b)(1) of such Act, or licensed under sec-
tion 351(a) of the Public Health Service Act (42 
U.S.C. 262(a)); 
(B) whether, and to what extent, the vouch-
er impacted the sponsor’s decision to develop the 
drug; and 
(C) whether, and to what extent, the ap-
proval or licensure of the drug, as applicable and 
appropriate— 
(i) addressed a global unmet need re-
lated to the treatment or prevention of a ne-
glected tropical disease, including whether 
the sponsor of a drug coordinated with 
international development organizations; 
(ii) addressed an unmet need related to 
the treatment of a rare pediatric disease; or 
(iii) affected the Nation’s preparedness 
against a chemical, biological, radiological, 
or nuclear threat, including naturally oc-
curring threats; 
(2) for each drug for which a priority review 
voucher has been used— 
(A) the indications for which such drug is 
approved under section 505(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C.
155 
355(c)), pursuant to an application under sec-
tion 505(b)(1) of such Act, or licensed under sec-
tion 351(a) of the Public Health Service Act (42 
U.S.C. 262); 
(B) the value of the voucher, if transferred; 
and 
(C) the length of time between the date on 
which the voucher was awarded and the date on 
which the voucher was used; and 
(3) an analysis of the priority review voucher 
programs described in subsection (a), including— 
(A) the resources used by the Food and 
Drug Administration in reviewing drugs for 
which vouchers were used, including the effect of 
the programs on the Food and Drug Administra-
tion’s review of drugs for which priority review 
vouchers were not awarded or used; 
(B) whether any improvements to such pro-
grams are necessary to appropriately target in-
centives for the development of drugs that would 
likely not otherwise be developed, or developed in 
as timely a manner, and, as applicable and ap-
propriate— 
(i) address global unmet needs related 
to the treatment or prevention of neglected
156 
tropical diseases, including in countries in 
which neglected tropical diseases are en-
demic; or 
(ii) address unmet needs related to the 
treatment of rare pediatric diseases; and 
(C) whether the sunset of the rare pediatric 
disease program and medical countermeasure 
program has had an impact on the program, in-
cluding any potential unintended consequences. 
(d) PROTECTION
OF
NATIONAL
SECURITY.—The 
Comptroller General shall conduct the study and issue re-
ports under this section in a manner that does not com-
promise national security. 
SEC. 3015. AMENDMENTS TO THE ORPHAN DRUG GRANTS. 
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, in-
cluding 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
157 
(C) by adding at the end the following: 
‘‘(C) prospectively planned and designed ob-
servational studies and other analyses conducted 
to assist in the understanding of the natural his-
tory of a rare disease or condition and in the de-
velopment of a therapy, including studies and 
analyses to— 
‘‘(i) develop or validate a drug develop-
ment tool related to a rare disease or condi-
tion; or 
‘‘(ii) understand the full spectrum of 
the disease manifestations, including de-
scribing genotypic and phenotypic varia-
bility and identifying and defining distinct 
subpopulations affected by a rare disease or 
condition.’’. 
SEC. 3016. GRANTS FOR STUDYING CONTINUOUS DRUG 
MANUFACTURING. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services may award grants to institutions of higher 
education and nonprofit organizations for the purpose of 
studying and recommending improvements to the process 
of continuous manufacturing of drugs and biological prod-
ucts and similar innovative monitoring and control tech-
niques.
158 
(b) DEFINITIONS.—In this section— 
(1) the term ‘‘drug’’ has the meaning given such 
term in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321); 
(2) the term ‘‘biological product’’ has the mean-
ing given such term in section 351(i) of the Public 
Health Service Act (42 U.S.C. 262(i)); and 
(3) the term ‘‘institution of higher education’’ 
has the meaning given such term in section 101(a) of 
the Higher Education Act of 1965 (20 U.S.C. 
1001(a)). 
Subtitle C—Modern Trial Design 
and Evidence Development 
SEC. 3021. NOVEL CLINICAL TRIAL DESIGNS. 
(a) PROPOSALS FOR USE OF NOVEL CLINICAL TRIAL 
DESIGNS FOR DRUGS AND BIOLOGICAL PRODUCTS.—For 
purposes of assisting sponsors in incorporating complex 
adaptive and other novel trial designs into proposed clinical 
protocols and applications for new drugs under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) and biological products under section 351 of the Public 
Health Service Act (42 U.S.C. 262), the Secretary of Health 
and Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall conduct a public meeting and issue guidance 
in accordance with subsection (b).
159 
(b) GUIDANCE ADDRESSING USE OF NOVEL CLINICAL 
TRIAL DESIGNS.— 
(1) IN GENERAL.—The Secretary, acting through 
the Commissioner of Food and Drugs, shall update or 
issue guidance addressing the use of complex adaptive 
and other novel trial design in the development and 
regulatory review and approval or licensure for drugs 
and biological products. 
(2) CONTENTS.—The guidance under paragraph 
(1) shall address— 
(A) the use of complex adaptive and other 
novel trial designs, including how such clinical 
trials proposed or submitted help to satisfy the 
substantial evidence standard under section 
505(d) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(d)); 
(B) how sponsors may obtain feedback from 
the Secretary on technical issues related to mod-
eling and simulations prior to— 
(i) completion of such modeling or sim-
ulations; or 
(ii) the submission of resulting infor-
mation to the Secretary;
160 
(C) the types of quantitative and qualitative 
information that should be submitted for review; 
and 
(D) recommended analysis methodologies. 
(3) PUBLIC
MEETING.—Prior to updating or 
issuing the guidance required by paragraph (1), the 
Secretary shall consult with stakeholders, including 
representatives of regulated industry, academia, pa-
tient advocacy organizations, consumer groups, and 
disease research foundations, through a public meet-
ing to be held not later than 18 months after the date 
of enactment of this Act. 
(4) TIMING.—The Secretary shall update or issue 
a draft version of the guidance required by paragraph 
(1) not later than 18 months after the date of the pub-
lic meeting required by paragraph (3) and finalize 
such guidance not later than 1 year after the date on 
which the public comment period for the draft guid-
ance closes. 
SEC. 3022. REAL WORLD EVIDENCE. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 505E (21 U.S.C. 
355f) the following:
161 
‘‘SEC. 505F. UTILIZING REAL WORLD EVIDENCE. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
program to evaluate the potential use of real world evi-
dence— 
‘‘(1) to help to support the approval of a new in-
dication for a drug approved under section 505(c); 
and 
‘‘(2) to help to support or satisfy postapproval 
study requirements. 
‘‘(b) REAL WORLD EVIDENCE DEFINED.—In this sec-
tion, the term ‘real world evidence’ means data regarding 
the usage, or the potential benefits or risks, of a drug de-
rived from sources other than randomized clinical trials. 
‘‘(c) PROGRAM FRAMEWORK.— 
‘‘(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of the 21st Century Cures Act, 
the Secretary shall establish a draft framework for 
implementation of the program under this section. 
‘‘(2) CONTENTS
OF
FRAMEWORK.—The frame-
work shall include information describing— 
‘‘(A) the sources of real world evidence, in-
cluding ongoing safety surveillance, observational 
studies, registries, claims, and patient-centered 
outcomes research activities; 
‘‘(B) the gaps in data collection activities;
162 
‘‘(C) the standards and methodologies for 
collection and analysis of real world evidence; 
and 
‘‘(D) the priority areas, remaining chal-
lenges, and potential pilot opportunities that the 
program established under this section will ad-
dress. 
‘‘(3) CONSULTATION.— 
‘‘(A) IN GENERAL.—In developing the pro-
gram framework under this subsection, the Sec-
retary shall consult with regulated industry, aca-
demia, medical professional organizations, rep-
resentatives of patient advocacy organizations, 
consumer organizations, disease research founda-
tions, and other interested parties. 
‘‘(B) PROCESS.—The consultation under 
subparagraph (A) may be carried out through 
approaches such as— 
‘‘(i) a public-private partnership with 
the entities described in such subparagraph 
in which the Secretary may participate; 
‘‘(ii) a contract, grant, or other ar-
rangement, as the Secretary determines ap-
propriate, with such a partnership or an 
independent research organization; or
163 
‘‘(iii) public workshops with the enti-
ties described in such subparagraph. 
‘‘(d) PROGRAM
IMPLEMENTATION.—The Secretary 
shall, not later than 2 years after the date of enactment 
of the 21st Century Cures Act and in accordance with the 
framework established under subsection (c), implement the 
program to evaluate the potential use of real world evidence. 
‘‘(e) GUIDANCE
FOR
INDUSTRY.—The Secretary 
shall— 
‘‘(1) utilize the program established under sub-
section (a), its activities, and any subsequent pilots or 
written reports, to inform a guidance for industry 
on— 
‘‘(A) the circumstances under which spon-
sors of drugs and the Secretary may rely on real 
world evidence for the purposes described in 
paragraphs (1) and (2) of subsection (a); and 
‘‘(B) the appropriate standards and meth-
odologies for collection and analysis of real world 
evidence submitted for such purposes; 
‘‘(2) not later than 5 years after the date of en-
actment of the 21st Century Cures Act, issue draft 
guidance for industry as described in paragraph (1); 
and
164 
‘‘(3) not later than 18 months after the close of 
the public comment period for the draft guidance de-
scribed in paragraph (2), issue revised draft guidance 
or final guidance. 
‘‘(f) RULE OF CONSTRUCTION.— 
‘‘(1) IN
GENERAL.—Subject to paragraph (2), 
nothing in this section prohibits the Secretary from 
using real world evidence for purposes not specified in 
this section, provided the Secretary determines that 
sufficient basis exists for any such nonspecified use. 
‘‘(2) STANDARDS
OF
EVIDENCE
AND
SEC-
RETARY’S AUTHORITY.—This section shall not be con-
strued to alter— 
‘‘(A) the standards of evidence under— 
‘‘(i) subsection (c) or (d) of section 505, 
including the substantial evidence standard 
in such subsection (d); or 
‘‘(ii) section 351(a) of the Public 
Health Service Act; or 
‘‘(B) the Secretary’s authority to require 
postapproval studies or clinical trials, or the 
standards of evidence under which studies or 
trials are evaluated.’’.
165 
SEC. 3023. PROTECTION OF HUMAN RESEARCH SUBJECTS. 
(a) IN GENERAL.—In order to simplify and facilitate 
compliance by researchers with applicable regulations for 
the protection of human subjects in research, the Secretary 
of Health and Human Services (referred to in this section 
as the ‘‘Secretary’’) shall, to the extent practicable and con-
sistent with other statutory provisions, harmonize dif-
ferences between the HHS Human Subject Regulations and 
the FDA Human Subject Regulations in accordance with 
subsection (b). 
(b) AVOIDING REGULATORY DUPLICATION AND UN-
NECESSARY
DELAYS.—The Secretary shall, as appro-
priate— 
(1) make such modifications to the provisions of 
the HHS Human Subject Regulations, the FDA 
Human Subject Regulations, and the vulnerable pop-
ulations rules as may be necessary— 
(A) to reduce regulatory duplication and 
unnecessary delays; 
(B) to modernize such provisions in the con-
text of multisite and cooperative research 
projects; and 
(C) to protect vulnerable populations, incor-
porate local considerations, and support commu-
nity engagement through mechanisms such as 
consultation with local researchers and human
166 
research protection programs, in a manner con-
sistent with subparagraph (B); and 
(2) ensure that human subject research that is 
subject to the HHS Human Subject Regulations and 
to the FDA Human Subject Regulations may— 
(A) use joint or shared review; 
(B) rely upon the review of— 
(i) an independent institutional review 
board; or 
(ii) an institutional review board of an 
entity other than the sponsor of the re-
search; or 
(C) use similar arrangements to avoid du-
plication of effort. 
(c) CONSULTATION.—In harmonizing or modifying 
regulations or guidance under this section, the Secretary 
shall consult with stakeholders (including researchers, aca-
demic organizations, hospitals, institutional research 
boards, pharmaceutical, biotechnology, and medical device 
developers, clinical research organizations, patient groups, 
and others). 
(d) TIMING.—The Secretary shall complete the harmo-
nization described in subsection (a) not later than 3 years 
after the date of enactment of this Act.
167 
(e) PROGRESS REPORT.—Not later than 2 years after 
the date of enactment of this Act, the Secretary shall submit 
to Congress a report on the progress made toward com-
pleting such harmonization. 
(f) DEFINITIONS.— 
(1) HUMAN
SUBJECT
REGULATIONS.—In this 
section: 
(A) FDA HUMAN SUBJECT REGULATIONS.— 
The term ‘‘FDA Human Subject Regulations’’ 
means the provisions of parts 50, 56, 312, and 
812 of title 21, Code of Federal Regulations (or 
any successor regulations). 
(B) 
HHS 
HUMAN
SUBJECT
REGULA-
TIONS.—The term ‘‘HHS Human Subject Regu-
lations’’ means the provisions of subpart A of 
part 46 of title 45, Code of Federal Regulations 
(or any successor regulations). 
(C) VULNERABLE POPULATION RULES.—The 
term ‘‘vulnerable population rules’’ means— 
(i) except in the case of research de-
scribed in clause (ii), the provisions of sub-
parts B through D of part 46, Code of Fed-
eral Regulations (or any successor regula-
tions); and
168 
(ii) in the case of research that is sub-
ject to FDA Human Subject Regulations, 
the provisions applicable to vulnerable pop-
ulations under part 56 of title 21, Code of 
Federal Regulations (or any successor regu-
lations) and subpart D of part 50 of such 
title 21 (or any successor regulations). 
(2) INSTITUTIONAL REVIEW BOARD DEFINED.— 
In this section, the term ‘‘institutional review board’’ 
has the meaning that applies to the term ‘‘institu-
tional review board’’ under the HHS Human Subject 
Regulations. 
SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION 
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 amend-
ed— 
(1) in subparagraph (D), by striking ‘‘except 
where subject to such conditions as the Secretary may 
prescribe, the investigator’’ and inserting the fol-
lowing: ‘‘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 safeguards to protect
169 
the rights, safety, and welfare of the human sub-
ject; or 
‘‘(ii) the investigator’’; and 
(2) in the matter following subparagraph (D), by 
striking ‘‘subparagraph (D)’’ and inserting ‘‘subpara-
graph (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 
‘‘except where it is not feasible, it is contrary to the best 
interests of such human beings, or the proposed clinical test-
ing poses no more than minimal risk to such human beings 
and includes appropriate safeguards as prescribed to pro-
tect the rights, safety, and welfare of such human beings’’. 
Subtitle D—Patient Access to 
Therapies and Information 
SEC. 3031. SUMMARY LEVEL REVIEW. 
(a) FFDCA.—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 ap-
plication, with respect to a qualified indication for a drug,
170 
submitted under subsection (b), if such supplemental appli-
cation 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 accept-
able 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) The Secretary shall post on the Internet website 
of the Food and Drug Administration and update annu-
ally— 
‘‘(i) the number of applications reviewed solely 
under subparagraph (A) or section 351(a)(2)(E) of 
the Public Health Service Act; 
‘‘(ii) the average time for completion of review 
under subparagraph (A) or section 351(a)(2)(E) of 
the Public Health Service Act; 
‘‘(iii) the average time for review of supple-
mental applications where the Secretary did not use 
review flexibility under subparagraph (A) or section 
351(a)(2)(E) of the Public Health Service Act; and 
‘‘(iv) the number of applications reviewed under 
subparagraph (A) or section 351(a)(2)(E) of the Pub-
171 
lic Health Service Act for which the Secretary made 
use of full data sets in addition to the qualified data 
summary. 
‘‘(D) In this paragraph— 
‘‘(i) the term ‘qualified indication’ means an in-
dication 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.’’. 
(b) PHSA.—Section 351(a)(2) of the Public Health 
Service Act (42 U.S.C. 262(a)(2)) is amended by adding 
at the end the following: 
‘‘(E)(i) The Secretary may rely upon qualified data 
summaries to support the approval of a supplemental ap-
plication, with respect to a qualified indication for a drug, 
submitted under this subsection, if such supplemental appli-
cation complies with the requirements of subparagraph (B) 
of section 505(c)(5) of the Federal Food, Drug, and Cos-
metic Act. 
‘‘(ii) In this subparagraph, the terms ‘qualified indica-
tion’ and ‘qualified data summary’ have the meanings
172 
given such terms in section 505(c)(5) of the Federal Food, 
Drug, and Cosmetic Act.’’. 
SEC. 3032. 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 IN-
VESTIGATIONAL DRUGS. 
‘‘(a) IN GENERAL.—The manufacturer or distributor 
of one or more investigational drugs for the diagnosis, mon-
itoring, or treatment of one or more serious diseases or con-
ditions shall make available the policy of the manufacturer 
or distributor on evaluating and responding to requests sub-
mitted 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 poli-
cies 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 sub-
section (a) shall include— 
‘‘(1) contact information for the manufacturer or 
distributor to facilitate communication about requests 
described in subsection (a);
173 
‘‘(2) procedures for making such requests; 
‘‘(3) the general criteria the manufacturer or dis-
tributor will use to evaluate such requests for indi-
vidual patients, and for responses to such requests; 
‘‘(4) the length of time the manufacturer or dis-
tributor anticipates will be necessary to acknowledge 
receipt of such requests; and 
‘‘(5) a hyperlink or other reference to the clinical 
trial record containing information about the ex-
panded access for such drug that is required under 
section 402(j)(2)(A)(ii)(II)(gg) of the Public Health 
Service Act. 
‘‘(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 pol-
icy required under this section at any time. 
‘‘(f) APPLICATION.—This section shall apply to a man-
ufacturer 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 21st Century Cures Act; or
174 
‘‘(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 inves-
tigational drug.’’. 
SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE 
ADVANCED THERAPIES. 
(a) IN GENERAL.—Section 506 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356) is amended— 
(1) by transferring subsection (e) (relating to 
construction) so that it appears before subsection (f) 
(relating to awareness efforts); and 
(2) by adding at the end the following: 
‘‘(g) REGENERATIVE ADVANCED THERAPY.— 
‘‘(1) IN GENERAL.—The Secretary, at the request 
of the sponsor of a drug, shall facilitate an efficient 
development program for, and expedite review of, such 
drug if the drug qualifies as a regenerative advanced 
therapy under the criteria described in paragraph 
(2). 
‘‘(2) CRITERIA.—A drug is eligible for designa-
tion as a regenerative advanced therapy under this 
subsection if— 
‘‘(A) the drug is a regenerative medicine 
therapy (as defined in paragraph (8));
175 
‘‘(B) the drug is intended to treat, modify, 
reverse, or cure a serious or life-threatening dis-
ease or condition; and 
‘‘(C) preliminary clinical evidence indicates 
that the drug has the potential to address unmet 
medical needs for such a disease or condition. 
‘‘(3) REQUEST FOR DESIGNATION.—The sponsor 
of a drug may request the Secretary to designate the 
drug as a regenerative advanced therapy concurrently 
with, or at any time after, submission of an applica-
tion for the investigation of the drug under section 
505(i) of this Act or section 351(a)(3) of the Public 
Health Service Act. 
‘‘(4) DESIGNATION.—Not later than 60 calendar 
days after the receipt of a request under paragraph 
(3), the Secretary shall determine whether the drug 
that is the subject of the request meets the criteria de-
scribed in paragraph (2). If the Secretary determines 
that the drug meets the criteria, the Secretary shall 
designate the drug as a regenerative advanced therapy 
and shall take such actions as are appropriate under 
paragraph (1). If the Secretary determines that a 
drug does not meet the criteria for such designation, 
the Secretary shall include with the determination a
176 
written description of the rationale for such deter-
mination. 
‘‘(5) ACTIONS.—The sponsor of a regenerative 
advanced therapy shall be eligible for the actions to 
expedite development and review of such therapy 
under subsection (a)(3)(B), including early inter-
actions to discuss any potential surrogate or inter-
mediate endpoint to be used to support the accelerated 
approval of an application for the product under sub-
section (c). 
‘‘(6) ACCESS TO EXPEDITED APPROVAL PATH-
WAYS.—An application for a regenerative advanced 
therapy under section 505(b)(1) of this Act or section 
351(a) of the Public Health Service Act may be— 
‘‘(A) eligible for priority review, as de-
scribed in the Manual of Policies and Procedures 
of the Food and Drug Administration and goals 
identified in the letters described in section 
101(b) of the Prescription Drug User Fee 
Amendments of 2012; and 
‘‘(B) eligible for accelerated approval under 
subsection (c), as agreed upon pursuant to sub-
section (a)(3)(B), through, as appropriate—
177 
‘‘(i) 
surrogate 
or 
intermediate 
endpoints reasonably likely to predict long- 
term clinical benefit; or 
‘‘(ii) reliance upon data obtained from 
a meaningful number of sites, including 
through expansion to additional sites, as 
appropriate. 
‘‘(7) POSTAPPROVAL REQUIREMENTS.—The spon-
sor of a regenerative advanced therapy that is granted 
accelerated approval and is subject to the post-
approval requirements under subsection (c) may, as 
appropriate, fulfill such requirements, as the Sec-
retary may require, through— 
‘‘(A) the submission of clinical evidence, 
clinical studies, patient registries, or other 
sources of real world evidence, such as electronic 
health records; 
‘‘(B) the collection of larger confirmatory 
data sets, as agreed upon pursuant to subsection 
(a)(3)(B); or 
‘‘(C) postapproval monitoring of all pa-
tients treated with such therapy prior to ap-
proval of the therapy. 
‘‘(8) DEFINITION.—For purposes of this section, 
the term ‘regenerative medicine therapy’ includes cell
178 
therapy, therapeutic tissue engineering products, 
human cell and tissue products, and combination 
products using any such therapies or products, except 
for those regulated solely under section 361 of the 
Public Health Service Act and part 1271 of title 21, 
Code of Federal Regulations.’’. 
(b) RULE OF CONSTRUCTION.—Nothing in this section 
and the amendments made by this section shall be construed 
to alter the authority of the Secretary of Health and 
Human Services— 
(1) to approve drugs pursuant to the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
and section 351 of the Public Health Service Act (42 
U.S.C. 262) as authorized prior to the date of enact-
ment of the 21st Century Cures Act, including the 
standards of evidence, and applicable conditions, for 
approval under such Acts; or 
(2) to alter the authority of the Secretary to re-
quire postapproval studies pursuant to such Acts, as 
authorized prior to the date of enactment of the 21st 
Century Cures Act. 
(c) CONFORMING AMENDMENT.—Section 506(e)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356(e)(1)) is amended by inserting ‘‘and the 21st Century
179 
Cures Act’’ after ‘‘Food and Drug Administration Safety 
and Innovation Act’’. 
SEC. 3034. GUIDANCE REGARDING DEVICES USED IN THE 
RECOVERY, ISOLATION, OR DELIVERY OF RE-
GENERATIVE ADVANCED THERAPIES. 
(a) DRAFT GUIDANCE.—Not later than 1 year after 
the date of enactment of the 21st Century Cures Act, the 
Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall issue draft guid-
ance clarifying how, in the context of regenerative advanced 
therapies, the Secretary will evaluate devices used in the 
recovery, isolation, or delivery of regenerative advanced 
therapies. In doing so, the Secretary shall specifically ad-
dress— 
(1) how the Food and Drug Administration in-
tends to simplify and streamline regulatory require-
ments for combination device and cell or tissue prod-
ucts; 
(2) what, if any, intended uses or specific at-
tributes would result in a device used with a regen-
erative therapy product to be classified as a class III 
device; 
(3) when the Food and Drug Administration 
considers it is necessary, if ever, for the intended use
180 
of a device to be limited to a specific intended use 
with only one particular type of cell; and 
(4) application of the least burdensome approach 
to demonstrate how a device may be used with more 
than one cell type. 
(b) FINAL GUIDANCE.—Not later than 12 months after 
the close of the period for public comment on the draft guid-
ance under subsection (a), the Secretary of Health and 
Human Services shall finalize such guidance. 
SEC. 3035. REPORT ON REGENERATIVE ADVANCED THERA-
PIES. 
(a) REPORT TO CONGRESS.—Before March 1 of each 
calendar year, the Secretary of Health and Human Services 
shall, with respect to the previous calendar year, submit a 
report to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives on— 
(1) the number and type of applications for ap-
proval of regenerative advanced therapies filed, ap-
proved or licensed as applicable, withdrawn, or de-
nied; and 
(2) how many of such applications or therapies, 
as applicable, were granted accelerated approval or 
priority review.
181 
(b) REGENERATIVE ADVANCED THERAPY.—In this sec-
tion, the term ‘‘regenerative advanced therapy’’ has the 
meaning given such term in section 506(g) of the Federal 
Food, Drug, and Cosmetic Act, as added by section 3033 
of this Act. 
SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND 
REGENERATIVE 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 REGENERATIVE ADVANCED THERAPIES. 
‘‘(a) IN GENERAL.—Not later than 2 years after the 
date of enactment of the 21st Century Cures Act, the Sec-
retary, in consultation with the National Institute of 
Standards and Technology and stakeholders (including re-
generative medicine and advanced therapies manufacturers 
and clinical trial sponsors, contract manufacturers, aca-
demic institutions, practicing clinicians, regenerative medi-
cine and advanced therapies industry organizations, and 
standard setting organizations), shall facilitate an effort to 
coordinate and prioritize the development of standards and 
consensus definition of terms, through a public process, to 
support, through regulatory predictability, the development, 
evaluation, and review of regenerative medicine therapies
182 
and regenerative advanced therapies, including with respect 
to the manufacturing processes and controls of such prod-
ucts. 
‘‘(b) ACTIVITIES.— 
‘‘(1) IN GENERAL.—In carrying out this section, 
the Secretary shall continue to— 
‘‘(A) identity opportunities to help advance 
the development of regenerative medicine thera-
pies and regenerative advanced therapies; 
‘‘(B) identify opportunities for the develop-
ment of laboratory regulatory science research 
and documentary standards that the Secretary 
determines would help support the development, 
evaluation, and review of regenerative medicine 
therapies and regenerative 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.—Not later 
than 1 year after the development of standards as de-
scribed in subsection (a), the Secretary shall review 
relevant regulations and guidance and, through a 
public process, update such regulations and guidance 
as the Secretary determines appropriate.
183 
‘‘(c) DEFINITIONS.—For purposes of this section, the 
terms ‘regenerative medicine therapy’ and ‘regenerative ad-
vanced therapy’ have the meanings given such terms in sec-
tion 506(g).’’. 
SEC. 3037. HEALTH CARE ECONOMIC INFORMATION. 
Section 502(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352(a)) is amended— 
(1) by striking ‘‘(a) If its’’ and inserting ‘‘(a)(1) 
If its’’; 
(2) by striking ‘‘a formulary committee, or other 
similar entity, in the course of the committee or the 
entity carrying out its responsibilities for the selec-
tion of drugs for managed care or other similar orga-
nizations’’ and inserting ‘‘a payor, formulary com-
mittee, or other similar entity with knowledge and ex-
pertise in the area of health care economic analysis, 
carrying out its responsibilities for the selection of 
drugs for coverage or reimbursement’’; 
(3) by striking ‘‘directly relates’’ and inserting 
‘‘relates’’; 
(4) by striking ‘‘and is based on competent and 
reliable scientific evidence. The requirements set forth 
in section 505(a) or in section 351(a) of the Public 
Health Service Act shall not apply to health care eco-
nomic information provided to such a committee or
184 
entity in accordance with this paragraph’’ and in-
serting ‘‘, is based on competent and reliable scientific 
evidence, and includes, where applicable, a con-
spicuous and prominent statement describing any 
material differences between the health care economic 
information and the labeling approved for the drug 
under section 505 or under section 351 of the Public 
Health Service Act. The requirements set forth in sec-
tion 505(a) or in subsections (a) and (k) of section 
351 of the Public Health Service Act shall not apply 
to health care economic information provided to such 
a payor, committee, or entity in accordance with this 
paragraph’’; and 
(5) by striking ‘‘In this paragraph, the term’’ 
and all that follows and inserting the following: 
‘‘(2)(A) For purposes of this paragraph, the term 
‘health care economic information’ means any analysis (in-
cluding the clinical data, inputs, clinical or other assump-
tions, methods, results, and other components underlying or 
comprising the analysis) that identifies, measures, or de-
scribes the economic consequences, which may be based on 
the separate or aggregated clinical consequences of the rep-
resented health outcomes, of the use of a drug. Such analysis 
may be comparative to the use of another drug, to another 
health care intervention, or to no intervention.
185 
‘‘(B) Such term does not include any analysis that re-
lates only to an indication that is not approved under sec-
tion 505 or under section 351 of the Public Health Service 
Act for such drug.’’. 
SEC. 3038. COMBINATION PRODUCT INNOVATION. 
(a) IN GENERAL.—Section 503(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353(g)) is amended— 
(1) by striking paragraph (3); 
(2) by redesignating paragraph (2) as para-
graph (7); 
(3) by redesignating paragraphs (4) and (5) as 
paragraphs (8) and (9), respectively; 
(4) by striking ‘‘(g)(1)’’ and all that follows 
through the end of paragraph (1) and inserting the 
following: 
‘‘(g)(1)(A) The Secretary shall, in accordance with this 
subsection, assign a primary agency center to regulate 
products that constitute a combination of a drug, device, 
or biological product. 
‘‘(B) The Secretary shall conduct the premarket review 
of any combination product under a single application, 
whenever appropriate. 
‘‘(C) For purposes of this subsection, the term ‘primary 
mode of action’ means the single mode of action of a com-
bination product expected to make the greatest contribution
186 
to the overall intended therapeutic effects of the combination 
product. 
‘‘(D) The Secretary shall determine the primary mode 
of action of the combination product. If the Secretary deter-
mines that the primary mode of action is that of— 
‘‘(i) a drug (other than a biological product), the 
agency center charged with premarket review of drugs 
shall have primary jurisdiction; 
‘‘(ii) a device, the agency center charged with 
premarket review of devices shall have primary juris-
diction; or 
‘‘(iii) a biological product, the agency center 
charged with premarket review of biological products 
shall have primary jurisdiction. 
‘‘(E) In determining the primary mode of action of 
a combination product, the Secretary shall not determine 
that the primary mode of action is that of a drug or biologi-
cal product solely because the combination product has any 
chemical action within or on the human body. 
‘‘(F) If a sponsor of a combination product disagrees 
with the determination under subparagraph (D)— 
‘‘(i) such sponsor may request, and the Secretary 
shall provide, a substantive rationale to such sponsor 
that references scientific evidence provided by the
187 
sponsor and any other scientific evidence relied upon 
by the Secretary to support such determination; and 
‘‘(ii)(I) the sponsor of the combination product 
may propose one or more studies (which may be non-
clinical, clinical, or both) to establish the relevance, if 
any, of the chemical action in achieving the primary 
mode of action of such product; 
‘‘(II) if the sponsor proposes any such studies, 
the Secretary and the sponsor of such product shall 
collaborate and seek to reach agreement, within a rea-
sonable time of such proposal, not to exceed 90 cal-
endar days, on the design of such studies; and 
‘‘(III) if an agreement is reached under sub-
clause (II) and the sponsor conducts one or more of 
such studies, the Secretary shall consider the data re-
sulting from any such study when reevaluating the 
determination of the primary mode of action of such 
product, and unless and until such reevaluation has 
occurred and the Secretary issues a new determina-
tion, the determination of the Secretary under sub-
paragraph (D) shall remain in effect. 
‘‘(2)(A)(i) To establish clarity and certainty for the 
sponsor, the sponsor of a combination product may request 
a meeting on such combination product. If the Secretary 
concludes that a determination of the primary mode of ac-
188 
tion pursuant to paragraph (1)(D) is necessary, the sponsor 
may request such meeting only after the Secretary makes 
such determination. If the sponsor submits a written meet-
ing request, the Secretary shall, not later than 75 calendar 
days after receiving such request, meet with the sponsor of 
such combination product. 
‘‘(ii) A meeting under clause (i) may— 
‘‘(I) address the standards and requirements for 
market approval or clearance of the combination 
product; 
‘‘(II) address other issues relevant to such com-
bination product, such as requirements related to 
postmarket modification of such combination product 
and good manufacturing practices applicable to such 
combination product; and 
‘‘(III) identify elements under subclauses (I) and 
(II) that may be more appropriate for discussion and 
agreement with the Secretary at a later date given 
that scientific or other information is not available, 
or agreement is otherwise not feasible regarding such 
elements, at the time a request for such meeting is 
made. 
‘‘(iii) Any agreement under this subparagraph shall 
be in writing and made part of the administrative record 
by the Secretary.
189 
‘‘(iv) Any such agreement shall remain in effect, ex-
cept— 
‘‘(I) upon the written agreement of the Secretary 
and the sponsor or applicant; or 
‘‘(II) pursuant to a decision by the director of 
the reviewing division of the primary agency center, 
or a person more senior than such director, in con-
sultation with consulting centers and the Office, as 
appropriate, that an issue essential to determining 
whether the standard for market clearance or other 
applicable standard under this Act or the Public 
Health Service Act applicable to the combination 
product has been identified since the agreement was 
reached, or that deviating from the agreement is oth-
erwise justifiable based on scientific evidence, for pub-
lic health reasons. 
‘‘(3) For purposes of conducting the premarket review 
of a combination product that contains an approved con-
stituent part described in paragraph (4), the Secretary may 
require that the sponsor of such combination product sub-
mit to the Secretary only data or information that the Sec-
retary determines is necessary to meet the standard for 
clearance or approval, as applicable, under this Act or the 
Public Health Service Act, including any incremental risks 
and benefits posed by such combination product, using a
190 
risk-based approach and taking into account any prior 
finding of safety and effectiveness or substantial equivalence 
for the approved constituent part relied upon by the appli-
cant in accordance with paragraph (5). 
‘‘(4) For purposes of paragraph (3), an approved con-
stituent part is— 
‘‘(A) a drug constituent part of a combination 
product being reviewed in a single application or re-
quest under section 515, 510(k), or 513(f)(2) (sub-
mitted in accordance with paragraph (5)), that is an 
approved drug, provided such application or request 
complies with paragraph (5); 
‘‘(B) a device constituent part approved under 
section 515 that is referenced by the sponsor and that 
is available for use by the Secretary under section 
520(h)(4); or 
‘‘(C) any constituent part that was previously 
approved, cleared, or classified under section 505, 
510(k), 513(f)(2), or 515 of this Act for which the 
sponsor has a right of reference or any constituent 
part that is a nonprescription drug, as defined in sec-
tion 760(a)(2). 
‘‘(5)(A) If an application is submitted under section 
515 or 510(k) or a request is submitted under section 
513(f)(2), consistent with any determination made under
240 
‘‘(m)(1) The Secretary shall— 
‘‘(A) not later than 90 days after the date of en-
actment of the 21st Century Cures Act and at least 
once every 5 years thereafter, as the Secretary deter-
mines appropriate— 
‘‘(i) publish in the Federal Register a notice 
that contains a list of each type of class II device 
that the Secretary determines no longer requires 
a report under subsection (k) to provide reason-
able assurance of safety and effectiveness; and 
‘‘(ii) provide for a period of not less than 
60 calendar days for public comment beginning 
on the date of the publication of such notice; and 
‘‘(B) not later than 210 calendar days after the 
date of enactment of the 21st Century Cures Act, pub-
lish in the Federal Register a list representing the 
Secretary’s final determination with respect to the de-
vices contained in the list published under subpara-
graph (A).’’; and 
(2) in paragraph (2)— 
(A) by striking ‘‘1 day after the date of 
publication of a list under this subsection,’’ and 
inserting ‘‘1 calendar day after the date of publi-
cation of the final list under paragraph (1)(B),’’; 
and