I 
113TH CONGRESS 
2D SESSION 
H. R. 4879 
To amend the Federal Food, Drug, and Cosmetic Act to provide for expedited 
review of drugs and biological products to provide safer or more effective 
treatment for males or females, to amend the Public Health Service 
Act to enhance the consideration of sex differences in basic and clinical 
research, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 17, 2014 
Mr. COOPER (for himself and Mrs. LUMMIS) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
provide for expedited review of drugs and biological prod-
ucts to provide safer or more effective treatment for 
males or females, to amend the Public Health Service 
Act to enhance the consideration of sex differences in 
basic and clinical research, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Research for All Act 
of 2014’’. 
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SEC. 2. SUFFICIENCY OF DESIGN AND SIZE OF CLINICAL 
TRIALS DURING EXPEDITED REVIEW. 
The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall re-
view and develop policies, as appropriate, to ensure that 
the design and size of clinical trials for products granted 
expedited approval pursuant to section 506 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356) are suffi-
cient to determine the safety and effectiveness of such 
products for men and women using subgroup analysis. 
SEC. 3. EXPEDITED REVIEW OF DRUGS AND BIOLOGICAL 
PRODUCTS TO PROVIDE SAFER OR MORE EF-
FECTIVE TREATMENT FOR MALES OR FE-
MALES. 
(a) IN GENERAL.—Section 506 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356) is amended by 
adding at the end the following: 
‘‘(g) EXPEDITED REVIEW OF DRUGS AND BIOLOGI-
CAL PRODUCTS TO PROVIDE SAFER OR MORE EFFECTIVE 
TREATMENT FOR MALES OR FEMALES.— 
‘‘(1) ELIGIBLE PRODUCT.—The Secretary shall, 
at the request of the sponsor of a new drug, facili-
tate the development and expedite the review of such 
drug if the drug— 
‘‘(A) is intended— 
‘‘(i) to avoid serious adverse events; or 
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‘‘(ii) to treat a serious or life-threat-
ening disease or condition; 
‘‘(B) whether alone or in combination with 
one or more other drugs or biological products, 
is intended for safer or more effective treatment 
for men or women than a currently available 
product approved to treat the general popu-
lation or the other sex; and 
‘‘(C) is supported by results of clinical 
trials that include and separately examine out-
comes for both men and women. 
‘‘(2) DESIGNATION.—At the request of the 
sponsor of an eligible product described in para-
graph (1), the Secretary shall designate the drug as 
an expedited product to provide safer or more effec-
tive treatment for males or females. 
‘‘(3) EARLY
AND
FREQUENT
COMMUNICA-
TION.—The Secretary shall, with respect to each ex-
pedited product designated under this subsection, 
provide early and frequent communication and re-
view of incomplete applications to the same extent 
and in the same manner as is provided under sub-
sections (b) and (d). 
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed— 
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‘‘(A) to lessen or otherwise alter the stand-
ard of safety and effectiveness required for the 
approval or licensing of drugs or biological 
products under section 505 of this Act or sec-
tion 351 of the Public Health Service Act; or 
‘‘(B) to authorize application of the provi-
sions of subsection (c) (relating to the use of 
surrogate endpoints) to expedited products des-
ignated under this subsection.’’. 
(b) TECHNICAL CORRECTIONS.—Subsection (f) of 
section 506 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356) (relating to awareness efforts), as des-
ignated by section 902(a) of Public Law 112–144, is 
amended— 
(1) in paragraph (1), by striking ‘‘and and’’ 
and inserting ‘‘and’’; and 
(2) by moving such subsection (f) so that it fol-
lows subsection (e) of such section 506. 
SEC. 4. RESEARCH ON SEX DIFFERENCES. 
(a) INCLUSION IN NIH RESEARCH.— 
(1) IN GENERAL.—Section 492B of the Public 
Health Service Act (42 U.S.C. 289a–2) is amend-
ed— 
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(A) 
by 
redesignating 
subsections 
(b) 
through (g) as subsections (c) through (h), re-
spectively; and 
(B) by inserting after subsection (a) the 
following: 
‘‘(b) INCLUSION OF SEX DIFFERENCES IN BASIC RE-
SEARCH.— 
‘‘(1) APPLICABILITY TO BASIC RESEARCH.— 
‘‘(A) IN GENERAL.—The Director of NIH 
shall determine when it is appropriate for 
projects of basic research involving cells, tissues 
or animals to include both male and female 
cells, tissues, or animals. 
‘‘(B) DEADLINE FOR INITIAL DETERMINA-
TION; UPDATES.—The Director of NIH— 
‘‘(i) shall make the initial determina-
tions required by subparagraph (A) not 
later than one year after the date of enact-
ment of the Research for All Act of 2014; 
and 
‘‘(ii) may subsequently update or re-
vise such determinations as the Director 
determines appropriate. 
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‘‘(C) CONSULTATION.—In making the ini-
tial determinations required by subparagraph 
(A), the Director of NIH— 
‘‘(i) shall consult with the Office of 
Research on Women’s Health, the Institute 
of Medicine, the Office of Laboratory Ani-
mal Welfare, and appropriate members of 
the scientific and academic communities; 
and 
‘‘(ii) may conduct outreach and edu-
cational initiatives within the scientific and 
academic communities on the influence of 
sex as a variable in basic research in order 
to develop a consensus within such commu-
nities on when it is appropriate for projects 
of basic research involving cells, tissues or 
animals to include both male and female 
cells, tissues, or animals. 
‘‘(2) INCLUSION.—Beginning on the date that 
is 1 year after the date of enactment of the Re-
search for All Act of 2014, in conducting or sup-
porting basic research in accordance with paragraph 
(1), the Director of NIH shall, subject to paragraph 
(3), ensure that— 
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‘‘(A) in the case of research on cells or tis-
sues— 
‘‘(i) cells or tissues, as applicable, are 
derived from both male and female orga-
nisms in each project of such research; and 
‘‘(ii) the results are disaggregated ac-
cording to whether the cells or tissues are 
derived from male or female organisms; 
and 
‘‘(B) in the case of animal research— 
‘‘(i) both male and female animals are 
included as subjects in each project of such 
research; and 
‘‘(ii) the results are disaggregated ac-
cording to whether the subjects are male 
or female. 
‘‘(3) EXCEPTION.—Paragraph (2) shall not 
apply to a project of basic research if the Director 
of NIH determines that the inclusion of cells or tis-
sues derived from both male and female organisms, 
or the inclusion of both male and female animals as 
subjects, as applicable, is inappropriate in the case 
of such project.’’. 
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(2) DESIGN OF RESEARCH.—Subsection (d) of 
section 492B of the Public Health Service Act (42 
U.S.C. 289a–2), as redesignated, is amended— 
(A) by striking ‘‘(d)’’ and all that follows 
through ‘‘In the case’’ and inserting the fol-
lowing: 
‘‘(d) DESIGN OF RESEARCH.— 
‘‘(1) CLINICAL TRIALS.—In the case’’; and 
(B) by adding at the end the following: 
‘‘(2) BASIC RESEARCH.—In the case of basic 
research in which cells or tissues derived from both 
male and female organisms will be included in ac-
cordance with subsection (b)(2)(A) or both male and 
female animals will be included as subjects in ac-
cordance with subsection (b)(2)(B), the Director of 
NIH shall ensure that sex differences are examined 
and analyzed, as appropriate.’’. 
(3) UPDATING GUIDELINES FOR CLINICAL AND 
BASIC RESEARCH.—Section 492B(f)(1) of the Public 
Health Service Act (42 U.S.C. 289a–2), as redesig-
nated, is amended to read as follows: 
‘‘(1) DATE CERTAIN; UPDATE.—The guidelines 
required in subsection (e) regarding the require-
ments of this section for clinical and basic research 
shall— 
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‘‘(A) be updated and published in the Fed-
eral Register not later than 1 year after the 
date of enactment of the Research for All Act 
of 2014; 
‘‘(B) reflect the growing understanding 
that sex differences matter; 
‘‘(C) ensure better enforcement of the re-
quirements of this section by the personnel of 
the agencies of the National Institutes of 
Health responsible for reviewing grant pro-
posals; and 
‘‘(D) include guidance on when research 
strongly supports or strongly negates the con-
clusion that there is a significant difference in 
how the variables being studied affect women or 
members of minority groups, as the case may 
be, relative to how such variables affect other 
subjects in the research.’’. 
(4) APPLICABILITY.—Section 492B(f)(2) of the 
Public Health Service Act (42 U.S.C. 289a–2), as 
redesignated, is amended by adding at the end the 
following: ‘‘For fiscal year 2016 and subsequent fis-
cal years, the Director of NIH may not approve any 
proposal of basic research to be conducted or sup-
ported by any agency of the National Institutes of 
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Health unless the proposal specifies the manner in 
which the research will comply with this section.’’. 
(5) CONFORMING CHANGES.—Section 492B of 
the Public Health Service Act (42 U.S.C. 289a–2) 
is amended— 
(A) in the heading of subsection (a), by 
striking ‘‘REQUIREMENT OF INCLUSION’’ and 
inserting 
‘‘INCLUSION
IN
CLINICAL
RE-
SEARCH’’; 
(B) in subsection (a)(1), by striking ‘‘sub-
section (b)’’ and inserting ‘‘subsection (c)’’; 
(C) in subsection (e)(1)(A), as redesig-
nated, by striking ‘‘subsection (b)’’ and insert-
ing ‘‘subsection (c)’’; 
(D) in subsection (e)(1)(B), as redesig-
nated, by striking ‘‘subsection (c)’’ and insert-
ing ‘‘subsection (d)’’; and 
(E) in subsection (e)(2), as redesignated, 
by striking ‘‘subsection (b)’’ and inserting ‘‘sub-
section (c)’’. 
(b) BIENNIAL REPORTS OF DIRECTOR OF NIH.— 
Subparagraph (C) of section 403(a)(4) of the Public 
Health Service Act (42 U.S.C. 283(a)(4)) is amended— 
(1) by redesignating clause (vi) as clause (vii); 
and 
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(2) by inserting after clause (v) the following: 
‘‘(vi) Basic research, including a 
breakdown of the sex of organisms from 
which cells and tissues are derived, a 
breakdown of the sex of animal subjects, 
and such other information as may be nec-
essary to demonstrate compliance with sec-
tion 492B (regarding sex differences in 
basic research).’’. 
(c) SPECIAL CENTERS OF RESEARCH ON SEX DIF-
FERENCES.—Part H of title IV of the Public Health Serv-
ice Act is amended by inserting after section 492B of such 
Act (42 U.S.C. 289a–2) the following: 
‘‘SEC. 492C. SPECIAL CENTERS OF RESEARCH ON SEX DIF-
FERENCES. 
‘‘The Secretary may award grants or other support 
to entities for the continued operation and expansion of 
Special Centers of Research on Sex Differences.’’. 
(d) RULE OF CONSTRUCTION.—Nothing in this Act 
or the amendments made by this Act shall be construed 
to lessen any standard or requirement set forth in part 
1, 2, or 3 of subchapter A of chapter I of title 9, Code 
of Federal Regulations. 
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SEC. 5. GAO REPORTS. 
Not later than 1 year after the date of enactment 
of the Research for All Act of 2014, the Comptroller Gen-
eral of the United States shall— 
(1) submit to the Congress updated versions of 
the reports of the Government Accountability Office 
entitled ‘‘Women’s Health: NIH Has Increased Its 
Efforts To Include Women in Research’’ (published 
in May 2000; GAO/HEHS–00–96) and ‘‘Women’s 
Health: Women Sufficiently Represented in New 
Drug Testing, But FDA Oversight Needs Improve-
ment’’ (published in July 2001; GAO–01–754); and 
(2) in such updated reports— 
(A) examine the inclusion of women, fe-
male animals, and female-derived cells and tis-
sues in federally funded research over the past 
decade; 
(B) examine how Federal agencies report 
and analyze subgroup information and translate 
any differences to the medical community and 
patients; 
(C) determine whether the quality of care 
which women receive is being negatively im-
pacted by inclusion rates in basic and clinical 
research; and 
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(D) address current efforts within National 
Institutes of Health and other government 
agencies to encourage the sharing of research 
data on sex differences and evaluate mecha-
nisms to improve such sharing, including a pub-
licly accessible online system that will conform 
with policies protecting commercial, proprietary, 
or private information. 
Æ 
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