retary pursuant to this subsection on the clinical investiga-
tion of the new drug and to the extent appropriate, infor-
mation stratified by sex, race, and ethnicity, including any 
differences in safety and effectiveness. 
‘‘(B) The Secretary shall place a clinical hold (as de-
scribed in paragraph (3)) on an investigation if the manu-
facturer or sponsor of the investigation fails to submit the 
required information described in subparagraph (A). 
‘‘(C) The Secretary shall develop standards that en-
sure that submissions to the Secretary pursuant to this 
subsection on clinical investigations of new drugs are ade-
quately reviewed to determine whether such submissions 
include the information required under this paragraph.’’. 
(c) ABBREVIATED NEW DRUG APPLICATIONS.—Sec-
tion 505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)) is amended— 
(1) in paragraph (2)(A), by inserting before the 
period at the end the following: ‘‘, subject to para-
graph (10)’’; 
(2) in paragraph (3)(A), by adding at the end 
the following: ‘‘The Secretary shall require such in-
dividuals who review such applications to ensure 
that such applications include the information on 
sex, race, and ethnicity data required under para-
graph (10).’’; 
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(3) in paragraph (4)— 
(A) in subparagraph (J), by striking ‘‘or’’ 
after the semicolon; 
(B) in subparagraph (K), by striking the 
period at the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(L) the application does not include ap-
propriate information stratified by sex, race, 
and ethnicity, as required under paragraph 
(10).’’; and 
(4) by adding at the end the following: 
‘‘(10)(A) Notwithstanding any other provision of this 
Act, a person shall include in any submission to the Sec-
retary pursuant to this subsection appropriate drug infor-
mation stratified by sex, race, and ethnicity, including any 
differences in safety and effectiveness. 
‘‘(B) The Secretary shall develop standards that en-
sure that submissions to the Secretary pursuant to this 
subsection are adequately reviewed to determine whether 
such submissions include the information required under 
this paragraph. 
‘‘(C) Upon the approval under this subsection of an 
application for a drug, the Secretary shall report to the 
scientific community and make available to the public, in 
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a timely manner, data regarding such drug stratified by 
sex, race, and ethnicity.’’. 
(d) PREMARKET APPROVALS.—Section 515 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) 
is amended— 
(1) in subsection (c)— 
(A) in paragraph (1)— 
(i) in subparagraph (F), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (G), by striking 
the period and inserting ‘‘; and’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(H) information regarding the device, to the 
extent appropriate, stratified by sex, race, and eth-
nicity, including differences in safety and effective-
ness.’’; and 
(B) by adding at the end the following: 
‘‘(5) The Secretary shall develop standards that en-
sure that submissions to the Secretary pursuant to this 
subsection are adequately reviewed to determine whether 
such submissions include the information required under 
paragraph (1)(H).’’; and 
(2) in subsection (d)— 
(A) in paragraph (2)— 
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