(ii) by inserting before the period the 
following: ‘‘; and (H) the information re-
quired under paragraph (7)’’; and 
(B) by adding at the end the following: 
‘‘(7)(A) With respect to clinical data in an application 
under this subsection, the Secretary may deny such an ap-
plication if the application fails to meet the requirements 
of sections 314.50(d)(5)(v) and 314.50(d)(5)(vi)(a) of title 
21, Code of Federal Regulations. 
‘‘(B) The Secretary shall modify the sections referred 
to in subparagraph (A) to require that an application 
under this subsection include any clinical data possessed 
by the applicant that relates to the safety or effectiveness 
of the drug involved by gender, age, and racial subgroup. 
‘‘(C) Promptly after approving an application under 
this subsection, the Secretary shall, through an Internet site 
of the Department of Health and Human Services, make 
available to the public the information submitted to the Sec-
retary pursuant to subparagraphs (A) and (B), subject to 
sections 301(j) and 520(h)(4) of this Act, subsection (b)(4) 
of section 552 of title 5, United States Code (commonly re-
ferred to as the ‘Freedom of Information Act’), and other 
provisions of law that relate to trade secrets or confidential 
commercial information. 
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‘‘(D) The Secretary shall develop guidance for staff of 
the Food and Drug Administration to ensure that applica-
tions under this subsection are adequately reviewed to deter-
mine whether the applications include the information re-
quired pursuant to subparagraphs (A) and (B).’’. 
(2) INVESTIGATIONAL
NEW
DRUG
APPLICA-
TIONS.—Section 505(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(i)) is amended— 
(A) in paragraph (2), by striking ‘‘Subject 
to paragraph (3),’’ and inserting ‘‘Subject to 
paragraphs (3) and (5),’’ ; and 
(B) by adding at the end the following: 
‘‘(5)(A) The Secretary may place a clinical hold (as 
described in paragraph (3)) on an investigation if the spon-
sor of the investigation fails to meet the requirements of 
section 312.33(a) of title 21, Code of Federal Regulations. 
‘‘(B) The Secretary shall modify the section referred 
to in subparagraph (A) to require that reports under such 
section include any clinical data possessed by the sponsor 
of the investigation that relates to the safety or effectiveness 
of the drug involved by gender, age, and racial subgroup.’’. 
(b) BIOLOGICS LICENSE APPLICATIONS.—Section 351 
of the Public Health Service Act (42 U.S.C. 262) is amend-
ed by adding at the end the following: 
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‘‘(k) The provisions of section 505(b)(7) of the Federal 
Food, Drug, and Cosmetic Act (relating to clinical data 
submission) apply with respect to an application under 
subsection (a) of this section to the same extent and in the 
same manner as such provisions apply with respect to an 
application under section 505(b) of such Act.’’. 
(c) DEVICES.— 
(1) PREMARKET APPROVAL.—Section 515 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360e) is amended— 
(A) in subsection (c)(1)— 
(i) in subparagraph (G)— 
(I) by moving the margin 2 ems 
to the left; and 
(II) by striking ‘‘and’’ after the 
semicolon at the end; 
(ii) by redesignating subparagraph 
(H) as subparagraph (I); and 
(iii) by inserting after subparagraph 
(G) the following subparagraph: 
‘‘(H) the information required under subsection 
(d)(7); and’’; and 
(B) in subsection (d), by adding at the end 
the following paragraph: 
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