HR 1014 RDS 
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 Secretary pursuant to subparagraphs (A) and (B), 
subject to sections 301(j) and 520(h)(4) of this Act, sub-
section (b)(4) of section 552 of title 5, United States Code 
(commonly referred to as the ‘Freedom of Information 
Act’), and other provisions of law that relate to trade se-
crets or confidential commercial information. 
‘‘(D) The Secretary shall develop guidance for staff 
of the Food and Drug Administration to ensure that appli-
cations under this subsection are adequately reviewed to 
determine whether the applications include the informa-
tion required 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: 
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‘‘(5)(A) The Secretary may place a clinical hold (as 
described in paragraph (3)) on an investigation if the 
sponsor of the investigation fails to meet the requirements 
of section 312.33(a) of title 21, Code of Federal Regula-
tions. 
‘‘(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 effective-
ness of the drug involved by gender, age, and racial sub-
group.’’. 
(b) BIOLOGICS LICENSE APPLICATIONS.—Section 
351 of the Public Health Service Act (42 U.S.C. 262) is 
amended by adding at the end the following: 
‘‘(k) The provisions of section 505(b)(7) of the Fed-
eral 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 re-
spect 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)— 
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(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: 
‘‘(7) To the extent consistent with the regulation of 
devices, the provisions of section 505(b)(7) (relating to 
clinical data submission) apply with respect to an applica-
tion for premarket approval of a device under subsection 
(c) of this section to the same extent and in the same man-
ner as such provisions apply with respect to an application 
for premarket approval of a drug under section 505(b).’’. 
(2) 
INVESTIGATIONAL
DEVICES.—Section 
520(g)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j(g)(2)) is amended by adding at 
the end the following subparagraph: 
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‘‘(D) To the extent consistent with the regulation of 
devices, the provisions of section 505(i)(5) (relating to in-
dividual study information) apply with respect to an appli-
cation for an exemption pursuant to subparagraph (A) of 
this paragraph to the same extent and in the same manner 
as such provisions apply with respect to an application for 
an exemption under section 505(i).’’. 
(d) RULES OF CONSTRUCTION.—This Act and the 
amendments made by this Act may not be construed— 
(1) as establishing new requirements under the 
Federal Food, Drug, and Cosmetic Act relating to 
the design of clinical investigations
that were not 
otherwise in effect on the day before the date of the 
enactment of this Act; or 
(2) as having any effect on the authority of the 
Secretary of Health and Human Services to enforce 
regulations under the Federal Food, Drug, and Cos-
metic Act that are not expressly referenced in this 
Act or the amendments made by this Act. 
(e) APPLICATION.—This section and the amendments 
made by this section apply only with respect to applica-
tions received under section 505 or 515 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360e) or 
section 351 of the Public Health Service Act (42 U.S.C. 
262) on or after the date of the enactment of this Act. 
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