215 
of NIH shall make publicly available on 
the results database the clinical trial infor-
mation submitted for such clinical trial on 
the earlier of the date that is 30 days after 
the date— 
‘‘(I) the new use of the drug or 
device is approved under such section 
505, licensed under such section 351, 
cleared under such section 510(k), or 
approved under such section 515; 
‘‘(II) the Secretary issues a not 
approvable letter or a not substan-
tially equivalent letter for the new use 
of the drug or device under such sec-
tion 505, 351, 510(k), or 515; or 
‘‘(III) the application or pre-
market notification under such section 
505, 351, 510(k), or 515 is with-
drawn. 
‘‘(ii) 
LIMITATION
ON
CERTIFI-
CATION.—If a manufacturer makes a cer-
tification under clause (i) with respect to a 
clinical trial, the manufacturer shall make 
such a certification with respect to each 
applicable clinical trial that is required to
216 
be submitted in an application for approval 
of the use studied in the clinical trial. 
‘‘(iii) 2-YEAR LIMITATION.—The clin-
ical trial information subject to clause (i) 
shall be made publicly available on the re-
sults database on the date that is 2 years 
after the date the certification referred to 
in clause (i) was made to the Director of 
NIH, if a regulatory action referred to in 
subclause (I), (II), or (III) of clause (i) has 
not occurred by such date. 
‘‘(iv) MEDICAL AND CLINICAL PHAR-
MACOLOGY REVIEWS.—Not later than 90 
days after the date applicable under sub-
clause (I), (II), or (III) of clause (i) or 
clause (iii) with respect to an applicable 
clinical trial, the Director of NIH shall 
make publicly available on the results data-
base a summary of the available medical 
and clinical pharmacology reviews con-
ducted by the Food and Drug Administra-
tion for such trial. 
‘‘(E) SEEKING PUBLICATION.— 
‘‘(i) IN GENERAL.—If the principal in-
vestigator of an applicable clinical trial is
217 
seeking publication in a peer-reviewed bio-
medical journal of a manuscript based on 
the results of the clinical trial and the re-
sponsible party so certifies to the Director 
of NIH— 
‘‘(I) the responsible party shall 
notify the Director of NIH of the pub-
lication date of such manuscript not 
later than 15 days after such date; 
and 
‘‘(II) the Director of NIH shall 
make publicly available on the results 
database the clinical trial information 
submitted for such clinical trial on the 
date that is 30 days after the publica-
tion date of such manuscript. 
‘‘(ii) LIMITATIONS.—The clinical trial 
information subject to clause (i)— 
‘‘(I) shall be made publicly avail-
able on the results database on the 
date that is 2 years after the date 
that the clinical trial information was 
required to be submitted to the Direc-
tor of NIH if the manuscript referred
218 
to in such clause has not been pub-
lished by such date; and 
‘‘(II) shall not be required to be 
made publicly available under section 
552 of title 5, United States Code 
(commonly known as the ‘Freedom of 
Information Act’), prior to the date 
applicable to such clinical trial infor-
mation under this subparagraph. 
‘‘(7) VERIFICATION OF SUBMISSION PRIOR TO 
PUBLIC AVAILABILITY.—In the case of clinical trial 
information that is submitted under this subsection, 
but is not made publicly available pending either 
regulatory action or publication under subparagraph 
(D) or (E) of paragraph (6), as applicable, the Di-
rector of NIH shall respond to inquiries from other 
Federal agencies and peer-reviewed journals to con-
firm that such clinical trial information has been 
submitted but has not yet been made publicly avail-
able on the results database. 
‘‘(d) UPDATES; TRACKING
OF CHANGES
IN SUB-
MITTED INFORMATION.—The Director of NIH shall en-
sure that updates submitted to the Director under sub-
sections (b)(7) and (c)(4) do not result in the removal 
from the registry database or the results database of the
219 
original submissions or of any preceding updates, and that 
information in such databases is presented in a manner 
that enables users to readily access each original submis-
sion and to track the changes made by the updates. 
‘‘(e) COORDINATION AND COMPLIANCE.— 
‘‘(1) CONSULTATION
WITH
OTHER
FEDERAL 
AGENCIES.—The Secretary shall— 
‘‘(A) consult with other agencies that con-
duct human studies in accordance with part 46 
of title 45, Code of Federal Regulations (or any 
successor regulations), to determine if any such 
studies are applicable clinical trials; and 
‘‘(B) develop with such agencies appro-
priate procedures to ensure that clinical trial in-
formation for such applicable clinical trials is 
submitted under subsection (b) and (c). 
‘‘(2) COORDINATION
OF
REGISTRY
DATABASE 
AND RESULTS DATABASE.— 
‘‘(A) IN GENERAL.—Each entry in the reg-
istry database under subsection (b) or the re-
sults database under subsection (c) shall in-
clude a link to the corresponding entry in the 
results database or the registry database, re-
spectively. 
‘‘(B) MISSING ENTRIES.—