230 
(5) REFUSAL TO APPROVE NEW DEVICE APPLI-
CATION.—Paragraph (2) of section 515(d) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360e(d)) is amended— 
(A) in subparagraph (D), by striking ‘‘or’’ 
at the end; 
(B) in subparagraph (E), by striking the 
period at the end and inserting ‘‘; or’’; and 
(C) by inserting after subparagraph (E) 
the following: 
‘‘(F) the applicant is in violation of the require-
ments under section 492C of the Public Health 
Service Act for the submission of clinical trial infor-
mation for inclusion in the registry database or the 
results database described in such section.’’. 
(c) GUIDANCE.—Not later than 180 days after the 
date of the enactment of this Act, the Commissioner of 
Food and Drugs, in consultation with the Director of the 
National Institutes of Health, shall issue guidance to clar-
ify which clinical trials are applicable clinical trials (as de-
fined in section 492C of the Public Health Service Act, 
as amended by this section) and required to be submitted 
for inclusion in the clinical trial registry database de-
scribed in such section. 
(d) PREEMPTION.— 
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231 
(1) IN GENERAL.—No State or political subdivi-
sion of a State may establish or continue in effect 
any requirement for the registration of clinical trials 
or any requirement for the inclusion of information 
relating to the results of clinical trials in a database. 
(2) RULE OF CONSTRUCTION.—The fact of sub-
mission of clinical trial information, if submitted in 
compliance with section 492C of the Public Health 
Service Act (as amended by this section), that re-
lates to a use of a drug or device not included in the 
official labeling of the approved drug or device shall 
not be construed by the Secretary or in any adminis-
trative or judicial proceeding, as evidence of a new 
intended use of the drug or device that is different 
from the intended use of the drug or device set forth 
in the official labeling of the drug or device. The 
availability of clinical trial information through the 
databases under subsections (b) and (c) of such sec-
tion 492C, if submitted in compliance with such sec-
tion 492C, shall not be considered as labeling, adul-
teration, or misbranding of the drug or device under 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.). 
(e) EFFECTIVE DATES.— 
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232 
(1) ESTABLISHMENT OF REGISTRY DATABASE 
AND RESULTS DATABASE.—Not later than 1 year 
after the date of the enactment of this Act, the Di-
rector of NIH shall establish the registry database 
and the results database of clinical trials of drugs 
and devices in accordance with section 492C of the 
Public Health Service Act (as amended by sub-
section (a)). 
(2) CLINICAL TRIALS INITIATED PRIOR TO OP-
ERATION OF REGISTRY DATABASE.—The responsible 
party (as defined in such section 492C) for an appli-
cable clinical trial (as defined in such section 492C) 
that is initiated after the date of the enactment of 
this Act and before the date such registry database 
is established under paragraph (1) of this sub-
section, shall submit required clinical trial informa-
tion not later than 120 days after the date such reg-
istry database is established. 
(3) CLINICAL TRIALS INITIATED AFTER OPER-
ATION
OF
REGISTRY
DATABASE.—The responsible 
party (as defined in such section 492C) for an appli-
cable clinical trial (as defined in such section 492C) 
that is initiated after the date such registry database 
is established under paragraph (1) of this subsection 
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233 
shall submit required clinical trial information in ac-
cordance with subsection (b) of such section 492C. 
(4) TRIALS
COMPLETED
BEFORE
OPERATION 
OF RESULTS DATABASE.— 
(A) IN GENERAL.—Subsection (c) of such 
section 492C shall take effect 90 days after the 
date the results database is established under 
paragraph (1) of this subsection with respect to 
any applicable clinical trial (as defined in such 
section 492C) that— 
(i) involves a drug to treat a serious 
or life-threatening condition; and 
(ii) is completed between the date of 
the enactment of this Act and such date of 
establishment under paragraph (1) of this 
subsection. 
(B) OTHER TRIALS.—Except as provided 
in subparagraph (A), subsection (c) of such sec-
tion 492C shall take effect 180 days after the 
date that the results database is established 
under paragraph (1) of this subsection with re-
spect to any applicable clinical trial that is com-
pleted between the date of the enactment of this 
Act and such date of establishment under para-
graph (1). 
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234 
(5) TRIALS
COMPLETED
AFTER
ESTABLISH-
MENT OF RESULTS DATABASE.—Subsection (c) of 
such section 492C shall apply to any clinical trial 
that is completed after the date that the results 
database is established under paragraph (1) of this 
subsection. 
(6) RETROACTIVITY OF DATABASE.— 
(A) VOLUNTARY SUBMISSIONS.—The Sec-
retary of Health and Human Services (referred 
to in this paragraph as the ‘‘Secretary’’) shall 
establish procedures and mechanisms to allow 
for the voluntary submission to the Secretary— 
(i) of clinical trial information for in-
clusion in the registry database (as defined 
in such section 492C) on applicable clinical 
trials (as defined in such section 492C) 
initiated before the date of the enactment 
of this Act; and 
(ii) of clinical trial information for in-
clusion in the results database (as defined 
in such section 492C) on applicable clinical 
trials (as defined in such section 492C) 
completed before the date of the enactment 
of this Act. 
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