on the date on which information is 
due under clause (i); and 
‘‘(II) shall identify the dates on 
which the changes were made; and 
‘‘(III) shall include, not later 
than 30 days after any change in the 
regulatory status of the drug or device 
involved, an update informing the Di-
rector of NIH of such change. 
‘‘(E) TRUTHFUL CLINICAL TRIAL INFOR-
MATION.— 
‘‘(i) IN GENERAL.—The clinical trial 
information submitted by a responsible 
party under this paragraph shall not be 
false or misleading in any particular. 
‘‘(ii) EFFECT.—Clause (i) shall not 
have the effect of requiring clinical trial in-
formation with respect to a clinical trial to 
include information from any source other 
than such clinical trial. 
‘‘(F) 
PUBLIC
AVAILABILITY
OF
RE-
SULTS.— 
‘‘(i) PRE-APPROVAL
STUDIES.—Ex-
cept as provided in clause (v), with respect 
to an applicable clinical trial that is com-
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pleted before the drug is initially approved 
under section 505 of the Federal Food, 
Drug, and Cosmetic Act or initially li-
censed under section 351 of this Act, or 
the device is initially cleared under section 
510(k) or approved under section 515 of 
the Federal Food, Drug, and Cosmetic 
Act, the Director of NIH shall make pub-
licly available on the results database the 
clinical trial information submitted for 
such clinical trial not later than 30 days 
after— 
‘‘(I) the drug or device is ap-
proved under such section 505, li-
censed 
under 
such 
section 
351, 
cleared under such section 510(k), or 
approved under such section 515, as 
applicable; or 
‘‘(II) the Secretary issues a not 
approvable letter or a not substan-
tially equivalent letter for the drug or 
device under such section 505, 351, 
510(k), or 515, as applicable. 
‘‘(ii) MEDICAL AND CLINICAL PHAR-
MACOLOGY
REVIEWS
OF
PRE-APPROVAL 
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STUDIES.—Not later than 90 days after 
the date applicable under subclause (I) or 
(II) of clause (i) with respect to an appli-
cable clinical trial, the Director of NIH 
shall make publicly available on the results 
database a summary of the available med-
ical and clinical pharmacology reviews con-
ducted by the Food and Drug Administra-
tion for such trial. 
‘‘(iii) POST-APPROVAL STUDIES.—Ex-
cept as provided in clauses (iv) and (v), 
with respect to an applicable clinical trial 
that is completed after the drug is initially 
approved under such section 505 or li-
censed under such section 351, or the de-
vice is initially cleared under such section 
510(k) or approved under such section 
515, the Director of NIH shall make pub-
licly available on the results database the 
clinical trial information submitted for 
such clinical trial not later than 30 days 
after the date of such submission. 
‘‘(iv) SEEKING APPROVAL OF A NEW 
USE FOR THE DRUG OR DEVICE.— 
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‘‘(I) IN GENERAL.—If the manu-
facturer of the drug or device is the 
sponsor or a financial sponsor of an 
applicable clinical trial, and such man-
ufacturer certifies to the Director of 
NIH that such manufacturer has 
filed, or will file within 1 year, an ap-
plication seeking approval under such 
section 505, licensing under such sec-
tion 351, clearance under such section 
510(k), or approval under such sec-
tion 515 for the use studied in such 
clinical trial (which use is not included 
in the labeling of the approved drug 
or device), then the Director of NIH 
shall make publicly available on the 
results database the clinical trial in-
formation submitted for such clinical 
trial on the earlier of the date that is 
30 days after the date— 
‘‘(aa) the new use of the 
drug or device is approved under 
such section 505, licensed under 
such section 351, cleared under 
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such section 510(k), or approved 
under such section 515; 
‘‘(bb) the Secretary issues a 
not approvable letter or a not 
substantially equivalent letter for 
the new use of the drug or device 
under such section 505, 351, 
510(k), or 515; or 
‘‘(cc) the application or pre-
market notification under such 
section 505, 351, 510(k), or 515 
is withdrawn. 
‘‘(II) LIMITATION
ON
CERTIFI-
CATION.—If a manufacturer makes a 
certification under subclause (I) with 
respect to a clinical trial, the manu-
facturer shall make such a certifi-
cation with respect to each applicable 
clinical trial that is required to be 
submitted in an application for ap-
proval of the use studied in the clin-
ical trial. 
‘‘(III) 2-YEAR LIMITATION.—The 
clinical trial information subject to 
subclause (I) shall be made publicly 
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available on the results database on 
the date that is 2 years after the date 
the certification referred to in sub-
clause (I) was made to the Director of 
NIH, if a regulatory action referred to 
in item (aa), (bb), or (cc) of subclause 
(I) has not occurred by such date. 
‘‘(IV) MEDICAL
AND
CLINICAL 
PHARMACOLOGY REVIEWS.—Not later 
than 90 days after the date applicable 
under item (aa), (bb), or (cc) of sub-
clause (I) or subclause (III) with re-
spect to an applicable clinical trial, 
the Director of NIH shall make pub-
licly available on the results database 
a summary of the available medical 
and clinical pharmacology reviews 
conducted by the Food and Drug Ad-
ministration for such trial. 
‘‘(v) SEEKING PUBLICATION.— 
‘‘(I) IN GENERAL.—If the prin-
cipal investigator of an applicable clin-
ical trial is seeking publication in a 
peer-reviewed biomedical journal of a 
manuscript based on the results of the 
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clinical trial and the responsible party 
so certifies to the Director of NIH— 
‘‘(aa) the responsible party 
shall notify the Director of NIH 
of the publication date of such 
manuscript not later than 15 
days after such date; and 
‘‘(bb) 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 subclause 
(I)— 
‘‘(aa) shall be made publicly 
available on the results database 
on the date that is 2 years after 
the date that the clinical trial in-
formation was required to be 
submitted to the Director of NIH 
if the manuscript referred to in 
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such subclause has not been pub-
lished by such date; and 
‘‘(bb) shall not be required 
to be made publicly available 
under section 552 of title 5, 
United States Code (commonly 
known as the ‘Freedom of Infor-
mation Act’), prior to the date 
applicable to such clinical trial 
information under this clause. 
‘‘(G) VERIFICATION OF SUBMISSION PRIOR 
TO PUBLIC AVAILABILITY.—In the case of clin-
ical trial information that is submitted under 
this paragraph, but is not made publicly avail-
able pending either regulatory action or publica-
tion under clause (iv) or (v) of subparagraph 
(F), as applicable, the Director of NIH shall re-
spond to inquiries from other Federal agencies 
and peer-reviewed journals to confirm that such 
clinical trial information has been submitted 
but has not yet been made publicly available on 
the results database. 
‘‘(4) UPDATES; TRACKING OF CHANGES IN SUB-
MITTED INFORMATION.—The Director of NIH shall 
ensure that updates submitted to the Director under 
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paragraphs (2)(G) and (3)(D) do not result in the 
removal from the registry database or the results 
database of the original submissions or of any pre-
ceding updates, and that information in such data-
bases is presented in a manner that enables users to 
readily access each original submission and to track 
the changes made by the updates. 
‘‘(5) COORDINATION AND COMPLIANCE.— 
‘‘(A) CLINICAL
TRIALS
SUPPORTED
BY 
GRANTS FROM FEDERAL AGENCIES.— 
‘‘(i) IN GENERAL.—No Federal agen-
cy may release funds under a research 
grant to a person who has not complied 
with paragraphs (2) and (3) for any appli-
cable clinical trial for which such person is 
the responsible party. 
‘‘(ii) GRANTS
FROM
CERTAIN
FED-
ERAL AGENCIES.—If an applicable clinical 
trial is funded in whole or in part by a 
grant from the National Institutes of 
Health, the Agency for Healthcare Re-
search and Quality, or the Department of 
Veterans Affairs, any grant or progress re-
port forms required under such grant shall 
include a certification that the responsible 
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party has made all required submissions to 
the Director of NIH under paragraphs (2) 
and (3). 
‘‘(iii) VERIFICATION
BY
FEDERAL 
AGENCIES.—The heads of the agencies re-
ferred to in clause (ii), as applicable, shall 
verify that the clinical trial information for 
each applicable clinical trial for which a 
grantee is the responsible party has been 
submitted under paragraph (2) and (3), as 
applicable, before releasing funding for a 
grant to such grantee. 
‘‘(iv) NOTICE AND OPPORTUNITY TO 
REMEDY.—If the head of an agency re-
ferred to in clause (ii), as applicable, 
verifies that a grantee has not submitted 
clinical trial information as described in 
clause (iii), such agency head shall provide 
notice to such grantee of such noncompli-
ance and allow such grantee 30 days to 
correct such noncompliance and submit the 
required clinical trial information. 
‘‘(v) CONSULTATION
WITH
OTHER 
FEDERAL
AGENCIES.—The 
Secretary 
shall— 
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‘‘(I) consult with other agencies 
that conduct human studies in accord-
ance 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 
‘‘(II) develop with such agencies 
procedures comparable to those de-
scribed in clauses (ii), (iii), and (iv) to 
ensure that clinical trial information 
for such applicable clinical trials is 
submitted under paragraphs (2) and 
(3). 
‘‘(B) COORDINATION OF REGISTRY DATA-
BASE AND RESULTS DATABASE.— 
‘‘(i) IN GENERAL.—Each entry in the 
registry database under paragraph (2) or 
the results database under paragraph (3) 
shall include a link to the corresponding 
entry in the results database or the reg-
istry database, respectively. 
‘‘(ii) MISSING ENTRIES.— 
‘‘(I) IN GENERAL.—If, based on 
a review of the entries in the registry 
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database under paragraph (2), the Di-
rector of NIH determines that a re-
sponsible party has failed to submit 
required clinical trial information to 
the results database under paragraph 
(3), the Director of NIH shall inform 
the responsible party involved of such 
failure and permit the responsible 
party to correct the failure within 30 
days. 
‘‘(II) FAILURE TO CORRECT.—If 
the responsible party does not correct 
a failure to submit required clinical 
trial information within the 30-day 
period described under subclause (I), 
the Director of NIH shall report such 
noncompliance to the scientific peer 
review committees of the Federal re-
search agencies and to the Office of 
Human Research Protections. 
‘‘(III) PUBLIC NOTICE OF FAIL-
URE TO CORRECT.—The Director of 
NIH shall include in the clinical trial 
registry database entry and the clin-
ical trial results database entry for 
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each applicable clinical trial a notice 
of any uncorrected failure to submit 
required clinical trial information and 
shall provide that the public may eas-
ily search for such entries. 
‘‘(C) ACTION ON APPLICATIONS.— 
‘‘(i) VERIFICATION
PRIOR
TO
FIL-
ING.—The Secretary, acting through the 
Commissioner of Food and Drugs, shall 
verify that the clinical trial information re-
quired under paragraphs (2) and (3) for 
an applicable clinical trial is submitted 
pursuant to such paragraphs, as applica-
ble— 
‘‘(I) when considering a drug or 
device for an exemption under section 
505(i) or section 520(g) of the Fed-
eral Food, Drug, and Cosmetic Act; 
and 
‘‘(II) prior to filing an applica-
tion or premarket notification under 
section 505, 510(k), or 515 of the 
Federal Food, Drug, and Cosmetic 
Act or section 351 of this Act, that 
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100 
includes information from such clin-
ical trial. 
‘‘(ii) NOTIFICATION.—If the Secretary 
determines under clause (i) that clinical 
trial information has not been submitted 
as required by paragraph (2) or (3), the 
Secretary shall notify the applicant and the 
responsible party of such noncompliance 
and require submission of such information 
within 30 days. 
‘‘(iii) REFUSAL TO FILE.—If the re-
sponsible party does not remedy such non-
compliance within 30 days of receipt of no-
tification under clause (ii), the Secretary 
shall refuse to file, approve, or clear such 
application or premarket notification. 
‘‘(D) CONTENT REVIEW.— 
‘‘(i) IN
GENERAL.—To ensure that 
the summary documents described in para-
graph (3)(C) are non-promotional, and are 
not false or misleading in any particular 
under paragraph (3)(E), the Secretary 
shall compare such documents to the re-
sults data of the clinical trial for a rep-
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101 
resentative sample of applicable clinical 
trials by— 
‘‘(I) acting through the Commis-
sioner of Food and Drugs to examine 
the results data for such clinical trials 
submitted to Secretary when such 
data are submitted— 
‘‘(aa) for review as part of 
an application under section 505 
or 515 of the Federal Food, 
Drug, and Cosmetic Act or under 
section 351 of this Act or a pre-
market notification under section 
510(k) of the Federal Food, 
Drug, and Cosmetic Act; or 
‘‘(bb) in an annual status 
report on the drug or device 
under such application; 
‘‘(II) acting with the Federal 
agency that funds such clinical trial in 
whole or in part by a grant to exam-
ine the results data for such clinical 
trials; and 
‘‘(III) acting through inspections 
under section 704 of the Federal 
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102 
Food, Drug, and Cosmetic Act to ex-
amine results data for such clinical 
trials not described in subclause (I) or 
(II). 
‘‘(ii) NOTICE OF NONCOMPLIANCE.— 
If the Secretary determines that the clin-
ical trial information submitted in such a 
summary document is promotional, or false 
or misleading in any particular, the Sec-
retary shall notify the responsible party 
and give such party an opportunity to rem-
edy such noncompliance by submitting the 
required revised clinical trial information 
within 30 days of such notification. 
‘‘(6) PENALTIES FOR NONCOMPLIANCE.— 
‘‘(A) IN
GENERAL.—The following acts 
and the causing thereof are deemed to be pro-
hibited by section 301 of the Federal Food, 
Drug, and Cosmetic Act: 
‘‘(i) The failure to submit clinical trial 
information as required by this section. 
‘‘(ii) The submission of clinical trial 
information under this section that is pro-
motional or false or misleading in any par-
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103 
ticular in violation of paragraph (2)(E) or 
(3)(E). 
‘‘(B) CONSIDERATIONS.—In determining 
whether to apply a penalty under the Federal 
Food, Drug, and Cosmetic Act or under sub-
paragraph (C) of this paragraph for a violation 
described in subparagraph (A), the Secretary, 
acting through the Commissioner of Food and 
Drugs, shall consider— 
‘‘(i) whether the responsible party 
promptly corrects the noncompliance when 
provided notice; 
‘‘(ii) whether the responsible party 
has engaged in a pattern or practice of 
noncompliance; and 
‘‘(iii) the extent to which the non-
compliance involved may have significantly 
misled health care providers or patients 
concerning the safety or effectiveness of 
the drug involved. 
‘‘(C) CIVIL PENALTIES.— 
‘‘(i) IN GENERAL.—A person is sub-
ject to a civil penalty in accordance with 
this subparagraph if the person commits a 
violation described in subparagraph (A) 
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104 
and fails to correct the violation by the end 
of the 30-day period described in clause 
(ii). 
‘‘(ii) NOTIFICATION.—If a person is 
in violation of subparagraph (A), the Sec-
retary shall notify the person of such non-
compliance and give the person a 30-day 
period to correct such violation before im-
posing a civil penalty under this subpara-
graph. 
‘‘(iii) AMOUNT
OF
PENALTY.—The 
amount of a civil penalty under this para-
graph shall be not more than a total of 
$15,000 for all violations adjudicated in a 
single proceeding in the case of an indi-
vidual, and not more than $10,000 per day 
until the violation is corrected in the case 
of any other person, except that if the per-
son is a nonprofit entity the penalty may 
not exceed a total of $15,000 for all viola-
tions adjudicated in a single proceeding. 
‘‘(iv) PROCEDURES.—The provisions 
of paragraphs (4) through (6) of section 
303(f) of the Federal Food, Drug, and 
Cosmetic Act apply to the imposition of a 
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105 
penalty under this paragraph to the same 
extent and in the same manner as such 
provisions apply to a penalty imposed 
under such section 303(f). 
‘‘(7) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this subsection $10,000,000 for each fiscal year.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) INVESTIGATIONAL
NEW
DRUGS.—Section 
505(i) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(i)) is amended— 
(A) in paragraph (1)— 
(i) in subparagraph (C), by striking 
‘‘and’’ after the semicolon; 
(ii) in subparagraph (D)— 
(I) by aligning the indentation of 
such subparagraph with the indenta-
tion of subparagraphs (A), (B), and 
(C); and 
(II) by striking the period at the 
end and inserting ‘‘; and’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(E) the submission to the Director of NIH of 
clinical trial information for the clinical investigation 
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106 
at issue required under section 402(i) of the Public 
Health Service Act for inclusion in the registry data-
base and the results database described in such sec-
tion.’’; 
(B) in paragraph (3)(B)— 
(i) in clause (i), by striking ‘‘or’’ after 
the semicolon; 
(ii) in clause (ii), by striking the pe-
riod at the end and inserting ‘‘; or’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(iii) clinical trial information for the clinical 
investigation at issue was not submitted in compli-
ance with section 402(i) of the Public Health Service 
Act.’’; and 
(C) in paragraph (4), by adding at the end 
the following: ‘‘The Secretary shall update such 
regulations to require inclusion in the informed 
consent form a statement that clinical trial in-
formation for such clinical investigation will be 
submitted for inclusion in the registry database 
and results database, as applicable, described in 
section 402(i) of the Public Health Service 
Act.’’. 
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107 
(2) REFUSAL TO APPROVE NEW DRUG APPLICA-
TION.—Section 505(d) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(d)) is amended— 
(A) in the first sentence, by inserting after 
‘‘or any particular;’’ the following: ‘‘or (8) the 
applicant failed to submit the clinical trial in-
formation for any applicable clinical trial as re-
quired by section 402(i) of the Public Health 
Service Act;’’; and 
(B) in the second sentence, by striking 
‘‘clauses (1) through (6)’’ and inserting ‘‘para-
graphs (1) through (8)’’. 
(3) INVESTIGATIONAL
NEW
DEVICES.—Sub-
paragraph (B) of section 520(g)(2) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
360j(g)(2)) is amended— 
(A) by redesignating clause (iii) as clause 
(iv); and 
(B) by inserting after clause (ii) the fol-
lowing: 
‘‘(iii) A requirement that the person 
applying for an exemption for a device as-
sure that such person is in compliance with 
the requirements of section 402(i) of the 
Public Health Service Act for the submis-
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108 
sion of clinical trial information for inclu-
sion in the registry database and the re-
sults database described in such section.’’. 
(4) REFUSAL
TO
CLEAR
NEW
DEVICE
PRE-
MARKET NOTIFICATION REPORT.—Subsection (k) of 
section 510 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360) is amended— 
(A) in paragraph (1), by striking ‘‘and’’ at 
the end; and 
(B) in paragraph (2), by striking the pe-
riod at the end and inserting ‘‘, and’’; and 
(C) by adding at the end the following: 
‘‘(3) action taken by such person to comply 
with requirements under section 402(i) of the Public 
Health Service Act for the submission of clinical 
trial information for inclusion in the registry data-
base and the results database described in such sec-
tion.’’. 
(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; 
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109 
(B) in subparagraph (E), by striking the 
period at the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(F) the applicant is in violation of the re-
quirements under section 402(i) of the Public 
Health Service Act for the submission of clin-
ical trial information for inclusion in the reg-
istry database or the results database described 
in such section.’’. 
(c) GUIDANCE.—Not later than 180 days after the 
date of enactment of this Act, the Commissioner of Food 
and Drugs, in consultation with the Director of the Na-
tional Institutes of Health, shall issue guidance to clarify 
which clinical trials are applicable clinical trials (as de-
fined in section 402(i)(2) 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.— 
(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 for the inclusion of information relating to the re-
sults of clinical trials in a database. 
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110 
(2) RULE OF CONSTRUCTION.—The fact of sub-
mission of clinical trial information, if submitted in 
compliance with section 402(i) 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 paragraphs (2) and (3) of such sec-
tion 402(i), if submitted in compliance with such 
section 402(i), shall not be considered as labeling, 
adulteration, 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.— 
(1) ESTABLISHMENT OF REGISTRY DATABASE 
AND RESULTS DATABASE.—Not later than 1 year 
after the date of enactment of this Act, the Director 
of NIH shall establish the registry database and the 
results database of clinical trials of drugs and de-
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111 
vices in accordance with section 402(i) of the Public 
Health Service Act (as amended by subsection (a)). 
(2) CLINICAL TRIALS INITIATED PRIOR TO OP-
ERATION OF REGISTRY DATABASE.—The responsible 
party (as defined in such section 402(i)) for an ap-
plicable clinical trial (as defined in such section 
402(i)) that is initiated after the date of enactment 
of this Act and before the date such registry data-
base 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 402(i)) for an ap-
plicable clinical trial (as defined in such section 
402(i)) that is initiated after the date such registry 
database is established under paragraph (1) of this 
subsection shall submit required clinical trial infor-
mation in accordance with paragraph (2) of such 
section 402(i). 
(4) TRIALS
COMPLETED
BEFORE
OPERATION 
OF RESULTS DATABASE.— 
(A) IN GENERAL.—Paragraph (3) of such 
section 402(i) shall take effect 90 days after 
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112 
the date the results database is established 
under paragraph (1) of this subsection with re-
spect to any applicable clinical trial (as defined 
in such section 402(i)) that— 
(i) involves a drug to treat a serious 
or life-threatening condition; and 
(ii) is completed between the date of 
enactment of this Act and such date of es-
tablishment under paragraph (1) of this 
subsection. 
(B) OTHER TRIALS.—Except as provided 
in subparagraph (A), paragraph (3) of such 
section 402(i) 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 enactment of this 
Act and such date of establishment under para-
graph (1). 
(5) TRIALS
COMPLETED
AFTER
ESTABLISH-
MENT OF RESULTS DATABASE.—Paragraph (3) of 
such section 402(i) shall apply to any clinical trial 
that is completed after the date that the results 
database is established under paragraph (1) of this 
subsection. 
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113 
(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 402(i)) on applicable clin-
ical trials (as defined in such section 
402(i)) initiated before the date of the en-
actment of this Act; and 
(ii) of clinical trial information for in-
clusion in the results database (as defined 
in such section 402(i)) on applicable clin-
ical trials (as defined in such section 
402(i)) completed before the date of the 
enactment of this Act. 
(B) REQUIRED
SUBMISSIONS.—Notwith-
standing the preceding paragraphs of this sub-
section, in any case in which the Secretary de-
termines that submission of clinical trial infor-
mation for an applicable clinical trial (as de-
fined in such section 402(i)) described in clause 
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114 
(i) or (ii) of subparagraph (A) is in the interest 
of the public health— 
(i) the Secretary may require that 
such information be submitted to the Sec-
retary in accordance with such section 
402(i); and 
(ii) failure to comply with such a re-
quirement shall be treated as a violation of 
the corresponding requirement of such sec-
tion 402(i). 
(7) FUNDING
RESTRICTIONS.—Subparagraph 
(A) of paragraph (5) of such section 402(i) shall 
take effect 210 days after the date that the clinical 
trial registry database and the clinical trial results 
database are established under paragraph (1) of this 
subsection. 
(8) 
STATUS
OF
CLINICALTRIALS.GOV 
WEBSITE.— 
(A) IN GENERAL.—After receiving public 
comment and not later than 90 days after the 
date of enactment of this Act, the Secretary 
shall publish in the Federal Register a notice 
determining the more efficient approach to es-
tablishing the registry database described in 
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115 
paragraph (2) of such section 402(i) and 
whether such approach is— 
(i) that such registry database should 
expand and build upon the database de-
scribed in section 402(i) of the Public 
Health Service Act (as in effect on the day 
before the date of enactment of this Act); 
or 
(ii) that such registry database should 
supplant the database described in such 
section 402(i) (as in effect on the day be-
fore the date of enactment of this Act). 
(B) CLINICALTRIALS.GOV SUPPLANTED.— 
If the Secretary determines to apply the ap-
proach described under subparagraph (A)(ii), 
the Secretary shall maintain an archive of the 
database described in such section 402(i) (as in 
effect on the day before the date of enactment 
of this Act) on the Internet website of the Na-
tional Library of Medicine. 
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116 
TITLE IV—CONFLICTS OF 
INTEREST 
SEC. 401. CONFLICTS OF INTEREST. 
(a) IN GENERAL.—Subchapter A of chapter VII of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 
et seq.) is amended by inserting at the end the following: 
‘‘SEC. 712. CONFLICTS OF INTEREST. 
‘‘(a) DEFINITIONS.—For purposes of this section: 
‘‘(1) ADVISORY COMMITTEE.—The term ‘advi-
sory committee’ means an advisory committee under 
the Federal Advisory Committee Act that provides 
advice or recommendations to the Secretary regard-
ing activities of the Food and Drug Administration. 
‘‘(2) FINANCIAL INTEREST.—The term ‘finan-
cial interest’ means a financial interest under section 
208(a) of title 18, United States Code. 
‘‘(3) INDUSTRY
FINANCIAL
INTEREST.—The 
term ‘industry financial interest’, with respect to ap-
pointment for a term to an advisory committee, 
means an interest in a company that is a member 
of the relevant industry that would be a financial in-
terest were an advisory committee to consider a par-
ticular matter involving such company. 
‘‘(4) RELEVANT
INDUSTRY.—The term ‘rel-
evant industry’ means— 
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117 
‘‘(A) with respect to an advisory committee 
that advises the Secretary on human drugs, bio-
logics, or devices, the pharmaceutical, bio-
technology, and device industries; 
‘‘(B) with respect to an advisory committee 
that advises the Secretary on animal drugs or 
devices, the animal drug and the animal device 
industries; and 
‘‘(C) with respect to an advisory committee 
that advises the Secretary on foods, the food in-
dustry. 
‘‘(b) APPOINTMENTS TO ADVISORY COMMITTEES.— 
‘‘(1) DISCLOSURE OF INDUSTRY FINANCIAL IN-
TERESTS.—Each individual under consideration for 
a term appointment to an advisory committee shall 
disclose to the Secretary all industry financial inter-
ests. 
‘‘(2) DISCLOSURES
NOT
PUBLICLY
AVAIL-
ABLE.—No disclosure required under paragraph (1) 
shall be made available to the public. 
‘‘(3) EVALUATION AND CRITERIA.—When con-
sidering a term appointment to an advisory com-
mittee, the Secretary— 
‘‘(A) shall review the expertise and the in-
dustry financial interests, as disclosed under 
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118 
paragraph (1), of each individual under consid-
eration for the appointment, so as to appoint 
the individuals, from among those individuals 
under consideration for appointment, who are 
the most qualified relative to their industry fi-
nancial interests that could require a written 
determination 
as 
referred 
to 
in 
section 
208(b)(1) of title 18, United States Code, a 
written certification as referred to in section 
208(b)(3) of title 18, United States Code, or a 
waiver as referred to in subsection (c)(3) for 
service on the committee at a meeting of the 
committee; and 
‘‘(B) may appoint 2 or more qualified indi-
viduals with similar expertise and whose indus-
try financial interests are nonoverlapping or 
minimally overlapping, so as to minimize the 
likelihood that an advisory committee will need 
the expertise of an appointed individual who re-
quires a written determination as referred to in 
section 208(b)(1) of title 18, United States 
Code, a written certification as referred to in 
section 208(b)(3) of title 18, United States 
Code, or a waiver as referred to in subsection 
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119 
(c)(3) for service on the committee at a meeting 
of the committee. 
‘‘(c) GRANTING AND DISCLOSURE OF WAIVERS.— 
‘‘(1) IN GENERAL.—Not later then 45 days be-
fore a meeting of an advisory committee, each mem-
ber of the committee shall disclose to the Secretary 
all financial interests in accordance with section 
208(b) of title 18, United States Code. 
‘‘(2) FINANCIAL GAIN OF ADVISORY COMMITTEE 
MEMBER OR FAMILY MEMBER.—No member of an 
advisory committee may vote with respect to any 
matter considered by the advisory committee if such 
member or an immediate family member of such 
member could gain financially from the advice given 
to the Secretary with respect to such matter. 
‘‘(3) WAIVER.—In addition to considerations 
under section 208(b) of title 18, United States Code, 
the Secretary may grant a waiver of a conflict of in-
terest requirement if such waiver is necessary to af-
ford the advisory committee essential expertise. 
‘‘(4) LIMITATION.—In no case may the Sec-
retary grant a waiver under paragraph (3) for a 
member of an advisory committee if the scientific 
work of such member is under consideration by the 
committee. 
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120 
‘‘(5) DISCLOSURE OF WAIVER.— 
‘‘(A) MORE THAN 15 DAYS IN ADVANCE.— 
As soon as practicable, but in no case later 
than 15 days prior to a meeting of an advisory 
committee to which a written determination as 
referred to in section 208(b)(1) of title 18, 
United States Code, a written certification as 
referred to in section 208(b)(3) of title 18, 
United States Code, or a waiver as referred to 
in paragraph (3) applies, the Secretary shall 
disclose (other than information exempted from 
disclosure under section 552 of title 5, United 
States Code, and section 552a of title 5, United 
States Code (popularly known as the Freedom 
of Information Act and the Privacy Act of 
1974, respectively)) on the Internet website of 
the Food and Drug Administration— 
‘‘(i) the financial interests of the advi-
sory committee member to which such de-
termination, certification, or waiver ap-
plies; and 
‘‘(ii) the reasons of the Secretary for 
such determination, certification, or waiv-
er. 
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121 
‘‘(B) LESS THAN 15 DAYS IN ADVANCE.— 
In the case of a financial interest that becomes 
known to the Secretary less than 30 days prior 
to a meeting of an advisory committee to which 
a written determination as referred to in section 
208(b)(1) of title 18, United States Code, a 
written certification as referred to in section 
208(b)(3) of title 18, United States Code, or a 
waiver as referred to in paragraph (3) applies, 
the Secretary shall disclose (other than infor-
mation exempted from disclosure under section 
552 of title 5, United States Code, and section 
552a of title 5, United States Code) on the 
Internet website of the Food and Drug Admin-
istration, the information described in clauses 
(i) and (ii) of subparagraph (A) as soon as the 
Secretary makes such determination, certifi-
cation, or waiver, but in no event later than the 
date of such meeting. 
‘‘(d) PUBLIC RECORD.—The Secretary shall ensure 
that the public record and transcript of each meeting of 
an advisory committee includes the disclosure required 
under subsection (c)(5) (other than information exempted 
from disclosure under section 552 of title 5, United States 
Code, and section 552a of title 5, United States Code). 
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122 
‘‘(e) ANNUAL REPORT.—Not later than January 15 
of each year, the Secretary shall submit a report to the 
Inspector General of the Department of Health and 
Human Services, the Committee on Appropriations and 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate, and the Committee on Appropriations 
and the Committee on Energy and Commerce of the 
House of Representatives— 
‘‘(1) with respect to the fiscal year that ended 
on September 30 of the previous year, the number 
of vacancies on each advisory committee, the number 
of nominees received for each committee, and the 
number of such nominees willing to serve; 
‘‘(2) with respect to such year, the aggregate 
number of disclosures required under subsection 
(c)(5) for each meeting of each advisory committee 
and the percentage of individuals to whom such dis-
closures did not apply who served on such committee 
for each such meeting; 
‘‘(3) with respect to such year, the number of 
times the disclosures required under subsection 
(c)(5) occurred under subparagraph (B) of such sub-
section; and 
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123 
‘‘(4) how the Secretary plans to reduce the 
number of vacancies reported under paragraph (1) 
during the fiscal year following such year.’’. 
(b) GUIDANCE.— 
(1) NOMINATIONS.—Not later than 270 days 
after the date of enactment of this Act, and after 
seeking input from professional medical and sci-
entific societies, the Secretary shall publish in the 
Federal Register for public comment a proposed 
mechanism for encouraging the nomination of indi-
viduals who are classified by the Food and Drug Ad-
ministration as academicians or practitioners for 
service on an advisory committee. 
(2) WAIVER DETERMINATIONS.—Not later than 
270 days after the date of enactment of this Act the 
Secretary shall issue or revise guidance— 
(A) that clarifies the circumstances in 
which the Secretary may make a written deter-
mination as referred to in section 208(b)(1) of 
title 18, United States Code, make a written 
certification as referred to in section 208(b)(3) 
of title 18, United States Code, or grant a waiv-
er as referred to section 712(c)(3) of the Fed-
eral Food, Drug, and Cosmetic Act (as added 
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124 
by this section), including those circumstances 
that— 
(i) favor the inclusion of an individual 
on an advisory committee; 
(ii) favor making such a determina-
tion, certification, or waiver for an indi-
vidual on an advisory committee; 
(iii) favor limitations on an individ-
ual’s ability to act when making such a de-
termination, certification, or waiver for the 
individual on an advisory committee; and 
(iv) disfavor the inclusion of an indi-
vidual on an advisory committee; 
(B) that defines how financial interests im-
puted to an individual bear upon his or her eli-
gibility for service on an advisory committee or 
for service at a meeting of an advisory com-
mittee; and 
(C) to ensure consistency within and 
among the centers of the Food and Drug Ad-
ministration in applying section 208(b) of title 
18, United States Code, and such section 
712(c)(3). 
(3) PERIODIC REVIEW.—At least once every 5 
years, the Secretary shall review the guidance de-
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125 
scribed under paragraph (2) and update such guid-
ance as necessary. 
(c) REVIEW BY INSPECTOR GENERAL.— 
(1) IN
GENERAL.—The Inspector General of 
the Department of Health and Human Services shall 
conduct a review, which may include surveys of past 
or current members of advisory committees, of the 
processes of the Food and Drug Administration 
for— 
(A) evaluating the financial interests of a 
member of such an advisory committee while 
the member serves on such a committee and 
after the member has served on such a com-
mittee; and 
(B) assuring the completeness and accu-
racy of information contained in the disclosures 
described in subsections (b)(1) and (c)(1) of 
such section 712 of the Federal Food, Drug, 
and Cosmetic Act (as added by this section). 
(2) SUBMISSION OF REPORT.—Not later than 
18 months after the effective date of this section, 
the Inspector General of the Department of Health 
and Human Services shall submit to Congress a re-
port based on the review required under paragraph 
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126 
(1), and include any recommendations for the im-
provement of such processes. 
(d) DEFINITIONS.—For purposes of this section, the 
terms ‘‘advisory committee’’ and ‘‘financial interest’’ have 
the meaning given such terms in section 712 of the Fed-
eral Food, Drug, and Cosmetic Act (as added by this sec-
tion). 
(e) CONFORMING AMENDMENT.—Section 505(n) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(n)) is amended by— 
(1) striking paragraph (4); and 
(2) redesignating paragraphs (5), (6), (7), and 
(8) as paragraphs (4), (5), (6), and (7), respectively. 
(f) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on October 1, 2007. 
Æ 
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