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stricts in any manner the ability of the in-
dividual— 
‘‘(I) to discuss the results of the 
trial at a scientific meeting or any 
other public or private forum; or 
‘‘(II) to publish the results of the 
trial, or a description or discussion of 
the results of the trial, in a scientific 
or academic journal. 
‘‘(vi) The completion date of the clin-
ical trial. 
‘‘(vii) A link to the Internet web post-
ing of any adverse regulatory actions taken 
by the Food and Drug Administration, 
such as a warning letter, that was sub-
stantively based on the clinical trial design, 
outcome, or representation made by the 
applicant about the design or outcome of 
the clinical trial. 
‘‘(C) LINKS IN DATABASE.—The Director 
of NIH shall ensure that the results database 
includes the following: 
‘‘(i) Links to Medline citations to pub-
lications reporting results from each appli-
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cable drug clinical trial and applicable de-
vice clinical trial. 
‘‘(ii) Links to the entry for the prod-
uct that is the subject of an applicable 
drug clinical trial in the National Library 
of Medicine database of structured product 
labels, if available. 
‘‘(iii) Links described in clauses (i) 
and (ii) for data bank entries for clinical 
trials submitted to the data bank prior to 
enactment of this section, as available. 
‘‘(4) TIMING.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraphs (B) and (C), a responsible party 
shall submit to the Director of NIH for inclu-
sion in the results database clinical trial infor-
mation for an applicable clinical trial not later 
than 1 year after the earlier of— 
‘‘(i) the estimated completion date of 
the trial, as submitted under subsection 
(b)(2); or 
‘‘(ii) the actual date of the completion, 
or termination before completion, of the 
trial, as applicable. 
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‘‘(B) EXTENSIONS.—The Director of NIH 
may provide an extension of the deadline for 
submission of clinical trial information under 
subparagraph (A) if the responsible party for 
the trial submits to the Director a written re-
quest that demonstrates good cause for the ex-
tension and provides an estimate of the date on 
which the information will be submitted. The 
Director of NIH may grant more than one such 
extension for the clinical trial involved. 
‘‘(C) UPDATES.—The responsible party for 
an applicable clinical trial shall submit to the 
Director of NIH for inclusion in the results 
database periodic updates to reflect changes in 
the clinical trial information submitted under 
this subsection. Such updates— 
‘‘(i) shall be provided not less fre-
quently than once every 6 months during 
the 10-year period beginning on the date 
on which information is due under sub-
paragraph (A); 
‘‘(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 
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status of the drug or device involved, an 
update informing the Director of NIH of 
such change. 
‘‘(5) TRUTHFUL
CLINICAL
TRIAL
INFORMA-
TION.— 
‘‘(A) IN GENERAL.—The clinical trial in-
formation submitted by a responsible party 
under this subsection shall not be false or mis-
leading in any particular. 
‘‘(B) EFFECT.—Subparagraph (A) shall 
not have the effect of requiring clinical trial in-
formation with respect to a clinical trial to in-
clude information from any source other than 
such clinical trial. 
‘‘(6) PUBLIC AVAILABILITY OF RESULTS.— 
‘‘(A) PRE-APPROVAL STUDIES.—Except as 
provided in subparagraph (E), with respect to 
an applicable clinical trial that is completed be-
fore the drug is initially approved under section 
505 of the Federal Food, Drug, and Cosmetic 
Act or initially licensed 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 publicly available 
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on the results database the clinical trial infor-
mation submitted for such clinical trial not 
later than 30 days after— 
‘‘(i) the drug or device is approved 
under such section 505, licensed under 
such section 351, cleared under such sec-
tion 510(k), or approved under such sec-
tion 515, as applicable; or 
‘‘(ii) the Secretary issues a not ap-
provable letter or a not substantially equiv-
alent letter for the drug or device under 
such section 505, 351, 510(k), or 515, as 
applicable. 
‘‘(B) MEDICAL
AND
CLINICAL
PHARMA-
COLOGY
REVIEWS
OF
PRE-APPROVAL
STUD-
IES.—Not later than 90 days after the date ap-
plicable under clause (i) or (ii) of subparagraph 
(A) with respect to an applicable clinical trial, 
the Director of NIH shall make publicly avail-
able on the results database a summary of the 
available medical and clinical pharmacology re-
views conducted by the Food and Drug Admin-
istration for such trial. 
‘‘(C) POST-APPROVAL
STUDIES.—Except 
as provided in subparagraphs (D) and (E), with 
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respect to an applicable clinical trial that is 
completed after the drug is initially approved 
under such section 505 or licensed under such 
section 351, or the device is initially cleared 
under such section 510(k) or approved under 
such section 515, the Director of NIH shall 
make publicly 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. 
‘‘(D) SEEKING APPROVAL OF A NEW USE 
FOR THE DRUG OR DEVICE.— 
‘‘(i) IN
GENERAL.—If the manufac-
turer of the drug or device is the sponsor 
or a financial sponsor of an applicable clin-
ical trial, and such manufacturer certifies 
to the Director of NIH that such manufac-
turer has filed, or will file within 1 year, 
an application seeking approval under such 
section 505, licensing under such section 
351, clearance under such section 510(k), 
or approval under such section 515 for the 
use studied in such clinical trial (which use 
is not included in the labeling of the ap-
proved drug or device), then the Director 
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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 
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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 
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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 
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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 
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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.— 
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‘‘(i) IN GENERAL.—If, based on a re-
view of the entries in the registry database 
under subsection (b), the Director of NIH 
determines that a responsible party has 
failed to submit required clinical trial in-
formation to the results database under 
subsection (c), 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 informa-
tion within the 30-day period described 
under clause (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 FAILURE TO 
CORRECT.—The Director of NIH shall in-
clude in the clinical trial registry database 
entry and the clinical trial results database 
entry for each applicable clinical trial a no-
tice of any uncorrected failure to submit 
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required clinical trial information and shall 
provide that the public may easily search 
for such entries. 
‘‘(3) ACTION ON APPLICATIONS.— 
‘‘(A) VERIFICATION
PRIOR
TO
FILING.— 
The Secretary, acting through the Commis-
sioner of Food and Drugs, shall verify that the 
clinical trial information required under sub-
sections (b) and (c) for an applicable clinical 
trial is submitted pursuant to such subsections, 
as applicable— 
‘‘(i) when considering a drug or device 
for an exemption under section 505(i) or 
section 520(g) of the Federal Food, Drug, 
and Cosmetic Act; and 
‘‘(ii) prior to filing an application 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 includes information from such 
clinical trial. 
‘‘(B) NOTIFICATION.—If the Secretary de-
termines under subparagraph (A) that clinical 
trial information has not been submitted as re-
quired by subsection (b) or (c), the Secretary 
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shall notify the applicant and the responsible 
party of such noncompliance and require sub-
mission of such information within 30 days. 
‘‘(C) REFUSAL TO FILE.—If the respon-
sible party does not remedy such noncompliance 
within 30 days of receipt of notification under 
subparagraph (B), the Secretary shall refuse to 
file, approve, or clear such application or pre-
market notification. 
‘‘(4) CONTENT REVIEW.— 
‘‘(A) IN
GENERAL.—To ensure that the 
summary documents described in subsection 
(c)(3) are non-promotional, and are not false or 
misleading in any particular under subsection 
(c)(5), the Secretary shall compare such docu-
ments to the results data of the clinical trial for 
a representative sample of applicable clinical 
trials by— 
‘‘(i) acting through the Commissioner 
of Food and Drugs to examine the results 
data for such clinical trials submitted to 
Secretary when such data are submitted— 
‘‘(I) for review as part of an ap-
plication under section 505 or 515 of 
the Federal Food, Drug, and Cos-
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metic Act or under section 351 of this 
Act or a premarket notification under 
section 510(k) of the Federal Food, 
Drug, and Cosmetic Act; or 
‘‘(II) in an annual status report 
on the drug or device under such ap-
plication; 
‘‘(ii) acting with the Federal agency 
that funds such clinical trial in whole or in 
part by a grant to examine the results data 
for such clinical trials; and 
‘‘(iii) acting through inspections under 
section 704 of the Federal Food, Drug, 
and Cosmetic Act to examine results data 
for such clinical trials not described in 
clause (i) or (ii). 
‘‘(B) NOTICE OF NONCOMPLIANCE.—If the 
Secretary determines that the clinical trial in-
formation submitted in such a summary docu-
ment is false or misleading in any particular, 
the Secretary shall notify the responsible party 
and give such party an opportunity to remedy 
such noncompliance by submitting the required 
revised clinical trial information within 30 days 
of such notification. 
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‘‘(f) PENALTIES FOR NONCOMPLIANCE.— 
‘‘(1) IN GENERAL.—The following acts and the 
causing thereof are unlawful: 
‘‘(A) The failure to submit clinical trial in-
formation as required by this section. 
‘‘(B) The submission of clinical trial infor-
mation under this section that is false or mis-
leading in any particular in violation of sub-
section (b)(5) or (c)(5). 
‘‘(2) CERTAIN PENALTIES.—Section 303(a) of 
the Federal Food, Drug, and Cosmetic Act applies 
with respect to a violation of paragraph (1) to the 
same extent and in the same manner as such section 
303(a) applies with respect to a violation of section 
301 of such Act. 
‘‘(3) CONSIDERATIONS.—In determining wheth-
er to apply a penalty under paragraph (2) or under 
paragraph (4) for a violation described in paragraph 
(1), the Secretary, acting through the Commissioner 
of Food and Drugs, shall consider— 
‘‘(A) 
whether 
the 
responsible 
party 
promptly corrects the noncompliance when pro-
vided notice; 
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‘‘(B) whether the responsible party has en-
gaged in a pattern or practice of noncompli-
ance; and 
‘‘(C) the extent to which the noncompli-
ance involved may have significantly misled 
health care providers or patients concerning the 
safety or effectiveness of the drug involved. 
‘‘(4) CIVIL PENALTIES.— 
‘‘(A) IN GENERAL.—A person is subject to 
a civil penalty in accordance with this para-
graph if the person commits a violation de-
scribed in paragraph (1) and fails to correct the 
violation by the end of the 30-day period de-
scribed in subparagraph (B). 
‘‘(B) NOTIFICATION.—If a person is in vio-
lation of paragraph (1), the Secretary shall no-
tify the person of such noncompliance and give 
the person a 30-day period to correct such vio-
lation before imposing a civil penalty under this 
paragraph. 
‘‘(C) AMOUNT OF PENALTY.—The amount 
of a civil penalty under this subsection shall be 
not more than a total of $15,000 for all viola-
tions adjudicated in a single proceeding in the 
case of an individual, and not more than 
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$10,000 per day until the violation is corrected 
in the case of any other person, except that if 
the person is a nonprofit entity the penalty may 
not exceed a total of $15,000 for all violations 
adjudicated in a single proceeding. 
‘‘(D) 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 penalty under this 
subsection to the same extent and in the same 
manner as such provisions apply to a penalty 
imposed under such section 303(f). 
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$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-
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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 
at issue required under section 492C 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 492C of the Public Health Service 
Act.’’; and 
(C) in paragraph (4), by adding at the end 
the following: ‘‘The Secretary shall update such 
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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 492C of the Public Health Service 
Act.’’. 
(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 
‘‘in 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 492C 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 
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(B) by inserting after clause (ii) the fol-
lowing: 
‘‘(iii) A requirement that the person applying 
for an exemption for a device assure that such per-
son is in compliance with the requirements of section 
492C of the Public Health Service Act for the sub-
mission of clinical trial information for inclusion in 
the registry database and the results database de-
scribed 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 492C 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.’’. 
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(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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(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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(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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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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(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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(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 492C) described in clause 
(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 
492C; and 
(ii) failure to comply with such a re-
quirement shall be treated as a violation of 
the corresponding requirement of such sec-
tion 492C. 
(7) 
STATUS
OF
CLINICALTRIALS.GOV 
WEBSITE.— 
(A) IN GENERAL.—After receiving public 
comment and not later than 90 days after the 
date of the 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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subsection (b) of such section 492C and wheth-
er such approach is— 
(i) that such registry database should 
expand and build upon the data bank de-
scribed in section 402(i) of the Public 
Health Service Act (as in effect on the day 
before the date of the enactment of this 
Act); or 
(ii) that such registry database should 
supplant the data bank described in such 
section 402(i) (as in effect on the day be-
fore the date of the 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 
data bank described in such section 402(i) (as 
in effect on the day before the date of the en-
actment of this Act) on the Internet website of 
the National Library of Medicine. 
SEC. 802. STUDY BY GOVERNMENT ACCOUNTABILITY OF-
FICE. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study to determine whether 
information on the trials registry and database is consid-
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ered promotional and to evaluate the implementation of 
this database. 
(b) REPORT.—Not later than one year after the date 
of the enactment of this Act, the Comptroller General shall 
complete the study under subsection (a) and submit to the 
Congress a report on the results of such study. 
TITLE IX—ENHANCED AUTHORI-
TIES 
REGARDING 
POSTMARKET 
SAFETY 
OF 
DRUGS 
SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS RE-
GARDING HUMAN DRUGS; RISK EVALUATION 
AND MITIGATION STRATEGIES. 
(a) IN GENERAL.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 
adding at the end the following subsections: 
‘‘(o) POSTMARKET STUDIES AND CLINICAL TRIALS; 
LABELING.— 
‘‘(1) IN GENERAL.—A responsible person may 
not introduce or deliver for introduction into inter-
state commerce the new drug involved if the person 
is in violation of a requirement established under 
paragraph (3) or (4) with respect to the drug. 
‘‘(2) DEFINITIONS.—For purposes of this sub-
section: 
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‘‘(A) RESPONSIBLE
PERSON.—The term 
‘responsible person’ means a person who— 
‘‘(i) has submitted to the Secretary a 
covered application that is pending; or 
‘‘(ii) is the holder of an approved cov-
ered application. 
‘‘(B) COVERED
APPLICATION.—The term 
‘covered application’ means— 
‘‘(i) an application under subsection 
(b) for a drug that is subject to section 
503(b); and 
‘‘(ii) an application under section 351 
of the Public Health Service Act. 
‘‘(C) NEW SAFETY INFORMATION; SERIOUS 
RISK.—The terms ‘new safety information’, ‘se-
rious risk’, and ‘signal of a serious risk’ have 
the meanings given such terms in section 505– 
1(b). 
‘‘(3) STUDIES AND CLINICAL TRIALS.— 
‘‘(A) IN GENERAL.—For any or all of the 
purposes specified in subparagraph (B), the 
Secretary may, subject to subparagraph (C), re-
quire a responsible person for a drug to conduct 
a postapproval study or studies of the drug, or 
a postapproval clinical trial or trials of the 
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drug, on the basis of scientific information, in-
cluding information regarding chemically-re-
lated or pharmacologically-related drugs. 
‘‘(B) PURPOSES
OF
STUDY
OR
TRIAL.— 
The purposes referred to in this subparagraph 
with respect to a postapproval study or post-
approval clinical trial are the following: 
‘‘(i) To assess a known serious risk 
related to the use of the drug involved. 
‘‘(ii) To assess signals of serious risk 
related to the use of the drug. 
‘‘(iii) To identify a serious risk. 
‘‘(C) ESTABLISHMENT
OF
REQUIREMENT 
AFTER APPROVAL OF COVERED APPLICATION.— 
The Secretary may require a postapproval study 
or studies or postapproval trial or trials for a 
drug for which an approved covered application 
is in effect as of the date on which the Sec-
retary seeks to establish such requirement only 
if the Secretary becomes aware of new safety 
information. For each study required to be con-
ducted under this subparagraph, the Secretary 
shall require that the applicant submit a time-
table for completion of the study and shall re-
quire the applicant to periodically report to the 
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Secretary on the status of the study. Unless the 
applicant demonstrates good cause for failure to 
comply with such timeline, the applicant shall 
be in violation of this subsection. The Secretary 
shall determine what constitutes good cause 
under the preceding sentence. 
‘‘(4) SAFETY LABELING CHANGES REQUESTED 
BY SECRETARY.— 
‘‘(A) NEW
SAFETY
INFORMATION.—The 
Secretary shall promptly notify the responsible 
person if the Secretary becomes aware of new 
safety information that the Secretary believes 
should be included in the labeling of the drug. 
‘‘(B) RESPONSE TO NOTIFICATION.—Fol-
lowing notification pursuant to subparagraph 
(A), the responsible person shall within 30 
days— 
‘‘(i) submit a supplement proposing 
changes to the approved labeling to reflect 
the new safety information, including 
changes to boxed warnings, contraindica-
tions, warnings, precautions, or adverse re-
actions; or 
‘‘(ii) notify the Secretary that the re-
sponsible person does not believe a labeling 
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change is warranted and submit a state-
ment detailing the reasons why such a 
change is not warranted. 
‘‘(C) REVIEW.—Upon receipt of such sup-
plement, the Secretary shall promptly review 
and act upon such supplement. If the Secretary 
disagrees with the proposed changes in the sup-
plement or with the statement setting forth the 
responsible person’s reasons why no labeling 
change is necessary, the Secretary shall initiate 
discussions with the responsible person to reach 
agreement on whether the labeling for the drug 
should be modified to reflect the new safety in-
formation, and if so, the contents of such label-
ing changes. 
‘‘(D) 
DISCUSSIONS.—Such 
discussions 
shall not extend for more than 30 days after 
the response to the notification under subpara-
graph (B), unless the Secretary determines an 
extension of such discussion period is war-
ranted. 
‘‘(E) ORDER.—Within 15 days of the con-
clusion of the discussions under subparagraph 
(D), the Secretary may issue an order directing 
the responsible person to make such a labeling 
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change as the Secretary deems appropriate to 
address the new safety information. Within 15 
days of such an order, the responsible person 
shall submit a supplement containing the label-
ing change. 
‘‘(F) DISPUTE
RESOLUTION.—Within 5 
days of receiving an order under subparagraph 
(E), the responsible person may appeal using 
the Food and Drug Administration’s normal 
dispute resolution procedures established by the 
Secretary in regulation and guidance. 
‘‘(G) VIOLATION.—If the change required 
by an order under subparagraph (E) is not 
made by the date so specified, the responsible 
person shall be considered to be in violation of 
this section. 
‘‘(H) SERIOUS PUBLIC HEALTH THREAT.— 
Notwithstanding subparagraphs (A) through 
(F), if the Secretary concludes that failure to 
make such a labeling change is necessary to 
protect against a serious public health threat, 
the Secretary may accelerate the timelines in 
such subparagraphs. 
‘‘(I) RULE OF CONSTRUCTION.—This para-
graph shall not be construed to affect the re-
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sponsibility of the responsible person to main-
tain its label in accordance with existing re-
quirements, including subpart B and section 
314.70 of title 21, Code of Federal Regulations 
(or any successor regulations). 
‘‘(p) RISK EVALUATION AND MITIGATION STRAT-
EGY.— 
‘‘(1) IN GENERAL.—A person may not intro-
duce or deliver for introduction into interstate com-
merce a new drug if— 
‘‘(A)(i) the application for such drug is ap-
proved under subsection (b) or (j) and is sub-
ject to section 503(b); or 
‘‘(ii) the application for such drug is ap-
proved under section 351 of the Public Health 
Service Act; and 
‘‘(B) a risk evaluation and mitigation 
strategy is required under section 505–1 with 
respect to the drug and— 
‘‘(i) the person fails to maintain com-
pliance with the requirements of the ap-
proved strategy or with other requirements 
under section 505–1, including require-
ments regarding assessments of approved 
strategies; or 
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‘‘(ii) in the case of a requirement for 
such a strategy that is first established 
after the applicable application referred to 
in subparagraph (A) was approved with re-
spect to the drug, the Secretary, after no-
tice and opportunity for a hearing, pub-
lishes in the Federal Register a statement 
that the person is not cooperating with the 
Secretary in developing such a strategy for 
the drug. 
‘‘(2) REQUIRED STATEMENT DURING APPROVAL 
PROCESS.—In the case of an application approved 
under subsection (b) or (j) for a new drug that is 
subject to section 503(b), or an application approved 
under section 351 of the Public Health Service Act, 
or a supplement to such an application that requires 
substantive data, the Secretary may not approve the 
application or supplement unless the person involved 
has complied with the following: 
‘‘(A) The person has submitted to the Sec-
retary a statement that provides the following 
information: 
‘‘(i) Whether the person believes that 
a risk evaluation and mitigation strategy 
should be required under section 505–1. 
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‘‘(ii) Whether a postmarket study or 
clinical trial should be required under sub-
section (o)(3). 
‘‘(B) In making the statement under sub-
paragraph (A), the person took into account 
each of the following factors: 
‘‘(i) The estimated size of the popu-
lation likely to use the drug involved. 
‘‘(ii) The seriousness of the disease or 
condition that is to be treated with the 
drug. 
‘‘(iii) The expected benefit of the drug 
with respect to such disease or condition. 
‘‘(iv) The expected or actual duration 
of treatment with the drug. 
‘‘(v) The seriousness of any known or 
potential adverse events that may be re-
lated to the drug and the background inci-
dence of such events in the population like-
ly to use the drug. 
‘‘(3) CERTAIN
POSTMARKET
STUDIES.—The 
failure to conduct a postmarket study under subpart 
H of part 314 of title 21, Code of Federal Regula-
tions (or any successor regulation), is deemed to be 
a violation of paragraph (1).’’. 
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(b) REQUIREMENTS
REGARDING
STRATEGIES.— 
Chapter V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351 et seq.) is amended by inserting after sec-
tion 505 the following section: 
‘‘SEC. 505–1. RISK EVALUATION AND MITIGATION STRATE-
GIES. 
‘‘(a) SUBMISSION OF PROPOSED STRATEGY.— 
‘‘(1) INITIAL APPROVAL.—A person who sub-
mits 
an 
application 
referred 
to 
in 
section 
505(p)(1)(A) (referred to in this section as a ‘cov-
ered application’) shall submit to the Secretary as 
part of the application a proposed risk evaluation 
and mitigation strategy if the Secretary determines 
such a strategy is necessary to ensure that the bene-
fits of the drug involved outweigh the risks of the 
drug. In making such a determination, the Secretary 
shall consider the statement submitted by the person 
under section 505(p)(2) with respect to the drug and 
shall consider the following factors: 
‘‘(A) The estimated size of the population 
likely to use the drug involved. 
‘‘(B) The seriousness of the disease or con-
dition that is to be treated with the drug. 
‘‘(C) The expected benefit of the drug with 
respect to such disease or condition. 
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‘‘(D) The expected or actual duration of 
treatment with the drug. 
‘‘(E) The seriousness of any known or po-
tential adverse events that may be related to 
the drug and the background incidence of such 
events in the population likely to use the drug. 
‘‘(F) The availability and safety of a drug 
or other treatment, if any, for such disease or 
condition to which the safety of the drug may 
be compared. 
‘‘(G) Whether the drug is a new molecular 
entity. 
‘‘(2) POSTAPPROVAL REQUIREMENT.— 
‘‘(A) IN GENERAL.—If the Secretary ap-
proves a covered application and does not when 
approving the application require a risk evalua-
tion and mitigation strategy under paragraph 
(1), the Secretary may subsequently require 
such a strategy for the drug involved if the Sec-
retary becomes aware of new safety information 
and makes a determination that such a strategy 
is necessary to ensure that the benefits of the 
drug outweigh the risks of the drug. 
‘‘(B) SUBMISSION
OF
PROPOSED
STRAT-
EGY.—Not later than 120 days after the Sec-
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retary notifies the holder of an approved cov-
ered application that the Secretary has made a 
determination under subparagraph (A) with re-
spect to the drug involved, or within such other 
time as the Secretary requires to protect the 
public health, the holder shall submit to the 
Secretary a proposed risk evaluation and miti-
gation strategy. 
‘‘(3) APPROVAL
OF
NEW
INDICATION
FOR 
USE.—The applicability of paragraph (2) includes 
applicability to a drug for which an approved cov-
ered application was in effect on the day before the 
effective date of this section and for which, on or 
after such effective date, the holder of the approved 
application submits to the Secretary a supplemental 
application seeking approval of a new indication for 
use of the drug. 
‘‘(4) 
ABBREVIATED
NEW
DRUG
APPLICA-
TIONS.—The applicability of this section to an appli-
cation under section 505(j) is subject to subsection 
(i). 
‘‘(b) DEFINITIONS.—For purposes of this section: 
‘‘(1) ADVERSE DRUG EXPERIENCE.—The term 
‘adverse drug experience’ means any adverse event 
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associated with the use of a drug in humans, wheth-
er or not considered drug related, including— 
‘‘(A) an adverse event occurring in the 
course of the use of the drug in professional 
practice; 
‘‘(B) an adverse event occurring from an 
overdose of the drug, whether accidental or in-
tentional; 
‘‘(C) an adverse event occurring from 
abuse of the drug; 
‘‘(D) an adverse event occurring from 
withdrawal of the drug; and 
‘‘(E) any failure of expected pharma-
cological action of the drug. 
‘‘(2) COVERED APPLICATION.—The term ‘cov-
ered application’ has the meaning indicated for such 
term in subsection (a)(1). 
‘‘(3) NEW
SAFETY
INFORMATION.—The term 
‘new safety information’ with respect to a drug 
means information about— 
‘‘(A) a serious risk or an unexpected seri-
ous risk associated with use of the drug that 
the Secretary has become aware of since the 
drug was approved, since the risk evaluation 
and mitigation strategy was required, or since 
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the last assessment of the approved risk evalua-
tion and mitigation strategy for the drug; or 
‘‘(B) the effectiveness of the approved risk 
evaluation and mitigation strategy for the drug 
obtained since the last assessment of such 
strategy. 
‘‘(4) SERIOUS ADVERSE DRUG EXPERIENCE.— 
The term ‘serious adverse drug experience’ is an ad-
verse event that— 
‘‘(A) results in— 
‘‘(i) death; 
‘‘(ii) an adverse drug experience that 
places the patient at immediate risk of 
death from the adverse drug experience as 
it occurred (not including an adverse drug 
experience that might have caused death 
had it occurred in a more severe form); 
‘‘(iii) inpatient hospitalization or pro-
longation of existing hospitalization; 
‘‘(iv) a persistent or significant inca-
pacity or substantial disruption of the abil-
ity to conduct normal life functions; or 
‘‘(v) a congenital anomaly or birth de-
fect; or 
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‘‘(B) based on appropriate medical judg-
ment, may jeopardize the patient and may re-
quire a medical or surgical intervention to pre-
vent an outcome described under subparagraph 
(A). 
‘‘(5) SERIOUS RISK.—The term ‘serious risk’ 
means a risk of a serious adverse drug experience. 
‘‘(6) SIGNAL OF A SERIOUS RISK.—The term 
‘signal of a serious risk’ means information related 
to a serious adverse drug experience associated with 
use of a drug and derived from— 
‘‘(A) a clinical trial; 
‘‘(B) adverse event reports; 
‘‘(C) a postapproval study, including a 
study under section 505(o)(3); 
‘‘(D) peer-reviewed biomedical literature; 
or 
‘‘(E) data derived from a postmarket risk 
identification and analysis system under section 
505(k)(3). 
‘‘(7) RESPONSIBLE
PERSON.—The term ‘re-
sponsible person’ has the meaning indicated for such 
term in subsection (e)(2). 
‘‘(8) UNEXPECTED SERIOUS RISK.—The term 
‘unexpected serious risk’ means a serious adverse 
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drug experience that is not listed in the labeling of 
a drug, or that may be symptomatically and 
pathophysiologically related to an adverse drug expe-
rience identified in the labeling, but differs from 
such adverse drug experience because of greater se-
verity, specificity, or prevalence. 
‘‘(c) CONTENTS.—A proposed risk evaluation and 
mitigation strategy under subsection (a) shall— 
‘‘(1) include the timetable required under sub-
section (d); and 
‘‘(2) to the extent required by the Secretary, in-
clude additional elements described in subsections 
(e) and (f). 
‘‘(d) MINIMAL STRATEGY.—For purposes of sub-
section (c)(1), the risk evaluation and mitigation strategy 
for a drug shall require a timetable for submission of as-
sessments of the strategy that— 
‘‘(1) is not less frequent than once annually for 
the first 3 years after the strategy is initially ap-
proved; 
‘‘(2) includes an assessment in the seventh year 
after the strategy is so approved; and 
‘‘(3) subject to paragraph (2), for subsequent 
years— 
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‘‘(A) is at a frequency specified in the 
strategy; 
‘‘(B) is increased or reduced in frequency 
as necessary as provided for in subsection 
(g)(4)(A); and 
‘‘(C) is eliminated after the 3-year period 
described in paragraph (1) if the Secretary de-
termines that serious risks of the drug have 
been adequately identified and assessed and are 
being adequately managed. 
‘‘(e) ADDITIONAL POTENTIAL ELEMENTS OF STRAT-
EGY.— 
‘‘(1) IN GENERAL.—The Secretary may under 
subsection (c)(2) require that the risk evaluation 
and mitigation strategy for a drug include 1 or more 
of the additional elements described in this sub-
section if the Secretary makes the determination re-
quired with respect to the element involved. 
‘‘(2) MEDGUIDE; PATIENT PACKAGE INSERT.— 
The risk evaluation and mitigation strategy for a 
drug may require that, as applicable, the person sub-
mitting the covered application or the holder of the 
approved such application (referred to in this section 
as the ‘responsible person’) develop for distribution 
to each patient when the drug is dispensed— 
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‘‘(A) a Medication Guide, as provided for 
under part 208 of title 21, Code of Federal 
Regulations (or any successor regulations); and 
‘‘(B) a patient package insert, if the Sec-
retary determines that such insert may help 
mitigate a serious risk of the drug. 
‘‘(3) COMMUNICATION PLAN.—The risk evalua-
tion and mitigation strategy for a drug may require 
that the responsible person conduct a communica-
tion plan to health care providers, if, with respect to 
such drug, the Secretary determines that such plan 
may support implementation of an element of the 
strategy. Such plan may include— 
‘‘(A) sending letters to health care pro-
viders; 
‘‘(B) disseminating information about the 
elements of the risk evaluation and mitigation 
strategy to encourage implementation by health 
care providers of components that apply to such 
health care providers, or to explain certain safe-
ty protocols (such as medical monitoring by 
periodic laboratory tests); or 
‘‘(C) disseminating information to health 
care providers through professional societies 
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about any serious risks of the drug and any 
protocol to assure safe use. 
‘‘(f) RESTRICTIONS ON DISTRIBUTION OR USE.— 
‘‘(1) IN GENERAL.—If the Secretary determines 
that a drug shown to be effective can be safely used 
only if distribution or use of such drug is restricted, 
the Secretary may under subsection (c)(2) require as 
elements of the risk evaluation and mitigation strat-
egy such restrictions on distribution or use as are 
needed to ensure safe use of the drug. 
‘‘(2) ASSURING ACCESS AND MINIMIZING BUR-
DEN.—Elements of a risk evaluation and mitigation 
strategy included under paragraph (1) shall— 
‘‘(A) be commensurate with a specific seri-
ous risk listed in the labeling of the drug; 
‘‘(B) be posted publicly by the Secretary 
with an explanation of how such elements will 
mitigate the observed safety risk, which posting 
shall be made within 30 days after the date on 
which the Secretary requires the element in-
volved; 
‘‘(C) considering the risk referred to in 
subparagraph (A), not be unduly burdensome 
on patient access to the drug, considering in 
particular— 
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‘‘(i) patients with serious or life- 
threatening diseases or conditions; and 
‘‘(ii) patients who have difficulty ac-
cessing health care (such as patients in 
rural or medically underserved areas); and 
‘‘(D) to the extent practicable, so as to 
minimize the burden on the health care delivery 
system— 
‘‘(i) conform with elements to assure 
safe use for other drugs with similar, seri-
ous risks; and 
‘‘(ii) be designed to be compatible 
with established distribution, procurement, 
and dispensing systems for drugs. 
‘‘(3) ELEMENTS.—The restrictions on distribu-
tion or use described in paragraph (1) shall include 
1 or more goals to evaluate or mitigate a serious 
risk listed in the labeling of the drug, and may re-
quire that— 
‘‘(A) health care providers that prescribe 
the drug have special training or experience, or 
are specially certified, which training or certifi-
cation with respect to the drug is available to 
any willing provider from a frontier area; 
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‘‘(B) pharmacies, practitioners, or health 
care settings that dispense the drug are spe-
cially certified, which training or certification 
with respect to the drug is available to any will-
ing provider from a frontier area; 
‘‘(C) the drug be dispensed to patients only 
in certain health care settings, such as hos-
pitals; 
‘‘(D) the drug be dispensed to patients 
with evidence or other documentation of safe- 
use conditions, such as laboratory test results; 
‘‘(E) each patient using the drug be sub-
ject to certain monitoring; or 
‘‘(F) each patient using the drug be en-
rolled in a registry. 
‘‘(4) IMPLEMENTATION SYSTEM.—The restric-
tions on distribution or use described in paragraph 
(1) may require a system through which the respon-
sible person is able to— 
‘‘(A) monitor and evaluate implementation 
of the restrictions by health care providers, 
pharmacists, patients, and other parties in the 
health care system who are responsible for im-
plementing the restrictions; 
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‘‘(B) work to improve implementation of 
the restrictions by health care providers, phar-
macists, patients, and other parties in the 
health care system who are responsible for im-
plementing the restrictions; and 
‘‘(C) notify wholesalers of the drug of 
those health care providers— 
‘‘(i) who are responsible for imple-
menting the restrictions; and 
‘‘(ii) whom the responsible person 
knows have failed to meet their responsibil-
ities for implementing the restrictions, 
after the responsible person has informed 
such party of such failure and such party 
has not remedied such failure. 
‘‘(5) LIMITATION.—No holder of an approved 
application shall use any restriction on distribution 
required by the Secretary as necessary to assure safe 
use of the drug to block or delay approval of an ap-
plication under section 505(b)(2) or (j) or to prevent 
application of such restriction under subsection 
(i)(1)(B) to a drug that is the subject of an abbre-
viated new drug application. 
‘‘(6) 
BIOEQUIVALENCE
TESTING.—Notwith-
standing any other provisions in this subsection, the 
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holder of an approved application that is subject to 
distribution restrictions required under this sub-
section that limit the ability of a sponsor seeking ap-
proval of an application under subsection 505(b)(2) 
or (j) to purchase on the open market a sufficient 
quantity of drug to conduct bioequivalence testing 
shall provide to such a sponsor a sufficient amount 
of drug to conduct bioequivalence testing if the spon-
sor seeking approval under section 505(b)(2) or 
(j)— 
‘‘(A) agrees to such restrictions on dis-
tribution as the Secretary finds necessary to as-
sure safe use of the drug during bioequivalence 
testing; and 
‘‘(B) pays the holder of the approved appli-
cation the fair market value of the drug pur-
chased for bioequivalence testing. 
‘‘(7) LETTER BY SECRETARY.—Upon a showing 
by the sponsor seeking approval under section 
505(b)(2) or (j) that the sponsor has agreed to such 
restrictions necessary to assure safe use of the drug 
during bioequivalence testing, the Secretary shall 
issue to the sponsor seeking to conduct bioequiva-
lence testing a letter that describes the Secretary’s 
finding which shall serve as proof that the sponsor 
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has satisfied the requirements of subparagraph 
(6)(A). 
‘‘(8) EVALUATION OF ELEMENTS TO ASSURE 
SAFE USE.—The Secretary, acting through the Drug 
Safety and Risk Management Advisory Committee 
(or any successor committee) of the Food and Drug 
Administration, shall— 
‘‘(A) seek input from patients, physicians, 
pharmacists, and other health care providers 
about how elements to assure safe use under 
this subsection for 1 or more drugs may be 
standardized so as not to be— 
‘‘(i) unduly burdensome on patient ac-
cess to the drug; and 
‘‘(ii) to the extent practicable, mini-
mize the burden on the health care delivery 
system; 
‘‘(B) at least annually, evaluate, for 1 or 
more drugs, the elements to assure safe use of 
such drug to assess whether the elements— 
‘‘(i) assure safe use of the drug; 
‘‘(ii) are not unduly burdensome on 
patient access to the drug; and 
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‘‘(iii) to the extent practicable, mini-
mize the burden on the health care delivery 
system; and 
‘‘(C) considering such input and evalua-
tions— 
‘‘(i) issue or modify agency guidance 
about how to implement the requirements 
of this subsection; and 
‘‘(ii) modify elements under this sub-
section for 1 or more drugs as appropriate. 
‘‘(9) WAIVER
IN
PUBLIC
HEALTH
EMER-
GENCIES.—The Secretary may waive any restriction 
on distribution or use under this subsection during 
the period described in section 319(a) of the Public 
Health Service Act with respect to a qualified coun-
termeasure described under section 319F–1(a)(2) of 
such Act, to which a restriction or use under this 
subsection has been applied, if the Secretary has— 
‘‘(A) declared a public health emergency 
under such section 319; and 
‘‘(B) determined that such waiver is re-
quired to mitigate the effects of, or reduce the 
severity of, such public health emergency. 
‘‘(g) ASSESSMENT AND MODIFICATION OF APPROVED 
STRATEGY.— 
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‘‘(1) VOLUNTARY ASSESSMENTS.—After the ap-
proval of a risk evaluation and mitigation strategy 
under subsection (a), the responsible person involved 
may, subject to paragraph (2), submit to the Sec-
retary an assessment of, and propose a modification 
to, the approved strategy for the drug involved at 
any time. 
‘‘(2) REQUIRED ASSESSMENTS.—A responsible 
person shall, subject to paragraph (5), submit an as-
sessment of, and may propose a modification to, the 
approved risk evaluation and mitigation strategy for 
a drug— 
‘‘(A) when submitting a supplemental ap-
plication for a new indication for use under sec-
tion 505(b) or under section 351 of the Public 
Health Service Act, unless the drug is not sub-
ject to section 503(b) and the risk evaluation 
and mitigation strategy for the drug includes 
only the timetable under subsection (d); 
‘‘(B) when required by the strategy, as 
provided for in such timetable under subsection 
(d); 
‘‘(C) within a time period to be determined 
by the Secretary, if the Secretary determines 
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that new safety or effectiveness information in-
dicates that— 
‘‘(i) an element under subsection (d) 
or (e) should be modified or included in 
the strategy; or 
‘‘(ii) an element under subsection (f) 
should be modified or included in the strat-
egy; or 
‘‘(D) within 15 days when ordered by the 
Secretary, if the Secretary determines that 
there may be a cause for action by the Sec-
retary under section 505(e). 
‘‘(3) REQUIREMENTS FOR ASSESSMENTS.—An 
assessment under paragraph (1) or (2) of an ap-
proved risk evaluation and mitigation strategy for a 
drug shall include— 
‘‘(A) with respect to any goal under sub-
section (f), an assessment of the extent to 
which the restrictions on distribution or use are 
meeting the goal or whether the goal or such 
restrictions should be modified; 
‘‘(B) with respect to any postapproval 
study required under section 505(o)(3), the sta-
tus of such study, including whether any dif-
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ficulties completing the study have been en-
countered; and 
‘‘(C) with respect to any postapproval clin-
ical trial required under section 505(o), the sta-
tus of such clinical trial, including whether en-
rollment has begun, the number of participants 
enrolled, the expected completion date, whether 
any difficulties completing the clinical trial have 
been encountered, and registration information 
with respect to requirements under section 
492C of the Public Health Service Act. 
‘‘(4) MODIFICATION.—A modification (whether 
an enhancement or a reduction) to the approved risk 
evaluation and mitigation strategy for a drug may 
include the addition or modification of any element 
under subsection (d) or the addition, modification, 
or removal of any element under subsection (e) or 
(f), such as— 
‘‘(A) modifying the timetable for assess-
ments of the strategy under subsection (d), in-
cluding to eliminate assessments; or 
‘‘(B) adding, modifying, or removing a re-
striction on distribution or use under subsection 
(f). 
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