198 
‘‘(1) DETAIL FROM FEDERAL AGENCIES.—Fed-
eral Government employees may be detailed from 
Federal agencies with or without reimbursement to 
those agencies to the Foundation at any time, and 
such detail shall be without interruption or loss of 
civil service status or privilege. Each such employee 
shall abide by the statutory, regulatory, ethical, and 
procedural standards applicable to the employees of 
the agency from which such employee is detailed and 
those of the Foundation. 
‘‘(2) VOLUNTARY
SERVICE; ACCEPTANCE
OF 
FEDERAL EMPLOYEES.— 
‘‘(A) FOUNDATION.—The Executive Direc-
tor of the Foundation may accept the services 
of employees detailed from Federal agencies 
with or without reimbursement to those agen-
cies. 
‘‘(B) FOOD AND DRUG ADMINISTRATION.— 
The Commissioner may accept the uncompen-
sated services of Foundation fellows or trainees. 
Such services shall be considered to be under-
taking an activity under contract with the Sec-
retary as described in section 708. 
‘‘(l) ANNUAL REPORTS.— 
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‘‘(1) REPORTS TO FOUNDATION.—Any recipient 
of a grant, contract, fellowship, memorandum of un-
derstanding, or cooperative agreement from the 
Foundation under this section shall submit to the 
Foundation a report on an annual basis for the du-
ration of such grant, contract, fellowship, memo-
randum of understanding, or cooperative agreement, 
that describes the activities carried out under such 
grant, contract, fellowship, memorandum of under-
standing, or cooperative agreement. 
‘‘(2) REPORT TO CONGRESS AND THE FDA.— 
Beginning with fiscal year 2009, the Executive Di-
rector shall submit to Congress and the Commis-
sioner an annual report that— 
‘‘(A) describes the activities of the Foun-
dation and the progress of the Foundation in 
furthering the goals and priorities established 
under subsection (c)(2), including the practical 
impact of the Foundation on regulated product 
development; 
‘‘(B) provides a specific accounting of the 
source and use of all funds used by the Foun-
dation to carry out such activities; and 
‘‘(C) provides information on how the re-
sults of Foundation activities could be incor-
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porated into the regulatory and product review 
activities of the Food and Drug Administration. 
‘‘(m) SEPARATION OF FUNDS.—The Executive Di-
rector shall ensure that the funds received from the Treas-
ury are held in separate accounts from funds received 
from entities under subsection (i). 
‘‘(n) FUNDING.—From amounts appropriated to the 
Food and Drug Administration for each fiscal year, the 
Commissioner shall transfer not less than $500,000 and 
not more than $1,250,000, to the Foundation to carry out 
subsections (a), (b), and (d) through (m).’’. 
(b) OTHER FOUNDATION PROVISIONS.—Chapter VII 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
371 et seq.) (as amended by subsection (a)) is amended 
by adding at the end the following: 
‘‘SEC. 771. LOCATION OF FOUNDATION. 
‘‘The Foundation shall, if practicable, be located not 
more than 20 miles from the District of Columbia. 
‘‘SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINIS-
TRATION. 
‘‘(a) IN GENERAL.—The Commissioner shall receive 
and assess the report submitted to the Commissioner by 
the Executive Director of the Foundation under section 
770(l)(2). 
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‘‘(b) REPORT TO CONGRESS.—Beginning with fiscal 
year 2009, the Commissioner shall submit to Congress an 
annual report summarizing the incorporation of the infor-
mation provided by the Foundation in the report described 
under section 770(l)(2) and by other recipients of grants, 
contracts, memoranda of understanding, or cooperative 
agreements into regulatory and product review activities 
of the Food and Drug Administration. 
‘‘(c) EXTRAMURAL GRANTS.—The provisions of this 
subchapter and section 566 shall have no effect on any 
grant, contract, memorandum of understanding, or coop-
erative agreement between the Food and Drug Adminis-
tration and any other entity entered into before, on, or 
after the date of the enactment of this subchapter.’’. 
(c) CONFORMING AMENDMENT.—Section 742(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379l(b)) is amended by adding at the end the following: 
‘‘Any such fellowships and training programs under this 
section or under section 770(d)(2)(A)(ix) may include pro-
vision by such scientists and physicians of services on a 
voluntary and uncompensated basis, as the Secretary de-
termines appropriate. Such scientists and physicians shall 
be subject to all legal and ethical requirements otherwise 
applicable to officers or employees of the Department of 
Health and Human Services.’’. 
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202 
SEC. 602. OFFICE OF THE CHIEF SCIENTIST. 
Chapter IX of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 910. OFFICE OF THE CHIEF SCIENTIST. 
‘‘(a) ESTABLISHMENT; APPOINTMENT.—The Sec-
retary shall establish within the Office of the Commis-
sioner an office to be known as the Office of the Chief 
Scientist. The Secretary shall appoint a Chief Scientist to 
lead such Office. 
‘‘(b) DUTIES OF THE OFFICE.—The Office of the 
Chief Scientist shall— 
‘‘(1) oversee, coordinate, and ensure quality and 
regulatory focus of the intramural research pro-
grams of the Food and Drug Administration; 
‘‘(2) track and, to the extent necessary, coordi-
nate intramural research awards made by each cen-
ter of the Administration or science-based office 
within the Office of the Commissioner, and ensure 
that there is no duplication of research efforts sup-
ported by the Reagan-Udall Foundation for the 
Food and Drug Administration; 
‘‘(3) develop and advocate for a budget to sup-
port intramural research; 
‘‘(4) develop a peer review process by which in-
tramural research can be evaluated; 
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‘‘(5) identify and solicit intramural research 
proposals from across the Food and Drug Adminis-
tration through an advisory board composed of em-
ployees of the Administration that shall include— 
‘‘(A) representatives of each of the centers 
and the science-based offices within the Office 
of the Commissioner; and 
‘‘(B) experts on trial design, epidemiology, 
demographics, pharmacovigilance, basic science, 
and public health; and 
‘‘(6) develop postmarket safety performance 
measures that are as measurable and rigorous as the 
ones already developed for premarket review.’’. 
SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 
amended by adding at the end the following: 
‘‘SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNER-
SHIPS. 
‘‘(a) 
ESTABLISHMENT.—The 
Secretary, 
acting 
through the Commissioner of Food and Drugs, may enter 
into collaborative agreements, to be known as Critical 
Path Public-Private Partnerships, with one or more eligi-
ble entities to implement the Critical Path Initiative of the 
Food and Drug Administration by developing innovative, 
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collaborative projects in research, education, and outreach 
for the purpose of fostering medical product innovation, 
enabling the acceleration of medical product development, 
manufacturing, and translational therapeutics, and en-
hancing medical product safety. 
‘‘(b) ELIGIBLE ENTITY.—In this section, the term 
‘eligible entity’ means an entity that meets each of the 
following: 
‘‘(1) The entity is— 
‘‘(A) an institution of higher education (as 
such term is defined in section 101 of the High-
er Education Act of 1965) or a consortium of 
such institutions; or 
‘‘(B) an organization described in section 
501(c)(3) of the Internal Revenue Code of 1986 
and exempt from tax under section 501(a) of 
such Code. 
‘‘(2) The entity has experienced personnel and 
clinical and other technical expertise in the bio-
medical sciences, which may include graduate train-
ing programs in areas relevant to priorities of the 
Critical Path Initiative. 
‘‘(3) The entity demonstrates to the Secretary’s 
satisfaction that the entity is capable of— 
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205 
‘‘(A) developing and critically evaluating 
tools, methods, and processes— 
‘‘(i) to increase efficiency, predict-
ability, and productivity of medical product 
development; and 
‘‘(ii) to more accurately identify the 
benefits and risks of new and existing med-
ical products; 
‘‘(B) establishing partnerships, consortia, 
and collaborations with health care practitioners 
and other providers of health care goods or 
services; pharmacists; pharmacy benefit man-
agers and purchasers; health maintenance orga-
nizations and other managed health care orga-
nizations; health care insurers; government 
agencies; patients and consumers; manufactur-
ers of prescription drugs, biological products, 
diagnostic technologies, and devices; and aca-
demic scientists; and 
‘‘(C) securing funding for the projects of a 
Critical Path Public-Private Partnership from 
Federal and nonfederal governmental sources, 
foundations, and private individuals. 
‘‘(c) FUNDING.—The Secretary may not enter into 
a collaborative agreement under subsection (a) unless the 
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eligible entity involved provides an assurance that the enti-
ty will not accept funding for a Critical Path Public-Pri-
vate Partnership project from any organization that man-
ufactures or distributes products regulated by the Food 
and Drug Administration unless the entity provides assur-
ances in its agreement with the Food and Drug Adminis-
tration that the results of the Critical Path Public-Private 
Partnership project will not be influenced by any source 
of funding. 
‘‘(d) ANNUAL REPORT.—Not later than 18 months 
after the date of the enactment of this section, and annu-
ally thereafter, the Secretary, in collaboration with the 
parties to each Critical Path Public-Private Partnership, 
shall submit a report to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives— 
‘‘(1) reviewing the operations and activities of 
the Partnerships in the previous year; and 
‘‘(2) addressing such other issues relating to 
this section as the Secretary determines to be appro-
priate. 
‘‘(e) DEFINITION.—In this section, the term ‘medical 
product’ includes a drug, a biological product as defined 
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in section 351 of the Public Health Service Act, a device, 
and any combination of such products. 
‘‘(f) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated $5,000,000 for fiscal year 2008 and such sums 
as may be necessary for each of fiscal years 2009 through 
2012.’’. 
TITLE VII—CONFLICTS OF 
INTEREST 
SEC. 701. 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. 
‘‘(b) APPOINTMENTS TO ADVISORY COMMITTEES.— 
‘‘(1) RECRUITMENT.— 
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‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) develop and implement strategies 
on effective outreach to potential members 
of advisory committees at universities, col-
leges, other academic research centers, 
professional and medical societies, and pa-
tient and consumer groups; 
‘‘(ii) seek input from professional 
medical and scientific societies to deter-
mine the most effective informational and 
recruitment activities; and 
‘‘(iii) take into account the advisory 
committees with the greatest number of 
vacancies. 
‘‘(B) RECRUITMENT ACTIVITIES.—The re-
cruitment activities under subparagraph (A) 
may include— 
‘‘(i) advertising the process for becom-
ing an advisory committee member at med-
ical and scientific society conferences; 
‘‘(ii) making widely available, includ-
ing by using existing electronic commu-
nications channels, the contact information 
for the Food and Drug Administration 
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point of contact regarding advisory com-
mittee nominations; and 
‘‘(iii) developing a method through 
which an entity receiving funding from the 
National Institutes of Health, the Agency 
for Healthcare Research and Quality, the 
Centers for Disease Control and Preven-
tion, or the Veterans Health Administra-
tion can identify a person who the Food 
and Drug Administration can contact re-
garding the nomination of individuals to 
serve on advisory committees. 
‘‘(2) EVALUATION AND CRITERIA.—When con-
sidering a term appointment to an advisory com-
mittee, the Secretary shall review the expertise of 
the individual and the financial disclosure report 
filed by the individual pursuant to the Ethics in 
Government Act of 1978 for each individual under 
consideration for the appointment, so as to reduce 
the likelihood that an appointed individual will later 
require a written determination as referred to in sec-
tion 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 waiv-
er as referred to in subsection (c)(2) of this section 
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for service on the committee at a meeting of the 
committee. 
‘‘(c) DISCLOSURES; PROHIBITIONS ON PARTICIPA-
TION; WAIVERS.— 
‘‘(1) DISCLOSURE OF FINANCIAL INTEREST.— 
Prior to a meeting of an advisory committee regard-
ing a ‘particular matter’ (as that term is used in 
section 208 of title 18, United States Code), each 
member of the committee who is a full-time Govern-
ment employee or special Government employee shall 
disclose to the Secretary financial interests in ac-
cordance with subsection (b) of such section 208. 
‘‘(2) PROHIBITIONS AND WAIVERS ON PARTICI-
PATION.— 
‘‘(A) IN
GENERAL.—Except as provided 
under subparagraph (B), a member of an advi-
sory committee may not participate with respect 
to a particular matter considered in an advisory 
committee meeting if such member (or an im-
mediate family member of such member) has a 
financial interest that could be affected by the 
advice given to the Secretary with respect to 
such matter, excluding interests exempted in 
regulations issued by the Director of the Office 
of Government Ethics as too remote or incon-
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211 
sequential to affect the integrity of the services 
of the Government officers or employees to 
which such regulations apply. 
‘‘(B) WAIVER.—If the Secretary deter-
mines it necessary to afford the advisory com-
mittee essential expertise, the Secretary may 
grant a waiver of the prohibition in subpara-
graph (A) to permit a member described in 
such subparagraph to— 
‘‘(i) participate as a non-voting mem-
ber with respect to a particular matter 
considered in a committee meeting; or 
‘‘(ii) participate as a voting member 
with respect to a particular matter consid-
ered in a committee meeting. 
‘‘(C) LIMITATION ON WAIVERS AND OTHER 
EXCEPTIONS.— 
‘‘(i) DEFINITION.—For purposes of 
this subparagraph, the term ‘exception’ 
means each of the following with respect to 
members of advisory committees: 
‘‘(I) A waiver under section 
505(n)(4) (as in effect on the day be-
fore the date of the enactment of the 
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212 
Food 
and 
Drug 
Administration 
Amendments Act of 2007). 
‘‘(II) A written determination 
under section 208(b) of title 18, 
United States Code. 
‘‘(III) A written certification 
under section 208(b)(3) of such title. 
‘‘(ii) 
DETERMINATION
OF
TOTAL 
NUMBER OF MEMBERS SLOTS AND MEM-
BER
EXCEPTIONS
DURING
FISCAL
YEAR 
2007.—The Secretary shall determine— 
‘‘(I)(aa) for each meeting held by 
any advisory committee during fiscal 
year 2007, the number of members 
who participated in the meeting; and 
‘‘(bb) the sum of the respective 
numbers determined under item (aa) 
(referred to in this subparagraph as 
the ‘‘total number of 2007 meeting 
slots’’); and 
‘‘(II)(aa) for each meeting held 
by any advisory committee during fis-
cal year 2007, the number of mem-
bers who received an exception for the 
meeting; and 
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‘‘(bb) the sum of the respective 
numbers determined under item (aa) 
(referred to in this subparagraph as 
the ‘‘total number of 2007 meeting 
exceptions’’). 
‘‘(iii) DETERMINATION OF PERCENT-
AGE REGARDING EXCEPTIONS DURING FIS-
CAL YEAR 2007.—The Secretary shall de-
termine the percentage constituted by— 
‘‘(I) the total number of 2007 
meeting exceptions; divided by 
‘‘(II) the total number of 2007 
meeting slots. 
‘‘(iv) LIMITATION FOR FISCAL YEARS 
2008 THROUGH 2012.—The number of ex-
ceptions at the Food and Drug Adminis-
tration for members of advisory commit-
tees for a fiscal year may not exceed the 
following: 
‘‘(I) For fiscal year 2008, 95 per-
cent of the percentage determined 
under clause (iii) (referred to in this 
clause as the ‘‘base percentage’’). 
‘‘(II) For fiscal year 2009, 90 
percent of the base percentage. 
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‘‘(III) For fiscal year 2010, 85 
percent of the base percentage. 
‘‘(IV) For fiscal year 2011, 80 
percent of the base percentage. 
‘‘(V) For fiscal year 2012, 75 
percent of the base percentage. 
‘‘(v) ALLOCATION OF EXCEPTIONS.— 
The exceptions authorized under clause 
(iv) for a fiscal year may be allocated with-
in the centers or other organizational units 
of the Food and Drug Administration as 
determined appropriate by the Secretary. 
‘‘(3) 
DISCLOSURE
OF
WAIVER.—Notwith-
standing section 107(a)(2) of the Ethics in Govern-
ment Act (5 U.S.C. App.), the following shall apply: 
‘‘(A) 15 OR MORE DAYS IN ADVANCE.—As 
soon as practicable, but (except as provided in 
subparagraph (B)) not 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 (2)(B) ap-
plies, the Secretary shall disclose (other than 
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(b) CONFORMING AMENDMENTS.—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. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on October 1, 2007. 
TITLE VIII—CLINICAL TRIAL 
DATABASES 
SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA 
BANK. 
(a) IN GENERAL.—Section 402 of the Public Health 
Service Act (42 U.S.C. 282) is amended by— 
(1) redesignating subsections (j) and (k) as 
subsections (k) and (l), respectively; and 
(2) inserting after subsection (i) the following: 
‘‘(j) EXPANDED CLINICAL TRIAL REGISTRY DATA 
BANK.— 
‘‘(1) DEFINITIONS; REQUIREMENT.— 
‘‘(A) DEFINITIONS.—In this subsection: 
‘‘(i) APPLICABLE CLINICAL TRIAL.— 
The term ‘applicable clinical trial’ means 
an applicable device clinical trial or an ap-
plicable drug clinical trial. 
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‘‘(ii) APPLICABLE
DEVICE
CLINICAL 
TRIAL.—The term ‘applicable device clin-
ical trial’ means— 
‘‘(I) a prospective clinical study 
of health outcomes comparing an 
intervention with a device subject to 
section 510(k), 515, or 520(m) of the 
Federal Food, Drug, and Cosmetic 
Act against a control in human sub-
jects (other than a small clinical trial 
to determine the feasibility of a de-
vice, or a clinical trial to test proto-
type devices where the primary out-
come measure relates to feasibility 
and not to health outcomes); and 
‘‘(II) a pediatric postmarket sur-
veillance as required under section 
522 of the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(iii) APPLICABLE
DRUG
CLINICAL 
TRIAL.— 
‘‘(I) IN
GENERAL.—The term 
‘applicable drug clinical trial’ means a 
controlled clinical investigation, other 
than a phase I clinical investigation, 
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of a drug subject to section 505 of the 
Federal Food, Drug, and Cosmetic 
Act or to section 351 of this Act. 
‘‘(II) 
CLINICAL
INVESTIGA-
TION.—For purposes of subclause (I), 
the term ‘clinical investigation’ has 
the meaning given that term in sec-
tion 312.3 of title 21, Code of Federal 
Regulations (or any successor regula-
tion). 
‘‘(III) PHASE
I.—For purposes 
of subclause (I), the term ‘phase I’ 
has the meaning given that term in 
section 312.21 of title 21, Code of 
Federal Regulations (or any successor 
regulation). 
‘‘(iv) 
CLINICAL
TRIAL
INFORMA-
TION.—The term ‘clinical trial information’ 
means, with respect to an applicable clin-
ical trial, those data elements that the re-
sponsible party is required to submit under 
paragraph (2) or under paragraph (3). 
‘‘(v) COMPLETION
DATE.—The term 
‘completion date’ means, with respect to an 
applicable clinical trial, the date that the 
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final subject was examined or received an 
intervention for the purposes of final col-
lection of data for the primary outcome, 
whether the clinical trial concluded accord-
ing to the prespecified protocol or was ter-
minated. 
‘‘(vi) DEVICE.—The term ‘device’ 
means a device as defined in section 
201(h) of the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(vii) DRUG.—The term ‘drug’ means 
a drug as defined in section 201(g) of the 
Federal Food, Drug, and Cosmetic Act or 
a biological product as defined in section 
351 of this Act. 
‘‘(viii) ONGOING.—The term ‘ongoing’ 
means, with respect to a clinical trial of a 
drug or a device and to a date, that— 
‘‘(I) 1 or more patients is en-
rolled in the clinical trial; and 
‘‘(II) the date is before the com-
pletion date of the clinical trial. 
‘‘(ix) 
RESPONSIBLE
PARTY.—The 
term ‘responsible party’, with respect to a 
clinical trial of a drug or device, means— 
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‘‘(I) the sponsor of the clinical 
trial (as defined in section 50.3 of 
title 21, Code of Federal Regulations 
(or any successor regulation)); or 
‘‘(II) the principal investigator of 
such clinical trial if so designated by 
a sponsor, grantee, contractor, or 
awardee, so long as the principal in-
vestigator is responsible for con-
ducting the trial, has access to and 
control over the data from the clinical 
trial, has the right to publish the re-
sults of the trial, and has the ability 
to meet all of the requirements under 
this subsection for the submission of 
clinical trial information. 
‘‘(B) REQUIREMENT.—The Secretary shall 
develop a mechanism by which the responsible 
party for each applicable clinical trial shall sub-
mit the identity and contact information of such 
responsible party to the Secretary at the time 
of submission of clinical trial information under 
paragraph (2). 
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223 
‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY 
DATA BANK WITH RESPECT TO CLINICAL TRIAL IN-
FORMATION.— 
‘‘(A) IN GENERAL.— 
‘‘(i) EXPANSION OF DATA BANK.—To 
enhance patient enrollment and provide a 
mechanism to track subsequent progress of 
clinical 
trials, 
the 
Secretary, 
acting 
through the Director of NIH, shall expand, 
in accordance with this subsection, the 
clinical trials registry of the data bank de-
scribed under subsection (i)(1) (referred to 
in this subsection as the ‘registry data 
bank’). The Director of NIH shall ensure 
that the registry data bank is made pub-
licly available through the Internet. 
‘‘(ii) CONTENT.—The clinical trial in-
formation required to be submitted under 
this paragraph for an applicable clinical 
trial shall include— 
‘‘(I) descriptive information, in-
cluding— 
‘‘(aa) a brief title, intended 
for the lay public; 
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‘‘(bb) a brief summary, in-
tended for the lay public; 
‘‘(cc) the primary purpose; 
‘‘(dd) the study design; 
‘‘(ee) for an applicable drug 
clinical trial, the study phase; 
‘‘(ff) study type; 
‘‘(gg) the primary disease or 
condition being studied, or the 
focus of the study; 
‘‘(hh) the intervention name 
and intervention type; 
‘‘(ii) the study start date; 
‘‘(jj) the expected completion 
date; 
‘‘(kk) the target number of 
subjects; and 
‘‘(ll) outcomes, including pri-
mary and secondary outcome 
measures; 
‘‘(II) recruitment information, in-
cluding— 
‘‘(aa) eligibility criteria; 
‘‘(bb) gender; 
‘‘(cc) age limits; 
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‘‘(iii) POINT OF CONTACT.—A point of 
contact for scientific information about the 
clinical trial results. 
‘‘(iv) 
CERTAIN
AGREEMENTS.— 
Whether there exists an agreement (other 
than an agreement solely to comply with 
applicable provisions of law protecting the 
privacy of participants) between the spon-
sor or its agent and the principal investi-
gator (unless the sponsor is an employer of 
the principal investigator) that restricts in 
any manner the ability of the principal in-
vestigator, after the completion date of the 
trial, to discuss the results of the trial at 
a scientific meeting or any other public or 
private forum, or to publish in a scientific 
or academic journal information con-
cerning the results of the trial. 
‘‘(D) EXPANDED REGISTRY AND RESULTS 
DATA BANK.— 
‘‘(i) EXPANSION
BY
RULEMAKING.— 
To provide more complete results informa-
tion and to enhance patient access to and 
understanding of the results of clinical 
trials, not later than 3 years after the date 
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238 
of the enactment of the Food and Drug 
Administration Amendments Act of 2007, 
the Secretary shall by regulation expand 
the registry and results data bank as pro-
vided under this subparagraph. 
‘‘(ii) CLINICAL TRIALS.— 
‘‘(I) APPROVED PRODUCTS.—The 
regulations under this subparagraph 
shall require the inclusion of the re-
sults information described in clause 
(iii) for— 
‘‘(aa) each applicable drug 
clinical trial for a drug that is 
approved under section 505 of 
the Federal Food, Drug, and 
Cosmetic Act or licensed under 
section 351 of this Act; and 
‘‘(bb) each applicable device 
clinical trial for a device that is 
cleared under section 510(k) of 
the Federal Food, Drug, and 
Cosmetic Act or approved under 
section 515 or 520(m) of such 
Act. 
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239 
‘‘(II) UNAPPROVED PRODUCTS.— 
The regulations under this subpara-
graph shall establish whether or not 
the results information described in 
clause (iii) shall be required for— 
‘‘(aa) an applicable drug 
clinical trial for a drug that is 
not approved under section 505 
of the Federal Food, Drug, and 
Cosmetic Act and not licensed 
under section 351 of this Act 
(whether approval or licensure 
was sought or not); and 
‘‘(bb) an applicable device 
clinical trial for a device that is 
not cleared under section 510(k) 
of the Federal Food, Drug, and 
Cosmetic Act and not approved 
under section 515 or section 
520(m) of such Act (whether 
clearance or approval was sought 
or not). 
‘‘(iii) 
REQUIRED
ELEMENTS.—The 
regulations under this subparagraph shall 
require, in addition to the elements de-
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240 
scribed in subparagraph (C), information 
within each of the following categories: 
‘‘(I) A summary of the clinical 
trial and its results that is written in 
non-technical, 
understandable 
lan-
guage for patients, if the Secretary 
determines that such types of sum-
mary can be included without being 
misleading or promotional. 
‘‘(II) A summary of the clinical 
trial and its results that is technical 
in nature, if the Secretary determines 
that such types of summary can be in-
cluded without being misleading or 
promotional. 
‘‘(III) The full protocol or such 
information on the protocol for the 
trial as may be necessary to help to 
evaluate the results of the trial. 
‘‘(IV) Such other categories as 
the Secretary determines appropriate. 
‘‘(iv) RESULTS SUBMISSION.—The re-
sults information described in clause (iii) 
shall be submitted to the Director of NIH 
for inclusion in the registry and results 
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241 
data bank as provided by subparagraph 
(E), except that the Secretary shall by reg-
ulation determine— 
‘‘(I) whether the 1-year period 
for submission of clinical trial infor-
mation described in subparagraph 
(E)(i) should be increased from 1 year 
to a period not to exceed 18 months; 
‘‘(II) whether the clinical trial in-
formation described in clause (iii) 
should be required to be submitted for 
an applicable clinical trial for which 
the clinical trial information described 
in subparagraph (C) is submitted to 
the registry and results data bank be-
fore the effective date of the regula-
tions issued under this subparagraph; 
and 
‘‘(III) in the case when the clin-
ical trial information described in 
clause (iii) is required to be submitted 
for the applicable clinical trials de-
scribed in clause (ii)(II), the date by 
which such clinical trial information 
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242 
shall be required to be submitted, tak-
ing into account— 
‘‘(aa) the certification proc-
ess under subparagraph (E)(iii) 
when 
approval, 
licensure, 
or 
clearance is sought; and 
‘‘(bb) whether there should 
be a delay of submission when 
approval, licensure, or clearance 
will not be sought. 
‘‘(v) ADDITIONAL
PROVISIONS.—The 
regulations under this subparagraph shall 
also establish— 
‘‘(I) a standard format for the 
submission of clinical trial information 
under this paragraph to the registry 
and results data bank; 
‘‘(II) additional information on 
clinical trials and results that is writ-
ten in nontechnical, understandable 
language for patients; 
‘‘(III) considering the experience 
under the pilot quality control project 
described in paragraph (5)(C), proce-
dures for quality control, including 
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243 
using representative samples, with re-
spect to completeness and content of 
clinical trial information under this 
subsection, to help ensure that data 
elements are not false or misleading 
and are non-promotional; 
‘‘(IV) the appropriate timing and 
requirements for updates of clinical 
trial information, and whether and, if 
so, how such updates should be 
tracked; 
‘‘(V) a statement to accompany 
the entry for an applicable clinical 
trial when the primary and secondary 
outcome measures for such clinical 
trial are submitted under paragraph 
(4)(A) after the date specified for the 
submission of such information in 
paragraph (2)(C); and 
‘‘(VI) additions or modifications 
to the manner of reporting of the data 
elements established under subpara-
graph (C). 
‘‘(vi) 
CONSIDERATION
OF
WORLD 
HEALTH
ORGANIZATION
DATA
SET.—The 
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250 
‘‘(vi) EXTENSIONS.—The Director of 
NIH may provide an extension of the 
deadline for submission of clinical trial in-
formation under clause (i) if the respon-
sible party for the trial submits to the Di-
rector a written request that demonstrates 
good cause for the extension and provides 
an estimate of the date on which the infor-
mation will be submitted. The Director of 
NIH may grant more than one such exten-
sion for a clinical trial. 
‘‘(F) NOTICE TO DIRECTOR OF NIH.—The 
Commissioner of Food and Drugs shall notify 
the Director of NIH when there is an action de-
scribed in subparagraph (E)(iv) or item (aa), 
(bb), or (cc) of subparagraph (E)(v)(I) with re-
spect to an application or a report that includes 
a certification required under paragraph (5)(B) 
of such action not later than 30 days after such 
action. 
‘‘(G) POSTING OF DATA.—The Director of 
NIH shall ensure that the clinical trial informa-
tion described in subparagraphs (C) and (D) 
for an applicable clinical trial submitted in ac-
cordance with this paragraph is posted publicly 
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251 
in the registry and results database not later 
than 30 days after such submission. 
‘‘(H) WAIVERS REGARDING CERTAIN CLIN-
ICAL
TRIAL
RESULTS.—The Secretary may 
waive any applicable requirements of this para-
graph for an applicable clinical trial, upon a 
written request from the responsible party, if 
the Secretary determines that extraordinary cir-
cumstances justify the waiver and that pro-
viding the waiver is consistent with the protec-
tion of public health, or in the interest of na-
tional security. Not later than 30 days after 
any part of a waiver is granted, the Secretary 
shall notify, in writing, the appropriate commit-
tees of Congress of the waiver and provide an 
explanation for why the waiver was granted. 
‘‘(I) ADVERSE EVENTS.— 
‘‘(i) REGULATIONS.—Not later than 
18 months after the date of the enactment 
of the Food and Drug Administration 
Amendments Act of 2007, the Secretary 
shall by regulation determine the best 
method for including in the registry and 
results data bank appropriate results infor-
mation on serious adverse and frequent ad-
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252 
verse events for drugs described in sub-
paragraph (C) in a manner and form that 
is useful and not misleading to patients, 
physicians, and scientists. 
‘‘(ii) DEFAULT.—If the Secretary fails 
to issue the regulation required by clause 
(i) by the date that is 24 months after the 
date of the enactment of the Food and 
Drug Administration Amendments Act of 
2007, clause (iii) shall take effect. 
‘‘(iii) ADDITIONAL ELEMENTS.—Upon 
the application of clause (ii), the Secretary 
shall include in the registry and results 
data bank for drugs described in subpara-
graph (C), in addition to the clinical trial 
information described in subparagraph (C), 
the following elements: 
‘‘(I) 
SERIOUS
ADVERSE 
EVENTS.—A table of anticipated and 
unanticipated serious adverse events 
grouped by organ system, with num-
ber and frequency of such event in 
each arm of the clinical trial. 
‘‘(II) 
FREQUENT
ADVERSE 
EVENTS.—A table of anticipated and 
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unanticipated adverse events that are 
not included in the table described in 
subclause (I) that exceed a frequency 
of 5 percent within any arm of the 
clinical trial, grouped by organ sys-
tem, with number and frequency of 
such event in each arm of the clinical 
trial. 
‘‘(iv) POSTING OF OTHER INFORMA-
TION.—In carrying out clause (iii), the 
Secretary shall, in consultation with ex-
perts in risk communication, post with the 
tables information to enhance patient un-
derstanding and to ensure such tables do 
not mislead patients or the lay public. 
‘‘(v) RELATION
TO
SUBPARAGRAPH 
(C).—Clinical trial information included in 
the registry and results data bank pursu-
ant to this subparagraph is deemed to be 
clinical trial information included in such 
data bank pursuant to subparagraph (C). 
‘‘(4) ADDITIONAL
SUBMISSIONS
OF
CLINICAL 
TRIAL INFORMATION.— 
‘‘(A) VOLUNTARY
SUBMISSIONS.—A re-
sponsible party for a clinical trial that is not an 
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applicable clinical trial, or that is an applicable 
clinical trial that is not subject to paragraph 
(2)(C), may submit complete clinical trial infor-
mation described in paragraph (2) or paragraph 
(3) provided the responsible party submits clin-
ical trial information for each applicable clinical 
trial that is required to be submitted under sec-
tion 351 or under section 505, 510(k), 515, or 
520(m) of the Federal Food, Drug, and Cos-
metic Act in an application or report for licen-
sure, approval, or clearance of the drug or de-
vice for the use studied in the clinical trial. 
‘‘(B) REQUIRED SUBMISSIONS.— 
‘‘(i) IN
GENERAL.—Notwithstanding 
paragraphs (2) and (3) and subparagraph 
(A), in any case in which the Secretary de-
termines for a specific clinical trial de-
scribed in clause (ii) that posting in the 
registry and results data bank of clinical 
trial information for such clinical trial is 
necessary to protect the public health— 
‘‘(I) the Secretary may require 
by notification that such information 
be submitted to the Secretary in ac-
cordance with paragraphs (2) and (3) 
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except with regard to timing of sub-
mission; 
‘‘(II) unless the responsible party 
submits a certification under para-
graph (3)(E)(iii), such information 
shall be submitted not later than 30 
days after the date specified by the 
Secretary in the notification; and 
‘‘(III) failure to comply with the 
requirements under subclauses (I) and 
(II) shall be treated as a violation of 
the corresponding requirement of such 
paragraphs. 
‘‘(ii) CLINICAL TRIALS DESCRIBED.— 
A clinical trial described in this clause is— 
‘‘(I) an applicable clinical trial 
for a drug that is approved under sec-
tion 505 of the Federal Food, Drug, 
and Cosmetic Act or licensed under 
section 351 of this Act or for a device 
that is cleared under section 510(k) of 
the Federal Food, Drug, and Cos-
metic Act or approved under section 
515 or section 520(m) of such Act, 
whose completion date is on or after 
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257 
‘‘(III) not later than 30 days 
after the recruitment status of such 
clinical trial changes, shall include an 
update of the recruitment status; and 
‘‘(IV) not later than 30 days 
after the completion date of the clin-
ical trial, shall include notification to 
the Director that such clinical trial is 
complete. 
‘‘(ii) PUBLIC
AVAILABILITY
OF
UP-
DATES.—The Director of NIH shall make 
updates submitted under clause (i) publicly 
available in the registry data bank. Except 
with regard to overall recruitment status, 
individual site status, location, and contact 
information, the Director of NIH shall en-
sure that updates to elements required 
under subclauses (I) to (V) of paragraph 
(2)(A)(ii) do not result in the removal of 
any information from the original submis-
sions or any preceding updates, and infor-
mation in such databases is presented in a 
manner that enables users to readily access 
each original element submission and to 
track the changes made by the updates. 
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The Director of NIH shall provide a link 
from the table of primary and secondary 
outcomes 
required 
under 
paragraph 
(3)(C)(ii) to the tracked history required 
under this clause of the primary and sec-
ondary outcome measures submitted under 
paragraph (2)(A)(ii)(I)(ll). 
‘‘(5) COORDINATION AND COMPLIANCE.— 
‘‘(A) CLINICAL
TRIALS
SUPPORTED
BY 
GRANTS FROM FEDERAL AGENCIES.— 
‘‘(i) GRANTS FROM CERTAIN FEDERAL 
AGENCIES.—If an applicable clinical trial is 
funded in whole or in part by a grant from 
any agency of the Department of Health 
and Human Services, including the Food 
and Drug Administration, the National In-
stitutes of Health, or the Agency for 
Healthcare Research and Quality, any 
grant or progress report forms required 
under such grant shall include a certifi-
cation that the responsible party has made 
all required submissions to the Director of 
NIH under paragraph (2) and (3). 
‘‘(ii) 
VERIFICATION
BY
FEDERAL 
AGENCIES.—The heads of the agencies re-
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259 
ferred to in clause (i), 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) be-
fore releasing any remaining funding for a 
grant or funding for a future grant to such 
grantee. 
‘‘(iii) NOTICE AND OPPORTUNITY TO 
REMEDY.—If the head of an agency re-
ferred to in clause (i), as applicable, 
verifies that a grantee has not submitted 
clinical trial information as described in 
clause (ii), such agency head shall provide 
notice to such grantee of such non-compli-
ance and allow such grantee 30 days to 
correct such non-compliance and submit 
the required clinical trial information. 
‘‘(iv) CONSULTATION
WITH
OTHER 
FEDERAL
AGENCIES.—The 
Secretary 
shall— 
‘‘(I) consult with other agencies 
that 
conduct 
research 
involving 
human subjects in accordance with 
any section of part 46 of title 45, 
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260 
Code of Federal Regulations (or any 
successor regulations), to determine if 
any such research is an applicable 
clinical trial; and 
‘‘(II) develop with such agencies 
procedures comparable to those de-
scribed in clauses (i), (ii), and (iii) to 
ensure that clinical trial information 
for such applicable clinical trial is 
submitted under paragraph (2) and 
(3). 
‘‘(B) 
CERTIFICATION
TO
ACCOMPANY 
DRUG, BIOLOGICAL PRODUCT, AND DEVICE SUB-
MISSIONS.—At the time of submission of an ap-
plication under section 505 of the Federal 
Food, Drug, and Cosmetic Act, section 515 of 
such Act, section 520(m) of such Act, or section 
351 of this Act, or submission of a report under 
section 510(k) of such Act, such application or 
submission shall be accompanied by a certifi-
cation that all applicable requirements of this 
subsection have been met. Where available, such 
certification shall include the appropriate Na-
tional Clinical Trial control numbers. 
‘‘(C) QUALITY CONTROL.— 
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261 
‘‘(i) 
PILOT
QUALITY
CONTROL 
PROJECT.—Until the effective date of the 
regulations issued under paragraph (3)(D), 
the Secretary, acting through the Director 
of NIH and the Commissioner of Food and 
Drugs, shall conduct a pilot project to de-
termine the optimal method of verification 
to help to ensure that the clinical trial in-
formation 
submitted 
under 
paragraph 
(3)(C) is non-promotional and is not false 
or misleading in any particular under sub-
paragraph (D). The Secretary shall use the 
publicly available information described in 
paragraph (3)(A) and any other informa-
tion available to the Secretary about appli-
cable clinical trials to verify the accuracy 
of the clinical trial information submitted 
under paragraph (3)(C). 
‘‘(ii) NOTICE OF COMPLIANCE.—If the 
Secretary determines that any clinical trial 
information was not submitted as required 
under this subsection, or was submitted 
but is false or misleading in any particular, 
the Secretary shall notify the responsible 
party and give such party an opportunity 
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262 
to remedy such noncompliance by submit-
ting the required revised clinical trial infor-
mation not later than 30 days after such 
notification. 
‘‘(D) TRUTHFUL CLINICAL TRIAL INFOR-
MATION.— 
‘‘(i) IN GENERAL.—The clinical trial 
information submitted by a responsible 
party under this subsection shall not be 
false or misleading in any particular. 
‘‘(ii) EFFECT.—Clause (i) shall not 
have the effect of— 
‘‘(I) requiring clinical trial infor-
mation with respect to an applicable 
clinical trial to include information 
from any source other than such clin-
ical trial involved; or 
‘‘(II) requiring clinical trial infor-
mation described in paragraph (3)(D) 
to be submitted for purposes of para-
graph (3)(C). 
‘‘(E) PUBLIC NOTICES.— 
‘‘(i) NOTICE OF VIOLATIONS.—If the 
responsible party for an applicable clinical 
trial fails to submit clinical trial informa-
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265 
‘‘(v) NON-SUBMISSION
OF
STATE-
MENT.—The notice under clause (ii) for a 
violation described in clause (ii) shall in-
clude the following statement: ‘The entry 
for this clinical trial did not contain infor-
mation on the primary and secondary out-
comes at the time of submission, as re-
quired by law. This may or may not have 
any bearing on the accuracy of the infor-
mation in the entry.’ 
‘‘(vi) COMPLIANCE
SEARCHES.—The 
Director of NIH shall provide that the 
public may easily search the registry and 
results data bank for entries that include 
notices required under this subparagraph. 
‘‘(6) LIMITATION ON DISCLOSURE OF CLINICAL 
TRIAL INFORMATION.— 
‘‘(A) IN GENERAL.—Nothing in this sub-
section (or under section 552 of title 5, United 
States Code) shall require the Secretary to pub-
licly disclose, by any means other than the reg-
istry and results data bank, information de-
scribed in subparagraph (B). 
‘‘(B) INFORMATION
DESCRIBED.—Infor-
mation described in this subparagraph is— 
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266 
‘‘(i) information submitted to the Di-
rector of NIH under this subsection, or in-
formation of the same general nature as 
(or integrally associated with) the informa-
tion so submitted; and 
‘‘(ii) information not otherwise pub-
licly available, including because it is pro-
tected from disclosure under section 552 of 
title 5, United States Code. 
‘‘(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) PROHIBITED
ACTS.—Section 301 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331) is amended by adding at the end the following: 
‘‘(jj)(1) The failure to submit the certification re-
quired by section 402(j)(5)(B) of the Public Health Serv-
ice Act, or knowingly submitting a false certification under 
such section. 
‘‘(2) The failure to submit clinical trial information 
required under subsection (j) of section 402 of the Public 
Health Service Act. 
‘‘(3) The submission of clinical trial information 
under subsection (j) of section 402 of the Public Health 
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Service Act that is false or misleading in any particular 
under paragraph (5)(D) of such subsection (j).’’. 
(2) CIVIL MONEY PENALTIES.—Subsection (f) 
of section 303 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 333), as redesignated by sec-
tion 226, is amended— 
(A) by redesignating paragraphs (3), (4), 
and (5) as paragraphs (5), (6), and (7), respec-
tively; 
(B) by inserting after paragraph (2) the 
following: 
‘‘(3)(A) Any person who violates section 301(jj) shall 
be subject to a civil monetary penalty of not more than 
$10,000 for all violations adjudicated in a single pro-
ceeding. 
‘‘(B) If a violation of section 301(jj) is not corrected 
within the 30-day period following notification under sec-
tion 402(j)(5)(C)(ii), the person shall, in addition to any 
penalty under subparagraph (A), be subject to a civil mon-
etary penalty of not more than $10,000 for each day of 
the violation after such period until the violation is cor-
rected.’’; 
(C) in paragraph (2)(C), by striking 
‘‘paragraph (3)(A)’’ and inserting ‘‘paragraph 
(5)(A)’’; 
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(D) in paragraph (5), as so redesignated, 
by striking ‘‘paragraph (1) or (2)’’ each place 
it appears and inserting ‘‘paragraph (1), (2),or 
(3)’’; 
(E) in paragraph (6), as so redesignated, 
by striking ‘‘paragraph (3)(A)’’ and inserting 
‘‘paragraph (5)(A)’’; and 
(F) in paragraph (7), as so redesignated, 
by striking ‘‘paragraph (4)’’ each place it ap-
pears and inserting ‘‘paragraph (6)’’. 
(3) NEW DRUGS AND DEVICES.— 
(A) INVESTIGATIONAL NEW DRUGS.—Sec-
tion 505(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(i)) is amended in 
paragraph (4), by adding at the end the fol-
lowing: ‘‘The Secretary shall update such regu-
lations to require inclusion in the informed con-
sent documents and process a statement that 
clinical trial information for such clinical inves-
tigation has been or will be submitted for inclu-
sion in the registry data bank pursuant to sub-
section (j) of section 402 of the Public Health 
Service Act.’’. 
(B) NEW
DRUG
APPLICATIONS.—Section 
505(b) of the Federal Food, Drug, and Cos-
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269 
metic Act (21 U.S.C. 355(b)) is amended by 
adding at the end the following: 
‘‘(6) An application submitted under this sub-
section shall be accompanied by the certification re-
quired under section 402(j)(5)(B) of the Public 
Health Service Act. Such certification shall not be 
considered an element of such application.’’. 
(C) DEVICE
REPORTS
UNDER
SECTION 
510(k).—Section 510(k) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(k)) is 
amended by adding at the end the following: 
‘‘A notification submitted under this subsection that con-
tains clinical trial data for an applicable device clinical 
trial (as defined in section 402(j)(1) of the Public Health 
Service Act) shall be accompanied by the certification re-
quired under section 402(j)(5)(B) of such Act. Such cer-
tification shall not be considered an element of such notifi-
cation.’’. 
(D) DEVICE PREMARKET APPROVAL APPLI-
CATION.—Section 515(c)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
360e(c)(1)) is amended— 
(i) in subparagraph (F), by striking ‘‘; 
and’’ and inserting a semicolon; 
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(ii) by redesignating subparagraph 
(G) as subparagraph (H); and 
(iii) by inserting after subparagraph 
(F) the following: 
‘‘(G) the certification required under sec-
tion 402(j)(5)(B) of the Public Health Service 
Act (which shall not be considered an element 
of such application); and’’. 
(E) 
HUMANITARIAN
DEVICE
EXEMP-
TION.—Section 520(m)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is 
amended in the first sentence in the matter fol-
lowing subparagraph (C), by inserting at the 
end before the period ‘‘and such application 
shall include the certification required under 
section 402(j)(5)(B) of the Public Health Serv-
ice Act (which shall not be considered an ele-
ment of such application)’’. 
(c) SURVEILLANCES.—Not later than 12 months 
after the date of the enactment of this Act, the Secretary 
of Health and Human Services shall issue guidance on 
how the requirements of section 402(j) of the Public 
Health Service Act, as added by this section, apply to a 
pediatric postmarket surveillance described in paragraph 
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(1)(A)(ii)(II) of such section 402(j) that is not a clinical 
trial. 
(d) PREEMPTION.— 
(1) IN GENERAL.—Upon the expansion of the 
registry and results data bank under section 
402(j)(3)(D) of the Public Health Service Act, as 
added by this section, 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. 
(2) RULE OF CONSTRUCTION.—The fact of sub-
mission of clinical trial information, if submitted in 
compliance with subsection (j) of section 402 of the 
Public Health Service Act (as amended by this sec-
tion), that relates 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 of 
Health and Human Services or in any administra-
tive or judicial proceeding, as evidence of a new in-
tended 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 
registry and results data bank under such subsection 
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‘‘(2) DEFINITIONS.—For purposes of this sub-
section: 
‘‘(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 (D), 
require a responsible person for a drug to con-
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duct a postapproval study or studies of the 
drug, or a postapproval clinical trial or trials of 
the drug, on the basis of scientific data deemed 
appropriate by the Secretary, including infor-
mation regarding chemically-related or pharma-
cologically-related drugs. 
‘‘(B) PURPOSES OF STUDY OR CLINICAL 
TRIAL.—The purposes referred to in this sub-
paragraph with respect to a postapproval study 
or postapproval 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 an unexpected seri-
ous risk when available data indicates the 
potential for a serious risk. 
‘‘(C) ESTABLISHMENT
OF
REQUIREMENT 
AFTER APPROVAL OF COVERED APPLICATION.— 
The Secretary may require a postapproval study 
or studies or postapproval clinical trial or trials 
for a drug for which an approved covered appli-
cation is in effect as of the date on which the 
Secretary seeks to establish such requirement 
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only if the Secretary becomes aware of new 
safety information. 
‘‘(D) DETERMINATION BY SECRETARY.— 
‘‘(i) POSTAPPROVAL
STUDIES.—The 
Secretary may not require the responsible 
person to conduct a study under this para-
graph, unless the Secretary makes a deter-
mination that the reports under subsection 
(k)(1) and the active postmarket risk iden-
tification and analysis system as available 
under subsection (k)(3) will not be suffi-
cient to meet the purposes set forth in sub-
paragraph (B). 
‘‘(ii) 
POSTAPPROVAL
CLINICAL 
TRIALS.—The Secretary may not require 
the responsible person to conduct a clinical 
trial under this paragraph, unless the Sec-
retary makes a determination that a post-
approval study or studies will not be suffi-
cient to meet the purposes set forth in sub-
paragraph (B). 
‘‘(E) NOTIFICATION; TIMETABLES; PERI-
ODIC REPORTS.— 
‘‘(i) NOTIFICATION.—The Secretary 
shall notify the responsible person regard-
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ing a requirement under this paragraph to 
conduct a postapproval study or clinical 
trial by the target dates for communication 
of feedback from the review team to the re-
sponsible person regarding proposed label-
ing and postmarketing study commitments 
as set forth in the letters described in sec-
tion 101(c) of the Food and Drug Admin-
istration Amendments Act of 2007. 
‘‘(ii) 
TIMETABLE; 
PERIODIC
RE-
PORTS.—For each study or clinical trial re-
quired to be conducted under this para-
graph, the Secretary shall require that the 
responsible person submit a timetable for 
completion of the study or clinical trial. 
With respect to each study required to be 
conducted under this paragraph or other-
wise undertaken by the responsible person 
to investigate a safety issue, the Secretary 
shall require the responsible person to peri-
odically report to the Secretary on the sta-
tus of such study including whether any 
difficulties in completing the study have 
been encountered. With respect to each 
clinical trial required to be conducted 
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under this paragraph or otherwise under-
taken by the responsible person to inves-
tigate a safety issue, the Secretary shall 
require the responsible person to periodi-
cally report to the Secretary on the status 
of such clinical trial including whether en-
rollment has begun, the number of partici-
pants enrolled, the expected completion 
date, whether any difficulties completing 
the clinical trial have been encountered, 
and registration information with respect 
to the requirements under section 402(j) of 
the Public Health Service Act. If the re-
sponsible person fails to comply with such 
timetable or violates any other requirement 
of this subparagraph, the responsible per-
son shall be considered in violation of this 
subsection, unless the responsible person 
demonstrates good cause for such non-
compliance or such other violation. The 
Secretary shall determine what constitutes 
good cause under the preceding sentence. 
‘‘(F) DISPUTE RESOLUTION.—The respon-
sible person may appeal a requirement to con-
duct a study or clinical trial under this para-
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graph using dispute resolution procedures es-
tablished by the Secretary in regulation and 
guidance. 
‘‘(4) SAFETY LABELING CHANGES REQUESTED 
BY SECRETARY.— 
‘‘(A) NEW SAFETY INFORMATION.—If the 
Secretary becomes aware of new safety informa-
tion that the Secretary believes should be in-
cluded in the labeling of the drug, the Secretary 
shall promptly notify the responsible person or, 
if the same drug approved under section 505(b) 
is not currently marketed, the holder of an ap-
proved application under 505(j). 
‘‘(B) RESPONSE TO NOTIFICATION.—Fol-
lowing notification pursuant to subparagraph 
(A), the responsible person or the holder of the 
approved application under section 505(j) 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 
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considered to be in violation of this subsection. 
If at the conclusion of any dispute resolution 
procedures the Secretary determines that a sup-
plement must be submitted and such a supple-
ment is not submitted within 15 days of the 
date of that determination, the responsible per-
son or holder shall be in violation of this sub-
section. 
‘‘(H) PUBLIC HEALTH THREAT.—Notwith-
standing subparagraphs (A) through (F), if the 
Secretary concludes that such a labeling change 
is necessary to protect the public health, the 
Secretary may accelerate the timelines in such 
subparagraphs. 
‘‘(I) RULE OF CONSTRUCTION.—This para-
graph shall not be construed to affect the re-
sponsibility of the responsible person or the 
holder of the approved application under section 
505(j) to maintain its label in accordance with 
existing requirements, including subpart B of 
part 201 and sections 314.70 and 601.12 of 
title 21, Code of Federal Regulations (or any 
successor regulations). 
‘‘(5) 
NON-DELEGATION.—Determinations 
by 
the Secretary under this subsection for a drug shall 
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be made by individuals at or above the level of indi-
viduals empowered to approve a drug (such as divi-
sion directors within the Center for Drug Evaluation 
and Research). 
‘‘(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 the person fails to 
maintain compliance with the requirements of 
the approved strategy or with other require-
ments under section 505–1, including require-
ments regarding assessments of approved strat-
egies. 
‘‘(2) CERTAIN
POSTMARKET
STUDIES.—The 
failure to conduct a postmarket study under section 
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506, subpart H of part 314, or subpart E of part 
601 of title 21, Code of Federal Regulations (or any 
successor regulations), is deemed to be a violation of 
paragraph (1).’’. 
(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.—If the Secretary, in 
consultation with the office responsible for reviewing 
the drug and the office responsible for postapproval 
safety with respect to the drug, determines that a 
risk evaluation and mitigation strategy is necessary 
to ensure that the benefits of the drug outweigh the 
risks of the drug, and informs the person who sub-
mits such application of such determination, then 
such person shall submit to the Secretary as part of 
such application a proposed risk evaluation and miti-
gation strategy. In making such a determination, the 
Secretary shall consider the following factors: 
‘‘(A) The estimated size of the population 
likely to use the drug involved. 
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‘‘(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. 
‘‘(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) Whether the drug is a new molecular 
entity. 
‘‘(2) POSTAPPROVAL REQUIREMENT.— 
‘‘(A) IN GENERAL.—If the Secretary has 
approved a covered application (including an 
application approved before the effective date of 
this section) and did not when approving the 
application require a risk evaluation and mitiga-
tion strategy under paragraph (1), the Sec-
retary, in consultation with the offices described 
in paragraph (1), may subsequently require 
such a strategy for the drug involved (including 
when acting on a supplemental application seek-
ing approval of a new indication for use of the 
drug) if the Secretary becomes aware of new 
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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-
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 
reasonable time as the Secretary requires to 
protect the public health, the holder shall sub-
mit to the Secretary a proposed risk evaluation 
and mitigation strategy. 
‘‘(3) 
ABBREVIATED
NEW
DRUG
APPLICA-
TIONS.—The applicability of this section to an appli-
cation under section 505(j) is subject to subsection 
(i). 
‘‘(4) 
NON-DELEGATION.—Determinations 
by 
the Secretary under this subsection for a drug shall 
be made by individuals at or above the level of indi-
viduals empowered to approve a drug (such as divi-
sion directors within the Center for Drug Evaluation 
and Research). 
‘‘(b) DEFINITIONS.—For purposes of this section: 
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(c)(2), determines that new safety or effective-
ness information indicates 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, in consultation with the offices de-
scribed in subsection (c)(2), if the Secretary de-
termines that there may be a cause for action 
by the Secretary 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 elements to assure safe use are meet-
ing the goal or whether the goal or such ele-
ments should be modified; 
‘‘(B) with respect to any postapproval 
study required under section 505(o) or other-
wise undertaken by the responsible person to 
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