H. R. 3580—78 
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 ‘advisory committee’ 
means an advisory committee under the Federal Advisory Com-
mittee Act that provides advice or recommendations to the 
Secretary regarding activities of the Food and Drug Administra-
tion. 
‘‘(2) FINANCIAL
INTEREST.—The term ‘financial interest’ 
means a financial interest under section 208(a) of title 18, 
United States Code. 
‘‘(b) APPOINTMENTS TO ADVISORY COMMITTEES.— 
‘‘(1) RECRUITMENT.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) develop and implement strategies on effective 
outreach to potential members of advisory committees 
at universities, colleges, other academic research cen-
ters, professional and medical societies, and patient 
and consumer groups; 
‘‘(ii) seek input from professional medical and sci-
entific societies to determine 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 recruitment activi-
ties under subparagraph (A) may include— 
‘‘(i) advertising the process for becoming an 
advisory committee member at medical and scientific 
society conferences; 
‘‘(ii) making widely available, including by using 
existing electronic communications channels, the con-
tact information for the Food and Drug Administration 
point of contact regarding advisory committee nomina-
tions; 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 Administration can iden-
tify a person who the Food and Drug Administration 
can contact regarding the nomination of individuals 
to serve on advisory committees. 
‘‘(2) EVALUATION AND CRITERIA.—When considering a term 
appointment to an advisory committee, the Secretary shall 
review the expertise of the individual and the financial disclo-
sure report filed by the individual pursuant to the Ethics in 
Government Act of 1978 for each individual under consideration
H. R. 3580—79 
for the appointment, so as to reduce the likelihood that an 
appointed individual will later require a written determination 
as referred to in section 208(b)(1) of title 18, United States 
Code, a written certification as referred to in section 208(b)(3) 
of title 18, United States Code, or a waiver as referred to 
in subsection (c)(2) of this section for service on the committee 
at a meeting of the committee. 
‘‘(c) DISCLOSURES; PROHIBITIONS ON PARTICIPATION; WAIVERS.— 
‘‘(1) DISCLOSURE
OF
FINANCIAL
INTEREST.—Prior to a 
meeting of an advisory committee regarding 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 Government employee or special Government employee 
shall disclose to the Secretary financial interests in accordance 
with subsection (b) of such section 208. 
‘‘(2) PROHIBITIONS AND WAIVERS ON PARTICIPATION.— 
‘‘(A) IN GENERAL.—Except as provided under subpara-
graph (B), a member of an advisory committee may not 
participate with respect to a particular matter considered 
in an advisory committee meeting if such member (or an 
immediate 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 inconsequential 
to affect the integrity of the services of the Government 
officers or employees to which such regulations apply. 
‘‘(B) WAIVER.—If the Secretary determines it necessary 
to afford the advisory committee essential expertise, the 
Secretary may grant a waiver of the prohibition in subpara-
graph (A) to permit a member described in such subpara-
graph to— 
‘‘(i) participate as a non-voting member with 
respect to a particular matter considered in a com-
mittee meeting; or 
‘‘(ii) participate as a voting member with respect 
to a particular matter considered in a committee 
meeting. 
‘‘(C) LIMITATION ON WAIVERS AND OTHER EXCEPTIONS.— 
‘‘(i) DEFINITION.—For purposes of this subpara-
graph, 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 before the date of the enactment 
of the 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 MEM-
BERS SLOTS AND MEMBER 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
H. R. 3580—80 
‘‘(bb) the sum of the respective numbers deter-
mined under item (aa) (referred to in this subpara-
graph as the ‘‘total number of 2007 meeting slots’’); 
and 
‘‘(II)(aa) for each meeting held by any advisory 
committee during fiscal year 2007, the number 
of members who received an exception for the 
meeting; and 
‘‘(bb) the sum of the respective numbers deter-
mined under item (aa) (referred to in this subpara-
graph as the ‘‘total number of 2007 meeting excep-
tions’’). 
‘‘(iii) DETERMINATION OF PERCENTAGE REGARDING 
EXCEPTIONS DURING FISCAL YEAR 2007.—The Secretary 
shall determine the percentage constituted by— 
‘‘(I) the total number of 2007 meeting excep-
tions; divided by 
‘‘(II) the total number of 2007 meeting slots. 
‘‘(iv) LIMITATION FOR FISCAL YEARS 2008 THROUGH 
2012.—The number of exceptions at the Food and Drug 
Administration for members of advisory committees 
for a fiscal year may not exceed the following: 
‘‘(I) For fiscal year 2008, 95 percent 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. 
‘‘(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 within the centers or other organizational 
units of the Food and Drug Administration as deter-
mined appropriate by the Secretary. 
‘‘(3) DISCLOSURE
OF
WAIVER.—Notwithstanding section 
107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), 
the following shall apply: 
‘‘(A) 15 OR MORE DAYS IN ADVANCE.—As soon as prac-
ticable, but (except as provided in subparagraph (B)) not 
later than 15 days prior to a meeting of an advisory com-
mittee to which a written determination as referred to 
in section 208(b)(1) of title 18, United States Code, a writ-
ten 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) applies, the Secretary shall disclose (other 
than information exempted from disclosure under section 
552 of title 5, United States Code, and section 552a of 
title 5, United States Code (popularly known as the 
Freedom of Information Act and the Privacy Act of 1974, 
respectively)) on the Internet Web site of the Food and 
Drug Administration— 
‘‘(i) the type, nature, and magnitude of the finan-
cial interests of the advisory committee member to
H. R. 3580—81 
which such determination, certification, or waiver 
applies; and 
‘‘(ii) the reasons of the Secretary for such deter-
mination, certification, or waiver. 
‘‘(B) LESS
THAN
DAYS
IN
ADVANCE.—In the case 
of a financial interest that becomes known to the Secretary 
less than 30 days prior to a meeting of an advisory com-
mittee to which a written determination as referred to 
in section 208(b)(1) of title 18, United States Code, a writ-
ten 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) applies, the Secretary shall disclose (other 
than information exempted from disclosure under section 
552 of title 5, United States Code, and section 552a of 
title 5, United States Code) on the Internet Web site of 
the Food and Drug Administration, the information 
described in clauses (i) and (ii) of subparagraph (A) as 
soon as practicable after the Secretary makes such deter-
mination, certification, or waiver, but in no case later than 
the date of such meeting. 
‘‘(d) PUBLIC RECORD.—The Secretary shall ensure that the 
public record and transcript of each meeting of an advisory com-
mittee includes the disclosure required under subsection (c)(3) (other 
than information exempted from disclosure under section 552 of 
title 5, United States Code, and section 552a of title 5, United 
States Code). 
‘‘(e) ANNUAL REPORT.—Not later than February 1 of each year, 
the Secretary shall submit to the Committee on Appropriations 
and the Committee on Health, Education, Labor, and Pensions 
of the Senate, and the Committee on Appropriations and the Com-
mittee on Energy and Commerce of the House of Representatives 
a report that describes— 
‘‘(1) with respect to the fiscal year that ended on September 
30 of the previous year, the number of vacancies on each 
advisory committee, the number of nominees received for each 
committee, and the number of such nominees willing to serve; 
‘‘(2) with respect to such year, the aggregate number of 
disclosures required under subsection (c)(3) for each meeting 
of each advisory committee and the percentage of individuals 
to whom such disclosures did not apply who served on such 
committee for each such meeting; 
‘‘(3) with respect to such year, the number of times the 
disclosures required under subsection (c)(3) occurred under 
subparagraph (B) of such subsection; and 
‘‘(4) how the Secretary plans to reduce the number of 
vacancies reported under paragraph (1) during the fiscal year 
following such year, and mechanisms to encourage the nomina-
tion of individuals for service on an advisory committee, 
including those who are classified by the Food and Drug 
Administration as academicians or practitioners. 
‘‘(f) PERIODIC REVIEW OF GUIDANCE.—Not less than once every 
5 years, the Secretary shall review guidance of the Food and Drug 
Administration regarding conflict of interest waiver determinations 
with respect to advisory committees and update such guidance 
as necessary.’’. 
(b) CONFORMING AMENDMENTS.—Section 505(n) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended by—
H. R. 3580—82 
(1) striking paragraph (4); and 
(2) redesignating paragraphs (5), (6), (7), and (8) as para-
graphs (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 applicable drug clinical trial. 
‘‘(ii) APPLICABLE DEVICE CLINICAL TRIAL.—The term 
‘applicable device clinical trial’ means— 
‘‘(I) a prospective clinical study of health out-
comes 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 subjects (other than a small clin-
ical trial to determine the feasibility of a device, 
or a clinical trial to test prototype devices where 
the primary outcome measure relates to feasibility 
and not to health outcomes); and 
‘‘(II) a pediatric postmarket surveillance 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 investiga-
tion, other than a phase I clinical investigation, 
of a drug subject to section 505 of the Federal 
Food, Drug, and Cosmetic Act or to section 351 
of this Act. 
‘‘(II) CLINICAL INVESTIGATION.—For purposes 
of subclause (I), the term ‘clinical investigation’ 
has the meaning given that term in section 312.3 
of title 21, Code of Federal Regulations (or any 
successor regulation). 
‘‘(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 INFORMATION.—The term ‘clin-
ical trial information’ means, with respect to an 
applicable clinical trial, those data elements that the 
responsible party is required to submit under para-
graph (2) or under paragraph (3).
H. R. 3580—83 
‘‘(v) COMPLETION
DATE.—The term ‘completion 
date’ means, with respect to an applicable clinical trial, 
the date that the final subject was examined or 
received an intervention for the purposes of final collec-
tion of data for the primary outcome, whether the 
clinical trial concluded according to the prespecified 
protocol or was terminated. 
‘‘(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 enrolled in the clin-
ical trial; and 
‘‘(II) the date is before the completion date 
of the clinical trial. 
‘‘(ix) RESPONSIBLE PARTY.—The term ‘responsible 
party’, with respect to a clinical trial of a drug or 
device, means— 
‘‘(I) the sponsor of the clinical trial (as defined 
in section 50.3 of title 21, Code of Federal Regula-
tions (or any successor regulation)); or 
‘‘(II) the principal investigator of such clinical 
trial if so designated by a sponsor, grantee, con-
tractor, or awardee, so long as the principal inves-
tigator is responsible for conducting the trial, has 
access to and control over the data from the clinical 
trial, has the right to publish the results of the 
trial, and has the ability to meet all of the require-
ments 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 submit the identity and con-
tact information of such responsible party to the Secretary 
at the time of submission of clinical trial information under 
paragraph (2). 
‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK 
WITH RESPECT TO CLINICAL TRIAL INFORMATION.— 
‘‘(A) IN GENERAL.— 
‘‘(i) EXPANSION OF DATA BANK.—To enhance patient 
enrollment and provide a mechanism to track subse-
quent progress of clinical trials, the Secretary, acting 
through the Director of NIH, shall expand, in accord-
ance with this subsection, the clinical trials registry 
of the data bank described under subsection (i)(1) 
(referred to in this subsection as the ‘registry data 
bank’). The Director of NIH shall ensure that the reg-
istry data bank is made publicly available through 
the Internet.
H. R. 3580—84 
‘‘(ii) CONTENT.—The clinical trial information 
required to be submitted under this paragraph for 
an applicable clinical trial shall include— 
‘‘(I) descriptive information, including— 
‘‘(aa) a brief title, intended for the lay 
public; 
‘‘(bb) a brief summary, intended 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 interven-
tion type; 
‘‘(ii) the study start date; 
‘‘(jj) the expected completion date; 
‘‘(kk) the target number of subjects; and 
‘‘(ll) outcomes, including primary and sec-
ondary outcome measures; 
‘‘(II) recruitment information, including— 
‘‘(aa) eligibility criteria; 
‘‘(bb) gender; 
‘‘(cc) age limits; 
‘‘(dd) whether the trial accepts healthy vol-
unteers; 
‘‘(ee) overall recruitment status; 
‘‘(ff) individual site status; and 
‘‘(gg) in the case of an applicable drug 
clinical trial, if the drug is not approved under 
section 505 of the Federal Food, Drug, and 
Cosmetic Act or licensed under section 351 
of this Act, specify whether or not there is 
expanded access to the drug under section 561 
of the Federal Food, Drug, and Cosmetic Act 
for those who do not qualify for enrollment 
in the clinical trial and how to obtain informa-
tion about such access; 
‘‘(III) 
location 
and 
contact 
information, 
including— 
‘‘(aa) the name of the sponsor; 
‘‘(bb) the responsible party, by official title; 
and 
‘‘(cc) the facility name and facility contact 
information (including the city, State, and zip 
code for each clinical trial location, or a toll- 
free number through which such location 
information may be accessed); and 
‘‘(IV) administrative data (which the Secretary 
may make publicly available as necessary), 
including— 
‘‘(aa) the unique protocol identification 
number; 
‘‘(bb) other protocol identification num-
bers, if any; and
H. R. 3580—85 
‘‘(cc) the Food and Drug Administration 
IND/IDE protocol number and the record 
verification date. 
‘‘(iii) MODIFICATIONS.—The Secretary may by regu-
lation modify the requirements for clinical trial 
information under this paragraph, if the Secretary pro-
vides a rationale for why such a modification improves 
and does not reduce such clinical trial information. 
‘‘(B) FORMAT AND STRUCTURE.— 
‘‘(i) SEARCHABLE
CATEGORIES.—The Director of 
NIH shall ensure that the public may, in addition 
to keyword searching, search the entries in the registry 
data bank by 1 or more of the following criteria: 
‘‘(I) The disease or condition being studied in 
the clinical trial, using Medical Subject Headers 
(MeSH) descriptors. 
‘‘(II) The name of the intervention, including 
any drug or device being studied in the clinical 
trial. 
‘‘(III) The location of the clinical trial. 
‘‘(IV) The age group studied in the clinical 
trial, including pediatric subpopulations. 
‘‘(V) The study phase of the clinical trial. 
‘‘(VI) The sponsor of the clinical trial, which 
may be the National Institutes of Health or 
another Federal agency, a private industry source, 
or a university or other organization. 
‘‘(VII) The recruitment status of the clinical 
trial. 
‘‘(VIII) The National Clinical Trial number or 
other study identification for the clinical trial. 
‘‘(ii) ADDITIONAL
SEARCHABLE
CATEGORY.—Not 
later than 18 months after the date of the enactment 
of the Food and Drug Administration Amendments 
Act of 2007, the Director of NIH shall ensure that 
the public may search the entries of the registry data 
bank by the safety issue, if any, being studied in the 
clinical trial as a primary or secondary outcome. 
‘‘(iii) OTHER ELEMENTS.—The Director of NIH shall 
also ensure that the public may search the entries 
of the registry data bank by such other elements as 
the Director deems necessary on an ongoing basis. 
‘‘(iv) FORMAT.—The Director of the NIH shall 
ensure that the registry data bank is easily used by 
the public, and that entries are easily compared. 
‘‘(C) DATA SUBMISSION.—The responsible party for an 
applicable clinical trial, including an applicable drug clin-
ical trial for a serious or life-threatening disease or condi-
tion, that is initiated after, or is ongoing on the date 
that is 90 days after, the date of the enactment of the 
Food and Drug Administration Amendments Act of 2007, 
shall submit to the Director of NIH for inclusion in the 
registry data bank the clinical trial information described 
in of subparagraph (A)(ii) not later than the later of— 
‘‘(i) 90 days after such date of enactment; 
‘‘(ii) 21 days after the first patient is enrolled in 
such clinical trial; or
H. R. 3580—86 
‘‘(iii) in the case of a clinical trial that is not 
for a serious or life-threatening disease or condition 
and that is ongoing on such date of enactment, 1 
year after such date of enactment. 
‘‘(D) POSTING OF DATA.— 
‘‘(i) 
APPLICABLE
DRUG
CLINICAL
TRIAL.—The 
Director of NIH shall ensure that clinical trial informa-
tion for an applicable drug clinical trial submitted in 
accordance with this paragraph is posted in the reg-
istry data bank not later than 30 days after such 
submission. 
‘‘(ii) APPLICABLE
DEVICE
CLINICAL
TRIAL.—The 
Director of NIH shall ensure that clinical trial informa-
tion for an applicable device clinical trial submitted 
in accordance with this paragraph is posted publicly 
in the registry data bank— 
‘‘(I) not earlier than the date of clearance 
under section 510(k) of the Federal Food, Drug, 
and Cosmetic Act, or approval under section 515 
or 520(m) of such Act, as applicable, for a device 
that was not previously cleared or approved, and 
not later than 30 days after such date; or 
‘‘(II) for a device that was previously cleared 
or approved, not later than 30 days after the clin-
ical trial information under paragraph (3)(C) is 
required to be posted by the Secretary. 
‘‘(3) EXPANSION
OF
REGISTRY
DATA
BANK
TO
INCLUDE 
RESULTS OF CLINICAL TRIALS.— 
‘‘(A) LINKING
REGISTRY
DATA
BANK
TO
EXISTING 
RESULTS.— 
‘‘(i) IN GENERAL.—Beginning not later than 90 days 
after the date of the enactment of the Food and Drug 
Administration Amendments Act of 2007, for those 
clinical trials that form the primary basis of an efficacy 
claim or are conducted after the drug involved is 
approved or after the device involved is cleared or 
approved, the Secretary shall ensure that the registry 
data bank includes links to results information as 
described in clause (ii) for such clinical trial— 
‘‘(I) not earlier than 30 days after the date 
of the approval of the drug involved or clearance 
or approval of the device involved; or 
‘‘(II) not later than 30 days after the results 
information described in clause (ii) becomes pub-
licly available. 
‘‘(ii) REQUIRED INFORMATION.— 
‘‘(I) FDA INFORMATION.—The Secretary shall 
ensure that the registry data bank includes links 
to the following information: 
‘‘(aa) If an advisory committee considered 
at a meeting an applicable clinical trial, any 
posted Food and Drug Administration sum-
mary document regarding such applicable clin-
ical trial. 
‘‘(bb) If an applicable drug clinical trial 
was conducted under section 505A or 505B 
of the Federal Food, Drug, and Cosmetic Act,
H. R. 3580—87 
a link to the posted Food and Drug Adminis-
tration assessment of the results of such trial. 
‘‘(cc) Food and Drug Administration public 
health advisories regarding the drug or device 
that is the subject of the applicable clinical 
trial, if any. 
‘‘(dd) For an applicable drug clinical trial, 
the Food and Drug Administration action 
package for approval document required under 
section 505(l)(2) of the Federal Food, Drug, 
and Cosmetic Act. 
‘‘(ee) For an applicable device clinical trial, 
in the case of a premarket application under 
section 515 of the Federal Food, Drug, and 
Cosmetic Act, the detailed summary of 
information 
respecting 
the 
safety 
and 
effectiveness of the device required under sec-
tion 520(h)(1) of such Act, or, in the case of 
a report under section 510(k) of such Act, the 
section 510(k) summary of the safety and 
effectiveness data required under section 
807.95(d) of title 21, Code of Federal Regula-
tions (or any successor regulation). 
‘‘(II) NIH INFORMATION.—The Secretary shall 
ensure that the registry data bank includes links 
to the following information: 
‘‘(aa) Medline citations to any publications 
focused on the results of an applicable clinical 
trial. 
‘‘(bb) The entry for the drug that is the 
subject of an applicable drug clinical trial in 
the National Library of Medicine database of 
structured product labels, if available. 
‘‘(iii) RESULTS FOR EXISTING DATA BANK ENTRIES.— 
The Secretary may include the links described in clause 
(ii) for data bank entries for clinical trials submitted 
to the data bank prior to enactment of the Food and 
Drug Administration Amendments Act of 2007, as 
available. 
‘‘(B) INCLUSION
OF
RESULTS.—The Secretary, acting 
through the Director of NIH, shall— 
‘‘(i) expand the registry data bank to include the 
results of applicable clinical trials (referred to in this 
subsection as the ‘registry and results data bank’); 
‘‘(ii) ensure that such results are made publicly 
available through the Internet; 
‘‘(iii) post publicly a glossary for the lay public 
explaining technical terms related to the results of 
clinical trials; and 
‘‘(iv) in consultation with experts on risk commu-
nication, provide information with the information 
included under subparagraph (C) in the registry and 
results data bank to help ensure that such information 
does not mislead the patients or the public. 
‘‘(C) BASIC RESULTS.—Not later than 1 year after the 
date of the enactment of the Food and Drug Administration 
Amendments Act of 2007, the Secretary shall include in
H. R. 3580—88 
the registry and results data bank the following elements 
for drugs that are approved under section 505 of the Fed-
eral Food, Drug, and Cosmetic Act or licensed under section 
351 of this Act and devices that are cleared under section 
510(k) of the Federal Food, Drug, and Cosmetic Act or 
approved under section 515 or 520(m) of such Act: 
‘‘(i) DEMOGRAPHIC AND BASELINE CHARACTERISTICS 
OF PATIENT SAMPLE.—A table of the demographic and 
baseline data collected overall and for each arm of 
the clinical trial to describe the patients who partici-
pated in the clinical trial, including the number of 
patients who dropped out of the clinical trial and the 
number of patients excluded from the analysis, if any. 
‘‘(ii) PRIMARY
AND
SECONDARY
OUTCOMES.—The 
primary and secondary outcome measures as submitted 
under paragraph (2)(A)(ii)(I)(ll), and a table of values 
for each of the primary and secondary outcome meas-
ures for each arm of the clinical trial, including the 
results of scientifically appropriate tests of the statis-
tical significance of such outcome measures. 
‘‘(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 sponsor or 
its agent and the principal investigator (unless the 
sponsor is an employer of the principal investigator) 
that restricts in any manner the ability of the principal 
investigator, 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 information and to enhance patient 
access to and understanding of the results of clinical 
trials, not later than 3 years after the date of the 
enactment of the Food and Drug Administration 
Amendments Act of 2007, the Secretary shall by regu-
lation expand the registry and results data bank as 
provided under this subparagraph. 
‘‘(ii) CLINICAL TRIALS.— 
‘‘(I) APPROVED
PRODUCTS.—The regulations 
under this subparagraph shall require the inclu-
sion of the results 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 Cos-
metic Act or approved under section 515 or 
520(m) of such Act.
H. R. 3580—89 
‘‘(II) UNAPPROVED PRODUCTS.—The regulations 
under this subparagraph 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 Cos-
metic Act and not approved under section 515 
or section 520(m) of such Act (whether clear-
ance or approval was sought or not). 
‘‘(iii) REQUIRED ELEMENTS.—The regulations under 
this subparagraph shall require, in addition to the 
elements described 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, under-
standable language for patients, if the Secretary 
determines that such types of summary 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 
included 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 results informa-
tion described in clause (iii) shall be submitted to the 
Director of NIH for inclusion in the registry and results 
data bank as provided by subparagraph (E), except 
that the Secretary shall by regulation determine— 
‘‘(I) whether the 1-year period for submission 
of clinical trial information described in subpara-
graph (E)(i) should be increased from 1 year to 
a period not to exceed 18 months; 
‘‘(II) whether the clinical trial information 
described in clause (iii) should be required to be 
submitted for an applicable clinical trial for which 
the clinical trial information described in subpara-
graph (C) is submitted to the registry and results 
data bank before the effective date of the regula-
tions issued under this subparagraph; and 
‘‘(III) in the case when the clinical trial 
information described in clause (iii) is required 
to be submitted for the applicable clinical trials 
described in clause (ii)(II), the date by which such 
clinical trial information shall be required to be 
submitted, taking into account—
H. R. 3580—90 
‘‘(aa) 
the 
certification 
process 
under 
subparagraph (E)(iii) when approval, licen-
sure, or clearance is sought; and 
‘‘(bb) whether there should be a delay of 
submission when approval, licensure, or clear-
ance 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 written in nontechnical, under-
standable language for patients; 
‘‘(III) considering the experience under the 
pilot quality control project described in paragraph 
(5)(C), procedures for quality control, including 
using representative samples, with respect to 
completeness and content of clinical trial informa-
tion 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 informa-
tion in paragraph (2)(C); and 
‘‘(VI) additions or modifications to the manner 
of reporting of the data elements established under 
subparagraph (C). 
‘‘(vi) CONSIDERATION OF WORLD HEALTH ORGANIZA-
TION
DATA
SET.—The Secretary shall consider the 
status of the consensus data elements set for reporting 
clinical trial results of the World Health Organization 
when issuing the regulations under this subparagraph. 
‘‘(vii) PUBLIC MEETING.—The Secretary shall hold 
a public meeting no later than 18 months after the 
date of the enactment of the Food and Drug Adminis-
tration Amendments Act of 2007 to provide an oppor-
tunity for input from interested parties with regard 
to the regulations to be issued under this subpara-
graph. 
‘‘(E) SUBMISSION OF RESULTS INFORMATION.— 
‘‘(i) IN GENERAL.—Except as provided in clauses 
(iii), (iv), (v), and (vi) the responsible party for an 
applicable clinical trial that is described in clause (ii) 
shall submit to the Director of NIH for inclusion in 
the registry and results data bank the clinical trial 
information described in subparagraph (C) not later 
than 1 year, or such other period as may be provided 
by regulation under subparagraph (D), after the earlier 
of—
H. R. 3580—91 
‘‘(I) the estimated completion date of the trial 
as described in paragraph (2)(A)(ii)(I)(jj)); or 
‘‘(II) the actual date of completion. 
‘‘(ii) CLINICAL
TRIALS
DESCRIBED.—An applicable 
clinical trial described in this clause is an applicable 
clinical trial subject to— 
‘‘(I) paragraph (2)(C); and 
‘‘(II)(aa) subparagraph (C); or 
‘‘(bb) the regulations issued under subpara-
graph (D). 
‘‘(iii) DELAYED SUBMISSION OF RESULTS WITH CER-
TIFICATION.—If the responsible party for an applicable 
clinical trial submits a certification that clause (iv) 
or (v) applies to such clinical trial, the responsible 
party shall submit to the Director of NIH for inclusion 
in the registry and results data bank the clinical trial 
information described in subparagraphs (C) and (D) 
as required under the applicable clause. 
‘‘(iv) SEEKING
INITIAL
APPROVAL
OF
A
DRUG
OR 
DEVICE.—With respect to an applicable clinical trial 
that is completed before the drug is initially approved 
under section 505 of the Federal Food, Drug, and Cos-
metic Act or initially licensed under section 351 of 
this Act, or the device is initially cleared under section 
510(k) or initially approved under section 515 or 520(m) 
of the Federal Food, Drug, and Cosmetic Act, the 
responsible party shall submit to the Director of NIH 
for inclusion in the registry and results data bank 
the clinical trial information described in subpara-
graphs (C) and (D) not later than 30 days after 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 
or 520(m), as applicable. 
‘‘(v) SEEKING APPROVAL OF A NEW USE FOR THE 
DRUG OR DEVICE.— 
‘‘(I) 
IN
GENERAL.—With 
respect 
to 
an 
applicable clinical trial where the manufacturer 
of the drug or device is the sponsor of an applicable 
clinical trial, and such manufacturer has filed, or 
will file within 1 year, an application seeking 
approval under section 505 of the Federal Food, 
Drug, and Cosmetic Act, licensing under section 
351 of this Act, or clearance under section 510(k), 
or approval under section 515 or 520(m), of the 
Federal Food, Drug, and Cosmetic Act for the use 
studied in such clinical trial (which use is not 
included in the labeling of the approved drug or 
device), then the responsible party shall submit 
to the Director of NIH for inclusion in the registry 
and results data bank the clinical trial information 
described in subparagraphs (C) and (D) on the 
earlier of the date that is 30 days after the date— 
‘‘(aa) the new use of the drug or device 
is approved under such section 505, licensed 
under such section 351, cleared under such
H. R. 3580—92 
section 510(k), or approved under such section 
515 or 520(m); 
‘‘(bb) the Secretary issues a letter, such 
as a complete response letter, not approving 
the submission or not clearing the submission, 
a not approvable letter, or a not substantially 
equivalent letter for the new use of the drug 
or device under such section 505, 351, 510(k), 
515, or 520(m); or 
‘‘(cc) except as provided in subclause (III), 
the application or premarket notification 
under such section 505, 351, 510(k), 515, or 
520(m) is withdrawn without resubmission for 
no less than 210 days. 
‘‘(II) REQUIREMENT THAT EACH CLINICAL TRIAL 
IN APPLICATION BE TREATED THE SAME.—If a manu-
facturer makes a certification under clause (iii) 
that this clause applies with respect to a clinical 
trial, the manufacturer shall make such a certifi-
cation with respect to each applicable clinical trial 
that is required to be submitted in an application 
or report for licensure, approval, or clearance 
(under section 351 of this Act or section 505, 
510(k), 515, or 520(m) of the Federal Food, Drug, 
and Cosmetic Act, as applicable) of the use studied 
in the clinical trial. 
‘‘(III) TWO-YEAR LIMITATION.—The responsible 
party shall submit to the Director of NIH for inclu-
sion in the registry and results data bank the 
clinical trial information subject to subclause (I) 
on the date that is 2 years after the date a certifi-
cation under clause (iii) was made to the Director 
of NIH, if an action referred to in item (aa), (bb), 
or (cc) of subclause (I) has not occurred by such 
date. 
‘‘(vi) EXTENSIONS.—The Director of NIH may pro-
vide an extension of the deadline for submission of 
clinical trial information under clause (i) if the respon-
sible party for the trial submits to the Director a 
written request that demonstrates good cause for the 
extension 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 
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 described in subparagraph (E)(iv) or 
item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with respect 
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 information described in sub-
paragraphs (C) and (D) for an applicable clinical trial sub-
mitted in accordance with this paragraph is posted publicly 
in the registry and results database not later than 30 
days after such submission.
H. R. 3580—93 
‘‘(H) WAIVERS
REGARDING
CERTAIN
CLINICAL
TRIAL 
RESULTS.—The Secretary may waive any applicable 
requirements of this paragraph 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 providing the 
waiver is consistent with the protection of public health, 
or in the interest of national security. Not later than 30 
days after any part of a waiver is granted, the Secretary 
shall notify, in writing, the appropriate committees of Con-
gress 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 appro-
priate results information on serious adverse and fre-
quent adverse events for drugs described in subpara-
graph (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 number and 
frequency of such event in each arm of the clinical 
trial. 
‘‘(II) FREQUENT ADVERSE EVENTS.—A table of 
anticipated and 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 
system, with number and frequency of such event 
in each arm of the clinical trial. 
‘‘(iv) POSTING OF OTHER INFORMATION.—In carrying 
out clause (iii), the Secretary shall, in consultation 
with experts in risk communication, post with the 
tables information to enhance patient understanding 
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 pursuant 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 INFORMA-
TION.—
H. R. 3580—94 
‘‘(A) VOLUNTARY SUBMISSIONS.—A responsible party for 
a clinical trial that is not an applicable clinical trial, or 
that is an applicable clinical trial that is not subject to 
paragraph (2)(C), may submit complete clinical trial 
information described in paragraph (2) or paragraph (3) 
provided the responsible party submits clinical trial 
information for each applicable clinical trial that is required 
to be submitted under section 351 or under section 505, 
510(k), 515, or 520(m) of the Federal Food, Drug, and 
Cosmetic Act in an application or report for licensure, 
approval, or clearance of the drug or device 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 determines for a specific clinical trial 
described 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 Sec-
retary in accordance with paragraphs (2) and (3) 
except with regard to timing of submission; 
‘‘(II) unless the responsible party submits a 
certification under paragraph (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 section 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 Cosmetic Act or approved under section 515 
or section 520(m) of such Act, whose completion 
date is on or after the date 10 years before the 
date of the enactment of the Food and Drug 
Administration Amendments Act of 2007; or 
‘‘(II) an applicable clinical trial that is 
described by both by paragraph (2)(C) and para-
graph (3)(D)(ii)(II)). 
‘‘(C) UPDATES TO CLINICAL TRIAL DATA BANK.— 
‘‘(i) SUBMISSION
OF
UPDATES.—The responsible 
party for an applicable clinical trial shall submit to 
the Director of NIH for inclusion in the registry and 
results data bank updates to reflect changes to the 
clinical trial information submitted under paragraph 
(2). Such updates— 
‘‘(I) shall be provided not less than once every 
12 months, unless there were no changes to the
H. R. 3580—95 
clinical trial information during the preceding 12- 
month period; 
‘‘(II) shall include identification of the dates 
of any such changes; 
‘‘(III) not later than 30 days after the recruit-
ment status of such clinical trial changes, shall 
include an update of the recruitment status; and 
‘‘(IV) not later than 30 days after the comple-
tion date of the clinical trial, shall include notifica-
tion to the Director that such clinical trial is com-
plete. 
‘‘(ii) 
PUBLIC
AVAILABILITY
OF
UPDATES.—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, indi-
vidual site status, location, and contact information, 
the Director of NIH shall ensure that updates to ele-
ments required under subclauses (I) to (V) of paragraph 
(2)(A)(ii) do not result in the removal of any informa-
tion from the original submissions or any preceding 
updates, and information in such databases is pre-
sented in a manner that enables users to readily access 
each original element submission and to track the 
changes made by the updates. 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 secondary outcome measures sub-
mitted under paragraph (2)(A)(ii)(I)(ll). 
‘‘(5) COORDINATION AND COMPLIANCE.— 
‘‘(A) CLINICAL TRIALS SUPPORTED BY GRANTS FROM FED-
ERAL 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 Institutes of 
Health, or the Agency for Healthcare Research and 
Quality, any grant or progress report forms required 
under such grant shall include a certification that the 
responsible party has made all required submissions 
to the Director of NIH under paragraphs (2) and (3). 
‘‘(ii) VERIFICATION
BY
FEDERAL
AGENCIES.—The 
heads of the agencies referred to in clause (i), as 
applicable, shall verify that the clinical trial informa-
tion for each applicable clinical trial for which a 
grantee is the responsible party has been submitted 
under paragraphs (2) and (3) before 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 referred 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-compliance and allow such grantee 30 days
H. R. 3580—96 
to correct such non-compliance and submit the required 
clinical trial information. 
‘‘(iv) CONSULTATION WITH OTHER FEDERAL AGEN-
CIES.—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, 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 described in clauses (i), (ii), 
and (iii) to ensure that clinical trial information 
for such applicable clinical trial is submitted under 
paragraphs (2) and (3). 
‘‘(B) CERTIFICATION TO ACCOMPANY DRUG, BIOLOGICAL 
PRODUCT, AND DEVICE SUBMISSIONS.—At the time of submis-
sion of an application 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 certification that all applicable requirements of this 
subsection have been met. Where available, such certifi-
cation shall include the appropriate National Clinical Trial 
control numbers. 
‘‘(C) QUALITY CONTROL.— 
‘‘(i) PILOT QUALITY CONTROL PROJECT.—Until the 
effective date of the regulations issued under para-
graph (3)(D), the Secretary, acting through the Director 
of NIH and the Commissioner of Food and Drugs, 
shall conduct a pilot project to determine the optimal 
method of verification to help to ensure that the clinical 
trial information submitted under paragraph (3)(C) is 
non-promotional and is not false or misleading in any 
particular under subparagraph (D). The Secretary shall 
use the publicly available information described in 
paragraph (3)(A) and any other information available 
to the Secretary about applicable 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 to remedy such non-
compliance by submitting the required revised clinical 
trial information not later than 30 days after such 
notification. 
‘‘(D) TRUTHFUL CLINICAL TRIAL INFORMATION.— 
‘‘(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—
H. R. 3580—97 
‘‘(I) requiring clinical trial information 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 
information 
described in paragraph (3)(D) to be submitted for 
purposes of paragraph (3)(C). 
‘‘(E) PUBLIC NOTICES.— 
‘‘(i) NOTICE
OF
VIOLATIONS.—If the responsible 
party for an applicable clinical trial fails to submit 
clinical trial information for such clinical trial as 
required under paragraphs (2) or (3), the Director of 
NIH shall include in the registry and results data 
bank entry for such clinical trial a notice— 
‘‘(I) that the responsible party is not in compli-
ance with this Act by— 
‘‘(aa) failing to submit required clinical 
trial information; or 
‘‘(bb) submitting false or misleading clin-
ical trial information; 
‘‘(II) of the penalties imposed for the violation, 
if any; and 
‘‘(III) whether the responsible party has cor-
rected the clinical trial information in the registry 
and results data bank. 
‘‘(ii) NOTICE OF FAILURE TO SUBMIT PRIMARY AND 
SECONDARY
OUTCOMES.—If the responsible party for 
an applicable clinical trial fails to submit the primary 
and secondary outcomes as required under section 
2(A)(ii)(I)(ll), the Director of NIH shall include in the 
registry and results data bank entry for such clinical 
trial a notice that the responsible party is not in 
compliance by failing to register the primary and sec-
ondary outcomes in accordance with this act, and that 
the primary and secondary outcomes were not publicly 
disclosed in the database before conducting the clinical 
trial. 
‘‘(iii) FAILURE TO SUBMIT STATEMENT.—The notice 
under clause (i) for a violation described in clause 
(i)(I)(aa) shall include the following statement: ‘The 
entry for this clinical trial was not complete at the 
time of submission, as required by law. This may or 
may not have any bearing on the accuracy of the 
information in the entry.’. 
‘‘(iv) SUBMISSION
OF
FALSE
INFORMATION
STATE-
MENT.—The notice under clause (i) for a violation 
described in clause (i)(I)(bb) shall include the following 
statement: ‘The entry for this clinical trial was found 
to be false or misleading and therefore not in compli-
ance with the law.’. 
‘‘(v) NON-SUBMISSION OF STATEMENT.—The notice 
under clause (ii) for a violation described in clause 
(ii) shall include the following statement: ‘The entry 
for this clinical trial did not contain information on 
the primary and secondary outcomes at the time of 
submission, as required by law. This may or may not
H. R. 3580—98 
have any bearing on the accuracy of the information 
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 subsection (or under 
section 552 of title 5, United States Code) shall require 
the Secretary to publicly disclose, by any means other 
than the registry and results data bank, information 
described in subparagraph (B). 
‘‘(B) INFORMATION DESCRIBED.—Information described 
in this subparagraph is— 
‘‘(i) information submitted to the Director of NIH 
under this subsection, or information of the same gen-
eral nature as (or integrally associated with) the 
information so submitted; and 
‘‘(ii) information not otherwise publicly available, 
including because it is protected 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 required by section 
402(j)(5)(B) of the Public Health Service Act, or knowingly submit-
ting 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 sub-
section (j) of section 402 of the Public Health 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 Cosmetic Act (21 U.S.C. 333), 
as redesignated by section 226, is amended— 
(A) by redesignating paragraphs (3), (4), and (5) as 
paragraphs (5), (6), and (7), respectively; 
(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 viola-
tions adjudicated in a single proceeding. 
‘‘(B) If a violation of section 301(jj) is not corrected within 
the 30-day period following notification under section 402(j)(5)(C)(ii), 
the person shall, in addition to any penalty under subparagraph 
(A), be subject to a civil monetary penalty of not more than $10,000 
for each day of the violation after such period until the violation 
is corrected.’’; 
(C) in paragraph (2)(C), by striking ‘‘paragraph (3)(A)’’ 
and inserting ‘‘paragraph (5)(A)’’;
H. R. 3580—99 
(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 appears and inserting ‘‘para-
graph (6)’’. 
(3) NEW DRUGS AND DEVICES.— 
(A) INVESTIGATIONAL
NEW
DRUGS.—Section 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 
following: ‘‘The Secretary shall update such regulations 
to require inclusion in the informed consent documents 
and process a statement that clinical trial information for 
such clinical investigation has been or will be submitted 
for inclusion 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 Cosmetic Act (21 U.S.C. 355(b)) 
is amended by adding at the end the following: 
‘‘(6) An application submitted under this subsection shall 
be accompanied by the certification required 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 fol-
lowing: 
‘‘A notification submitted under this subsection that contains clin-
ical trial data for an applicable device clinical trial (as defined 
in section 402(j)(1) of the Public Health Service Act) shall be accom-
panied by the certification required under section 402(j)(5)(B) of 
such Act. Such certification shall not be considered an element 
of such notification.’’. 
(D) DEVICE PREMARKET APPROVAL APPLICATION.—Sec-
tion 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; 
(ii) by redesignating subparagraph (G) as subpara-
graph (H); and 
(iii) by inserting after subparagraph (F) the fol-
lowing: 
‘‘(G) the certification required under section 402(j)(5)(B) 
of the Public Health Service Act (which shall not be consid-
ered an element of such application); and’’. 
(E) 
HUMANITARIAN
DEVICE
EXEMPTION.—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 following 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 Service Act (which shall not be consid-
ered an element 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
H. R. 3580—100 
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 
(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 
subdivision 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 results of clinical trials 
in a database. 
(2) RULE
OF
CONSTRUCTION.—The fact of submission of 
clinical trial information, if submitted in compliance with sub-
section (j) of section 402 of the Public Health Service Act 
(as amended by this section), 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 administrative 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 registry 
and results data bank under such subsection (j), if submitted 
in compliance with such subsection, shall not be considered 
as labeling, adulteration, or misbranding of the drug or device 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.). 
TITLE 
IX—ENHANCED 
AUTHORITIES 
REGARDING POSTMARKET SAFETY OF 
DRUGS 
Subtitle A—Postmarket Studies and 
Surveillance 
SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS REGARDING 
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 interstate 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 subsection: 
‘‘(A) RESPONSIBLE PERSON.—The term ‘responsible per-
son’ means a person who— 
‘‘(i) has submitted to the Secretary a covered 
application that is pending; or
H. R. 3580—101 
‘‘(ii) is the holder of an approved covered applica-
tion. 
‘‘(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’, ‘serious 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 speci-
fied in subparagraph (B), the Secretary may, subject to 
subparagraph (D), require 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 drug, on 
the basis of scientific data deemed appropriate by the Sec-
retary, including information regarding chemically-related 
or pharmacologically-related drugs. 
‘‘(B) PURPOSES OF STUDY OR CLINICAL TRIAL.—The pur-
poses referred to in this subparagraph 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 serious 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 applica-
tion is in effect as of the date on which the Secretary 
seeks to establish such requirement 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 paragraph, unless the Secretary makes a 
determination that the reports under subsection (k)(1) 
and the active postmarket risk identification and anal-
ysis system as available under subsection (k)(3) will 
not be sufficient to meet the purposes set forth in 
subparagraph (B). 
‘‘(ii) POSTAPPROVAL
CLINICAL
TRIALS.—The Sec-
retary may not require the responsible person to con-
duct a clinical trial under this paragraph, unless the 
Secretary makes a determination that a postapproval 
study or studies will not be sufficient to meet the 
purposes set forth in subparagraph (B). 
‘‘(E) NOTIFICATION; TIMETABLES; PERIODIC REPORTS.— 
‘‘(i) NOTIFICATION.—The Secretary shall notify the 
responsible person regarding a requirement under this
H. R. 3580—102 
paragraph to conduct a postapproval study or clinical 
trial by the target dates for communication of feedback 
from the review team to the responsible person 
regarding proposed labeling and postmarketing study 
commitments as set forth in the letters described in 
section 101(c) of the Food and Drug Administration 
Amendments Act of 2007. 
‘‘(ii) TIMETABLE; PERIODIC
REPORTS.—For each 
study or clinical trial required to be conducted under 
this paragraph, 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 otherwise undertaken by the responsible person to 
investigate a safety issue, the Secretary shall require 
the responsible person to periodically report to the 
Secretary on the status of such study including 
whether any difficulties in completing the study have 
been encountered. With respect to each clinical trial 
required to be conducted under this paragraph or 
otherwise undertaken by the responsible person to 
investigate a safety issue, the Secretary shall require 
the responsible person to periodically report to the 
Secretary on the status of such clinical trial including 
whether enrollment 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 responsible 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 noncompliance or such other violation. The 
Secretary shall determine what constitutes good cause 
under the preceding sentence. 
‘‘(F) DISPUTE
RESOLUTION.—The responsible person 
may appeal a requirement to conduct a study or clinical 
trial under this paragraph using dispute resolution proce-
dures established by the Secretary in regulation and guid-
ance. 
‘‘(4) SAFETY
LABELING
CHANGES
REQUESTED
BY
SEC-
RETARY.— 
‘‘(A) NEW
SAFETY
INFORMATION.—If the Secretary 
becomes aware of new safety information that the Secretary 
believes should be included 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 approved application 
under 505(j). 
‘‘(B) RESPONSE TO NOTIFICATION.—Following notifica-
tion 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,
H. R. 3580—103 
including changes to boxed warnings, contraindica-
tions, warnings, precautions, or adverse reactions; or 
‘‘(ii) notify the Secretary that the responsible per-
son or the holder of the approved application under 
section 505(j) does not believe a labeling change is 
warranted and submit a statement detailing the rea-
sons why such a change is not warranted. 
‘‘(C) REVIEW.—Upon receipt of such supplement, the 
Secretary shall promptly review and act upon such supple-
ment. If the Secretary disagrees with the proposed changes 
in the supplement or with the statement setting forth 
the reasons why no labeling change is necessary, the Sec-
retary shall initiate discussions to reach agreement on 
whether the labeling for the drug should be modified to 
reflect the new safety information, and if so, the contents 
of such labeling changes. 
‘‘(D) DISCUSSIONS.—Such discussions shall not extend 
for more than 30 days after the response to the notification 
under subparagraph (B), unless the Secretary determines 
an extension of such discussion period is warranted. 
‘‘(E) ORDER.—Within 15 days of the conclusion of the 
discussions under subparagraph (D), the Secretary may 
issue an order directing the responsible person or the holder 
of the approved application under section 505(j) to make 
such a labeling change as the Secretary deems appropriate 
to address the new safety information. Within 15 days 
of such an order, the responsible person or the holder 
of the approved application under section 505(j) shall 
submit a supplement containing the labeling change. 
‘‘(F) DISPUTE RESOLUTION.—Within 5 days of receiving 
an order under subparagraph (E), the responsible person 
or the holder of the approved application under section 
505(j) may appeal using dispute resolution procedures 
established by the Secretary in regulation and guidance. 
‘‘(G) VIOLATION.—If the responsible person or the 
holder of the approved application under section 505(j) 
has not submitted a supplement within 15 days of the 
date of such order under subparagraph (E), and there is 
no appeal or dispute resolution proceeding pending, the 
responsible person or holder shall be considered to be in 
violation of this subsection. If at the conclusion of any 
dispute resolution procedures the Secretary determines 
that a supplement must be submitted and such a supple-
ment is not submitted within 15 days of the date of that 
determination, the responsible person or holder shall be 
in violation of this subsection. 
‘‘(H) PUBLIC HEALTH THREAT.—Notwithstanding sub-
paragraphs (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 paragraph shall not 
be construed to affect the responsibility 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
H. R. 3580—104 
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 be made by individuals 
at or above the level of individuals empowered to approve 
a drug (such as division directors within the Center for Drug 
Evaluation and Research). 
‘‘(p) RISK EVALUATION AND MITIGATION STRATEGY.— 
‘‘(1) IN GENERAL.—A person may not introduce or deliver 
for introduction into interstate commerce a new drug if— 
‘‘(A)(i) the application for such drug is approved under 
subsection (b) or (j) and is subject to section 503(b); or 
‘‘(ii) the application for such drug is approved 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 
requirements under section 505–1, including requirements 
regarding assessments of approved strategies. 
‘‘(2) CERTAIN POSTMARKET STUDIES.—The failure to conduct 
a postmarket study under section 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 section 505 the following section: 
‘‘SEC. 505–1. RISK EVALUATION AND MITIGATION STRATEGIES. 
‘‘(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 submits 
such application of such determination, then such person shall 
submit to the Secretary as part of such application a proposed 
risk evaluation and mitigation strategy. In making such a 
determination, the Secretary shall consider the following fac-
tors: 
‘‘(A) The estimated size of the population likely to 
use the drug involved. 
‘‘(B) The seriousness of the disease or condition 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 potential 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.—
H. R. 3580—105 
‘‘(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 
mitigation strategy under paragraph (1), the Secretary, 
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 applica-
tion seeking approval of a new indication for use of the 
drug) if the Secretary becomes aware of new safety informa-
tion 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 STRATEGY.—Not later 
than 120 days after the Secretary notifies the holder of 
an approved covered application that the Secretary has 
made a determination under subparagraph (A) with respect 
to the drug involved, or within such other reasonable time 
as the Secretary requires to protect the public health, the 
holder shall submit to the Secretary a proposed risk evalua-
tion and mitigation strategy. 
‘‘(3) ABBREVIATED NEW DRUG APPLICATIONS.—The applica-
bility of this section to an application 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 individuals empowered to approve 
a drug (such as division directors within the Center for Drug 
Evaluation and Research). 
‘‘(b) DEFINITIONS.—For purposes of this section: 
‘‘(1) ADVERSE DRUG EXPERIENCE.—The term ‘adverse drug 
experience’ means any adverse event associated with the use 
of a drug in humans, whether 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 intentional; 
‘‘(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 pharmacological action of 
the drug. 
‘‘(2) COVERED APPLICATION.—The term ‘covered application’ 
means an application referred to in section 505(p)(1)(A). 
‘‘(3) NEW
SAFETY
INFORMATION.—The term ‘new safety 
information’, with respect to a drug, means information derived 
from a clinical trial, an adverse event report, a postapproval 
study (including a study under section 505(o)(3)), or peer- 
reviewed 
biomedical 
literature; 
data 
derived 
from 
the 
postmarket risk identification and analysis system under sec-
tion 505(k); or other scientific data deemed appropriate by 
the Secretary about— 
‘‘(A) a serious risk or an unexpected serious risk associ-
ated with use of the drug that the Secretary has become 
aware of (that may be based on a new analysis of existing
H. R. 3580—106 
information) since the drug was approved, since the risk 
evaluation and mitigation strategy was required, or since 
the last assessment of the approved risk evaluation 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 adverse drug experience 
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 prolongation of 
existing hospitalization; 
‘‘(iv) a persistent or significant incapacity or 
substantial disruption of the ability to conduct normal 
life functions; or 
‘‘(v) a congenital anomaly or birth defect; or 
‘‘(B) based on appropriate medical judgment, may jeop-
ardize the patient and may require a medical or surgical 
intervention to prevent 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; 
‘‘(E) data derived from the postmarket risk identifica-
tion and analysis system under section 505(k)(4); or 
‘‘(F) other scientific data deemed appropriate by the 
Secretary. 
‘‘(7) RESPONSIBLE PERSON.—The term ‘responsible person’ 
means the person submitting a covered application or the holder 
of the approved such application. 
‘‘(8) UNEXPECTED
SERIOUS
RISK.—The term ‘unexpected 
serious risk’ means a serious adverse drug experience that 
is not listed in the labeling of a drug, or that may be sympto-
matically and pathophysiologically related to an adverse drug 
experience identified in the labeling, but differs from such 
adverse drug experience because of greater severity, specificity, 
or prevalence. 
‘‘(c) CONTENTS.—A proposed risk evaluation and mitigation 
strategy under subsection (a) shall— 
‘‘(1) include the timetable required under subsection (d); 
and
H. R. 3580—107 
‘‘(2) to the extent required by the Secretary, in consultation 
with the office responsible for reviewing the drug and the 
office responsible for postapproval safety with respect to the 
drug, include additional elements described in subsections (e) 
and (f). 
‘‘(d) MINIMAL STRATEGY.—For purposes of subsection (c)(1), the 
risk evaluation and mitigation strategy for a drug shall require 
a timetable for submission of assessments of the strategy that— 
‘‘(1) includes an assessment, by the date that is 18 months 
after the strategy is initially approved; 
‘‘(2) includes an assessment by the date that is 3 years 
after the strategy is initially approved; 
‘‘(3) includes an assessment in the seventh year after the 
strategy is so approved; and 
‘‘(4) subject to paragraphs (1), (2), and (3)— 
‘‘(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 determines that serious 
risks of the drug have been adequately identified and 
assessed and are being adequately managed. 
‘‘(e) ADDITIONAL POTENTIAL ELEMENTS OF STRATEGY.— 
‘‘(1) IN GENERAL.—The Secretary, in consultation with the 
offices described in subsection (c)(2), may under such subsection 
require that the risk evaluation and mitigation strategy for 
a drug include 1 or more of the additional elements described 
in this subsection if the Secretary makes the determination 
required with respect to each element involved. 
‘‘(2) MEDICATION
GUIDE; PATIENT
PACKAGE
INSERT.—The 
risk evaluation and mitigation strategy for a drug may require 
that, as applicable, the responsible person develop for distribu-
tion to each patient when the drug is dispensed— 
‘‘(A) a Medication Guide, as provided for under part 
208 of title 21, Code of Federal Regulations (or any suc-
cessor regulations); and 
‘‘(B) a patient package insert, if the Secretary deter-
mines that such insert may help mitigate a serious risk 
of the drug. 
‘‘(3) COMMUNICATION PLAN.—The risk evaluation and miti-
gation strategy for a drug may require that the responsible 
person conduct a communication 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 (including under this paragraph). Such plan may 
include— 
‘‘(A) sending letters to health care providers; 
‘‘(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 safety protocols (such as medical monitoring by 
periodic laboratory tests); or 
‘‘(C) disseminating information to health care providers 
through professional societies about any serious risks of 
the drug and any protocol to assure safe use.
H. R. 3580—108 
‘‘(f) PROVIDING SAFE ACCESS FOR PATIENTS TO DRUGS WITH 
KNOWN SERIOUS RISKS THAT WOULD OTHERWISE BE UNAVAIL-
ABLE.— 
‘‘(1) ALLOWING SAFE ACCESS TO DRUGS WITH KNOWN SERIOUS 
RISKS.—The Secretary, in consultation with the offices described 
in subsection (c)(2), may require that the risk evaluation and 
mitigation strategy for a drug include such elements as are 
necessary to assure safe use of the drug, because of its inherent 
toxicity or potential harmfulness, if the Secretary determines 
that— 
‘‘(A) the drug, which has been shown to be effective, 
but is associated with a serious adverse drug experience, 
can be approved only if, or would be withdrawn unless, 
such elements are required as part of such strategy to 
mitigate a specific serious risk listed in the labeling of 
the drug; and 
‘‘(B) for a drug initially approved without elements 
to assure safe use, other elements under subsections (c), 
(d), and (e) are not sufficient to mitigate such serious 
risk. 
‘‘(2) ASSURING ACCESS AND MINIMIZING BURDEN.—Such ele-
ments to assure safe use under paragraph (1) shall— 
‘‘(A) be commensurate with the specific serious risk 
listed in the labeling of the drug; 
‘‘(B) within 30 days of the date on which any element 
under paragraph (1) is imposed, be posted publicly by the 
Secretary with an explanation of how such elements will 
mitigate the observed safety risk; 
‘‘(C) considering such risk, not be unduly burdensome 
on patient access to the drug, considering in particular— 
‘‘(i) patients with serious or life-threatening dis-
eases or conditions; and 
‘‘(ii) patients who have difficulty accessing health 
care (such as patients in rural or medically under-
served 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, serious risks; and 
‘‘(ii) be designed to be compatible with established 
distribution, procurement, and dispensing systems for 
drugs. 
‘‘(3) ELEMENTS
TO
ASSURE
SAFE
USE.—The elements to 
assure safe use under paragraph (1) shall include 1 or more 
goals to mitigate a specific serious risk listed in the labeling 
of the drug and, to mitigate such risk, may require that— 
‘‘(A) health care providers who prescribe the drug have 
particular training or experience, or are specially certified 
(the opportunity to obtain such training or certification 
with respect to the drug shall be available to any willing 
provider from a frontier area in a widely available training 
or certification method (including an on-line course or via 
mail) as approved by the Secretary at reasonable cost to 
the provider);
H. R. 3580—109 
‘‘(B) pharmacies, practitioners, or health care settings 
that dispense the drug are specially certified (the oppor-
tunity to obtain such certification shall be available to 
any willing provider from a frontier area); 
‘‘(C) the drug be dispensed to patients only in certain 
health care settings, such as hospitals; 
‘‘(D) the drug be dispensed to patients with evidence 
or other documentation of safe-use conditions, such as lab-
oratory test results; 
‘‘(E) each patient using the drug be subject to certain 
monitoring; or 
‘‘(F) each patient using the drug be enrolled in a reg-
istry. 
‘‘(4) IMPLEMENTATION SYSTEM.—The elements to assure safe 
use under paragraph (1) that are described in subparagraphs 
(B), (C), and (D) of paragraph (3) may include a system through 
which the applicant is able to take reasonable steps to— 
‘‘(A) monitor and evaluate implementation of such ele-
ments by health care providers, pharmacists, and other 
parties in the health care system who are responsible for 
implementing such elements; and 
‘‘(B) work to improve implementation of such elements 
by such persons. 
‘‘(5) EVALUATION OF ELEMENTS TO ASSURE SAFE USE.—The 
Secretary, through the Drug Safety and Risk Management 
Advisory Committee (or 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 access to the 
drug; and 
‘‘(ii) to the extent practicable, minimize 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 
‘‘(iii) to the extent practicable, minimize the burden 
on the health care delivery system; and 
‘‘(C) considering such input and evaluations— 
‘‘(i) issue or modify agency guidance about how 
to implement the requirements of this subsection; and 
‘‘(ii) modify elements under this subsection for 1 
or more drugs as appropriate. 
‘‘(6) ADDITIONAL
MECHANISMS
TO
ASSURE
ACCESS.—The 
mechanisms under section 561 to provide for expanded access 
for patients with serious or life-threatening diseases or condi-
tions may be used to provide access for patients with a serious 
or life-threatening disease or condition, the treatment of which 
is not an approved use for the drug, to a drug that is subject 
to elements to assure safe use under this subsection. The Sec-
retary shall promulgate regulations for how a physician may 
provide the drug under the mechanisms of section 561.
H. R. 3580—110 
‘‘(7) WAIVER IN PUBLIC HEALTH EMERGENCIES.—The Sec-
retary may waive any requirement of this subsection during 
the period described in section 319(a) of the Public Health 
Service Act with respect to a qualified countermeasure 
described under section 319F–1(a)(2) of such Act, to which 
a requirement 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 required to miti-
gate the effects of, or reduce the severity of, such public 
health emergency. 
‘‘(8) LIMITATION.—No holder of an approved covered 
application shall use any element to assure safe use required 
by the Secretary under this subsection to block or delay 
approval of an application under section 505(b)(2) or (j) or 
to prevent application of such element under subsection (i)(1)(B) 
to a drug that is the subject of an abbreviated new drug 
application. 
‘‘(g) ASSESSMENT AND MODIFICATION OF APPROVED STRATEGY.— 
‘‘(1) VOLUNTARY
ASSESSMENTS.—After the approval of a 
risk evaluation and mitigation strategy under subsection (a), 
the responsible person involved may, subject to paragraph (2), 
submit to the Secretary an assessment of, and propose a modi-
fication to, the approved strategy for the drug involved at 
any time. 
‘‘(2) REQUIRED ASSESSMENTS.—A responsible person shall, 
subject to paragraph (5), submit an assessment of, and may 
propose a modification to, the approved risk evaluation and 
mitigation strategy for a drug— 
‘‘(A) when submitting a supplemental application for 
a new indication for use under section 505(b) or under 
section 351 of the Public Health Service Act, unless the 
drug is not subject 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, in consultation with the offices 
described in subsection (c)(2), determines that new safety 
or effectiveness 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 strategy; or 
‘‘(D) within 15 days when ordered by the Secretary, 
in consultation with the offices described in subsection 
(c)(2), if the Secretary determines 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 approved risk evaluation 
and mitigation strategy for a drug shall include— 
‘‘(A) with respect to any goal under subsection (f), 
an assessment of the extent to which the elements to 
assure safe use are meeting the goal or whether the goal 
or such elements should be modified;
H. R. 3580—111 
‘‘(B) with respect to any postapproval study required 
under section 505(o) or otherwise undertaken by the 
responsible person to investigate a safety issue, the status 
of such study, including whether any difficulties completing 
the study have been encountered; and 
‘‘(C) with respect to any postapproval clinical trial 
required under section 505(o) or otherwise undertaken by 
the responsible party to investigate a safety issue, the 
status of such clinical trial, including whether enrollment 
has begun, the number of participants enrolled, the 
expected completion date, whether any difficulties com-
pleting the clinical trial have been encountered, and reg-
istration information with respect to requirements under 
subsections (i) and (j) of section 402 of the Public Health 
Service Act. 
‘‘(4) MODIFICATION.—A modification (whether an enhance-
ment or a reduction) to the approved risk evaluation and mitiga-
tion strategy for a drug may include the addition or modification 
of any element under subsection (d) or the addition, modifica-
tion, or removal of any element under subsection (e) or (f), 
such as— 
‘‘(A) modifying the timetable for assessments of the 
strategy as provided in subsection (d)(3), including to elimi-
nate assessments; or 
‘‘(B) adding, modifying, or removing an element to 
assure safe use under subsection (f). 
‘‘(h) REVIEW
OF PROPOSED STRATEGIES; REVIEW
OF ASSESS-
MENTS OF APPROVED STRATEGIES.— 
‘‘(1) IN GENERAL.—The Secretary, in consultation with the 
offices described in subsection (c)(2), shall promptly review 
each proposed risk evaluation and mitigation strategy for a 
drug submitted under subsection (a) and each assessment of 
an approved risk evaluation and mitigation strategy for a drug 
submitted under subsection (g). 
‘‘(2) DISCUSSION.—The Secretary, in consultation with the 
offices described in subsection (c)(2), shall initiate discussions 
with the responsible person for purposes of this subsection 
to determine a strategy not later than 60 days after any such 
assessment is submitted or, in the case of an assessment sub-
mitted under subsection (g)(2)(D), not later than 30 days after 
such assessment is submitted. 
‘‘(3) ACTION.— 
‘‘(A) IN
GENERAL.—Unless the dispute resolution 
process described under paragraph (4) or (5) applies, the 
Secretary, in consultation with the offices described in sub-
section (c)(2), shall describe any required risk evaluation 
and mitigation strategy for a drug, or any modification 
to any required strategy— 
‘‘(i) as part of the action letter on the application, 
when a proposed strategy is submitted under sub-
section (a) or a modification to the strategy is proposed 
as part of an assessment of the strategy submitted 
under subsection (g)(1); or 
‘‘(ii) in an order issued not later than 90 days 
after the date discussions of such modification begin 
under paragraph (2), when a modification to the 
strategy is proposed as part of an assessment of the
H. R. 3580—112 
strategy submitted under subsection (g)(1) or under 
any of subparagraphs (B) through (D) of subsection 
(g)(2). 
‘‘(B) INACTION.—An approved risk evaluation and miti-
gation strategy shall remain in effect until the Secretary 
acts, if the Secretary fails to act as provided under subpara-
graph (A). 
‘‘(C) PUBLIC AVAILABILITY.—Any action letter described 
in subparagraph (A)(i) or order described in subparagraph 
(A)(ii) shall be made publicly available. 
‘‘(4) DISPUTE RESOLUTION AT INITIAL APPROVAL.—If a pro-
posed risk evaluation and mitigation strategy is submitted 
under subsection (a)(1) in an application for initial approval 
of a drug and there is a dispute about the strategy, the respon-
sible person shall use the major dispute resolution procedures 
as set forth in the letters described in section 101(c) of the 
Food and Drug Administration Amendments Act of 2007. 
‘‘(5) DISPUTE RESOLUTION IN ALL OTHER CASES.— 
‘‘(A) REQUEST FOR REVIEW.— 
‘‘(i) IN GENERAL.—Not earlier than 15 days, and 
not later than 35 days, after discussions under para-
graph (2) have begun, the responsible person may 
request in writing that a dispute about the strategy 
be reviewed by the Drug Safety Oversight Board under 
subsection (j), except that the determination of the 
Secretary to require a risk evaluation and mitigation 
strategy is not subject to review under this paragraph. 
The preceding sentence does not prohibit review under 
this paragraph of the particular elements of such a 
strategy. 
‘‘(ii) SCHEDULING.—Upon receipt of a request under 
clause (i), the Secretary shall schedule the dispute 
involved for review under subparagraph (B) and, not 
later than 5 business days of scheduling the dispute 
for review, shall publish by posting on the Internet 
or otherwise a notice that the dispute will be reviewed 
by the Drug Safety Oversight Board. 
‘‘(B) SCHEDULING
REVIEW.—If a responsible person 
requests review under subparagraph (A), the Secretary— 
‘‘(i) shall schedule the dispute for review at 1 of 
the next 2 regular meetings of the Drug Safety Over-
sight Board, whichever meeting date is more prac-
ticable; or 
‘‘(ii) may convene a special meeting of the Drug 
Safety Oversight Board to review the matter more 
promptly, including to meet an action deadline on an 
application (including a supplemental application). 
‘‘(C) AGREEMENT AFTER DISCUSSION OR ADMINISTRATIVE 
APPEALS.— 
‘‘(i) FURTHER
DISCUSSION
OR
ADMINISTRATIVE 
APPEALS.—A request for review under subparagraph 
(A) shall not preclude further discussions to reach 
agreement on the risk evaluation and mitigation 
strategy, and such a request shall not preclude the 
use of administrative appeals within the Food and 
Drug Administration to reach agreement on the 
strategy, including appeals as described in the letters
H. R. 3580—113 
described in section 101(c) of the Food and Drug 
Administration Amendments Act of 2007 for procedural 
or scientific matters involving the review of human 
drug applications and supplemental applications that 
cannot be resolved at the divisional level. At the time 
a review has been scheduled under subparagraph (B) 
and notice of such review has been posted, the respon-
sible person shall either withdraw the request under 
subparagraph (A) or terminate the use of such adminis-
trative appeals. 
‘‘(ii) AGREEMENT
TERMINATES
DISPUTE
RESOLU-
TION.—At any time before a decision and order is issued 
under subparagraph (G) , the Secretary (in consultation 
with the offices described in subsection (c)(2)) and the 
responsible person may reach an agreement on the 
risk evaluation and mitigation strategy through further 
discussion or administrative appeals, terminating the 
dispute resolution process, and the Secretary shall 
issue an action letter or order, as appropriate, that 
describes the strategy. 
‘‘(D) MEETING OF THE BOARD.—At a meeting of the 
Drug Safety Oversight Board described in subparagraph 
(B), the Board shall— 
‘‘(i) hear from both parties via written or oral 
presentation; and 
‘‘(ii) review the dispute. 
‘‘(E) RECORD
OF
PROCEEDINGS.—The Secretary shall 
ensure that the proceedings of any such meeting are 
recorded, transcribed, and made public within 90 days of 
the meeting. The Secretary shall redact the transcript to 
protect any trade secrets and other information that is 
exempted from disclosure under section 552 of title 5, 
United States Code, or section 552a of title 5, United 
States Code. 
‘‘(F) RECOMMENDATION OF THE BOARD.—Not later than 
5 days after any such meeting, the Drug Safety Oversight 
Board shall provide a written recommendation on resolving 
the dispute to the Secretary. Not later than 5 days after 
the Board provides such written recommendation to the 
Secretary, the Secretary shall make the recommendation 
available to the public. 
‘‘(G) ACTION BY THE SECRETARY.— 
‘‘(i) ACTION LETTER.—With respect to a proposal 
or assessment referred to in paragraph (1), the Sec-
retary shall issue an action letter that resolves the 
dispute not later than the later of— 
‘‘(I) the action deadline for the action letter 
on the application; or 
‘‘(II) 7 days after receiving the recommenda-
tion of the Drug Safety Oversight Board. 
‘‘(ii) ORDER.—With respect to an assessment of 
an approved risk evaluation and mitigation strategy 
under subsection (g)(1) or under any of subparagraphs 
(B) through (D) of subsection (g)(2), the Secretary shall 
issue an order, which shall be made public, that 
resolves the dispute not later than 7 days after
H. R. 3580—114 
receiving the recommendation of the Drug Safety Over-
sight Board. 
‘‘(H) INACTION.—An approved risk evaluation and miti-
gation strategy shall remain in effect until the Secretary 
acts, if the Secretary fails to act as provided for under 
subparagraph (G). 
‘‘(I) EFFECT ON ACTION DEADLINE.—With respect to a 
proposal or assessment referred to in paragraph (1), the 
Secretary shall be considered to have met the action dead-
line for the action letter on the application if the responsible 
person requests the dispute resolution process described 
in this paragraph and if the Secretary— 
‘‘(i) has initiated the discussions described under 
paragraph (2) not less than 60 days before such action 
deadline; and 
‘‘(ii) has complied with the timing requirements 
of scheduling review by the Drug Safety Oversight 
Board, providing a written recommendation, and 
issuing an action letter under subparagraphs (B), (F), 
and (G), respectively. 
‘‘(J) DISQUALIFICATION.—No individual who is an 
employee of the Food and Drug Administration and who 
reviews a drug or who participated in an administrative 
appeal under subparagraph (C)(i) with respect to such drug 
may serve on the Drug Safety Oversight Board at a meeting 
under subparagraph (D) to review a dispute about the 
risk evaluation and mitigation strategy for such drug. 
‘‘(K) ADDITIONAL EXPERTISE.—The Drug Safety Over-
sight Board may add members with relevant expertise 
from the Food and Drug Administration, including the 
Office of Pediatrics, the Office of Women’s Health, or the 
Office of Rare Diseases, or from other Federal public health 
or health care agencies, for a meeting under subparagraph 
(D) of the Drug Safety Oversight Board. 
‘‘(6) USE OF ADVISORY COMMITTEES.—The Secretary may 
convene a meeting of 1 or more advisory committees of the 
Food and Drug Administration to— 
‘‘(A) review a concern about the safety of a drug or 
class of drugs, including before an assessment of the risk 
evaluation and mitigation strategy or strategies of such 
drug or drugs is required to be submitted under any of 
subparagraphs (B) through (D) of subsection (g)(2); 
‘‘(B) review the risk evaluation and mitigation strategy 
or strategies of a drug or group of drugs; or 
‘‘(C) review a dispute under paragraph (4) or (5). 
‘‘(7) PROCESS FOR ADDRESSING DRUG CLASS EFFECTS.— 
‘‘(A) IN GENERAL.—When a concern about a serious 
risk of a drug may be related to the pharmacological class 
of the drug, the Secretary, in consultation with the offices 
described in subsection (c)(2), may defer assessments of 
the approved risk evaluation and mitigation strategies for 
such drugs until the Secretary has convened 1 or more 
public meetings to consider possible responses to such con-
cern. 
‘‘(B) NOTICE.—If the Secretary defers an assessment 
under subparagraph (A), the Secretary shall—
H. R. 3580—115 
‘‘(i) give notice of the deferral to the holder of 
the approved covered application not later than 5 days 
after the deferral; 
‘‘(ii) publish the deferral in the Federal Register; 
and 
‘‘(iii) give notice to the public of any public 
meetings to be convened under subparagraph (A), 
including a description of the deferral. 
‘‘(C) PUBLIC
MEETINGS.—Such public meetings may 
include— 
‘‘(i) 1 or more meetings of the responsible person 
for such drugs; 
‘‘(ii) 1 or more meetings of 1 or more advisory 
committees of the Food and Drug Administration, as 
provided for under paragraph (6); or 
‘‘(iii) 1 or more workshops of scientific experts and 
other stakeholders. 
‘‘(D) ACTION.—After considering the discussions from 
any meetings under subparagraph (A), the Secretary may— 
‘‘(i) announce in the Federal Register a planned 
regulatory action, including a modification to each risk 
evaluation and mitigation strategy, for drugs in the 
pharmacological class; 
‘‘(ii) seek public comment about such action; and 
‘‘(iii) after seeking such comment, issue an order 
addressing such regulatory action. 
‘‘(8) INTERNATIONAL COORDINATION.—The Secretary, in con-
sultation with the offices described in subsection (c)(2), may 
coordinate the timetable for submission of assessments under 
subsection (d), or a study or clinical trial under section 505(o)(3), 
with efforts to identify and assess the serious risks of such 
drug by the marketing authorities of other countries whose 
drug approval and risk management processes the Secretary 
deems comparable to the drug approval and risk management 
processes of the United States. If the Secretary takes action 
to coordinate such timetable, the Secretary shall give notice 
to the responsible person. 
‘‘(9) EFFECT.—Use of the processes described in paragraphs 
(7) and (8) shall not be the sole source of delay of action 
on an application or a supplement to an application for a 
drug. 
‘‘(i) ABBREVIATED NEW DRUG APPLICATIONS.— 
‘‘(1) IN GENERAL.—A drug that is the subject of an abbre-
viated new drug application under section 505(j) is subject 
to only the following elements of the risk evaluation and mitiga-
tion strategy required under subsection (a) for the applicable 
listed drug: 
‘‘(A) A Medication Guide or patient package insert, 
if required under subsection (e) for the applicable listed 
drug. 
‘‘(B) Elements to assure safe use, if required under 
subsection (f) for the listed drug. A drug that is the subject 
of an abbreviated new drug application and the listed drug 
shall use a single, shared system under subsection (f). 
The Secretary may waive the requirement under the pre-
ceding sentence for a drug that is the subject of an abbre-
viated new drug application, and permit the applicant to
H. R. 3580—116 
use a different, comparable aspect of the elements to assure 
safe use, if the Secretary determines that— 
‘‘(i) the burden of creating a single, shared system 
outweighs the benefit of a single, system, taking into 
consideration the impact on health care providers, 
patients, the applicant for the abbreviated new drug 
application, and the holder of the reference drug 
product; or 
‘‘(ii) an aspect of the elements to assure safe use 
for the applicable listed drug is claimed by a patent 
that has not expired or is a method or process that, 
as a trade secret, is entitled to protection, and the 
applicant for the abbreviated new drug application cer-
tifies that it has sought a license for use of an aspect 
of the elements to assure safe use for the applicable 
listed drug and that it was unable to obtain a license. 
A certification under clause (ii) shall include a description 
of the efforts made by the applicant for the abbreviated 
new drug application to obtain a license. In a case described 
in clause (ii), the Secretary may seek to negotiate a vol-
untary agreement with the owner of the patent, method, 
or process for a license under which the applicant for 
such abbreviated new drug application may use an aspect 
of the elements to assure safe use, if required under sub-
section (f) for the applicable listed drug, that is claimed 
by a patent that has not expired or is a method or process 
that as a trade secret is entitled to protection. 
‘‘(2) ACTION BY SECRETARY.—For an applicable listed drug 
for which a drug is approved under section 505(j), the Sec-
retary— 
‘‘(A) shall undertake any communication plan to health 
care providers required under subsection (e)(3) for the 
applicable listed drug; and 
‘‘(B) shall inform the responsible person for the drug 
that is so approved if the risk evaluation and mitigation 
strategy for the applicable listed drug is modified. 
‘‘(j) DRUG SAFETY OVERSIGHT BOARD.— 
‘‘(1) IN GENERAL.—There is established a Drug Safety Over-
sight Board. 
‘‘(2) COMPOSITION; MEETINGS.—The Drug Safety Oversight 
Board shall— 
‘‘(A) be composed of scientists and health care practi-
tioners appointed by the Secretary, each of whom is an 
employee of the Federal Government; 
‘‘(B) include representatives from offices throughout 
the Food and Drug Administration, including the offices 
responsible for postapproval safety of drugs; 
‘‘(C) include at least 1 representative each from the 
National Institutes of Health and the Department of Health 
and Human Services (other than the Food and Drug 
Administration); 
‘‘(D) include such representatives as the Secretary shall 
designate from other appropriate agencies that wish to 
provide representatives; and 
‘‘(E) meet at least monthly to provide oversight and 
advice to the Secretary on the management of important 
drug safety issues.’’.