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point of contact regarding advisory com-
mittee nominations; and 
‘‘(iii) developing a method through 
which an entity receiving funding from the 
National Institutes of Health, the Agency 
for Healthcare Research and Quality, the 
Centers for Disease Control and Preven-
tion, or the Veterans Health Administra-
tion can identify a person who the Food 
and Drug Administration can contact re-
garding the nomination of individuals to 
serve on advisory committees. 
‘‘(2) EVALUATION AND CRITERIA.—When con-
sidering a term appointment to an advisory com-
mittee, the Secretary shall review the expertise of 
the individual and the financial disclosure report 
filed by the individual pursuant to the Ethics in 
Government Act of 1978 for each individual under 
consideration for the appointment, so as to reduce 
the likelihood that an appointed individual will later 
require a written determination as referred to in sec-
tion 208(b)(1) of title 18, United States Code, a 
written certification as referred to in section 
208(b)(3) of title 18, United States Code, or a waiv-
er as referred to in subsection (c)(2) of this section 
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for service on the committee at a meeting of the 
committee. 
‘‘(c) DISCLOSURES; PROHIBITIONS ON PARTICIPA-
TION; WAIVERS.— 
‘‘(1) DISCLOSURE OF FINANCIAL INTEREST.— 
Prior to a meeting of an advisory committee regard-
ing a ‘particular matter’ (as that term is used in 
section 208 of title 18, United States Code), each 
member of the committee who is a full-time Govern-
ment employee or special Government employee shall 
disclose to the Secretary financial interests in ac-
cordance with subsection (b) of such section 208. 
‘‘(2) PROHIBITIONS AND WAIVERS ON PARTICI-
PATION.— 
‘‘(A) IN
GENERAL.—Except as provided 
under subparagraph (B), a member of an advi-
sory committee may not participate with respect 
to a particular matter considered in an advisory 
committee meeting if such member (or an im-
mediate family member of such member) has a 
financial interest that could be affected by the 
advice given to the Secretary with respect to 
such matter, excluding interests exempted in 
regulations issued by the Director of the Office 
of Government Ethics as too remote or incon-
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sequential to affect the integrity of the services 
of the Government officers or employees to 
which such regulations apply. 
‘‘(B) WAIVER.—If the Secretary deter-
mines it necessary to afford the advisory com-
mittee essential expertise, the Secretary may 
grant a waiver of the prohibition in subpara-
graph (A) to permit a member described in 
such subparagraph to— 
‘‘(i) participate as a non-voting mem-
ber with respect to a particular matter 
considered in a committee meeting; or 
‘‘(ii) participate as a voting member 
with respect to a particular matter consid-
ered in a committee meeting. 
‘‘(C) LIMITATION ON WAIVERS AND OTHER 
EXCEPTIONS.— 
‘‘(i) DEFINITION.—For purposes of 
this subparagraph, the term ‘exception’ 
means each of the following with respect to 
members of advisory committees: 
‘‘(I) A waiver under section 
505(n)(4) (as in effect on the day be-
fore the date of the enactment of the 
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Food 
and 
Drug 
Administration 
Amendments Act of 2007). 
‘‘(II) A written determination 
under section 208(b) of title 18, 
United States Code. 
‘‘(III) A written certification 
under section 208(b)(3) of such title. 
‘‘(ii) 
DETERMINATION
OF
TOTAL 
NUMBER OF MEMBERS SLOTS AND MEM-
BER
EXCEPTIONS
DURING
FISCAL
YEAR 
2007.—The Secretary shall determine— 
‘‘(I)(aa) for each meeting held by 
any advisory committee during fiscal 
year 2007, the number of members 
who participated in the meeting; and 
‘‘(bb) the sum of the respective 
numbers determined under item (aa) 
(referred to in this subparagraph as 
the ‘‘total number of 2007 meeting 
slots’’); and 
‘‘(II)(aa) for each meeting held 
by any advisory committee during fis-
cal year 2007, the number of mem-
bers who received an exception for the 
meeting; and 
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‘‘(bb) the sum of the respective 
numbers determined under item (aa) 
(referred to in this subparagraph as 
the ‘‘total number of 2007 meeting 
exceptions’’). 
‘‘(iii) DETERMINATION OF PERCENT-
AGE REGARDING EXCEPTIONS DURING FIS-
CAL YEAR 2007.—The Secretary shall de-
termine the percentage constituted by— 
‘‘(I) the total number of 2007 
meeting exceptions; divided by 
‘‘(II) the total number of 2007 
meeting slots. 
‘‘(iv) LIMITATION FOR FISCAL YEARS 
2008 THROUGH 2012.—The number of ex-
ceptions at the Food and Drug Adminis-
tration for members of advisory commit-
tees for a fiscal year may not exceed the 
following: 
‘‘(I) For fiscal year 2008, 95 per-
cent of the percentage determined 
under clause (iii) (referred to in this 
clause as the ‘‘base percentage’’). 
‘‘(II) For fiscal year 2009, 90 
percent of the base percentage. 
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‘‘(III) For fiscal year 2010, 85 
percent of the base percentage. 
‘‘(IV) For fiscal year 2011, 80 
percent of the base percentage. 
‘‘(V) For fiscal year 2012, 75 
percent of the base percentage. 
‘‘(v) ALLOCATION OF EXCEPTIONS.— 
The exceptions authorized under clause 
(iv) for a fiscal year may be allocated with-
in the centers or other organizational units 
of the Food and Drug Administration as 
determined appropriate by the Secretary. 
‘‘(3) 
DISCLOSURE
OF
WAIVER.—Notwith-
standing section 107(a)(2) of the Ethics in Govern-
ment Act (5 U.S.C. App.), the following shall apply: 
‘‘(A) 15 OR MORE DAYS IN ADVANCE.—As 
soon as practicable, but (except as provided in 
subparagraph (B)) not later than 15 days prior 
to a meeting of an advisory committee to which 
a written determination as referred to in section 
208(b)(1) of title 18, United States Code, a 
written certification as referred to in section 
208(b)(3) of title 18, United States Code, or a 
waiver as referred to in paragraph (2)(B) ap-
plies, the Secretary shall disclose (other than 
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(b) CONFORMING AMENDMENTS.—Section 505(n) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(n)) is amended by— 
(1) striking paragraph (4); and 
(2) redesignating paragraphs (5), (6), (7), and 
(8) as paragraphs (4), (5), (6), and (7), respectively. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on October 1, 2007. 
TITLE VIII—CLINICAL TRIAL 
DATABASES 
SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA 
BANK. 
(a) IN GENERAL.—Section 402 of the Public Health 
Service Act (42 U.S.C. 282) is amended by— 
(1) redesignating subsections (j) and (k) as 
subsections (k) and (l), respectively; and 
(2) inserting after subsection (i) the following: 
‘‘(j) EXPANDED CLINICAL TRIAL REGISTRY DATA 
BANK.— 
‘‘(1) DEFINITIONS; REQUIREMENT.— 
‘‘(A) DEFINITIONS.—In this subsection: 
‘‘(i) APPLICABLE CLINICAL TRIAL.— 
The term ‘applicable clinical trial’ means 
an applicable device clinical trial or an ap-
plicable drug clinical trial. 
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‘‘(ii) APPLICABLE
DEVICE
CLINICAL 
TRIAL.—The term ‘applicable device clin-
ical trial’ means— 
‘‘(I) a prospective clinical study 
of health outcomes comparing an 
intervention with a device subject to 
section 510(k), 515, or 520(m) of the 
Federal Food, Drug, and Cosmetic 
Act against a control in human sub-
jects (other than a small clinical trial 
to determine the feasibility of a de-
vice, or a clinical trial to test proto-
type devices where the primary out-
come measure relates to feasibility 
and not to health outcomes); and 
‘‘(II) a pediatric postmarket sur-
veillance as required under section 
522 of the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(iii) APPLICABLE
DRUG
CLINICAL 
TRIAL.— 
‘‘(I) IN
GENERAL.—The term 
‘applicable drug clinical trial’ means a 
controlled clinical investigation, other 
than a phase I clinical investigation, 
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of a drug subject to section 505 of the 
Federal Food, Drug, and Cosmetic 
Act or to section 351 of this Act. 
‘‘(II) 
CLINICAL
INVESTIGA-
TION.—For purposes of subclause (I), 
the term ‘clinical investigation’ has 
the meaning given that term in sec-
tion 312.3 of title 21, Code of Federal 
Regulations (or any successor regula-
tion). 
‘‘(III) PHASE
I.—For purposes 
of subclause (I), the term ‘phase I’ 
has the meaning given that term in 
section 312.21 of title 21, Code of 
Federal Regulations (or any successor 
regulation). 
‘‘(iv) 
CLINICAL
TRIAL
INFORMA-
TION.—The term ‘clinical trial information’ 
means, with respect to an applicable clin-
ical trial, those data elements that the re-
sponsible party is required to submit under 
paragraph (2) or under paragraph (3). 
‘‘(v) COMPLETION
DATE.—The term 
‘completion date’ means, with respect to an 
applicable clinical trial, the date that the 
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final subject was examined or received an 
intervention for the purposes of final col-
lection of data for the primary outcome, 
whether the clinical trial concluded accord-
ing to the prespecified protocol or was ter-
minated. 
‘‘(vi) DEVICE.—The term ‘device’ 
means a device as defined in section 
201(h) of the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(vii) DRUG.—The term ‘drug’ means 
a drug as defined in section 201(g) of the 
Federal Food, Drug, and Cosmetic Act or 
a biological product as defined in section 
351 of this Act. 
‘‘(viii) ONGOING.—The term ‘ongoing’ 
means, with respect to a clinical trial of a 
drug or a device and to a date, that— 
‘‘(I) 1 or more patients is en-
rolled in the clinical trial; and 
‘‘(II) the date is before the com-
pletion date of the clinical trial. 
‘‘(ix) 
RESPONSIBLE
PARTY.—The 
term ‘responsible party’, with respect to a 
clinical trial of a drug or device, means— 
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‘‘(I) the sponsor of the clinical 
trial (as defined in section 50.3 of 
title 21, Code of Federal Regulations 
(or any successor regulation)); or 
‘‘(II) the principal investigator of 
such clinical trial if so designated by 
a sponsor, grantee, contractor, or 
awardee, so long as the principal in-
vestigator is responsible for con-
ducting the trial, has access to and 
control over the data from the clinical 
trial, has the right to publish the re-
sults of the trial, and has the ability 
to meet all of the requirements under 
this subsection for the submission of 
clinical trial information. 
‘‘(B) REQUIREMENT.—The Secretary shall 
develop a mechanism by which the responsible 
party for each applicable clinical trial shall sub-
mit the identity and contact information of such 
responsible party to the Secretary at the time 
of submission of clinical trial information under 
paragraph (2). 
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‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY 
DATA BANK WITH RESPECT TO CLINICAL TRIAL IN-
FORMATION.— 
‘‘(A) IN GENERAL.— 
‘‘(i) EXPANSION OF DATA BANK.—To 
enhance patient enrollment and provide a 
mechanism to track subsequent progress of 
clinical 
trials, 
the 
Secretary, 
acting 
through the Director of NIH, shall expand, 
in accordance with this subsection, the 
clinical trials registry of the data bank de-
scribed under subsection (i)(1) (referred to 
in this subsection as the ‘registry data 
bank’). The Director of NIH shall ensure 
that the registry data bank is made pub-
licly available through the Internet. 
‘‘(ii) CONTENT.—The clinical trial in-
formation required to be submitted under 
this paragraph for an applicable clinical 
trial shall include— 
‘‘(I) descriptive information, in-
cluding— 
‘‘(aa) a brief title, intended 
for the lay public; 
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‘‘(bb) a brief summary, in-
tended for the lay public; 
‘‘(cc) the primary purpose; 
‘‘(dd) the study design; 
‘‘(ee) for an applicable drug 
clinical trial, the study phase; 
‘‘(ff) study type; 
‘‘(gg) the primary disease or 
condition being studied, or the 
focus of the study; 
‘‘(hh) the intervention name 
and intervention type; 
‘‘(ii) the study start date; 
‘‘(jj) the expected completion 
date; 
‘‘(kk) the target number of 
subjects; and 
‘‘(ll) outcomes, including pri-
mary and secondary outcome 
measures; 
‘‘(II) recruitment information, in-
cluding— 
‘‘(aa) eligibility criteria; 
‘‘(bb) gender; 
‘‘(cc) age limits; 
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‘‘(iii) POINT OF CONTACT.—A point of 
contact for scientific information about the 
clinical trial results. 
‘‘(iv) 
CERTAIN
AGREEMENTS.— 
Whether there exists an agreement (other 
than an agreement solely to comply with 
applicable provisions of law protecting the 
privacy of participants) between the spon-
sor or its agent and the principal investi-
gator (unless the sponsor is an employer of 
the principal investigator) that restricts in 
any manner the ability of the principal in-
vestigator, after the completion date of the 
trial, to discuss the results of the trial at 
a scientific meeting or any other public or 
private forum, or to publish in a scientific 
or academic journal information con-
cerning the results of the trial. 
‘‘(D) EXPANDED REGISTRY AND RESULTS 
DATA BANK.— 
‘‘(i) EXPANSION
BY
RULEMAKING.— 
To provide more complete results informa-
tion and to enhance patient access to and 
understanding of the results of clinical 
trials, not later than 3 years after the date 
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of the enactment of the Food and Drug 
Administration Amendments Act of 2007, 
the Secretary shall by regulation expand 
the registry and results data bank as pro-
vided under this subparagraph. 
‘‘(ii) CLINICAL TRIALS.— 
‘‘(I) APPROVED PRODUCTS.—The 
regulations under this subparagraph 
shall require the inclusion of the re-
sults information described in clause 
(iii) for— 
‘‘(aa) each applicable drug 
clinical trial for a drug that is 
approved under section 505 of 
the Federal Food, Drug, and 
Cosmetic Act or licensed under 
section 351 of this Act; and 
‘‘(bb) each applicable device 
clinical trial for a device that is 
cleared under section 510(k) of 
the Federal Food, Drug, and 
Cosmetic Act or approved under 
section 515 or 520(m) of such 
Act. 
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‘‘(II) UNAPPROVED PRODUCTS.— 
The regulations under this subpara-
graph shall establish whether or not 
the results information described in 
clause (iii) shall be required for— 
‘‘(aa) an applicable drug 
clinical trial for a drug that is 
not approved under section 505 
of the Federal Food, Drug, and 
Cosmetic Act and not licensed 
under section 351 of this Act 
(whether approval or licensure 
was sought or not); and 
‘‘(bb) an applicable device 
clinical trial for a device that is 
not cleared under section 510(k) 
of the Federal Food, Drug, and 
Cosmetic Act and not approved 
under section 515 or section 
520(m) of such Act (whether 
clearance or approval was sought 
or not). 
‘‘(iii) 
REQUIRED
ELEMENTS.—The 
regulations under this subparagraph shall 
require, in addition to the elements de-
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scribed in subparagraph (C), information 
within each of the following categories: 
‘‘(I) A summary of the clinical 
trial and its results that is written in 
non-technical, 
understandable 
lan-
guage for patients, if the Secretary 
determines that such types of sum-
mary can be included without being 
misleading or promotional. 
‘‘(II) A summary of the clinical 
trial and its results that is technical 
in nature, if the Secretary determines 
that such types of summary can be in-
cluded without being misleading or 
promotional. 
‘‘(III) The full protocol or such 
information on the protocol for the 
trial as may be necessary to help to 
evaluate the results of the trial. 
‘‘(IV) Such other categories as 
the Secretary determines appropriate. 
‘‘(iv) RESULTS SUBMISSION.—The re-
sults information described in clause (iii) 
shall be submitted to the Director of NIH 
for inclusion in the registry and results 
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data bank as provided by subparagraph 
(E), except that the Secretary shall by reg-
ulation determine— 
‘‘(I) whether the 1-year period 
for submission of clinical trial infor-
mation described in subparagraph 
(E)(i) should be increased from 1 year 
to a period not to exceed 18 months; 
‘‘(II) whether the clinical trial in-
formation described in clause (iii) 
should be required to be submitted for 
an applicable clinical trial for which 
the clinical trial information described 
in subparagraph (C) is submitted to 
the registry and results data bank be-
fore the effective date of the regula-
tions issued under this subparagraph; 
and 
‘‘(III) in the case when the clin-
ical trial information described in 
clause (iii) is required to be submitted 
for the applicable clinical trials de-
scribed in clause (ii)(II), the date by 
which such clinical trial information 
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shall be required to be submitted, tak-
ing into account— 
‘‘(aa) the certification proc-
ess under subparagraph (E)(iii) 
when 
approval, 
licensure, 
or 
clearance is sought; and 
‘‘(bb) whether there should 
be a delay of submission when 
approval, licensure, or clearance 
will not be sought. 
‘‘(v) ADDITIONAL
PROVISIONS.—The 
regulations under this subparagraph shall 
also establish— 
‘‘(I) a standard format for the 
submission of clinical trial information 
under this paragraph to the registry 
and results data bank; 
‘‘(II) additional information on 
clinical trials and results that is writ-
ten in nontechnical, understandable 
language for patients; 
‘‘(III) considering the experience 
under the pilot quality control project 
described in paragraph (5)(C), proce-
dures for quality control, including 
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using representative samples, with re-
spect to completeness and content of 
clinical trial information under this 
subsection, to help ensure that data 
elements are not false or misleading 
and are non-promotional; 
‘‘(IV) the appropriate timing and 
requirements for updates of clinical 
trial information, and whether and, if 
so, how such updates should be 
tracked; 
‘‘(V) a statement to accompany 
the entry for an applicable clinical 
trial when the primary and secondary 
outcome measures for such clinical 
trial are submitted under paragraph 
(4)(A) after the date specified for the 
submission of such information in 
paragraph (2)(C); and 
‘‘(VI) additions or modifications 
to the manner of reporting of the data 
elements established under subpara-
graph (C). 
‘‘(vi) 
CONSIDERATION
OF
WORLD 
HEALTH
ORGANIZATION
DATA
SET.—The 
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