I 
108TH CONGRESS 
2D SESSION 
H. R. 5252 
To amend the Public Health Service Act and the Federal Food, Drug, 
and Cosmetic Act with respect to the availability to the public of informa-
tion on clinical trials to determine the safety and effectiveness of drugs, 
biological products, and devices, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 7, 2004 
Mr. MARKEY (for himself and Mr. WAXMAN) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act and the Federal 
Food, Drug, and Cosmetic Act with respect to the avail-
ability to the public of information on clinical trials to 
determine the safety and effectiveness of drugs, biological 
products, and devices, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Fair Access to Clinical 
Trials Act’’.
SEC. 2. REGISTRATION OF CLINICAL TRIALS UNDER PUB-
LIC HEALTH SERVICE ACT. 
(a) IN GENERAL.—Title IV of the Public Health 
Service Act (42 U.S.C. 281 et seq.) is amended— 
(1) in section 402, by striking subsection (j); 
and 
(2) by inserting after section 491 the following 
section: 
‘‘SEC. 491A. REGISTRATION OF CLINICAL TRIALS; DATA 
BANK. 
‘‘(a) IN GENERAL.— 
‘‘(1) CONDITIONS FOR FINANCIAL AWARDS.— 
Except as provided in paragraph (2), an entity may 
not receive an award of a grant, contract, or cooper-
ative agreement under this Act for the conduct of a 
clinical trial to determine the safety or effectiveness 
of a use of a drug or device (referred to in this sec-
tion as a ‘product’) unless the responsible person for 
the trial— 
‘‘(A) agrees to register the trial with the 
Secretary in accordance with subsection (d)(1); 
‘‘(B) agrees to provide to the Secretary in-
formation on the results of the trial in accord-
ance with subsection (d)(2);
‘‘(C) agrees to the disclosure to the public 
of information regarding the trial in accordance 
with subsection (e); and 
‘‘(D) agrees to be subject to audits under 
subsection (f)(1), and as applicable, to liq-
uidated penalties and the requirement to submit 
reports under subsection (g)(1). 
‘‘(2) EXCEPTION.—Paragraph (1) does not 
apply to a clinical trial to determine the safety of a 
use of a drug if the trial is designed solely to detect 
major toxicities in the drug or to investigate phar-
macokinetics, except that such paragraph does apply 
if the trial is designed solely to investigate phar-
macokinetics in a special population or populations. 
‘‘(b) DATA BANK.— 
‘‘(1) IN
GENERAL.— The Secretary, acting 
through the Director of NIH, shall establish, main-
tain, and operate a data bank of information pro-
vided to the Secretary pursuant to subsection (a), 
including collecting, cataloging, and storing the in-
formation, and disseminating the information in ac-
cordance with subsection (e). The activities of the 
data bank shall be integrated and coordinated with 
related activities of other agencies of the Depart-
ment of Health and Human Services, and to the ex-
tent practicable, coordinated with other data banks 
containing similar information. 
‘‘(2) INFORMATION
FROM
ELECTIVE
SUBMIS-
SIONS.— 
‘‘(A) CLINICAL TRIALS REGARDING DRUGS 
OR DEVICES.—The Secretary may accept for in-
clusion in the data bank information on clinical 
trials that are trials to determine the safety or 
effectiveness of a use of a product but are not 
subject to requirements under subsection (a). 
The inclusion of information in the data bank 
under the preceding sentence is subject to the 
condition that the responsible person for the 
clinical trial involved make each of the agree-
ments described in subsection (a)(1). 
‘‘(B) OTHER CLINICAL TRIALS.—The Sec-
retary may accept for inclusion in the data 
bank information on clinical trials that do not 
involve drugs or devices if the responsible per-
son for the trial involved agrees to such condi-
tions regarding the submission and disclosure of 
the information as the Secretary determines to 
be appropriate, taking into account the require-
ments of this section for clinical trials that do 
involve drugs or devices.
‘‘(3) CONSULTATION.—The Secretary shall op-
erate the data bank in consultation with the Com-
missioner of Food and Drugs, the directors of the 
appropriate agencies of the National Institutes of 
Health, and the Director of the Centers for Disease 
Control and Prevention. 
‘‘(4) NATIONAL LIBRARY OF MEDICINE.—The 
Director of NIH shall assign to the National Library 
of Medicine the primary responsibility for carrying 
out paragraph (1). 
‘‘(5) ENTRY
OF
INFORMATION.—Information 
provided to the Secretary under this section by re-
sponsible persons for clinical trials shall be entered 
in the data bank promptly after the Secretary re-
ceives the information, except to the extent that the 
Secretary determines that the information has not 
been submitted to the Secretary in accordance with 
this section, in which case the Secretary shall 
promptly inform the responsible person involved that 
corrective actions by the person are necessary to 
maintain compliance with this section. 
‘‘(6) AUTHORITY OF SECRETARY.— 
‘‘(A) INCLUSION
OF
STATEMENTS
TO 
AVOID
MISINTERPRETATIONS.—The Secretary 
may include in the data bank such statements
as the Secretary determines to be appropriate 
to assist the public in avoiding misinterpreta-
tions of information in the data bank. State-
ments under the preceding sentence may in-
clude statements regarding the data bank in 
general and statements regarding particular 
items of information submitted to the data 
bank. The Secretary may not under the pre-
ceding sentence alter any information as sub-
mitted. 
‘‘(B) FALSE
OR
MISLEADING
INFORMA-
TION.— 
‘‘(i) IN
GENERAL.—If under sub-
section (f) the Secretary determines that 
information presented or cited in the data 
bank is false or misleading, the Secretary 
shall, promptly after making such deter-
mination, identify in the data bank the in-
formation as false or misleading (as appli-
cable), and shall, to the extent practicable, 
include in the data bank an accurate 
version of the information. The Secretary 
shall in addition make appropriate public 
notification.
‘‘(ii) LIMITATION.—Clause (i) does 
not authorize the disclosure of information 
if— 
‘‘(I) the disclosure would con-
stitute a clearly unwarranted invasion 
of personal privacy; or 
‘‘(II) the information concerns a 
method or process that is a trade se-
cret entitled to protection within the 
meaning of section 301(j) of the Fed-
eral Food, Drug, and Cosmetic Act. 
‘‘(c) INSTITUTIONAL REVIEW BOARDS.—For pur-
poses of subsection (a), the Secretary shall amend part 
46 of title 45, Code of Federal Regulations, to provide 
that— 
‘‘(1) the functions of institutional review boards 
under such part include— 
‘‘(A) determining whether clinical trials to 
determine the safety or effectiveness of prod-
ucts are registered under subsection (a)(1)(A); 
and 
‘‘(B) denying the approval of the boards 
for such trials that are not registered under 
such subsection;
‘‘(2) any approval of an institutional review 
board regarding such a trial is not effective under 
such part if the trial is not registered under such 
subsection; and 
‘‘(3) upon request of an institutional review 
board for such a trial, the Secretary will provide to 
the board a copy of the registration for the trial 
under such subsection (which copy will be the reg-
istration as submitted to the Secretary, together 
with all updates to the registration). 
‘‘(d) SUBMISSION OF REQUIRED INFORMATION.— 
‘‘(1) SUBMISSION OF REGISTRATION INFORMA-
TION.— 
‘‘(A) IN
GENERAL.—A registration of a 
clinical trial under subsection (a)(1)(A) is in ac-
cordance with this paragraph if, subject to sub-
paragraph (B), the registration is in such form 
and is submitted in such manner as the Sec-
retary requires, and the registration contains 
such information on the design and goals of the 
trial as the Secretary determines to be impor-
tant to clinicians or researchers. Such informa-
tion shall include the following: 
‘‘(i) A brief title for the trial, provided 
in lay language.
‘‘(ii) The disease or condition with 
which the trial is concerned. 
‘‘(iii) The medical intervention or 
interventions being investigated in the 
trial. 
‘‘(iv) A statement that— 
‘‘(I) identifies the product as an 
unapproved product or as an approved 
product, as applicable; and 
‘‘(II) in addition, in the case of 
an approved product, identifies the 
trial as investigating the approved use 
of the product or an unapproved use 
of the product, as applicable. 
‘‘(v) The purpose of the trial, includ-
ing a statement of the interventions and 
comparisons involved. 
‘‘(vi) A statement of the hypothesis 
being tested in the trial. 
‘‘(vii) Information on— 
‘‘(I) study design; 
‘‘(II) methods; 
‘‘(III) study phase; and 
‘‘(IV) study type.
‘‘(viii) The definition of the primary 
and secondary outcomes for the trial. 
‘‘(ix) The length of time for which 
data on the primary and secondary out-
comes will be collected on each patient. 
‘‘(x) Eligibility criteria for participa-
tion in the trial. 
‘‘(xi) The total number of subjects an-
ticipated to participate in the trial. 
‘‘(xii) The anticipated or actual date 
on which the trial will begin. 
‘‘(xiii) The anticipated or actual date 
of final data collection from subjects in the 
trial on the primary outcome. 
‘‘(xiv) The identity of each responsible 
person for the trial. 
‘‘(xv) Sources of funding for the trial 
in addition to the award under this Act. 
‘‘(xvi) The identity of the principal in-
vestigator in the trial. 
‘‘(xvii) Contact information for the 
principal investigator. 
‘‘(xviii) A unique protocol number 
identification number for the trial, which 
number shall be assigned by the Secretary.
‘‘(xix) After the initial submission of 
the registration, periodic updates to reflect 
changes to information provided under this 
subparagraph 
and 
subparagraph 
(B), 
which updates— 
‘‘(I) are provided not less fre-
quently than once every six months 
until the results of the trial are sub-
mitted under paragraph (2)(A)(i) or a 
waiver is provided under paragraph 
(2)(C); and 
‘‘(II) identify the dates on which 
the changes were made. 
‘‘(B) SERIOUS OR LIFE-THREATENING DIS-
EASES; TEST OF EFFECTIVENESS.—In the case 
of a registration under subsection (a)(1)(A) of 
a clinical trial to test the effectiveness of the 
use of a product with respect to a serious or 
life-threatening disease or condition, the reg-
istration is in accordance with this paragraph 
if, in addition to the information described in 
subparagraph (A), the registration provides the 
following information: 
‘‘(i) A brief summary of the trial, pro-
vided in lay language.
‘‘(ii) A description of the location of 
trial sites. 
‘‘(iii) A point of contact for individ-
uals desiring to enroll as subjects in the 
trial, including a single point of contact for 
all trial sites. 
‘‘(iv) The status of the trial with re-
spect to the enrollment of subjects, stated 
for the trial in general and for individual 
trial sites. 
‘‘(v) Information that may be avail-
able— 
‘‘(I) under a treatment investiga-
tional new drug application, or a 
treatment investigational device ex-
emption, that has been submitted to 
the Secretary under section 561(c) of 
the Federal Food, Drug, and Cos-
metic Act (relating to expanded access 
protocols); or 
‘‘(II) as a Group C cancer drug 
(as defined by the National Cancer 
Institute). 
‘‘(2) SUBMISSION OF RESULTS OF TRIAL.—
‘‘(A) IN GENERAL.—For purposes of sub-
section (a)(1)(B), information on the results of 
a clinical trial is provided in accordance with 
this paragraph if, subject to subparagraphs (B) 
and (C), the following conditions are met: 
‘‘(i) The results are submitted— 
‘‘(I) not later than 12 months 
after the earlier of the anticipated 
date that applies under paragraph 
(1)(A)(xiii) or the actual date that ap-
plies under such paragraph; or 
‘‘(II) such later date as may 
apply under an extension under sub-
paragraph (B). 
‘‘(ii) The results are provided in the 
form of a structured abstract and in such 
manner as the Secretary may require. 
‘‘(iii) The results consist of informa-
tion determined by the Secretary to be im-
portant to clinicians or researchers, in a 
form that ensures that the information is 
accurate and not likely to mislead or dis-
tort the results of the trial. Such informa-
tion shall include the following:
‘‘(I) The date on which the trial 
commenced. 
‘‘(II) The actual date for the 
final collection of data from subjects 
in the trial. 
‘‘(III) Primary and secondary 
outcomes, presented succinctly as 
quantitative data and as tests of 
hypotheses. 
‘‘(IV) Basic demographic infor-
mation on subjects. 
‘‘(V) In the group of subjects re-
ceiving the product, and in each com-
parison group of subjects, the percent-
age of individuals who decided to 
cease participation as subjects and the 
reasons for ceasing participation. 
‘‘(VI) Information on significant 
adverse events in subjects that may be 
associated with the product involved, 
including such events for which a 
causal relationship has not been es-
tablished. 
‘‘(iv) If the trial is investigating an 
unapproved use of an approved product, a
statement is submitted to the data bank 
that the Food and Drug Administration, 
as applicable— 
‘‘(I) is currently reviewing an ap-
plication for approval of the unap-
proved use; 
‘‘(II) has disapproved such an 
application; 
‘‘(III) has reviewed such an ap-
plication, but the application was 
withdrawn prior to approval or dis-
approval; or 
‘‘(IV) has not reviewed or ap-
proved such an application. 
‘‘(v) After the initial submission of the 
results, periodic updates are submitted to 
the data bank to reflect changes in the in-
formation submitted under this subpara-
graph, which updates— 
‘‘(I) are provided not less fre-
quently than once every six months 
during the 10-year period beginning 
on the date on which the results are 
due under clause (i); and
‘‘(II) identify the dates on which 
the changes were made. 
‘‘(vi) For each covered article pub-
lished in a peer-reviewed scientific or aca-
demic journal, the responsible person for 
the trial submits to the data bank a state-
ment that provides a citation to the article. 
An article published in such a journal is a 
covered article for purposes of this clause 
if— 
‘‘(I) the article discusses the re-
sults of the trial; 
‘‘(II) the responsible person or 
the principal investigator for the clin-
ical trial contributed to the article; 
and 
‘‘(III) MEDLINE includes a ci-
tation to the article. 
‘‘(vii) If the due date under clause (i) 
for the trial is a date that is more than 
three years after the date on which the 
trial was registered under subsection 
(a)(1)(A): 
‘‘(I) Upon the expiration of such 
three-year period, the responsible per-
son for the trial submits to the data 
bank a report that describes the 
progress being made toward submis-
sion of the results. 
‘‘(II) For each two-year period 
that lapses after the submission of the 
report under subclause (I), the re-
sponsible person submits to the data 
bank an additional report that de-
scribes such progress, except that no 
report is required under this sub-
clause after such due date. 
‘‘(B) EXTENSIONS.— 
‘‘(i) IN
GENERAL.—The Secretary 
may provide an extension of the due date 
under subparagraph (A)(i) for the results 
of a clinical trial if the responsible person 
for the trial submits to the Secretary a 
written request that demonstrates good 
cause for the extension and provides an es-
timate of the date on which the results will 
be submitted. More than one such exten-
sion may be provided by the Secretary for 
the clinical trial involved.
‘‘(ii) EXTENSIONS REGARDING JOUR-
NAL PUBLICATION.— 
‘‘(I) ARTICLE UNDER CONSIDER-
ATION FOR PUBLICATION.—The Sec-
retary shall under clause (i) provide 
an extension of 18 months regarding 
the submission of the results of a clin-
ical trial if— 
‘‘(aa) the request under such 
clause demonstrates that an arti-
cle providing the information de-
scribed in subparagraph (A)(iii) 
has been submitted to a peer-re-
viewed scientific or academic 
journal for which references are 
included in MEDLINE, and the 
request demonstrates that the ar-
ticle is being considered by the 
journal for publication; and 
‘‘(bb) such request is made 
before the expiration of the 12- 
month period described in sub-
paragraph (A)(i). 
‘‘(II) ARTICLE
ACCEPTED
FOR 
PUBLICATION.—If the responsible per-
son for a clinical trial has received an 
extension under subclause (I) for the 
trial, the Secretary shall provide an 
additional extension of six months, be-
ginning upon the expiration of such 
first extension, if the person dem-
onstrates to the Secretary, before the 
expiration of the first extension, that 
the article involved has been accepted 
for publication by a journal referred 
to in such subclause. 
‘‘(C) WAIVERS
REGARDING
RESULTS
OF 
TRIAL.—With respect to the requirement under 
subsection (a)(1)(B) to submit to the Secretary 
the results of a clinical trial, the Secretary may 
waive the requirement upon a written request to 
the Secretary by the responsible person for the 
trial if the Secretary determines that extraor-
dinary circumstances justify the waiver and 
that providing the waiver is in the public inter-
est or consistent with the protection of the pub-
lic health. The Secretary shall ensure that in-
formation on each such waiver is included in 
the data bank.
as subjects in clinical trials, the Secretary shall 
through such means disclose all information in 
the data bank, except that the Secretary may 
exclude any information that the Secretary de-
termines is not useful to such patients. The 
Secretary may not under the preceding sentence 
exclude information of the type referred to in 
paragraph (3)(B). 
‘‘(6) REGISTRATION
INFORMATION; DATE
OF 
DISCLOSURE.—In the case of information regarding 
a clinical trial that is contained in the data bank 
pursuant to subparagraph (A) or (B) of subsection 
(d)(1), disclosures required in paragraph (5) shall 
begin in accordance with the following: 
‘‘(A) All such disclosures shall begin 
promptly after the registration involved is sub-
mitted to the Secretary, other than disclosure of 
the definitions of the primary and secondary 
outcomes. 
‘‘(B) Disclosure of the definition of the pri-
mary and secondary outcomes shall begin at the 
same time as disclosure of the results of the 
trial begin under paragraph (7)(A). 
‘‘(7) RESULTS
OF
TRIAL; DATE
OF
DISCLO-
SURE.—
‘‘(A) IN GENERAL.—In the case of infor-
mation regarding a clinical trial that is con-
tained in the data bank pursuant to subsection 
(d)(2), disclosures required in paragraph (5) 
shall begin promptly after the information is 
submitted to the Secretary, subject to subpara-
graph (B). 
‘‘(B) WAIVER
REGARDING
RESULTS
OF 
TRIAL.—In the case of information contained in 
the data bank on waivers under subsection 
(d)(2)(C), disclosures required in paragraph (5) 
shall begin promptly after the waiver is pro-
vided. 
‘‘(f) DETERMINATION OF VIOLATIONS.— 
‘‘(1) COMPLIANCE AUDITS.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
conduct periodic audits of responsible persons 
for clinical trials receiving awards described in 
subsection (a)(1) in order to determine whether 
the persons have submitted information as re-
quired under agreements under subparagraphs 
(A) and (B) of such subsection, including deter-
mining whether any of the information is false 
or misleading.
‘‘(B) PRIORITY.—In conducting audits 
under subparagraph (A), the Secretary shall 
give priority to responsible persons for clinical 
trials who have at any time been included on 
the list under subsection (g)(1)(A)(i), taking 
into account the number and severity of the vio-
lations involved. 
‘‘(2) NOTICE
TO
RESPONSIBLE
PERSONS.— 
Promptly after determining that a responsible per-
son for a clinical trial is in violation of a require-
ment under subparagraph (A) or (B) of subsection 
(a)(1), the Secretary shall notify the person in writ-
ing of the violation. 
‘‘(g) ACTIONS OF SECRETARY REGARDING VIOLA-
TIONS.— 
‘‘(1) IN GENERAL.—If a responsible person for 
a clinical trial is in violation of an agreement under 
subparagraph (A) or (B) of subsection (a)(1) (in-
cluding submitting information under such a sub-
paragraph that is false or misleading), the following 
applies, subject to paragraph (4) of this subsection: 
‘‘(A) In any case in which the violation is 
not corrected within 30 days after the Secretary 
provides to the responsible person a notice 
under subsection (f)(2) regarding the violation:
‘‘(i) Through Internet sites under sub-
section (e)(3) and such other means as the 
Secretary determines to be appropriate, the 
Secretary shall announce to the public that 
the responsible person is in violation of 
this section. For purposes of the preceding 
sentence, the Secretary shall maintain a 
list of responsible persons in violation that 
is available to the public. 
‘‘(ii) The responsible person is, pursu-
ant to subsection (a)(1)(D), subject to a 
liquidated penalty of not more than a total 
of $15,000 for all violations adjudicated in 
a single proceeding in the case of an indi-
vidual, and $10,000 per day until the vio-
lation is corrected in the case of any other 
person, except that if the person is a non-
profit entity the penalty may not exceed a 
total of $15,000 for all violations adju-
dicated in a single proceeding. Paragraphs 
(3) through (5) of section 303(f) of the 
Federal Food, Drug, and Cosmetic Act 
apply to the imposition of such a penalty 
to the same extent and in the same man-
ner as such paragraphs apply to a penalty
imposed under paragraph (1) or (2) of 
such section. 
‘‘(B) In any case in which the violation is 
a significant violation and is not corrected with-
in 60 days after the Secretary provides to the 
responsible person a notice under subsection 
(f)(2) regarding the violation, the Secretary 
shall, after notice and an opportunity for a 
hearing, consider the person to be ineligible for 
any future awards described in subsection 
(a)(1) until the violation is corrected, except 
that notice and an opportunity for a hearing 
are not required if a hearing regarding such 
violation was held pursuant to subparagraph 
(A)(ii). 
‘‘(C) In any case in which the violation is 
a failure to submit to the data bank the results 
of the trial by the due date under subsection 
(d)(2)(A)(i), the Secretary shall order the re-
sponsible person to submit to the data bank 
periodic reports on the progress being made to-
ward submission of the results, which reports 
shall be submitted not less frequently that once 
every two years until the results are submitted 
to the data bank.
‘‘(2) 
RELATION
TO
RELATED
REQUIRE-
MENTS.—If a responsible person for a clinical trial 
is ineligible for purposes of section 565(f)(1)(B) or 
566(a)(2) of the Federal Food, Drug, and Cosmetic 
Act, the person is ineligible for any award described 
in subsection (a)(1) during the period of such ineli-
gibility, without regard to whether the person is in-
eligible under paragraph (1)(B) of this subsection. 
‘‘(3) FALSE OR MISLEADING INFORMATION.—If 
the Secretary determines that the responsible person 
for a clinical trial has submitted to the data bank 
information that is false or misleading, and if on 
such basis a civil money has been imposed under 
paragraph (1)(A)(ii) on such person or the person 
has becomes ineligible within the meaning of para-
graph (1)(B) or (2), the Secretary shall remove the 
information from the data bank, subject to any judi-
cial review of such action or actions of the Secretary. 
‘‘(4) WAIVER
REGARDING
INELIGIBILITY
FOR 
FUNDING.—With respect to a responsible person 
who is ineligible for purposes of paragraph (1)(B) or 
(2), the Secretary may waive the applicability of 
such paragraph in order to provide for a clinical 
trial if the Secretary determines that providing the 
waiver is in the public interest or consistent with the
protection of the public health. Each such deter-
mination of the Secretary shall be published in the 
Federal Register. 
‘‘(5) FUNDING
OF
COMPARATIVE
STUDIES.— 
Penalties collected by the Secretary under paragraph 
(1)(A)(ii) shall be used by the Secretary to make 
awards of grants, contracts, or cooperative agree-
ments for the conduct of comparative clinical trials 
to determine the safety or relative effectiveness of 
products. 
‘‘(h) CRITERIA.—The Secretary shall establish cri-
teria regarding compliance with this section. 
‘‘(i) AWARD
FOR CONDUCT
OF CLINICAL TRIAL; 
COMPLIANCE
COSTS
AS
DIRECT
COSTS.—In admin-
istering an award of a grant, contract, or cooperative 
agreement that is subject to subsection (a)(1), the Sec-
retary shall consider the costs of complying with require-
ments under such subsection as part of the direct costs 
of conducting the clinical trial involved. 
‘‘(j) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘approved product’ means a 
product that is approved, licensed, or cleared for 
commercial distribution under section 505, 510(k), 
or 515 of the Federal Food, Drug, and Cosmetic Act 
or under section 351 of this Act.
‘‘(2) The term ‘approved use’, with respect to 
an approved product, means a use that is an ap-
proved, licensed, or cleared use of the product under 
a provision of law referred to in paragraph (1). 
‘‘(3) The term ‘clinical trial’, with respect to a 
product, means a clinical investigation within the 
meaning of section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (in the case of drug), or 
within the meaning of section 520(g) of such Act (in 
the case of a device), as applicable, except that such 
term does not include such an investigation that 
does not prospectively assign human subjects to 
intervention or comparison groups to study the caus-
al relationship between a medical intervention and 
an outcome. 
‘‘(4) The term ‘data bank’ means the data bank 
under subsection (b). 
‘‘(5) The term ‘device’ has the meaning given 
such term in section 201(h) of the Federal Food, 
Drug, and Cosmetic Act. 
‘‘(6) The term ‘drug’ has the meaning given 
such term in section 201(g)(1) of the Federal Food, 
Drug, and Cosmetic Act. Such term includes a bio-
logical product.
‘‘(7) The term ‘MEDLINE’ means the biblio-
graphic electronic data base of references to journal- 
published articles that is operated by the National 
Library of Medicine and is designated by such Li-
brary as the Medical Literature, Analysis, and Re-
trieval System Online. 
‘‘(8) The term ‘product’ has the meaning indi-
cated for such term in subsection (a)(1). 
‘‘(9) The term ‘researchers’ means individuals 
who conduct research on drugs or devices. 
‘‘(10) The term ‘responsible person’, with re-
spect to a clinical trial to determine the safety or ef-
fectiveness of a use of a product, has the following 
meaning, as applicable: 
‘‘(A) In any case in which an application 
has been submitted for an exemption under sec-
tion 505(i) or 520(g)(2)(A) with respect to the 
trial, such term means the entity who, within 
the meaning of such section, is the sponsor of 
the trial. 
‘‘(B) In any case in which such an applica-
tion has not been submitted, such term means 
the entity who is or will be providing the largest 
share of the monetary support for the trial
(without regard to any in-kind support for the 
trial), subject to the following: 
‘‘(i) If the Federal Government or a 
State is or will be providing the largest 
share, such term means the principal in-
vestigator for the trial. 
‘‘(ii) If a nonprofit private entity is or 
will be providing the largest share, such 
term means the principal investigator for 
the trial in any case in which such entity 
and investigator have jointly certified to 
the Secretary that the investigator will be 
the responsible person for purposes of this 
section. 
‘‘(iii) If two or more entities provide 
equal monetary support for the trial and 
no other entity provides a greater amount 
of monetary support, such term means 
each of the entities providing such equal 
support, other than the Federal Govern-
ment or a State. 
‘‘(iv) 
Notwithstanding 
clauses 
(i) 
through (iii), if an entity submits to the 
Secretary a written request to be the re-
sponsible person for purposes of this sec-