shall begin promptly after the waiver is 
provided. 
‘‘(E) STUDY REGARDING DATE FOR DIS-
CLOSURE OF PRIMARY AND SECONDARY OUT-
COMES; AUTHORITY OF SECRETARY.— 
‘‘(i) IN GENERAL.—The Secretary, in 
consultation with appropriate government 
agencies, shall conduct a study to deter-
mine whether the delay in disclosure of the 
definitions of the primary and secondary 
outcomes under clause (ii) of subparagraph 
(C), relative to the timing of disclosures 
under clause (i) of such subparagraph, is 
consistent with the protection of the public 
health. Not later than three years after the 
date of the enactment of the Fair Access 
to Clinical Trials Act, the Secretary shall 
complete the study and submit to the ap-
propriate committees of the Congress a re-
port describing the findings of the study. 
‘‘(ii) AUTHORITY OF SECRETARY.—If 
on the basis of the study under clause (i) 
the Secretary determines that the delay re-
ferred to in such clause is not consistent 
with the protection of the public health,
the Secretary shall by regulation establish 
an earlier date for disclosures of the defini-
tions referred to in such clause, which date 
may not be earlier than the date of disclo-
sures under subparagraph (C)(i). A final 
rule shall be issued under the preceding 
sentence not later than one year after the 
date on which the report under clause (i) 
of this subparagraph is submitted to the 
appropriate committees of the Congress. 
‘‘(5) LIMITATION ON USE OF INFORMATION.— 
Information on a clinical trial that is disclosed 
through the data bank, including information dis-
closed under subsection (e)(8), may not be used by 
a person other than the responsible person for the 
trial (or an entity acting with the permission of such 
person) as part of any FDA application (as defined 
in subsection (l)) unless the information is available 
in accordance with law from a source other than the 
data bank. 
‘‘(6) SUBMISSION
FORMAT
AND
TECHNICAL 
STANDARDS.— 
‘‘(A) IN GENERAL.—The Secretary shall, 
to the extent practicable, accept submissions re-
quired in subsection (d) in an electronic format
and shall establish interoperable technical 
standards for such submissions. 
‘‘(B) CONSISTENCY
OF
STANDARDS.—To 
the extent practicable, the standards established 
under subparagraph (A) shall be consistent 
with standards adopted by the Consolidated 
Health Informatics Initiative (or a successor or-
ganization to such Initiative) to the extent such 
Initiative (or successor) is in operation. 
‘‘(7) TRIALS NOT INVOLVING DRUGS, BIOLOGI-
CAL PRODUCTS, OR DEVICES.—The Secretary shall 
establish procedures and mechanisms to allow for 
the voluntary submission to the Secretary of infor-
mation described in subsection (d)(2)(B) on clinical 
trials that are not subject to subsection (c)(1). Infor-
mation received by the Secretary under this para-
graph shall be included in the data bank. In any 
case in which it is in the interest of public health, 
the Secretary may require that information on such 
trials be submitted to the Secretary. Failure to com-
ply with such a requirement shall be deemed to be 
a failure to submit information as required under 
this section, and the appropriate remedies and sanc-
tions under this section shall apply.
‘‘(8) AWARD FOR CONDUCT OF CLINICAL TRIAL; 
COMPLIANCE COSTS AS DIRECT COSTS.—In admin-
istering an award of a grant, contract, or coopera-
tive agreement that is subject to subsection (c)(1), 
the Secretary shall consider the costs of complying 
with requirements under this section as part of the 
direct costs of conducting the clinical trial involved. 
‘‘(k) CRITERIA.—The Secretary shall establish cri-
teria regarding compliance with this section. 
‘‘(l) 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 ‘biological product’ has the 
meaning given such term in section 351. 
‘‘(4) The term ‘classified’, with respect to infor-
mation, means information on matters referred to in 
section 552(b)(1)(A) of title 5, United States Code.
‘‘(5) 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. 
‘‘(6) The term ‘data bank’ means the data bank 
under subsection (a). 
‘‘(7) The term ‘device’ has the meaning given 
such term in section 201(h) of the Federal Food, 
Drug, and Cosmetic Act. 
‘‘(8) 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. 
‘‘(9) The term ‘FDA application’, with respect 
to a product, means each of the following: 
‘‘(A) An application or report submitted to 
the Secretary for the purpose of seeking a deci-
sion by the Secretary for the product to become
an approved product (as defined in paragraph 
(1)). Such term includes a supplement to such 
an application or report. 
‘‘(B) An application for an exemption 
under section 505(i) or 520(g) of the Federal 
Food, Drug, and Cosmetic Act (relating to in-
vestigational use). 
‘‘(10) 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. 
‘‘(11) The term ‘postmarket’, with respect to a 
clinical trial to investigate a product, means a clin-
ical trial that is conducted after the product has be-
come an approved product. 
‘‘(12) The term ‘product’ means a drug, biologi-
cal product, or device. 
‘‘(13) The term ‘responsible person’, with re-
spect to a clinical trial that is subject to subsection 
(c)(1), has the following meaning, as applicable: 
‘‘(A) In any case in which an application 
has with respect to the trial been submitted for 
an 
exemption 
under 
section 
505(i) 
or
520(g)(2)(A) of the Federal Food, Drug, and 
Cosmetic Act, such term means the entity who, 
within the meaning of such section, is the spon-
sor 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-
tion, such term means that entity in any 
case in which the Secretary determines 
that the entity is responsible for con-
ducting the trial, has access to and control 
over the data, has the right to publish the 
results of the trial, and has the responsi-
bility to meet all of the requirements under 
this section that are applicable to respon-
sible persons. 
‘‘(14) The term ‘unapproved product’ means a 
product that is not an approved product. 
‘‘(15) The term ‘unapproved use’, with respect 
to an approved product, means a use that is not an 
approved use. 
‘‘(m) AUTHORIZATION
OF APPROPRIATIONS.—For 
the purpose of carrying out this section, there are author-
ized to be appropriated such sums as may be necessary
for fiscal year 2005 and each subsequent fiscal year. Fees 
collected under section 736 or 738 of the Federal Food, 
Drug, and Cosmetic Act shall not be used in carrying out 
this section.’’. 
(b) APPLICABILITY.—With respect to section 402A of 
the Public Health Service Act (as added by subsection (a) 
of this section): 
(1) Subject to paragraphs (2) and (3), such 
section 402A applies to all clinical trials that are 
commenced on or after the date of the enactment of 
this Act, or are in progress as of such date, to the 
extent the trials are described in subsection (c)(1) of 
such section and not within an exception under sub-
section (c)(2) of such section. 
(2) For purposes of paragraph (1), such section 
402A applies to a trial that is in progress only if the 
final data collection from subjects in the trial on the 
primary outcome has not been completed as of the 
date of the enactment of this Act. Such a trial be-
comes subject to such section upon the expiration of 
30 days after such date of enactment, except that 
registration information required pursuant to sub-
section (d)(1) of such section is due upon the expira-
tion of such 30 days.
(3) The Secretary of Health and Human Serv-
ices (referred to in this paragraph as the ‘‘Sec-
retary’’) shall establish procedures and mechanisms 
to allow for the voluntary submission to the Sec-
retary of information described in subsection 
(d)(2)(B) of such section 402A on clinical trials that 
were completed prior to such date of enactment, or 
were in progress as of such date but not subject to 
paragraph (2). Information received by the Sec-
retary under this paragraph shall be included in the 
data bank. In any case in which it is in the interest 
of public health, the Secretary may require that in-
formation on such trials be submitted to the Sec-
retary. Failure to comply with such a requirement 
shall be deemed to be a failure to submit informa-
tion as required under such section, and the appro-
priate remedies and sanctions under such section 
shall apply. 
(4) Definitions applicable to such section 402A 
apply for purposes of this subsection. 
(c) RULE
OF CONSTRUCTION REGARDING PRIOR 
PROVISION.—With respect to the data bank program 
under section 402(j) of the Public Health Service Act as 
in effect on the day before the date of the enactment of 
this Act:
(1) Subsection (a) shall be construed as a 
transfer and modification of the program, and not as 
the termination of the program and the establish-
ment of a different program. 
(2) All information contained in the data bank 
on such day shall continue to be contained in the 
data bank, subject to section 402A of the Public 
Health Service Act (as added by subsection (a) of 
this section) or other applicable provisions of law. 
(d) CONFORMING AMENDMENTS.—Chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended— 
(1) in section 505(i), by adding at the end the 
following paragraph: 
‘‘(5) The provision of an exemption under paragraph 
(1) is subject to section 402A(e)(4) of the Public Health 
Service Act (relating to a data bank on clinical trials).’’; 
and 
(2) in section 520(g), by adding at the end the 
following paragraph: 
‘‘(8) The provision of an exemption under paragraph 
(2)(A) is subject to section 402A(e)(4) of the Public 
Health Service Act (relating to a data bank on clinical 
trials).’’.
SEC. 3. REPORTS. 
(a) IMPLEMENTATION REPORT.—Not later than one 
year after the date of enactment of this Act, the Secretary 
of Health and Human Services (referred to in this section 
as the ‘‘Secretary’’) shall submit to the appropriate com-
mittees of the Congress a report on the status of the im-
plementation of the requirements of the amendments 
made by section 2 that includes a description of the num-
ber and types of clinical trials for which information has 
been submitted under such amendments. 
(b) DATA COLLECTION.— 
(1) IN GENERAL.—The Secretary shall request 
the Institute of Medicine to enter into a contract 
with the Secretary for the conduct of a study con-
cerning the extent to which information submitted to 
the data bank under section 402A of the Public 
Health Service Act (as added by section 2(a)) has 
impacted the public health. 
(2) REPORT.—The Secretary shall ensure that 
the contract under paragraph (1) provides that, not 
later than six months after the date on which a con-
tract is entered into, the Institute of Medicine will 
submit to the Secretary a report on the results of 
the study under such paragraph, and that the report 
may include any recommendations of the Institute 
for changes to the program carried out under the
section referred to in such paragraph that the Insti-
tute considers appropriate to benefit the public 
health. 
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