tion, such term means that entity in any 
case in which the Secretary determines 
that the entity is or will be providing mon-
etary support for the trial and is respon-
sible for conducting the trial. 
‘‘(11) The term ‘unapproved product’ means a 
product that is not an approved product. 
‘‘(12) The term ‘unapproved use’, with respect 
to an approved product, means a use that is not an 
approved use. 
‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated such sums as may be necessary for fis-
cal year 2004 and each subsequent fiscal year. Fees col-
lected under section 736 or 738 of the Federal Food, 
Drug, and Cosmetic Act shall not be used in carrying out 
this section.’’. 
(b) CLINICAL INVESTIGATIONS IN PROGRESS.—With 
respect to a clinical investigation to determine the safety 
or effectiveness of a use of a drug, biological product, or 
device, 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, and if the investigation 
is being conducted with an award of a grant, contract, 
or cooperative agreement under the Public Health Service
Act, the investigation becomes subject to section 491A of 
such Act (as added by subsection (a) of this section) upon 
the expiration of 30 days after the date of the enactment 
of this Act, except that registration information required 
pursuant to subsection (d)(1) of such section 491A is due 
upon the expiration of such 30 days. For purposes of the 
preceding sentence, the term ‘‘clinical investigation’’ has 
the meaning that applies for purposes of subsection (j)(3) 
of such section 491A. 
(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 491A of the Public 
Health Service Act (as added by subsection (a) of 
this section) or other applicable provisions of law.
SEC. 3. OTHER CONDITIONS REGARDING DATA BANK ON 
CLINICAL TRIALS. 
(a) INVESTIGATIONAL DRUGS AND DEVICES.— 
(1) IN GENERAL.—Subchapter E of chapter V 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb et seq.) is amended by adding at the 
end the following section: 
‘‘SEC. 565. INVESTIGATIONAL DRUGS AND DEVICES; CONDI-
TIONS REGARDING DATA BANK ON CLINICAL 
TRIALS. 
‘‘(a) IN GENERAL.— 
‘‘(1) CONDITIONS
FOR
EXEMPTIONS.—Except 
as provided in paragraph (2), an exemption under 
section 505(i) or 520(g)(2)(A) for an investigation 
to determine the safety or effectiveness of the use of 
a drug or device (referred to in this section as a 
‘product’) may not be considered to be in effect un-
less— 
‘‘(A) the sponsor of the investigation 
agrees to register the investigation with the 
Secretary; 
‘‘(B) the sponsor of the investigation 
agrees to provide to the Secretary information 
on the results of the investigation; and
‘‘(C) the sponsor of the investigation 
agrees to the disclosure to the public of infor-
mation regarding the investigation. 
‘‘(2) EXCEPTION.—Paragraph (1) does not 
apply to an investigation to determine the safety of 
a use of a drug if the trial is designed solely to de-
tect major toxicities in the drug or to investigate 
pharmacokinetics, except that such paragraph does 
apply if the trial is designed solely to investigate 
pharmacokinetics in a special population or popu-
lations. 
‘‘(b) INSTITUTIONAL REVIEW BOARDS.—For pur-
poses of subsection (a), the Secretary shall amend parts 
50, 56, and 812 of title 21, Code of Federal Regulations, 
to provide that— 
‘‘(1) the functions of institutional review boards 
under such parts include— 
‘‘(A) determining whether investigations 
are registered under subsection (a)(1)(A); and 
‘‘(B) denying the approval of the boards 
for investigations that are not registered under 
such subsection; 
‘‘(2) any approval of an institutional review 
board regarding an investigation is not effective
under such parts if the investigation is not reg-
istered under such subsection; and 
‘‘(3) upon request of an institutional review 
board for such an investigation, the Secretary will 
provide to the board a copy of the registration for 
the investigation under such subsection (which copy 
will be the registration as submitted to the Sec-
retary, together with all updates to the registration). 
‘‘(c) CERTAIN EXEMPTIONS.—The reference in sub-
section (a) to an exemption under section 505(i) includes 
an exemption described in section 312.2(b) of title 21, 
Code of Federal Regulations. The reference in such sub-
section to an exemption under section 520(g)(2)(A) in-
cludes an exemption described in section 812.2(b) of such 
title 21. 
‘‘(d) RELATIONSHIP TO SIMILAR REQUIREMENTS.— 
For purposes of subsection (a): 
‘‘(1) The responsibilities of a sponsor of an in-
vestigation, and of the Secretary, are the same as 
apply under section 491A of the Public Health Serv-
ice Act with respect to responsible persons, except to 
the extent of taking into account that this section 
concerns conditions for exemptions referred to in 
subsection (a)(1) and section 491A of such Act con-
cerns conditions for the receipt of an award under 
such Act. 
‘‘(2) The Secretary shall administer the pro-
gram under this section and the program under sec-
tion 491A of such Act as substantially a single pro-
gram, shall not require duplicative registrations, and 
shall otherwise avoid duplicative activities. 
‘‘(e) DETERMINATION OF VIOLATIONS.— 
‘‘(1) COMPLIANCE AUDITS.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
conduct periodic audits of sponsors of investiga-
tions for which exemptions referred to in sub-
section (a)(1) are in effect in order to deter-
mine whether the sponsors have submitted in-
formation as required under agreements under 
subparagraphs (A) and (B) of such subsection, 
including determining whether any of the infor-
mation is false or misleading. 
‘‘(B) PRIORITY.—In conducting audits 
under subparagraph (A), the Secretary shall 
give priority to sponsors of investigations who 
have at any time been included on the list 
under subsection (f)(1)(A)(i), taking into ac-
count the number and severity of the violations 
involved.
‘‘(2) NOTICE
TO
SPONSORS.—Promptly after 
determining that a sponsor of an investigation is in 
violation of a requirement under subparagraph (A) 
or (B) of subsection (a)(1), the Secretary shall no-
tify the sponsor in writing of the violation. 
‘‘(f) ACTIONS OF SECRETARY REGARDING VIOLA-
TIONS.— 
‘‘(1) IN GENERAL.—If a sponsor of an inves-
tigation is in violation of an agreement under sub-
paragraph (A) or (B) of subsection (a)(1) (including 
submitting information under such a subparagraph 
that is false or misleading), the following applies, 
subject to paragraph (2) of this subsection: 
‘‘(A) In any case in which the violation is 
not corrected within 30 days after the Secretary 
provides to the sponsor a notice under sub-
section (e)(2) regarding the violation: 
‘‘(i) Through Internet sites operated 
pursuant to subsection (d) and such other 
means as the Secretary determines to be 
appropriate, the Secretary shall announce 
to the public that the sponsor is in viola-
tion of this section. For purposes of the 
preceding sentence, the Secretary shall
maintain a list of sponsors in violation that 
is available to the public. 
‘‘(ii) The sponsor is subject to a civil 
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) apply to 
the imposition of such a penalty to the 
same extent and in the same manner as 
such paragraphs apply to a penalty im-
posed 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 
sponsor a notice under subsection (e)(2) regard-
ing the violation, the Secretary may, after no-
tice and an opportunity for a hearing, consider 
the sponsor to be ineligible for any future ex-
emptions referred to in subsection (a)(1) for 
any investigation 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 subpara-
graph (A)(ii). 
‘‘(C) In any case in which the violation is 
a failure to submit to the data bank the results 
of the investigation by the due date that applies 
pursuant to subsection (d), the Secretary shall 
order the sponsor of the investigation to submit 
to the data bank periodic reports on the 
progress being made toward 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) FALSE OR MISLEADING INFORMATION.—If 
the Secretary determines that the sponsor of an in-
vestigation has submitted to the data bank informa-
tion that is false or misleading, and if on such basis 
a civil money has been imposed under paragraph 
(1)(A)(ii) on the sponsor or the sponsor has becomes 
ineligible within the meaning of paragraph (1)(B), 
the Secretary shall remove the information from the
data bank, subject to any judicial review of such ac-
tion or actions of the Secretary. 
‘‘(3) WAIVER
REGARDING
INELIGIBILITY
FOR 
EXEMPTIONS.—With respect to a sponsor who is in-
eligible for purposes of paragraph (1)(B), the Sec-
retary may waive the applicability of such paragraph 
in order to provide for an investigation if the Sec-
retary determines that providing the waiver is in the 
public interest or consistent with the protection of 
the public health. Each such determination of the 
Secretary shall be published in the Federal Register. 
‘‘(4) 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 or contracts for the conduct of 
comparative investigations to determine the safety or 
relative effectiveness of products. 
‘‘(g) DEFINITIONS.— 
‘‘(1) IN GENERAL.—Definitions under section 
491A(j) of the Public Health Service Act apply for 
purposes of this section, subject to paragraph (2). 
‘‘(2) INVESTIGATION.—For purposes of this 
section, the term ‘investigation’ means a clinical in-
vestigation within the meaning of section 505(i) (in 
the case of drug), or within the meaning of section
520(g) (in the case of a device), as applicable, except 
that such term does not include such an investiga-
tion that does not prospectively assign human sub-
jects to intervention or comparison groups to study 
the causal relationship between a medical interven-
tion and an outcome.’’. 
(2) CONFORMING AMENDMENTS.—Chapter V of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 351 et seq.) is amended— 
(A) 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 565 (relating to information on 
investigations).’’; and 
(B) 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 565 (relating to information 
on investigations).’’. 
(b) PREMARKET APPLICATION OR REPORT; LABEL-
ING AND ADVERTISING.—Subchapter E of chapter V of 
the Federal Food, Drug, and Cosmetic Act, as amended 
by subsection (a) of this section, is amended by adding 
at the end the following section:
‘‘SEC. 566. PREMARKET APPLICATION OR REPORT; LABEL-
ING AND ADVERTISING; RELATION TO DATA 
BANK ON CLINICAL TRIALS. 
‘‘(a) PREMARKET APPLICATION OR REPORT.—If a 
person submits to the Secretary an application under sec-
tion 505(b) or 515 or a report under section 510(k), and 
one or more of the investigations presented to the Sec-
retary by the person for purposes of the application or 
report are investigations that are not subject to require-
ments under section 565 or under section 491A of the 
Public Health Service, and if the person was the principal 
investigator or the responsible person for the investigation 
involved, the following applies: 
‘‘(1) The person is subject to a civil penalty— 
‘‘(A) in any case in which information on 
the investigation has not, as of the date on 
which the application or report is submitted to 
the Secretary, been submitted to the data bank 
described in such section 491A to the same ex-
tent as would have been required as of such 
date if the investigation had been subject to 
such requirements (without regard to time-
frames for the submission of information that 
would have applied before such date under such 
section); and
‘‘(B) in any case in which, after such date, 
information on the investigation is not sub-
mitted to the data bank to the same extent as 
would be required if the investigation were sub-
ject to such requirements. 
‘‘(2) If the person is subject to a civil penalty 
under paragraph (1), the Secretary, in addition to 
such penalty, may, after notice and an opportunity 
for a hearing, consider the person to be ineligible for 
any future exemptions under section 505(i) or 
520(g)(2)(A) for any investigation until the informa-
tion involved is submitted to the data bank as de-
scribed in paragraph (1), except that notice and an 
opportunity for a hearing are not required if a hear-
ing regarding such violation was held pursuant to 
paragraph (1). 
‘‘(b) LABELING AND ADVERTISEMENTS.—If a person 
disseminates labeling, or an advertisement or other de-
scriptive printed matter, for a drug or device for human 
use and the labeling, advertisement, or other matter refers 
to an investigation that is not subject to requirements 
under section 565 or under section 491A of the Public 
Health Service, and if the person was the principal investi-
gator or the responsible person for the investigation, the 
person is subject to a civil penalty—
‘‘(1) in any case in which information on the in-
vestigation has not, as of the date on which the la-
beling, advertisement, or other matter enters the 
market, been submitted to the data bank described 
in such section 491A to the same extent as would 
have been required as of such date if the investiga-
tion had been subject to such requirements (without 
regard to timeframes for the submission of informa-
tion that would have applied before such date under 
such section); and 
‘‘(2) in any case in which, after such date, in-
formation on the investigation is not submitted to 
the data bank to the same extent as would be re-
quired if the investigation were subject to such re-
quirements. 
‘‘(c) AMOUNT OF CIVIL PENALTY; PROCEDURE.—A 
civil penalty under subsection (a)(1) or (b) shall be not 
more than a total of $15,000 for all violations adjudicated 
in a single proceeding in the case of an individual, and 
$10,000 per day until the violation 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 adjudicated in a single proceeding. Para-
graphs (3) through (5) of section 303(f) apply to the im-
position of such a penalty to the same extent and in the
same manner as such paragraphs apply to a penalty im-
posed under paragraph (1) or (2) of such section. 
‘‘(d) 
BIOLOGICS
LICENSE
APPLICATION.—Sub-
sections (a) and (c) apply with respect to a biologics li-
cense application under section 351 of the Public Health 
Service Act to the same extent and in the same manner 
as such subsections apply with respect to an application 
or report referred to in subsection (a). 
‘‘(e) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘investigation’ has the meaning 
given such term in section 565(g). 
‘‘(2) The term ‘responsible person’ has the 
meaning given such term in section 491A(j) of the 
Public Health Service Act. ’’. 
(c) CLINICAL INVESTIGATIONS IN PROGRESS.—With 
respect to a clinical investigation to determine the safety 
or effectiveness of a use of a drug, biological product, or 
device, if the final data collection from subjects in the in-
vestigation on the primary outcome has not been com-
pleted as of the date of the enactment of this Act, and 
if the investigation is one for which an exemption under 
section 505(i) or 520(g)(2)(A) of the Federal Food, Drug, 
and Cosmetic Act is in effect, the investigation becomes 
subject to section 565 of such Act (as added by subsection 
(a) of this section) upon the expiration of 30 days after
the date of the enactment of this Act, except that registra-
tion information required pursuant to subsection (d) of 
such section 565 is due upon the expiration of such 30 
days. For purposes of the preceding sentence, the term 
‘‘clinical investigation’’ has the meaning given such term 
in subsection (g)(2) of such section 565. 
SEC. 4. RULE OF CONSTRUCTION REGARDING AUTHORITY 
OF SECRETARY FOR PUBLIC DISCLOSURE OF 
INFORMATION ON CLINICAL TRIALS. 
This Act and the amendments made by this Act may 
not be construed as limiting the authority of the Secretary 
of Health and Human Services to disclose to the public 
information on clinical trials to determine the safety or 
effectiveness of the use of drugs, which authority was in 
effect as of the day before the date of the enactment of 
this Act. 
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