‘‘(A) Notwithstanding section 301(j) of the 
Federal Food, Drug, and Cosmetic Act, section 
1905 of title 18, United States Code, subsection 
(j)(4)(C)(ii) of this section, or any other provi-
sion of law, the Secretary shall begin disclosure 
through the data bank of the definitions of the 
primary and secondary outcomes for the clinical 
trial involved unless the definitions have already 
been 
disclosed 
pursuant 
to 
subsection 
(j)(4)(C)(ii). 
‘‘(B) Notwithstanding section 301(j) of the 
Federal Food, Drug, and Cosmetic Act, section 
1905 of title 18, United States Code, or any 
other provision of law, if the responsible person 
is the manufacturer or a distributor of the 
product involved, the Secretary shall through 
the data bank disclose information on the prod-
uct that— 
‘‘(i) is required to be submitted under 
subsection (d); and 
‘‘(ii) is included in any FDA applica-
tion for the product (as defined in sub-
section (l)) that the responsible person has 
submitted to the Secretary.
‘‘(f) 
TRIALS
CONDUCTED
OUTSIDE
UNITED 
STATES.— 
‘‘(1) IN GENERAL.—If a covered person submits 
to the Secretary an FDA application for a product 
(as defined in subsection (l)), and one or more of the 
investigations presented to the Secretary by such 
person for purposes of the document are covered for-
eign investigations, 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 is submitted to the Sec-
retary, been submitted to the data bank to the 
same extent as would have been required as of 
such date under subsection (d) if the investiga-
tion had been subject to subsection (c)(1); 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 subsection (c)(1). 
‘‘(2) PROCEDURES.—The provisions of para-
graphs (2), (3), (6), and (7) of subsection (e) apply 
to a civil penalty under paragraph (1) to the same
extent and in the same manner as such provisions 
apply to a civil penalty under subsection (e)(1)(A). 
‘‘(3) DEFINITIONS.—With respect to an FDA 
application for a product, for purposes of this sub-
section: 
‘‘(A) The term ‘covered foreign investiga-
tion’ means an investigation that was not con-
ducted in any of the States and was not subject 
to subsection (c)(1). 
‘‘(B) The term ‘covered person’ means the 
person who was the principal investigator or the 
responsible person for any of the covered for-
eign investigation or investigations involved. 
‘‘(g) LABELING AND ADVERTISEMENTS.—- 
‘‘(1) IN GENERAL.—If a person disseminates la-
beling, or an advertisement or other descriptive 
printed matter, for an approved product for human 
use and the labeling, advertisement, or other matter 
refers to an investigation that is not subject to sub-
section (c)(1), and if the person was the principal in-
vestigator or the responsible person for the inves-
tigation, 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 labeling, advertisement, or other mat-
ter enters the market, been submitted to the 
data bank to the same extent as would have 
been required as of such date under subsection 
(d) if the investigation had been subject to sub-
section (c)(1); 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 subsection (c)(1). 
‘‘(2) PROCEDURES.—The provisions of para-
graphs (2), (3), (6), and (7) of subsection (e) apply 
to a civil penalty under paragraph (1) to the same 
extent and in the same manner as such provisions 
apply to a civil penalty under subsection (e)(1)(A). 
‘‘(h) PUBLIC LIST OF NONCOMPLIANT RESPONSIBLE 
PERSONS.—In any case in which a notice of noncompli-
ance is submitted to a person under subsection (e)(2)(A), 
(f)(2), or (g)(2), the Secretary shall include with the infor-
mation in the data bank that concerns the clinical trial 
involved a statement, prominently displayed, that such 
person has not reported information to the data bank as 
required by law, which statement shall remain in the data 
bank until the information involved is submitted to the 
Secretary. For purposes of the preceding sentence, the
Secretary shall maintain a list of noncompliant persons 
that is available to the public. 
‘‘(i) COMPLIANCE AUDITS.— 
‘‘(1) IN GENERAL.—The Secretary shall con-
duct periodic audits of responsible persons for clin-
ical trials that are subject to subsection (c)(1) in 
order to determine whether such persons have sub-
mitted information as required in subsection (d), in-
cluding determining whether any of the information 
is false or misleading. 
‘‘(2) 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 
(h), taking into account the number and severity of 
the violations involved. 
‘‘(j) GENERAL PROVISIONS.— 
‘‘(1) 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.—If the Secretary determines that infor-
mation presented or cited in the data bank is 
false or misleading, the Secretary shall, prompt-
ly after making such determination, identify in 
the data bank the information as false or mis-
leading (as applicable), and shall, to the extent 
practicable, include in the data bank an accu-
rate version of the information. The Secretary 
shall in addition make appropriate public notifi-
cation. 
‘‘(2) LIMITATION ON DISCLOSURES.—This sec-
tion may not be construed as authorizing the disclo-
sure of information through the data bank if— 
‘‘(A) such disclosure would constitute a 
clearly unwarranted invasion of personal pri-
vacy; or 
‘‘(B) such information concerns a method 
or process which as a trade secret is entitled to
protection within the meaning of section 301(j) 
of the Federal Food, Drug, and Cosmetic Act. 
‘‘(3) INSTITUTIONAL
REVIEW
BOARDS.—The 
Secretary shall amend part 46 of title 45, Code of 
Federal Regulations, and parts 50, 56, and 812 of 
title 21 of Code, to provide as follows: 
‘‘(A) That the functions of institutional re-
view boards under such parts include— 
‘‘(i) determining whether clinical trials 
that are subject to subsection (c)(1) are 
registered under subsection (d)(1)(A); and 
‘‘(ii) denying the approval of the 
boards for such trials that are not so reg-
istered. 
‘‘(B) That any approval of an institutional 
review board regarding such a trial is not effec-
tive under such parts if the trial is not so reg-
istered. 
‘‘(C) That 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 subsection (d)(1)(A) (which 
copy will be the registration as submitted to the 
Secretary, together with all updates to the reg-
istration).
‘‘(4) DISCLOSURE OF INFORMATION.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
disseminate information in the data bank 
through an Internet site or sites under subpara-
graph (B) and through any other means deter-
mined appropriate by the Secretary. Informa-
tion required in this section to be submitted to 
the Secretary shall not be considered confiden-
tial commercial information or trade secrets, 
notwithstanding any other provision of law. 
‘‘(B) INTERNET SITES.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall operate one or more searchable Inter-
net sites for purposes of presenting to cli-
nicians and researchers, and to patients 
seeking to enroll as subjects in clinical 
trials, information in the data bank. The 
Secretary shall ensure that— 
‘‘(I) such a site, or a portion of 
a site, is designed specifically for use 
by clinicians and researchers; and 
‘‘(II) such a site, or a portion of 
a site, is designed specifically for use 
by patients seeking to enroll as sub-
jects in clinical trials.
‘‘(ii) RELATION TO CERTAIN INTER-
NET
SITE.—The Secretary shall ensure 
that the Internet site or portion thereof op-
erated under clause (i)(II) includes infor-
mation of the type that was available on 
ClinicalTrials.gov as of the day before the 
date of the enactment of the Fair Access 
to Clinical Trials Act (relating to serious 
or life-threatening diseases). This section 
may not be construed as requiring the Sec-
retary 
to 
terminate 
or 
alter 
ClinicalTrials.gov, or as prohibiting the 
Secretary from terminating or altering 
such site. 
‘‘(C) REGISTRATION INFORMATION; DATE 
OF DISCLOSURE.—In the case of information 
regarding a clinical trial that is submitted to 
the Secretary under subsection (d)(1), disclo-
sures of the information through the data bank 
shall, subject to subsection (e)(8), begin in ac-
cordance with the following: 
‘‘(i) All such disclosures shall begin 
promptly after the registration involved is 
submitted to the Secretary, other than dis-
closure of the definitions of the primary 
and secondary outcomes. 
‘‘(ii) Disclosure of the definition of 
the primary and secondary outcomes shall 
begin at the same time as disclosure of the 
results of the trial begin under subpara-
graph (D)(i), unless the responsible person 
for the trial requests earlier disclosure, or 
unless the Secretary requires earlier disclo-
sure pursuant to subparagraph (E)(ii). 
‘‘(D) RESULTS OF TRIAL; DATE OF DIS-
CLOSURE.— 
‘‘(i) IN GENERAL.—In the case of in-
formation regarding a clinical trial that is 
submitted to the Secretary under sub-
section (d)(2)(A), disclosures of the infor-
mation through the data bank shall begin 
promptly after the information is sub-
mitted to the Secretary, subject to clause 
(ii). 
‘‘(ii) WAIVER
REGARDING
RESULTS 
OF TRIAL.—In the case of information on 
waivers that is contained in the data bank 
under subsection (d)(2)(D), disclosures of 
the information through the data bank