no report is required under this sub-
clause after such due date. 
‘‘(iii) EXTENSIONS.— 
‘‘(I) IN
GENERAL.—The Sec-
retary may provide an extension of 
the due date under clause (i)(I) for in-
formation on the results of a clinical 
trial if the responsible person for the 
trial submits to the Secretary a writ-
ten request that demonstrates good 
cause for the extension and provides 
an estimate of the date on which in-
formation on the results will be sub-
mitted. More than one such extension 
may be provided by the Secretary for 
the clinical trial involved. 
‘‘(II) EXTENSIONS
REGARDING 
JOURNAL PUBLICATION.— 
‘‘(aa) ARTICLE UNDER CON-
SIDERATION
FOR
PUBLICA-
TION.—With respect to the sub-
mission of information on the re-
sults of a clinical trial, the Sec-
retary shall under subclause (I) 
provide 
an 
extension 
of
months after the due date under 
clause (i)(I) (or if such an exten-
sion previously has been pro-
vided, 18 months beginning upon 
the expiration of the most recent 
extension) if— 
‘‘(AA) 
the 
request 
under such subclause dem-
onstrates that an article pro-
viding the information de-
scribed in subparagraph (B) 
has been submitted to a 
peer-reviewed scientific or 
academic journal for which 
references are included in 
MEDLINE, and the request 
demonstrates that the article 
is being considered by the 
journal for publication; and 
‘‘(BB) such request is 
made before the expiration 
of the one-year period de-
scribed in clause (i)(I) (or if 
such an extension previously 
has been provided, before
the expiration of the most 
recent extension). 
‘‘(bb) ARTICLE
ACCEPTED 
FOR
PUBLICATION.—If the re-
sponsible person for a clinical 
trial has received an extension 
under item (aa) regarding the 
trial, the Secretary shall provide 
an additional extension of six 
months, beginning upon the expi-
ration of such first extension, if 
the person demonstrates to the 
Secretary, before the expiration 
of the first extension, that the ar-
ticle involved has been accepted 
for publication by a journal re-
ferred to in such item. 
‘‘(cc) PUBLICATION DURING 
PERIOD
OF
EXTENSION.—With 
respect to an extension under 
item (aa) or (bb), if during the 
period of extension the article in-
volved is published in a journal 
referred to in item (aa)—
‘‘(AA) 
the 
extension 
terminates upon publication 
of the article; and 
‘‘(BB) the due date 
under clause (i) regarding 
the clinical trial involved be-
comes the date of such pub-
lication. 
‘‘(D) WAIVERS
REGARDING
RESULTS
OF 
TRIAL.—With respect to the requirement under 
subparagraph (A) to submit to the Secretary in-
formation on the results of a clinical trial, the 
Secretary may waive the requirement upon a 
written request to the Secretary by the respon-
sible person for the trial if the Secretary deter-
mines that extraordinary circumstances justify 
the waiver and that providing the waiver is in 
the public interest or consistent with the protec-
tion of the public health. The Secretary shall 
ensure that information on each such waiver is 
included in the data bank. 
‘‘(3) UPDATES; TRACKING OF CHANGES IN SUB-
MITTED INFORMATION.—The Secretary shall ensure 
that updates submitted to the Secretary under para-
graphs (1)(A)(xvii) and (2)(B)(xii) do not result in
the removal from the data bank of the original sub-
missions or of any preceding updates, and that in-
formation in the data bank is presented in a manner 
that enables users to readily access each original 
submission and to track the changes made by the 
updates. 
‘‘(e) ENFORCEMENT.— 
‘‘(1) EFFECT OF FAILURE TO PROVIDE INFOR-
MATION.—In the case of a clinical trial that is sub-
ject to subsection (c)(1): 
‘‘(A) Subject to paragraph (2), if the Sec-
retary determines that with respect to the trial 
the responsible person is not in compliance with 
requirements under subsection (d) to submit in-
formation to the Secretary, the following ap-
plies: 
‘‘(i) Such person is subject to a civil 
penalty in accordance with paragraph (3). 
‘‘(ii) The person is, during the period 
of such noncompliance, ineligible for any 
award from the Secretary of a grant, coop-
erative agreement, or contract for the con-
duct of any trial that is subject to sub-
section (c)(1), including all current awards
for such trials, except that such period of 
ineligibility may not exceed five years. 
‘‘(iii) The person is subject to the 
sanction described in paragraph (4) (relat-
ing to the investigational use of products) 
if the noncompliance is serious or repeated. 
‘‘(B) The submission to the Secretary of 
information under subsection (d) that is false or 
misleading constitutes noncompliance for pur-
poses of subparagraph (A). 
‘‘(2) PROCEDURES
REGARDING
NONCOMPLI-
ANCE.— 
‘‘(A) NOTICE OF NONCOMPLIANCE.—With 
respect to a clinical trial that is subject to sub-
section (c)(1), if the Secretary determines that 
the responsible person involved has not sub-
mitted information to the Secretary in accord-
ance with subsection (d), the Secretary— 
‘‘(i) shall transmit to such person a 
notice specifying the required information 
and stating that the person will be subject 
to applicable sanctions referred to in para-
graph (1)(A) if the information is not sub-
mitted to the Secretary within 90 days
after the date on which the notice is trans-
mitted; 
‘‘(ii) shall through the notice inform 
the person that under subsection (h) the 
person is being identified in the data bank 
as a noncompliant person; and 
‘‘(iii) shall through the notice inform 
the person of the provisions of paragraph 
(8). 
‘‘(B) FAILURE TO CORRECT NONCOMPLI-
ANCE.—Upon the expiration of the 90-day pe-
riod beginning on the date on which the Sec-
retary transmits a notice under subparagraph 
(A) to a responsible person, the Secretary shall 
impose on such person the sanctions referred to 
in clauses (i) and (ii) of paragraph (1)(A) if the 
information involved has not been submitted to 
the Secretary, except that the Secretary may 
elect not to impose such a sanction or sanctions 
if the Secretary determines that the noncompli-
ance involved is not serious or repeated. 
‘‘(3) AMOUNT
OF
CIVIL
PENALTY; HEARING 
PROCEDURES.—With respect to a civil penalty im-
posed under paragraph (1)(A)(i) on a responsible 
person:
‘‘(A) The amount of the penalty shall be 
not more than a total of $15,000 for all viola-
tions adjudicated in a single proceeding in the 
case of an individual, and not more than 
$10,000 per day until the violation is corrected 
in the case of any other person, except that if 
the person is a nonprofit entity the penalty may 
not exceed a total of $15,000 for all violations 
adjudicated in a single proceeding. 
‘‘(B) The provisions of paragraphs (3) 
through (5) of section 303(f) of the Federal 
Food, Drug, and Cosmetic Act apply to the im-
position of such a penalty to the same extent 
and in the same manner as such provisions 
apply to a penalty imposed under such section 
303(f). 
‘‘(4) ELIGIBILITY FOR INVESTIGATIONAL USE 
EXEMPTIONS.—In any case in which the noncompli-
ance referred to in paragraph (1)(A) is serious or re-
peated, the Secretary may, upon the expiration of 
the 90-day period beginning on the date on which 
the Secretary transmits a notice under paragraph 
(2)(A) to the responsible person involved, consider 
such person to be ineligible for any future exemp-
tions under section 505(i) or 520(g) of the Federal
Food, Drug, and Cosmetic Act for any investigation 
until the violation is corrected, except that such pe-
riod of ineligibility may not exceed five years. The 
Secretary may impose such sanction only after no-
tice and an opportunity for a hearing, unless a hear-
ing regarding such noncompliance is held pursuant 
to paragraph (3) and through such hearing the Sec-
retary determines that the noncompliance was seri-
ous or repeated. 
‘‘(5) FAILURE TO SUBMIT INFORMATION ON RE-
SULTS; REQUIREMENT OF REPORTS.—In any case in 
which the noncompliance referred to in paragraph 
(1)(A) is a failure to submit to the Secretary infor-
mation on the results of the trial by the due date 
under subsection (d)(2)(C)(i), the Secretary shall 
order the responsible person to submit to the Sec-
retary periodic reports on the progress being made 
toward submission of information on the results, 
which reports shall be submitted not less frequently 
that once each year until the information is sub-
mitted to the Secretary. 
‘‘(6) RULE OF CONSTRUCTION.—With respect 
to a responsible person who is subject to a sanction 
referred to in paragraph (1)(A), this subsection may 
not be construed as providing that any other person
associated with the clinical trial involved is subject 
to the sanction. 
‘‘(7) USE OF FUNDS.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
deposit the funds collected under paragraph 
(1)(A) into an account and use such funds, in 
consultation with the Director of the Agency for 
Healthcare Research and Quality, to fund stud-
ies that compare the clinical effectiveness of two 
or more treatments for a disease or condition. 
‘‘(B) FUNDING DECISIONS.—The Secretary 
shall award funding under subparagraph (A) 
based on a priority list established not later 
than six months after the date of enactment of 
the Fair Access to Clinical Trials Act by the 
Director of the Agency for Healthcare Research 
and Quality and periodically updated as deter-
mined appropriate by the Director. 
‘‘(8) DISCLOSURE
OF
CERTAIN
INFORMA-
TION.—In the case of a responsible person to whom 
a notice under paragraph (2) has been transmitted, 
if such person has not submitted the information in-
volved to the Secretary by the expiration of the 180- 
day period beginning on the date on which the notice 
was transmitted to the person, the following applies: