be made effective under paragraph (5) of such 
subsection, including subparagraphs (B)(iii) 
and (F) (as applicable), or 210 days prior to 
the expiration of any 30-month stay under such 
subparagraph (B)(iii) with respect to the appli-
cation, whichever is later. 
‘‘(iii) The restriction established in clause 
(i) or (ii) (as the case may be) does not apply 
to the petition if the Secretary determines that 
the petitioner has shown good cause for the 
failure to submit the petition by the applicable 
date under such clause. 
‘‘(B)(i) The Secretary may not, on the 
basis of the petition, delay approval of the ap-
plication unless the Secretary determines that a 
delay is necessary to protect the public health. 
Consideration of a petition shall be separate 
and apart from the review and approval of the 
application. 
‘‘(ii) With respect to a determination by 
the Secretary under clause (i) that a delay is 
necessary to protect the public health: 
‘‘(I) The Secretary shall publish on 
the Internet site of the Food and Drug Ad-
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ministration a statement providing the rea-
sons underlying the determination. 
‘‘(II) Not later than 10 days after 
making the determination, the Secretary 
shall provide notice to the sponsor of the 
application and an opportunity for a meet-
ing with the Commissioner to discuss the 
determination. 
‘‘(C) The Secretary shall take final agency 
action on the petition not later than 180 days 
after the date on which the petition is sub-
mitted. The Secretary shall not extend such pe-
riod, even with the consent of the petitioner, for 
any reason, including based upon the submis-
sion of comments relating to the petition or 
supplemental information supplied by the peti-
tioner. 
‘‘(D) If the filing of the application re-
sulted in first-applicant status under subsection 
(j)(5)(D)(i)(IV), the 30-month period under 
such subsection is deemed to be extended by a 
period of time equal to the period beginning on 
the date on which the Secretary received the pe-
tition and ending on the date of final agency 
action on the petition (inclusive of such begin-
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ning and ending dates), without regard to 
whether the Secretary grants, in whole or in 
part, or denies, in whole or in part, the petition. 
‘‘(E) The Secretary may not consider the 
petition for review unless it is signed and con-
tains the following verification: ‘I certify that, 
to my best knowledge and belief: (a) this peti-
tion includes all information and views upon 
which the petition relies; (b) this petition in-
cludes representative data and/or information 
known to the petitioner which are unfavorable 
to the petition; and (c) I have taken reasonable 
steps to ensure that any representative data 
and/or information which are unfavorable to the 
petition were disclosed to me. I further certify 
that the information upon which I have based 
the action requested herein first became known 
to the party on whose behalf this petition is 
submitted on or about the following date: 
llllllllll. I received or expect to 
receive payments, including cash and other 
forms of consideration, from the following per-
sons or organizations to file this petition: 
lllllllllllll. I verify under 
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penalty of perjury that the foregoing is true 
and correct.’. 
‘‘(2) EXHAUSTION
OF
ADMINISTRATIVE
REM-
EDIES.— 
‘‘(A) FINAL AGENCY ACTION WITHIN 180 
DAYS .—The Secretary shall be considered to 
have taken final agency action on a petition re-
ferred to in paragraph (1) if— 
‘‘(i) during the 180-day period re-
ferred to in subparagraph (C) of such 
paragraph, the Secretary makes a final de-
cision within the meaning of section 
10.45(d) of title 21, Code of Federal Regu-
lations; or 
‘‘(ii) such period expires without the 
Secretary having made such a final deci-
sion. 
‘‘(B) DISMISSAL
OF
CERTAIN
CIVIL
AC-
TIONS.—If a civil action is filed with respect to 
a petition referred to in paragraph (1) before 
final agency action within the meaning of sub-
paragraph (A) has occurred, the court shall dis-
miss the action for failure to exhaust adminis-
trative remedies. 
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‘‘(3) APPLICABILITY
OF
CERTAIN
REGULA-
TIONS.—The provisions of this section are in addi-
tion to the requirements for the submission of a pe-
tition to the Secretary that apply under section 
10.30 or 10.35 of title 21, Code of Federal Regula-
tions. 
‘‘(4) ANNUAL REPORT ON DELAYS IN APPROV-
ALS PER PETITIONS.—The Secretary shall annually 
submit to the Congress a report that specifies— 
‘‘(A) the number of applications under 
subsections (b)(2) and (j) that were approved 
during the preceding 12-month period; 
‘‘(B) the number of such applications 
whose effective dates were delayed by petitions 
referred to in paragraph (1) during such period; 
and 
‘‘(C) the number of days by which the ap-
plications were so delayed. 
‘‘(5) EXCEPTIONS.—This subsection does not 
apply to— 
‘‘(A) a petition that relates solely to the 
timing of the approval of an application pursu-
ant to subsection (j)(5)(B)(iv); or 
‘‘(B) a petition that is made by the spon-
sor of an application under subsection (b)(2) or 
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(j) and that seeks only to have the Secretary 
take or refrain from taking any form of action 
with respect to that application. 
‘‘(6) DEFINITION.—For purposes of this sub-
section, the term ‘petition’ includes any request to 
the Secretary, without regard to whether the request 
is characterized as a petition.’’. 
Æ 
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