missioner to discuss the determina-
tion. 
‘‘(ii) The Secretary shall take final 
agency action on the petition not later 
than 180 days after the date on which the 
petition is submitted. The Secretary shall 
not extend such period, even with the con-
sent of the petitioner, for any reason, in-
cluding based upon the submission of com-
ments relating to the petition or supple-
mental information supplied by the peti-
tioner. 
‘‘(iii) The Secretary may not consider 
the petition for review unless it is signed 
and contains the following verification: ‘I 
certify that, to my best knowledge and be-
lief: (a) this petition includes all informa-
tion and views upon which the petition re-
lies; (b) this petition includes representa-
tive data and/or information known to the 
petitioner which are unfavorable to the pe-
tition; and (c) I have taken reasonable 
steps to ensure that any representative 
data and/or information which are unfavor-
able to the petition were disclosed to me. 
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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: 
lllllll. I received or expect to 
receive payments, including cash and other 
forms of consideration, from the following 
persons or organizations to file this peti-
tion: llllllll. I verify under 
penalty of perjury that the foregoing is 
true and correct.’. 
‘‘(B) EXHAUSTION
OF
ADMINISTRATIVE 
REMEDIES.— 
‘‘(i) FINAL AGENCY ACTION WITHIN 
180 DAYS.—The Secretary shall be consid-
ered to have taken final agency action on 
a petition referred to in subparagraph (A) 
if— 
‘‘(I) during the 180-day period 
referred to in clause (ii) of such sub-
paragraph, the Secretary makes a 
final decision within the meaning of 
section 10.45(d) of title 21, Code of 
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Federal Regulations (or any successor 
regulations); or 
‘‘(II) such period expires without 
the Secretary having made such a 
final decision. 
‘‘(ii) DISMISSAL
OF
CERTAIN
CIVIL 
ACTIONS.—If a civil action is filed with re-
spect to a petition referred to in subpara-
graph (A) before final agency action within 
the meaning of clause (i) has occurred, the 
court shall dismiss the action for failure to 
exhaust administrative remedies. 
‘‘(C) APPLICABILITY OF CERTAIN REGULA-
TIONS.—The provisions of this section are in 
addition to the requirements for the submission 
of a petition to the Secretary that apply under 
section 10.30 or 10.35 of title 21, Code of Fed-
eral Regulations (or any successor regulations). 
‘‘(D) ANNUAL REPORT ON DELAYS IN AP-
PROVALS PER PETITIONS.—The Secretary shall 
annually submit to the Congress a report that 
specifies— 
‘‘(i) the number of applications under 
this subsection that were approved during 
the preceding 12-month period; 
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‘‘(ii) the number of such applications 
whose effective dates were delayed by peti-
tions referred to in subparagraph (A) dur-
ing such period; and 
‘‘(iii) the number of days by which the 
applications were so delayed. 
‘‘(E) EXCEPTION.—This paragraph does 
not apply to a petition that is made by the 
sponsor of an application under this subsection 
and that seeks only to have the Secretary take 
or refrain from taking any form of action with 
respect to that application. 
‘‘(F) DEFINITION.—For purposes of this 
paragraph, the term ‘petition’ includes any re-
quest to the Secretary, without regard to 
whether the request is characterized as a peti-
tion.’’. 
(b) ADDITIONAL AMENDMENTS.— 
(1) PATENTS.—Section 271(e) of title 35, 
United States Code, is amended— 
(A) in paragraph (2)— 
(i) by striking ‘‘or’’ at the end of sub-
paragraph (A); 
(ii) by adding ‘‘or’’ at the end of sub-
paragraph (B); 
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