ment that is counter-signed by the Secretary 
and the applicant no later than 30 days prior 
to such date. 
‘‘(13) REQUEST
FOR
DELAY
OF
FINAL
AC-
TION.—Notwithstanding paragraph (18) or any 
other provision of law, the Secretary shall not fail or 
refuse to take a final action on an abbreviated bio-
logical product application by the final action date 
on the basis that a person, other than the com-
parable biological product applicant, has requested 
(in a petition or otherwise) that the Secretary refuse 
to take or otherwise defer such final action, and no 
court shall enjoin the Secretary from taking final ac-
tion or stay the effect of final action previously 
taken by the Secretary, except by issuance of a per-
manent injunction based upon an express finding of 
clear and convincing evidence that the person seek-
ing to have the Secretary refuse to take or otherwise 
to defer final action by the final action date— 
‘‘(A) has prevailed on the merits of the 
person’s complaint against the Secretary; 
‘‘(B) will suffer imminent and actual irrep-
arable injury, constituting more than irrecover-
able economic loss, and that also will threaten 
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hsrobinson on PROD1PC76 with BILLS
imminent destruction of such person’s business; 
and 
‘‘(C) has an interest that outweighs the 
overwhelming interest that the public has in ob-
taining prompt access to a comparable biologi-
cal product. 
‘‘(14) REPORT ON EXTENSIONS OF FINAL AC-
TION DATE.—The Secretary shall prepare and sub-
mit to the President, the Committee on Energy and 
Commerce of the House of Representatives, and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate a report regarding any jointly 
executed written agreement to extend the final ac-
tion date under this Act within 15 calendar days 
after the joint execution of any such written agree-
ment. 
‘‘(15) REPORT ON FAILURE TO TAKE FINAL AC-
TION.—The Secretary shall prepare and submit an-
nually to the President, the Committee on Energy 
and Commerce of the House of Representatives, and 
the Committee on Health, Education, Labor, and 
Pensions of the Senate a report detailing the specific 
and particularized reasons enumerated by the re-
viewing division for each instance of the Secretary’s 
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failure to take final action by the final action date 
in the previous year. 
‘‘(16) REGULATIONS.—The Secretary shall es-
tablish, by regulation within 2 years after the date 
of the enactment of this subsection, requirements for 
the efficient review, approval, suspension, and rev-
ocation of abbreviated biological product applications 
under this subsection. 
‘‘(17) PATENTS.— 
‘‘(A) REQUEST
FOR
PATENT
INFORMA-
TION.— 
‘‘(i) IN GENERAL.—At any time, in-
cluding at the initial stages of develop-
ment, an applicant or a prospective appli-
cant under this subsection may send a 
written request for patent information to 
the holder of the approved application for 
the reference product. The holder of the 
approved application for the reference 
product shall, not later than 60 days after 
the date on which the holder receives the 
request, provide to the applicant or pro-
spective applicant a list of all those patents 
owned by, or licensed to, the holder of the 
approved application that the holder be-
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