ties include the conduct of syndicated market 
research studies of the pharmaceutical industry 
and the international monitoring of prescription 
drug sales. 
‘‘(4) CRITERIA.—The Secretary shall by regula-
tion establish criteria for making projections under 
paragraph (1).’’. 
(c) FINAL RULE FOR CRITERIA FOR PROJECTION OF 
SALES REVENUE; EFFECTIVE DATE.— 
(1) FINAL
RULE.—With respect to criteria 
under subsection (d)(4) of section 505A of the Fed-
eral Food, Drug, and Cosmetic Act, as added by 
subsection (b) of this section, the Secretary of 
Health and Human Services shall promulgate the 
final rule not later than 180 days after the date of 
the enactment of this Act. 
(2) EFFECTIVE DATE.—The amendments made 
by this subsection take effect 180 days after the 
date of the enactment of this Act, without regard to 
whether the final rule under paragraph (1) has been 
promulgated, subject to subsection (e). The pre-
ceding sentence does not affect the requirement 
under paragraph (1) for the Secretary to promulgate 
a final rule, notwithstanding circumstances under 
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the preceding sentence in which such amendments 
have taken effect in the absence of a final rule. 
(d) CONFORMING AMENDMENTS; TECHNICAL COR-
RECTIONS.—Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a), as amended by subsection 
(b)(1) of this section, is amended— 
(1) in subsection (e)(4)(C), by inserting ‘‘of the 
Public Health Service Act’’ after ‘‘499(j)(9)(B)(i)’’; 
and 
(2) in each of subsections (f) and (g), by strik-
ing ‘‘subsection (d)’’ each place such term appears 
and inserting ‘‘subsection (e)’’; and 
(3) in subsection (n), by striking ‘‘under sub-
section (a) or (c)’’ and inserting ‘‘under subsection 
(b) or (c)’’. 
(e) EFFECTIVE DATE.—The amendments made by 
this section apply to requests by the Secretary of Health 
and Human Services for pediatric studies under section 
505A of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a) after the date of the enactment of this Act. 
SEC. 5. CITIZEN PETITIONS AND PETITIONS FOR STAY OF 
AGENCY ACTION. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended by adding at the end the 
following: 
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‘‘(o) PETITIONS AND CIVIL ACTIONS REGARDING AP-
PROVAL OF CERTAIN APPLICATIONS.— 
‘‘(1) IN GENERAL.—With respect to a pending 
application under subsection (b)(2) or (j), if a peti-
tion is submitted to the Secretary that seeks to have 
the Secretary take, or refrain from taking, any form 
of action relating to the approval of the application, 
including a delay in the effective date of the applica-
tion, the following applies, subject to paragraph (5): 
‘‘(A)(i) In the case of an application under 
subsection (b)(2), the Secretary may not, sub-
ject to clause (iii), consider the petition if it is 
submitted later than 210 days prior to the date 
on which the approval of the application may 
first be made effective under subsection (c)(3), 
including subparagraphs (C) and (E) (as appli-
cable), or 210 days prior to the expiration of 
any 30-month stay under such subparagraph 
(C) with respect to the application, whichever is 
later. 
‘‘(ii) In the case of an application under 
subsection (j), the Secretary may not, subject to 
clause (iii), consider the petition if it is sub-
mitted later than 210 days prior to the date on 
which the approval of the application may first 
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