303 
‘‘(c) For grants and contracts under subsection (a), 
there is authorized to be appropriated $30,000,000 for 
each of fiscal years 2008 through 2012.’’. 
SEC. 912. AUTHORIZATION OF APPROPRIATIONS. 
(a) IN GENERAL.—For carrying out this title and the 
amendments made by this title, there is authorized to be 
appropriated $25,000,000 for each of fiscal years 2008 
through 2012. 
(b) RELATION TO OTHER FUNDING.—The authoriza-
tion of appropriations under subsection (a) is in addition 
to any other funds available for carrying out this title and 
the amendments made by this title. 
SEC. 913. EFFECTIVE DATE AND APPLICABILITY. 
(a) EFFECTIVE DATE.—This title takes effect 180 
days after the date of the enactment of this Act. 
(b) DRUGS DEEMED TO HAVE RISK EVALUATION 
AND MITIGATION STRATEGIES.— 
(1) IN GENERAL.—A drug that was approved 
before the effective date of this Act is, in accordance 
with paragraph (2), deemed to have in effect an ap-
proved risk evaluation and mitigation strategy under 
section 505–1 of the Federal Food, Drug, and Cos-
metic Act (as added by section 901 of this title) (re-
ferred to in this section as the ‘‘Act’’ ) if there are 
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in effect on the effective date of this Act restrictions 
on distribution or use— 
(A) required under section 314.520 or sec-
tion 601.42 of title 21, Code of Federal Regula-
tions; or 
(B) otherwise agreed to by the applicant 
and the Secretary for such drug. 
(2) 
ELEMENTS
OF
STRATEGY; 
ENFORCE-
MENT.—The approved risk evaluation and mitigation 
strategy in effect for a drug under paragraph (1)— 
(A) is deemed to consist of the elements 
described in paragraphs (1) and (2) of section 
505–1(d) of the Act and any additional ele-
ments under subsections (d) and (e) of such 
section in effect for such drug on the effective 
date of this Act; and 
(B) is subject to enforcement by the Sec-
retary to the same extent as any other risk 
evaluation and mitigation strategy under sec-
tion 505–1 of the Act. 
(3) SUBMISSION.—Not later than 180 days 
after the effective date of this Act, the holder of an 
approved application for which a risk evaluation and 
mitigation strategy is deemed to be in effect under 
paragraph (1) shall submit to the Secretary a pro-
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posed risk evaluation and mitigation strategy. Such 
proposed strategy is subject to section 505–1 of the 
Act as if included in such application at the time of 
submission of the application to the Secretary. 
(c) OTHER DRUGS APPROVED BEFORE THE EFFEC-
TIVE DATE.—The Secretary, on a case-by-case basis, may 
require the holder of an application approved before the 
effective date of this Act to which subsection (b) does not 
apply to submit a proposed risk evaluation and mitigation 
strategy in accordance with the timeframes provided for 
in subparagraphs (C) through (D) of section 505–1(g)(2) 
of the Act if the Secretary determines (with respect to 
such drug or with respect to the group of drugs to which 
such drug belongs) that— 
(1) an element described under section 505– 
1(d)(1) of the Act may require modification; or 
(2) a standard for adding an element described 
in subsection (e) or (d) of section 505–1 of the Act 
that is not in effect with respect to such drug or 
class of drugs may apply. 
(d) USE OF ADVISORY COMMITTEES; PROCESS FOR 
ADDRESSING DRUG CLASS EFFECTS.—In imposing a re-
quirement under subsection (c), the Secretary— 
(1) may convene a meeting of 1 or more advi-
sory committees of the Food and Drug Administra-
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