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PPACT: Page 1861, Patient Protection and Affordable Care Act of 2009

1861
HR 3590 EAS/PP
(iii) provide for a period of 30 days for
1
the public to provide written comments on
2
such recommendations;
3
(iv) hold a meeting at which the public
4
may present its views on such recommenda-
5
tions; and
6
(v) after consideration of such public
7
views and comments, revise such rec-
8
ommendations as necessary.
9
(C) T
RANSMITTAL
OF
RECOMMENDA
-
10
TIONS
.--Not later than January 15, 2012, the
11
Secretary shall transmit to Congress the revised
12
recommendations under subparagraph (B), a
13
summary of the views and comments received
14
under such subparagraph, and any changes
15
made to the recommendations in response to such
16
views and comments.
17
(2) E
STABLISHMENT OF USER FEE PROGRAM
.--
18
It is the sense of the Senate that, based on the rec-
19
ommendations transmitted to Congress by the Sec-
20
retary pursuant to paragraph (1)(C), Congress should
21
authorize a program, effective on October 1, 2012, for
22
the collection of user fees relating to the submission of
23
biosimilar biological product applications under sec-
24

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