[Federal Register Volume 76, Number 15 (Monday, January 24, 2011)]
[Notices]
[Pages 4119-4120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1274]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0381]
Generic Drug User Fee; Notice of Public Meeting; Reopening of the
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA) is reopening until
February 23, 2011, the comment period for the notice of public meeting
entitled Generic Drug User Fee; Public Meeting; Request for Comments,
published in the Federal Register of August 9, 2010 (75 FR 47820). In
that notice, FDA announced a public meeting that took place on
September 17, 2010, to gather stakeholder input on the development of a
generic drug user fee program. FDA is reopening the comment period to
permit public consideration of late-received comments and to provide an
opportunity for all interested parties to provide information and share
views on the matter.
DATES: Submit either electronic or written comments by February 23,
2011.
[[Page 4120]]
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Peter C. Beckerman, Office of Policy,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm.
4238, Silver Spring, MD 20993. 301-796-4830. FAX: 301-847-3541. e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 9, 2010 (75 FR 47820), FDA
published a notice of a public meeting on the development of a generic
drug user fee program. In that notice, FDA posed several questions
related to a user fee for human generic drugs, and sought public input
on such a program. The Agency received submissions and presentations
from the public meeting, which are now posted on FDA's Web site. In the
Federal Register of November 4, 2010 (75 FR 67984), FDA subsequently
reopened the comment period for 30 days to allow consideration of
submissions received after the original docket closing date. Because
FDA has since received multiple requests to reopen the docket,
including requests from generic industry segments that did not
previously comment, FDA has decided to reopen the docket to permit
public input on all the submissions.
Interested persons were originally given until October 17, 2010, to
comment on the development of a generic drug user fee program. FDA is
now reopening the docket to permit comment until February 23, 2011.
II. Request for Comments
FDA has received several requests to allow interested persons
additional time to comment. The requesters represent manufacturers of
active pharmaceutical ingredients who did not previously respond to
FDA's specific requests for comments. In light of these requests, FDA
is reopening the comment period for an additional 30 days.
III. How To Submit Comments
Regardless of attendance at the public meeting interested persons
may submit either electronic or written comments to the Division of
Dockets Management (see ADDRESSES). It is only necessary to send one
set of comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: January 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1274 Filed 1-21-11; 8:45 am]
BILLING CODE 4160-01-P