Document ID: FDA-2010-N-0381-0035
Agency: fda
Document Type: Notice
Title: Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period
Posted Date: 2011-01-24T05:00Z

[Federal Register: January 24, 2011 (Volume 76, Number 15)]
[Notices]               
[Page 4119-4120]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja11-64]                         

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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: 
peter.beckerman@fda.hhs.gov.

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