Document ID: FDA-2010-N-0381-0031
Agency: fda
Document Type: Notice
Title: Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period
Posted Date: 2010-11-04T04:00Z

[Federal Register: November 4, 2010 (Volume 75, Number 213)]
[Notices]               
[Page 67984-67985]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no10-52]                         

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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 
December 6, 2010, 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 December 6, 
2010.

[[Page 67985]]

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 20993-0002, 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. Some 
submissions arrived after the formal closing of the docket and 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 December 6, 2010.

II. Request for Comments

    Following publication of the August 9, 2010, meeting notice and 
request for comment, FDA received a request to allow interested persons 
additional time to comment. The requester asserted that the time period 
of 30 days was insufficient to respond fully to FDA's specific requests 
for comments and to allow potential respondents to thoroughly evaluate 
and address pertinent issues. In light of this request, and the arrival 
of late submitted comments, 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 to the Division of Dockets Management (see ADDRESSES) either 
electronic or written comments regarding this document. 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: October 29, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-27824 Filed 11-3-10; 8:45 am]
BILLING CODE 4160-01-P