Document ID: FDA-2010-N-0381-0042
Agency: fda
Document Type: Notice
Title: Generic Drug User Fee; Extension of Comment Period
Posted Date: 2011-06-08T04:00Z

[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Page 33307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14120]

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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; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice of public meeting, that appeared in the 
Federal Register of August 9, 2010 (75 FR 47820). In the notice, FDA 
requested comments to gather stakeholder input on the development of a 
generic drug user fee program. The Agency is taking this action to 
allow interested persons additional time to submit comments.

DATES: Submit either electronic or written comments by August 1, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0381, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and docket number for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 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 soliciting comment on development of a generic drug 
user fee program, and indicated an intent to keep the docket open for 
the duration of its negotiations.
    FDA and the industry trade organizations with which it is 
negotiating have extended the negotiations until the end of July 2011. 
Consequently, FDA is extending the comment period for the notice until 
August 1, 2011. The Agency believes this extension allows adequate time 
for interested persons to submit comments and reflects the Agency's 
previously-articulated commitment to receiving input from all 
interested parties.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments on 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: June 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14120 Filed 6-7-11; 8:45 am]
BILLING CODE 4160-01-P