[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Page 33307]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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