Document ID: FDA-2010-N-0381-0038
Agency: fda
Document Type: Notice
Title: Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period
Posted Date: 2011-03-15T04:00Z

[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Page 14028]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5917]

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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 June 
30, 2011, the comment period for the notice of public meeting, 
published in the Federal Register of August 9, 2010 (75 FR 47820), 
entitled ``Generic Drug User Fee; Public Meeting; Request for 
Comments.'' 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 for the expected duration of the active negotiation 
phase to ensure that all interested stakeholders have the opportunity 
to share their views on the matter.

DATES: Submit either electronic or written comments by June 30, 2011.

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 (GDUF) 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. On 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 after that 
reopening FDA received multiple requests to reopen the docket, 
including requests from generic industry segments that did not 
previously comment, FDA reopened the docket again 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. In the 
last docket reopening on January 24, 2011 (76 FR 4119), FDA reopened 
the docket to permit comments until February 23, 2011.
    To ensure that all interested persons, whether a member of a trade 
organization at the negotiating table or not, have sufficient 
opportunity to share their views on the GDUF program throughout the 
negotiation phase, FDA is reopening the comment period until June 30, 
2011. FDA expects that the public component of the GDUF negotiations 
will be complete by the end of June 2011. Therefore, the Agency is 
reopening the comment period for this anticipated duration.

II. Additional Information on GDUF

    There is information on FDA's Web site that may be useful for 
interested stakeholders to better understand FDA's effort to establish 
a generic drug user fee and its current status. Information on the 
September 17, 2010, public meeting on GDUF, the Federal Register notice 
announcing the meeting, the transcript of the meeting, and slide 
presentations from the meeting are available at http://www.fda.gov/Drugs/NewsEvents/ucm224121.htm. Additional information on that Web page 
includes subsequent FDA updates, slide presentations, and speeches 
related to generic drug user fees, and this is also where FDA will post 
meeting minutes from the negotiation sessions with industry.

III. How To Submit Comments

    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: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5917 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P