[Federal Register Volume 75, Number 213 (Thursday, November 4, 2010)]
[Notices]
[Pages 67984-67985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27824]
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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: [email protected].
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