Federal Register: November 4, 2010 (Volume 75, Number 213)
DOCID: fr04no10-52 FR Doc 2010-27824
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. FDA-2010-N-0381]
ACTION: Agency Information Collection Activities; Proposals, Submissions, and Approvals:
DOCUMENT ACTION: Notice; reopening of the comment period.
Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period
DATES: Submit either electronic or written comments by December 6, 2010.
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 latereceived comments and to provide an opportunity for all interested parties to provide information and share views on the matter.
Generic Drug User Fee
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.
Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 201027824 Filed 11310; 8:45 am]
BILLING CODE 416001P
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 209930002, 3017964830, Fax: 3018473541, E mail: firstname.lastname@example.org.