2010-26253. Medical Device User Fees; Public Meeting; Extension of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA) is extending to November 1, 2010, the comment period for the notice that appeared in the Federal Register of August 13, 2010 (75 FR 49502). In the notice, FDA requested input and comments from interested stakeholders on the Agency's medical user fee program and requested suggestions regarding the commitments FDA should propose for the next reauthorized program. The Agency is taking this action to allow interested persons additional time to submit comments.

DATES:

Submit either electronic or written comments and information by November 1, 2010.

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. To ensure consideration, all comments must be received by November 1, 2010. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1609, Silver Spring, MD 20993-0002, 301-796-6313, FAX: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of August 13, 2010 (75 FR 49502), FDA published a notice announcing a public meeting on September 14, 2010, and the opening of a public docket to seek input and comments from interested stakeholders to discuss the Agency's medical user fee program and requested suggestions regarding the commitments FDA should propose for the next reauthorized program. Interested persons were invited to submit comments to the public docket by October 14, 2010. At this time, the Agency is announcing its intention to post the transcript of the September 14, 2010, public meeting and is extending the comment period until November 1, 2010, to continue to receive public comments.

II. Request for 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: October 14, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.