2011-3712. Unapproved Animal Drugs; Extension of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Request for comments; extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA) is extending to April 19, 2011, the comment period for the notice that appeared in the Federal Register of December 20, 2010 (75 FR 79383). In the notice FDA requested comments on strategies to address the prevalence of animal drug products marketed in the United States without approval or other legal marketing status. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

DATES:

Submit electronic or written comments by April 19, 2011.

ADDRESSES:

You may submit comments, identified by Docket No. FDA-2010-N-0528 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: [phone].
• 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 No. FDA-2010-N-0528. 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:

Tracey H. Forfa, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-9000, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of December 20, 2010 (75 FR 79383), FDA published a notice with a 60-day comment period to request comments from stakeholders on strategies to address the prevalence of animal drug products marketed in the United States without approval or other legal marketing status. The notice expressed FDA's interest in receiving comments on strategies that utilize FDA's existing regulatory framework for addressing this issue as well as on novel strategies not currently employed by the Agency.

The Agency has received requests for a 60-day extension of the comment period. The requests conveyed concern that the current 60-day comment period does not allow respondents sufficient time to address fully the many important issues FDA raised in the notice.

FDA has considered the requests and is extending the comment period for the notice for 60 days, until April 19, 2011. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying the Agency's consideration of these important issues.

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: February 15, 2011.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.