E7-8781. Voluntary Self-Inspection of Medicated Feed Manufacturing Facilities; Draft Compliance Policy Guide; Availability; Reopening of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; reopening of comment period.

SUMMARY:

The Food and Drug Administration (FDA) is reopening to June 8, 2007, the comment period for the notice of availability that appeared in the Federal Register of February 12, 2007 (72 FR 6572). In the notice, FDA requested comments on the draft compliance policy guide on voluntary self-inspection of medicated feed manufacturing facilities. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

DATES:

Submit written and electronic comments by June 8, 2007.

ADDRESSES:

Submit written comments on the draft compliance policy guide to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the documents.

FOR FURTHER INFORMATION CONTACT:

Paul Bachman, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9225, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of February 12, 2007 (72 FR 6572), FDA published a notice of availability with a 75-day comment period to request comments on a draft compliance policy guide (CPG) on voluntary self inspection of medicated feed manufacturing facilities. The purpose of this CPG is intended to provide guidance to FDA field offices on considering, among other factors, the conduct of self-inspections when prioritizing inspections of medicated feed manufacturing facilities for compliance with Current Good Manufacturing Practices for Medicated Feeds regulations.

The agency has received a request for an extension of the comment period for the draft compliance policy guide. This request conveyed concern that the current 75-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the compliance policy guide.

FDA has considered the request and is reopening the comment period for the draft compliance policy guide until June 8, 2007. The agency believes this reopening allows adequate time for interested persons to submit comments.

II. Request for Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on these documents. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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: May 1, 2007.

David Horowitz,

Assistant Commissioner for Regulatory Affairs.