Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery Products for Export to the European Union and the European Free Trade Association; 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 January 25, 2005, the comment period for the notice that appeared in the Federal Register of November 26, 2004 (69 FR 68948). In the notice, FDA announced the availability and requested comments on the draft guidance entitled “Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery Products for Export to the European Union and the European Free Trade Association.” 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 or electronic comments by January 25, 2005.

ADDRESSES:

Submit written comments 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 .

FOR FURTHER INFORMATION CONTACT:

Tim Hansen, Center for Food Safety and Applied Nutrition (HFS-415), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1405, e-mail: thansen@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November 26, 2004 (69 FR 68948), FDA published a notice with a 30-day comment period on a draft guidance entitled “Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery Products for Export to the European Union and the European Free Trade Association.”

The agency has received several requests for an extension of the comment period for the notice, ranging from an additional 30 to 90 days. Each request conveyed concern that the current 30-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the draft guidance document.

FDA has considered the requests for additional time to submit comments and is extending the comment period for the notice and related guidance document for 30 days, until January 25, 2005. The agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying implementation of this important program.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on this document. 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.