[Federal Register Volume 67, Number 25 (Wednesday, February 6, 2002)]
[Notices]
[Pages 5604-5605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2753]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0032]


Guidance for Industry; Implementation of Section 755 of the 
Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies Appropriations Act of 2002, Pub. L. No. 107-76, 
Sec. 755 (2001) Regarding Common or Usual Names for Catfish; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry; 
Implementation of Section 755 of the Agriculture, Rural Development, 
Food and Drug Administration, and Related Agencies Appropriations Act 
of 2002, Pub. L. No. 1076-76, Sec. 755 (2001) regarding Common or Usual 
Names for Catfish.'' Section 755 of the Agriculture, Rural Development, 
Food and Drug Administration, and Related Agencies Appropriations Act 
of 2002, provides that FDA may not spend any of its 2002 appropriation 
to allow admission of fish or fish products labeled in whole or in part 
with the term ``catfish'' unless the fish are from the Ictaluridae 
family. This guidance discusses how FDA plans to exercise enforcement 
discretion with regard to certain fish whose common or usual name 
contains the term ``catfish.''

DATES: Submit written or electronic comments at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Office of Seafood (HFS-400), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740. Send one self-adhesive address label to assist 
that office in processing your request, or include a fax number to 
which the guidance may be sent. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the Supplementary Information 
section for electronic access to this guidance document.

FOR FURTHER INFORMATION CONTACT: Mary I. Snyder, Center for Food Safety 
and Applied Nutrition (HFS-415), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2303, FAX 301-436-
2599.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of guidance for industry 
implementing section 755 of the Agriculture, Rural Development, Food 
and Drug Administration, and Related Agencies Appropriations Act of 
2002 (Public Law 107-76, Sec. 755 (2001), which provides that FDA may 
not spend any of its 2002 appropriation to allow admission of fish or 
fish products labeled in whole or in part with the term ``catfish'' 
unless the fish are from the Ictaluridae family. This guidance 
discusses how FDA plans to exercise enforcement discretion with regard 
to certain fish whose common or usual name contains the term 
``catfish''.
    This guidance is a level 1 guidance issued consistent with FDA's 
regulation on good guidance practices (GGPs) (Sec. 10.115 (21 CFR 
10.115)) relating to the development, issuance, and use of guidance 
documents. Consistent with GGPs, the agency is soliciting public 
comment, but is implementing the guidance document immediately in 
accordance with Sec. 10.115(g)(2) because the agency has determined 
that prior public participation is not feasible or appropriate. FDA's 
2002 appropriation law was enacted on November 28, 2001, and section 
755 is now in effect and must be implemented immediately. There is a 
need for guidance to help effect such implementation. Thus, FDA is 
making the guidance effective immediately.

II. Comments

    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written or electronic comments on the 
guidance. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments should be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the document and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http:/

[[Page 5605]]

/www.cfsan.fda.gov/dms/guidance/html or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: January 18, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-2753 Filed 2-5-02; 8:45 am]
BILLING CODE 4160-01-S