[Federal Register: February 6, 2002 (Volume 67, Number 25)]
[Notices]
[Page 5604-5605]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06fe02-78]
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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