[Federal Register Volume 67, Number 235 (Friday, December 6, 2002)]
[Notices]
[Pages 72691-72692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30901]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0463]


Guidance for Industry; Implementation of the Federal Food, Drug, 
and Cosmetic Act Regarding the Use of the Term ``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 403(t) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343(t)) Regarding the Use of the Term 
`Catfish.''' Section 10806 of the Farm Security and Rural Investment 
Act of 2002 amends the Federal Food, Drug, and Cosmetic Act (the act) 
to provide that a food shall be deemed to be misbranded ``[i]f it 
purports to be or is represented as catfish, unless it is fish 
classified within the family Ictaluridae.'' This guidance assists 
importers and domestic distributors of fish previously called 
``catfish'' in selecting a new common or usual name that is consistent 
with the act.

DATES: Submit written or electronic comments at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
    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. Include a self-adhesive address label to assist 
that office in processing your request, or include a fax number to 
which the guidance may be sent. See the Supplementary Information 
section for electronic access to this guidance document.

FOR FURTHER INFORMATION CONTACT: Spring C. Randolph, 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

    On May 13, 2002, Public Law 107-171, entitled the Farm Security and 
Rural Investment Act of 2002 (FSRIA), became law. Section 10806 of the 
FSRIA amends the food misbranding provision in section 403 of the act 
(21 U.S.C. 343) to provide that a food shall be deemed to be misbranded 
``[i]f it purports to be or is represented as catfish, unless it is 
fish classified within the family Ictaluridae.'' This amendment 
overrides prior guidance that lists fish other than those from the 
family Ictaluridae as fish bearing the acceptable name ``catfish.''
    The guidance document states that, consistent with the amendment to 
section 403 of the act, importers, domestic distributors, and sellers 
of fish in interstate commerce bearing the term ``catfish,'' that are 
not classified within the family Ictaluridae, may no longer use the 
term ``catfish'' on labeling, in whole or as part of their common or 
usual name. This guidance relates to all fish that are distributed in 
interstate commerce, including imports.
    The document discusses how to apply FDA's common or usual name 
``general principles'' regulation (21 CFR 102.5) in determining a name 
that can be used for the fish once known as ``catfish,'' but for which 
that name can no longer be used.
    This guidance represents the agency's current thinking on 
acceptable common or usual names for fish bearing the name ``catfish'' 
that are not from the family Ictaluridae. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.
    This guidance is a level 1 guidance issued consistent with FDA's 
good guidance practices (GGPs) regulation (Sec.  10.115 (21 CFR 
10.115)). 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. Section 
403(t) of the act is now in effect and must be implemented immediately. 
Thus, FDA is making the guidance effective immediately.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the guidance at any time. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments should be identified with the docket 
number

[[Page 72692]]

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 
http://www.cfsan.fda.gov/[tilde]dms/guidance.html.

    Dated: November 15, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-30901 Filed 12-5-02; 8:45 am]
BILLING CODE 4160-01-S