[Federal Register Volume 66, Number 86 (Thursday, May 3, 2001)]
[Notices]
[Pages 22240-22241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11072]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0184]


Compliance Policy Guide: ``Statement of Policy for Labeling and 
Preventing Cross-Contact of Common Food Allergens;'' 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 compliance policy guide (CPG) entitled ``Statement of 
Policy for Labeling and Preventing Cross-Contact of Common Food 
Allergens.'' This CPG is intended to set forth FDA's internal 
enforcement priorities concerning undeclared food allergens.

DATES: Submit written comments on this CPG at any time.

ADDRESSES: Submit written requests for single copies of the CPG 
entitled ``Statement of Policy for Labeling and Preventing Cross-
Contact of Common Food Allergens'' to the Director, Division of 
Compliance Policy (HFC-230), Office of Enforcement, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send two self-
addressed adhesive labels to assist that office in processing your 
request, or fax your request to 301-827-0482. See the SUPPLEMENTARY 
INFORMATION  section for electronic access to the document.
    Submit written comments on the CPG to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Technical questions concerning allergens in foods: Kathy Gombas, 
Office of Field Programs (HFS-615), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, 202-205-4231, FAX 202-260-0136.
    Questions concerning regulatory actions: MaryLynn Datoc, Office of 
Enforcement (HFC-230), Office of Regulatory Affairs, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0413, 
FAX 301-827-0482.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed a CPG on FDA's internal enforcement process 
concerning undeclared allergens in

[[Page 22241]]

foods. The purpose of this CPG is to provide clear policy and 
regulatory guidance to FDA's field and headquarters staff. It also 
contains information that may be useful to the regulated industry and 
to the public. FDA is issuing this CPG as Level 1 guidance consistent 
with FDA's good guidance practices regulation (21 CFR 10.115; 65 FR 
56468, September 19, 2000). The guidance represents the agency's 
current thinking on the subject. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. The guidance is intended to further FDA's efforts to prevent 
potential serious allergic reactions in sensitive individuals resulting 
from undeclared allergens in foods. FDA is making this guidance 
document effective immediately because public participation prior to 
its implementation is not appropriate in these circumstances (21 CFR 
10.115(g)(2); 65 FR 56478). Although the guidance document announced in 
this notice is being implemented immediately, FDA is requesting 
comments on the guidance. FDA will review all comments received, revise 
the guidance in response to the comments as appropriate, and publish a 
notice of availability if the guidance is revised.

II. Comments

    Interested persons may, at any time, submit written comments on the 
CPG entitled ``Statement of Policy for Labeling and Preventing Cross-
Contact of Common Food Allergens,'' to the Dockets Management Branch 
(address above). Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. A copy of the CPG and received comments are available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.

III. Electronic Access

    Copies of the CPG may also be downloaded to a personal computer 
with access to the Internet. The Office of Regulatory Affairs (ORA) 
home page includes the CPG and may be accessed at http://www.fda.gov/ora under ``Compliance References.''

    Dated: April 27, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-11072 Filed 5-2-01; 8:45 am]
BILLING CODE 4160-01-S