[Federal Register: December 14, 2005 (Volume 70, Number 239)]
[Notices]               
[Page 74020]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14de05-76]                         


[[Page 74020]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0483]

 
Guidance for Industry and Food and Drug Administration; 
Requesting an Extension to Use Existing Label Stock After the Trans Fat 
Labeling Effective Date of January 1, 2006; 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 guidance document entitled, ``Requesting an Extension 
to Use Existing Label Stock after the Trans Fat Labeling Effective Date 
of January 1, 2006.'' The trans fat final rule published in the Federal 
Register on July 11, 2003. This guidance document provides guidance to 
FDA and the food industry about when and how businesses may request the 
agency to consider enforcement discretion for the use, on products 
introduced into interstate commerce on or after the January 1, 2006, 
effective date, of some or all existing label stock that does not 
declare trans fat labeling in compliance with the final rule.

DATES:  This guidance is final upon the date of publication. Submit 
written or electronic comments on the guidance at any time.

ADDRESSES:  Submit written requests for single copies of this guidance 
to the Office of Nutritional Products, Labeling and Dietary Supplements 
(HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. Submit written comments on the guidance 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 

INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Julie Moss, Center for Food Safety and 
Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740-3835, 301-436-2373, FAX: 301-436-
2636.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance document entitled 
``Requesting an Extension to Use Existing Label Stock after the Trans 
Fat Labeling Effective Date of January 1, 2006.'' FDA issued a final 
rule on July 11, 2003 (68 FR 41434), to require food labels to bear the 
gram amount of trans fat without a percent Daily Value in the Nutrition 
Facts panel (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/~acrobat/fr03711a.pdf). The trans 

fat final rule becomes effective on January 1, 2006. This guidance 
document provides guidance to FDA staff and the food industry about 
when and how businesses may request the agency to consider enforcement 
discretion for the use, on products introduced into interstate commerce 
on or after the January 1, 2006 effective date, of some or all existing 
label stock that does not declare trans fat labeling in compliance with 
the final rule.
    In compliance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act (Public Law 104-121), we are making available 
this guidance that states in plain language the factors the agency 
intends to consider concerning requests for enforcement discretion by 
small and other businesses regarding compliance with this regulation.
    FDA is issuing this guidance as a level 1 guidance consistent with 
FDA's good guidance practices regulation Sec.  10.115 (21 CFR 10.115). 
Consistent with FDA's good guidance practices regulation, the agency 
will accept 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. This document affects the trans fat labeling effective 
date of January 1, 2006, so it is urgent that FDA explains its new 
enforcement policy before that date. This 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. You may use an alternative approach if such approach satisfies 
the requirements of the applicable statutes and regulations. If you 
want to discuss an alternative approach, contact the FDA staff 
responsible for implementing this guidance (see FOR FURTHER INFORMATION 
CONTACT).

II. Paperwork Reduction Act of 1995

    This final guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0571.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document 
at any time. 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. The guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/guidance.html.


    Dated: December 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23987 Filed 12-13-05; 8:45 am]

BILLING CODE 4160-01-S