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74020 Federal Register / Vol. 70, No.

239 / Wednesday, December 14, 2005 / Notices

DEPARTMENT OF HEALTH AND I. Background the Paperwork Reduction Act of 1995

HUMAN SERVICES FDA is announcing the availability of (44 U.S.C. 3501–3520). The collection of
a guidance document entitled information in this guidance was
Food and Drug Administration approved under OMB control number
‘‘Requesting an Extension to Use
Existing Label Stock after the Trans Fat 0910–0571.
[Docket No. 2005D–0483] Labeling Effective Date of January 1, III. Comments
2006.’’ FDA issued a final rule on July Interested persons may submit to the
Guidance for Industry and Food and 11, 2003 (68 FR 41434), to require food
Drug Administration; Requesting an Division of Dockets Management (see
labels to bear the gram amount of trans ADDRESSES) written or electronic
Extension to Use Existing Label Stock fat without a percent Daily Value in the
After the Trans Fat Labeling Effective comments regarding this document at
Nutrition Facts panel (http:// any time. Submit a single copy of
Date of January 1, 2006; Availability electronic comments or two paper
AGENCY: Food and Drug Administration, fr03711a.pdf). The trans fat final rule copies of any mailed comments, except
HHS. becomes effective on January 1, 2006. that individuals may submit one paper
This guidance document provides copy. Comments are to be identified
ACTION: Notice. guidance to FDA staff and the food with the docket number found in
SUMMARY: The Food and Drug
industry about when and how brackets in the heading of this
Administration (FDA) is announcing the businesses may request the agency to document. The guidance and received
availability of a guidance document consider enforcement discretion for the comments may be seen in the Division
entitled, ‘‘Requesting an Extension to use, on products introduced into of Dockets Management between 9 a.m.
Use Existing Label Stock after the Trans interstate commerce on or after the and 4 p.m., Monday through Friday.
Fat Labeling Effective Date of January 1, January 1, 2006 effective date, of some
or all existing label stock that does not IV. Electronic Access
2006.’’ The trans fat final rule published
in the Federal Register on July 11, 2003. declare trans fat labeling in compliance Persons with access to the Internet
This guidance document provides with the final rule. may obtain the guidance document at
In compliance with section 212 of the
guidance to FDA and the food industry
Small Business Regulatory Enforcement guidance.html.
about when and how businesses may
Fairness Act (Public Law 104–121), we
request the agency to consider Dated: December 5, 2005.
are making available this guidance that
enforcement discretion for the use, on Jeffrey Shuren,
states in plain language the factors the
products introduced into interstate Assistant Commissioner for Policy.
agency intends to consider concerning
commerce on or after the January 1, [FR Doc. 05–23987 Filed 12–13–05; 8:45 am]
requests for enforcement discretion by
2006, effective date, of some or all
small and other businesses regarding BILLING CODE 4160–01–S
existing label stock that does not declare
compliance with this regulation.
trans fat labeling in compliance with the
FDA is issuing this guidance as a level
1 guidance consistent with FDA’s good
DATES: This guidance is final upon the guidance practices regulation § 10.115 HUMAN SERVICES
date of publication. Submit written or (21 CFR 10.115). Consistent with FDA’s
electronic comments on the guidance at Indian Health Service
good guidance practices regulation, the
any time. agency will accept comment, but is [Funding Opportunity Number: HHS–2006–
ADDRESSES: Submit written requests for implementing the guidance document IHS–TSGP–0001; CFDA Number: 93.210]
single copies of this guidance to the immediately in accordance with
§ 10.115(g)(2), because the agency has Tribal Self-Governance Program
Office of Nutritional Products, Labeling
determined that prior public Planning Cooperative Agreement; New
and Dietary Supplements (HFS–800),
participation is not feasible or Funding Cycle for Fiscal Year 2006
Center for Food Safety and Applied
Nutrition, Food and Drug appropriate. This document affects the Key Dates: Applications Due—January
Administration, 5100 Paint Branch trans fat labeling effective date of 20, 2006; Objective Review Committee
Pkwy., College Park, MD 20740. Send January 1, 2006, so it is urgent that FDA to Evaluate Applications—March 8–9,
one self-addressed adhesive label to explains its new enforcement policy 2006; Anticipated Project Start Date—
assist that office in processing your before that date. This guidance April 1 , 2006.
requests. Submit written comments on represents the agency’s current thinking
on the subject. It does not create or I. Funding Opportunity Description
the guidance to the Division of Dockets
Management (HFA-305), Food and Drug confer any rights for or on any person The purpose of the program is to
Administration, 5630 Fishers Lane, rm. and does not operate to bind FDA or the award cooperative agreements that
1061, Rockville, MD 20852. Submit public. You may use an alternative provide planning resources to Tribes
electronic comments to http:// approach if such approach satisfies the interested in participating in the Tribal See requirements of the applicable statutes Self-Governance Program (TSGP) as
the SUPPLEMENTARY INFORMATION section and regulations. If you want to discuss authorized by Title V, Tribal Self-
for electronic access to the guidance an alternative approach, contact the Governance Amendments of 2000 of the
document. FDA staff responsible for implementing Indian Self-Determination and
this guidance (see FOR FURTHER Education Assistance Act of Public Law
Moss, Center for Food Safety and TSGP is designed to promote self-
Applied Nutrition (HFS–830), Food and II. Paperwork Reduction Act of 1995 determination by allowing Tribes to
Drug Administration, 5100 Paint Branch This final guidance contains assume more control of Indian Health
Pkwy., College Park, MD 20740–3835, information collection provisions that Service (IHS) programs and services
301–436–2373, FAX: 301–436–2636. are subject to review by the Office of through compacts negotiated with the
SUPPLEMENTARY INFORMATION: Management and Budget (OMB) under IHS. The Planning Cooperative

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