[Federal Register Volume 73, Number 138 (Thursday, July 17, 2008)]
[Notices]
[Page 41090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16394]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0361]


Small Entity Compliance Guide: Standard of Identity for White 
Chocolate; 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 small entity compliance guide (SECG) for a final rule 
published in the Federal Register of October 4, 2002 (67 FR 62171). 
This SECG entitled ``Standard of Identity for White Chocolate'' is 
intended to set forth, in plain language, the requirements of the 
regulation and to help small businesses understand the regulation.

DATES: Submit written or electronic comments on the SECG at any time.

ADDRESSES: Submit written comments on the SECG to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
on the SECG to http://www.regulations.gov. Submit written requests for 
single copies of the SECG to the Office of Nutrition, 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. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT: Geraldine June, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 4, 2002, FDA issued a final rule 
establishing a standard of identity for white chocolate. That final 
rule became effective January 1, 2004.
    FDA examined the economic implementation of the final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-602) and 
determined that the final rule would have a significant economic impact 
on a substantial number of small entities. In compliance with section 
212 of the Small Business Regulatory Enforcement Fairness Act (Public 
Law 104-121), FDA is making this SECG available by stating, in plain 
language, the requirements of the regulation.
    FDA is issuing this SECG as level 2 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 
represents the agency's current thinking on this subject. 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.

II. Comments

    Interested persons may submit to the Division of Dockets Management
    (see ADDRESSES) written or electronic comments regarding this SECG. 
Submit a single copy of electronic comments to 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 SECG and received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.cfsan.fda.gov/guidance.html.

    Dated: July 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16394 Filed 7-16-08; 8:45 am]
BILLING CODE 4160-01-S