[Federal Register Volume 66, Number 174 (Friday, September 7, 2001)]
[Notices]
[Pages 46802-46803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 94P-0240]


Small Entity Compliance Guide: ``Food Labeling; Serving Sizes; 
Reference Amount for Baking Powder, Baking Soda, Pectin;'' 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 March 16, 1999 (64 FR 12887), 
entitled ``Food Labeling; Serving Sizes; Reference Amount for Baking 
Powder, Baking Soda, and Pectin.'' The SECG is intended to set forth 
the requirements of that final rule in plain language and to help small 
businesses understand the regulation.

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

ADDRESSES: Submit written comments concerning this SECG 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 the SECG to Lori A. LeGault (address below). Send one 
self-adhesive address label to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the SECG.

FOR FURTHER INFORMATION CONTACT: Lori A. LeGault, Center for Food 
Safety and Applied Nutrition (HFS-840), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5269.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 18, 1997 (62 FR 61476), FDA 
published a proposed rule to amend the nutrition labeling regulations 
to change the reference amount customarily consumed per eating occasion 
for the food category ``Baking powder, baking soda, pectin.'' A final 
rule based on that proposed rule was published in the Federal Register 
of March 16, 1999 (64 FR 12887).
    FDA examined the economic implications of that final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-602). The 
agency 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 
Fairness Act (Public Law 104-121), FDA made available (via the 
Internet) a small entity compliance guide stating in plain language the 
requirements of this 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 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. An

[[Page 46803]]

alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments on the SECG entitled ``Food Labeling; Serving Sizes; Reference 
Amount for Baking Powder, Baking Soda, Pectin'' to the Dockets 
Management Branch (address above). Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments should 
be identified with the docket number found in brackets in the heading 
of this document. A copy of the document 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 SECG may also be viewed on a personal computer with 
access to the Internet. The Center for Food Safety and Applied 
Nutrition's home page includes the SECG and can be found at http://
www.cfsan.fda.gov/~dms/sodaguid.html.

    Dated: August 28, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-22481 Filed 9-6-01; 8:45 am]
BILLING CODE 4160-01-S