[Federal Register: September 7, 2001 (Volume 66, Number 174)]
[Notices]
[Page 46803]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se01-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 98N-1230, 96P-0418, and 97P-0197]
Small Entity Compliance Guide: ``Food Labeling: Safe Handling
Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held
for Retail Distribution;'' 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
that published in the Federal Register of December 5, 2000 (65 FR
76092), entitled ``Food Labeling: Safe Handling Statements, Labeling of
Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution.''
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 this 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 the Office of Nutritional Products,
Labeling and Dietary Supplements (HFS-800), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 200 C St., Washington,
DC 20204, 202-205-4561. 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:
For the labeling provisions: Geraldine A. June, Center for Food
Safety and Applied Nutrition (HFS-822), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4168.
For refrigeration provisions: Nancy S. Bufano, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-401-2022.
SUPPLEMENTARY INFORMATION:
I. Background
To reduce the risk of illness and death from consumption of eggs
contaminated with Salmonella enteritidis (SE), FDA published in the
Federal Register of July 6, 1999 (64 FR 36492), a proposed rule
requiring the labeling of shell eggs with a safe handling statement and
the refrigeration of shell eggs at retail. FDA published the final rule
in the Federal Register of December 5, 2000 (65 FR 76092).
FDA examined the economic implications of that 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
Fairness Act (Public Law 104-121), FDA made available (via the
Internet) a SECG stating in plain language the requirements of this
regulation.
FDA is issuing this SECG as level 2 guidance consistent with FDAs
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 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: Safe Handling
Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held
for Retail Distribution'' 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. Center for Food Safety and Applied Nutrition's
home page includes the SECG and can be found at http://
www.cfsan.fda.gov/dms/eggsguid.html.
Dated: August 28, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-22482 Filed 9-6-01; 8:45 am]
BILLING CODE 4160-01-S