
[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Notices]
[Page 81513]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33292]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0313]


Guidance for Industry: Prevention of Salmonella Enteritidis in 
Shell Eggs During Production, Storage, and Transportation; 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 for industry entitled ``Prevention of 
Salmonella Enteritidis in Shell Eggs During Production, Storage, and 
Transportation.'' The document provides guidance to egg producers on 
how to comply with certain provisions contained in FDA's final rule 
``Prevention of Salmonella Enteritidis in Shell Eggs During Production, 
Storage, and Transportation'' (the final rule), including how to 
implement Salmonella Enteritidis (SE) prevention measures, how to 
sample for SE., and how to maintain records documenting compliance with 
the final rule.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Plant and Dairy Food Safety/Office of Food Safety, 
Center for Food Safety and Applied Nutrition (HFS-315), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. 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.

FOR FURTHER INFORMATION CONTACT: Nancy Bufano, Center for Food Safety 
and Applied Nutrition (HFS-316), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, (240) 402-1493.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a 
final rule requiring shell egg producers to implement measures to 
prevent SE from contaminating eggs on the farm and from further growth 
during storage and transportation, to maintain records concerning their 
compliance with the final rule, and to register with FDA. This final 
rule became effective September 8, 2009. In the Federal Register of 
August 12, 2010 (75 FR 48973), FDA made available a draft guidance 
entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During 
Production, Storage, and Transportation'' and gave interested parties 
an opportunity to submit comments by October 12, 2010. The Agency 
reviewed and evaluated these comments and has modified the guidance 
where appropriate.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on how to comply with certain SE prevention 
measures, how to sample for SE., and how to maintain records 
documenting compliance with the final rule. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternate approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in 21 CFR 118.5, 118.6, 118.10, and 118.11 
have been approved under OMB control number 0910-0660.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
guidance. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. 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 document at 
http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Always 
access an FDA document using the FDA Web site listed previously to find 
the most current version of the guidance.

    Dated: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33292 Filed 12-27-11; 8:45 am]
BILLING CODE 4160-01-P


