Document ID: FDA-2010-D-0313-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry; Availability: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation
Posted Date: 2010-08-12T04:00Z

[Federal Register: August 12, 2010 (Volume 75, Number 155)]
[Notices]               
[Page 48973-48974]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au10-63]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Draft Guidance for Industry: Prevention of Salmonella Enteritidis 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availability of a draft guidance entitled ``Prevention of Salmonella 
Enteritidis in Shell Eggs During Production, Storage, and 
Transportation'' (the draft guidance). The draft guidance, when 
finalized, will provide 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

[[Page 48974]]

Enteritidis (SE) prevention measures, how to sample for SE, and how to 
maintain records documenting compliance with the final rule.

DATES: Although you can comment on any guidance at any time (see Sec.  
10.115(g)(5) (21 CFR 10.115(g)(5))), to ensure that the agency 
considers your comments on the draft guidance before it begins work on 
the final version of the guidance, submit either electronic or written 
comments on the draft guidance by October 12, 2010.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Plant and Dairy Food Safety/Office of Food 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, or fax your request to 301-436-1070. Send two self-addressed 
adhesive labels to assist that office in processing your request. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance. Submit electronic comments on the draft guidance to 
http://www.regulations.gov. Submit written comments 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, 301-436-1493.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued 
the 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, and requiring these producers to 
maintain records concerning their compliance with the final rule and to 
register with FDA. The final rule became effective September 8, 2009.
    FDA is issuing the draft guidance as a level 1 draft guidance 
consistent with FDA's good guidance practices regulation (Sec.  
10.115). The draft guidance, when finalized, will represent the 
agency's current thinking on how to comply with certain measures 
designed to prevent SE from contaminating eggs on the farm, as well as 
how to sample for SE and 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 alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

     This draft 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 this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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 draft guidance 
at http://www.fda.gov/FoodGuidances or http://www.regulations.gov.

    Dated: August 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19905 Filed 8-11-10; 8:45 am]
BILLING CODE 4160-01-S