[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Proposed Rules]
[Pages 44483-44484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 118

[Docket No. FDA-2000-N-0190 (formerly Docket No. 2000N-0504)]


Draft Guidance for Industry: Questions and Answers Regarding the 
Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During 
Production, Storage, and Transportation (Layers With Outdoor Access); 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance entitled ``Guidance for Industry: 
Questions and Answers Regarding the Final Rule, Prevention of 
Salmonella Enteritidis in Shell Eggs During Production, Storage, and 
Transportation (Layers with Outdoor Access)'' (the draft guidance). The 
document provides guidance to egg producers on certain provisions 
contained in FDA's final rule entitled, ``Prevention of Salmonella 
Enteritidis in Shell Eggs During Production, Storage, and 
Transportation'' concerning the management of production systems that 
provide laying hens with access to the outdoors. Laying hens are 
provided outdoor access in some production systems, including certified 
organic production systems governed by the U.S. Department of 
Agriculture's National Organic Program regulations.

DATES: Although you can comment on any guidance at any time (see 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draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 
by September 23, 2013.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Submit written requests for single copies of the draft guidance to the 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 301-436-2632. Send one self-addressed adhesive label to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance.

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 Salmonella Enteritidis (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, with a compliance date of July 9, 
2010, for producers with 50,000 or more laying hens. For producers with 
fewer than 50,000, but at least 3,000 laying hens, the compliance date 
was July 9, 2012. The compliance date for persons who must comply with 
only the refrigeration requirements was July 9, 2010. The final rule is 
codified at 21 CFR part 118.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent our current thinking on how to interpret the 
requirements in the final rule with regard to production systems that 
provide laying hens with access to the outdoors, including questions 
and answers on coverage; definitions; SE prevention measures; and 
environmental sampling for SE. 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 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 Sec. Sec.  118.5, 118.6, 118.10, and 
118.11 have been approved under OMB control number 0910-0660.

[[Page 44484]]

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm or 
http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: July 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17750 Filed 7-23-13; 8:45 am]
BILLING CODE 4160-01-P