[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Proposed Rules]
[Pages 41157-41158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-17457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 118

[Docket No. FDA-2011-D-0398]


Guidance for Industry: Questions and Answers Regarding the Final 
Rule, Prevention of Salmonella Enteritidis in Shell Eggs During 
Production, Storage, and Transportation; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) 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availability of a draft guidance entitled ``Guidance for Industry: 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Transportation'' (the draft guidance). The draft guidance provides 
guidance to egg producers and other persons who are covered by FDA's 
final rule entitled ``Prevention of Salmonella Enteritidis in Shell 
Eggs During Production, Storage, and Transportation'' (the final rule). 
The draft guidance contains questions FDA has received on the final 
rule since its publication and responses to those questions.

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draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 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 12, 2011.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 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Submit written requests for single copies of the draft guidance to the 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INFORMATION section for electronic access to the draft guidance.

[[Page 41158]]


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. This 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 is July 9, 2012. The compliance date for persons who must comply 
with only the refrigeration requirements was July 9, 2010.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the Agency's current thinking on how to 
interpret the requirements in the final rule, including questions and 
answers on compliance dates; coverage; definitions; SE prevention 
measures; sampling and testing for SE; registration; and compliance and 
enforcement. 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 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/RegulatoryInformation/Guidances/default.htm or 
http://www.regulations.gov.

    Dated: July 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17457 Filed 7-12-11; 8:45 am]
BILLING CODE 4160-01-P