[Federal Register Volume 77, Number 162 (Tuesday, August 21, 2012)]
[Rules and Regulations]
[Pages 50372-50373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20383]
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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 or we) is announcing the
availability of a 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 guidance contains questions we have received on
the final rule since its publication and responses to those questions,
and is intended to assist egg producers and other persons who are
covered by the final rule.
[[Page 50373]]
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
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.
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), we 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. In the Federal Register of
July 13, 2011 (76 FR 41157), we made available a draft guidance
entitled ``Questions and Answers Regarding the Final Rule, Prevention
of Salmonella Enteritidis in Shell Eggs During Production, Storage, and
Transportation'' and gave interested parties an opportunity to submit
comments by September 12, 2011. We have reviewed and evaluated these
comments and have modified the guidance where appropriate.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents our
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 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 written comments regarding this
document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. 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 guidance 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: August 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20383 Filed 8-20-12; 8:45 am]
BILLING CODE 4160-01-P