[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Draft Guidance for Industry: Prevention of Salmonella Enteritidis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availability of a draft guidance entitled ``Prevention of Salmonella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Transportation'' (the draft guidance). The draft guidance, when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considers your comments on the draft guidance before it begins work on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comments on the draft guidance by October 12, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Plant and Dairy Food Safety/Office of Food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draft guidance. Submit electronic comments on the draft guidance to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