[Federal Register Volume 75, Number 70 (Tuesday, April 13, 2010)]
[Notices]
[Pages 18849-18850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0183]


Small Entity Compliance Guide: 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 guidance entitled ``Prevention of Salmonella 
Enteritidis in Shell Eggs During Production, Storage, and 
Transportation--Small Entity Compliance Guide.'' The small entity 
compliance guide (SECG) is being issued for a final rule published in 
the Federal Register of July 9, 2009, and is intended to set forth in 
plain language the requirements of the regulation and to help small 
businesses understand the regulation. Elsewhere in this issue of the 
Federal Register, FDA is amending its July 9, 2009, regulation to 
correct the date by which producers must register their farm with FDA, 
reflect a change in the address and telephone number for requesting 
copies of Form No. 3733, and reflect a change in the address to which 
producers must send their CD-ROM.

DATES: Submit electronic or written comments on the SECG at any time.

ADDRESSES:  Submit electronic comments on the SECG to http://www.regulations.gov. Submit written comments on the SECG 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 SECG 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

[[Page 18850]]

SUPPLEMENTARY INFORMATION section for electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT: Nancy S. Bufano, Center for Food 
Safety and Applied Nutrition (HFS-315), 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 
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 rule and to register with FDA. The final rule 
became effective September 8, 2009.
    FDA examined the economic implications of the final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and 
determined that the final rule will have a significant economic impact 
on a substantial number of small entities. In compliance with section 
212 of the Small Business Regulatory Enforcement Fairness Act (Public 
Law 104-121), FDA is making available this SECG stating in plain 
language the requirements of the regulation.
    FDA is issuing this SECG as level 2 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 
represents FDA's current thinking on the prevention of SE in shell 
eggs. 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 SECG refers to collections of information described in FDA's 
final rule that published in the Federal Register of July 9, 2009 (74 
FR 33030 at 33089), and that became effective on September 8, 2009. As 
stated in the final rule, these collections of information are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). In 
compliance with the PRA (44 U.S.C. 3507(d)), the agency has submitted 
the information collection provisions of the final rule to OMB for 
review. FDA will publish a notice in the Federal Register announcing 
OMB's decision to approve, modify, or disapprove the information 
collection provisions in this final rule. An agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this SECG. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The SECG and 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 document at 
http://www.fda.gov/FoodGuidances or http://www.regulations.gov.

    Dated: April 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8359 Filed 4-12-10; 8:45 am]
BILLING CODE 4160-01-S