[Federal Register Volume 73, Number 229 (Wednesday, November 26, 2008)]
[Notices]
[Pages 72062-72063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28189]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0597]


Draft Guidance for Industry: Small Entities Compliance Guide for 
Renderers--Substances Prohibited From Use in Animal Food or Feed; 
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availability of a draft guidance for industry 195, entitled 
``Draft Guidance for Industry: Small Entities Compliance Guide for 
Renderers--Substances Prohibited From Use in Animal Food or Feed.'' 
This small entities compliance guide aids renderers in complying with 
the requirements of the final rule published in the Federal Register of 
April 25, 2008 (73 FR 22720). FDA's goal is to strengthen existing 
safeguards to prevent the spread of bovine spongiform encephalopathy 
(BSE) in U.S. cattle and to reduce the risk of human exposure to the 
BSE agent.

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 comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by January 26, 2009.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. Submit written comments on the draft guidance to the 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 electronic 
comments to http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Shannon Jordre, Division of 
Compliance, Center for Veterinary Medicine (HFV-230), Food and Drug 
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9229, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
195, entitled ``Draft Guidance for Industry: Small Entities 
Compliance Guide for Renderers--Substances Prohibited From Use in 
Animal Food or Feed.'' In the Federal Register of April 25, 2008 (73 FR 
22720), FDA published a final rule entitled ``Substances Prohibited 
From Use in Animal Food or Feed.'' This

[[Page 72063]]

regulation is designed to further strengthen existing safeguards 
against the establishment and amplification of BSE, sometimes referred 
to as ``Mad Cow Disease,'' through animal feed. The regulation 
prohibits the use of certain cattle origin materials in the food or 
feed of all animals.
    FDA has prepared this draft Small Entities Compliance Guide in 
accordance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act (Public Law 104-121). This document is 
intended to provide guidance to small businesses on the requirements of 
Title 21, Code of Federal Regulations, new Sec.  589.2001 and amended 
Sec.  589.2000.

II. Significance of Guidance

    FDA is issuing this small entities compliance guide as a 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 this topic. 
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.

III. 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 589.2001 have been approved under 
OMB Control Number 0910-0627.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cvm or http://www.regulations.gov.

    Dated: November 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28189 Filed 11-25-08; 8:45 am]
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