Document ID: FDA-2008-D-0597-0008
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Small Entities Compliance Guide for Renderers Substances, etc; Availability
Posted Date: 2009-05-01T04:00Z

[Federal Register: May 1, 2009 (Volume 74, Number 83)]
[Notices]               
[Page 20324-20325]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01my09-53]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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 guidance for industry 195 entitled ``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:  Submit written or electronic comments on agency guidances at 
any time.

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 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 guidance document.

FOR FURTHER INFORMATION CONTACT:  Shannon Jordre, Center for Veterinary 
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9229, Shannon.jordre@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 26, 2008 (73 FR 72062), FDA 
published the notice of availability for a draft guidance entitled 
``Small Entities Compliance Guide for Renderers--Substances Prohibited 
From Use in Animal Food or Feed'' giving interested persons until 
January 26, 2009, to comment on the draft guidance. FDA received 
several comments on the draft guidance and those comments were 
considered as the guidance was finalized. FDA received a number of 
comments that were outside the scope of the draft guidance, and thus 
those comments were not addressed in the final version.
    The comments raised a number of questions including the following:
     Inquiries from an industry organization regarding the 
difference between cattle materials prohibited in animal feed (CMPAF) 
and specified risk materials (SRM);
     Industry requests for clarification on the provisions of 
the regulation concerning insoluble impurity standards for tallow and 
how to achieve compliance;
     Whether a certificate of analysis is necessary for each 
shipment of tallow;
     Whether edible tallow must meet the 0.15 percent insoluble 
impurities

[[Page 20325]]

standard for use in ruminant feed, and if so whether this requirement 
is consistent with FDA's requirement that tallow for human food and 
cosmetics be free of prohibited material or contain less than 0.15 
percent insoluble impurities;
     Whether the impurity standard applies to blended fats and 
oils;
     Whether a renderer can be held responsible for the 
impurity level in tallow after it is delivered to a customer's storage 
tanks;
     Whether the new regulation applies to cattle material fed 
to mink; and finally,
     A request to use the word ``effective'' in the guidance 
when referring to the removal of brains and spinal cords of cattle.
FDA has responded to these comments and concerns in the question and 
answer portion of the final guidance. The guidance announced in this 
notice finalizes the draft guidance dated November 25, 2008.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking on the 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 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

    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.
    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.

V. Electronic Access

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

    Dated: April 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-10034 Filed 4-30-09; 8:45 am]

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