Guidance for Industry: Small Entities Compliance Guide for Renderers-Substances Prohibited From Use in Animal Food or Feed; Availability, 20324-20325 [E9-10034]

Download as PDF 20324 Federal Register / Vol. 74, No. 83 / Friday, May 1, 2009 / Notices Health and Human Services; State directors of the Medicaid Program under title XIX of the Act; State directors of the State Children’s Health Insurance Program under title XXI of the Act; employers, including owners of small businesses and their trade or industry representatives and certified human resource and payroll professionals; plan administrators and plan sponsors of group health plans as defined in section 607(1) of the Employee Retirement Income Security Act of 1974, as amended; health insurance issuers; and children and other beneficiaries of medical assistance under title XIX of the Act or child health assistance or other health benefits coverage under title XXI of the Act. III. Submission of Nominations The Department of Labor and the Department of Health and Human Services (the Departments) are requesting nominations for membership on the CHIP Working Group. The Departments will consider qualified individuals who are self-nominated or are nominated by organizations representing affected stakeholders when selecting those representatives. The Departments will make every effort to appoint members to serve on the advisory board from among those candidates determined to meet specific statutory categories and Departmental needs and in a manner to ensure an appropriate balance of membership. The Secretaries, however, reserve the discretion to appoint members to serve on the advisory board in response to this notice if necessary to meet specific statutory categories and Departmental needs in a manner to ensure an appropriate balance of membership. Any interested person may nominate one or more qualified individuals (selfnominations will also be accepted) for each of the categories listed in section II.B of this notice. Each nomination must include the following information: 1. A letter of nomination that contains contact information for both the nominator and nominee (if not the same). 2. A statement from the nominee that he or she is willing to serve on the Working Group for its duration and an explanation of interest in serving on the advisory board. The nominee should also indicate which category or categories he or she is willing to represent and whether he or she would be willing to serve as the chair of the advisory board. (For self-nominations, this information may be included in the nomination letter.) 3. A curriculum vitae that indicates the nominee’s educational and/or VerDate Nov<24>2008 15:15 Apr 30, 2009 Jkt 217001 experience with Medicaid, CHIP, or experience with employment-based health coverage. 4. Two letters of reference that support the nominee’s qualifications for participation on the advisory board. (For nominations other than selfnominations, a nomination letter that includes information supporting the nominee’s qualifications may be counted as one of the letters of reference.) To ensure that a nomination is considered, the Departments must receive all of the nomination information specified in section III of this notice by June 1, 2009. Nominations should be mailed to the address specified in the ADDRESSES section of this notice. Authority: Section 311(b)(1)(C) of the Children’s Health Insurance Program Reauthorization Act of 2009 (Pub. L. 111–3) (Feb. 4, 2009). The Children’s Health Insurance Program (CHIP) Working Group is governed by the provisions of the Federal Advisory Committee Act, (Pub. L. 92–463) (Oct. 6, 1972), as amended, 5 U.S.C. App. Dated: April 10, 2009. Charlene Frizzera, Acting Administrator, Centers for Medicare & Medicaid Services, Department of Health and Human Services. Dated: April 28, 2009. Alan D. Lebowitz, Deputy Assistant Secretary for Program Operations, Employee Benefits Security Administration, Department of Labor. [FR Doc. E9–10083 Filed 4–30–09; 8:45 am] BILLING CODE 4120–01–4510–29–P 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. 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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 selfaddressed 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 https:// 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 E:\FR\FM\01MYN1.SGM 01MYN1 Federal Register / Vol. 74, No. 83 / Friday, May 1, 2009 / Notices 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 selfaddressed 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. VerDate Nov<24>2008 15:15 Apr 30, 2009 Jkt 217001 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 https:// www.fda.gov/cvm or https:// 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] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC) Notice of Cancellation: This notice was published in the Federal Register on April 13, 2009, Volume 74, Number 69, page 16877. The meeting previously scheduled to convene on April 30, 2009 has been cancelled. Contact Person for More Information: Brad Perkins, M.D., M.B.A., ACD, CDC, 1600 Clifton Road, NE., Mail Stop D–14, Atlanta, GA 30303; Telephone: (404) 639–7000. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: April 27, 2009. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E9–10051 Filed 4–30–09; 8:45 am] 20325 (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the aforementioned review group: Times and Date: 12:30 p.m.–1 p.m., May 20, 2009 (Open). 1 p.m.–3 p.m., May 20, 2009 (Closed). Place: Teleconference, Toll Free: 888–793– 2154, Participant Passcode: 4424802. Status: Portions of the meetings will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5, U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Section 10(d) of Public Law 92–463. Purpose: This group is charged with providing advice and guidance to the Secretary, Department of Health and Human Services, and the Director, CDC, concerning the scientific and technical merit of grant and cooperative agreement applications received from academic institutions and other public and private profit and nonprofit organizations, including State and local government agencies, to conduct specific injury research that focuses on prevention and control. Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of individual research cooperative agreement applications submitted in response to Fiscal Year 2009 Requests for Applications related to the following individual research announcement: RFA– EH–09–002 ‘‘Program to Expand State Public Health Laboratory Capacity for Newborn Bloodspot Screening (U01)’’. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Jane Suen, Dr.P.H., M.S., NCIPC, CDC, 4770 Buford Highway, NE., Mailstop F–62, Atlanta, Georgia 30341, Telephone: (770) 488–4281. The Director, Management Analysis and Services Office has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: April 24, 2009. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E9–10031 Filed 4–30–09; 8:45 am] BILLING CODE 4163–18–P BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Injury Prevention and Control, Initial Review Group (NCIPC, IRG) In accordance with section 10(a)(2) of the Federal Advisory Committee Act PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, May 18, 2009, 8 a.m. to May 18, 2009, 5 p.m., St. Gregory Hotel, 2033 M Street, NW., E:\FR\FM\01MYN1.SGM 01MYN1

Agencies

[Federal Register Volume 74, Number 83 (Friday, May 1, 2009)]
[Notices]
[Pages 20324-20325]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10034]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 https://www.fda.gov/cvm or https://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]
BILLING CODE 4160-01-S
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