Animal Feed Safety System: A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds; Notice of Public Meeting, 6448-6449 [05-2210]

Download as PDF 6448 Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section 11.100 1There Annual Frequency per Response No. of Respondents 4,500 Total Annual Responses 1 Hours per Response 4,500 Total Hours 1 4,500 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers Annual Frequency of Recordkeeping 11.10 2,500 1 2,500 20 45,000 11.30 2,500 1 2,500 20 45,000 11.50 4,500 1 4,500 20 90,000 11.300 4,500 1 4,500 20 90,000 21 CFR Section Total Annual Records Hours per Recordkeeper Total 1 There 270,000 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 1, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–2298 Filed 2–4–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003N–0312] Animal Feed Safety System: A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds; Notice of Public Meeting AGENCY: Total Hours Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting to discuss our progress on development of a comprehensive, risk-based Animal Feed Safety System (AFSS) describing how animal feeds (individual ingredients and mixed feeds) should be manufactured, distributed, and used to minimize risks to humans and animals. We are seeking comments and assistance in our consideration of this safety program to effectively minimize the hazards to public health posed by animal feed products. Date and Time: The public meting will be held on Tuesday, April 5, 2005, from 8 a.m. to 5 p.m., and Wednesday, April 6, 2005, from 8 a.m. to 12:15 p.m. VerDate jul<14>2003 21:04 Feb 04, 2005 Jkt 205001 You may submit written or electronic comments at any time, but they would be most helpful if received on or before March 4, 2005. Location: The public meeting will be held at The Crowne Plaza, 655 North 108th Ave., Omaha, NE 68154, 402– 496–0850. ADDRESSES: You may submit written comments 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.fda.gov/dockets/ecomments. Follow the instructions for submitting comments. You can view comments FDA has received on the Internet at https://www.fda.gov/ohrms/dockets/. Contacts: For General Information: Zoe Gill, Center for Veterinary Medicine (HFV– 226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453–6867, FAX: 240–453–6882, or e-mail: zoe.gill@fda.gov. For Information About Registration: Brenda Boateng, Center for Veterinary Medicine (HFV–220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453–6850, FAX: 240–453–6882, or e-mail: brenda.boateng@fda.gov. Registration: Registration forms are available on the Division of Dockets Management Web site at https:// www.accessdata.fda.gov/scripts/oc/ dockets/meetings/meetingdocket.cfm. Although there is no registration fee for this meeting, registration is required. Due to limited meeting space, and to permit the agency to adequately prepare for the meeting, early registration is PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 strongly encouraged. We are asking that registration occur by March 11, 2005. You may register by telephone, fax, or e-mail by contacting Brenda Boateng (see Contacts). If you need special accommodations due to a disability, please contact Toni Wooten at 301–595–0796 or by e-mail at toni.wooten@fda.gov at least 7 days in advance of the meeting. Transcripts: You may request a transcript of the meeting’s general session in writing from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A–16, Rockville, MD 20857. The transcript will not include the individual breakout sessions, although their summaries will be included in the general session transcript. The transcript of the public meeting will be available after the meeting, at a cost of 10 cents per page. You may also examine the transcript of the meeting at the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday and on the CVM Web site at https:// www.fda.gov/cvm. SUPPLEMENTARY INFORMATION: I. Background We envision the AFSS as an umbrella regulatory program aimed at protecting human and animal health, It is intended to cover the labeling, production, and distribution of all feed ingredients and mixed feeds at all stages of manufacture, distribution, and use. On September 23 and 24, 2003, we held a public meeting in Herndon, VA to discuss the AFSS. The public meeting included active participation of people E:\FR\FM\07FEN1.SGM 07FEN1 Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices representing consumers, animal feed processors, animal producers, and State and other Federal Government agencies. Following the meeting, we placed a number of documents in the FDA Docket named at the beginning of this notice. These documents included a transcript of the meeting, summaries of breakout discussion groups, presentations of invited speakers, and a summary of the meeting. We stated our view that an AFSS should be comprehensive and risk-based, and we have since drafted definitions for these terms and placed them in this Docket. Likewise, we created and placed in the Docket a listing of elements we felt would be essential for process control under an AFSS. After reviewing comments to these items in the Docket, we drafted the following framework for the AFSS, including the four major components we see as comprising the AFSS: • Component 1—Ingredients and the approval process. • Component 2—Limits for animal feed contaminants. • Component 3—Process control for the production of feed ingredients and mixed feed. • Component 4—Regulatory oversight. This new document has been added to our Web site and the Docket and will be discussed at the meeting. We also intend to discuss a draft risk-ranking model under development by the agency for determining the relative risks of the numerous hazards that may be present in animal feed. Your comments on our proposed framework, including Components 1 through 4, and any riskrelated topics would be most appreciated. Please submit all comments by March 4, 2005. II. Meeting We are holding the meeting in an effort to further gather information from you, our stakeholders, on the design of an effective, comprehensive, preventive, risk-based AFSS that is intended to help minimize risks associated with animal feeds. Resources and costs are important considerations in any such undertaking, and we are receptive to suggestions about how these can be controlled or used most effectively while focusing preventive efforts on important known and emerging health risks associated with animal feeds. We are particularly interested in your thoughts on the application of Hazard Analysis and Critical Control Point (HACCP) (mandatory or voluntary) to any or all segments of the industry, development of risk standards for contaminants, VerDate jul<14>2003 21:04 Feb 04, 2005 Jkt 205001 revising existing good manufacturing practices (GMPs) to make them more risk-based, development of GMP-type regulations and/or guidance for producers of feed ingredients and nonmedicated feeds, extending regulatory control to users of feed, and the role of State and first-party inspections. On the morning of the first day of the meeting, we will summarize the aforementioned documents placed in our docket, followed by breakout sessions in the afternoon to discuss each topic. Additionally, one group will be asked to discuss the perceived benefits of the AFSS. The breakout group(s) on risk analysis and risk-ranking is likely to be of greatest interest to meeting attendees who have a scientific background. If you are interested in participating in the breakout group on risk analysis and risk-ranking, please indicate this on your registration form. We will do our best to accommodate these requests. Discussions will be summarized in breakout group reports on the final day of the meeting. The meeting will wrap up with an open discussion and closing remarks. III. Comments Interested persons may submit written or electronic comments to the Division of Dockets Management (see ADDRESSES). Comments should be identified with the full title and the docket number found in brackets in the heading of this document. A copy of the received comments will be available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 28, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–2210 Filed 2–4–05; 8:45 am] BILLING CODE 4160–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D–0466] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing (VICH GL–37); Availability AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 ACTION: 6449 Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (#160) entitled ‘‘Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing’’ (VICH GL–37). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to establish recommendations for internationally harmonized repeatdose chronic toxicity testing. DATES: Submit written or electronic comments at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine (CVM), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. 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.fda.gov/dockets/ecomments. Comments should be identified with the full title of the guidance and the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Louis T. Mulligan, Center for Veterinary Medicine (HFV–153), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6984, email: lmulliga@cvm.fda.gov. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development E:\FR\FM\07FEN1.SGM 07FEN1

Agencies

[Federal Register Volume 70, Number 24 (Monday, February 7, 2005)]
[Notices]
[Pages 6448-6449]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2210]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0312]


Animal Feed Safety System: A Comprehensive Risk-Based Safety 
Program for the Manufacture and Distribution of Animal Feeds; Notice of 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss our progress on development of a comprehensive, 
risk-based Animal Feed Safety System (AFSS) describing how animal feeds 
(individual ingredients and mixed feeds) should be manufactured, 
distributed, and used to minimize risks to humans and animals. We are 
seeking comments and assistance in our consideration of this safety 
program to effectively minimize the hazards to public health posed by 
animal feed products.
    Date and Time: The public meting will be held on Tuesday, April 5, 
2005, from 8 a.m. to 5 p.m., and Wednesday, April 6, 2005, from 8 a.m. 
to 12:15 p.m. You may submit written or electronic comments at any 
time, but they would be most helpful if received on or before March 4, 
2005.
    Location: The public meeting will be held at The Crowne Plaza, 655 
North 108th Ave., Omaha, NE 68154, 402-496-0850.

ADDRESSES: You may submit written comments 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.fda.gov/dockets/ecomments. Follow the instructions for submitting 
comments. You can view comments FDA has received on the Internet at 
https://www.fda.gov/ohrms/dockets/.
    Contacts:
    For General Information: Zoe Gill, Center for Veterinary Medicine 
(HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-453-6867, FAX: 240-453-6882, or e-mail: zoe.gill@fda.gov.
    For Information About Registration: Brenda Boateng, Center for 
Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-453-6850, FAX: 240-453-6882, or 
e-mail: brenda.boateng@fda.gov.
    Registration: Registration forms are available on the Division of 
Dockets Management Web site at https://www.accessdata.fda.gov/scripts/
oc/dockets/meetings/meetingdocket.cfm. Although there is no 
registration fee for this meeting, registration is required. Due to 
limited meeting space, and to permit the agency to adequately prepare 
for the meeting, early registration is strongly encouraged. We are 
asking that registration occur by March 11, 2005. You may register by 
telephone, fax, or e-mail by contacting Brenda Boateng (see Contacts).
    If you need special accommodations due to a disability, please 
contact Toni Wooten at 301-595-0796 or by e-mail at toni.wooten@fda.gov 
at least 7 days in advance of the meeting.
    Transcripts: You may request a transcript of the meeting's general 
session in writing from the Freedom of Information Office (HFI-35), 
Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, 
MD 20857. The transcript will not include the individual breakout 
sessions, although their summaries will be included in the general 
session transcript. The transcript of the public meeting will be 
available after the meeting, at a cost of 10 cents per page. You may 
also examine the transcript of the meeting at the Division of Dockets 
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through 
Friday and on the CVM Web site at https://www.fda.gov/cvm.

SUPPLEMENTARY INFORMATION:

I. Background

    We envision the AFSS as an umbrella regulatory program aimed at 
protecting human and animal health, It is intended to cover the 
labeling, production, and distribution of all feed ingredients and 
mixed feeds at all stages of manufacture, distribution, and use.
    On September 23 and 24, 2003, we held a public meeting in Herndon, 
VA to discuss the AFSS. The public meeting included active 
participation of people

[[Page 6449]]

representing consumers, animal feed processors, animal producers, and 
State and other Federal Government agencies. Following the meeting, we 
placed a number of documents in the FDA Docket named at the beginning 
of this notice. These documents included a transcript of the meeting, 
summaries of breakout discussion groups, presentations of invited 
speakers, and a summary of the meeting. We stated our view that an AFSS 
should be comprehensive and risk-based, and we have since drafted 
definitions for these terms and placed them in this Docket. Likewise, 
we created and placed in the Docket a listing of elements we felt would 
be essential for process control under an AFSS. After reviewing 
comments to these items in the Docket, we drafted the following 
framework for the AFSS, including the four major components we see as 
comprising the AFSS:
     Component 1--Ingredients and the approval process.
     Component 2--Limits for animal feed contaminants.
     Component 3--Process control for the production of feed 
ingredients and mixed feed.
     Component 4--Regulatory oversight.
    This new document has been added to our Web site and the Docket and 
will be discussed at the meeting. We also intend to discuss a draft 
risk-ranking model under development by the agency for determining the 
relative risks of the numerous hazards that may be present in animal 
feed. Your comments on our proposed framework, including Components 1 
through 4, and any risk-related topics would be most appreciated. 
Please submit all comments by March 4, 2005.

II. Meeting

    We are holding the meeting in an effort to further gather 
information from you, our stakeholders, on the design of an effective, 
comprehensive, preventive, risk-based AFSS that is intended to help 
minimize risks associated with animal feeds.
    Resources and costs are important considerations in any such 
undertaking, and we are receptive to suggestions about how these can be 
controlled or used most effectively while focusing preventive efforts 
on important known and emerging health risks associated with animal 
feeds. We are particularly interested in your thoughts on the 
application of Hazard Analysis and Critical Control Point (HACCP) 
(mandatory or voluntary) to any or all segments of the industry, 
development of risk standards for contaminants, revising existing good 
manufacturing practices (GMPs) to make them more risk-based, 
development of GMP-type regulations and/or guidance for producers of 
feed ingredients and nonmedicated feeds, extending regulatory control 
to users of feed, and the role of State and first-party inspections.
    On the morning of the first day of the meeting, we will summarize 
the aforementioned documents placed in our docket, followed by breakout 
sessions in the afternoon to discuss each topic. Additionally, one 
group will be asked to discuss the perceived benefits of the AFSS. The 
breakout group(s) on risk analysis and risk-ranking is likely to be of 
greatest interest to meeting attendees who have a scientific 
background. If you are interested in participating in the breakout 
group on risk analysis and risk-ranking, please indicate this on your 
registration form. We will do our best to accommodate these requests.
    Discussions will be summarized in breakout group reports on the 
final day of the meeting. The meeting will wrap up with an open 
discussion and closing remarks.

III. Comments

    Interested persons may submit written or electronic comments to the 
Division of Dockets Management (see ADDRESSES). Comments should be 
identified with the full title and the docket number found in brackets 
in the heading of this document. A copy of the received comments will 
be available for public examination in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2210 Filed 2-4-05; 8:45 am]
BILLING CODE 4160-01-M

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