6448 Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency 

per Response 

Total Annual Responses Hours per Response Total Hours 

11.100 4,500 1 4,500 1 4,500

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section 

No. of

Recordkeepers

Annual

Frequency of 

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours 

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

Total 270,000

1There 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: 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 http://

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments. You can view comments 

FDA has received on the Internet at 

http://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 http://

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 http://

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 

Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices 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 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, 

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.

ACTION: 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 http://

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