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 

6450 Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices 

among regulatory agencies in different 

countries.

FDA has actively participated in the 

International Conference on 

Harmonisation of Technical 

Requirements for Approval of 

Pharmaceuticals for Human Use for 

several years to develop harmonized 

technical requirements for the approval 

of human pharmaceutical and biological 

products among the European Union, 

Japan, and the United States. The VICH 

is a parallel initiative for veterinary 

medicinal products. The VICH is 

concerned with developing harmonized 

technical requirements for the approval 

of veterinary medicinal products in the 

European Union, Japan, and the United 

States, and includes input from both 

regulatory and industry representatives.

The VICH Steering Committee is 

composed of member representatives 

from the European Commission, 

European Medicines Evaluation Agency; 

European Federation of Animal Health; 

Committee on Veterinary Medicinal 

Products; the U.S. FDA; the U.S. 

Department of Agriculture; the Animal 

Health Institute; the Japanese Veterinary 

Pharmaceutical Association; the 

Japanese Association of Veterinary 

Biologics; and the Japanese Ministry of 

Agriculture, Forestry and Fisheries.

Four observers are eligible to 

participate in the VICH Steering 

Committee: One representative from the 

government of Australia/New Zealand, 

one representative from the industry in 

Australia/New Zealand, one 

representative from the government of 

Canada, and one representative from the 

industry of Canada. The VICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation for Animal Health (IFAH). 

An IFAH representative also 

participates in the VICH Steering 

Committee meetings.

II. Guidance on Repeat-Dose Chronic 

Toxicity Testing

In the Federal Register of October 23, 

2003 (68 FR 60703), FDA published the 

notice of availability of the VICH draft 

guidance, giving interested persons 

until November 24, 2003, to submit 

comments. After consideration of 

comments received, the draft guidance 

was changed in response to the 

comments and submitted to the VICH 

Steering Committee. At a meeting held 

on May 3, 2004, the VICH Steering 

Committee endorsed the final guidance 

for industry, VICH GL–37. This VICH 

guidance is one of a series of guidances 

developed to facilitate the mutual 

acceptance of safety data necessary for 

the determination of acceptable daily 

intakes for veterinary drug residues in 

human food. This guidance was 

developed after consideration of the 

current practices for evaluating 

veterinary drug residues in human food 

in the European Union, Japan, the 

United States, Australia, New Zealand, 

and Canada. It also took account of 

available data from subchronic and 

chronic toxicity studies.

Information collection is covered 

under the Office of Management and 

Budget (OMB) control number 0910–

0032.

III. Significance of Guidance

This document, developed under the 

VICH process, has been revised to 

conform to FDA’s good guidance 

practices regulation (21 CFR 10.115). 

For example, the document has been 

designated ‘‘guidance’’ rather than 

‘‘guideline.’’ Because guidance 

documents are not binding, mandatory 

words such as ‘‘must,’’ ‘‘shall,’’ and 

‘‘will’’ in the original VICH document 

have been substituted with ‘‘should.’’

Similarly, words such as ‘‘require’’ or 

‘‘requirement’’ have been replaced by 

‘‘recommend’’ or ‘‘recommendation’’ as 

appropriate to the context.

The VICH guidance (#160) is 

consistent with the agency’s current 

thinking on the safety of residues of 

veterinary drugs in human foods. This 

guidance does not create or confer any 

rights for or on any person and will not 

operate to bind FDA or the public. An 

alternative method may be used as long 

as it satisfies the requirements of 

applicable statutes and regulations.

IV. Comments

As with all of FDA’s guidances, the 

public is encouraged to submit written 

or electronic comments pertinent to this 

guidance. FDA will periodically review 

the comments in the docket and, where 

appropriate, will amend the guidance. 

The agency will notify the public of any 

such amendments through a notice in 

the Federal Register.

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

Copies of the guidance document 

entitled ‘‘Studies to Evaluate the Safety 

of Residues of Veterinary Drugs in 

Human Food: Repeat-Dose (Chronic) 

Toxicity Testing’’ (VICH GL–37) may be 

obtained on the Internet from the CVM 

home page at http://www.fda.gov/cvm.

Dated: January 25, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–2266 Filed 2–4–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

University of Arkansas/Food and Drug 

Administration Food Labeling; Public 

Workshop

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice of public workshops.

SUMMARY: The Food and Drug 

Administration (FDA), Office of 

Regulatory Affairs (ORA), Southwest 

Regional Small Business Representative 

Program (SWR SBR), in collaboration 

with The University of Arkansas (UA), 

is announcing a public workshop 

entitled ‘‘UA/FDA Food Labeling 

Workshop.’’ This public workshop is 

intended to provide information about 

FDA food labeling regulations and other 

related subjects to the regulated 

industry, particularly small businesses 

and startups.

Date and Time: This public workshop 

will be held on April 5, 2005, from 8 

a.m. to 5 p.m., and on April 6, 2005, 

from 8 a.m. to 3 p.m.

Location: The public workshop will 

be held at the Continuing Education 

Center in Fayetteville, AR, located 

downtown (2 East Center St.).

Contact: Steven C. Seideman, 2650 

North Young Ave., Institute of Food 

Science & Engineering, University of 

Arkansas, Fayetteville, AR 72704, 479–

575–4221, FAX: 479–575–2165, or email: seideman@uark.edu.

For information on accommodation 

options, contact Steven C. Seideman 

(see Contact).

Registration: Registration by March 

21, 2005, is encouraged. The University 

of Arkansas has a $75 registration fee to 

cover the cost of facilities, materials, 

speakers, and breaks. Seats are limited, 

please submit your registration as soon 

as possible. Course space will be filled 

in order of receipt of registration. Those 

accepted into the course will receive 

confirmation. Registration will close