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comments received, the draft guidance 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 

Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices 6451

after the course is filled. Registration at 

the site is not guaranteed but may be 

possible on a space available basis on 

the day of the public workshop 

beginning at 8 a.m. The cost of 

registration at the site is $80 payable to 

The University of Arkansas. If you need 

special accommodations due to a 

disability, please contact Steven C. 

Seideman (see Contact) at least 7 days 

in advance.

Registration Form Instructions: To 

register, please complete the form below 

and submit along with a check or money 

order for $75 payable to the ‘‘The 

University of Arkansas.’’ Mail to: 

Institute of Food Science & Engineering, 

University of Arkansas, 2650 North 

Young Ave., Fayetteville, AR 72704.

Name: ______________________

Affiliation: ____________________

Mailing Address: ____________________

City: ____________________ State:_____

Zip Code: ________

Phone: ( ) ________________

Fax: ( ) ________________

E-mail: ( ) _________________

Special Accommodations Required: 

____________________________________

Transcripts: Transcripts of the public 

workshop will not be available due to 

the format of this workshop. Course 

handouts may be requested at cost 

through the Freedom of Information 

Office (HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

12A–16, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page.

SUPPLEMENTARY INFORMATION: The FDA 

Southwest Regional Small Business 

Representative previously presented 

this workshop in Kansas City, MO on 

January 10 and 11, 2002 (66 FR 65976) 

and in Dallas, TX on April 14 and 15, 

2002 (67 FR 15211).

This public workshop is being held in 

response to the large volume of food 

labeling inquiries from small food 

manufacturers and startups originating 

from the area covered by the FDA 

Denver District Office. The Southwest 

Regional Small Business Representative 

presents these workshops to help 

achieve objectives set forth in section 

406 of the Food and Drug 

Administration Modernization Act of 

1997 (21 U.S.C. 393), which include 

working closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. This is consistent with the 

purposes of the Small Business 

Representative Program, which are in 

part to respond to industry inquiries, 

develop educational materials, sponsor 

workshops and conferences to provide 

firms, particularly small businesses, 

with firsthand working knowledge of 

FDA’s requirements and compliance 

policies. This workshop is also 

consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Public Law 104–121), as outreach 

activities by Government agencies to 

small businesses.

The goal of this public workshop is to 

present information that will enable 

manufacturers and regulated industry to 

better comply with labeling 

requirements, especially in light of 

growing concerns about obesity and 

food allergens. Information presented 

will be based on agency position as 

articulated through regulation, 

compliance policy guides, and 

information previously made available 

to the public. Topics to be discussed at 

the workshop include: (1) Mandatory 

label elements, (2) nutrition labeling 

requirements, (3) health and nutrition 

claims, (4) FDA’s allergen declaration 

policy, and (5) special labeling issues 

such as exemptions. FDA expects that 

participation in this public workshop 

will provide regulated industry with 

greater understanding of the regulatory 

and policy perspectives on food labeling 

and increase voluntary compliance.

Dated: February 1, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–2299 Filed 2–4–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Publication and Release of the 

National Response Plan

AGENCY: Department of Homeland 

Security.

ACTION: Notice.

SUMMARY: This Notice informs the 

public that the Department of Homeland 

Security (DHS) has developed and 

published the National Response Plan, 

which is now available to the public.

Authority: Homeland Security Act of 2002, 

Public Law 107–296; Homeland Security 

Presidential Directive -5, Management of 

Domestic Incidents.

FOR FURTHER INFORMATION CONTACT:

National Response Plan: Bob Shea, 

Operational Integration Staff, DHS, 

Washington, DC 20528, 202–282–9651 

or Robert.shea@dhs.gov. 

National Incident Management 

System: Gil Jamieson, National Incident 

Management System Integration Center, 

DHS/FEMA, Washington, DC 20472, 

202–646–4090, or 

Gil.Jamieson@dhs.gov.

SUPPLEMENTARY INFORMATION: Homeland 

Security Presidential Directive -5 

required the Secretary of Homeland 

Security to develop and administer a 

National Incident Management System 

and a National Response Plan. The 

National Incident Management System 

(NIMS), released in March 2004, 

established a unified and standardized 

approach within the United States for 

protecting citizens and managing 

homeland security incidents. The 

National Response Plan standardizes 

Federal incident management actions by 

integrating existing and formerly 

distinct processes. Using the 

comprehensive framework of the NIMS, 

the National Response Plan provides the 

structure and mechanisms for the 

coordination of Federal support to State, 

local, and tribal incident managers and 

for exercising direct Federal authorities 

and responsibilities. It is applicable to 

all Federal departments and agencies 

that may be requested to provide 

assistance or conduct operations in the 

context of actual or potential incidents 

of national significance. 

The purpose of the National Response 

Plan is to establish a comprehensive, 

national, all-hazards approach to 

domestic incident management across a 

spectrum of activities including 

prevention, preparedness, response, and 

recovery. The National Response Plan 

incorporates the best practices and 

procedures from various incident 

management disciplines—homeland 

security, emergency management, law 

enforcement, firefighting, hazardous 

materials response, public works, public 

health, emergency medical services, and 

responder and recovery worker health 

and safety—and integrates them into a 

unified coordinating structure. As such, 

it is intended to replace the Initial 

National Response Plan, the Federal 

Response Plan, the U.S. Government 

Domestic Terrorism Concept of 

Operations Plan, and the Federal 

Radiological Emergency Response Plan, 

all of which are currently in effect. 

The National Response Plan 

represents a true ‘‘national’’ framework 

in terms of both product and process. 

The National Response Plan 

development process included 

extensive vetting and coordination with 

Federal, State, local, and tribal agencies, 

nongovernmental organizations, privatesector entities, and the first-responder 

and emergency management 

communities across the country. The 

activation of the National Response Plan 

and its coordinating structures and 

protocols—either partially or fully—for 

specific incidents of national 

significance provides mechanisms for 

the coordination and implementation of