75236 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Notices

ADDRESSES: Please send four copies of

your comment (an original and three

copies) to: Docket No. 00–116–1,

Regulatory Analysis and Development,

PPD, APHIS, Suite 3C03, 4700 River

Road Unit 118, Riverdale, MD 20737–

1238.

Please state that your comment refers to

Docket No. 00–116–1.

You may read any comments that we

receive on this docket in our reading

room. The reading room is located in

room 1141 of the USDA South Building,

14th Street and Independence Avenue

SW., Washington, DC. Normal reading

room hours are 8 a.m. to 4:30 p.m.,

Monday through Friday, except

holidays. To be sure someone is there to

help you, please call (202) 690–2817

before coming.

APHIS documents published in the

Federal Register, and related

information, including the names of

organizations and individuals who have

commented on APHIS rules, are

available on the Internet at http://

www.aphis.usda.gov/ppd/rad/

webrepor.html.

You may request a copy of the draft

guideline ‘‘Pharmacovigilance of

Veterinary Medicinal Products:

Management of Adverse Event Reports’’

by writing to or calling the person listed

under FOR FURTHER INFORMATION

CONTACT.

FOR FURTHER INFORMATION CONTACT: Dr.

Albert P. Morgan, Center for Veterinary

Biologics-Licensing and Policy

Development, VS, APHIS, 4700 River

Road Unit 148, Riverdale, MD 20737–

1231; phone (301) 734–8245.

SUPPLEMENTARY INFORMATION: The

International Cooperation on

Harmonization of Technical

Requirements for the Registration of

Veterinary Medicinal Products (VICH) is

a unique project conducted under the

auspices of the International Office of

Epizootics (OIE, the Office International

des Epizooties) that brings together the

regulatory authorities of the European

Union, Japan, and the United States and

representatives from the animal health

industry in the three regions. The

purpose of VICH is to harmonize

technical requirements for veterinary

products (both drugs and biologics).

Regulatory authorities and industry

experts from Australia and New Zealand

participate in an observer capacity. The

World Federation of the Animal Health

Industry (COMISA, the Confederation

Mondiale de L’Industrie de la Sante

Animale) provides the secretarial and

administrative support for VICH

activities.

The United States Government is

represented in VICH by the Food and

Drug Administration (FDA) and the

Animal and Plant Health Inspection

Service (APHIS). The FDA provides

expertise regarding veterinary drugs,

while APHIS fills a corresponding role

for veterinary biological products. As

VICH members, APHIS and FDA

participate in efforts to enhance

harmonization and have expressed their

commitment to seeking scientifically

based harmonized technical

requirements for the development of

veterinary drugs and biological

products. One of the goals of

harmonization is to identify and reduce

the differences in technical

requirements for veterinary drugs and

biologics among regulatory agencies in

different countries.

The draft document that is the subject

of this notice, ‘‘Pharmacovigilance of

Veterinary Medicinal Products:

Management of Adverse Event Reports’’

(VICH Topic GL24), has been made

available by the VICH Steering

Committee for comments by interested

parties. The draft guideline, which

defines pharmacovigilance of veterinary

medicinal products as the detection and

investigation of the effects of veterinary

medicinal products, mainly aimed at

safety and efficacy in animals and safety

in people exposed to these products,

deals with the spontaneous reporting

system for identification of possible

adverse events following the use of

marketed veterinary medicinal

products. Because the draft guideline

applies to some veterinary biological

products regulated by APHIS under the

Virus-Serum-Toxin Act—particularly

with regard to adverse event reports—

we are requesting comments on its

provisions so that we may include any

relevant public input on the draft in the

Agency’s comments to the VICH

Steering Committee.

The draft document reflects current

APHIS thinking on the generation and

submission of adverse event reports

concerning veterinary biological

products. (The draft guideline refers to

such products as ‘‘veterinary medicinal

products.’’) In accordance with the

VICH process, once a final draft of

‘‘Pharmacovigilance of Veterinary

Medicinal Products: Management of

Adverse Event Reports’’ has been

approved, the guideline will be

recommended for adoption by the

regulatory bodies of the European

Union, Japan, and the United States. As

with all VICH documents, the final

guideline will not create or confer any

rights for or on any person and will not

operate to bind APHIS or the public.

Further, the VICH guidelines

specifically provide for the use of

alternative approaches if those

approaches satisfy applicable regulatory

requirements.

Ultimately, APHIS intends to consider

the VICH Steering Committee’s final

guidance document for use by U.S.

veterinary biologics licensees,

permittees, and applicants. In addition,

APHIS will consider its use as a basis

for the investigation of adverse event

reports that raise questions regarding

the purity, safety, potency, or efficacy of

veterinary biological products under 9

CFR 116.5. APHIS may also use the final

guidance document as the basis for

proposed additions or amendments to

its regulations in 9 CFR chapter I,

subchapter E (Viruses, Serums, Toxins,

and Analogous Products; Organisms and

Vectors). Because we anticipate that

applicable provisions of the final

version of ‘‘Pharmacovigilance of

Veterinary Medicinal Products:

Management of Adverse Event Reports’’

may be introduced into APHIS’

veterinary biologics regulatory program

in the future, we encourage your

comments on the draft version.

Authority: 21 U.S.C. 151 et seq.

Done in Washington, DC, this 22nd day of

November 2000.

Craig A. Reed,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 00–30599 Filed 11–30–00; 8:45 am]

BILLING CODE 3410–34–U

DEPARTMENT OF AGRICULTURE

Forest Service

Helena National Forest Travel Plan,

Helena National Forest, Broadwater,

Lewis and Clark, Meagher and Powell

Counties, Montana

AGENCY: Forest Service, USDA.

ACTION: Notice; intent to prepare

Environmental Impact Statement.

SUMMARY: The Forest Service will

prepare an Environmental Impact

Statement on a proposal to update travel

management and approximately 390,000

acres of National Forest lands on the

Townsend, Helena and Lincoln Ranger

Districts. These 390,000 acres are the

remaining lands that have not been

subject to recent motorized travel

management decisions or have

decisions pending. The project covers

three separate areas in the Blackfoot,

Divide/Little Blackfoot and the South

Belts areas. Motorized travel activities

in these areas are presently subject to

the June 30, 1994 Helena National

Forest Travel Plan.

DATES: Comments concerning the

proposal and scope of the analysis

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Notices 75237

should be received in writing by January

5, 2001.

ADDRESSES: Send written comments to

USDA Forest Service, Helena National

Forest, 2880 Skyway Drive, Helena, MT

59601.

FOR FURTHER INFORMATION CONTACT:

Charlie Hester, Team Leader, (406) 362–

4265.

SUPPLEMENTARY INFORMATION: The

current Travel Management Plan for the

Helena National Forest was approved in

June 1994. Since then, site-specific

travel management has been completed

or is nearing completion on

approximately 500,000 acres. These

recent efforts have generally prohibited

cross-country motorized travel by

restricting motorized vehicles, except

snowmobiles, to designated routes.

These areas are not affected by this

proposal.

The remaining areas that do not have

recent decisions or decisions pending

are the focus of this proposal. The

proposal retains current area and route

closures and restrictions except where

specific changes are identified. The

major change proposed is to limit

motorized vehicles, except

snowmobiles, to designated Forest

Development Road and Forest

Developmental trails. Designations will

specify the classes of vehicles permitted

and the authorized period of use.

Motorized use has increased

substantially over most areas in the past

10–15 years as off-highway vehicles

have become more stable, maneuverable

and powerful and riders have become

more skilled. This increased use has

resulted in the creation of networks of

user-created routes often resulting in

undesirable impacts to soils,

watersheds, vegetation and wildlife

resources. Conflicts between motorized

and non-motorized users have also

become more common and intense. The

intent of this proposal is to provide

opportunities for motorized activities

without duly impacting other forest

resources or uses.

The Forest Service is seeking

information and scoping comments

from Federal, State and local agencies as

well as individuals and organizations

that may be interested in, or affected by,

the proposed action. The Forest Service

invites written comments and

suggestions related to the proposal.

Information received will be used in

preparation of the Draft Environmental

Impact Statement. For the most effective

use, comments should be submitted to

the Forest Service within 30 days from

the date of publication of the Notice in

the Federal Register.

The Forest Service expects to release

a Draft Environmental Impact Statement

in August 2001. A Final Environmental

Impact Statement and Record of

Decision are expected in April 2002.

The comment period on the Draft

Environmental Impact Statement will be

45 days from the date the

Environmental Protection Agency

publishes the notice of availability in

the Federal Register.

The Forest Service believes it is

important to give reviewers notice at

this early stage of several court rulings

related to public participation in the

environmental review process. First,

reviewers of Draft Environmental

Impact Statements must structure their

participation in the environmental

review of the proposal so that it is

meaningful and alerts an agency to the

reviewer’s position and contentions.

(Vermont Yankee Nuclear Power Corp.

v. NRDC, 435 U.S. 519, 553 (1978).)

Also, environmental objections that

could be raised at the Draft

Environmental Impact Statement stage

but that are not raised until after

completion of the Final Environmental

Impact Statement may be waived or

dismissed by the courts. (Wisconsin

Heritage, Inc. v. Harris, 490 F. Supp.

1334, 1338 (E.D. Wis. 1980).) Because of

these court rulings, it is very important

that those interested in this proposed

action participate by the close of the 45-

day comment period so that substantive

comments and objections are made

available to the Forest Service at a time

when it can meaningfully consider them

and respond to them in the Final

Environmental Impact Statement.

To assist the Forest Service in

identifying and considering issues and

concerns on the proposed action,

comments on the Draft Environmental

Impact Statement should be as specific

as possible. It is also helpful if

comments refer to specific pages or

chapters of the draft statement.

Comments may also address the

adequacy of the Draft Environmental

Impact Statement or the merits of the

alternatives formulated and discussed in

the statement. (Reviewers may wish to

refer to the Council on Environmental

Quality Regulations for implementing

the procedural provisions of the

National Environmental Policy Act at 40

CFR 1503.3 in addressing these points.).

The responsible official is Thomas J.

Clifford, Forest Supervisor, Helena

National Forest, 2880 Skyway Drive,

Helena, MT 59601.

Thomas J. Clifford,

Helena Forest Supervisor.

[FR Doc. 00–30584 Filed 11–30–00; 8:45 am]

BILLING CODE 3410–11–M

DEPARTMENT OF AGRICULTURE

Grain Inspection, Packers and

Stockyards Administration

[00–04–A]

Opportunity for Designation in the

Fremont (NE), Muncie (IN), and West

Lafayette (IN) Areas, and Request for

Comments on the Official Agencies

Serving These Areas

AGENCY: Grain Inspection, Packers and

Stockyards Administration (GIPSA).

ACTION: Notice.

SUMMARY: The designations of the

official agencies listed below will end in

August 2001. GIPSA is asking persons

interested in providing official services

in the areas served by these agencies to

submit an application for designation.

GIPSA is also asking for comments on

the services provided by these currently

designated agencies:

• East Indiana Grain Inspection, Inc.

(East Indiana)

• Fremont Grain Inspection

Department, Inc. (Fremont); and

• Titus Grain Inspection, Inc. (Titus).

DATES: Applications and comments

must be postmarked or sent by

telecopier (FAX) on or before December

31, 2000.

ADDRESSES: Submit applications and

comments to USDA, GIPSA, Janet M.

Hart, Chief, Review Branch, Compliance

Division, STOP 3604, Room 1647–S,

1400 Independence Avenue, SW.,

Washington, DC 20250–3604; FAX 202–

690–2755. If an application is submitted

by FAX, GIPSA reserves the right to

request an original application. All

applications and comments will be

made available for public inspection at

Room 1647–S, 1400 Independence

Avenue, SW., during regular business

hours.

FOR FURTHER INFORMATION CONTACT:

Janet M. Hart at 202–720–8525, e-mail

janhart@gipsadc.usda.gov.

SUPPLEMENTARY INFORMATION: This

Action has been reviewed and

determined not to be a rule or regulation

as defined in Executive Order 12866

and Departmental Regulation 1512–1;

therefore, the Executive Order and

Departmental Regulation do not apply

to this Action.

Section 7(f)(1) of the United States

Grain Standards Act, as amended (Act),

authorizes GIPSA’s Administrator to

designate a qualified applicant to

provide official services in a specified

area after determining that the applicant

is better able than any other applicant

to provide such official services.