This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

13696

Vol. 66, No. 45

Wednesday, March 7, 2001

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 01–011–1]

Public Meeting; Veterinary Biologics

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice of public meeting on

biologics for cancer diagnosis,

prevention, and immunotherapy.

SUMMARY: We are issuing this notice to

inform interested individuals, including

producers and users of human and

veterinary biological products, that we

will be holding a public meeting to

discuss regulatory and policy issues

related to the manufacture, distribution,

and use of biological products for the

diagnosis, prevention, and treatment of

cancer in humans and animals. The

meeting is being organized by the Food

and Drug Administration, Center for

Biologics Evaluation and Research, and

the Animal and Plant Health Inspection

Service, Veterinary Services, Center for

Veterinary Biologics. The Institute for

International Cooperation in Animal

Biologics is sponsoring the meeting.

DATES: The public meeting will be held

on Thursday and Friday, April 12 and

13, 2001, from 8 a.m. to approximately

5 p.m.

ADDRESSES: The public meeting will be

held in the Scheman Building at the

Iowa State Center, Iowa State

University, Ames, IA.

FOR FURTHER INFORMATION CONTACT: For

further information about the meeting,

contact Dr. Dave M. Dusek, Center for

Veterinary Biologics, Veterinary

Services, APHIS, 510 South 17th Street,

Suite 104, Ames, IA 50010–8197; phone

(515) 232–5785, fax (515) 232–7120, or

e-mail Dave.M.Dusek@usda.gov. For

registration information, contact Ms.

Dawne Buhrow at the Institute for

International Cooperation in Animal

Biologics, room 2160, College of

Veterinary Medicine, Iowa State

University, Ames, IA 50011; phone

(515) 294–7632, fax (515) 294–8259, or

e-mail iicab@iastate.edu. Information is

also available online at http://

www.vetmed.iastate.edu/iicab/

cancerbiologics.htm.

SUPPLEMENTARY INFORMATION: The

Animal and Plant Health Inspection

Service (APHIS) specifies licensing

requirements for veterinary biological

products for the treatment of animals in

title 9 of the Code of Federal

Regulations, parts 101 to118. Veterinary

biological products include, but are not

limited to, viruses, serums, toxins

(except antibiotics), immunostimulants,

cytokines, diagnostic components, and

analogous products that are intended for

use in the treatment of animals and that

act primarily through the direct

stimulation, supplementation,

enhancement, or modulation of the

immune system or immune response.

To date, most cancer biologics licensed

by APHIS have been conventional in

design. However, APHIS anticipates

receiving applications for licenses to

produce veterinary biological products

intended for use in the diagnosis,

prevention, or treatment of cancer that

are based on advances in biotechnology.

The Food and Drug Administration

(FDA) regulates the production of

biologics for use in humans under its

regulations in title 21 of the Code of

Federal Regulations. Within the FDA,

the Center for Biologics Evaluation and

Research has received applications for

licensure of biologics for the diagnosis,

prevention, or treatment of cancer.

To provide a forum for the discussion

of regulatory and policy issues related to

the manufacture, distribution, and use

of biological products intended for use

in the diagnosis, prevention, or

treatment of cancer, APHIS and FDA are

organizing a public meeting. This public

meeting, which is sponsored by the

Institute for International Cooperation

in Animal Biologics, is scheduled for

April 12–13, 2001, will provide an

opportunity for the exchange of

information and discussion of issues of

common concern among APHIS and

FDA representatives; producers and

users of biological products intended for

use in the diagnosis, prevention, or

treatment of cancer; and other interested

persons. The public meeting will begin

at 8 a.m. and is scheduled to end at 5

p.m. each day.

Information regarding the meeting

and registration instructions may be

obtained from the persons listed under

FOR FURTHER INFORMATION CONTACT.

Done in Washington, DC, this 1st day of

March 2001.

Bobby R. Acord,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 01–5591 Filed 3–6–01; 8:45 am]

BILLING CODE 3410–34–U

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 97–093–6]

Commercially Produced Official

Identification Eartags and Backtags for

Sheep and Goats

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are giving notice that the

Animal and Plant Health Inspection

Service has established a contact office

for companies that wish to produce

official identification eartags and

backtags for sheep and goats. This office

will advise companies on production

standards necessary for eartags and

backtags to qualify as the official

identification that is required for certain

sheep and goats under our regulations.

FOR FURTHER INFORMATION CONTACT: Dr.

Diane Sutton, National Scrapie Program

Coordinator, National Animal Health

Programs Staff, VS, APHIS, 4700 River

Road Unit 43, Riverdale, MD 20737–

1231; (301) 734–6954.

SUPPLEMENTARY INFORMATION: Scrapie is

a degenerative and eventually fatal

disease affecting the central nervous

systems of sheep and goats. To control

the spread of scrapie within the United

States, the Animal and Plant Health

Inspection Service (APHIS), U.S.

Department of Agriculture (USDA),

administers regulations at 9 CFR part

79, which restrict the interstate

movement of certain sheep and goats.

APHIS also has regulations at 9 CFR

part 54, which describe a voluntary

scrapie control program.

These regulations require that, in

some circumstances, certain sheep and

Federal Register / Vol. 66, No. 45 / Wednesday, March 7, 2001 / Notices 13697

goats must be either individually

identified, or identified with their

premises of origin. Eartags and backtags

are two of the most common devices for

accomplishing the required

identification. As APHIS continues to

revise and expand its scrapie programs,

we anticipate that the demand for

eartags and backtags for official

identification will increase over the next

few years. Federal and State agencies,

accredited veterinarians, and sheep and

goat flock owners will be looking for

commercial sources to supply the

needed eartags and backtags.

To assist interested companies that

wish to produce eartags and backtags for

sheep and goats, APHIS has identified

the office of the National Scrapie

Program Coordinator as the contact

point for companies to obtain advice on

the production standards eartags and

backtags must meet to qualify as official

identification in accordance with our

regulations. Further details on

production standards for eartags and

backtags may be obtained from the

office identified in the FOR FURTHER

INFORMATION CONTACT section above.

This office will also review sample tags

for suitability and approve companies to

produce official identification eartags

and backtags.

In general, tags may be plastic or

metal and must be an appropriate size

for use in sheep and goats. Tags must be

able to legibly accommodate any

required alphanumeric sequences to

identify individual animals or their

premises. Tags must resist removal and

must be difficult to place on another

animal once removed, but need not be

tamper-proof. Tags must be readily

distinguishable as USDA official sheep

and goat tags, must carry the

alphanumeric sequences, symbols, or

logos specified by APHIS, and must

have a means of discouraging

counterfeiting, such as use of a unique

copyrighted logo or trade mark.

Done in Washington, DC, this 1st day of

March 2001.

Bobby R. Acord,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 01–5589 Filed 3–6–01 8:45am]

BILLING CODE 3410–34–P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 01–009–1]

Control of Rabies in Wildlife; Request

for Public Involvement

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: The Animal and Plant Health

Inspection Service’s Wildlife Services

program is soliciting public

involvement in the planning of a

proposed cooperative program to stop

the spread of rabies in the States of New

York, Ohio, Texas, Vermont, and West

Virginia. A small portion of

northeastern New Hampshire and the

western counties in Pennsylvania that

border Ohio could also be included in

these control efforts. In addition,

Wildlife Services may cooperate in

smaller scale oral rabies vaccine projects

in the States of Florida, Massachusetts,

Maryland, New Jersey, Virginia, and

Alabama. The information received in

response to this notice will be

considered during the planning of the

proposed program and development of

an environmental assessment that will

be prepared in accordance with the

National Environmental Policy Act.

DATES: We invite you to comment on

this notice. We will consider all

comments that we receive by April 6,

2001.

ADDRESSES: Please send four copies of

your comment (an original and three

copies) to: Docket No. 01–009–1,

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. 01–009–1.

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 dockets, are

available on the Internet at http://

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

webrepor.html.

FOR FURTHER INFORMATION CONTACT: Mr.

Dennis Slate, Rabies Program

Coordinator, Wildlife Services, APHIS,

59 Chennell Drive, Suite 7, Concord, NH

03301–8548; phone (603) 223–6832.

SUPPLEMENTARY INFORMATION: Rabies is

an acute, fatal viral disease of mammals

most often transmitted through the bite

of a rabid animal. The disease can be

effectively prevented in humans and

domestic animals, but abundant and

widely distributed reservoirs among

wild mammals complicate rabies

control. The vast majority of rabies cases

reported to the Centers for Disease

Control and Prevention (CDC) each year

occur in raccoons, skunks, bats, foxes,

and other wild animals. Domestic

animals account for less than 10 percent

of the reported rabies cases, with cats,

dogs, and cattle among those most often

reported.

Public health importance of rabies.

Over the last 100 years, the rabies

situation in the United States has

changed dramatically. About 90 percent

or greater of all animal cases reported

annually to CDC now occur in wildlife,

whereas before 1960 the majority of

cases were reported in domestic

animals. The principal rabies hosts

today are wild carnivores and bats. The

number of rabies-related human deaths

in the United States has declined from

more than 100 annually at the beginning

of the 20th century to an average of one

or two people per year in the 1990’s.

Modern prophylaxis, which consists of

a series of vaccine injections given to

people who have been exposed, has

proven nearly 100 percent successful in

preventing mortality when administered

promptly after exposure. In the United

States, human fatalities associated with

rabies occur in people who fail to seek

timely medical assistance, usually

because they were unaware of their

exposure.

Although human rabies deaths are

rare, the estimated public health costs

associated with disease detection,

prevention, and control have risen,

exceeding $300 million annually. These

costs include the vaccination of

companion animals, animal control

programs, maintenance of rabies

laboratories, and medical costs, such as

those incurred for exposure case

investigations and rabies post-exposure

prophylaxis (PEP).

Accurate estimates of these

expenditures are not available.

Although the number of PEP’s given in

the United States each year is unknown,

it is estimated to be about 40,000. When

rabies becomes epizootic (epidemics in

animals) or enzootic (i.e., present in an

area over time but at low case