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

20476

Vol. 60, No. 80

Wednesday, April 26, 1995

AGENCY FOR INTERNATIONAL

DEVELOPMENT

Notice of Partially Closed Meeting

Committee: Malaria Vaccine Program

Advisory Committee.

Date and Location: TvT Conference

Room, 1601 North Kent Street, Suite

1104, Arlington, VA 22209.

1. April 27, 9 am–1 pm, (open session)

2. April 27, 1 pm–2:00 pm, (closed

session)

3. April 27, 2 pm–5:00 pm, (open

session)

Agenda: The committee will (1)

review progress towards malaria vaccine

development by USAID-funded and

other invited investigators and (2)

review procurement actions, both

current and planned. Closed Meeting:

Portions of the meeting are closed under

exemption 9(B) of 5 U.S.C. 552(b) to

discuss proposals, scopes of work, cost

estimates, and other sensitive

procurement information. Disclosures of

such information would be likely to

significantly frustrate implementation of

current and futures procurement by

USAID.

FOR FURTHER INFORMATION CONTACT:

Steve Landry, Ph.D., Malaria Vaccine

Development Program, USAID Office of

Health and Nutrition, (SA–18 Room

1238), Washington, DC 20523–1817,

(703) 875–4508. John Tomaro, Chief,

Environmental Health Division, Office

of Health and Nutrition, Center for

Population, Health and Nutrition,

Bureau for Global Programs, Field

Support and Research.

Dated: April 21, 1995.

Mike Kitay,

Office of the General Counsel.

Charge to the Scientific Consultants Group

April 27, 1995.

The Scientific Consultants Group (SCG) is

charged with providing USAID with advice

regarding its efforts to develop vaccines

against malaria. During this meeting, the SCG

is requested to make comments and

recommendations in the following areas:

(1) The role of the SCG

(2) The MVDP progress on:

• MAP Initiative

• MSP–1 Initiatives

• MVDP Primate Program

• Field Studies in Kenya

(3) The appropriateness of MVDP plans for

new activities:

• SERA Initiative

• AMA–1 Initiative

(4) The MVDP processes for selecting and

developing new antigens

(5) The coordination among USAID/TDR/

CEC

(6) The projected future scope and direction

of the MVDP

USAID-Malaria Vaccine Development

Program, Meeting of the Scientific

Consultants Group

April 27, 1995.

9:00 a.m. to 5 p.m.

• Welcome—Representative of the Office

of Health and Nutrition.

• Announcements/Introductions—Dr.

Steve Landry.

• Review of Agenda—Dr. Steve Landry/Dr.

Robin Powell.

• Approval of Winter ’94 Minutes—Dr.

Robin Powell/SCG Members.

• Review of the Role of the SCG—Dr. Steve

Landry/Dr. Robin Powell.

• Discussion and Comment—SCG

Members.

• Charge to the SCG—John Tomaro/Dr.

Robin Powell.

Coffee Break

• MVDP Update.

Current Initiatives-Overview—Dr. Steve

Landry

MAP Initiative—Dr. Carter Diggs

MSP–1 Initiatives—Dr. Carter Diggs

MVDP Primate Program—Dr. Steve Landry

Field Studies in Kenya—Dr. Steve Landry

Discussion and Comment—SCG Members

New Initiatives

SERA Initiative—Dr. Carter Diggs

AMA-1 Initiative—Dr. Carter Diggs

Discussion and Comment—SCG Members

Lunch

• MVDP process for selecting developing

new antigens (closed session—Drs. Landry

and Diggs.

• Discussion and Comment (closed

session)—SCG Members.

• MVDP/TDR/CEC Coordination—Dr.

Steve Landry.

• Discussion and Comment—SCG

Members.

• Future directions/priorities for the

MVDP—Drs. Landry and Diggs/SCG

Members.

• Discussion and Comment—SCG

Members.

• Deliberations, Conclusions and

Recommendations—SCG Members.

• Debriefing—SCG/David Oot.

• Plans for the next meeting.

[FR Doc. 95–10269 Filed 4–25–95; 8:45 am]

BILLING CODE 6116–01–M

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 95–031–1]

Availability of Environmental

Assessment and Finding of No

Significant Impact

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are advising the public

that the Animal and Plant Health

Inspection Service has prepared an

environmental assessment and a finding

of no significant impact for the issuance

of a conditional veterinary biological

product license. A risk analysis, which

forms the basis for the environmental

assessment, has led us to conclude that

issuance of this conditional license will

not have a significant impact on the

quality of the human environment.

Based on our finding of no significant

impact, we have determined that an

environmental impact statement need

not be prepared.

ADDRESSES: Copies of the environmental

assessment and finding of no significant

impact may be obtained by writing to

the person listed under FOR FURTHER

INFORMATION CONTACT. Please refer to the

docket number of this notice when

requesting copies. Copies of the

environmental assessment and finding

of no significant impact (as well as the

risk analysis with confidential business

information removed) are also available

for public inspection at USDA, room

1141, South Building, 14th Street and

Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing to

inspect those documents are requested

to call ahead on (202) 690–2817 to

facilitate entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr.

Jeanette Greenberg, Veterinary

Biologics, BBEP, APHIS, 4700 River

Road Unit 148, Riverdale, MD 20737–
Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices 20477

1237; telephone (301) 734–8400; fax

(301) 734–8910.

SUPPLEMENTARY INFORMATION: A

veterinary biological product regulated

under the Virus-Serum-Toxin Act (21

U.S.C. 151 et seq.) must be shown to be

pure, safe, potent, and efficacious before

a veterinary biological product license

may be issued. The regulations in 9 CFR

part 102 regarding the licensing of

biological products provide that a

conditional veterinary biological

product license may be issued to meet

an emergency situation, limited market,

local situation, or other special

circumstance. The special circumstance

addressed here is the current raccoon

rabies epizootic in the United States.

The product being issued a conditional

license is intended for vaccinating

raccoons against rabies. No other

licensed product is currently available

for this purpose. The vaccination of

raccoons is proposed to limit the further

spread of the raccoon rabies epizootic,

and to prevent the spread of rabies to

domestic animals and to humans.

Conditionally licensed products are

required to be pure and safe, and have

a reasonable expectation of efficacy.

In determining whether to issue a

conditional license for the veterinary

biological product referenced in this

notice, the Animal and Plant Health

Inspection Service (APHIS) conducted a

risk analysis to assess the product’s

potential effects on the safety of

animals, public health, and the

environment. Based on that risk

analysis, APHIS has prepared an

environmental assessment. APHIS has

concluded that issuance of a conditional

veterinary biological product license for

the veterinary biological product

referenced in this notice will not

significantly affect the quality of the

human environment. Based on the

finding of no significant impact, we

have determined that there is no need

to prepare an environmental impact

statement.

An environmental assessment and a

finding of no significant impact have

been prepared for the issuance of a

conditional veterinary biological

product license for the following

veterinary biological product: Rabies

Vaccine, Live Vaccinia Vector; Code

1901.R0; to be issued to Rhone Merieux,

Inc., Establishment License No. 298.

This recombinant rabies vaccine is

intended for vaccinating raccoons

against rabies, and is not intended for

use in pets. The conditional license

restricts the use of this product to State

or Federal Government agencies

administering wildlife rabies control

programs. The availability of the

recombinant rabies vaccine for use in

rabies control programs may be useful

in limiting the spread of the current

rabies epizootic in the United States.

A conditional license has been issued

on the basis that the product has been

demonstrated to be pure and safe, and

to have a reasonable expectation of

efficacy. The product has not met the

efficacy requirements of title 9, Code of

Federal Regulations, § 113.312 for rabies

vaccines; however, a reasonable

expectation of efficacy has been

demonstrated in the studies that have

been conducted to date. The efficacy of

this recombinant rabies vaccine will be

further evaluated during the conditional

license period. The State and Federal

Government agencies using the rabies

vaccine will be provided with detailed

instructions for safely using the

recombinant vaccine. These instructions

include continued use of the following

mitigative procedures that have been

implemented for the field tests

previously conducted with this product:

1. Public education efforts, including

education efforts directed at school-aged

children, should be conducted prior to

distributing the baits containing the

recombinant rabies vaccine. Warning

labels should be attached to the baits to

minimize the possibility of accidental

exposure of members of the local

populations in the areas where the

vaccine-laden baits are distributed. The

warning labels should clearly identify

the recombinant vaccine and list the

phone number for the local public

health authorities. The public education

efforts should be conducted prior to

distributing the baits and should

include newspaper articles, local

television reports, and the distribution

of brochures and posters. Public

information meetings may also be used.

In addition, when the baits are

distributed, signs should be posted at

the periphery and at strategic points

within the distribution area notifying

visitors of the rabies control efforts and

warning them not to disturb the

vaccine-laden baits.

2. The local public health authorities

in the areas where the recombinant

rabies vaccine is used should be notified

prior to the distribution of the baits. The

public health authorities should be

instructed to inform the authorizing

State or Federal Government agency of

any reported human contacts with the

vaccine-laden baits. Individuals who

may have been exposed to the vaccine

should be examined for any adverse

reactions or clinical signs of

orthopoxvirus infection, and have blood

samples drawn and analyzed for the

presence of antibodies of rabies and/or

vaccinia.

3. The personnel conducting the

rabies control programs should be

trained in the appropriate precautions

and techniques for assembling,

handling, and distributing the vaccineladen baits. These personnel should be

encouraged to be vaccinated against

vaccinia, as recommended by the U.S.

Public Health Service [Morbidity and

Mortality Weekly Report;

Recommendations and Reports;

Vaccinia (Smallpox) Vaccine,

Recommendations of the Immunization

Practices Advisory Committee (ACIP),

Vol. 40, pp. 1–10 (1991)], and also be

vaccinated against rabies. All personnel

should be non-pregnant adults at least

18 years of age, who are free of any

known immunosuppressive conditions.

Regular blood samples should be

collected from the personnel and

monitored for the presence of rabies and

vaccinia antibodies.

4. The filling of the liquid vaccine

into ampules for assembly into the baits

should be conducted according to

Biosafety Level-2 (BL–2) criteria [CDC–

NIH Manual: Biosafety in

Microbiological and Biomedical

Laboratories, Third Edition (1993) pp.

18–24].

5. Any adverse reactions observed in

the areas where the recombinant rabies

vaccine is used should be reported to

the licensed manufacturer, who will

forward this information to Veterinary

Biologics, APHIDS.

The environmental assessment and

finding of no significant impact have

been prepared in accordance with: (1)

The National Environmental Policy Act

of 1969 (NEPA) (42 U.S.C. 4321 et seq.),

(2) Regulations of the Council on

Environmental Quality for

Implementing the Procedural Provisions

of NEPA (40 CFR parts 1500–1508), (3)

USDA Regulations Implementing NEPA

(7 CFR part 1b), and (4) APHIS NEPA

Implementing Procedures (60 FR 6000–

6005, February 1, 1995).

Done in Washington, DC, this 20th day of

April 1995.

Lonnie J. King,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–10241 Filed 4–25–95; 8:45 am]

BILLING CODE 3410–34–M