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

64349

Vol. 62, No. 234

Friday, December 5, 1997

AFRICAN DEVELOPMENT

FOUNDATION

Sunshine Act Meeting; Board of

Directors Meeting

TIME: 9:00 a.m.–12:00 noon.

PLACE: ADF Headquarters.

DATE: Wednesday, 10 December 1997.

STATUS: Open.

Agenda

Wednesday, 10 December 1997

9:00 a.m. Chairman’s Report

10:00 a.m. President’s Report

11:30 a.m. Executive Session (Closed)

12:00 noon Adjournment

If you have any questions or

comments, please direct them to Ms.

Janis McCollim, Executive Assistant to

the President, who can be reached at

(202) 673–3916.

William R. Ford,

President.

[FR Doc. 97–32101 Filed 12–3–97; 3:58 pm]

BILLING CODE 6116–01–M

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 97–088–1]

Notice of Request for Extension of

Approval of an Information Collection

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Extension of approval of an

information collection; comment

request.

SUMMARY: In accordance with the

Paperwork Reduction Act of 1995, this

notice announces the Animal and Plant

Health Inspection Service’s intention to

request an extension of approval of an

information collection in support of the

Virus-Serum-Toxin Act and regulations.

DATES: Comments on this notice must be

received by February 3, 1998 to be

assured of consideration.

ADDRESSES: Send comments regarding

the accuracy of burden estimate, ways to

minimize the burden (such as through

the use of automated collection

techniques or other forms of information

technology), or any other aspect of this

collection of information to: Docket No.

97–088–1, Regulatory Analysis and

Development, PPD, APHIS, suite 3C03,

4700 River Road Unit 118, Riverdale,

MD 20737–1238. Please send an original

and three copies, and state that your

comments refer to Docket 97–088–1.

Comments received may be inspected 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 comments are requested to call

ahead on (202) 690–2817 to facilitate

entry into the comment reading room.

FOR FURTHER INFORMATION: For

information regarding the Virus-SerumToxin Act and regulations, contact Dr.

David Espeseth, Director, Center for

Veterinary Biologics, Licensing and

Policy Development, VS, APHIS, 4700

River Road Unit 148, Riverdale, MD

20737–1237, (301) 734–8245 or e-mail

despeseth@aphis.usda.gov. For copies of

more detailed information on the

information collection, contact Ms.

Cheryl Jenkins, Agency Support Service

Specialist, at (301) 734–5360.

SUPPLEMENTARY INFORMATION:

Title: Virus-Serum-Toxin Act and

Regulations.

OMB Number: 0579–0013.

Expiration Date of Approval: March

31, 1998.

Type of Request: Extension of

approval of an information collection.

Abstract: The Animal and Plant

Health Inspection Service (APHIS) of

the U.S. Department of Agriculture is

responsible for preventing the

importation, preparation, sale, or

shipment of worthless, contaminated,

dangerous or harmful veterinary

biological products. This program is

conducted under the Virus-SerumToxin Act (21 U.S.C. 151, et seq.) and

the regulations issued thereunder (9

CFR, chapter I, subchapter E).

Veterinary biological products are

defined as all viruses, serums, toxins

(excluding substances that are

selectively toxic to microorganisms, e.g.,

antibiotics), or analogous products at

any stage of production, shipment,

distribution, or sale, which are intended

for use in the treatment of animals and

which act primarily through the direct

stimulation, supplementation,

enhancement, or modulation of the

immune system or immune response.

The term ‘‘biological products’’

includes, but is not limited to, vaccines,

bacterins, allergens, antibodies,

antitoxins, toxoids, immunostimulants,

certain cytokines, antigenic or

immunizing components of live

organisms, and diagnostic components

that are of natural or synthetic origin, or

that are derived from synthesizing or

altering various substances or

components of substances such as

microorganisms, genes or genetic

sequences, carbohydrates, proteins,

antigens, allergens, or antibodies.

To accomplish this mission, APHIS

issues licenses to qualified

establishments that produce biological

products and issues permits to

importers of such products. We also

enforce requirements concerning

production, packaging, labeling, and

shipping of these products, and set

standards for the testing of these

products.

Fulfilling this responsibility requires

us to employ a number of informationgathering tools such as establishment

license applications, product license

applications, product permit

applications, product and test report

forms, and field study summaries.

The information we obtain with the

help of these documents enables us to

ensure that biological products used in

the United States are pure, safe, potent,

and effective. If we did not collect this

information, we would be unable to

carry out this mission.

We are asking the Office of

Management and Budget (OMB) to

approve the continued use of this

information collection activity.

The purpose of this notice is to solicit

comments from the public (as well as

affected agencies) concerning our

information collection. We need this

outside input to help us:

(1) Evaluate whether the proposed

collection of information is necessary

for the proper performance of the

functions of the Agency, including

whether the information will have

practical utility;
64350 Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Notices

(2) Evaluate the accuracy of our

estimate of the burden of the proposed

collection of information, including the

validity of the methodology and

assumptions used;

(3) Enhance the quality, utility, and

clarity of the information to be

collected; and

(4) Minimize the burden of the

collection of information on those who

are to respond, through use, as

appropriate, of automated, electronic,

mechanical, and other collection

technologies, e.g., permitting electronic

submission of responses.

Estimate of burden: The public

reporting burden for this collection of

information is estimated to average

2.2063 hours per response.

Respondents: U.S. importers of

biological products, shippers, operators

of establishments that produce or test

biological products or that engage in

product research and development.

Estimated number of respondents:

114.

Estimated number of responses per

respondent: 298.73.

Estimated annual number of

responses: 34,056.

Estimated total annual burden on

respondents: 75,138 hours. (Due to

rounding, the total annual burden hours

may not equal the product of the annual

number of responses multiplied by the

average reporting burden per response.)

All responses to this notice will be

summarized and included in the request

for OMB approval. All comments will

also become a matter of public record.

Done in Washington, DC, this 28th day of

November.

Craig A. Reed,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 97–31903 Filed 12–4–97; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 97–052–2]

Monsanto Co. and Dekalb Genetics

Corp.; Availability of Determination of

Nonregulated Status for Genetically

Engineered Corn Line

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are advising the public of

our determination that a corn line

developed by Monsanto Company and

Dekalb Genetics Corporation designated

as GA21, which has been genetically

engineered for tolerance to the herbicide

glyphosate, is no longer considered a

regulated article under our regulations

governing the introduction of certain

genetically engineered organisms. Our

determination is based on our

evaluation of data submitted by

Monsanto Company and Dekalb

Genetics Corporation in their petition

for a determination of nonregulated

status and an analysis of other scientific

data. This notice also announces the

availability of our written determination

document and its associated

environmental assessment and finding

of no significant impact.

EFFECTIVE DATE: November 18, 1997.

ADDRESSES: The determination, an

environmental assessment and finding

of no significant impact, the petition,

and any written comments received

regarding the petition may be inspected

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 asked to

call in advance of visiting at (202) 690–

2817 to facilitate entry into the reading

room.

FOR FURTHER INFORMATION CONTACT: Dr.

Ray Dobert, Biotechnology Evaluation,

BSS, PPQ, APHIS, 4700 River Road Unit

147, Riverdale, MD 20737–1236; (301)

734–8365. To obtain a copy of the

determination or the environmental

assessment and finding of no significant

impact, contact Ms. Kay Peterson at

(301) 734–4885; e-mail:

mkpeterson@aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

On April 9, 1997, the Animal and

Plant Health Inspection Service (APHIS)

received a petition (APHIS Petition No.

97–099–01p) from Monsanto Company

of St. Louis, MO, and Dekalb Genetics

Corporation of Mystic, CT (Monsanto/

Dekalb), seeking a determination that a

corn line designated as GA21, which

has been genetically engineered for

tolerance to the herbicide glyphosate,

does not present a plant pest risk and,

therefore, is not a regulated article

under APHIS’ regulations in 7 CFR part

340.

On August 13, 1997, APHIS published

a notice in the Federal Register (62 FR

43311–43312, Docket No. 97–052–1)

announcing that the Monsanto/Dekalb

petition had been received and was

available for public review. The notice

also discussed the role of APHIS, the

Environmental Protection Agency, and

the Food and Drug Administration in

regulating the subject corn line and food

products derived from it. In the notice,

APHIS solicited written comments from

the public as to whether the subject corn

line posed a plant pest risk. The

comments were to have been received

by APHIS on or before October 14, 1997.

APHIS received no comments on the

subject petition during the designated

60-day comment period.

Analysis

Corn line GA21 has been genetically

engineered to contain a modified corn 5-

enolpyruvylshikimate-3-phosphatesynthase (EPSPS) gene, which, when

expressed in the plant, confers tolerance

to the herbicide glyphosate. The

modified corn EPSPS gene was

introduced into the parental inbred corn

line AT by the particle acceleration

method, and its expression is controlled

in part by the rice actin promoter and

intron and the NOS 3′ termination

sequence derived from the plant

pathogen Agrobacterium tumefaciens.

Corn line GA21 has been considered

a regulated article under APHIS’

regulations in 7 CFR part 340 because it

contains gene sequences derived from a

plant pathogen. However, evaluation of

field data reports from field tests of the

subject corn line conducted under

APHIS notifications since 1994

indicates that there were no deleterious

effects on plants, nontarget organisms,

or the environment as a result of the

subject corn plants’ release into the

environment.

Determination

Based on its analysis of the data

submitted by Monsanto/Dekalb, and a

review of other scientific data and field

tests of the subject corn line, APHIS has

determined that corn line GA21: (1)

Exhibits no plant pathogenic properties;

(2) is no more likely to become a weed

than corn developed by traditional

breeding techniques; (3) is unlikely to

increase the weediness potential for any

other cultivated or wild species with

which it can interbreed; (4) will not

harm other organisms, including

agriculturally beneficial organisms and

threatened and endangered species; and

(5) should not cause damage to raw or

processed agricultural commodities.

Therefore, APHIS has concluded that

corn line GA21 and any progeny

derived from hybrid crosses with

nontransformed corn varieties will be

just as safe to grow as traditionally bred

corn lines that are not regulated under

7 CFR part 340.

The effect of this determination is that

the Monsanto/Dekalb corn line

designated as GA21 is no longer

considered a regulated article under

APHIS’ regulations in 7 CFR part 340.