Federal Register / Vol. 65, No. 12 / Wednesday, January 19, 2000 / Notices 2947

Dated: January 6, 2000.

Joanne Martin,

Acting Director, Information Resources and

Services Division, Office of Pesticide

Programs.

[FR Doc. 00–1216 Filed 1–18–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–00621; FRL–6385–7]

Pesticides: Data Submitter Rights for

Data Submitted in Support of

Tolerance Actions; Notice of

Availability

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA is announcing the

availability for comment of a paper

discussing options to enable the Agency

to appropriately implement the new

provisions contained in section 408(i) of

the Federal Food, Drug, and Cosmetic

Act (FFDCA) to address exclusive use

and compensation rights for data

submitted to EPA in support of

tolerance and tolerance exemption

actions.

DATES: Comments, identified by docket

control number OPP–00621, must be

received on or before March 20, 2000.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I. of the

‘‘SUPPLEMENTARY INFORMATION.’’

To ensure proper receipt by EPA, it is

imperative that you identify docket

control number OPP–00621 in the

subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT:

Cameo G. Smoot, Field and External

Affairs Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460; telephone

number: (703) 305–5454; fax number:

(703) 305–5884; e-mail address:

smoot.cameo@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public

in general. This action may, however, be

of interest to you if you submit data to

EPA in support of establishing or

maintaining tolerances for pesticides, or

are a pesticide registrant or a person

applying for pesticide registration under

the Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA). You may also

be interested in commenting if you

submit data to EPA in support of an

exemption from a tolerance. Since other

entities may also be interested, the

Agency has not attempted to describe all

the specific entities that may be affected

by this action. If you have any questions

regarding the applicability of this action

to a particular entity, consult the person

listed under ‘‘FOR FURTHER

INFORMATION CONTACT.’’

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register-—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. You may obtain

a copy of the options paper titled ‘‘Data

Submitter Rights for Data Submitted in

Support of Tolerance Actions’’

described in this notice by accessing

this Federal Register notice using the

Federal Register--Environmental

Documents cite on the EPA’s Internet

and selecting ‘‘Related Documents.’’

Hard copies of the options paper are

available by consulting with the person

listed under ‘‘FOR FURTHER

INFORMATION CONTACT.’’

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–00621. The official record consists

of the documents specifically referenced

in this action, any public comments

received during an applicable comment

period, and other information related to

this action, including any information

claimed as confidential business

information (CBI). This official record

includes the documents that are

physically located in the docket, as well

as the documents that are referenced in

those documents. The public version of

the official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period, is

available for inspection in the Public

Information and Records Integrity

Branch (PIRIB), Rm. 119, Crystal Mall 2,

1921 Jefferson Davis Hwy., Arlington,

VA, from 8:30 a.m. to 4 p.m., Monday

through Friday, excluding legal

holidays. The PIRIB telephone number

is (703) 305–5805.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number OPP–00621 in the

subject line on the first page of your

response.

1. By mail. Submit your comments to:

Public Information and Records

Integrity Branch (PIRIB), Information

Resources and Services Division

(7502C), Office of Pesticide Programs

(OPP), Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, Crystal

Mall 2, 1921 Jefferson Davis Hwy.,

Arlington, VA. The PIRIB is open from

8:30 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays. The

PIRIB telephone number is (703) 305–

5805.

3. Electronically. You may submit

your comments electronically by e-mail

to: ‘‘opp-docket@epa.gov,’’ or you can

submit a computer disk as described in

this unit. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

WordPerfect 6.1/8.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number OPP–00621. Electronic

comments may also be filed online at

many Federal Depository Libraries.

D. How Should I Handle CBI that I Want

to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI by marking any part or

all of that information as CBI.

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

2948 Federal Register / Vol. 65, No. 12 / Wednesday, January 19, 2000 / Notices

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under ‘‘FOR FURTHER INFORMATION

CONTACT.’’

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Offer alternative ways to improve

the rule or collection activity.

7. Make sure to submit your

comments by the deadline in this

notice.

8. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. What Action is the Agency Taking?

EPA is making available for comment

an options paper on exclusive use and

data compensation rights for data

submitted to the Agency in support of

tolerance and tolerance exemption

actions. As part of the Food Quality

Protection Act of 1996, Congress

amended section 408(i) of the Federal

Food, Drug, and Cosmetic Act (FFDCA)

addressing such rights. The Agency is

currently evaluating how to implement

this new provision and is seeking public

comment. The options paper briefly

discusses the new section 408(i) of the

FFDCA and the Agency’s practices

regarding data compensation and

exclusive use; the current compensation

and exclusive use process the Agency

implements under section 3 of the

FIFRA, and presents three options for

implementing the new provision. The

options represent different

interpretations focusing on who the data

submitters may be. However, the

Agency also seeks comments on other

interpretations of section 408(i) and

suggested procedures for implementing

any option. Commenters are particularly

encouraged to offer suggestions for

workable procedures for their preferred

options.

EPA will consider the comments

received and develop a detailed

proposal for implementing data rights

under section 408(i) of FFDCA.

List of Subjects

Environmental protection, Pesticide

tolerances, Data compensation.

Dated: January 5, 2000.

Marcia E. Mulkey,

Director, Office of Pesticide Programs.

[FR Doc. 00–1063 Filed 1–18–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–30489; FRL–6485–1]

Pesticide Products; Registration

Application

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces receipt

of application to register a pesticide

product containing a new active

ingredient not included in any

previously registered product pursuant

to the provisions of section 3(c)(4) of the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA), as amended.

DATES: Written comments, identified by

the docket control number OPP–30489,

must be received on or before February

18, 2000.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I. of the

‘‘SUPPLEMENTARY INFORMATION.’’

To ensure proper receipt by EPA, it is

imperative that you identify docket

control number OPP–30489 in the

subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Mary L. Waller, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., Washington, DC

20460 telephone number: (703) 308–

9354 and e-mail address:

waller.mary@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

CategoriesNAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS), codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under ‘‘FOR FURTHER

INFORMATION CONTACT.’’

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register--Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–30489. The official record consists

of the documents specifically referenced

in this action, any public comments

received during an applicable comment

period, and other information related to

this action, including any information

claimed as confidential business

information (CBI). This official record

includes the documents that are

physically located in the docket, as well

as the documents that are referenced in

those documents. The public version of

the official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period, is

available for inspection in the Public

Information and Records Integrity