26360 Federal Register / Vol. 60, No. 95 / Wednesday, May 17, 1995 / Rules and Regulations

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857,

between 9 a.m. and 4 p.m., Monday

through Friday.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

approval for food-producing animals

qualifies for 3 years of marketing

exclusivity beginning April 6, 1995,

because the supplemental NADA

contains reports of new clinical

investigations (other than

bioequivalence or residue studies)

essential to the approval and conducted

or sponsored by the applicant. Three

years of marketing exclusivity applies

only to the use for which the

supplemental NADA is approved.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects in 21 CFR Part 522

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 522.2680 is amended by

adding new paragraph (d)(3) to read as

follows:

§ 522.2680 Zeranol.

* * * * *

(d) * * *

(3) Steers—(i) Amount. 72 milligrams

(six 12-milligram pellets) per animal.

(ii) Indications for use. For increased

rate of weight gain in steers fed in

confinement for slaughter.

(iii) Limitations. Implant

subcutaneously in ear only.

Dated: May 5, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–12094 Filed 5–16–95; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–30072L; FRL–4950–7]

Tolerance Processing Fees

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule increases fees

charged for processing tolerance

petitions for pesticides under the

Federal Food, Drug, and Cosmetic Act

(FFDCA). The change in fees reflects a

3.22 percent increase in locality pay for

civilian Federal General Schedule (GS)

employees working in the Washington,

DC/Baltimore, MD metropolitan area in

1995.

EFFECTIVE DATE: June 16, 1995.

FOR FURTHER INFORMATION CONTACT:

Concerning this rule contact: By mail:

Delores A. Furman, Program

Management and Support Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number and

e-mail address: Rm. 700–G, CM #2, 1921

Jefferson Davis Highway, Arlington, VA

(703–305–7016), furman.delores.

Concerning tolerance petitions and

individual fees contact: Jim Tompkins

(703–305–5697)

SUPPLEMENTARY INFORMATION: The EPA

is charged with administration of

section 408 of the Federal Food, Drug,

and Cosmetic Act (FFDCA). Section 408

authorizes the Agency to establish

tolerance levels and exemptions from

the requirements for tolerances for raw

agricultural commodities. Section

408(o) requires that the Agency collect

fees as will, in the aggregate, be

sufficient to cover, among other things,

the costs of processing petitions for

pesticide products, i.e., that the

tolerance process be as self-supporting

as possible. The current fee schedule for

tolerance petitions (40 CFR 180.33) was

published in the Federal Register on

June 2, 1994 (59 FR 28482) and became

effective on July 5, 1994. At that time

the fees were increased 4.23 percent in

accordance with a provision in the

regulation that provides for automatic

annual adjustments to the fees based on

annual percentage changes in Federal

salaries. The specific language in the

regulation is contained in paragraph (o)

of § 180.33 and reads in part as follows:

(o) This fee schedule will be changed

annually by the same percentage as the

percent change in the Federal General

Schedule (GS) pay scale.... When automatic

adjustments are made based on the GS pay

scale, the new fee schedule will be published

in the Federal Register as a final rule to

become effective thirty days or more after

publication, as specified in the rule.

The Federal Employees Pay

Comparability Act of 1990 (FEPCA)

initiated locality-based comparability

pay, known as ‘‘locality pay.’’ The

intent of the legislation is to make

Federal pay more responsive to local

labor market conditions by adjusting

General Schedule salaries on the basis

of a comparison with non-Federal rates

on a geographic, locality basis.

The processing and review of

tolerance petitions is conducted by EPA

employees working in the Washington,

DC/ Baltimore, MD pay area. The pay

raise in 1995 for Federal General

Schedule employees working in the

Washington, DC/Baltimore, MD

metropolitan pay area is 3.22 percent;

therefore, the tolerance petition fees are

being increased 3.22 percent. All fees

have been rounded to the nearest

$25.00.

List of subjects in 40 CFR Part 180

Administrative practice and

procedures, Agricultural commodities,

Pesticides and pests, Reporting and

recordkeeping requirements.

Dated: May 5, 1995.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I, part 180

is amended as follows:

1. The authority citation for Part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. Section 180.33 is amended by

revising paragraphs (a), (b), (c), (d), (e),

(f), (g), (i), (j)(3), and (m) to read as

follows:

§ 180.33 Fees.

(a) Each petition or request for the

establishment of a new tolerance or a

tolerance higher than already

established, shall be accompanied by a

fee of $60,425, plus $1,500 for each raw

agricultural commodity more than nine

on which the establishment of a

tolerance is requested, except as

provided in paragraphs (b), (d), and (h)

of this section.

(b) Each petition or request for the

establishment of a tolerance at a lower

numerical level or levels than a

tolerance already established for the
Federal Register / Vol. 60, No. 95 / Wednesday, May 17, 1995 / Rules and Regulations 26361

same pesticide chemical, or for the

establishment of a tolerance on

additional raw agricultural commodities

at the same numerical level as a

tolerance already established for the

same pesticide chemical, shall be

accompanied by a fee of $13,825 plus

$925 for each raw agricultural

commodity on which a tolerance is

requested.

(c) Each petition or request for an

exemption from the requirement of a

tolerance or repeal of an exemption

shall be accompanied by a fee of

$11,150.

(d) Each petition or request for a

temporary tolerance or a temporary

exemption from the requirement of a

tolerance shall be accompanied by a fee

of $24,150 except as provided in

paragraph (e) of this section. A petition

or request to renew or extend such

temporary tolerance or temporary

exemption shall be accompanied by a

fee of $3,425.

(e) A petition or request for a

temporary tolerance for a pesticide

chemical which has a tolerance for other

uses at the same numerical level or a

higher numerical level shall be

accompanied by a fee of $12,050 plus

$925 for each raw agricultural

commodity on which the temporary

tolerance is sought.

(f) Each petition or request for repeal

of a tolerance shall be accompanied by

a fee of $7,550. Such fee is not required

when, in connection with the change

sought under this paragraph, a petition

or request is filed for the establishment

of new tolerances to take the place of

those sought to be repealed and a fee is

paid as required by paragraph (a) of this

section.

(g) If a petition or a request is not

accepted for processing because it is

technically incomplete, the fee, less

$1,500 for handling and initial review,

shall be returned. If a petition is

withdrawn by the petitioner after initial

processing, but before significant

Agency scientific review has begun, the

fee, less $1,500 for handling and initial

review, shall be returned. If an

unacceptable or withdrawn petition is

resubmitted, it shall be accompanied by

the fee that would be required if it were

being submitted for the first time.

* * * * *

(i) Objections under section 408(d)(5)

of the Act shall be accompanied by a

filing fee of $3,025.

(j) * * *

(3) An advance deposit shall be made

in the amount of $30,175 to cover the

costs of the advisory committee. Further

advance deposits of $30,175 each shall

be made upon request of the

Administrator when necessary to

prevent arrears in the payment of such

costs. Any deposits in excess of actual

expenses will be refunded to the

depositor.

* * * * *

(m) The Administrator may waive or

refund part or all of any fee imposed by

this section if the Administrator

determines in his or her sole discretion

that such a waiver or refund will

promote the public interest or that

payment of the fee would work an

unreasonable hardship on the person on

whom the fee is imposed. A request for

waiver or refund of a fee shall be

submitted in writing to the

Environmental Protection Agency,

Office of Pesticide Programs,

Registration Division (7505C),

Washington, DC 20460. A fee of $1,500

shall accompany every request for a

waiver or refund, except that the fee

under this sentence shall not be

imposed on any person who has no

financial interest in any action

requested by such person under

paragraphs (a) through (k) of this

section. The fee for requesting a waiver

or refund shall be refunded if the

request is granted.

* * * * *

[FR Doc. 95–12143 Filed 5–16–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Parts 180, 185, and 186

[FAP 4H5683/R2131; FRL–4952–5]

RIN 2070–AB78

Hexazinone; Pesticide Tolerances and

Food/Feed Additive Regulations

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document amends the

current tolerance for residues of the

herbicide hexazinone (3-(cyclohexyl-6-

(dimethylamino)-1-methyl-1,3,5-

triazine-2,4(1H,3H)-dione) and its

metabolites (calculated as hexazinone)

in or on sugarcane at 0.2 part per

million (ppm) by revoking the current

tolerance and reestablishing the same

tolerance with regional registration and

tolerance as described in 40 CFR

180.1(n). EPA also establishes food and

feed additive regulations for residues of

hexazinone and its metabolites in

sugarcane molasses at 0.5 ppm. E.I. du

Pont de Nemours & Co., Inc., requested

these regulations pursuant to the

Federal Food, Drug and Cosmetic Act.

EFFECTIVE DATE: These regulations

become effective May 17, 1995.

ADDRESSES: Written objections,

identified by the document control

number, [PP 4H5683/R2131], may be

submitted to: Hearing Clerk (1900),

Environmental Protection Agency, Rm.

M3708, 401 M St., SW., Washington, DC

20460. A copy of any objections and

hearing requests filed with the Hearing

Clerk should be identified by the

document control number and

submitted to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

copy of objections and hearing requests

to: Rm. 1132, CM #2, 1921 Jefferson

Davis Hwy., Arlington, VA 22202. Fees

accompanying objections shall be

labeled ‘‘Tolerance Petition Fees’’ and

forwarded to: EPA Headquarters

Accounting Operations Branch, OPP

(Tolerance Fees), P.O. Box 360277M,

Pittsburgh, PA 15251.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [FAP 4H5683/

R2131]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries. Additional

information on electronic submissions

can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne I. Miller, Product Manager

(PM) 23, Registration Division (7505C),

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location and telephone number:

Rm. 237, 1921 Jefferson Davis Hwy.,

Arlington, VA 22202, (703)-305-7830; email: miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of March 22, 1995 (60

FR 15113), EPA issued a proposed rule

that gave notice that E.I. du Pont de

Nemours & Co., Inc., had petitioned

EPA under section 408 of the Federal

Food, Drug, and Cosmetic Act, 21 U.S.C.

346a, to amend 40 CFR parts 180, 185,

and 186 to establish tolerances with

regional registration for combined

residues of the herbicde hexazinone (3-