Federal Register / Vol. 60, No. 95 / Wednesday, May 17, 1995 / Rules and Regulations 26359

1502, 1651(b)(2), 42 U.S.C. 1857f–10, 4321 et

seq.; E.O. 11514; and 49 U.S.C. 106(g).

The Special Conditions

Accordingly, the following special

conditions are issued as part of the type

certification basis for the Raytheon

Corporate Jets, Inc., Model Hawker 800

series airplanes equipped with Garrett

TFE731–5BR–1H turbo fan engines and

electronically controlled mach trim

system. These special conditions would

apply only to electrical and electronic

components that perform critical

functions and are embodied in the mach

trim system or TFE731–5BR–1H engine

electronic control system.

1. Protection from Unwanted Effects

of High-Intensity Radiated Fields

(HIRF). Each electrical and electronic

system that performs critical functions

must be designed and installed to

ensure that the operation and

operational capability of these systems

to perform critical functions are not

adversely affected when the airplane is

exposed to high-intensity radiated

fields.

2. For the purpose of these special

conditions, the following definition

applies: Critical Functions. Functions

whose failure would contribute to or

cause a failure condition that would

prevent the continued safe flight and

landing of the airplane.

Issued in Renton, Washington, on May 9,

1995.

Darrell M. Pederson,

Assistant Manager, Transport Airplane

Directorate, Aircraft Certification Service,

ANM–101.

[FR Doc. 95–12155 Filed 5–16–95; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Penicillin G Potassium in Turkey

Drinking Water

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of an abbreviated new animal

drug application (ANADA) filed by

Wade Jones Co., Inc. The ANADA

provides for use of penicillin G

potassium powder to make a medicated

turkey drinking water for the treatment

of erysipelas caused by Erysipelothrix

rhusiopathiae.

EFFECTIVE DATE: May 17, 1995.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Wade

Jones Co., Inc., Highway 71 North, 409

North Bloomington, Lowell, AR 72745,

has filed ANADA 200–122, which

provides for use of penicillin G

potassium powder to make a medicated

turkey drinking water used for the

treatment of erysipelas in turkeys

caused by E. rhusiopathiae.

Wade Jones’ ANADA 200–122 for

penicillin G potassium powder is

approved as a generic copy of Solvay’s

NADA 55–060 for the same product.

The ANADA is approved as of April 17,

1995, and the regulations are amended

in 21 CFR 520.1696b(b) to reflect the

approval. The basis for this approval is

discussed in the freedom of information

summary.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 514.11(e)(2)(ii)), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(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.

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 520

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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal

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

360b).

2. Section 520.1696b is amended by

revising paragraph (b) to read as follows:

§ 520.1696b Penicillin G potassium in

drinking water.

* * * * *

(b) Sponsors. See Nos. 017144,

047864, 050604, and 053501 in

§ 510.600(c) of this chapter.

* * * * *

Dated: May 5, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–12095 Filed 5–16–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation and Injectable Dosage

Form New Animal Drugs; Zeranol

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a supplemental new animal

drug application (NADA) filed by

Mallinckrodt Veterinary, Inc. The

supplemental NADA provides for use of

a 72-milligram (mg) zeranol implant in

steers being fed in confinement for

slaughter for increased rate of weight

gain.

EFFECTIVE DATE: May 17, 1995.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0217.

SUPPLEMENTARY INFORMATION:

Mallinckrodt Veterinary, Inc., 421 East

Hawley St., Mundelein, IL 60060, filed

supplemental NADA 38–233 to provide

for the use of Ralgro Magnum (a 72-mg

zeranol implant) in steers being fed in

confinement for slaughter for increased

rate of weight gain (i.e., use of six 12-

mg zeranol pellets). The supplemental

NADA is approved as of April 6, 1995,

and the regulations are amended in 21

CFR 522.2680(d) to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 514.11(e)(2)(ii)), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch
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