29480 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0217.

SUPPLEMENTARY INFORMATION: RousselUCLAF, Division Agro-Veterinaire, 163

Ave. Gambetta, 75020 Paris, France,

filed supplemental NADA 140–897,

which provides for use of an ear implant

containing 2 pellets, each pellet

containing 20 milligrams (mg) of

trenbolone acetate and 4 mg of estradiol.

The implant is used in pasture steers

(slaughter, stocker, feeder) for increased

rate of weight gain. The supplemental

NADA is approved as of March 27,

1996, and the regulations are amended

in 21 CFR 522.2477 by adding new

paragraph (c)(3) to reflect the approval.

The basis for 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, 12420 Parklawn Dr.,

rm. 1–23, 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 qualifies for a 3-year period of

marketing exclusivity beginning on

March 27, 1996, because new clinical or

field investigations (other than

bioequivalence or residue studies)

essential to the approval were

conducted or sponsored by the

applicant.

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 522.2477 is amended by

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

follows:

§ 522.2477 Trenbolone acetate and

estradiol.

* * * * *

(c) * * *

(3) Pasture steers (slaughter, stocker,

and feeder steers). (i) Amount. 40

milligrams of trenbolone acetate and 8

milligrams of estradiol (2 pellets, each

pellet containing 20 milligrams of

trenbolone acetate and 4 milligrams of

estradiol) per animal.

(ii) Indications for use. For increased

rate of weight gain.

(iii) Limitations. Implant

subcutaneously in ear only.

Dated: May 17, 1996.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–14646 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs;

Tripelennamine Hydrochloride

Injection

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

Phoenix Scientific, Inc. The ANADA

provides for use of tripelennamine

hydrochloride injection in cattle and

horses for conditions in which

antihistaminic therapy may be expected

to lead to alleviation of some signs of

disease.

EFFECTIVE DATE: June 11, 1996.

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: Phoenix

Scientific, Inc., 3915 South 48th Street

Ter., P.O. Box 6457, St. Joseph, MO

64506–0457, filed ANADA 200–162

which provides for intravenous and

intramuscular use in cattle and

intramuscular use in horses of

tripelennamine hydrochloride injection

for conditions in which antihistaminic

therapy is indicated. The drug is limited

to use by or on the order of a licensed

veterinarian.

Approval of ANADA 200–162 for

Phoenix’s tripelennamine hydrochloride

injection is as a generic copy of Solvay’s

NADA 006–417 for Re-Covr Injection

(tripelennamine hydrochloride). The

ANADA is approved as of March 28,

1996, and the regulations are amended

by revising § 522.2615(b) (21 CFR

522.2615(b)) to reflect the approval. The

basis of approval is discussed in the

freedom of information summary. In

addition, due to enactment of the

Generic Animal Drug and Patent Term

Restoration Act of 1988, § 522.2615(d) is

outdated and therefore removed.

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, 12420 Parklawn Dr.,

rm. 1–23, 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 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).

§ 522.2615 [Amended]

2. Section 522.2615 Tripelennamine

hydrochloride injection is amended in
Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations 29481

paragraph (b) by removing ‘‘No.

053501’’ and adding in its place ‘‘Nos.

053501 and 059130’’ and by removing

paragraph (d).

Dated: May 28, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–14644 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Semduramicin With Bacitracin

Methylene Disalicylate and Roxarsone

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 new animal drug

application (NADA) filed by Pfizer, Inc.

The NADA provides for using approved

single ingredient Type A medicated

articles to make combination drug Type

C medicated broiler chicken feeds

containing semduramicin with

bacitracin methylene disalicylate and

roxarsone. The Type C medicated feed

is used for prevention of coccidiosis and

for improved feed efficiency.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT:

James F. McCormack, Center for

Veterinary Medicine (HFV–128), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1607.

SUPPLEMENTARY INFORMATION: Pfizer,

Inc., 235 East 42d St., New York, NY

10017, filed NADA 141–058, which

provides for combining approved Type

A medicated articles containing Aviax

(semduramicin sodium) with BMD

(bacitracin methylene disalicylate) and

3–Nitro (roxarsone) to make

combination drug Type C medicated

broiler chicken feeds containing 22.7

grams (g) of semduramicin, 10 to 50 g

of bacitracin methylene disalicylate, and

45.4 g of roxarsone per ton. The Type

C medicated feed is used for the

prevention of coccidiosis caused by

Eimeria acervulina, E. brunetti, E.

maxima, E. mivati/E. miti, E. necatrix,

and E. tenella, including some field

strains of E. tenella that are more

susceptible to semduramicin combined

with roxarsone than semduramicin

alone, and for improved feed efficiency

in broiler chickens. The NADA is

approved as of June 11, 1996, and the

regulations are amended by adding new

21 CFR 558.555(b)(2) to reflect the

approval. The basis for approval is

discussed in the freedom of information

summary.

Roxarsone is a Category II drug which,

as provided in 21 CFR 558.4, requires an

approved medicated feed application

(Form FDA 1900) for making a Type C

medicated feed. Therefore, making a

Type C medicated feed containing

semduramicin, bacitracin methylene

disalicylate, and roxarsone requires an

approved Form FDA 1900.

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.

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

Federal Food, Drug, and Cosmetic Act

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

approval qualifies for 3 years marketing

exclusivity beginning June 11, 1996,

because the application contains reports

of new clinical or field investigations

(other than bioequivalence or residue

studies) essential to the approval of the

application and conducted or sponsored

by the applicant.

The agency has determined under 21

CFR 25.24(d)(1)(ii) that this action is of

a type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: Secs. 512, 701 of the Federal

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

360b, 371).

2. Section 558.555 is amended by

adding new paragraph (b)(2) to read as

follows:

§ 558.555 Semduramicin.

* * * * *

(b) * * *

(2) Amount. Semduramicin 22.7

grams with bacitracin methylene

disalicylate 10 to 50 grams and

roxarsone 45.4 grams per ton.

(i) Indications for use. For the

prevention of coccidiosis caused by

Eimeria acervulina, E. brunetti, E.

maxima, E. mivati/E. mitis, E. necatrix,

and E. tenella, including some field

strains of E. tenella that are more

susceptible to semduramicin combined

with roxarsone than semduramicin

alone, and for improved feed efficiency.

(ii) Limitations. Feed continuously as

sole ration. Use feed within 2 weeks of

production. Withdraw 5 days before

slaughter. Do not feed to laying hens.

Use as sole source of organic arsenic.

Poultry should have access to drinking

water at all times. Drug overdosage or

lack of water intake may result in leg

weakness or paralysis.

Dated: May 28, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–14650 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

DEPARTMENT OF TRANSPORTATION

Coast Guard

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 21

RIN 2900–AI04

Montgomery GI Bill—Selected

Reserve: Miscellaneous

AGENCIES: Department of Defense,

Department of Transportation (Coast

Guard), and Department of Veterans

Affairs.

ACTION: Final rule.

SUMMARY: This document amends

regulations concerning the Montgomery

GI Bill—Selected Reserve program. It

removes provisions that are obsolete,

duplicative, or otherwise unnecessary. It

also makes changes for purposes of

clarification.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT: June

C. Schaeffer, Assistant Director for

Policy and Program Administration,

Education Service, Veterans Benefits

Administration, Department of Veterans

Affairs, 202–273–7187.

SUPPLEMENTARY INFORMATION: The

regulations governing the Montgomery

GI Bill—Selected Reserve program are

found in 38 CFR, Part 21, Subpart L (see