Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations 29479

pleuropneumoniae, Pastureurella

multocida, Salmonella choleraesuis,

and Streptococcus suis Type 2 at 1.36 to

2.27 mg/pound body weight (3 to 5 mg/

kilograms). The NADA is approved as of

April 26, 1996, and the regulations are

amended by adding new 21 CFR

522.314 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)(ii) of the

Federal Food, Drug, and Cosmetic Act

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

approval qualifies for 3 years of

marketing exclusivity beginning April

26, 1996, because it contains reports of

new clinical or field investigations

(other than bioequivalence or residue

studies) or human food safety studies

(other than bioequivalence or residue

studies) essential to the approval and

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. New § 522.314 is added to read as

follows:

§ 522.314 Ceftiofur hydrochloride sterile

suspension.

(a) Specifications. Each milliliter

contains ceftiofur hydrochloride

equivalent to 50 milligrams of ceftiofur.

(b) Sponsor. See No. 000009 in

§ 510.600(c) of this chapter.

(c) Related tolerances. See § 556.113

of this chapter.

(d) Conditions of use. (1) Swine—(i)

Amount. 3 to 5 milligrams per kilogram

(1.36 to 2.27 milligrams per pound) of

body weight.

(ii) Indications for use. For treatment

and control of swine bacterial

respiratory disease (swine bacterial

pneumonia) associated with

Actinobacillus (Haemophilus)

pleuropneumoniae, Pastureurella

multocida, Salmonella choleraesuis,

and Streptococcus suis Type 2.

(iii) Limitations. For intramuscular

use only. Treatment should be repeated

at 24–hour intervals for a total of 3

consecutive days. Do not use in animals

previously found to be hypersensitive to

the drug. Use of dosages in excess of

those indicated or route of

administration other than that

recommended may result in illegal

residues in tissues. Safety of ceftiofur

has not been determined in breeding

swine. Federal law restricts this drug to

use by or on the order of a licensed

veterinarian.

(2) [Reserved]

Dated:May 28, 1996

Stephen F. Sundlof

Director,Center for Veterinary Medicine

[FR Doc. 96–14651 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Animal Drugs, Feeds, and Related

Products; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

change of sponsor for an approved new

animal drug application (NADA) from

Syntex Animal Health, Division of

Syntex Agri-business, Inc., to Fort

Dodge Laboratories, Division of

American Home Products.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Syntex

Animal Health, Division of Syntex Agribusiness, Inc., 3401 Hillview Ave., Palo

Alto, CA 94303, has informed FDA that

it has transferred the ownership of, and

all rights and interests in, the approved

NADA 141–043 (Synovex Plus) to Fort

Dodge Laboratories, Division of

American Home Products Corp., 800 5th

St. NW., Fort Dodge, IA 50501.

Accordingly, FDA is amending the

regulations in 21 CFR part 522.2478 to

reflect the change of sponsor.

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).

§ 522.2478 [Amended]

2. Section 522.2478 Trenbolone

acetate and estradiol benzoate is

amended in paragraph (a) by removing

‘‘000033’’ and adding in its place

‘‘000856’’.

Dated: May 22, 1996.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–14649 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Trenbolone

Acetate and Estradiol

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

Roussel-UCLAF, Division AgroVeterinaire. The supplemental NADA

provides for use of an ear implant

containing trenbolone acetate and

estradiol in pasture steers for increased

rate of weight gain.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug
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