29478 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations

withdrawal time for treated dairy cattle

of breeding age is the same as that

established for beef cattle in the original

NADA 128–620.

Supplemental NADA’s 128–620 and

132–872 are approved as of March 28,

1996, and §§ 520.905a and 520.905c are

amended to reflect the approvals.

Supplemental NADA 137–600 is

approved as of (insert date of

publication in the Federal Register),

and § 558.258 is amended to reflect the

approval. The basis for the approvals is

discussed in the freedom of information

summaries.

Approval of NADA 137–600 is for use

of fenbendazole Type A medicated

article to make Type C medicated feed.

Fenbendazole is a Category II drug

which, as provided in 21 CFR 558.4,

requires an appproved Form FDA 1900

for making a Type C medicated feed.

Therefore, use of fenbendazole Type A

medicated articles to Type C medicated

feeds as in NADA 137–600 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)), summaries of

safety and effectiveness data and

information submitted to support

approval of these applications 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)), these

approvals for food-producing animals

do not qualify for exclusivity because

the supplemental applications do not

contain new clinical or field

investigations (other than

bioequivalence or residue studies) and

new human food safety studies (other

than bioequivalence or residue studies)

essential to the approvals 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

21 CFR Part 520

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

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 parts 520, 556, and 558 are

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).

§ 520.905a [Amended]

2. Section 520.905a Fenbendazole

suspension is amended in paragraph

(d)(2) by revising the paragraph heading

to read ‘‘Beef and dairy cattle’’ and in

paragraph (d)(2)(i)(B) by removing the

third sentence.

§ 520.905c [Amended]

3. Section 520.905c Fenbendazole

paste is amended in paragraph (d)(2) by

revising the paragraph heading to read

‘‘Beef and dairy cattle’’ and in

paragraph (d)(2)(iii) by removing the

third sentence.

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

4. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: Secs. 402, 512, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 342, 360b, 371).

5. Section 556.275 is amended by

adding new paragraph (c) to read as

follows:

§ 556.275 Fenbendazole.

* * * * *

(c) Cattle milk. A safe concentration of

1.67 parts per million is established for

total fenbendazole residues. A tolerance

of 0.6 part per million is established

based on the fenbendazole sulfoxide

metabolite (marker residue).

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

6. 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).

7. Section 558.258 is amended by

revising the introductory text of

paragraph (c)(2), by removing the last

sentence of paragraph (c)(2)(iii), by

revising the introductory text of

paragraph (c)(3) , and by removing the

fourth sentence of paragraph (c)(3)(iii) to

read as follows:

§ 558.258 Fenbendazole.

* * * * *

(c) * * *

(2) It is used in the feed of beef and

dairy cattle as follows:

* * * * *

(3) It is used in free-choice beef and

dairy cattle feed as follows:

* * * * *

Dated: May 28, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–14645 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Ceftiofur

Hydrochloride Sterile Suspension

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 The

Upjohn Co. The NADA provides for use

of ceftiofur hydrochloride sterile

suspension for intramuscular injection

in swine for treatment and control of

certain forms of swine bacterial

respiratory disease.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: The

Upjohn Co., Kalamazoo, MI 49001, is

sponsor of NADA 140–890, which

provides for use of Excenel Sterile

Suspension (ceftiofur hydrochloride

equivalent to 50 milligrams (mg) per

milliliter ceftiofur). The NADA provides

for intramuscular injection in swine for

treatment and control of swine bacterial

respiratory disease (swine bacterial

pneumonia) associated with

Actinobacillus (Haemophilus)
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