Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Rules and Regulations 21283

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Ceftiofur

Sterile Powder for 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 a supplemental new animal

drug application (NADA) filed by

Pharmacia and Upjohn Co. The

supplemental NADA provides for

intramuscular injection of a solution of

reconstituted ceftiofur sodium powder

for treatment of caprine respiratory

disease (goat pneumonia).

DATES: This rule is effective April 30,

2001.

FOR FURTHER INFORMATION CONTACT:

Naba K. Das, Center for Veterinary

Medicine (HFV–130), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–7569.

SUPPLEMENTARY INFORMATION: Pharmacia

and Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001–0199, filed

supplemental NADA 140–338 that

provides for use of Naxcel (ceftiofur

sodium) sterile powder for injection for

treatment by intramuscular injection of

caprine respiratory disease (goat

pneumonia) associated with Pasteurella

haemolytica and P. multocida.

The supplemental NADA is approved

as of March 7, 2001, and the regulations

are amended in 21 CFR 522.313 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 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this supplemental

application may be seen in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852,

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

through Friday.

The agency has determined under 21

CFR 25.33(d)(4) 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.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

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 FOR NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

2. Section 522.313 is amended by

revising the section heading and by

adding paragraph (d)(8) to read as

follows:

§ 522.313 Ceftiofur sodium powder for

injection.

* * * * *

(d) * * *

(8) Goats—(i) Amount. 0.5 to 1.0

milligram per pound of body weight by

intramuscular injection at 24-hour

intervals for a total of 3 consecutive

days. Additional treatments may be

given on days 4 and 5 for animals that

do not show satisfactory response.

(ii) Indications for use. For treatment

of caprine respiratory disease (goat

pneumonia) associated with Pasteurella

haemolytica and P. multocida.

(iii) Limitations. Federal law restricts

this drug to use by or on the order of

a licensed veterinarian.

Dated: April 16, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–10620 Filed 4–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Ractopamine and Tylosin

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 Elanco

Animal Health. The NADA provides for

use of ractopamine and tylosin singleingredient Type A medicated articles to

make combination drug Type C

medicated feeds used for increased rate

of weight gain, improved feed

efficiency, increased carcass leanness,

and prevention and/or control of

porcine proliferative enteropathies

(ileitis) in swine.

DATES: This rule is effective April 30,

2001.

FOR FURTHER INFORMATION CONTACT:

Charles J. Andres, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–1600.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, A Division of Eli Lilly

& Co., Lilly Corporate Center,

Indianapolis, IN 46285, filed NADA

141–172 that provides for use of

Paylean (9 grams per pound (g/lb)

ractopamine hydrochloride) and Tylan

(10, 40, or 100 g/lb tylosin phosphate)

Type A medicated article to make

combination drug Type C medicated

feeds used for increased rate of weight

gain, improved feed efficiency, and

increased carcass leanness, and for

prevention and/or control of porcine

proliferative enteropathies (ileitis)

associated with Lawsonia intracellularis

in swine. The NADA is approved as of

February 20, 2001, and the regulations

are amended in 21 CFR 558.500 and

558.625 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 21 CFR part

20 and 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, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

The agency has determined under 21

CFR 25.33(a)(2) 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.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.