24420 Federal Register / Vol. 63, No. 85 / Monday, May 4, 1998 /Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Propofol

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 Abbott

Laboratories. The NADA provides for

veterinary prescription use of propofol

emulsion for intravenous injection in

dogs as an anesthetic.

EFFECTIVE DATE: May 4, 1998.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center ForVeterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1612.

SUPPLEMENTARY INFORMATION: Abbott

Laboratories, 1401 Sheridan Rd., North

Chicago, IL 60064–4000, filed NADA

141–098 that provides for veterinary

prescription use of PropoFlo

(propofol) emulsion for intravenous

injection in dogs for induction of

anesthesia, maintenance of anesthesia,

or induction of anesthesia where

maintenance is provided by inhalation

anesthetic. The NADA is approved as of

March 13, 1998, and the regulations are

amended in 21 CFR 522.2005(b) 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, 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 for nonfood-producing animals

qualifies for 3 years of marketing

exclusivity beginning March 13, 1998,

because the application contains

substantial evidence of the effectiveness

of the drug involved and studies of

animal safety required for approval and

conducted or sponsored by the

applicant.

The agency has determined under 21

CFR 25.33(d)(1) 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 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: 21 U.S.C. 360b.

§ 522.2005 [Amended]

2. Section 522.2005 Propofol injection

is amended in paragraph (b) by

removing ‘‘No. 000061’’ and adding in

its place ‘‘Nos. 000061 and 000074’’.

Dated: April 22, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–11740 Filed 5–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Monensin

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 two supplemental new

animal drug applications (NADA’s) filed

by Elanco Animal Health, Division of

Eli Lilly and Co. The supplemental

NADA’s provide a revised specification

for monensin bulk drug substance used

to make monensin Type A medicated

articles.

EFFECTIVE DATE: May 4, 1998.

FOR FURTHER INFORMATION CONTACT:

Mary G. Leadbetter, Center for

Veterinary Medicine (HFV–142), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1662.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, Division of Eli Lilly and

Co., Lilly Corporate Center,

Indianapolis, IN 46285, is the sponsor of

NADA 38–878 that provides for use of

monensin Type A medicated articles to

make monensin Type C medicated feeds

for chickens, turkeys, and quail, and

NADA 95–735 that provides for use of

monensin Type A medicated articles to

make monensin Type B and C

medicated feeds for cattle and goats.

Elanco filed supplemental NADA’s that

provide revised assay information used

in checking the specifications of the

monensin bulk drug substance used in

Type A medicated articles. The

supplemental NADA’s were approved as

of March 17, 1997, and the regulations

are amended in 21 CFR 558.355(a) to

reflect the approval.

Approval of these supplements did

not require a freedom of information

summary because the approvals concern

a change in specifications of the

monensin bulk drug substance. This

change does not affect the product’s

safety or effectiveness.

The agency has determined under 21

CFR 25.33(a)(3) 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: 21 U.S.C. 360b, 371.

§ 558.355 [Amended]

2. Section 558.355 Monensin is

amended in paragraph (a) after the

parenthetical phrase by removing the

period at the end of the second

sentence, and by adding the phrase ‘‘,

or, using High Performance Liquid

Chromatography, the factor distribution

of monensin Factor A or B is calculated

as the percentage of total biopotency of

all peaks.’’