Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 /Rules and Regulations 26981

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 524

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 two approved new

animal drug applications (NADA’s) from

Mallinckrodt Veterinary Operations

Inc., to Schering-Plough Animal Health

Corp.

EFFECTIVE DATE: May 15, 1998.

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:

Mallinckrodt Veterinary Operations,

Inc., Mundelein, IL 60060, has informed

FDA that it has transferred the

ownership of and all rights and interests

in the approved NADA’s 102–020

(dichlorophene and toluene capsules)

and 111–349 (selenium disulfide

suspension) to Schering-Plough Animal

Health Corp., 1095 Morris Ave., Union,

NJ 07083. The agency is amending the

regulations in 21 CFR 510.600(c)(1) and

(c)(2) to remove the sponsor name for

Mallinckrodt Veterinary Operations,

Inc., because the firm no longer is the

holder of any approved NADA’s. The

agency is also amending 21 CFR 520.580

and 524.2101 to reflect the change of

sponsor.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Parts 520 and 524

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 parts 510, 520, and 524 are

amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘Mallinckrodt

Veterinary Operations, Inc.’’; and in the

table in paragraph (c)(2) by removing

the entry for ‘‘015563’’.

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

3. The authority citation for 21 CFR

part 520 continues to read as follows:

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

§ 520.580 [Amended]

4. Section 520.580 Dichlorophene and

toluene capsules is amended in

paragraph (b)(1) by removing ‘‘015563,’’

and numerically adding ‘‘000061,’’.

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

5. The authority citation for 21 CFR

part 524 continues to read as follows:

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

§ 524.2101 [Amended]

6. Section 524.2101 Selenium

disulfide suspension is amended in

paragraph (c) by removing ‘‘015563’’

and adding in its place ‘‘000061’’.

Dated: May 4, 1998.

Andrew J. Beaulieu,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–12960 Filed 5–14–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Florfenicol

Solution

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

Schering-Plough Animal Health Corp.

The supplemental NADA provides for a

revised warning against use of

florfenicol injectable solution in veal

calves.

EFFECTIVE DATE: May 15, 1998.

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: ScheringPlough Animal Health Corp., 1095

Morris Ave., P.O. Box 1982, Union, NJ

07083–1982, is sponsor of NADA 141–

063 Nuflor Injectable Solution (300

milligrams florfenicol per milliliter) for

veterinary prescription use for

intramuscular treatment of cattle for

bovine respiratory disease. ScheringPlough filed a supplemental NADA

providing for a revised warning against

use of the product in veal calves. The

supplemental NADA is approved as of

April 2, 1998, and the regulations are

amended by revising 21 CFR

522.955(d)(1)(iii) 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.

The agency has determined under 21

CFR 25.33(a)(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.

§ 522.955 [Amended]

2. Section 522.955 Florfenicol

solution is amended in paragraph

(d)(1)(iii) by removing the sentences