Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29551

‘‘List of substances’’ and ‘‘Limitations’’

to read as follows:

§ 178.3400 Emulsifiers and/or surface

active agents.

* * * * *

(c) * * *

List of substances Limitations

* * * * * * *

Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl ether,

disodium salt (alcohol moiety produced by condensation of 1 mole

nonylphenol and an average of 9–10 moles of ethylene oxide) (CAS

Reg. No. 9040–38–4).

For use only at levels not to exceed 5 percent by weight of the total

coating monomers used in the emulsion polymerization of polyvinyl

acetate and vinyl-acrylate copolymers intended for use as coatings

for paper and paperboard.

* * * * * * *

* * * * *

Dated: May 15, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14296 Filed 5–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

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

Deprenyl Animal Health, Inc., to Pfizer,

Inc.

EFFECTIVE DATE: June 1, 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: Deprenyl

Animal Health, Inc., 7101 College Blvd.,

suite 580, Overland Park, KS 66210, has

informed FDA that it has transferred the

ownership of, and all rights and

interests in, the approved NADA 141–

080 (selegiline hydrochloride tablets) to

Pfizer, Inc., 235 East 42d St., New York,

NY 10017. The agency is amending 21

CFR 510.600(c)(1) and (c)(2) to remove

the sponsor name for Deprenyl Animal

Health, Inc., because the firm no longer

is the holder of any approved NADA’s.

The agency is also amending 21 CFR

520.2098 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

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 and 520 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 ‘‘Deprenyl

Animal Health, Inc.’’; and in the table in

paragraph (c)(2) by removing the entry

for ‘‘063248’’.

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.

§ 520.2098 [Amended]

4. Section 520.2098 Selegiline

hydrochloride tablets is amended in

paragraph (b) by removing ‘‘063248’’

and by adding in its place ‘‘000069’’.

Dated: May 12, 1998.

Andrew J. Beaulieu,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–14299 Filed 5–29–98; 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; Lufenuron

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 Novartis

Animal Health US, Inc. The NADA

provides for subcutaneous use of

lufenuron suspension in cats for control

of flea populations.

EFFECTIVE DATE: June 1, 1998.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1612.

SUPPLEMENTARY INFORMATION: Novartis

Animal Health US, Inc., P.O. Box 26402,

Greensboro, NC 27404–6402, is the

sponsor of NADA 141–105 that provides

for the subcutaneous use of ProgramTM

(lufenuron) 10 percent sterile

suspension for cats for the control of

flea populations. The drug is limited to

use by or on the order of a licensed

veterinarian. The NADA is approved as

of March 13, 1998, and the regulations

are amended by adding § 522.1289 to

reflect the approval. The basis of