41188 Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 /Rules and Regulations

2 (Type) of the Automated Export

Reporting Program (AERP) record

layout. This indicator code should be

used in lieu of the domestic (D) or

foreign (F) indicator code required in

those fields on the SED Form, the AES

record, and the AERP record. The FMS

indicator code will serve to identify

more accurately that segment of U.S.

exports that represent FMS deliveries in

the U.S. export statistics.

* * * * *

Dated: July 16, 1998.

Bradford R. Huther,

Deputy Director, Bureau of the Census.

[FR Doc. 98–20616 Filed 7–31–98; 8:45 am]

BILLING CODE 3510–07–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

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

Ohmeda Pharmaceutical Products

Division, Inc., to Baxter Pharmaceutical

Products, Inc.

EFFECTIVE DATE: August 3, 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: Ohmeda

Pharmaceutical Products Division, Inc.,

Liberty Corner, NJ 07938–0804, has

informed FDA that it has transferred the

ownership of, and all rights and

interests in, approved NADA 135–773

(isoflurane) to Baxter Pharmaceutical

Products, Inc., 110 Allen Rd., P.O. Box

804, Liberty Corner, NJ 07938. The new

sponsor will retain the drug labeler code

for Ohmeda, Pharmaceutical Products,

Inc. The agency is amending the

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

(c)(2) to reflect the new sponsor name.

List of Subject in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 510 is 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 ‘‘Ohmeda

Pharmaceutical Products Division,

Inc.,’’ and by alphabetically adding an

entry for ‘‘Baxter Pharmaceutical

Products, Inc., 110 Allen Rd., Liberty

Corner, NJ 07938’’; and in the table in

paragraph (c)(2) in the entry for

‘‘010019’’ by removing the sponsor

name ‘‘Ohmeda Pharmaceutical

Products Division, Inc.,’’ and adding in

its place ‘‘Baxter Pharmaceutical

Products, Inc., 110 Allen Rd.,’’.

Dated: July 10, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–20531 Filed 7–31–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

Animal Drugs, Feeds, and Related

Products; Change of Sponsor Name

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 name from RhonePoulenc Chemicals, Ltd., to Rhodia

Limited.

EFFECTIVE DATE: August 3, 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: RhonePoulenc Chemicals, Ltd., P.O. Box 46,

St. Andrews Rd., Avonmouth, Bristol

BS119YF, England, UK, has informed

FDA of a change of sponsor name to

Rhodia, Limited. Accordingly, the

agency is amending 21 CFR

510.600(c)(1) and (c)(2) to reflect the

change of sponsor name.

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 510 is 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 ‘‘Rhone-Poulenc

Chemicals, Ltd.,’’ and by alphabetically

adding an entry for ‘‘Rhodia Limited’’;

and in the table in paragraph (c)(2) in

the entry for ’’059258’’ by removing the

sponsor name for ‘‘Rhone-Poulenc

Chemicals, Ltd.,’’ and adding in its

place ‘‘Rhodia Limited’’.

Dated: July 10, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

EvaluationCenter for Veterinary Medicine.

[FR Doc. 98–20532 Filed 7–31–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Milbemycin Oxime Tablets

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

Novartis Animal Health US, Inc. The

supplemental NADA provides for use of

a lower dose of milbemycin oxime in

treating dogs and puppies for the

prevention of heartworm disease.

EFFECTIVE DATE: AUGUST 3, 1998.