Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Rules and Regulations 20731

Dated: March 20, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–9575 Filed 4–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

Oral Dosage Form New Animal Drugs;

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 a new animal drug

application (NADA) from Merial Ltd., to

Ve ́toquinol N.–A., Inc.

DATES: This rule is effective April 18,

2000.

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: Merial

Ltd., 2100 Ronson Rd., Iseline, NJ

08830–3077, has informed FDA that it

has transferred the ownership of, and all

rights and interests in, the approved

NADA 113–510 (phenylbutazone

granules) to Ve ́toquinol N.–A., Inc.,

2000 chemin Georges, Lavaltrie (PQ),

Canada, J0K 1H0. Accordingly, the

agency is amending the regulations in

21 CFR 510.600(c) and 520.1720b(b) to

reflect the change of sponsor.

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

congressional review requirements in 5

U.S.C. 801–808.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 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.

2. Section 510.600 is amended in the

table in paragraph (c)(1) by

alphabetically adding an entry for

‘‘Ve ́toquinol N.–A., Inc.,’’ and in the

table in paragraph (c)(2) by numerically

adding an entry for ‘‘059320’’ to read as

follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

*******

Ve ́toquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada,

J0K 1H0

059320

*******

(2) * * *

Drug labeler code Firm name and address

*******

059320 Ve ́toquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada,

J0K 1H0

*******

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.

§ 520.1720b [Amended]

4. Section 520.1720b Phenylbutazone

granules is amended in paragraph (b) by

removing ‘‘050604’’ and by adding in its

place ‘‘059320’’.

Dated: March 17, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–9573 Filed 4–17–00; 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; Hemoglobin

Glutamer-200 (bovine)

AGENCY: Food and Drug Administration,

HHS.