Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Rules and Regulations 20729

* * * * *

Dated: March 28, 2000.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 00–9570 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 510

New Animal Drugs; Change of Sponsor

Address

AGENCY: Food and Drug Administration

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor address for

International Nutrition, 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:

International Nutrition, Inc., 6664 ‘‘L’’

St., Omaha, NE 68117, has informed

FDA of a change of sponsor address to

7706 ‘I’ Plaza, Omaha, NE 68127.

Accordingly, the agency is amending

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

and (c)(2) to reflect the change of

sponsor address.

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 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.

2. Section 510.600 is amended in the

table in paragraph (c)(1) by revising the

entry for ‘‘International Nutrition, Inc.’’

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

revising the entry for ‘‘043733’’ 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

*******

International Nutrition, Inc., 7706 ‘I’ Plaza, Omaha, NE 68127 043733

*******

(2) * * *

Drug labeler code Firm name and address

*******

043733 International Nutrition, Inc., 7706 ‘I’ Plaza, Omaha, NE 68127

*******

Dated: March 17, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–9574 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;

(S)-methoprene

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 Wellmark

International. The NADA provides for

oral use of (S)-methoprene for the

prevention and control of flea

populations.

DATES: This rule is effective April 18,

2000.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–7540.

SUPPLEMENTARY INFORMATION: Wellmark

International, 1000 Tower Rd., suite