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

20730 Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Rules and Regulations

245, Bensenville, IL 60106, filed NADA

141–162 that provides for use in dogs,

9 weeks of age and older and 4 pounds

body weight or greater, for the

prevention and control of flea

populations. (S)-methoprene prevents

and controls flea populations by

preventing the development of flea eggs

but does not kill adult fleas. Concurrent

use of insecticides may be necessary for

adequate control of adult fleas. NADA

141–162 is approved as of January 24,

2000, and the regulations are amended

in 21 CFR part 520 by adding new

§ 520.1390 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, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

Under section 512(c)(2)(F)(i) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360b(c)(2)(F)(i)), this

approval qualifies for 5 years of

marketing exclusivity beginning January

24, 2000, because no active ingredient

(including any ester or salt of the drug)

has been previously approved in any

other application filed under section

512(b)(1) of the act.

The agency has determined under 21

CFR 25.33(d)(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.

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 the

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

‘‘Wellmark International’’ and in the

table in paragraph (c)(2) by numerically

adding an entry for ‘‘011536’’ 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

*******

Wellmark International, 1000 Tower Rd., suite 245, Bensenville, IL

60106

011536

*******

(2) * * *

Drug labeler code Firm name and address

*******

011536 Wellmark International, 1000 Tower Rd., suite 245, Bensenville, IL

60106

*******

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.

4. Section 520.1390 is added to read

as follows:

§ 520.1390 (S)-methoprene.

(a) Specifications. Each capsule

contains 154, 308, or 462 milligrams

(mg) of (S)-methoprene.

(b) Sponsor. See No. 011536 in

§ 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Amount.

Capsules are given orally, once per week

at the recommended minimum dosage

of 10 mg of (S)-methoprene per pound

of body weight (22 mg/kilograms).

(2) Indications for use. For oral use in

dogs, 9 weeks of age and older and 4

pounds body weight or greater, for the

prevention and control of flea

populations. (S)-methoprene prevents

and controls flea populations by

preventing the development of flea eggs

but does not kill adult fleas. Concurrent

use of insecticides may be necessary for

adequate control of adult fleas.

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.