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.

20732 Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Rules and Regulations

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

Biopure Corp. The supplemental NADA

provides for flexible dosing for use of

hemoglobin glutamer-200 (bovine) to

treat anemia in dogs.

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: Biopure

Corp., 11 Hurley St., Cambridge, MA

02141, is the sponsor of NADA 141–067

that provides for the veterinary

prescription use of Oxyglobin

(hemoglobin glutamer-200 (bovine)) for

the treatment of anemia in dogs. The

drug increases systemic oxygen content

(plasma hemoglobin concentration) and

improves the clinical signs associated

with anemia, regardless of the cause of

anemia (hemolysis, blood loss, or

ineffective erythropoiesis). The

supplemental NADA provides for use of

10 to 30 milliliters per kilogram of body

weight (mL/kg) administered at 10 mL/

kg/hour. The supplemental NADA is

approved as of January 11, 2000, and 21

CFR 522.1125(d) is amended 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)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

approval for nonfood-producing animals

qualifies for 3 years of marketing

exclusivity beginning January 11, 2000,

because the approval contains

substantial evidence of effectiveness of

the drug involved, or any studies of

animal safety, required for approval of

the supplement and conducted or

sponsored by the applicant. The 3 years

of marketing exclusivity applies only to

use of the dosing range of 10 to 30 mL/

kg.

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 in 21 CFR Part 522

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 part 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 522.1125 [Amended]

2. Section 522.1125 Hemoglobin

glutamer-200 (bovine) is amended in

paragraph (d)(1) by removing ‘‘30’’ and

adding in its place ‘‘10 to 30’’ and in

paragraph (d)(2) by removing the phrase

‘‘for at least 24 hours’’.

Dated: March 17, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–9576 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 526

Intramammary Dosage Form New

Animal Drugs; Cephapirin Sodium for

Intramammary Infusion

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 Fort

Dodge Animal Health. The

supplemental NADA provides for

amending the milk discard statement to

state the milk discard time only (i.e., to

remove reference to the number of

milkings).

DATES: This rule is effective April 18,

2000.

FOR FURTHER INFORMATION CONTACT:

Naba K. Das, Center for Veterinary

Medicine (HFV–130), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–7569.

SUPPLEMENTARY INFORMATION: Fort

Dodge Animal Health, Division of

American Home Products Corp., 800

Fifth Street NW., P.O. Box 518, Fort

Dodge, IA 50501, filed supplemental

NADA 97–222 that provides for a 96-

hour milk-discard time (i.e., removal of

the parenthetical reference to an 8-

milking milk discard time) for use of

CEFA–LAK and TODAY (cephapirin

sodium) intramammary infusion

products for treatment of lactating cows

for bovine mastitis. The supplemental

NADA is approved as of February 4,

2000, and the regulations are amended

in 21 CFR 526.365(d)(3) to reflect the

approval.

Approval of this supplemental NADA

conforms to the requirements of 21 CFR

510.105. Approval does not require

review of the safety or effectiveness data

required for approval of the NADA.

Therefore, a freedom of information

summary is not required.

The agency has determined under 21

CFR 25.33(a)(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 in 21 CFR Part 526

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 part 526 is amended as follows:

PART 526—INTRAMAMMARY DOSAGE

FORMS

1. The authority citation for 21 CFR

part 526 continues to read as follows:

Authority: 21 U.S.C. 360b.