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.

Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Rules and Regulations 20733

§ 526.365 [Amended]

2. Section 526.365 Cephapirin sodium

for intramammary infusion is amended

in paragraph (d)(3) by removing ‘‘(8

milkings)’’.

Dated: March 17, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–9572 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 556

Tolerances for Residues of New

Animal Drugs in Food; Fenbendazole

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

Hoechst Roussel Vet. The supplemental

NADA provides for establishing

tolerances for residues of fenbendazole

in edible tissues of swine. Technical

corrections are also made.

DATES: This rule is effective April 18,

2000.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–130), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578.

SUPPLEMENTARY INFORMATION: Hoechst

Roussel Vet, Perryville Corporate Park

III, P.O. Box 4010, Clinton, NJ 08809–

4010, filed a supplement to NADA 131–

675 that provides for use of Safe-Guard

(20 percent fenbendazole) Type A

medicated articles to make Type B and

C medicated swine feeds. The

supplement provides for establishing

tolerances for parent fenbendazole in

swine liver and muscle. The

supplement is approved as of February

10, 2000, and § 556.275 (21 CFR

556.275) is amended to reflect the

approval. The basis of approval is

discussed in the freedom of information

summary.

Section 556.275 is further amended

by deleting references to safe

concentrations and by adding the

previously established acceptable daily

intake (ADI) of total residues of

fenbendazole. The footnote for

‘‘tolerance’’ in that section is also

removed.

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, rm. 1061, 5630 Fishers

Lane, Rockville, MD 20852, from 9 a.m.

to 4 p.m., Monday through Friday.

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 556

Animal drugs, Foods.

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 556 is amended as follows:

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

1. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

2. Section 556.275 is revised to read

as follows:

§ 556.275 Fenbendazole.

(a) Acceptable daily intake (ADI). The

ADI for total residues of fenbendazole is

40 micrograms per kilogram of body

weight per day.

(b) Tolerances—(1) Cattle—(i) Liver

(the target tissue). The tolerance for

parent fenbendazole (the marker

residue) is 0.8 part per million (ppm).

(ii) [Reserved]

(iii) Milk. The tolerance for

fenbendazole sulfoxide metabolite (the

marker residue in cattle milk) is 0.6

ppm.

(2) Swine—(i) Liver (the target tissue).

The tolerance for parent fenbendazole

(the marker residue) is 6 ppm.

(ii) Muscle. The tolerance for parent

fenbendazole (the marker residue) is 2

ppm.

(3) Goats—(i) Liver (the target tissue).

The tolerance for parent fenbendazole

(the marker residue) is 0.8 ppm.

(ii) [Reserved]

Dated: March 17, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–9578 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 558

New Animal Drugs for Use in Animal

Feeds; Bambermycins; Technical

Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is updating the

animal drug regulations to correctly

reflect the previously approved use

level for bambermycins Type C

medicated cattle feed. This document

amends the regulations to state the

correct use level is 2 to 40 grams (g) of

bambermycins per ton of feed. This

action is being taken to improve the

accuracy of the agency’s regulations.

DATES: This rule is effective April 18,

2000.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0217.

SUPPLEMENTARY INFORMATION: Hoechst

Roussel Vet, Perryville Corporate Park

III, P.O. Box 4010, Clinton, NJ 08809–

4010, is sponsor of NADA 141–034 that

provides for use of GAINPRO

(bambermycins) Type A medicated

articles to make Type B and Type C

medicated cattle feeds. In its approval

letter of October 17, 1994, the Center for

Veterinary Medicine approved the use

of Type C medicated feeds containing 2

to 40 g of bambermycins per ton of feed,

used to provide 10 to 20 milligrams

bambermycins per head per day for

increased rate of weight gain in pasture

cattle. At this time, 21 CFR

558.95(d)(4)(ii) is amended by removing

‘‘4 to 20’’ and adding in its place ‘‘2 to

40’’ to reflect the correct Type C

medicated feed levels.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because