Federal Register / Vol. 65, No. 228 / Monday, November 27, 2000 / Rules and Regulations 70661

acid, hydrogen peroxide,

peroxyoctanoic acid, and 1-

hydroxyethylidene-1,1-diphosphonic

acid.

(b) The additive is used as an

antimicrobial agent on red meat

carcasses in accordance with current

industry practice where the maximum

concentration of peroxyacids is 220

parts per million (ppm) as peroxyacetic

acid and the maximum concentration of

hydrogen peroxide is 75 ppm.

(c) The concentrations of peroxyacids

and hydrogen peroxide in the additive

are determined by a method entitled

‘‘Hydrogen Peroxide and Peracid (as

Peracetic Acid) Content,’’ dated July 26,

2000, developed by Ecolab, Inc., which

is incorporated by reference. The

Director of the Office of the Federal

Register approves this incorporation by

reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. You may

obtain copies of this method from the

Division of Petition Control (HFS–215),

Center for Food Safety and Applied

Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204–0001, or you

may examine a copy at the Center for

Food Safety and Applied Nutrition’s

Library, 200 C St. SW., rm. 3321,

Washington, DC, or at the Office of the

Federal Register, 800 North Capitol St.

NW., suite 700, Washington, DC.

Dated: November 14, 2000.

L. Robert Lake,

Director of Regulations Policy, Center for

Food Safety and Applied Nutrition.

[FR Doc. 00–30050 Filed 11–24–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Ivermectin Paste

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 an abbreviated new animal

drug application (ANADA) filed by

Phoenix Scientific, Inc. The ANADA

provides for use of ivermectin oral paste

for the treatment and control of various

species of harmful gastrointestinal

parasites in horses.

DATES: This rule is effective November

27, 2000.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: Phoenix

Scientific, Inc., 3915 South 48th Street

Terrace, P.O. Box 6457, St. Joseph, MO

64506–0457, filed ANADA 200–286 that

provides for use of PHOENECTINTM

(ivermectin) Paste 1.87%. The ANADA

provides for oral use of ivermectin paste

for the treatment and control of various

species of harmful gastrointestinal

parasites in horses. The ANADA is

approved as a generic copy of Merial

Ltd.’s NADA 134–314 for EQVALAN

(ivermectin) Paste for Horses. ANADA

200–286 is approved as of September

20, 2000, and the regulations are

amended in 21 CFR 520.1192 to reflect

the approval. The basis for 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.

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 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 part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

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

2. Section 520.1192 is amended by

revising paragraphs (a) and (b), by

redesignating paragraph (c) as paragraph

(d), and by adding new paragraph (c) to

read as follows.

§ 520.1192 Ivermectin paste.

(a) Specifications. Each milligram of

paste contains 0.0187 milligram (1.87

percent) or 0.00153 milligram (0.153

percent) of ivermectin.

(b) Sponsors. See sponsor numbers in

§ 510.600(c) of this chapter, as follows:

(1) No. 050604 for use of a 1.87

percent paste as in paragraph (d)(1) of

this section and a 0.153 percent paste as

in paragraph (d)(2) of this section.

(2) No. 059130 for use of a 1.87

percent paste as in paragraph (d)(1) of

this section.

(c) Related tolerances. See § 556.344

of this chapter.

* * * * *

Dated: October 16, 2000.

Stephen S. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–30048 Filed 11–24–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Nitenpyram Tablets

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 Novartis

Animal Health US, Inc. The NADA

provides for the oral use of nitenpyram

tablets for the treatment of flea

infestations in dogs, puppies, cats, and

kittens that are 4 weeks of age and older

and 2 pounds (lb) of body weight or

greater.

DATES: This rule is effective November

27, 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: Novartis

Animal Health US, Inc., 3200 Northline

Ave., suite 300, Greensboro, NC 27408,

filed NADA 141–175 that provides for

the over-the-counter use of CAPSTARTM

(nitenpyram) tablets for the oral

treatment of flea infestations on dogs,

70662 Federal Register / Vol. 65, No. 228 / Monday, November 27, 2000 / Rules and Regulations

puppies, cats, and kittens that are 4

weeks of age and older and 2 lb of body

weight or greater. The NADA is

approved as of October 20, 2000, and

the regulations are amended in part 520

(21 CFR part 520) by adding § 520.1510

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 October

20, 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 in 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 part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

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

2. Section 520.1510 is added to read

as follows:

§ 520.1510 Nitenpyram.

(a) Specifications. Each tablet

contains 11.4 or 57 milligrams of

nitenpyram.

(b) Sponsor. See No. 058198 in

§ 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—Dogs and

cats—(1) Amount. One tablet given

orally, as needed.

(2) Indications for use. For the

treatment of flea infestations on dogs,

puppies, cats, and kittens 4 weeks of age

and older and 2 pounds of body weight

or greater.

Dated: November 8, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–30047 Filed 11–24–00; 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; Trenbolone

and Estradiol

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 abbreviated

new animal drug application (ANADA)

filed by Ivy Laboratories, Inc. The

supplemental ANADA provides for

adding tylosin tartrate as a local

antibacterial to an approved

subcutaneous cattle ear implant

containing trenbolone and estradiol

used in pasture cattle for increased rate

of weight gain.

DATES: This regulation is effective

November 27, 2000.

FOR FURTHER INFORMATION CONTACT:

Daniel A. Benz, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0223.

SUPPLEMENTARY INFORMATION: Ivy

Laboratories, Inc., 8857 Bond St.,

Overland Park, KS 66214, filed

supplemental ANADA 200–221 for

COMPONENT TE–G (trenbolone

acetate/estradiol) with Tylan, a

subcutaneous ear implant containing 40

of milligrams (mg) trenbolone acetate

and 8 mg of estradiol, in 2 pellets, each

pellet containing 20 mg of trenbolone

acetate and 4 mg of estradiol, and an

additional pellet containing 29 mg of

tylosin tartrate as a local antibacterial.

The implants are used in pasture cattle

(slaughter, stocker, and feeder steers and

heifers) for increased rate of weight

gain. The supplemental application is

approved as of September 18, 2000, and

the regulations are amended in 21 CFR

522.2477 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 food-producing animals

qualifies for 3 years of marketing

exclusivity beginning September 18,

2000, because the application contains

substantial evidence of the effectiveness

of the drug involved, any studies of

animal safety or, in the case of foodproducing animals, human food safety

studies (other than bioequivalence or

residue studies) required for the

approval and conducted or sponsored

by the applicant. The 3 years of

marketing exclusivity applies only to

the addition of tylosin tartrate to the

implant for which the supplemental

application was approved.

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 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.