70660 Federal Register / Vol. 65, No. 228 / Monday, November 27, 2000 / Rules and Regulations

a. In paragraph (g)(1) remove the

words ‘‘A child may become’’ and add,

in their place ‘‘There is a risk of a child

becoming’’.

b. In paragraph (g)(2)(iv) remove the

first word ‘‘If’’ and add, in its place ‘‘In

the event’’.

c. In paragraph (g)(2)(iv) add a second

sentence to read ‘‘For products not

having an emergency release use instead

‘In the event a person is trapped under

the door, push the control button’ ’’.

d. In paragraph (g)(3)(i) in the second

sentence, remove the word ‘‘If’’ and add

it its place ‘‘In the event’’.

e. In paragraph (i) remove the initial

word ‘‘A’’ and add, in its place ‘‘Except

for door operators complying with

§ 1211.9(b), a’’.

Dated: November 20, 2000.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 00–30041 Filed 11–24–00; 8:45 am]

BILLING CODE 6335–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 00F–1332]

Secondary Direct Food Additives

Permitted in Food for Human

Consumption

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of a mixture of peroxyacetic

acid, octanoic acid, acetic acid,

hydrogen peroxide, peroxyoctanoic

acid, and 1-hydroxyethylidene-1,1-

diphosphonic acid as an antimicrobial

agent on red meat carcasses. This action

is in response to a petition filed by

Ecolab, Inc.

DATES: This rule is effective November

27, 2000. Submit written objections and

requests for a hearing by December 27,

2000. The Director of the Office of the

Federal Register approves the

incorporation by reference in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51 of certain publications in 21

CFR 173.370, as of November 27, 2000.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Robert L. Martin, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204–0001, 202–418–

3074.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

June 13, 2000 (65 FR 37155), FDA

announced that a food additive petition

(FAP 0A4720) had been filed by Ecolab

Inc., Ecolab Center, 370 Wabasha St., St.

Paul, MN 55102. The petition proposed

to amend the food additive regulations

in part 173 (21 CFR part 173) to provide

for the safe use of a mixture of

peroxyacetic acid, octanoic acid, acetic

acid, hydrogen peroxide,

peroxyoctanoic acid, and 1-

hydroxyethylidene-1,1-diphosphonic

acid as an antimicrobial agent on red

meat carcasses.

FDA has evaluated data in the

petition and other relevant material.

Based on this information, the agency

concludes that the proposed use of the

additive is safe and the additive will

achieve its intended technical effect as

an antimicrobial agent on red meat

carcasses. The agency also concludes

that the regulation approving the

additive should be entitled

‘‘Peroxyacids.’’ Reaction of hydrogen

peroxide with acetic acid and octanoic

acid results in partial conversion to

peroxyacetic acid and peroxyoctanoic

acid, respectively. Therefore, part 173 is

amended as set forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the contact person listed above. As

provided in § 171.1(h), the agency will

delete from the documents any

materials that are not available for

public disclosure before making the

documents available for inspection.

In the notice of filing, FDA gave

interested parties an opportunity to

submit comments on the petitioner’s

environmental assessment. FDA

received no comments in response to

that notice.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

This final rule contains no collection

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

Any person who will be adversely

affected by this regulation may at any

time file with the Dockets Management

Branch (address above) written

objections by December 27, 2000. Each

objection shall be separately numbered,

and each numbered objection shall

specify with particularity the provisions

of the regulation to which objection is

made and the grounds for the objection.

Each numbered objection on which a

hearing is requested shall specifically so

state. Failure to request a hearing for

any particular objection shall constitute

a waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

are to be submitted and are to be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

List of Subjects in 21 CFR Part 173

Food additives, Incorporation by

reference.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 173 is

amended as follows:

PART 173—SECONDARY DIRECT

FOOD ADDITIVES PERMITTED IN

FOOD FOR HUMAN CONSUMPTION

1. The authority citation for 21 CFR

part 173 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348.

2. Section 173.370 is added to subpart

D to read as follows:

§ 173.370 Peroxyacids.

Peroxyacids may be safely used in

accordance with the following

prescribed conditions:

(a) The additive is a mixture of

peroxyacetic acid, octanoic acid, acetic

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,