Federal Register / Vol. 62, No. 154 / Monday, August 11, 1997 / Rules and Regulations 42901

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 304, 308, 310, 320, 327,

381, 416, and 417

[Docket No. 97–047N]

Availability of Guidelines for

Escherichia coli Testing

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Notice of availability of revised

guidelines.

SUMMARY: The Food Safety and

Inspection Service (FSIS) has made

revisions to the ‘‘Guidelines for

Escherichia coli Testing for Process

Control Verification in Cattle and Swine

Slaughter Establishments’’ (E. coli-1)

and ‘‘Guidelines for Escherichia coli

Testing for Process Control Verification

in Poultry Slaughter Establishments’’ (E.

coli-2). The revised guidelines are

available from FSIS.

ADDRESSES: Copies of the guidebooks

are available from the Public Outreach

Office, Room 1180, South Agriculture

Building, 1400 Independence Avenue,

SW, Washington, DC 20250–3700. To

obtain a copy, please mail your request

indicating the number (i.e., E. coli-1 or

E. coli-2) and title of the document to

the Public Outreach Office at the above

address; or FAX to (202) 720–9063.

FOR FURTHER INFORMATION CONTACT: Ms.

Patricia Stolfa, Assistant Deputy

Administrator, Regulations &

Inspection, Office of Policy, Program

Development and Evaluation, Food

Safety and Inspection Service at (202)

205–0699, FAX (202) 401–1760.

SUPPLEMENTARY INFORMATION: On July

25, 1996, FSIS published a final rule,

‘‘Pathogen Reduction; Hazard Analysis

and Critical Control Point (HACCP)

Systems,’’ (61 FR 38806). The new

regulations (1) require that each

establishment develop, implement, and

maintain written sanitation standard

operating procedures (Sanitation SOP’s);

(2) require regular microbial testing for

generic E. coli by slaughter

establishments to verify the adequacy of

the establishments’ process controls for

the prevention and removal of fecal

contamination and associated bacteria;

(3) establish pathogen reduction

performance standards for Salmonella

that slaughter establishments and

establishments producing raw ground

products must meet; and (4) require that

all meat and poultry establishments

develop and implement a system of

preventive controls designed to improve

the safety of their products, known as

HACCP (Hazard Analysis and Critical

Control Points).

As appendices to the final rule, FSIS

included guidelines for E. coli testing.

These guidelines outline the sampling

and microbial testing procedures that

would meet the regulatory requirements

and may be helpful to microbiologists or

analytic laboratories.

On May 13, 1997, FSIS published the

final rule, ‘‘Pathogen Reduction; Hazard

Analysis and Critical Control Point

(HACCP) Systems,’’ (62 FR 26211). In

light of some revisions to the E. coli

testing requirements, FSIS has revised

the guidelines. The new guidelines,

‘‘Guidelines for Escherichia coli Testing

for Process Control Verification in Cattle

and Swine Slaughter Establishments’ (E.

coli-1) and ‘‘Guidelines for Escherichia

coli Testing for Process Control

Verification in Poultry Slaughter

Establishments’’ (E. coli-2), are available

from FSIS (see ADDRESSES).

Done at Washington, DC, on: August 7,

1997.

Thomas J. Billy,

Administrator.

[FR Doc. 97–21123 Filed 8–8–97; 8:45 am]

BILLING CODE 3410–DM–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 96–AWP–33]

Amendment to Class E Airspace;

Salyer Farms, CA

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This action amends the Class

E airspace area at Salyer Farms, CA. The

development of a Special Global

Positioning System (GPS) Runway

(RWY) 32 Standard Instrument

Approach Procedure (SIAP) has made

this action necessary. The intended

effect of this action is to provide

adequate controlled airspace for

Instrument Flight Rules (IFR) operations

at Salyer Farms Airport, Salyer Farms,

CA.

EFFECTIVE DATE: 0901 UTC September

11, 1997.

FOR FURTHER INFORMATION CONTACT:

Larry Tonish, Airspace Specialist,

Airspace Branch, AWP–520, Air Traffic

Division, Western-Pacific Region,

Federal Aviation Administration, 15000

Aviation Boulevard, Lawndale,

California 90261, telephone (310) 725–

6555.

SUPPLEMENTARY INFORMATION:

History

On June 9, 1997, the FAA proposed to

amend part 71 of the Federal Aviation

Regulations (14 CFR part 71) by

amending the Class E airspace area at

Salyer Farms, CA (62 FR 31371). This

action will provided adequate

controlled airspace to accommodate the

Special GPS RWY 32 SIAP at Salyer

Farms Airport, Salyer Farms, CA.

Interested parties were invited to

participate in this rulemaking

proceeding by submitting written

comments on the proposal to the FAA.

No comments to the proposal were

received. Class E airspace designations

are published in paragraph 6005 of FAA

Order 7400.9D dated September 4, 1996,

and effective September 16, 1996, which

is incorporated by reference in 14 CFR

71.1. The Class E airspace designations

listed in this document will be

published subsequently in this Order.

The Rule

This amendment to part 71 of the

Federal Aviation Regulations (14 CFR

part 71) amends the Class E airspace

area at Salyer Farms, CA. The

development of a Special GPS SIAP has

made this action necessary. The

intended effect of this action is to

provide adequate airspace for aircraft

executing the Special GPS RWY 32

SIAP at Salyer Farms Airport, Salyer

Farms, CA.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. Therefore, this regulation—(1)
42902 Federal Register / Vol. 62, No. 154 / Monday, August 11, 1997 / Rules and Regulations

is not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979); and (3)

does not warrant preparation of a

Regulatory Evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule will not have

a significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 as follows:

PART 71—[AMENDED]

1. The authority citation for 14 CFR

part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9D, Airspace

Designations and Reporting Points,

dated September 4, 1996, and effective

September 16, 1996, is amended as

follows:

Paragraph 6005 Class E airspace area

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AWP CA E5 Salyer Farms, CA [Revised]

Salyer Farms Airport, CA

(Lat. 36°05′20′′ N, long. 119°32′33′′ W)

Salyer Farms RBN

(Lat. 36°05′05′′ N, long. 119°32′43′′ W)

El Rico Airport, CA

(Lat. 36°02′45′′ N, long. 119°38′48′′ W)

That airspace extending upward from 700

feet above the surface within a 6.6-mile

radius of Salyer Farms Airport and within 2

miles each side of the 151° bearing from the

Salyer Farms Radio Beacon extending from

the 6.6-miles radius to 8.3 miles southeast of

the Salyer Farms Radio Beacon, excluding

that airspace with a 1-mile radius of El Rico

Airport.

* * * * *

Issued in Lost Angeles, California on July

17, 1997.

Sabra W. Kaulia,

Assistant Manager, Air Traffic Division,

Western-Pacific Region.

[FR Doc. 97–21042 Filed 8–8–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Moxidectin Gel

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 Fort Dodge

Animal Health. The NADA provides for

oral use of moxidectin gel for horses and

ponies for treatment and control of

infections of certain gastrointestinal

parasites.

EFFECTIVE DATE: August 11, 1997.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1612.

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 original NADA

141–087 that provides for use of

QuestTM moxidectin 2 percent oral gel

in horses and ponies at 0.4 milligram

moxidectin per kilogram of body weight

for treatment and control of infections of

certain large strongyles, small strongyles

(adult and larvae), encysted

cyathostomes, ascarids, pinworms,

hairworms, large-mouth stomach

worms, and horse stomach bots, and for

supression of small strongyle egg

production for 84 days. The NADA is

approved as of July 11, 1997, and the

regulations are amended by adding new

21 CFR 520.1452 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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

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

Federal Food, Drug, and Cosmetic Act,

this approval qualifies for 3 years of

marketing exclusivity beginning July 11,

1997, 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 approval of

the application and conducted or

sponsored by the applicant.

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.

List of Subjects in 21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. New § 520.1452 is added to read as

follows:

§ 520.1452 Moxidectin gel.

(a) Specifications. The gel contains 2

percent moxidectin (20 milligrams per

milliliter).

(b) Sponsor. See No. 000856 in

§ 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Amount.

0.4 milligram moxidectin per kilogram

(2.2 pounds) of body weight.

(2) Indications for use. Horses and

ponies for treatment and control of large

strongyles (Strongylus vulgaris (adults

and L4/L5 arterial stages), S. edentatus

(adult and tissue stages),

Triodontophorus brevicauda (adults), T.

serratus (adults)); small strongyles

(Cyathostomum spp. (adults),

Cylicocyclus spp. (adults),

Cylicostephanus spp. (adults),

Gyalocephalus capitatus (adults),

undifferentiated lumenal larvae);

encysted cyathostomes (late L3 and L4

mucosal cyathostome larvae); ascarids

(Parascaris equorum (adults and L4

larval stages)); pinworms (Oxyuris equi

(adults and L4 larval stages)), hairworms

(Trichostrongylus axei (adults)), large-