55158 Federal Register / Vol. 62, No. 205 / Thursday, October 23, 1997 / Rules and Regulations

EFFECTIVE DATE: 0901 UTC January 01,

1998.

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–

6531.

SUPPLEMENTARY INFORMATION:

History

On August 11, 1997, the FAA

proposed to amend part 71 of the

Federal Aviation Regulations (14 CFR

part 71) by amending the Class E

airspace areas at Flagstaff, AZ (62 FR

42955). The development of a GPS SIAP

at Flagstaff Pulliam Airport has made

this action necessary. The intended

effect of this action is to provide

additional controlled airspace extending

700 feet or more above the surface for

aircraft executing the GPS RWY 3 SIAP

to Flagstaff Pulliam Airport, Flagstaff,

AZ.

Interested parties were invited to

participate in this rulemaking

proceeding by submitting written

comments on the proposal to the FAA.

No comments objecting to the proposal

were received. Class E airspace

designations are published in

paragraphs 6004 and 6005 of FAA Order

7400.9E, dated September 10, 1997, and

effective September 16, 1997, which is

incorporated by reference in 14 CFR

71.1. Class E airspace designations

listed in this document will be

published subsequently in the Order.

The Rule

This amendment to part 71 of the

Federal Aviation Regulations (14 CFR

part 71) amends the Class E airspace

areas at Flagstaff, AZ. The development

of a GPS SIAP at Flagstaff Pulliam

Airport has made this action necessary.

The intended effect of this action is to

provide additional controlled airspace

extending 700 feet or more above the

surface for aircraft executing the GPS

RWY 3 SIAP at Flagstaff Pulliam

Airport, Flagstaff, AZ.

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)

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 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is amended as

follows:

Paragraph 6004 Class E airspace areas

designated as an extension to a Class D or

Class E surface area.

* * * * *

AWP AZ E4 Flagstaff, AZ [Revised]

Flagstaff Pulliam Airport, AZ.

(Lat. 35°08′18′′ N, long. 111°40′16′′ W)

Flagstaff VOR/DME

(Lat. 35°08′50′′ N, long. 111°40′27′′ W)

That airspace extending upward from the

surface beginning where a line 1.8 miles

northwest of and parallel to the Flagstaff

VOR/DME 057° radial intercepts the 6.1-mile

radius of the Flagstaff Pulliam Airport,

thence clockwise to intercept a line 1.8 miles

northwest of and parallel to the Flagstaff

VOR/DME 218° radial, thence

northeastbound on a line 1.8 miles west of

and parallel to the Flagstaff VOR/DME 218°

radial to intercept the 3-mile arc of the

Flagstaff Pulliam Airport clockwise to

intercept the line 1.8 miles northwest of and

parallel to the Flagstaff VOR/DME 057° radial

and thence to the point of beginning and

within 1.8 miles each side of the Flagstaff

VOR/DME 127° radial, extending from the

6.1-mile radius to 8.6 miles southeast of the

VOR/DME. This Class E airspace area is

effective during the specific dates and times

established in advance by a Notice to

Airmen. The effective date and time will

thereafter be continuously published in the

Airport/Facility Directory.

* * * * *

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AWP AZ E5 Flagstaff, AZ [Revised]

Flagstaff Pulliam Airport, AZ

(Lat. 35°08′18′′ N, long. 111°40′16′′ W)

Flagstaff VOR/DME

(Lat. 35°08′50′′ N, long. 111°40′27′′ W)

That airspace extending upward from 700

feet above the surface within a 3.6-mile

radius of the Flagstaff Pulliam Airport and

within a 10-mile radius of the Flagstaff VOR

beginning at a line 1.8-miles northwest of

parallel to the Flagstaff VOR 043° radial

extending clockwise to a point beginning at

lat. 34°59′20′′ N, long. 111°36′35′′ W; to lat.

34°44′00′′ N, long. 111°50′00′′ W; to lat.

34°45′00′′ N, long. 112°01′00′′ W; to lat.

34°54′00′′ N, long. 112°05′00′′ W; to lat.

35°08′00′′ N, long. 111°52′00′′ W, thence

eastbound along the Flagstaff VOR 265°

radial to intercept the 3.6-mile radius of the

Flagstaff Pulliam Airport, thence clockwise

to the point of beginning. That airspace

extending upward from 1,200 feet above the

surface within 8.3 miles each side of the

Flagstaff VOR 127° and 307° radials,

extending from 7 miles northwest to 16.5

miles southeast of the Flagstaff VOR and that

airspace bounded by a line beginning at lat.

35°13′32′′ N, long. 111°04′31′′ W; to lat.

35°17′17′′ N, long. 111°02′35′′ W; to lat.

35°22′00′′ N, long. 111°16′43′′ W; to lat.

35°24′00′′ N, long. 111°26′16′′ W; to lat.

35°18′00′′ N, long. 111°25′33′′ W, thence

clockwise via a 10-mile radius of the Flagstaff

VOR to lat. 35°16′34′′ N, long. 111°32′42′′ W;

to lat. 35°19′58′′ N, long. 111°24′10′′ W,

thence to the point of beginning and that

airspace bounded by a line beginning at lat.

35°02′56′′ N, long. 111°20′38′′ W; to lat.

35°02′00′′ N, long. 111°15′00′′ W; to lat.

35°00′56′′ N, long. 111°22′28′′ W, thence to

the point of beginning, excluding the Sedona,

AZ, Class E airspace area.

* * * * *

Issued in Los Angeles, California, on

October 16, 1997.

Thomas L. Parks,

Acting Manager, Air Traffic Division WesternPacific Region.

[FR Doc. 97–28103 Filed 10–22–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

Animal Drugs, Feeds, and Related

Products; Selegiline Hydrochloride

Tablets; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a
Federal Register / Vol. 62, No. 205 / Thursday, October 23, 1997 / Rules and Regulations 55159

final rule that appeared in the Federal

Register of June 27, 1997 (62 FR 34631).

The document amended the animal

drug regulations to reflect approval of a

new animal drug application (NADA)

filed by Deprenyl Animal Health, Inc.

The NADA provides for oral use of

selegiline hydrochloride tables for dogs

for the control of clinical signs

associated with uncomplicated

pituitary-dependent

hyperadrenocorticism. The approved

use in dogs was inadvertently omitted

from the document. This document

corrects that error.

EFFECTIVE DATE: June 27, 1997.

FOR FURTHER INFORMATION CONTACT:

David L. Gordon, Center for Veterinary

Medicine (HFV–6), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1739.

In FR Doc. 97–16791, appearing on

page 34631 in the Federal Register of

Friday, June 27, 1997, the following

corrections are made:

1. On page 34631, in the first column,

in the heading ‘‘Tablet’’ is corrected to

read ‘‘Tablets’’.

§ 520.2098 [Corrected]

2. On page 34632, in the first column,

in § 520.2098 Selegiline hydrochloride

tablets, in paragraph (d), the heading

‘‘(d) Conditions of use—’’ is corrected to

read ‘‘(d) Conditions of use—Dogs—’’;

and in paragraph (d)(2), in the 4th line,

‘‘hyperadrenocorticism.’’ is corrected to

read ‘‘hyperadrenocorticism in dogs.’’

Dated: September 8, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–28017 Filed 10–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 558

New Animal Drugs and Related

Products; 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 a

change of sponsor for three new animal

drug applications (NADA’s) and three

abbreviated new animal drug

applications (ANADA’s) from WadeJones Co., Inc., and its manufacturing

subsidiary Arkansas Micro Specialties,

Inc., to Alpharma Inc. The agency is

also correcting a final rule that appeared

in the Federal Register of June 20, 1996

(61 FR 31398).

EFFECTIVE DATE: October 23, 1997.

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: WadeJones Co., Inc., 409 North Bloomington,

Lowell, AR 72745, and its

manufacturing subsidiary Arkansas

Micro Specialties, Inc., P.O. Box 308,

Highway 71 North, Lowell, AR 72745,

has informed FDA that it has transferred

ownership of, and all rights and

interests in, the following approved

NADA’s and ANADA’s to Alpharma

Inc., One Executive Dr., Fort Lee, NJ

07024.

NADA/ANADA Ingredient

065–140 Tetracycline Hcl Soluble Powder

140–443 Hygromycin B Type A Medicated Articles

140–578 Tetracycline Hcl Soluble Powder

200–122 Penicillin G Potassium Soluble Powder

200–130 Neomycin Sulfate Soluble Powder

200–233 Lincomycin Hcl Soluble Powder

The agency is amending parts 510,

520, and 558 (21 CFR parts 510, 520 and

558) to reflect the change of sponsor.

The agency is amending § 510.600(c)(1)

and (c)(2) to remove the sponsor name

for Wade-Jones Co., Inc., and Arkansas

Micro Specialties, Inc., because the firm

no longer is the holder of any approved

NADA’s.

The agency is also correcting a final

rule that appeared in the Federal

Register of June 20, 1996 (61 FR 31398).

This document amended the animal

drug regulations to reflect approval of a

supplemental NADA filed by The

Upjohn Co., and two supplemental

ANADA’s, one filed by Pfizer, Inc., and

the other filed by Rhone Merieux, Inc,

respectively. In § 520.1484(c)(3), the

drug labeler code (047864) for WadeJones Co., Inc., was inadvertently

omitted from the document. After that

document published, Wade-Jones Co.,

Inc., transferred ownership of and all

rights and interest to Alpharma Inc.

Accordingly, this document adds a drug

labeler code for Alpharma Inc. and,

thereby, corrects the error in the final

rule (61 FR 31398).

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 520

Animal drugs.

21 CFR Part 558

Animal drugs, Animal feeds.

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, 520, and 558 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.

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entries for ‘‘Arkansas

Micro Specialties, Inc.’’and ‘‘WadeJones’’ and in the table in paragraph

(c)(2) by removing the entries ‘‘047863’’

and ‘‘047864’’.