25784 Federal Register / Vol. 61, No. 101 / Thursday, May 23, 1996 / Rules and Regulations

publication in the Federal Register

expensive and impractical. Further,

airmen do not use the regulatory text of

the SIAPs, but refer to their graphic

depiction on charts printed by

publishers of aeronautical materials.

Thus, the advantages of incorporation

by reference are realized and

publication of the complete description

of each SIAP contained in FAA form

documents is unnecessary. The

provisions of this amendment state the

affected CFR (and FAR) sections, with

the types and effective dates of the

SIAPs. This amendment also identifies

the airport, its location, the procedure

identification and the amendment

number.

This amendment to part 97 is effective

upon publication of each separate SIAP

as contained in the transmittal. The

SIAPs contained in this amendment are

based on the criteria contained in the

United States Standard for Terminal

Instrument Approach Procedures

(TERPS). In developing these SIAPs, the

TERPS criteria were applied to the

conditions existing or anticipated at the

affected airports.

The FAA has determined through

testing that current non-localizer type,

non-precision instrument approaches

developed using the TERPS criteria can

be flown by aircraft equipped with

Global Positioning System (GPS)

equipment. In consideration of the

above, the applicable Standard

Instrument Approach Procedures

(SIAPs) will be altered to include ‘‘or

GPS’’ in the title without otherwise

reviewing or modifying the procedure.

(Once a stand alone GPS procedure is

developed, the procedure title will be

altered to remove ‘‘or GPS’’ from these

non-localizer, non-precision instrument

approach procedure titles.) Because of

the close and immediate relationship

between these SIAPs and safety in air

commerce, I find that notice and public

procedure before adopting these SIAPs

are, impracticable and contrary to the

public interest and, where applicable,

that good cause exists for making some

SIAPs effective in less than 30 days.

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. It, therefore—(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. For the same

reason, the FAA certifies that this

amendment 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 97

Air Traffic Control, Airports,

Navigation (Air).

Issued in Washington, DC on May 17,

1996.

Thomas C. Accardi,

Director, Flight Standards Service.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me, part 97 of the

Federal Aviation Regulations (14 CFR

part 97) is amended by establishing,

amending, suspending, or revoking

Standard Instrument Approach

Procedures, effective at 0901 UTC on

the dates specified, as follows:

PART 97—STANDARD INSTRUMENT

APPROACH PROCEDURES

1. The authority citation for part 97 is

revised to read as follows:

Authority: 49 U.S.C. 40103, 40113, 40120,

44701; 49 U.S.C. 106(g); and 14 CFR

11.49(b)(2).

2. Part 97 is amended to read as

follows:

§§ 97.23, 97.27, 97.33, 97.35 [Amended]

By amending: § 97.23 VOR, VOR/

DME, VOR or TACAN, and VOR/DME

or TACAN; § 97.27 NDB, NDB/DME;

§ 97.33 RNAV SIAPs; and § 97.35

COPTER SIAPs, identified as follows:

* * * Effective June 20, 1995

Bartow, FL, Bartow Muni, VOR/DME or GPS

RWY 9L, Amdt 1A Cancelled

Bartow, FL, Bartow Muni, VOR/DME RWY

9L, Amdt 1A

Blanding, UT, Blanding Muni, NDB or GPS

RWY 35, Amdt 7 Cancelled

Blanding, UT, Blanding Muni, NDB RWY 35,

Amdt 7

[FR Doc. 96–13033 Filed 5–22–96; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Tolazoline

Hydrochloride Injection

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 Lloyd, Inc.

The NADA provides for intravenous use

of tolazoline hydrochloride injection in

horses when it is desirable to reverse the

effects of sedation and analgesia caused

by xylazine.

EFFECTIVE DATE: May 23, 1996.

FOR FURTHER INFORMATION CONTACT:

Sandra K. Woods, Center for Veterinary

Medicine (HFV–114), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1616.

SUPPLEMENTARY INFORMATION: Lloyd,

Inc., 604 W. Thomas Ave., Shenandoah,

IA 51601, filed NADA 140–994, which

provides for intravenous use of

TolazineTM Injection (each milliliter

contains tolazoline hydrochloride

equivalent to 100 milligrams of base

activity) in horses when it is desirable

to reverse the effects of sedation and

analgesia caused by xylazine. The drug

is limited to use on or by the order of

a licensed veterinarian. The NADA is

approved as of April 19, 1996, and the

regulations are amended in part 522 (21

CFR part 522) by adding new § 522.2474

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 part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 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)(i) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360b(c)(2)(F)(i)), this

approval qualifies for a 5-year period of

marketing exclusivity beginning April

19, 1996, because no active ingredient

(including any ester or salt of the active

ingredient) has been approved in any

other application under section

512(b)(1) of the act.

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.
Federal Register / Vol. 61, No. 101 / Thursday, May 23, 1996 / Rules and Regulations 25785

List of Subjects 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: Sec. 512 of the Federal Food,

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

2. New § 522.2474 is added to read as

follows:

§ 522.2474 Tolazoline hydrochloride

injection.

(a) Specifications. Each milliliter of

sterile aqueous solution contains

tolazoline hydrochloride equivalent to

100 milligrams of base activity.

(b) Sponsor. See No. 061690 in

§ 510.600(c) of this chapter.

(c) Conditions of use. It is used as

follows:

(1) Horses—(i) Amount. Administer

slowly by intravenous injection 4

milligrams per kilogram of body weight

or 1.8 milligrams per pound (4

milliliters per 100 kilograms or 4

milliliters per 220 pounds).

(ii) Indications for use. For use in

horses when it is desirable to reverse the

effects of sedation and analgesia caused

by xylazine.

(iii) Limitations. The safety of

TolazineTM has not been established in

pregnant mares, lactating mares, horses

intended for breeding, foals, or horses

with metabolically unstable conditions.

The safety of TolazineTM has not been

evaluated for reversing xylazine used as

a preanesthetic to a general anesthetic.

This drug is for use in horses only and

not for use in food-producing animals.

Users with cardiovascular disease (for

example, hypertension or ischemic

heart disease) should take special

precautions to avoid accidental

exposure to this product.

Accidental spillage on the skin should

be washed off immediately with soap

and water. Federal law restricts this

drug to use by or on the order of a

licensed veterinarian.

(2) [Reserved]

Dated: May 15, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–12876 Filed 5–22–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF AGRICULTURE

Forest Service

36 CFR Part 242

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 100

RIN 1018–AC82

Subsistence Management Regulations

for Public Lands in Alaska, Subpart D;

Subsistence Taking of Fish and

Wildlife Regulations; Extension

AGENCY: Forest Service, USDA; Fish and

Wildlife Service, Interior.

ACTION: Final rule; extension of effective

date.

SUMMARY: This rule amends the

Subsistence Management Regulations

for Public Lands in Alaska

implementing the subsistence priority

for rural residents of Alaska under Title

VIII of the Alaska National Interest

Lands Conservation Act of 1980 by

extending the effective date of 50 CFR

100.25 and 36 CFR 242.25 (Subsistence

taking of wildlife) (60 FR 31542). The

regulations, now set to expire on June

30, 1996, are extended through July 31,

1996, to ensure continuity of the

subsistence hunting and fishing seasons

until the 1996–1997 season regulations

can be issued in final form.

EFFECTIVE DATE: Effective June 30, 1996,

the effective date of 50 CFR 100.25 and

36 CFR 242.25 (Subsistence taking of

wildlife) which were added at 60 FR

31553 is extended from July 1, 1996,

through July 31, 1996.

FOR FURTHER INFORMATION CONTACT:

Thomas H. Boyd, Office of Subsistence

Management, U.S. Fish and Wildlife

Service, 1011 E. Tudor Road,

Anchorage, Alaska 99503; telephone

(907) 786–3864. For questions specific

to National Forest System lands, contact

Ken Thompson, Regional Subsistence

Manager, USDA—Forest Service, Alaska

Region, P.O. Box 21628, Juneau, Alaska

99802; telephone (907) 586–7921.

SUPPLEMENTARY INFORMATION:

Background

Title VIII of the Alaska National

Interest Lands Conservation Act

(ANILCA) (16 U.S.C. 3111–3126)

requires that the Secretary of the Interior

and the Secretary of Agriculture

(Secretaries) implement a joint program

to grant a preference for subsistence

uses of fish and wildlife resources on

public lands, unless the State of Alaska

enacts and implements laws of general

applicability which are consistent with

ANILCA, and which provide for the

subsistence definition, preference, and

participation specified in Sections 803,

804, and 805 of ANILCA. The State

implemented a program that the

Department of the Interior previously

found to be consistent with ANILCA.

However, in December 1989, the Alaska

Supreme Court ruled in McDowell v.

State of Alaska that the rural preference

in the State subsistence statute violated

the Alaska Constitution. The court’s

ruling in McDowell required the State to

delete the rural preference from the

subsistence statute, and therefore,

negated State compliance with ANILCA.

The Court stayed the effect of the

decision until July 1, 1990.

As a result of the McDowell decision,

the Department of the Interior and the

Department of Agriculture assumed, on

July 1, 1990, responsibility for

implementation of Title VIII of ANILCA

on public lands. On June 29, 1990, the

Temporary Subsistence Management

Regulations for Public Lands in Alaska

were published in the Federal Register

(55 FR 27114–27170). Consistent with

Subparts A, B, and C of these

regulations, a Federal Subsistence Board

was established to administer the

Federal Subsistence Management

Program. The Board’s composition

includes a Chair appointed by the

Secretary of the Interior with

concurrence of the Secretary of

Agriculture; the Alaska Regional

Director, U.S. Fish and Wildlife Service;

the Alaska Regional Director, U.S.

National Park Service; the Alaska State

Director, U.S. Bureau of Land

Management; the Alaska Area Director,

U.S. Bureau of Indian Affairs; and the

Alaska Regional Forester, USDA Forest

Service. Through the Board, these

agencies have participated in

development of regulations for Subparts

A, B, and C, and the annual Subpart D

regulations.

On June 15, 1995, the 1995–1996

Seasons and Bag Limits for Subsistence

Management Regulations for Public

Lands in Alaska ware published in the

Federal Register (60 FR 31542–31594).

Those regulations included the section

on the taking of wildlife, scheduled to

expire June 30, 1996.

The Federal Subsistence Management

Program initiates a process each fall

with a proposed rule (60 FR 42085–

42130) to provide the public with an

opportunity to propose changes to the

subsistence regulations. The proposals

that are received are reviewed by the

public and analyzed by a regional team,

staff anthropologists, and biologists. The