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
25786 Federal Register / Vol. 61, No. 101 / Thursday, May 23, 1996 / Rules and Regulations

Regional Councils then meet in public

forum and develop recommendations to

the Federal Subsistence Board on each

proposal. Because of the Federal

furloughs occurring in November and

later in December and January, the

public review process and the proposal

analysis process were delayed. This

consequently resulted in scheduling

delays for the Regional Council

meetings and the Federal Subsistence

Board meeting. As a result,

implementation of the 1996–1997

Subsistence Management Regulations

for Public Lands in Alaska will be

delayed until August 1, 1996.

This rule effectively extends the

existing regulations through July 31,

1996.

The Board finds that public notice

and comment requirements under the

Administrative Procedures Act (APA)

for this extension are impracticable,

unnecessary, and contrary to the public

interest. A lapse in regulatory control

after July 1 could seriously affect the

continued viability of wildlife

populations, adversely impact future

subsistence opportunities for rural

Alaskans, and would generally fail to

serve the overall public interest.

Therefore, the Board finds good cause

pursuant to 5 U.S.C. 553(b)(B) to waive

the public notice and comment

procedures prior to publication of this

extension.

The Board also finds good cause for

the existing rule to be extended through

July 31, 1996. This July 31 date is

consistent with the anticipated Regional

Council and Board actions to implement

the 1996–1997 Federal Subsistence

Management Regulations for Public

Lands in Alaska scheduled for August 1,

1996. The Board therefore finds good

cause under 5 U.S.C. 553(d)(3) to make

this extension effective upon

publication.

Conformance with Statutory and

Regulatory Authorities

National Environmental Policy Act

Compliance

A Draft Environmental Impact

Statement (DEIS) that described four

alternatives for developing a Federal

Subsistence Management Program was

distributed for public comment on

October 7, 1991. That document

described the major issues associated

with Federal subsistence management

as identified through public meetings,

written comments and staff analysis and

examined the environmental

consequences of the four alternatives.

Proposed regulations (Subparts A, B,

and C) that would implement the

preferred alternative were included in

the DEIS as an appendix. The DEIS and

the proposed administrative regulations

presented a framework for an annual

regulatory cycle regarding subsistence

hunting and fishing regulations (Subpart

D). The Final Environmental Impact

Statement (FEIS) was published on

February 28, 1992.

Based on the public comment

received, the analysis contained in the

FEIS, and the recommendations of the

Federal Subsistence Board and the

Department of the Interior’s Subsistence

Policy Group, it was the decision of the

Secretary of the Interior, with the

concurrence of the Secretary of

Agriculture, through the U.S.

Department of Agriculture-Forest

Service, to implement Alternative IV as

identified in the DEIS and FEIS (Record

of Decision on Subsistence Management

for Federal Public Lands in Alaska

(ROD), signed April 6, 1992). The DEIS

and the selected alternative in the FEIS

defined the administrative framework of

an annual regulatory cycle for

subsistence hunting and fishing

regulations. The final rule for

Subsistence Management Regulations

for Public Lands in Alaska, Subparts A,

B, and C (57 FR 22940–22964)

implements the Federal Subsistence

Management Program and includes a

framework for an annual cycle for

subsistence hunting and fishing

regulations.

Compliance with Section 810 of

ANILCA

The intent of all Federal subsistence

regulations is to accord subsistence uses

of fish and wildlife on public lands a

priority over the taking of fish and

wildlife on such lands for other

purposes, unless restriction is necessary

to conserve healthy fish and wildlife

populations. A Section 810 analysis was

completed as part of the FEIS process.

The final Section 810 analysis

determination appears in the April 6,

1992, ROD which concluded that the

Federal Subsistence Management

Program, under Alternative IV with an

annual process for setting hunting and

fishing regulations, may have some local

impacts on subsistence uses, but it does

not appear that the program may

significantly restrict subsistence uses.

Paperwork Reduction Act

As required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

3507(d), the U.S. Fish and Wildlife

Service has received approval for this

collection of information, with approval

number 1018–0075, with the expiration

date of July 31, 1996.

The collection of information will be

achieved through the use of the Federal

Subsistence Hunt Permit Application.

This collection information will

establish whether the applicant qualifies

to participate in a Federal subsistence

hunt on public land in Alaska and will

provide a report of harvest and location

of harvest.

The likely respondents to this

collection of information are rural

Alaska residents who wish to

participate in specific subsistence hunts

on Federal land. The collected

information is necessary to determine

harvest success and harvest location in

order to make management decisions

relative to the conservation of healthy

wildlife populations. The annual

burden of reporting and recordkeeping

is estimated to average 0.25 hours per

response, including time for reviewing

instructions, gathering and maintaining

data, and completing and reviewing the

form. The estimated number of likely

respondents under the correcting

amendments is less than 50, yielding a

total annual reporting and

recordkeeping burden of 13 hours or

less.

Direct comments on the burden

estimate or any other aspect of this form

to: Information Collection Officer, U.S.

Fish and Wildlife Service, 1849 C Street,

NW., MS 224 ARLSQ, Washington, DC

20240; and the Office of Management

and Budget, Paperwork Reduction

Project (1018–0075), Washington, D.C.

20503. Additional information

collection requirements may be imposed

if Local Advisory Committees subject to

the Federal Advisory Committee Act are

established under subpart B. Such

requirements will be submitted to OMB

for approval prior to their

implementation.

Economic Effects

This rule was not subject to OMB

review under Executive Order 12866.

The Regulatory Flexibility Act of 1980

(5 U.S.C. 601 et seq.) requires

preparation of flexibility analyses for

rules that will have a significant effect

on a substantial number of small

entities, which include small

businesses, organizations or

governmental jurisdictions. The

Departments have determined that this

rulemaking will not have a significant

economic effect on a substantial number

of small entities within the meaning of

the Regulatory Flexibility Act.

This rulemaking will impose no

significant costs on small entities; the

exact number of businesses and the

amount of trade that will result from

this Federal land-related activity is

unknown. The aggregate effect is an

insignificant positive economic effect on

a number of small entities. The number
Federal Register / Vol. 61, No. 101 / Thursday, May 23, 1996 / Rules and Regulations 25787

of small entities affected is unknown;

but, the fact that the positive effects will

be seasonal in nature and will, in most

cases, merely continue preexisting uses

of public lands indicates that they will

not be significant.

As of the 1990 census there are

163,000 rural Alaskans qualified to

participate in subsistence hunting or

fishing. Although some of the

subsistence users may conduct their

activities on State or private lands, it is

likely that a large portion of the 163,000

rural Alaskans utilize Federal lands to

some extent.

These regulations do not meet the

threshold criteria of ‘‘Federalism

Effects’’ as set forth in Executive Order

12612. Title VIII of ANILCA requires the

Secretaries to administer a subsistence

preference on public lands. The scope of

this program is limited by definition to

certain public lands. Likewise, these

regulations have no significant takings

implication relating to any property

rights as outlined by Executive Order

12630.

The Service has determined and

certifies pursuant to the Unfunded

Mandates Act, 2 U.S.C. 1502 et seq., that

this rulemaking will not impose a cost

of $100 million or more in any given

year on local or State governments or

private entities.

Drafting Information

These regulations were drafted by

William Knauer under the guidance of

Thomas H. Boyd, Office of Subsistence

Management, Alaska Regional Office,

U.S. Fish and Wildlife Service,

Anchorage, Alaska. Additional guidance

was provided by Peggy Fox, Alaska

State Office, Bureau of Land

Management; Sandy Rabinowitch,

Alaska Regional Office, National Park

Service; John Borbridge, Alaska Area

Office, Bureau of Indian Affairs; and

Ken Thompson, USDA—Forest Service.

List of Subjects

36 CFR Part 242

Administrative practice and

procedure, Alaska, Fish, National

Forests, Public Lands, Reporting and

record keeping requirements, Wildlife.

50 CFR Part 100

Administrative practice and

procedure, Alaska, Fish, Public Lands,

Reporting and recordkeeping

requirements, Subsistence, Wildlife.

Words of Issuance

For the reasons set out in the

preamble, Title 36, Part 242, and Title

50, Part 100, of the Code of Federal

Regulations, are amended as set forth

below.

PARTlll—SUBSISTENCE

MANAGEMENT REGULATIONS FOR

PUBLIC LANDS IN ALASKA

1. The authority citation for both 36

CFR Part 242 and 50 CFR Part 100

continues to read as follows:

Authority: 16 U.S.C. 3, 472, 551, 668dd,

3101–3126; 18 U.S.C. 3551–3586; 43 U.S.C.

1733.

2. Effective June 30, 1996, the

effective date for 36 CFR 242.25 and 50

CFR 100.25 which were added at 60 FR

31553 is extended from July 1, 1996

through July 31, 1996.

Dated: April 3, 1996.

Thomas H. Boyd,

Acting Chair, Federal Subsistence Board.

Dated: April 15 1996.

John C. Capp,

Acting Regional Forester, USDA—Forest

Service.

[FR Doc. 96–12833 Filed 5–22–96; 8:45 am]

BILLING CODE 3410–11–M and 4310–55–M

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 3

RIN 2900–AH44

Compensation for Disability Resulting

From Hospitalization, Treatment,

Examination, or Vocational

Rehabilitation

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

SUMMARY: This document adopts as a

final rule with minor, nonsubstantive

changes an interim rule amending

Department of Veterans Affairs (VA)

adjudication regulations concerning

compensation for disability or death

resulting from VA hospitalization,

medical or surgical treatment, or

examination. Before the interim rule, to

establish entitlement to compensation

for adverse results of medical or surgical

treatment, the regulations required that

VA be at fault or that an accident occur.

In order to conform the regulations to a

recent United States Supreme Court

decision, the interim rule deleted the

fault-or-accident requirement and

instead provided that compensation is

not payable for the necessary

consequences of proper treatment to

which the veteran consented.

EFFECTIVE DATE: This final rule is

effective July 22, 1996.

FOR FURTHER INFORMATION CONTACT: Paul

Trowbridge, Consultant, Regulations

Staff, Compensation and Pension

Service, Veterans Benefits

Administration, 810 Vermont Avenue,

NW, Washington, DC 20420, telephone

(202) 273–7210.

SUPPLEMENTARY INFORMATION: 38 U.S.C.

1151 provides for the payment of

disability or dependency and indemnity

compensation for additional disability

or death resulting from an injury or

aggravation of an injury suffered as the

result of VA hospitalization, medical or

surgical treatment, examination, or

pursuit of a course of vocational

rehabilitation under 38 U.S.C. ch. 31.

VA had long interpreted the statute to

require a showing of fault on the part of

VA or the occurrence of an accident to

establish entitlement to § 1151

compensation for adverse consequences

of VA medical treatment. This

interpretation was codified at 38 CFR

3.358(c)(3).

In a recent decision, Brown v.

Gardner, 115 S. Ct. 552 (1994),

upholding a lower court decision, the

U.S. Supreme Court held that the faultor-accident requirement in former 38

CFR 3.358(c)(3) was inconsistent with

the plain language of 38 U.S.C. 1151 and

that no fault requirement was implicit

in the statute. The Supreme Court

determined that the statutory language

simply requires a causal connection

between an injury or aggravation of an

injury and VA hospitalization, medical

or surgical treatment, examination, or

vocational rehabilitation, but that

compensation is not payable for the

necessary consequences of treatment to

which a veteran consented.

In the Federal Register of March 16,

1995 (60 FR 14222), VA published an

interim rule amending 38 CFR 3.358(c)

in order to implement 38 U.S.C. 1151 as

interpreted in that decision of the

Supreme Court. Interested persons were

invited to submit written comments on

or before May 15, 1995. We received

comments from the Paralyzed Veterans

of America and from a concerned

individual.

One commenter, observing that VA

may provide disability examinations for

beneficiaries of the British Imperial and

Canadian governments and for

pensioners of other nations allied with

the U.S. during World War I and World

War II, and that VA may conduct

examinations for other Federal agencies

(e.g., Office of Personnel Management,

Railroad Retirement Board), asked

whether VA intends to cover under 38

U.S.C. 1151 those examinees. Since the

plain language of 38 U.S.C. 1151

provides for payment of benefits only

for a veteran, VA has no authority to

award § 1151 benefits for anyone who is

not a veteran.

The same commenter suggested

substituting the term ‘‘veteran’’ for the