Federal Register / Vol. 63, No. 151 /Thursday, August 6, 1998 /Rules and Regulations 41959

ACTION: Final rule.

SUMMARY: This action amends the Class

D airspace area at Colorado Springs

United States Air Force (USAF)

Academy Airstrip, CO. The effect of this

action provides additional airspace in

the Visual Flight Rules (VFR) traffic

pattern by increasing the ceiling of the

Class D airspace from 8600’MSL to

8800’MSL.

EFFECTIVE DATE: 0901 UTC, October 8,

1998.

FOR FURTHER INFORMATION CONTACT:

Dennis Ripley, ANM–520.6, Federal

Aviation Administration, Docket No.

98–ANM–07, 1601 Lind Avenue, SW.,

Renton, Washington, 98055–4056;

telephone number: (425) 227–2527.

SUPPLEMENTARY INFORMATION:

History

On May 4, 1998, the FAA proposed to

amend Title 14, Code of Federal

Regulations, part 71 (14 CFR part 71) by

modifying Class D airspace at Colorado

Springs USAF Academy Airstrip, CO

(63 FR 24500). The USAF Academy has

seen substantial development adjacent

to the airfield in recent years causing

the VFR traffic pattern altitude to be

increased to 7800’MSL (1000’AGL). In

the interest of safety at this high

intensity student training area, it is

considered reasonable and necessary to

have a 1000’ Class D airspace area above

the standard VFR traffic pattern. The

1000’ of Class D area allows a student

pilot a safety area of 500’ above the

standard VFR traffic pattern and still

have 500’ from overflights of the USAF

Class D airspace. This rule satisfies the

requirement of a 1000’ safety area by

increasing the Class D airspace area

from 8600’MSL to 8800’MSL. Interested

parties were invited to participate in the

rulemaking proceeding by submitting

written comments on the proposal. No

comments were received.

The coordinates for this airspace

docket are based on North American

Datum 83. Class D airspace areas

designated as surface areas are

published in Paragraph 5000 of FAA

Order 7400.9E, dated September 10,

1997, and effective September 16, 1997,

which is incorporated by reference in 14

CFR 71.1. The Class E airspace

designation listed in this document will

be published subsequently in the Order.

The Rule

This amendment to 14 CFR part 71

modifies Class D airspace at Colorado

Springs USAF Academy Airstrip, CO,

by providing the additional airspace

necessary to increase the Class D

airspace area from 8600’MSL to

8800’MSL. This modification of airspace

allows the VFR pattern to be fully

encompassed within Class D airspace

and still provide safe and efficient use

of the navigable airspace and to promote

safe flight operations under VFR at the

Colorado Springs USAF Academy

Airstrip.

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. 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—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D, AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

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 5000 General

* * * * *

ANM CO D Colorado Springs USAF

Academy, CO [Revised]

Colorado Springs USAF Academy Airstrip,

CO

(Lat. 38°58′11′′ N, long. 104°48′47′′ W)

That airspace extending upward from the

surface to and including 8,800 feet MSL

within a 3-mile radius of the USAF Academy

Airstrip, excluding that airspace within the

Colorado Springs, CO, Class C airspace area.

This Class D 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.

* * * * *

Issued in Seattle, Washington, on July 22,

1998.

Glenn A. Adams III,

Assistant Manager, Air Traffic Division,

Northwest Mountain Region.

[FR Doc. 98–21072 Filed 8–5–98; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5

Delegations of Authority and

Organization; Office of the

Commissioner

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

delegations of authority regulation that

covers general redelegations of authority

from the Commissioner of Food and

Drugs to other officers of FDA. The

amendment delegates an authority

related to the waiver and reduction of

prescription drug user fees to the

Deputy Commissioner for Management

and Systems and the Director, Office of

Financial Management. Redelegation of

this authority would allow for more

efficient operations. Additionally, this

amendment revokes part of the above

authority from the FDA User Fee Waiver

Officer, Deputy Chief Mediator and

Ombudsman, and the Deputy User Fee

Waiver Officer.

EFFECTIVE DATE: August 6, 1998.

FOR FURTHER INFORMATION CONTACT:

Suzanne O’Shea, Office of the Chief

Mediator and Ombudsman (HF–7),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–3390, or

Donna G. Page, Division of

Management Systems and Policy

(HFA–340), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

4816.

SUPPLEMENTARY INFORMATION: FDA is

amending the delegations of authority

under § 5.20 General redelegations of

authority from the Commissioner to

other officers of the Food and Drug

Administration (21 CFR 5.20) by
41960 Federal Register / Vol. 63, No. 151 /Thursday, August 6, 1998 /Rules and Regulations

revising § 5.20(h) to authorize the

Deputy Commissioner for Management

and Systems and the Director, Office of

Financial Management to perform the

functions of the Commissioner of Food

and Drugs under section 736(d)(c) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 379h(d)(C)), as amended

hereafter, to waive or reduce

prescription drug user fees in situations

where it is determined that ‘‘the fees

will exceed the anticipated present and

future costs.’’ Further, this authority is

revoked from the delegations to the

Chief Mediator and Ombudsman/

Deputy User Fee Waiver Officer, the

Deputy Chief Mediator and

Ombudsman, and the Deputy User Fee

Waiver Officer, who previously had the

authority.

Further redelegation of this authority

is not authorized at this time. Authority

delegated to a position by title may be

exercised by a person officially

designated to serve in such position in

an acting capacity or on a temporary

basis.

List of Subjects in 21 CFR Part 5

Authority delegations (Government

agencies), Imports, Organization and

functions (Government agencies).

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 5 is

amended as follows:

PART 5—DELEGATIONS OF

AUTHORITY AND ORGANIZATION

1. The authority citation for 21 CFR

part 5 continues to read as follows:

Authority: 5 U.S.C. 504, 552, App. 2; 7

U.S.C. 138a, 2271; 15 U.S.C. 638, 1261-1282,

3701-3711a; 15 U.S.C. 1451-1461; 21 U.S.C.

41-50, 61-63, 141-149, 321-394, 467f, 679(b),

801-886, 1031-1309; 35 U.S.C. 156; 42 U.S.C.

241, 242, 242a, 242l, 242n, 243, 262, 263,

264, 265, 300u-300u-5, 300aa-1; 1395y,

3246b, 4332, 4831(a), 10007-10008; E.O.

11921, 41 FR 24294, 3 CFR, 1977 Comp., p.

124-131; E.O. 12591, 52 FR 13414, 3 CFR,

1988 Comp., p. 220-223.

2. Section 5.20 is amended by revising

paragraph (h) to read as follows:

§ 5.20 General redelegations of authority

from the Commissioner to other officers of

the Food and Drug Administration.

* * * * *

(h)(1) The Chief Mediator and

Ombudsman, designated as the User Fee

Waiver Officer; the Deputy Chief

Mediator and Ombudsman; and the

Deputy User Fee Waiver Officer are

authorized to perform the functions of

the Commissioner under the

Prescription Drug User Fee Act of 1992,

as amended by the FDA Modernization

Act of 1997 (21 U.S.C. 379h(d)), as

amended hereafter, relating to waiving

or reducing prescription drug user fees

except for the functions under 21 U.S.C.

379h(d)(C), which pertains to situations

where ‘‘the fees will exceed the

anticipated present and future costs.’’

These authorities may not be further

redelegated.

(2) The Deputy Commissioner for

Management and Systems and the

Director, Office of Financial

Management are authorized to perform

the functions of the Commissioner

under 21 U.S.C. 379h(d)(C), as amended

hereafter, to waive or reduce

prescription drug user fees in situations

where it is determined that ‘‘the fees

will exceed the anticipated present and

future costs.’’ This authority may not be

further redelegated.

(3) The Deputy Commissioner for

Operations, designated as the User Fee

Appeals Officer, is authorized to hear

and decide user fee waiver appeals. The

decision of the User Fee Appeals Officer

will constitute final agency action on

such matters.

* * * * *

Dated: July 29, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20954 Filed 8–5–98; 8:45 am]

BILLING CODE 4160–01–F

NATIONAL INDIAN GAMING

COMMISSION

25 CFR Part 518

RIN 3141–AA04

Issuance of Certificates of Self

Regulation to Tribes for Class II

Gaming

AGENCY: National Indian Gaming

Commission.

ACTION: Final rule.

SUMMARY: The National Indian Gaming

Commission issues this rule which

provides a process for the review and

approval of petitions for tribal selfregulation of Class II gaming. This rule

implements the Class II self-regulatory

provisions of the Indian Gaming

Regulatory Act and will provide both a

financial benefit and reduction in

Federal regulations for tribes that obtain

certificates under this rule.

EFFECTIVE DATE: September 8, 1998.

FOR FURTHER INFORMATION CONTACT:

Maria Getoff, National Indian Gaming

Commission, 1441 L Street, NW, Suite

9100, Washington, DC 20036; telephone:

202–632–7003.

SUPPLEMENTARY INFORMATION: The

Indian Gaming Regulatory Act (IGRA, or

the Act), enacted on October 17, 1988,

established the National Indian Gaming

Commission (Commission). Under the

Act, the Commission is charged with

regulating class II gaming and certain

aspects of class III gaming on Indian

lands. On March 12, 1998, the

Commission proposed regulations for

the issuance of certificates of selfregulation for class II gaming to Tribes.

63 FR 12319–12323. The Commission

requested comments on those proposed

regulations. On April 1, 1998, the

Commission held a public hearing in

Portland, Oregon, on the proposed

regulations. Below is the Commission’s

analysis of the comments received both

in writing during the comment period,

and at the public hearing. In addition,

prior to the drafting of the proposed

rules, all gaming tribes were asked to

provide comments on the meaning of

the term, ‘‘self-regulating’’, which the

Commission has also considered. Below

is the Commission’s analysis of the

comments received during the comment

period and the text of the final

regulations.

General Comments

One commenter advocated for

negotiated rule making in the

promulgation of these regulations. The

Commission concluded that negotiated

rule making would not allow the

Commission to issue these regulations

in a timely manner. However, the

regulated community was provided

several opportunities to comment on

both the concept of self-regulation

generally and the proposed regulations

specifically. On November 13, 1997, the

Commission sent a ‘‘Notice to Interested

Parties’’ to all gaming tribes requesting

comments on the meaning of the term,

‘‘self-regulation.’’ In addition, on

November 18, 1997, NIGC Chairman

Tadd Johnson addressed a gathering of

tribes in Santa Fe, New Mexico, where

he discussed self regulation. Further, on

January 27, 1998, members of the

Commission staff met with tribal

representatives in Washington, D.C. to

discuss the concept of self-regulation. In

early February 1998, Commission staff

held an open meeting at the Gila River

reservation in Arizona for the purpose

of discussing self-regulation and other

regulations. Then, on April 1, 1998, the

Commission held a public hearing on

self-regulation in Portland, Oregon.

Seven witnesses testified, representing

tribes with both large and small gaming

operations.

Another commenter stated that ‘‘IGRA

prohibits the NIGC from regulating Class

II gaming by Tribes with certificates,