12082 Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Rules and Regulations

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

For the reasons discussed above, I

certify that this action (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)

will not have a significant economic

impact, positive or negative, on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act. A final evaluation has

been prepared for this action and it is

contained in the Rules Docket. A copy

of it may be obtained from the Rules

Docket at the location provided under

the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends part 39 of the

Federal Aviation Regulations (14 CFR

part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding the following new airworthiness

directive:

97–06–07 Dornier: Amendment 39–9964.

Docket 96–NM–117–AD.

Applicability: Model 328–100 series

airplanes equipped with Burns Aerospace

Corporation commuter seat models JB6.8–1–

22 and JB6.8–2–42 passenger seats;

certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

otherwise modified, altered, or repaired in

the area subject to the requirements of this

AD. For airplanes that have been modified,

altered, or repaired so that the performance

of the requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (b) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To prevent failure of the anchor point

fasteners on the seat restraining systems,

which could result in release of the seat

restraint and consequent injury to

passengers, accomplish the following:

(a) Within 60 days after the effective date

of this AD, replace each anchor point fastener

on the restraining system of each seat with

a fastener of improved design, in accordance

with Dornier Service Bulletin SB–328–25–

114, dated July 10, 1995.

Note 2: The Dornier service bulletin

references Burns Aerospace Corporation

Service Bulletin SB–25–20–989, Revision B,

dated June 14, 1995, as an additional source

of procedural service information for

replacement of the anchor point fasteners.

(b) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager,

Standardization Branch, ANM–113, FAA,

Transport Airplane Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, Standardization

Branch, ANM–113.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Standardization Branch,

ANM–113.

(c) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(d) The replacement shall be done in

accordance with Dornier Service Bulletin

SB–328–25–114, dated July 10, 1995. This

incorporation by reference was approved by

the Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1 CFR

part 51. Copies may be obtained from Dornier

Luftfahrt GmbH, P.O. Box 1103, D–82230

Wessling, Germany. Copies may be inspected

at the FAA, Transport Airplane Directorate,

1601 Lind Avenue, SW., Renton,

Washington; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

(e) This amendment becomes effective on

April 18, 1997.

Issued in Renton, Washington, on March 6,

1997.

Neil D. Schalekamp,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–6262 Filed 3–13–97; 8:45 am]

BILLING CODE 4910–13–U

14 CFR Part 71

[Airspace Docket No. 96–ASW–20]

Revision of Class E Airspace; Gallup,

NM

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This action revises the Class

E airspace extending upward from 700

feet above ground level (AGL) at Gallup,

NM. The development of a Global

Positioning System (GPS) Standard

Instrument Approach Procedure (SIAP)

to Runway (RWY) 24 at Gallup

Municipal Airport has made this action

necessary. This action is intended to

provide adequate Class E airspace to

contain instrument flight rule (IFR)

operations for aircraft executing the GPS

SIAP to RWY 24 at Gallup Municipal

Airport, Gallup, NM.

EFFECTIVE DATE: 0901 UTC, May 22,

1997.

FOR FURTHER INFORMATION CONTACT:

Donald J. Day, Operations Branch, Air

Traffic Division, Southwest Region,

Federal Aviation Administration, Fort

Worth, TX 76193–0530, telephone 817–

222–5593.

SUPPLEMENTARY INFORMATION:

History

On November 22, 1996, a proposal to

amend part 71 of the Federal Aviation

Regulations (14 CFR part 71) to revise

the Class E airspace at Gallup, NM, was

published in the Federal Register (61

FR 59383). A GPS SIAP to RWY 24

developed for Gallup Municipal

Airport, Gallup NM, requires the

revision of the Class E airspace at this

airport. The proposal was to revise the

controlled airspace extending upward

from 700 feet AGL to contain IFR

operations in controlled airspace during

portions of the terminal operation and

while transitioning between the enroute

and terminal environments.

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. The rule is adopted as

proposed.

The coordinates for this airspace

docket are based on North American

Datum 83. Class E airspace designations

for airspace areas extending upward

from 700 feet or more AGL 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 designation
Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Rules and Regulations 12083

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

located at Gallup Municipal Airport,

Gallup, NM, to provide controlled

airspace extending upward from 700

feet AGL for aircraft executing the GPS

SIAP to RWY 24.

The FAA has determined that this

regulation only involves an established

body of technical regulations that need

frequent and routine amendments 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 11035; 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 Subject 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. 40103, 40113, 40120;

E.O. 10854; 24 FR 9565, 3 CFR, 1959–1963

Comp., p. 389; 49 U.S.C. 106(g); 14 CFR

11.69.

§ 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 areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

ASW NM E5 Gallup, NM [Revised]

Gallup Municipal Airport, NM

(Lat 35°30′40′′N., long 108°47′22′′W.)

Gallup VORTAC

(Lat. 35°28′34′′N., long 108°52′21′′W.)

Gallup ILS Localizer

(Lat 35°30′53′′N., long 108°46′28′′W.)

That airspace extending upward from 700

feet above the surface within a 6.7-mile

radius of Gallup Municipal Airport and

within 1.9 miles each side of the Gallup ILS

Localizer southwest course extending from

the 6.7-mile radius to 12.6 miles southwest

of the airport and within 2 miles each side

of the 074° bearing from the airport extending

from the 6.7-mile radius to 9.1 miles east of

the airport and within 1.3 miles each side of

the 242° radial of the Gallup VORTAC

extending from the 6.7-mile radius to 11.5

miles southwest of the airport and that

airspace extending upward from 1,200 feet

above the surface within an area bounded by

a line beginning at lat 35°47′30′′N, long

108°34′02′′W; to lat 35°26′50′′N, long

108°34′02′′W; to lat 35°13′15′′N, long

109°06′02′′W’ to lat 35°20′25′′N, long

109°10′42′′W; to lat 35°52′00′′N, long

108°47′02′′W; to point of beginning

excluding that airspace within the New

Mexico, NM, Class E airspace area.

* * * * *

Issued in Fort Worth, TX, on March 7,

1997.

Albert L. Viselli,

Acting Manager, Air Traffic Division,

Southwest Region.

[FR Doc. 97–6529 Filed 3–13–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 200, 250, and 310

[Docket No. 96N–0183]

RIN 0910–AA53

Consolidation of Drug Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is consolidating a

list of drugs, previously determined by

rulemaking to be new drugs, into one

section. This document also removes

the sections now providing for these

drugs, except for certain information in

the regulations that FDA considers to be

necessary. This action, which will make

the regulations more concise and

efficient, is being taken in response to

the President’s regulatory reinvention

initiative (REGO).

EFFECTIVE DATE: April 14, 1997.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Food and Drug

Administration, Center for Drug

Evaluation and Research (HFD–7), 7500

Standish Pl., Rockville, MD 20855, 301–

594–2041.

SUPPLEMENTARY INFORMATION:

I. Background

On March 4, 1995, President Clinton

issued a memorandum titled

‘‘Regulatory Reinvention Initiative,’’

which directed all Federal agencies to

conduct a page-by-page review of their

existing regulations and to ‘‘eliminate or

revise those that are outdated or

otherwise in need of reform.’’ As a

result of that review and as part of its

response to the President’s directive,

FDA published a document in the

Federal Register of June 11, 1996 (61 FR

29502), proposing to amend those parts

of its drug regulations codified in parts

200, 250, and 310 (21 CFR parts 200,

250, and 310), regarding certain drugs

determined by rulemaking to be new

drugs.

FDA proposed the following: (1) To

revise § 310.502 to consolidate into one

section a list of drugs (now codified in

parts 200, 250, and 310) that have been

determined by rulemaking procedures

to be new drugs requiring approved new

drug applications, and (2) to remove

those sections in parts 200, 250, and 310

now providing for those drugs, except

for certain information in § 310.509 that

FDA considers to be necessary. The

agency received no comments in

response to the proposal to amend or

remove these regulations.

II. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. The Commissioner of Food and

Drugs certifies that the final rule will

not have a significant economic impact

on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.