Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Proposed Rules 7389

forwarded through an appropriate FAA

Principal Maintenance Inspector, who may

add comments and then send it to the

Manager, Engine Certification Office.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this airworthiness directive,

if any, may be obtained fmom the Engine

Certification Office.

(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 aircraft to

a location where the requirements of this AD

can be accomplished.

Issued in Burlington, Massachusetts, on

February 4, 1997.

Jay J. Pardee,

Manager, Engine and Propeller Directorate,

Aircraft Certification Service.

[FR Doc. 97–4013 Filed 2–18–97; 8:45 am]

BILLING CODE 4910–13–U

14 CFR Part 71

[Airspace Docket No. 97–AGL–6]

Modification of Class E Airspace;

Spearfish, SD, Black Hills-Clyde Ice

Field

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: This notice proposes to

modify Class E airspace at Spearfish,

SD. A Global Positioning System (GPS)

standard instrument approach

procedure (SIAP) to Runway 12 has

been developed for Black Hills-Clyde

Ice Field. Controlled airspace extending

upward from 700 to 1200 feet above

ground level (AGL) is needed to contain

aircraft executing the approach. The

intended affect of this proposal is to

provide segregation of aircraft using

instrument approach procedures in

instrument conditions from other

aircraft operating in visual weather

conditions.

DATES: Comments must be received on

or before April 7, 1997.

ADDRESSES: Send comments on the

proposal in triplicate to: Federal

Aviation Administration, Office of the

Assistant Chief Counsel, AGL–7, Rules

Docket No. 97–AGL–6, 2300 East Devon

Avenue, Des Plaines, Illinois, 60018.

The official docket may be examined

in the Office of the Assistant Chief

Counsel, Federal Aviation

Administration, 2300 East Devon

Avenue, Des Plaines, Illinois. An

informal docket may also be examined

during normal business hours at the Air

Traffic Division, Operations Branch,

Federal Aviation Administration, 2300

East Devon Avenue, Des Plaines,

Illinois.

FOR FURTHER INFORMATION CONTACT:

John A. Clayborn, Air Traffic Division,

Operations Branch, AGL–530, Federal

Aviation Administration, 2300 East

Devon Avenue, Des Plaines, Illinois

60018, telephone (847) 294–7568.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested parties are invited to

participate in this proposed rulemaking

by submitting such written data, views,

or arguments as they may desire.

Comments that provide the factual basis

supporting the views and suggestions

presented are particularly helpful in

developing reasoned regulatory

decisions on the proposal. Comments

are specifically invited on the overall

regulatory, aeronautical, economic,

environmental, and energy-related

aspects of the proposal.

Communications should identify the

airspace docket number and be

submitted in triplicate to the address

listed above. Commenters wishing the

FAA to acknowledge receipt of their

comments on this notice must submit

with those comments a self-addressed,

stamped postcard on which the

following statement is made:

‘‘Comments to Airspace Docket No. 97–

AGL–6.’’ The postcard will be date/time

stamped and returned to the

commenter. All communications

received on or before the specified

closing date for comments will be

considered before taking action on the

proposed rule. The proposal contained

in this notice may be changed in light

of comments received. All comments

submitted will be available for

examination in the Rules Docket, FAA,

Great Lakes Region, Office of the

Assistant Chief Counsel, 2300 East

Devon Avenue, Des Plaines, Illinois,

both before and after the closing date for

comments. A report summarizing each

substantive public contact with FAA

personnel concerned with this

rulemaking will be filed in the docket.

Availability of NPRM’s

Any person may obtain a copy of the

Notice of Proposed Rulemaking (NPRM)

by submitting a request to the Federal

Aviation Administration, Office of

Public Affairs, Attention: Public Inquiry

Center, APA–230, 800 Independence

Avenue, S.W., Washington, DC 20591,

or by calling (202) 267–3484.

Communications must identify the

notice number of this NPRM. Persons

interested in being placed on a mailing

list for future NPRM’s should also

request a copy of Advisory Circular No.

11–2A, which describes the application

procedure.

The Proposal

The FAA is considering an

amendment to part 71 of the Federal

Aviation Regulations (14 CFR part 71) to

modify Class E airspace at Spearfish,

SD; this proposal would provide

adequate Class E airspace for operators

executing the GPS Runway 12 SIAP at

Black Hills-Clyde Ice Field. Controlled

airspace extending upward from 700 to

1200 feet AGL is needed to contain

aircraft executing the approach. The

intended affect of this action is to

provide segregation of aircraft using

instrument approach procedures in

instrument conditions from other

aircraft operating in visual weather

conditions. The area would be depicted

on appropriate aeronautical charts

thereby enabling pilots to

circumnavigate the area or otherwise

comply with IFR procedures. Class E

airspace designations for airspace areas

extending upward from 700 feet or more

above the surface of the earth 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

listed in this document would be

published subsequently in the Order.

The FAA has determined that this

proposed regulation only involves an

established body of technical

regulations for which frequent and

routine amendments are necessary to

keep them operationally current.

Therefore this, proposed 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 proposed 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).

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me, the Federal

Aviation Administration proposes to

amend part 71 of the Federal Aviation

Regulations (14 CFR part 71) as follows:
7390 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Proposed Rules

PART 71—[Amended]

1. The authority citation for 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; 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

Designation 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.

* * * * *

AGL SD E5 Spearfish, SD [Revised]

Black Hills-Clyde Ice Field, SD

(lat. 44°28′49′′N, long. 103°46′37′′W)

That airspace extending upward from 700

feet above the surface within a 7-mile radius

of the Black Hills-Clyde Ice Field Airport and

within 2.1 miles each side of the 305° bearing

from the airport extending from the 7-mile

radius to 8.3 miles northwest 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.

44°29′22′′N, long. 103°56′48′′W; to lat.

44°13′37′′N, long. 104°14′00′′W; to lat.

44°18′41′′N, long. 104°23′24′′W; to lat.

44°44′11′′N, long. 103°57′49′′W; to lat.

44°50′13′′N, long. 103°28′11′′W; to lat.

44°47′27′′N, long. 102°57′40′′W; to lat.

44°39′31′′N, long. 102°56′34′′W; to lat.

44°38′27′′N, long. 103°12′26′′W; to lat.

44°25′29′′N, long. 103°38′30′′W; then

clockwise via the 7-mile radius of the airport

to the point of beginning.

* * * * *

Issued in Des Plaines, Illinois on February

5, 1997.

Maureen Woods,

Manager, Air Traffic Division.

[FR Doc. 97–4073 Filed 2–18–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Ch. I

[Docket No. 96N–0364]

RIN 0910–AA20

Regulation of Medical Foods;

Extension of Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Advance notice of proposed

rulemaking; extension of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) is extending to

April 28, 1997, the comment period for

the advance notice of proposed

rulemaking for the regulation of medical

foods that published in the Federal

Register of November 29, 1996. This

action is being taken in response to

several requests from interested persons

for an extension of the comment period

on this document.

DATES: Written comments by April 28,

1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Robert J. Moore, Center for Food Safety

and Applied Nutrition (HFS–456), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4605.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 29, 1996

(61 FR 60661), FDA published an

advance notice of proposed rulemaking

for the regulation of medical foods.

Interested persons were given until

February 27, 1997, to comment on the

advance notice of proposed rulemaking.

FDA has received requests for an

extension of the comment period from:

Manufacturers, a trade organization

representing manufacturers of medical

foods, and a professional society

representing health care providers and

research scientists. The interested

parties stated in their requests for an

extension of the comment period that

such an extension would help ensure

that the agency receives comprehensive

and carefully researched information

from experts to consider in response to

the notice. After careful consideration of

the requests submitted to the agency,

FDA has decided to grant an extension

of the comment period until April 28,

1997.

Interested persons may, on or before

April 28, 1997, submit to the Dockets

Management Branch (address above)

written comments regarding this

advanced notice of proposed

rulemaking. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

This document is issued under

sections 4, 5, and 6 of the Fair Packaging

and Labeling Act (15 U.S.C. 1453, 1454,

1455); sections 201, 301, 402, 403, 404,

405, 409, 411, 412, 501, 502, 503, 505,

and 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 342,

343, 344, 345, 348, 350, 350a, 351, 352,

353, 355, 371); and 21 U.S.C. 360ee(b)(3)

(section 5(b)(3) of the Orphan Drug

Amendments of 1988, as amended by

Pub. L. 100–290).

Dated: February 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4021 Filed 2–18–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 808

[Docket No. 96N–0249]

RIN 0910–AB03

Exemption From Preemption of State

and Local Cigarette and Smokeless

Tobacco Requirements; Applications

for Exemption Submitted by Various

State Governments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Federal Food, Drug, and

Cosmetic Act (the act) preempts State

and local device requirements that are

different from, or in addition to, Federal

requirements under the act. The act also

provides that the Food and Drug

Administration (FDA) may, by

regulation, exempt State and local

device requirements from preemption.

FDA is responding to applications for

exemption submitted by the States of

Alabama, Alaska, Utah, and

Washington. FDA is proposing to grant

exemptions from Federal preemption for

certain cigarette and smokeless tobacco

requirements in the States of Alabama,

Alaska, and Utah. The requirements in

the State of Washington are not

preempted, and therefore no exemption

needs to be granted. Elsewhere in this

issue of the Federal Register, FDA is

announcing an opportunity for

interested persons to request a public

hearing on the proposed regulation.

DATES: Written comments by March 21,

1997. FDA proposes that any final rule

that may be issued based on this

proposal become effective 30 days after

the date of its publication in the Federal

Register.

ADDRESSES: Written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Anne M. Kirchner, Office of Policy (HF–

23), Food and Drug Administration,