This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

9720

Vol. 62, No. 42

Tuesday, March 4, 1997

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 96–AAL–31]

Proposed Revision of Class E

Airspace; Klawock, AK

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: This action revises Class E

airspace at Klawock, AK. The revision

of the Global Positioning System (GPS)

instrument approach and creation of a

non-directional beacon (NDB)

instrument approach to RWY 1 has

made this action necessary. The area

would be depicted on aeronautical

charts for pilot reference. The intended

effect of this proposal is to provide

adequate controlled airspace for IFR

operations at Klawock, AK.

DATES: Comments must be received on

or before April 18, 1997.

ADDRESSES: Send comments on the

proposal in triplicate to: Manager,

System Management Branch, AAL–530,

Docket No. 96–AAL–31, Federal

Aviation Administration, 222 West 7th

Avenue, Box 14, Anchorage, AK 99513–

7587.

The official docket may be examined

in the Office of the Assistant Chief

Counsel for the Alaskan Region at the

same address.

An informal docket may also be

examined during normal business hours

in the Office of the Manager, System

Management Branch, Air Traffic

Division, at the address shown above.

FOR FURTHER INFORMATION CONTACT:

Robert van Haastert, System

Management Branch, AAL–538, Federal

Aviation Administration, 222 West 7th

Avenue, Box 14, Anchorage, AK 99513–

7587; telephone number: (907) 271–

5863; email:

Robert.van.Haastert@faa.dot.gov.

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. 96–

AAL–31.’’ 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 System Management

Branch, Air Traffic Division, Federal

Aviation Administration, 222 West 7th

Avenue, Box 14, Anchorage, AK, 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 this

Notice of Proposed Rulemaking (NPRM)

by submitting a request to the System

Management Branch, AAL–530, Federal

Aviation Administration, 222 West 7th

Avenue, Box 14, Anchorage, AK 99513–

7587. 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

revise Class E airspace for GPS and NDB

instrument approach procedures at

Klawock, AK. The coordinates for this

airspace docket are based on North

American Datum 83. The Class E

airspace areas designated as 700/1200

foot transition areas 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 (61 FR 48403; September 13, 1996).

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. 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,

when promulgated, 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

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 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.
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9721

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9D, Airspace

Designations and Reporting Points,

dated September 4, 1996, and effective

September 16, 1996, is amended as

follows:

* * * * *

AAL AK E5 Klawock, AK [Revised]

Klawock Airport, AK

(Lat. 55°34′48′′ N, long. 133°04′30′′ W)

Klawock NDB/DME

(Lat. 55°34′07′′ N, long. 133°04′46′′ W)

That airspace extending upward from 700

feet above the surface within a 6.7-mile

radius of the Klawock Airport and 6.5 miles

north and 10 miles south of the 243° bearing

from the Klawock NDB/DME extending to 16

miles southwest of the NDB/DME; and that

airspace extending upward from the 1,200

feet above the surface within 6.7 miles

northwest and 9.5 miles southeast of the 039°

bearing from the airport extending from the

airport to 6.7 miles northeast of the airport

and within 6.7 miles northwest and 9.5 miles

southeast of the 219° bearing from the airport

extending from the airport to 32 miles

southwest of the airport and 6.5 miles north

and 10 miles south of the 243° bearing from

the Klawock NDB/DME beginning 16 miles

west of the NDB/DME and extending to 35

miles west of the NDB/DME.

* * * * *

Issued in Anchorage, AK, on February 25,

1997.

Willis C. Nelson,

Manager, Air Traffic Division, Alaskan

Region.

[FR Doc. 97–5292 Filed 3–3–97; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. 97N–0068]

Proposed Approach to Regulation of

Cellular and Tissue-Based Products;

Availability and Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notification of proposed

regulatory approach; public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a document entitled,

‘‘Proposed Approach to Regulation of

Cellular and Tissue-Based Products.’’ In

addition, FDA is announcing a public

meeting to solicit information and views

from the interested public on the

agency’s proposed regulatory approach

for such products. These actions are

taken in response to the

Administration’s ‘‘Reinventing

Government’’ initiative which seeks to

streamline regulatory requirements to

ease the burden on regulated industry,

while providing adequate protection to

the public health.

DATES: Written comments may be

submitted at any time; however,

comments should be submitted by April

17, 1997, to ensure their adequate

consideration in preparing FDA’s final

approach to the regulation of cellular

and tissue-based products.

The public meeting will be held on

March 17, 1997, from 8 a.m. to 4:30 p.m.

Submit written notices of participation

by March 10, 1997, including a

summary of the presentation, which

will be submitted to the docket, and

approximate time requested.

Registration is not required; however,

groups are asked to limit the number of

individuals attending because of the

anticipated broad interest in the meeting

and the limited available seating.

ADDRESSES: The public meeting will be

held at the Parklawn Bldg., conference

rooms D and E, 5600 Fishers Lane,

Rockville, MD 20857.

Submit written requests for single

copies of the document ‘‘Proposed

Approach to Regulation of Cellular and

Tissue-Based Products’’ to the Office of

Communication, Training and

Manufacturer’s Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your request.

The document may also be obtained by

mail or by calling the CBER Voice

information System at 1–800–835–4709,

or 301–827–1800, or FAX at 1–888–

CBER–FAX, or 301–827–3844.

Persons with access to the Internet

may obtain the document using the

world wide web (WWW) or bounceback-e-mail. For WWW access, connect

to CBER at ‘‘http://www.fda.gov/cber/

cberftp.html’’. To receive the document

by bounce-back e-mail, send a message

to

‘‘CELL TISSUE@a1.CBER.FDA.GOV’’.

Submit written comments on the

document to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Two

copies of any comments are to be

submitted, except individuals may

submit one copy. Requests and

comments should be identified with the

docket number found in the brackets in

the heading of this document. A copy of

the document and received comments

are available for public examination in

the Dockets Management Branch,

address above, between 9 a.m. and 4

p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

For information regarding the meeting

or to submit a notice of intent to

participate: Martha A. Wells, Center

for Biologics Evaluation and

Research (HFM–305), Food and

Drug Administration, 1401

Rockville Pike, Rockville, MD

20852–1448, 301–827–0967, FAX

301–827–2844.

For information regarding this

document: Sharon A. Carayiannis,

Center for Biologics Evaluation and

Research (HFM–630), Food and

Drug Administration, 1401

Rockville Pike, Rockville, MD

20852–1448, 301–594–3074.

SUPPLEMENTARY INFORMATION:

FDA is announcing the availability of

a document entitled ‘‘Proposed

Approach to Regulation of Cellular and

Tissue-Based Products.’’ This document

is being issued as a part of FDA’s

continuing effort to reduce unnecessary

burdens for industry without

diminishing public health protection.

FDA has designed a new regulatory

framework for cells and tissues. The

document describes this new approach,

which FDA believes would provide

adequate protection of public health,

both from the risks of transmission of

communicable disease and from the

risks of therapies that may be ineffective

or dangerous, while enabling

investigators to develop new therapies

and products with as little regulatory

burden as possible. The proposed

approach would encompass, but not be

limited to, the regulation of the

following: Human tissue intended for

transplantation, currently regulated

under 21 part CFR 1270; demineralized

bone; reproductive tissue; heart valves;

peripheral blood hematopoietic stem

cells; placental/umbilical cord blood

hematopoietic stem cells; somatic cell

therapy products; and gene therapy

products.

The approach does not encompass

vascularized organs or minimallymanipulated bone marrow, transfusable

blood products (e.g., whole blood, red

blood cells, platelets, and plasma),

tissues derived from animals, products

used in the propagation of cells or

tissues, or products that are secreted by

or extracted from cells or tissues (e.g.,

human milk, collagen, urokinase,

cytokines, and growth factors and

hormones). Such products generally

raise different safety and effectiveness

issues, and generally are covered by

other rules, regulations, and/or