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
9722 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

standards. The agency intends to

implement this regulatory plan in a

step-by-step fashion and to issue

through notice and comment

rulemaking new regulatory

requirements.

The regulatory approach focuses on

five overarching public health and

regulatory concerns, which can be

stated as the following questions:

(1) How can the transmission of

communicable disease be prevented?

(2) What processing controls are

necessary, e.g., to prevent

contamination that could result in an

unsafe or ineffective product, and to

preserve integrity and function so that

products will work as they are

intended?

(3) How can clinical safety and

effectiveness be assured?

(4) What labeling is necessary, and

what kind of promotion is permissible,

for proper use of the product?

(5) Should manufacturers notify FDA

when they process and market tissue

products?

With these concerns in mind, FDA

categorized cells and tissues and their

uses by their risk relative to each

concern, so as to enable the agency to

provide only that level of oversight

relevant to each of the individual areas

of concern. Thus, under the plan, cells

and tissues would be regulated with a

tiered approach based on risk and the

necessity for FDA review.

In addition to making this document

available, FDA is announcing a public

meeting to discuss the proposed

approach to the regulation of cellular

and tissue-based products. At the public

meeting FDA intends to present a brief

overview of the proposed regulatory

approach and provide an opportunity

for public comments on the approach.

Individuals who wish to make a

presentation should contact Martha A.

Wells, address above. FDA will

determine the time available for

presentations based on the number of

participants. As time permits, those who

did not submit a notice of participation

will be given an opportunity to speak at

the end of the meeting. FDA is

requesting that those persons making

oral presentations also submit their

statements in writing, as described

below, to ensure their adequate

consideration.

Although all members of the public

will have an opportunity to comment on

the proposed regulations when they are

published, interested persons who wish

to comment on the agency’s proposed

approach to the regulation should

submit written comments on the

document, ‘‘Proposed Approach to

Regulation of Cellular and Tissue-Based

Products,’’ and written comments in

response to the public meeting to

Dockets Management Branch (address

above). Written comments may be

submitted at anytime, however,

comments should be submitted by April

17, 1997, to assure their adequate

consideration. Two copies of any

comments are to be submitted, except

individuals may submit one copy.

Comments and information are to be

identified with the docket number

found in brackets in the heading of this

document. A copy of the document and

received comments may be seen in the

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

Monday through Friday.

Written comments on this document

and comments received in response to

the public meeting will be considered in

determining whether revisions to the

document are warranted and in

preparing any future rulemaking.

Dated: February 26, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–5240 Filed 2–28–97; 2:13 pm]

BILLING CODE 4160–01–F

FEDERAL EMERGENCY

MANAGEMENT AGENCY

44 CFR Part 67

[Docket No. FEMA–7210]

Proposed Flood Elevation

Determinations

AGENCY: Federal Emergency

Management Agency (FEMA).

ACTION: Proposed rule.

SUMMARY: Technical information or

comments are requested on the

proposed base (1% annual chance) flood

elevations and proposed base flood

elevation modifications for the

communities listed below. The base

flood elevations and modified base

flood elevations are the basis for the

floodplain management measures that

the community is required either to

adopt or to show evidence of being

already in effect in order to qualify or

remain qualified for participation in the

National Flood Insurance Program

(NFIP).

DATES: The comment period is ninety

(90) days following the second

publication of this proposed rule in a

newspaper of local circulation in each

community.

ADDRESSES: The proposed base flood

elevations for each community are

available for inspection at the office of

the Chief Executive Officer of each

community. The respective addresses

are listed in the following table.

FOR FURTHER INFORMATION CONTACT:

Frederick H. Sharrocks, Jr., Chief,

Hazard Identification Branch, Mitigation

Directorate, 500 C Street SW.,

Washington, DC 20472, (202) 646–2796.

SUPPLEMENTARY INFORMATION: The

Federal Emergency Management Agency

proposes to make determinations of base

flood elevations and modified base

flood elevations for each community

listed below, in accordance with Section

110 of the Flood Disaster Protection Act

of 1973, 42 U.S.C. 4104, and 44 CFR

67.4(a).

These proposed base flood and

modified base flood elevations, together

with the floodplain management criteria

required by 44 CFR 60.3, are the

minimum that are required. They

should not be construed to mean that

the community must change any

existing ordinances that are more

stringent in their floodplain

management requirements. The

community may at any time enact

stricter requirements of its own, or

pursuant to policies established by other

Federal, State, or regional entities.

These proposed elevations are used to

meet the floodplain management

requirements of the NFIP and are also

used to calculate the appropriate flood

insurance premium rates for new

buildings built after these elevations are

made final, and for the contents in these

buildings.

National Environmental Policy Act

This proposed rule is categorically

excluded from the requirements of 44

CFR Part 10, Environmental

Consideration. No environmental

impact assessment has been prepared.

Regulatory Flexibility Act.

The Executive Associate Director,

Mitigation Directorate, certifies that this

proposed rule is exempt from the

requirements of the Regulatory

Flexibility Act because proposed or

modified base flood elevations are

required by the Flood Disaster

Protection Act of 1973, 42 U.S.C. 4104,

and are required to establish and

maintain community eligibility in the

NFIP. No regulatory flexibility analysis

has been prepared.

Regulatory Classification

This proposed rule is not a significant

regulatory action under the criteria of

Section 3(f) of Executive Order 12866 of

September 30, 1993, Regulatory

Planning and Review, 58 FR 51735.