1460 Federal Register / Vol. 62, No. 7 / Friday, January 10, 1997 / Notices

acquire from any one person during any

18-month period more than five miles of

gas gathering pipelines located within

certain portions of the Oklahoma

counties.

In a separate agreement with Phillips,

the Commission expressed concern that

it might not have an adequate legal

remedy if the proposed acquisition were

consummated prior to Commission

action. Phillips has agreed to maintain

the assets that are being divested in

their current condition and provide

gathering service at existing terms and

conditions to customers under contract

with ANR until the Schedule A assets

are either sold or the Commission

decides not to accept this order.

The purpose of this analysis is to

invite public comment concerning the

consent order. This analysis is not

intended to constitute an official

interpretation of the agreement and

order or to modify their terms in any

way.

Donald S. Clark,

Secretary.

[FR Doc. 97–606 Filed 1–9–97; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Health Care Policy and

Research

Notice of Meeting

In accordance with section 10(a) of

the Federal Advisory Committee Act (5

U.S.C., Appendix 2) announcement is

made of the following special emphasis

panel scheduled to meet during the

month of February 1997:

Name: Health Care Policy and Research

Special Emphasis Panel.

Date and Time: February 7, 1997, 8:00 a.m.

Place: Doubletree Hotel, 1750 Rockville

Pike, Halpine Room, Rockville, Maryland

20852.

Open February 7, 1997, 8:00 a.m. to 8:15

a.m. Closed for remainder of meeting.

Purpose: This Panel is charged with

conducting the initial review of grant

applications requesting dissertation support

for health services research undertaken as

part of an academic program to qualify for a

doctorate.

Agenda: The open session of the meeting

on February 7 from 8:00 a.m. to 8:15 a.m.,

will be devoted to a business meeting

covering administration matters. During the

closed session, the panel will be reviewing

and discussing grant applications dealing

with health services research issues. In

accordance with the Federal Advisory

Committee Act, section 10(d) of 5 U.S.C.,

Appendix 2 and 5 U.S.C., 552b(c)(6), the

Administrator, AHCPR, has made a formal

determination that this latter session will be

closed because the discussions are likely to

reveal personal information concerning

individuals associated with the grant

applications. This information is exempt

from mandatory disclosure.

Anyone wishing to obtain a roster of

members or other relevant information

should contact Carmen Johnson, Agency for

Health Care Policy and Research, Suite 400,

2101 East Jefferson Street, Rockville,

Maryland 20852, Telephone (301) 594–1449

x1613.

Agenda items for this meeting are subject

to change as priorities dictate.

Dated: January 3, 1997.

Clifton R. Gaus,

Administrator.

[FR Doc. 97–654 Filed 1–9–97; 8:45 am]

BILLING CODE 4160–90–M

Food and Drug Administration

[Docket No. 95N–0200]

Guidance for the Submission of

Chemistry, Manufacturing, and

Controls Information and

Establishment Description for

Autologous Somatic Cell Therapy

Products; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled

‘‘Guidance for the Submission of

Chemistry, Manufacturing, and Controls

Information and Establishment

Description for Autologous Somatic Cell

Therapy Products.’’ This guidance,

prepared by the Center for Biologics

Evaluation and Research (CBER) in

consultation with the Center for Devices

and Radiological Health, is intended to

assist applicants in the preparation of

the chemistry, manufacturing, and

controls (CMC) section and the

establishment description section of a

biologics license application (BLA) or in

the preparation of a product license

application (PLA) and establishment

license application (ELA) for all

autologous somatic cell therapy

products. This guidance may assist in

complying with certain requirements in

the Code of Federal Regulations.

DATES: Written comments may be

submitted at any time; however,

comments submitted by April 10, 1997,

will be considered for the next revision.

ADDRESSES: Submit written requests for

single copies of the guidance entitled,

‘‘Guidance for the Submission of

Chemistry, Manufacturing, and Controls

Information and Establishment

Description for Autologous Somatic Cell

Therapy Products’’ to the Office of

Communication, Training and

Manufacturers 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 requests.

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 1–800–

CBER–FAX, or 301–827–3844.

Persons with access to the Internet

may obtain the document in several

ways. Users of ‘‘Web Browser’’ software,

such as Mosaic, Netscape, or Microsoft

Internet Explorer may obtain this

document via the World Wide Web by

using the following Uniform Resource

Locators:

http://www.fda.gov/cber/cberftp.html

ftp://ftp.fda.gov/CBER/

The document may also be obtained

via File Transfer Protocol (FTP).

Requests should connect to the FDA’s

FTP Server,

FTP.FDA.GOV(192.73.61.21). CBER

documents are maintained in a

subdirectory called ‘‘CBER’’ on the

server. Logins with the user name of

anonymous are permitted, and the

user’s e-mail address should be sent as

the password. The ‘‘READ.ME’’ file in

that subdirectory describes the available

documents which may be available as

an ASCII text file (*.TXT), or a Word

Perfect 5.1 or 6.x document

(*.w51,wp6), or both. Finally, the

guidance can be obtained by ‘‘bounceback e-mail’’. A message should be sent

to: ‘‘XVCMC@al.cber.fda.gov’’.

Submit written comments on the

guidance to the Dockets Managements

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 that individuals may

submit one copy. Requests and

comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

FOR FURTHER INFORMATION CONTACT:

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:

Over the last several years, FDA has

worked to clarify its approach to the
Federal Register / Vol. 62, No. 7 / Friday, January 10, 1997 / Notices 1461

regulation of products that are

comprised in whole or in part of living

cellular materials. Recognizing that

sponsors developing tissue and cell

based therapies would soon want to

make these products commercially

available, FDA issued a notice in the

Federal Register of October 14, 1993 (58

FR 53248), entitled ‘‘Application of

Current Statutory Authorities to Human

Somatic Cell Therapy Products and

Gene Cell Therapy Products;’’ this

notice explained the regulatory

framework for somatic cell and gene

therapy products, but it did not provide

detailed technical guidance. As

announced in the Federal Register of

July 18, 1995 (60 FR 36808), FDA held

a public hearing on November 16 and

17, 1995, to solicit information on the

nature and diversity of a subset of

autologous somatic cell therapy

products for structural repair or

reconstruction called manipulated

autologous structural cell products

(MAS cell products) and to receive

comments on the formulation and

implementation of any new regulatory

requirements. As announced in the

Federal Register of March 7, 1996 (61

FR 9185), the agency held a

Commissioner’s roundtable public

meeting on March 15, 1996, to present

the elements of a planned regulatory

framework intended to help ensure

patient safety and confirmation of

patient benefit, while accommodating

the development of these therapies and

the need for a flexible regulatory

approach. Many of the concepts

presented at the meetings were derived

from ongoing FDA Reinventing

Government initiatives. In the Federal

Register of May 28, 1996 (61 FR 26523),

FDA announced the availability of a

guidance document entitled ‘‘Guidance

on Applications for Products Comprised

of Living Autologous Cells Manipulated

Ex Vivo and Intended for Structural

Repair or Reconstruction.’’ FDA now is

providing the CMC guidance document

that describes product characterization

and establishment information for MAS

cell products and other autologous

somatic cell therapy products. This

document is intended to assist

manufacturers of all autologous somatic

cell therapy products, whether used for

structural repair or reconstruction, or for

other purposes.

As outlined in the President’s

November 1995, National Performance

Review, ‘‘Reinventing the Regulation of

Drugs Made From Biotechnology,’’ and

as part of FDA’s continuing effort to

reduce unnecessary burdens for

industry without diminishing public

health protection, FDA committed to

using a standardized, single application

format for drug and biological product

approvals. An interim form for

submission of the BLA, FDA Form 3439,

is available from the Office of

Communication, Training and

Manufacturers Assistance (address

above). Use of this form is voluntary.

Establishments wishing to engage in

clinical studies of autologous somatic

cell therapy products, including MAS

cell products, should submit an

investigational new drug application

(IND). Establishments seeking approval

of autologous somatic cell therapy

products for clinical use should either

submit, as appropriate, a BLA or a

product license application (PLA) and

companion establishment license

application (ELA).

The information FDA received at the

public hearing of November 16 and 17,

1995, as well as comments received on

the FDA Commissioner’s roundtable

meeting of March 15, 1996, were

considered in developing the guidance

for preparation of the CMC and

establishment description sections of

the BLA for autologous somatic cell

therapy products.

The guidance document is divided

into three parts. The general information

section provides background

information. Part 1, the CMC section, is

divided into the following sections: (1)

Introduction; (2) Biological Substance/

Product, including discussions of

Description and Characterization,

Manufacturer(s), and Method(s) of

Manufacture, Process Controls,

Specifications/Analytical Methods,

Container and Closure Systems/

Shipping Containers, and Biological

Substance Stability; (3) Biological

Product, including discussions of

Method(s) of Manufacture and

Packaging, Specifications and Test

Methods for Final Biological Product,

Biological Product Stability, Container

and Closure System, and Microbiology;

(4) Environmental Assessment; and (5)

Method Validation. Part 2, the

establishment description section,

provides a description of establishment

information that should be submitted

and related good manufacturing practice

(GMP) controls for the manufacture of

autologous somatic cell therapy

products. Part 2 is divided into the

following sections: (1) Introduction; (2)

General Information; (3) Water Systems,

including discussions of General

Description of Water System, Validation

Summary and Routine Monitoring; (4)

Heating, Ventilation and Air

Conditioning Systems; and (5)

Contamination/Cross Contamination

Issues, including discussions of

Cleaning Procedures and Validation and

Containment Features. This document

provides guidance to manufacturers for

providing the information describing

establishment standards and GMP

controls that would be submitted as part

of the BLA or PLA and ELA.

As with other procedural guidance

documents, FDA does not intend that

this guidance would be all-inclusive.

Alternative approaches could be

warranted in specific situations, and

certain aspects might not be applicable

in all situations. If an applicant believed

a procedure described in this guidance

was inapplicable to a specific situation

for a particular product, the applicant

could provide, for CBER’s

consideration, information supporting

an alternative process. If an applicant

chooses to use alternative processes, the

applicant may wish to discuss the

matter further with the agency to

prevent expenditure of money and

resources on activities that later might

be determined to be inappropriate by

FDA. Additionally, FDA intends to

further revise this guidance, as needed.

FDA also encourages applicants who

use the BLA to contact CBER to discuss

use of the application further inasmuch

as the agency’s experience with its use

will evolve. Although this guidance

document does not create or confer any

rights for or on any person, and does not

operate to bind FDA or the public, it

does represent the agency’s current

thinking on the CMC and establishment

description sections of a BLA or PLA

and ELA submitted for an autologous

somatic cell therapy product.

Interested persons may, on or before

April 10, 1997, submit written

comments on the guidance document to

the Dockets Management Branch

(address above). Two copies of any

comments are to be submitted, except

that 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. The guidance

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

will be considered in determining

whether revisions to the guidance are

warranted.

Dated: January 6, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–579 Filed 1–9–97; 8:45 am]

BILLING CODE 4160–01–F