9348 Federal Register / Vol. 66, No. 26 / Wednesday, February 7, 2001 / Notices

received comments may be seen in the

Dockets Management Branch between 9

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

Friday.

Dated: January 22, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–3203 Filed 2–6–01; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1662]

Draft ‘‘Guidance for Industry: Source

Animal, Product, Preclinical, and

Clinical Issues Concerning the Use of

Xenotransplantation Products in

Humans;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Guidance for

Industry: Source Animal, Product,

Preclinical, and Clinical Issues

Concerning the Use of

Xenotransplantation Products in

Humans’’ dated February 2001. The

draft guidance document is intended to

provide guidance on the production,

testing, and evaluation of products

intended for use in xenotransplantation.

DATES: Submit written comments on the

draft guidance to ensure their adequate

consideration in preparation of the final

document by May 8, 2001.

ADDRESSES: Submit written requests for

single copies of the draft guidance

entitled ‘‘Guidance for Industry: Source

Animal, Product, Preclinical, and

Clinical Issues Concerning the Use of

Xenotransplantation Products in

Humans’’ dated February 2001 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

the office in processing your requests.

The document may also be obtained by

mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by fax by calling

the FAX Information System at 1–888–

CBER–FAX or 301–827–3844. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance

document.

Submit written comments on the draft

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Stephen Ripley, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance document entitled

‘‘Guidance for Industry: Source Animal,

Product, Preclinical, and Clinical Issues

Concerning the Use of

Xenotransplantation Products in

Humans’’ dated February 2001. For the

purpose of the draft guidance

‘‘xenotransplantation’’ refers to any

procedure that involves the

transplantation, implantation, or

infusion into a human recipient of

either: (1) Live cells, tissues, or organs

from a nonhuman animal source, or (2)

human body fluids, cells, tissues, or

organs that have had ex vivo contact

with live nonhuman animal cells,

tissues, or organs. This document is

intended to provide guidance on the

production, testing, and evaluation of

products intended for use in

xenotransplantation. The draft guidance

includes scientific questions that should

be addressed by sponsors during

protocol development and during the

preparation of submissions to FDA (e.g.,

investigational new drug application

and biologics license application). The

topics in the draft guidance include:

Regulatory responsibility; source animal

and xenotransplantation products

characterization; microbiological testing

of xenotransplantation products;

manufacturing and process-related good

manufacturing practice considerations

for harvest and processing of

xenotransplantation products;

preclinical considerations for

xenotransplantation products; and

clinical issues in xenotransplantation.

FDA has previously announced the

availability of the guidance document

entitled ‘‘Guidance for Industry: Public

Health Issues Posed by the Use of

Nonhuman Primate Xenografts in

Humans’’ dated April 1999, in the

Federal Register of April 6, 1999 (64 FR

16743). FDA also announced the

availability of the draft guidance

document ‘‘Guidance for Industry:

Precautionary Measures to Reduce the

Possible Risk of Transmission of

Zoonoses by Blood and Blood Products

From Xenotransplantion Product

Recipients and Their Contacts’’ dated

December 1999, in the Federal Register

of December 30, 1999 (64 FR 73562). In

the future, FDA intends to finalize the

guidance. Furthermore, FDA is

considering developing draft guidance

to address various issues pertaining to

FDA’s regulation of transgenic animals.

This draft guidance is being issued

consistent with FDA’s good guidance

practice regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). This

draft guidance document represents the

agency’s current thinking with regard to

the production, testing, and evaluation

of products intended for use in

xenotransplantation. It does not create

or confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirements of the applicable statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this document to be all-inclusive

and cautions that not all information

may be applicable to all situations. The

draft guidance document is intended to

provide information and does not set

forth requirements.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

draft guidance document. Submit

written comments to ensure adequate

consideration in preparation of the final

document by May 8, 2001. Two copies

of any comments are to be submitted,

except individuals may submit one

copy. 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 between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cber/guidelines.htm.

Dated: December 26, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–3202 Filed 2–6–01; 8:45 am]

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