[Federal Register Volume 67, Number 49 (Wednesday, March 13, 2002)]
[Notices]
[Pages 11343-11344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5963]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0073]


``Guidance for Industry: Validation of Procedures for Processing 
of Human Tissues Intended for Transplantation;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Guidance for Industry: 
Validation of Procedures for Processing of Human Tissues Intended for 
Transplantation'' dated March 2002. The guidance document is intended 
to remind all tissue establishments that the current requirement to 
prepare, validate, and follow procedures to prevent infectious disease 
contamination or cross-contamination during the processing of human 
tissues intended for transplantation includes such infectious disease 
agents as viruses, bacteria, fungi, and will include transmissible 
spongiform encephalopathy (TSE)-associated prions as technology 
progresses.

DATES: General comments on agency guidance documents are welcome at any 
time. The agency is soliciting public comment, but is implementing this 
guidance document immediately because of public health concerns. FDA is 
requesting that you submit with your comments any information on 
specific methods currently used by tissue establishments to prevent 
infectious disease contamination and cross-

[[Page 11344]]

contamination of tissue during processing.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), 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 guidance document.Submit written or electronic 
comments on the guidance document to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, 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 document entitled 
``Guidance for Industry: Validation of Procedures for Processing of 
Human Tissues Intended for Transplantation'' dated March 2002. The 
document is intended to remind all tissue establishments that the 
current requirement to prepare, validate, and follow procedures to 
prevent infectious disease contamination or cross-contamination during 
the processing of human tissues intended for transplantation (21 CFR 
1270.31(d)) includes such infectious disease agents as viruses, 
bacteria, fungi, and will include TSE-associated prions as technology 
progresses. Current regulations for human tissue intended for 
transplantation are found in 21 CFR parts 1270 and 1271.
    This guidance is being issued in accordance with FDA's good 
guidance practices regulation (21 CFR 10.115). This guidance document 
represents the agency's current thinking on the validation of 
procedures for processing of human tissues intended for 
transplantation. 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 requirement of the 
applicable statutes and regulations.

II. Comments

    The agency is soliciting public comment, but is implementing this 
guidance document immediately because of the public health concerns 
related to the possible risk of infectious disease contamination or 
cross-contamination during tissue processing. In particular, FDA's 
concern is heightened by recent reports from the Centers for Disease 
Control and Prevention about bacterial contamination of musculoskeletal 
allografts associated with injury as well as death in recipients of 
these tissues [MMWR; 50(46): 1035-1036, November 23, 2001; 50(48): 
1080-1083, December 7, 2001.] FDA is requesting that you submit with 
your comments any information on specific methods currently used by 
tissue establishments to prevent infectious disease contamination and 
cross-contamination of tissue during processing. FDA plans to have 
further public discussion on this issue and to develop additional 
guidance containing more specific recommendations on validation methods 
for tissues in the future.
    Interested persons may, at any time, submit written or electronic 
comments to the Dockets Management Branch (address above) regarding 
this guidance document. 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 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 4, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-5963 Filed 3-12-02; 8:45 am]
BILLING CODE 4160-01-S