[Federal Register: March 13, 2002 (Volume 67, Number 49)]
[Notices]
[Page 11343-11344]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13mr02-107]
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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