[Federal Register Volume 67, Number 107 (Tuesday, June 4, 2002)]
[Notices]
[Pages 38505-38506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13860]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0124]


Draft Guidance for Industry: Notifying FDA of Fatalities Related 
to Blood Collection or Transfusion; 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availability of a draft guidance document entitled ``Guidance for 
Industry: Notifying FDA of Fatalities Related to Blood Collection or 
Transfusion'' dated June 2002. The draft guidance document, when 
finalized, is intended to provide recommendations to blood collection 
or transfusion facilities on reporting fatalities related to blood or 
blood component collection or blood transfusion to FDA's Center for 
Biologics Evaluation and Research (CBER).

DATES: Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by September 3, 2002. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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electronic access to the draft guidance document.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 or electronic comments on the 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.

[[Page 38506]]


SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled `` 
Guidance for Industry: Notifying FDA of Fatalities Related to Blood 
Collection or Transfusion'' dated June 2002. Under 21 CFR 606.170(b), 
fatalities related to blood collection or transfusion are required to 
be reported to CBER. The draft guidance document is intended to provide 
recommendations to a blood collection or transfusion facility on 
reporting fatalities related to blood or blood component collection or 
blood transfusion to CBER.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance 
document represents the agency's current thinking on this topic. 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

    This draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (see ADDRESSES) written or 
electronic comments regarding this draft guidance document. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final document by September 3, 2002. Two copies of 
any written 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: April 26, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-13860 Filed 6-3-02; 8:45 am]
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