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Notice

Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion; Availability

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a document entitled “Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion” dated September 2003. The guidance document provides recommendations to blood collection and transfusion facilities on reporting fatalities related to human blood and blood component collection or transfusion to FDA's Center for Biologics Evaluation and Research (CBER). The guidance announced in this notice finalizes the draft guidance of the same title dated June 2002.

DATES:

Submit written or electronic comments on agency guidances at any time.

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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 guidance may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments.

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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.

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SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a document entitled “Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion” dated September 2003. The guidance provides recommendations to blood collection or transfusion facilities on reporting to CBER fatalities related to human blood and blood component collection and transfusion. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2002 (67 FR 38505, June 4, 2002).

The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance 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. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection(s) of information in 21 CFR 606.170(b) cited in the guidance has been approved by OMB under OMB control number 0910-0116.

III. Comments

Interested persons may, at any time, submit written or electronic comments to the Division of Dockets Management (see ADDRESSES) regarding this guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/​cber/​guidelines.htm or http://www.fda.gov/​ohrms/​dockets/​default.htm.

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Dated: September 12, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 03-23997 Filed 9-18-03; 8:45 am]

BILLING CODE 4160-01-S