Skip to Content

Notice

Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments; Availability

Document Details

Information about this document as published in the Federal Register.

Published Document

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

Start Preamble

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: Biological Product Deviation Reporting for Blood and Plasma Establishments,” dated October 2006. The guidance provides blood and plasma establishments, including licensed blood establishments, unlicensed registered blood establishments, and transfusion services, with the FDA's current thinking related to the biological product deviation reporting requirements. The guidance document will assist blood and plasma establishments in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report. The guidance finalizes the draft guidance document under the same title dated August 2001.

DATES:

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

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, suite 200N, 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 CBER 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.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Joseph L. Okrasinski, Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a document entitled “Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments” dated October 2006. The guidance is intended to provide Start Printed Page 61781assistance to blood and plasma establishments in the reporting of any event associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution, of blood or blood components that may effect the safety, purity, or potency of a distributed product as required under §§ 600.14 and 606.171 (21 CFR 600.14 and 606.171). The guidance provides additional information regarding the regulations in § 606.171 by describing who must report, what must be included in the report, when the establishment must report, and how to report either electronically or by mail using Form FDA-3486, a standardized reporting format. Examples of reportable and non-reportable events concerning donor suitability, product collection, component preparation, testing, labeling, quality control and distribution are discussed. The guidance also contains a Biological Product Deviation Reporting Flow Chart to aid the blood or plasma establishment in determining if an event is reportable.

In the Federal Register of August 13, 2001 (66 FR 42546) FDA announced the availability of the draft guidance of the same title. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated August 2001.

The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the FDA'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 refers to previously approved collections of information found in FDA regulations. These collections of information 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 collections of information under § 606.171 and 21 CFR 606.100 were approved under OMB control number 0910-0116. The collection of information under § 600.14 was approved under OMB control number 0910-0139. The collections of information under 21 CFR 820.90 and 820.100 were approved under OMB control number 0910-0458. The collections of information under 21 CFR 211.192 and 211.198 were approved under OMB control number 0910-0139.

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 the 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.

Start Signature

Dated: October 10, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. E6-17378 Filed 10-18-06; 8:45 am]

BILLING CODE 4160-01-S