Reports and guidance documents; availability, etc.: Licensed manufacturers of biological products other than blood and blood components; biological product deviation reporting,

[Federal Register: October 19, 2006 (Volume 71, Number 202)]

[Notices]

[Page 61781-61782]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr19oc06-103]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D-0221 (Formally Docket No. 01D-0221)]

Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components; Availability

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 Licensed Manufacturers of Biological Products Other than Blood and Blood Components,'' dated October 2006. The guidance document provides licensed manufacturers of biological products other than blood and blood components with the FDA's current thinking related to the biological product deviation reporting requirements. The guidance document will assist the licensed manufacturers of biological products other than blood and blood components 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. This guidance finalizes the draft guidance document of the same title dated August 2001.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 .

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.

SUPPLEMENTARY INFORMATION:

1. Background

   FDA is announcing the availability of a document entitled ``Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components,'' dated October 2006. The guidance is intended to provide assistance to licensed manufacturers of biological products other than blood and blood components 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 a licensed biological product which may affect the safety, purity, or potency of a distributed licensed product as required under Sec. 600.14 (21 CFR 600.14). The guidance provides additional information regarding the regulations in Sec. 600.14, which describe who must report, what must be included in the report, when the licensed manufacturer must report, and provides that the licensed

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   manufacturer must report either electronically or by mail using Form FDA-3486, a standardized reporting format. Examples of reportable and nonreportable events concerning the incoming material specifications, process controls, product specifications, product testing, product labeling, quality control procedures, and product distribution are discussed. These examples may not apply to all establishments because they include deviations and unexpected events related to standard operating procedures implemented at individual establishments and may not be an industry standard or a procedure at your facility. The guidance also contains a Biological Product Deviation Reporting Flowchart to aid in determining if an event is reportable.

   In the Federal Register of August 13, 2001 (66 FR 42547), 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.

   This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This 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.

2. 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 collection of information under Sec. 600.14 was approved under OMB control number 0910-0458. The collections of information under 21 CFR 606.100 and 606.171 were approved under OMB control number 0910-0116. The collections of information under 21 CFR 820.90 and 820.100 were approved under OMB control number 0910-0139, and the collections of information under 21 CFR 211.192 and 211.198 were approved under OMB control number 0910-0073.

3. 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.

4. 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.

   Dated: October 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy.

   [FR Doc. E6-17374 Filed 10-18-06; 8:45 am]

   BILLING CODE 4160-01-S