[Federal Register Volume 71, Number 202 (Thursday, October 19, 2006)]
[Notices]
[Pages 61781-61782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17374]


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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.

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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draft guidance document of the same title dated August 2001.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: 

I. 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

[[Page 61782]]

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.

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 
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.

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.

    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