[Federal Register Volume 71, Number 202 (Thursday, October 19, 2006)]
[Notices]
[Pages 61780-61781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17378]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D-0220 (Formally Docket No. 01D-0220)]


Guidance for Industry: Biological Product Deviation Reporting for 
Blood and Plasma Establishments; 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 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finalizes the draft guidance document under the same title dated August 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.

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 
Blood and Plasma Establishments'' dated October 2006. The guidance is 
intended to provide

[[Page 61781]]

assistance 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 
Sec. Sec.  600.14 and 606.171 (21 CFR 600.14 and 606.171). The guidance 
provides additional information regarding the regulations in Sec.  
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 Sec.  606.171 and 21 CFR 606.100 were 
approved under OMB control number 0910-0116. The collection of 
information under Sec.  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.

    Dated: October 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-17378 Filed 10-18-06; 8:45 am]
BILLING CODE 4160-01-S