[Federal Register Volume 66, Number 156 (Monday, August 13, 2001)]
[Notices]
[Pages 42546-42547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20157]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0220]


Draft ``Guidance for Industry: Biological Product Deviation 
Reporting for Blood and Plasma Establishments;'' 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 draft document entitled ``Guidance for Industry: 
Biological Product Deviation Reporting for Blood and Plasma 
Establishments'' dated August 2001. The draft guidance document 
provides licensed blood establishments, unlicensed registered blood 
establishments, and transfusion services with the agency's current 
thinking related to the requirements for biological product deviation 
reporting. The draft guidance document will assist blood and plasma 
establishments in determining when a report is required, who submits 
the report, the timeframe for reporting, and how to submit the report.

DATES: Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by November 13, 2001. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of ``Guidance for 
Industry: Biological Product Deviation Reporting for Blood and Plasma 
Establishments'' dated August 2001 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 
document may also be obtained by mail by calling the CBER Voice 
Information System at 1-800-835-4709 or 301-827-1800, or by fax by 
calling the FAX Information System at 1-888-CBER-FAX or 301-827-3844. 
See the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.
    Submit written comments on the document to the Dockets Management 
Branch (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, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Biological Product Deviation Reporting for 
Blood and Plasma Establishments'' dated August 2001. This draft 
guidance document is intended to provide assistance to blood and plasma 
establishments regarding the reporting of any event associated with the 
manufacturing, testing, processing, packing, labeling, or storage or 
with the holding or distribution of blood or a blood component in which 
the safety, purity, or potency of a distributed product may be affected 
as required under Secs. 600.14 and 606.171 (21 CFR 600.14 and 606.171) 
(65 FR 66621, November 7, 2000). The draft guidance document provides 
additional information regarding the regulations in Sec. 606.171, which 
describe who must report, what must be included in the report, when the 
establishment must report, and provide that the establishment must 
report either electronically or by mail using a standardized reporting 
format. Examples of reportable and nonreportable events concerning 
donor suitability, product collection, component preparation, testing, 
labeling, quality control, and 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

[[Page 42547]]

industry standard or a procedure at your facility. The draft guidance 
document also contains a biological product deviation reporting 
flowchart to aid in determining if an event is reportable.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
document represents the agency's current thinking with regard to the 
reporting of biological product deviations in manufacturing by blood 
and plasma establishments. 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. As with other 
guidance documents, FDA does not intend this document to be all-
inclusive and cautions that not all information may be applicable to 
all situations. The document is intended to provide information and 
does not set forth requirements.

II. Comments

    The draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (address above) written or 
electronic comments regarding this draft guidance document. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final document by November 13, 2001. Two copies of 
any comments are to be submitted, except individuals may submit one 
copy. Comments should be identified with the docket number found in the 
brackets in the heading of this document. A copy of the document and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cber/guidelines.htm.

    Dated: July 6, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-20157 Filed 8-10-01; 8:45 am]
BILLING CODE 4160-01-S