[Federal Register: August 13, 2001 (Volume 66, Number 156)]
[Notices]
[Page 42546-42547]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au01-66]
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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 The draft guidance document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 The draft guidance document will assist blood and plasma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DATES: Submit written or electronic comments on the draft guidance to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draft guidance document.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