[Federal Register: August 13, 2001 (Volume 66, Number 156)]
[Notices]
[Page 42547-42548]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au01-67]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0221]
Draft ``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 draft document entitled ``Guidance for Industry:
Biological Product Deviation Reporting for Licensed Manufacturers of
Biological Products Other Than Blood and Blood Components,'' dated
August 2001. The draft guidance document provides licensed
manufacturers of biological products other than blood and blood
components with the agency's current thinking related to the biological
product deviation reporting requirements. The draft guidance document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, 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DATES: Submit written or electronic comments on the draft guidance to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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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, 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for electronic access to the draft guidance document.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
Licensed Manufacturers of Biological Products Other Than Blood and
Blood Components,'' dated August 2001. This draft guidance document is
intended to provide assistance to licensed manufacturers of biological
products other than blood and blood components regarding the reporting
of any event associated with the manufacturing, testing, processing,
packing, labeling, and storage, or with the holding or distribution of
a biological product in which the safety, purity, or potency of a
distributed product may be affected as required under Sec. 600.14 (21
CFR 600.14) and 21 CFR 606.171 (65 FR 66621, November 7, 2000). The
draft guidance document 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
provide that the licensed manufacturer must report either
electronically or by mail using a standardized reporting format.
Examples of reportable and nonreportable events concerning 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 draft guidance document also contains a Biological
Product Deviation Reporting Flowchart to aid in determining if an event
is reportable.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This draft guidance
document represents the agency's current thinking with regard to the
reporting of biological product deviations in the licensed
[[Page 42548]]
manufacturing of biological products other than blood and blood
components. 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
This 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 draft guidance
document at http://www.fda.gov/cber/guidelines.htm.
Dated: July 6, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-20158 Filed 8-10-01; 8:45 am]
BILLING CODE 4160-01-S