[Federal Register Volume 66, Number 156 (Monday, August 13, 2001)]
[Notices]
[Pages 42547-42548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20158]


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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 The draft guidance document provides licensed 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 The draft guidance document 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DATES: Submit written or electronic comments on the draft guidance to 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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for electronic access to the draft guidance document.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