[Federal Register Volume 67, Number 70 (Thursday, April 11, 2002)]
[Notices]
[Pages 17704-17705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8747]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0081]


Draft ``Guidance for Industry: A Modified Lot-Release 
Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to 
Test Blood, Blood Components, and Source Plasma Donations;'' 
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: A 
Modified Lot-Release Specification for Hepatitis B Surface Antigen 
(HbsAg) Assays Used to Test Blood, Blood Components, and Source Plasma 
Donations,'' dated April 2002. The draft guidance document when 
finalized is intended to provide recommendations to manufacturers of 
assays for the detection of HBsAg that are intended to be used to test 
blood, blood components, and Source Plasma. Topics include 
recommendations on minimum sensitivity specifications for HbsAg assays 
used to test blood, blood components, and Source Plasma donations.

DATES: Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by July 10, 2002. 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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for electronic access to the draft guidance document.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.

[[Page 17705]]


FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski, 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: A Modified Lot-Release Specification for 
Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood 
Components, and Source Plasma Donations,'' dated April 2002. Under 21 
CFR 610.44, manufacturers of HBsAg assays used to test donations must 
verify acceptable sensitivity and specificity of such kits by testing 
the kit-lots using an FDA reference panel. This draft guidance document 
is intended to provide recommendations to manufacturers of assays for 
the detection of HBsAg that are intended to be used to test blood, 
blood components, and Source Plasma donations. The current limit of 
detection specification for HBsAg assays used to test blood donations 
corresponds to 1.0 nanogram (ng) HBsAg/milliliter (mL), and was 
established in 1996. The draft guidance contains the recommendation 
that all HBsAg detection assays that are used to test blood, blood 
components, and Source Plasma donations have a lower limit of detection 
specification of 0.50 ng HBsAg/mL or less.
    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 on the minimum 
sensitivity for the HBsAg assays used to test blood and Source Plasma 
donations. 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. 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 July 10, 2002. 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 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 29, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-8747 Filed 4-10-02; 8:45 am]
BILLING CODE 4160-01-S