[Federal Register: April 11, 2002 (Volume 67, Number 70)]
[Notices]
[Page 17704-17705]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ap02-69]
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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 The draft guidance document when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DATES: Submit written or electronic comments on the draft guidance to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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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for electronic access to the draft guidance document.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