[Federal Register Volume 72, Number 152 (Wednesday, August 8, 2007)]
[Notices]
[Pages 44560-44561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15472]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0081]
Guidance for Industry: Adequate and Appropriate Donor Screening
Tests for Hepatitis B; Hepatitis B Surface Antigen Assays Used to Test
Donors of Whole Blood and Blood Components, Including Source Plasma and
Source Leukocytes; 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 document entitled ``Guidance for Industry: Adequate
and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B
Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and
Blood Components, Including Source Plasma and Source Leukocytes'' dated
July 2007. The guidance document provides recommendations to
manufacturers of HBsAg assays that are intended to test donors of Whole
Blood and blood components, including Source Plasma and Source
Leukocytes, and to establishments using an HBsAg assay. Topics include
recommendations on minimum sensitivity standards for HBsAg assays. This
guidance finalizes the draft guidance entitled ``Guidance for Industry: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.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the 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, suite 200N, Rockville, MD
20852-1448. Send one self-addressed adhesive label to assist the office
in processing your requests. The guidance may also be obtained by mail
by calling CBER at 1-800-835-4709 or 301-827-1800. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
Submit written comments on the guidance to the Division of Dockets
Management (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, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Adequate and Appropriate Donor Screening Tests
for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to
Test Donors of Whole Blood and Blood Components, Including Source
Plasma and Source Leukocytes'' dated July 2007. The guidance document
provides recommendations to manufacturers of HBsAg assays that are
approved donor screening tests intended to screen donors of Whole Blood
and blood components, including Source Plasma and Source Leukocytes for
Hepatitis B, and to establishments using an HBsAg assay (See Sec.
610.40(b) (21 CFR 610.40(b)). The document represents FDA's current
thinking on minimum sensitivity for such HBsAg assays as they relate to
donor testing ``to reduce adequately and appropriately the risk of
transmission of communicable disease'' under Sec. 610.40(b). Under 21
CFR 610.44, the 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 guidance
document recommends that all HBsAg detection assays used to test donors
of Whole Blood and blood components, including Source Plasma and Source
Leukocytes, have a lower limit of detection standard of 0.5ng HBsAg/mL
or less.
In the Federal Register of April 11, 2002 (67 FR 17704), FDA
announced the availability of the draft guidance 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.'' FDA received a few comments on the draft
guidance, and those comments were considered as the guidance was
finalized. In addition, editorial changes were made to improve clarity.
The recommended implementation date for the recommendations in this
guidance is January 31, 2008. This guidance document finalizes the
draft guidance document entitled ``Guidance for
[[Page 44561]]
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 guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the FDA's
current thinking on this topic. 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
requirements of the applicable statutes and regulations.
II. Comments
Interested persons may, at any time, submit to the Division of
Dockets Management written or electronic comments (see ADDRESSES)
regarding the guidance. Submit a single copy of electronic comments or
two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in the brackets in the heading of this document. A copy of
the guidance and received comments are available for public examination
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: August 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15472 Filed 8-7-07; 8:45 am]
BILLING CODE 4160-01-S