[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guidance finalizes the draft guidance entitled ``Guidance for Industry: 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