Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc); Availability, 22813-22814 [2010-10046]

Download as PDF Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices Submission.’’ The notice published with an inadvertent error in the ADDRESSES section. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy (HF– 27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20957, 301–827–7010. SUPPLEMENTARY INFORMATION: In FR Doc. 2010–9134, appearing on page 20606, in the Federal Register of Tuesday, April 20, 2010, the following correction is made: 1. On page 20606, in the second column, in the ADDRESSES section, the second sentence is corrected to read: ‘‘Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent.’’ Dated: April 27, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–10160 Filed 4–29–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0263] Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc),’’ dated May 2010. The guidance document provides recommendations to establishments that collect Whole Blood or blood components intended for transfusion, with recommendations for a requalification method or process for reentering deferred donors into the donor pool based on a determination that previous tests that were repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) were falsely positive and that there is no evidence of infection with hepatitis B virus (HBV). These recommendations are based on the recent availability of FDA-licensed wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 SUMMARY: VerDate Mar<15>2010 13:41 Apr 29, 2010 Jkt 220001 hepatitis B virus nucleic acid tests (HBV NAT) that are particularly sensitive when single samples are tested. These tests provide an additional, powerful method of determining whether a donor who has been deferred because of antiHBc reactivity is truly infected by HBV. The guidance announced in this notice finalizes the draft guidance of the same title dated May 2008. 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, Outreach and Development (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 https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Paul E. Levine, 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: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc),’’ dated May 2010. The guidance document provides recommendations to establishments that collect Whole Blood or blood components for a requalification method or process for the reentry of deferred donors into the donor pool based on a determination that previous tests that were repeatedly reactive for anti-HBc were falsely positive and that there is no evidence of infection with HBV. Currently, donors who are repeatedly reactive on more than one occasion for anti-HBc (samples from more than one collection from the donor are repeatedly reactive for anti-HBc) must be indefinitely deferred in PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 22813 accordance with current regulations. Situations have occurred with some frequency in which two anti-HBc tests are false positives because of the relative non-specificity of these tests. The result is that many otherwise suitable donors are indefinitely deferred because of their anti-HBc test results even though medical follow-up of such donors indicates that they are not infected with HBV. FDA-licensed HBV NAT assays, which are particularly sensitive when single samples are tested, are now available and provide an additional, powerful method of determining whether a donor who has been deferred because of anti-HBc reactivity is truly infected by HBV. Due to the availability of FDA-licensed HBV NAT assays and the improved specificity of anti-HBc assays, FDA is recommending in the guidance a reentry algorithm for donors deferred due to falsely positive repeatedly reactive tests for anti-HBc. In the Federal Register of May 21, 2008 (73 FR 29519), FDA announced the availability of the draft guidance of the same title. FDA received several 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 guidance announced in this notice finalizes the draft guidance dated May 2008. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents 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. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 601.12 have been approved under OMB control number 0910–0338. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments 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 E:\FR\FM\30APN1.SGM 30APN1 22814 Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices with the docket number found in 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. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either: https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, https://www.fda.gov/cber/ guidelines.htm or https:// www.regulations.gov. Dated: April 16, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–10046 Filed 4–29–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2005–D–0140] (formerly Docket No. FDA–2005D–0261) Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV– 1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry; Availability AGENCY: Food and Drug Administration, HHS. wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV– 1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry’’ dated May 2010. The guidance document provides recommendations to blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for Human Immunodeficiency Virus Type 1 (HIV–1) Nucleic Acid Test (NAT) and Hepatitis C Virus (HCV) NAT, on testing individual samples or pooled samples from donors of human blood and blood components for HIV–1 ribonucleic acid (RNA) and HCV RNA. This guidance also contains recommendations regarding product disposition and donor management based on the results of NAT and serologic testing for markers of HIV–1 and HCV infection on samples, VerDate Mar<15>2010 13:41 Apr 29, 2010 Jkt 220001 collected at the time of donation, from donors of human blood and blood components. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2005. This guidance also supersedes the recommendations for reentry of donors deferred because of anti-HIV–1 test results, HIV–1 p24 antigen test results, and anti-HCV test results that were provided in the FDA memoranda entitled ‘‘Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV–1) Transmission by Blood and Blood Products,’’ April 23, 1992; ‘‘Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),’’ August 5, 1993; ‘‘Recommendations for Donor Screening with a Licensed Test for HIV–1 Antigen,’’ August 8, 1995. DATES: Submit electronic or written comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development (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 electronic or written comments on the guidance. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Paul Levine, 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: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV–1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry,’’ dated May 2010. The guidance document PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 provides recommendations to blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for Human Immunodeficiency Virus Type 1 (HIV–1) Nucleic Acid Test (NAT) and Hepatitis C Virus (HCV) NAT, on testing individual samples or pooled samples from donors of human blood and blood components for HIV–1 ribonucleic acid (RNA) and HCV RNA. This guidance also contains recommendations regarding product disposition and donor management based on the results of NAT and serologic testing for markers of HIV–1 and HCV infection on samples, collected at the time of donation, from donors of human blood and blood components. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 19, 2005. This guidance also supersedes the recommendations for reentry of donors deferred because of anti-HIV–1 test results, HIV–1 p24 antigen test results, and anti-HCV test results that were provided in the FDA memoranda entitled, ‘‘Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV–1) Transmission by Blood and Blood Products,’’ April 23, 1992; ‘‘Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),’’ August 5, 1993; ‘‘Recommendations for Donor Screening with a Licensed Test for HIV–1 Antigen,’’ August 8, 1995. In the Federal Register of July 27, 2005 (70 FR 43439), FDA announced the availability of the draft guidance of the same title. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated July 2005. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents 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 (see ADDRESSES) written or electronic comments regarding the guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except E:\FR\FM\30APN1.SGM 30APN1

Agencies

[Federal Register Volume 75, Number 83 (Friday, April 30, 2010)]
[Notices]
[Pages 22813-22814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10046]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0263]


Guidance for Industry: Requalification Method for Reentry of 
Blood Donors Deferred Because of Reactive Test Results for Antibody to 
Hepatitis B Core Antigen (Anti-HBc); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: 
Requalification Method for Reentry of Blood Donors Deferred Because of 
Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-
HBc),'' dated May 2010. The guidance document provides recommendations 
to establishments that collect Whole Blood or blood components intended 
for transfusion, with recommendations for a requalification method or 
process for reentering deferred donors into the donor pool based on a 
determination that previous tests that were repeatedly reactive for 
antibodies to hepatitis B core antigen (anti-HBc) were falsely positive 
and that there is no evidence of infection with hepatitis B virus 
(HBV). These recommendations are based on the recent availability of 
FDA-licensed hepatitis B virus nucleic acid tests (HBV NAT) that are 
particularly sensitive when single samples are tested. These tests 
provide an additional, powerful method of determining whether a donor 
who has been deferred because of anti-HBc reactivity is truly infected 
by HBV. The guidance announced in this notice finalizes the draft 
guidance of the same title dated May 2008.

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, Outreach and Development (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 https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, 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: Requalification Method for Reentry of Blood 
Donors Deferred Because of Reactive Test Results for Antibody to 
Hepatitis B Core Antigen (Anti-HBc),'' dated May 2010. The guidance 
document provides recommendations to establishments that collect Whole 
Blood or blood components for a requalification method or process for 
the reentry of deferred donors into the donor pool based on a 
determination that previous tests that were repeatedly reactive for 
anti-HBc were falsely positive and that there is no evidence of 
infection with HBV. Currently, donors who are repeatedly reactive on 
more than one occasion for anti-HBc (samples from more than one 
collection from the donor are repeatedly reactive for anti-HBc) must be 
indefinitely deferred in accordance with current regulations. 
Situations have occurred with some frequency in which two anti-HBc 
tests are false positives because of the relative non-specificity of 
these tests. The result is that many otherwise suitable donors are 
indefinitely deferred because of their anti-HBc test results even 
though medical follow-up of such donors indicates that they are not 
infected with HBV. FDA-licensed HBV NAT assays, which are particularly 
sensitive when single samples are tested, are now available and provide 
an additional, powerful method of determining whether a donor who has 
been deferred because of anti-HBc reactivity is truly infected by HBV. 
Due to the availability of FDA-licensed HBV NAT assays and the improved 
specificity of anti-HBc assays, FDA is recommending in the guidance a 
reentry algorithm for donors deferred due to falsely positive 
repeatedly reactive tests for anti-HBc.
    In the Federal Register of May 21, 2008 (73 FR 29519), FDA 
announced the availability of the draft guidance of the same title. FDA 
received several 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 guidance announced in this 
notice finalizes the draft guidance dated May 2008.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 601.12 have been approved under 
OMB control number 0910-0338.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
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

[[Page 22814]]

with the docket number found in 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either: https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/cber/guidelines.htm or https://www.regulations.gov.

    Dated: April 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10046 Filed 4-29-10; 8:45 am]
BILLING CODE 4160-01-S
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