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GUIDANCE DOCUMENT

Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection Guidance for Industry November 2011

Final

Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection

Docket Number:
FDA-2008-D-0263
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance document is intended for blood establishments that manufacture Whole Blood and blood components for transfusion or for further manufacture, including Source Plasma and Source Leucocytes. This guidance provides recommendations for a requalification method or process for the reentry of deferred donors who test repeatedly reactive for hepatitis B surface antigen (HBsAg), confirmed positive by neutralization, following a recent vaccination against hepatitis B virus (HBV) infection, and who are not infected by HBV.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0263.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010