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GUIDANCE DOCUMENT

Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components Guidance for Industry May 2016

Final
Docket Number:
FDA-2011-D-0722
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research

This guidance recognizes the standardized full-length and abbreviated donor history questionnaires (FL-DHQ and aDHQ, respectively) and accompanying materials, version 2.0 dated February 2016, prepared by the AABB donor History Task Force (referred to as “task force”), as an acceptable mechanism for collecting blood donor history information from donors of blood and blood components that is consistent with the FDA requirements and recommendations.


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Dockets Management
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-2011-D-0722.

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