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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 2023

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2016-D-1342
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance recognizes, as acceptable, the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 4.0 dated May 2023, prepared by the AABB Donor History Task Force .  This guidance also provides recommendations to licensed establishments on how to report implementation of the acceptable AABB donor history questionnaires and accompanying materials (DHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12). 

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Submit Comments Online

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:

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-2016-D-1342.

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
 
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