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GUIDANCE DOCUMENT

Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires Guidance for Industry July 2003

Final
Docket Number:
2002D-0080
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

Blood and plasma establishments (hereafter referred to as “blood establishments”) that collect blood and blood components intended for transfusion or for further manufacture may present donor screening questions to the donor by several methods. The blood establishment should choose the method that works best within its donor screening procedures. This guidance is intended for those blood establishments that wish to implement self-administered donor questionnaires, which allow donors to answer the pre-donation questions on their own; however, you (the blood establishment) may elect to continue to administer the donor questions by direct oral questioning. The guidance provides the recommendations of the Food and Drug Administration (FDA) for implementing self-administered donor questionnaires. In addition, the guidance describes the information the licensed blood establishments should include in a biologics license application supplement or annual report when they intend to implement self-administered questionnaires. This guidance finalizes the draft guidance of the same title dated April 2002. It also supersedes Section I.A of FDA’s memorandum dated April 23, 1992, entitled “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products.”


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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: 2002D-0080.

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