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GUIDANCE DOCUMENT

Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry December 2015

Final

Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

Docket Number:
FDA-2015-D-1211
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance document provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. We (FDA) are also recommending that you make corresponding revisions to your donor educational materials, donor history questionnaires and accompanying materials, along with revisions to your donor requalification and product management procedures. This guidance also incorporates certain other recommendations related to donor educational materials and testing contained in the memorandum to blood establishments entitled, "Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products," dated April 23, 1992 (1992 blood memo) (Ref. 1). This guidance finalizes the draft guidance of the same title dated May 2015 (80 FR 27973, May 15, 2015) and supersedes the 1992 blood memo. The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma.


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-2015-D-1211.

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