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GUIDANCE DOCUMENT

Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection August 2009

Final
Docket Number:
FDA-1997-N-0501
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, the Food and Drug Administration (FDA), are providing you, blood and plasma establishments, with a revised list of countries that should be included in questions for identifying donors at increased risk for HIV-1 group O infection. We are also providing you with recommendations for discontinuing the use of some questions used to identify these donors and for management of donors previously deferred.


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:

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-1997-N-0501.

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