- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
The attached recommendations by the Food and Drug Administration (FDA) to blood and plasma establishments concern the quarantine and disposition of prior collections of blood, blood components and Source Plasma from a donor who subsequently tests repeatedly reactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis B core (anti-HBc), antibody to hepatitis C virus (anti-HCV), or antibody to human T-lymphotropic virus, type I (anti-HTLV-I).
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:
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-2013-S-0610.