Date:
To:
Director, Division of Blood Application
HFM 370
Office of Blood Research and Review
Center for Biologics Research and Review
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
From: (Establishment Name)
(Mailing Address)
(A unique identification number that can be one of the following: FDA License
number; FDA Registration Number, FEI or CFN; or JCAHO, CMS or CLIA
number)
The purpose of this letter is to request re-entry of a donor who was previously deferred
because of a confirmed positive HBsAg test result following receipt of the hepatitis B
vaccine under the provisions of 21 CFR 610.41(b). Testing was performed by (your own
center or the name of the laboratory that was used). All other required testing, including
antibody to hepatitis B core antigen, is negative.
Please find test results from the index donation of (date) following receipt of hepatitis B
vaccine on (date) below. Documentation of the vaccination is on file at our facility.
(Insert table or other listing.)
The donor received the hepatitis B vaccine as a preventive measure, not because of a
recent exposure. If this variance request is allowed, we will re-enter this individual into
the donor pool, assuming all testing is negative and the donor is eligible on all other
criteria at the time of the re-entry donation.
.