Can blood establishments use an alternate question wording and/or procedures to the ones recommended by FDA for blood donors who have received a smallpox vaccination?

If licensed establishments wish to implement alternate wording and/or procedures that are different from the ones recommended in the guidance, they must report this to us under 21 CFR 601.12, Reporting Changes to an Approved Application. The supplement to request an alternate wording and/or procedure to the smallpox vaccination guidance must be submitted as follows:

1. The licensed blood establishment must submit a form FDA 356h "Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use."
2. The submission must include the Standard Operating Procedure manual for this procedure and the revised donor history questionnaire.
3. The submission may be made as a Changes Being Affected (CBE) under 21 CFR 601.12(c)(5), provided the alternative wording and/or procedure is consistent with those listed below. This is to allow for immediate implementation.

    

   1. Extension of the deferral period to two months for both vaccine recipients and symptomatic contacts of vaccine recipients
   2. No examination of vaccine scabs of recipients or of contacts who have contracted vaccinia virus infection
   3. Revision of the current UDHQ vaccination question to ask about vaccinations within the past 8 weeks, provided that the donor is also asked about contacts with a vaccine recipient

    

4. If the alternate wording and/or procedure is different from the one described above, the submission must be made as a Prior Approval Supplement (PAS) under 21 CFR 601.12(b).

Unlicensed blood establishments:

Unlicensed blood establishments may either implement the procedures described in our smallpox vaccination guidance document or an alternate procedure. They are not required to report these changes to FDA. We will examine the smallpox vaccination deferral policies during FDA inspections. However, if unlicensed blood establishments wish to implement a procedure that is different from the procedures described in our smallpox guidance document or as described above, we encourage them to discuss the alternate procedure with FDA.