Does anyone have a sample variance letter to the FDA requesting to extend the expiration date of thawed plasma from 24 hours to 5 days?

Thanks

An FDA variance is not required to modify Fresh Frozen Plasam or Plasma Frozen within 24 hours of phlebotomy to Plasma (with a 5 day expiration date from the original date of thawing). An FDA variance is needed though to use Fresh Frozen Plasma for 24 hours after thawing, rather than the 6 hours currently specified in the CFR.