definiens: . 1.39 means, with respect to an individual or entity, t hat such individual or entity has been debarred or suspended under 21 U.S.C. § 335(a ) or ( b ), the subject of a conviction described in 21 U.S.C. § 335a, disqualified as a clinical investigat or under 21 C.F.R. § § 312.70 or 812.119, disqualifie d as a testing facility under 21 C.F.R. § 58.202, excl uded from a federal or governmental health care program, debarred from federal contracting, convict ed of or pled nolo contendere to any felony, or to any federal or state legal violation ( including mis demeanors ) relating to prescription drug products o r fraud, the subject to OFAC sanctions or on the OFAC list of specially designated nationals, or the subject of any similar sanction of any governmental authority in the Territory