§ 110.20 How to establish a covered injury.

(a) General. Only serious injuries, as described in § 110.3(z), or deaths are covered under the Program. In order to be eligible for benefits under the Program, a requester must submit documentation showing that a covered injury, as described in § 110.3(g), was sustained as the direct result of the administration or use of a covered countermeasure pursuant to the terms of a declaration under section 319F–3(b) of the PHS Act (including administration or use during the effective period of the declaration) or as the direct result of the administration or use of a covered countermeasure in a good faith belief that it was administered or used pursuant to the terms of a declaration (including administration or use during the effective period of the declaration). A requester can establish that a covered injury was sustained by demonstrating to the Secretary that a Table injury occurred, as described in paragraph (c) of this section. In the alternative, a requester can establish that an injury was actually caused by a covered countermeasure, as described in paragraph (d) of this section. The Secretary may obtain the opinions of qualified medical experts in making determinations concerning covered injuries.