42 CFR 423.1002 - Definitions.
As used in this subpart -
Affected party means any Part D sponsor or manufacturer (as defined in § 423.2305) impacted by an initial determination or, if applicable, by a subsequent determination or decision issued under this part, and “party” means the affected party or CMS, as appropriate.
ALJ stands for Administrative Law Judge.
Part D sponsor has the meaning given the term in 423.4.