The requirements of this Subpart shall apply to:

(a) Health programs operated by the Indian Health Service (IHS).

(b) Health programs operated by an urban Indian organization through a contract or grant under Title V of the Indian Health Care Improvement Act (IHCIA), Public Law 94-437, as amended.

(c) Health programs operated by an Indian Tribe or Tribal organization pursuant to a contract or compact with the IHS under the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450 et seq.), provided that the Indian Tribe or Tribal organization has agreed in such contract or compact to be bound by this Subpart pursuant to 25 U.S.C. 450l and 458aaa-16(e), as applicable.