45 C.F.R. § 79.4 – Investigation.

(a) If an investigating official concludes that a subpoena pursuant to the authority conferred by 31 U.S.C. 3804(a) is warranted—
1. (1) The subpoena so issued shall notify the person to whom it is addressed of the authority under which the subpoena is issued and shall identify the records or documents sought;
2. (2) The investigating official may designate a person to act on his or her behalf to receive the documents sought; and
3. (3) The person receiving such subpoena shall be required to tender to the investigating official, or the person designated to receive the documents, a certification that—
  1. (i) The documents sought have been produced;
  2. (ii) Such documents are not available and the reasons therefor; or
  3. (iii) Such documents suitably identified, have been withheld based upon the assertion of an identified privilege.
(b) If the investigating official concludes that an action under the Program Fraud Civil Remedies Act may be warranted, the investigating official shall submit a report containing the findings and conclusions of such investigation to the reviewing official.
(c) Nothing in this section shall preclude or limit an investigating official's discretion to refer allegations directly to the Department of Justice for suit under the False Claims Act or other civil relief, or to defer or postpone a report or referral to the reviewing official to avoid interference with a criminal investigation or prosecution.
(d) Nothing in this section modifies any responsibility of an investigating official to report violations of criminal law to the Attorney General.