45 CFR § 2105.33
Will you receive notification of activities involving the submitter?
April 14, 2021
If any of the following occur, the Agency will notify you:
(a) The Agency provides the submitter with notice and an opportunity to object to disclosure;
(b) The Agency notifies the submitter of its intent to disclose the requested information; or
(c) A submitter files a lawsuit to prevent the disclosure of the information.