---
kind: "section"
citation: "42 C.F.R. § 8.21"
title: "42"
number: "8.21"
heading: "Applicability."
url: "https://uscodex.org/cfr/42/8.21"
---

# §8.21. Applicability.


The procedures in this subpart apply when:

- (a) The Secretary has notified an OTP in writing that its certification under the regulations in subpart B of this part has been suspended or that the Secretary proposes to revoke the certification; and
- (b) The OTP has, within 30 days of the date of the notification or within 3 days of the date of the notification when seeking an expedited review of a suspension, requested in writing to the reviewing official, an opportunity for an informal review of the suspension or proposed revocation.
- (c) The Secretary has notified an Accreditation Body of an adverse action taken regarding withdrawal of approval of the Accreditation Body under the regulations in subpart A of this part; and
- (d) The Accreditation Body has, within 30 days of the date of the notification, requested in writing an opportunity for a review of the adverse action.

## Notes

### Authority

Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 300x-23, 300x-27(a), 300y-11.

### Source

Source: 89 FR 7549, Feb. 2, 2024, unless otherwise noted.