Title 42

PART 8 SUBPART D

Subpart D - Procedures for Review of Suspension or Proposed Revocation of OTP Certification, and of Adverse Action Regarding Withdrawal of Approval of an Accreditation Body Source:Redesignated at 81 FR 44737, July 8, 2016, unless otherwise noted.

• 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 300x-23, 300x-27(a), 300y-11.
• Source: 66 FR 4090, Jan. 17, 2001, unless otherwise noted.

42:1.0.1.1.9.4.1.1	SECTION 8.21	8.21 Applicability.
42:1.0.1.1.9.4.1.2	SECTION 8.22	8.22 Definitions.
42:1.0.1.1.9.4.1.3	SECTION 8.23	8.23 Limitation on issues subject to review.
42:1.0.1.1.9.4.1.4	SECTION 8.24	8.24 Specifying who represents the parties.
42:1.0.1.1.9.4.1.5	SECTION 8.25	8.25 Informal review and the reviewing official's response.
42:1.0.1.1.9.4.1.6	SECTION 8.26	8.26 Preparation of the review file and written arguments.
42:1.0.1.1.9.4.1.7	SECTION 8.27	8.27 Opportunity for oral presentation.
42:1.0.1.1.9.4.1.8	SECTION 8.28	8.28 Expedited procedures for review of immediate suspension.
42:1.0.1.1.9.4.1.9	SECTION 8.29	8.29 Ex parte communications.
42:1.0.1.1.9.4.1.10	SECTION 8.30	8.30 Transmission of written communications by reviewing official and calculation of deadlines.
42:1.0.1.1.9.4.1.11	SECTION 8.31	8.31 Authority and responsibilities of the reviewing official.
42:1.0.1.1.9.4.1.12	SECTION 8.32	8.32 Administrative record.
42:1.0.1.1.9.4.1.13	SECTION 8.33	8.33 Written decision.
42:1.0.1.1.9.4.1.14	SECTION 8.34	8.34 Court review of final administrative action; exhaustion of administrative remedies.

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