Title 45

PART 160

Part 160 - General Administrative Requirements

PART 160 - GENERAL ADMINISTRATIVE REQUIREMENTS Authority:42 U.S.C. 1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)); 5 U.S.C. 552; secs. 13400-13424, Pub. L. 111-5, 123 Stat. 258-279; and sec. 1104 of Pub. L. 111-148, 124 Stat. 146-154. Source:65 FR 82798, Dec. 28, 2000, unless otherwise noted.

• Authority: 42 U.S.C. 1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)); 5 U.S.C. 552; secs. 13400-13424, Pub. L. 111-5, 123 Stat. 258-279; and sec. 1104 of Pub. L. 111-148, 124 Stat. 146-154.
• Source: 65 FR 82798, Dec. 28, 2000, unless otherwise noted.

45:2.0.1.2.18.1	SUBPART A	Subpart A - General Provisions
45:2.0.1.2.18.1.1.1	SECTION 160.101	160.101 Statutory basis and purpose.
45:2.0.1.2.18.1.1.2	SECTION 160.102	160.102 Applicability.
45:2.0.1.2.18.1.1.3	SECTION 160.103	160.103 Definitions.
45:2.0.1.2.18.1.1.4	SECTION 160.104	160.104 Modifications.
45:2.0.1.2.18.1.1.5	SECTION 160.105	160.105 Compliance dates for implementation of new or modified standards and implementation specifications.
45:2.0.1.2.18.2	SUBPART B	Subpart B - Preemption of State Law
45:2.0.1.2.18.2.1.1	SECTION 160.201	160.201 Statutory basis.
45:2.0.1.2.18.2.1.2	SECTION 160.202	160.202 Definitions.
45:2.0.1.2.18.2.1.3	SECTION 160.203	160.203 General rule and exceptions.
45:2.0.1.2.18.2.1.4	SECTION 160.204	160.204 Process for requesting exception determinations.
45:2.0.1.2.18.2.1.5	SECTION 160.205	160.205 Duration of effectiveness of exception determinations.
45:2.0.1.2.18.3	SUBPART C	Subpart C - Compliance and Investigations
45:2.0.1.2.18.3.1.1	SECTION 160.300	160.300 Applicability.
45:2.0.1.2.18.3.1.2	SECTION 160.302	160.302 [Reserved]
45:2.0.1.2.18.3.1.3	SECTION 160.304	160.304 Principles for achieving compliance.
45:2.0.1.2.18.3.1.4	SECTION 160.306	160.306 Complaints to the Secretary.
45:2.0.1.2.18.3.1.5	SECTION 160.308	160.308 Compliance reviews.
45:2.0.1.2.18.3.1.6	SECTION 160.310	160.310 Responsibilities of covered entities and business associates.
45:2.0.1.2.18.3.1.7	SECTION 160.312	160.312 Secretarial action regarding complaints and compliance reviews.
45:2.0.1.2.18.3.1.8	SECTION 160.314	160.314 Investigational subpoenas and inquiries.
45:2.0.1.2.18.3.1.9	SECTION 160.316	160.316 Refraining from intimidation or retaliation.
45:2.0.1.2.18.4	SUBPART D	Subpart D - Imposition of Civil Money Penalties
45:2.0.1.2.18.4.1.1	SECTION 160.400	160.400 Applicability.
45:2.0.1.2.18.4.1.2	SECTION 160.401	160.401 Definitions.
45:2.0.1.2.18.4.1.3	SECTION 160.402	160.402 Basis for a civil money penalty.
45:2.0.1.2.18.4.1.4	SECTION 160.404	160.404 Amount of a civil money penalty.
45:2.0.1.2.18.4.1.5	SECTION 160.406	160.406 Violations of an identical requirement or prohibition.
45:2.0.1.2.18.4.1.6	SECTION 160.408	160.408 Factors considered in determining the amount of a civil money penalty.
45:2.0.1.2.18.4.1.7	SECTION 160.410	160.410 Affirmative defenses.
45:2.0.1.2.18.4.1.8	SECTION 160.412	160.412 Waiver.
45:2.0.1.2.18.4.1.9	SECTION 160.414	160.414 Limitations.
45:2.0.1.2.18.4.1.10	SECTION 160.416	160.416 Authority to settle.
45:2.0.1.2.18.4.1.11	SECTION 160.418	160.418 Penalty not exclusive.
45:2.0.1.2.18.4.1.12	SECTION 160.420	160.420 Notice of proposed determination.
45:2.0.1.2.18.4.1.13	SECTION 160.422	160.422 Failure to request a hearing.
45:2.0.1.2.18.4.1.14	SECTION 160.424	160.424 Collection of penalty.
45:2.0.1.2.18.4.1.15	SECTION 160.426	160.426 Notification of the public and other agencies.
45:2.0.1.2.18.5	SUBPART E	Subpart E - Procedures for Hearings
45:2.0.1.2.18.5.1.1	SECTION 160.500	160.500 Applicability.
45:2.0.1.2.18.5.1.2	SECTION 160.502	160.502 Definitions.
45:2.0.1.2.18.5.1.3	SECTION 160.504	160.504 Hearing before an ALJ.
45:2.0.1.2.18.5.1.4	SECTION 160.506	160.506 Rights of the parties.
45:2.0.1.2.18.5.1.5	SECTION 160.508	160.508 Authority of the ALJ.
45:2.0.1.2.18.5.1.6	SECTION 160.510	160.510 Ex parte contacts.
45:2.0.1.2.18.5.1.7	SECTION 160.512	160.512 Prehearing conferences.
45:2.0.1.2.18.5.1.8	SECTION 160.514	160.514 Authority to settle.
45:2.0.1.2.18.5.1.9	SECTION 160.516	160.516 Discovery.
45:2.0.1.2.18.5.1.10	SECTION 160.518	160.518 Exchange of witness lists, witness statements, and exhibits.
45:2.0.1.2.18.5.1.11	SECTION 160.520	160.520 Subpoenas for attendance at hearing.
45:2.0.1.2.18.5.1.12	SECTION 160.522	160.522 Fees.
45:2.0.1.2.18.5.1.13	SECTION 160.524	160.524 Form, filing, and service of papers.
45:2.0.1.2.18.5.1.14	SECTION 160.526	160.526 Computation of time.
45:2.0.1.2.18.5.1.15	SECTION 160.528	160.528 Motions.
45:2.0.1.2.18.5.1.16	SECTION 160.530	160.530 Sanctions.
45:2.0.1.2.18.5.1.17	SECTION 160.532	160.532 Collateral estoppel.
45:2.0.1.2.18.5.1.18	SECTION 160.534	160.534 The hearing.
45:2.0.1.2.18.5.1.19	SECTION 160.536	160.536 Statistical sampling.
45:2.0.1.2.18.5.1.20	SECTION 160.538	160.538 Witnesses.
45:2.0.1.2.18.5.1.21	SECTION 160.540	160.540 Evidence.
45:2.0.1.2.18.5.1.22	SECTION 160.542	160.542 The record.
45:2.0.1.2.18.5.1.23	SECTION 160.544	160.544 Post hearing briefs.
45:2.0.1.2.18.5.1.24	SECTION 160.546	160.546 ALJ's decision.
45:2.0.1.2.18.5.1.25	SECTION 160.548	160.548 Appeal of the ALJ's decision.
45:2.0.1.2.18.5.1.26	SECTION 160.550	160.550 Stay of the Secretary's decision.
45:2.0.1.2.18.5.1.27	SECTION 160.552	160.552 Harmless error.

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