42:1.0.1.1.1 | PART 1
| Part 1 - XXX | |
42:1.0.1.1.2 | PART 2
| PART 2 - CONFIDENTIALITY OF SUBSTANCE USE DISORDER PATIENT RECORDS | |
42:1.0.1.1.2.1 | SUBPART A
| Subpart A - Introduction | |
42:1.0.1.1.2.1.1.1 | SECTION 2.1
| 2.1 Statutory authority for confidentiality of substance use disorder patient records. | |
42:1.0.1.1.2.1.1.2 | SECTION 2.2
| 2.2 Purpose and effect. | |
42:1.0.1.1.2.1.1.3 | SECTION 2.3
| 2.3 Criminal penalty for violation. | |
42:1.0.1.1.2.1.1.4 | SECTION 2.4
| 2.4 Reports of violations. | |
42:1.0.1.1.2.2 | SUBPART B
| Subpart B - General Provisions | |
42:1.0.1.1.2.2.1.1 | SECTION 2.11
| 2.11 Definitions. | |
42:1.0.1.1.2.2.1.2 | SECTION 2.12
| 2.12 Applicability. | |
42:1.0.1.1.2.2.1.3 | SECTION 2.13
| 2.13 Confidentiality restrictions and safeguards. | |
42:1.0.1.1.2.2.1.4 | SECTION 2.14
| 2.14 Minor patients. | |
42:1.0.1.1.2.2.1.5 | SECTION 2.15
| 2.15 Incompetent and deceased patients. | |
42:1.0.1.1.2.2.1.6 | SECTION 2.16
| 2.16 Security for records. | |
42:1.0.1.1.2.2.1.7 | SECTION 2.17
| 2.17 Undercover agents and informants. | |
42:1.0.1.1.2.2.1.8 | SECTION 2.18
| 2.18 Restrictions on the use of identification cards. | |
42:1.0.1.1.2.2.1.9 | SECTION 2.19
| 2.19 Disposition of records by discontinued programs. | |
42:1.0.1.1.2.2.1.10 | SECTION 2.20
| 2.20 Relationship to state laws. | |
42:1.0.1.1.2.2.1.11 | SECTION 2.21
| 2.21 Relationship to federal statutes protecting research subjects against compulsory disclosure of their identity. | |
42:1.0.1.1.2.2.1.12 | SECTION 2.22
| 2.22 Notice to patients of federal confidentiality requirements. | |
42:1.0.1.1.2.2.1.13 | SECTION 2.23
| 2.23 Patient access and restrictions on use. | |
42:1.0.1.1.2.3 | SUBPART C
| Subpart C - Disclosures With Patient Consent | |
42:1.0.1.1.2.3.1.1 | SECTION 2.31
| 2.31 Consent requirements. | |
42:1.0.1.1.2.3.1.2 | SECTION 2.32
| 2.32 Prohibition on re-disclosure. | |
42:1.0.1.1.2.3.1.3 | SECTION 2.33
| 2.33 Disclosures permitted with written consent. | |
42:1.0.1.1.2.3.1.4 | SECTION 2.34
| 2.34 Disclosures to prevent multiple enrollments. | |
42:1.0.1.1.2.3.1.5 | SECTION 2.35
| 2.35 Disclosures to elements of the criminal justice system which have referred patients. | |
42:1.0.1.1.2.3.1.6 | SECTION 2.36
| 2.36 Disclosures to prescription drug monitoring programs. | |
42:1.0.1.1.2.4 | SUBPART D
| Subpart D - Disclosures Without Patient Consent | |
42:1.0.1.1.2.4.1.1 | SECTION 2.51
| 2.51 Medical emergencies. | |
42:1.0.1.1.2.4.1.2 | SECTION 2.52
| 2.52 Research. | |
42:1.0.1.1.2.4.1.3 | SECTION 2.53
| 2.53 Audit and evaluation. | |
42:1.0.1.1.2.5 | SUBPART E
| Subpart E - Court Orders Authorizing Disclosure and Use | |
42:1.0.1.1.2.5.1.1 | SECTION 2.61
| 2.61 Legal effect of order. | |
42:1.0.1.1.2.5.1.2 | SECTION 2.62
| 2.62 Order not applicable to records disclosed without consent to researchers, auditors and evaluators. | |
42:1.0.1.1.2.5.1.3 | SECTION 2.63
| 2.63 Confidential communications. | |
42:1.0.1.1.2.5.1.4 | SECTION 2.64
| 2.64 Procedures and criteria for orders authorizing disclosures for noncriminal purposes. | |
42:1.0.1.1.2.5.1.5 | SECTION 2.65
| 2.65 Procedures and criteria for orders authorizing disclosure and use of records to criminally investigate or prosecute patients. | |
42:1.0.1.1.2.5.1.6 | SECTION 2.66
| 2.66 Procedures and criteria for orders authorizing disclosure and use of records to investigate or prosecute a part 2 program or the person holding the records. | |
42:1.0.1.1.2.5.1.7 | SECTION 2.67
| 2.67 Orders authorizing the use of undercover agents and informants to investigate employees or agents of a part 2 program in connection with a criminal matter. | |
42:1.0.1.1.3 | PART 2a
| PART 2a - PROTECTION OF IDENTITY - RESEARCH SUBJECTS | |
42:1.0.1.1.3.0.1.1 | SECTION 2a.1
| 2a.1 Applicability. | |
42:1.0.1.1.3.0.1.2 | SECTION 2a.2
| 2a.2 Definitions. | |
42:1.0.1.1.3.0.1.3 | SECTION 2a.3
| 2a.3 Application; coordination. | |
42:1.0.1.1.3.0.1.4 | SECTION 2a.4
| 2a.4 Contents of application; in general. | |
42:1.0.1.1.3.0.1.5 | SECTION 2a.5
| 2a.5 Contents of application; research projects in which drugs will be administered. | |
42:1.0.1.1.3.0.1.6 | SECTION 2a.6
| 2a.6 Issuance of Confidentiality Certificates; single project limitation. | |
42:1.0.1.1.3.0.1.7 | SECTION 2a.7
| 2a.7 Effect of Confidentiality Certificate. | |
42:1.0.1.1.3.0.1.8 | SECTION 2a.8
| 2a.8 Termination. | |
42:1.0.1.1.4 | PART 3
| PART 3 - PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT | |
42:1.0.1.1.4.1 | SUBPART A
| Subpart A - General Provisions | |
42:1.0.1.1.4.1.1.1 | SECTION 3.10
| 3.10 Purpose. | |
42:1.0.1.1.4.1.1.2 | SECTION 3.20
| 3.20 Definitions. | |
42:1.0.1.1.4.2 | SUBPART B
| Subpart B - PSO Requirements and Agency Procedures | |
42:1.0.1.1.4.2.1.1 | SECTION 3.102
| 3.102 Process and requirements for initial and continued listing of PSOs. | |
42:1.0.1.1.4.2.1.2 | SECTION 3.104
| 3.104 Secretarial actions. | |
42:1.0.1.1.4.2.1.3 | SECTION 3.106
| 3.106 Security requirements. | |
42:1.0.1.1.4.2.1.4 | SECTION 3.108
| 3.108 Correction of deficiencies, revocation, and voluntary relinquishment. | |
42:1.0.1.1.4.2.1.5 | SECTION 3.110
| 3.110 Assessment of PSO compliance. | |
42:1.0.1.1.4.2.1.6 | SECTION 3.112
| 3.112 Submissions and forms. | |
42:1.0.1.1.4.3 | SUBPART C
| Subpart C - Confidentiality and Privilege Protections of Patient Safety Work Product | |
42:1.0.1.1.4.3.1.1 | SECTION 3.204
| 3.204 Privilege of patient safety work product. | |
42:1.0.1.1.4.3.1.2 | SECTION 3.206
| 3.206 Confidentiality of patient safety work product. | |
42:1.0.1.1.4.3.1.3 | SECTION 3.208
| 3.208 Continued protection of patient safety work product. | |
42:1.0.1.1.4.3.1.4 | SECTION 3.210
| 3.210 Required disclosure of patient safety work product to the Secretary. | |
42:1.0.1.1.4.3.1.5 | SECTION 3.212
| 3.212 Nonidentification of patient safety work product. | |
42:1.0.1.1.4.4 | SUBPART D
| Subpart D - Enforcement Program | |
42:1.0.1.1.4.4.1.1 | SECTION 3.304
| 3.304 Principles for achieving compliance. | |
42:1.0.1.1.4.4.1.2 | SECTION 3.306
| 3.306 Complaints to the Secretary. | |
42:1.0.1.1.4.4.1.3 | SECTION 3.308
| 3.308 Compliance reviews. | |
42:1.0.1.1.4.4.1.4 | SECTION 3.310
| 3.310 Responsibilities of respondents. | |
42:1.0.1.1.4.4.1.5 | SECTION 3.312
| 3.312 Secretarial action regarding complaints and compliance reviews. | |
42:1.0.1.1.4.4.1.6 | SECTION 3.314
| 3.314 Investigational subpoenas and inquiries. | |
42:1.0.1.1.4.4.1.7 | SECTION 3.402
| 3.402 Basis for a civil money penalty. | |
42:1.0.1.1.4.4.1.8 | SECTION 3.404
| 3.404 Amount of a civil money penalty. | |
42:1.0.1.1.4.4.1.9 | SECTION 3.408
| 3.408 Factors considered in determining the amount of a civil money penalty. | |
42:1.0.1.1.4.4.1.10 | SECTION 3.414
| 3.414 Limitations. | |
42:1.0.1.1.4.4.1.11 | SECTION 3.416
| 3.416 Authority to settle. | |
42:1.0.1.1.4.4.1.12 | SECTION 3.418
| 3.418 Exclusivity of penalty. | |
42:1.0.1.1.4.4.1.13 | SECTION 3.420
| 3.420 Notice of proposed determination. | |
42:1.0.1.1.4.4.1.14 | SECTION 3.422
| 3.422 Failure to request a hearing. | |
42:1.0.1.1.4.4.1.15 | SECTION 3.424
| 3.424 Collection of penalty. | |
42:1.0.1.1.4.4.1.16 | SECTION 3.426
| 3.426 Notification of the public and other agencies. | |
42:1.0.1.1.4.4.1.17 | SECTION 3.504
| 3.504 Hearings before an ALJ. | |
42:1.0.1.1.4.4.1.18 | SECTION 3.506
| 3.506 Rights of the parties. | |
42:1.0.1.1.4.4.1.19 | SECTION 3.508
| 3.508 Authority of the ALJ. | |
42:1.0.1.1.4.4.1.20 | SECTION 3.510
| 3.510 Ex parte contacts. | |
42:1.0.1.1.4.4.1.21 | SECTION 3.512
| 3.512 Prehearing conferences. | |
42:1.0.1.1.4.4.1.22 | SECTION 3.514
| 3.514 Authority to settle. | |
42:1.0.1.1.4.4.1.23 | SECTION 3.516
| 3.516 Discovery. | |
42:1.0.1.1.4.4.1.24 | SECTION 3.518
| 3.518 Exchange of witness lists, witness statements, and exhibits. | |
42:1.0.1.1.4.4.1.25 | SECTION 3.520
| 3.520 Subpoenas for attendance at hearing. | |
42:1.0.1.1.4.4.1.26 | SECTION 3.522
| 3.522 Fees. | |
42:1.0.1.1.4.4.1.27 | SECTION 3.524
| 3.524 Form, filing, and service of papers. | |
42:1.0.1.1.4.4.1.28 | SECTION 3.526
| 3.526 Computation of time. | |
42:1.0.1.1.4.4.1.29 | SECTION 3.528
| 3.528 Motions. | |
42:1.0.1.1.4.4.1.30 | SECTION 3.530
| 3.530 Sanctions. | |
42:1.0.1.1.4.4.1.31 | SECTION 3.532
| 3.532 Collateral estoppel. | |
42:1.0.1.1.4.4.1.32 | SECTION 3.534
| 3.534 The hearing. | |
42:1.0.1.1.4.4.1.33 | SECTION 3.538
| 3.538 Witnesses. | |
42:1.0.1.1.4.4.1.34 | SECTION 3.540
| 3.540 Evidence. | |
42:1.0.1.1.4.4.1.35 | SECTION 3.542
| 3.542 The record. | |
42:1.0.1.1.4.4.1.36 | SECTION 3.544
| 3.544 Post hearing briefs. | |
42:1.0.1.1.4.4.1.37 | SECTION 3.546
| 3.546 ALJ's decision. | |
42:1.0.1.1.4.4.1.38 | SECTION 3.548
| 3.548 Appeal of the ALJ's decision. | |
42:1.0.1.1.4.4.1.39 | SECTION 3.550
| 3.550 Stay of the Secretary's decision. | |
42:1.0.1.1.4.4.1.40 | SECTION 3.552
| 3.552 Harmless error. | |
42:1.0.1.1.5 | PART 4
| PART 4 - NATIONAL LIBRARY OF MEDICINE | |
42:1.0.1.1.5.0.1.1 | SECTION 4.1
| 4.1 Programs to which these regulations apply. | |
42:1.0.1.1.5.0.1.2 | SECTION 4.2
| 4.2 Definitions. | |
42:1.0.1.1.5.0.1.3 | SECTION 4.3
| 4.3 Purpose of the Library. | |
42:1.0.1.1.5.0.1.4 | SECTION 4.4
| 4.4 Use of Library facilities. | |
42:1.0.1.1.5.0.1.5 | SECTION 4.5
| 4.5 Use of materials from the collections. | |
42:1.0.1.1.5.0.1.6 | SECTION 4.6
| 4.6 Reference, bibliographic, reproduction, and consultation services. | |
42:1.0.1.1.5.0.1.7 | SECTION 4.7
| 4.7 Fees. | |
42:1.0.1.1.5.0.1.8 | SECTION 4.8
| 4.8 Publication of the Library and information about the Library. | |
42:1.0.1.1.6 | PART 5
| PART 5 - DESIGNATION OF HEALTH PROFESSIONAL(S) SHORTAGE AREAS | |
42:1.0.1.1.6.0.1.1 | SECTION 5.1
| 5.1 Purpose. | |
42:1.0.1.1.6.0.1.2 | SECTION 5.2
| 5.2 Definitions. | |
42:1.0.1.1.6.0.1.3 | SECTION 5.3
| 5.3 Procedures for designation of health professional(s) shortage areas. | |
42:1.0.1.1.6.0.1.4 | SECTION 5.4
| 5.4 Notification and publication of designations and withdrawals. | |
42:1.0.1.1.6.0.1.5.1 | APPENDIX Appendix A
| Appendix A to Part 5 - Criteria for Designation of Areas Having Shortages of Primary Medical Care Professional(s) | |
42:1.0.1.1.6.0.1.5.2 | APPENDIX Appendix B
| Appendix B to Part 5 - Criteria for Designation of Areas Having Shortages of Dental Professional(s) | |
42:1.0.1.1.6.0.1.5.3 | APPENDIX Appendix C
| Appendix C to Part 5 - Criteria for Designation of Areas Having Shortages of Mental Health Professionals | |
42:1.0.1.1.6.0.1.5.4 | APPENDIX Appendix D
| Appendix D to Part 5 - Criteria for Designation of Areas Having Shortages of Vision Care Professional(s) | |
42:1.0.1.1.6.0.1.5.5 | APPENDIX Appendix E
| Appendix E to Part 5 - Criteria for Designation of Areas Having Shortages of Podiatric Professional(s) | |
42:1.0.1.1.6.0.1.5.6 | APPENDIX Appendix F
| Appendix F to Part 5 - Criteria for Designation of Areas Having Shortages of Pharmacy Professional(s) | |
42:1.0.1.1.6.0.1.5.7 | APPENDIX Appendix G
| Appendix G to Part 5 - Criteria for Designation of Areas Having Shortages of Veterinary Professional(s) | |
42:1.0.1.1.7 | PART 6
| PART 6 - FEDERAL TORT CLAIMS ACT COVERAGE OF CERTAIN GRANTEES AND INDIVIDUALS | |
42:1.0.1.1.7.0.1.1 | SECTION 6.1
| 6.1 Applicability. | |
42:1.0.1.1.7.0.1.2 | SECTION 6.2
| 6.2 Definitions. | |
42:1.0.1.1.7.0.1.3 | SECTION 6.3
| 6.3 Eligible entities. | |
42:1.0.1.1.7.0.1.4 | SECTION 6.4
| 6.4 Covered individuals. | |
42:1.0.1.1.7.0.1.5 | SECTION 6.5
| 6.5 Deeming process for eligible entities. | |
42:1.0.1.1.7.0.1.6 | SECTION 6.6
| 6.6 Covered acts and omissions. | |
42:1.0.1.1.8 | PART 7
| PART 7 - DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL PREPARATIONS | |
42:1.0.1.1.8.0.1.1 | SECTION 7.1
| 7.1 Applicability. | |
42:1.0.1.1.8.0.1.2 | SECTION 7.2
| 7.2 Establishment of a user charge. | |
42:1.0.1.1.8.0.1.3 | SECTION 7.3
| 7.3 Definitions. | |
42:1.0.1.1.8.0.1.4 | SECTION 7.4
| 7.4 Schedule of charges. | |
42:1.0.1.1.8.0.1.5 | SECTION 7.5
| 7.5 Payment procedures. | |
42:1.0.1.1.8.0.1.6 | SECTION 7.6
| 7.6 Exemptions. | |
42:1.0.1.1.9 | PART 8
| PART 8 - MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDERS | |
42:1.0.1.1.9.1 | SUBPART A
| Subpart A - General Provisions | |
42:1.0.1.1.9.1.1.1 | SECTION 8.1
| 8.1 Scope. | |
42:1.0.1.1.9.1.1.2 | SECTION 8.2
| 8.2 Definitions. | |
42:1.0.1.1.9.2 | SUBPART B
| Subpart B - Accreditation of Opioid Treatment Programs | |
42:1.0.1.1.9.2.1.1 | SECTION 8.3
| 8.3 Application for approval as an accreditation body. | |
42:1.0.1.1.9.2.1.2 | SECTION 8.4
| 8.4 Accreditation body responsibilities. | |
42:1.0.1.1.9.2.1.3 | SECTION 8.5
| 8.5 Periodic evaluation of accreditation bodies. | |
42:1.0.1.1.9.2.1.4 | SECTION 8.6
| 8.6 Withdrawal of approval of accreditation bodies. | |
42:1.0.1.1.9.3 | SUBPART C
| Subpart C - Certification and Treatment Standards for Opioid Treatment Programs | |
42:1.0.1.1.9.3.1.1 | SECTION 8.11
| 8.11 Opioid treatment program certification. | |
42:1.0.1.1.9.3.1.2 | SECTION 8.12
| 8.12 Federal opioid treatment standards. | |
42:1.0.1.1.9.3.1.3 | SECTION 8.13
| 8.13 Revocation of accreditation and accreditation body approval. | |
42:1.0.1.1.9.3.1.4 | SECTION 8.14
| 8.14 Suspension or revocation of certification. | |
42:1.0.1.1.9.3.1.5 | SECTION 8.15
| 8.15 Forms. | |
42:1.0.1.1.9.4 | 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 | |
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. | |
42:1.0.1.1.9.5 | SUBPART E
| Subpart E [Reserved] | |
42:1.0.1.1.9.6 | SUBPART F
| Subpart F - Authorization To Increase Patient Limit to 275 Patients | |
42:1.0.1.1.9.6.1.1 | SECTION 8.610
| 8.610 Which practitioners are eligible for a patient limit of 275 | |
42:1.0.1.1.9.6.1.2 | SECTION 8.615
| 8.615 What constitutes a qualified practice setting | |
42:1.0.1.1.9.6.1.3 | SECTION 8.620
| 8.620 What is the process to request a patient limit of 275 | |
42:1.0.1.1.9.6.1.4 | SECTION 8.625
| 8.625 How will a Request for Patient Limit Increase be processed | |
42:1.0.1.1.9.6.1.5 | SECTION 8.630
| 8.630 What must practitioners do in order to maintain their approval to treat up to 275 patients | |
42:1.0.1.1.9.6.1.6 | SECTION 8.635
| 8.635 What are the reporting requirements for practitioners whose Request for Patient Limit Increase is approved | |
42:1.0.1.1.9.6.1.7 | SECTION 8.640
| 8.640 What is the process for renewing a practitioner's Request for Patient Limit Increase approval | |
42:1.0.1.1.9.6.1.8 | SECTION 8.645
| 8.645 What are the responsibilities of practitioners who do not submit a renewal Request for Patient Limit Increase, or whose renewal request is denied | |
42:1.0.1.1.9.6.1.9 | SECTION 8.650
| 8.650 Can SAMHSA's approval of a practitioner's Request for Patient Limit Increase be suspended or revoked | |
42:1.0.1.1.9.6.1.10 | SECTION 8.655
| 8.655 Can a practitioner request to temporarily treat up to 275 patients in emergency situations | |
42:1.0.1.1.10 | PART 9
| PART 9 - STANDARDS OF CARE FOR CHIMPANZEES HELD IN THE FEDERALLY SUPPORTED SANCTUARY SYSTEM | |
42:1.0.1.1.10.0.1.1 | SECTION 9.1
| 9.1 Applicability and purpose. | |
42:1.0.1.1.10.0.1.2 | SECTION 9.2
| 9.2 Definitions. | |
42:1.0.1.1.10.0.1.3 | SECTION 9.3
| 9.3 Sanctuary policies and responsibilities. | |
42:1.0.1.1.10.0.1.4 | SECTION 9.4
| 9.4 Physical facility policies and design. | |
42:1.0.1.1.10.0.1.5 | SECTION 9.5
| 9.5 Chimpanzee ownership, fees, and studies. | |
42:1.0.1.1.10.0.1.6 | SECTION 9.6
| 9.6 Animal care, well-being, husbandry, veterinary care, and euthanasia. | |
42:1.0.1.1.10.0.1.7 | SECTION 9.7
| 9.7 Reproduction. | |
42:1.0.1.1.10.0.1.8 | SECTION 9.8
| 9.8 Animal records. | |
42:1.0.1.1.10.0.1.9 | SECTION 9.9
| 9.9 Facility staffing. | |
42:1.0.1.1.10.0.1.10 | SECTION 9.10
| 9.10 Occupational Health and Safety Program (OHSP) and biosafety requirements. | |
42:1.0.1.1.10.0.1.11 | SECTION 9.11
| 9.11 Animal transport. | |
42:1.0.1.1.10.0.1.12 | SECTION 9.12
| 9.12 Compliance with the Standards of Care, and USDA and PHS policies and regulations. | |
42:1.0.1.1.10.0.1.13 | SECTION 9.13
| 9.13 Other federal laws, regulations, and statutes that apply to the sanctuary. | |
42:1.0.1.1.11 | PART 10
| PART 10 - 340B DRUG PRICING PROGRAM | |
42:1.0.1.1.11.1 | SUBPART A
| Subpart A - General Provisions | |
42:1.0.1.1.11.1.1.1 | SECTION 10.1
| 10.1 Purpose. | |
42:1.0.1.1.11.1.1.2 | SECTION 10.2
| 10.2 Summary of 340B Drug Pricing Program. | |
42:1.0.1.1.11.1.1.3 | SECTION 10.3
| 10.3 Definitions. \ | |
42:1.0.1.1.11.2 | SUBPART B
| Subpart B - 340B Ceiling Price | |
42:1.0.1.1.11.2.1.1 | SECTION 10.10
| 10.10 Ceiling price for a covered outpatient drug. | |
42:1.0.1.1.11.2.1.2 | SECTION 10.11
| 10.11 Manufacturer civil monetary penalties. | |
42:1.0.1.1.11.3 | SUBPART C
| Subpart C - Administrative Dispute Resolution | |
42:1.0.1.1.11.3.1.1 | SECTION 10.20
| 10.20 Administrative Dispute Resolution Panel. | |
42:1.0.1.1.11.3.1.2 | SECTION 10.21
| 10.21 Claims. | |
42:1.0.1.1.11.3.1.3 | SECTION 10.22
| 10.22 Information requests. | |
42:1.0.1.1.11.3.1.4 | SECTION 10.23
| 10.23 Conduct of the ADR proceeding. | |
42:1.0.1.1.11.3.1.5 | SECTION 10.24
| 10.24 Final agency decision. | |
42:1.0.1.1.12 | PART 11
| PART 11 - CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION | |
42:1.0.1.1.12.1 | SUBPART A
| Subpart A - General Provisions | |
42:1.0.1.1.12.1.1.1 | SECTION 11.2
| 11.2 What is the purpose of this part | |
42:1.0.1.1.12.1.1.2 | SECTION 11.4
| 11.4 To whom does this part apply | |
42:1.0.1.1.12.1.1.3 | SECTION 11.6
| 11.6 What are the requirements for the submission of truthful information | |
42:1.0.1.1.12.1.1.4 | SECTION 11.8
| 11.8 In what format must clinical trial information be submitted | |
42:1.0.1.1.12.1.1.5 | SECTION 11.10
| 11.10 What definitions apply to this part | |
42:1.0.1.1.12.2 | SUBPART B
| Subpart B - Registration | |
42:1.0.1.1.12.2.1.1 | SECTION 11.20
| 11.20 Who must submit clinical trial registration information | |
42:1.0.1.1.12.2.1.2 | SECTION 11.22
| 11.22 Which applicable clinical trials must be registered | |
42:1.0.1.1.12.2.1.3 | SECTION 11.24
| 11.24 When must clinical trial registration information be submitted | |
42:1.0.1.1.12.2.1.4 | SECTION 11.28
| 11.28 What constitutes clinical trial registration information | |
42:1.0.1.1.12.2.1.5 | SECTION 11.35
| 11.35 By when will the NIH Director post clinical trial registration information submitted under § 11.28 | |
42:1.0.1.1.12.3 | SUBPART C
| Subpart C - Results Information Submission | |
42:1.0.1.1.12.3.1.1 | SECTION 11.40
| 11.40 Who must submit clinical trial results information | |
42:1.0.1.1.12.3.1.2 | SECTION 11.42
| 11.42 For which applicable clinical trials must clinical trial results information be submitted | |
42:1.0.1.1.12.3.1.3 | SECTION 11.44
| 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42 | |
42:1.0.1.1.12.3.1.4 | SECTION 11.48
| 11.48 What constitutes clinical trial results information | |
42:1.0.1.1.12.3.1.5 | SECTION 11.52
| 11.52 By when will the NIH Director post submitted clinical trial results information | |
42:1.0.1.1.12.3.1.6 | SECTION 11.54
| 11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission | |
42:1.0.1.1.12.4 | SUBPART D
| Subpart D - Additional Submission of Clinical Trial Information | |
42:1.0.1.1.12.4.1.1 | SECTION 11.60
| 11.60 What requirements apply to the voluntary submission of clinical trial information for clinical trials of FDA-regulated drug products (including biological products) and device products | |
42:1.0.1.1.12.4.1.2 | SECTION 11.62
| 11.62 What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health | |
42:1.0.1.1.12.4.1.3 | SECTION 11.64
| 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected | |
42:1.0.1.1.12.5 | SUBPART E
| Subpart E - Potential Legal Consequences of Non-Compliance | |
42:1.0.1.1.12.5.1.1 | SECTION 11.66
| 11.66 What are potential legal consequences of not complying with the requirements of this part | |