Title 42

Volume 1 CHAPTER I SUBCHAP A

Subchapter A - General Provisions

42:1.0.1.1.1PART 1
Part 1 - XXX
42:1.0.1.1.2PART 2
PART 2 - CONFIDENTIALITY OF SUBSTANCE USE DISORDER PATIENT RECORDS
42:1.0.1.1.2.1SUBPART A
Subpart A - Introduction
42:1.0.1.1.2.1.1.1SECTION 2.1
     2.1 Statutory authority for confidentiality of substance use disorder patient records.
42:1.0.1.1.2.1.1.2SECTION 2.2
     2.2 Purpose and effect.
42:1.0.1.1.2.1.1.3SECTION 2.3
     2.3 Criminal penalty for violation.
42:1.0.1.1.2.1.1.4SECTION 2.4
     2.4 Reports of violations.
42:1.0.1.1.2.2SUBPART B
Subpart B - General Provisions
42:1.0.1.1.2.2.1.1SECTION 2.11
     2.11 Definitions.
42:1.0.1.1.2.2.1.2SECTION 2.12
     2.12 Applicability.
42:1.0.1.1.2.2.1.3SECTION 2.13
     2.13 Confidentiality restrictions and safeguards.
42:1.0.1.1.2.2.1.4SECTION 2.14
     2.14 Minor patients.
42:1.0.1.1.2.2.1.5SECTION 2.15
     2.15 Incompetent and deceased patients.
42:1.0.1.1.2.2.1.6SECTION 2.16
     2.16 Security for records.
42:1.0.1.1.2.2.1.7SECTION 2.17
     2.17 Undercover agents and informants.
42:1.0.1.1.2.2.1.8SECTION 2.18
     2.18 Restrictions on the use of identification cards.
42:1.0.1.1.2.2.1.9SECTION 2.19
     2.19 Disposition of records by discontinued programs.
42:1.0.1.1.2.2.1.10SECTION 2.20
     2.20 Relationship to state laws.
42:1.0.1.1.2.2.1.11SECTION 2.21
     2.21 Relationship to federal statutes protecting research subjects against compulsory disclosure of their identity.
42:1.0.1.1.2.2.1.12SECTION 2.22
     2.22 Notice to patients of federal confidentiality requirements.
42:1.0.1.1.2.2.1.13SECTION 2.23
     2.23 Patient access and restrictions on use.
42:1.0.1.1.2.3SUBPART C
Subpart C - Disclosures With Patient Consent
42:1.0.1.1.2.3.1.1SECTION 2.31
     2.31 Consent requirements.
42:1.0.1.1.2.3.1.2SECTION 2.32
     2.32 Prohibition on re-disclosure.
42:1.0.1.1.2.3.1.3SECTION 2.33
     2.33 Disclosures permitted with written consent.
42:1.0.1.1.2.3.1.4SECTION 2.34
     2.34 Disclosures to prevent multiple enrollments.
42:1.0.1.1.2.3.1.5SECTION 2.35
     2.35 Disclosures to elements of the criminal justice system which have referred patients.
42:1.0.1.1.2.3.1.6SECTION 2.36
     2.36 Disclosures to prescription drug monitoring programs.
42:1.0.1.1.2.4SUBPART D
Subpart D - Disclosures Without Patient Consent
42:1.0.1.1.2.4.1.1SECTION 2.51
     2.51 Medical emergencies.
42:1.0.1.1.2.4.1.2SECTION 2.52
     2.52 Research.
42:1.0.1.1.2.4.1.3SECTION 2.53
     2.53 Audit and evaluation.
42:1.0.1.1.2.5SUBPART E
Subpart E - Court Orders Authorizing Disclosure and Use
42:1.0.1.1.2.5.1.1SECTION 2.61
     2.61 Legal effect of order.
42:1.0.1.1.2.5.1.2SECTION 2.62
     2.62 Order not applicable to records disclosed without consent to researchers, auditors and evaluators.
42:1.0.1.1.2.5.1.3SECTION 2.63
     2.63 Confidential communications.
42:1.0.1.1.2.5.1.4SECTION 2.64
     2.64 Procedures and criteria for orders authorizing disclosures for noncriminal purposes.
42:1.0.1.1.2.5.1.5SECTION 2.65
     2.65 Procedures and criteria for orders authorizing disclosure and use of records to criminally investigate or prosecute patients.
42:1.0.1.1.2.5.1.6SECTION 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.
42:1.0.1.1.2.5.1.7SECTION 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.
42:1.0.1.1.3PART 2a
PART 2a - PROTECTION OF IDENTITY - RESEARCH SUBJECTS
42:1.0.1.1.3.0.1.1SECTION 2a.1
     2a.1 Applicability.
42:1.0.1.1.3.0.1.2SECTION 2a.2
     2a.2 Definitions.
42:1.0.1.1.3.0.1.3SECTION 2a.3
     2a.3 Application; coordination.
42:1.0.1.1.3.0.1.4SECTION 2a.4
     2a.4 Contents of application; in general.
42:1.0.1.1.3.0.1.5SECTION 2a.5
     2a.5 Contents of application; research projects in which drugs will be administered.
42:1.0.1.1.3.0.1.6SECTION 2a.6
     2a.6 Issuance of Confidentiality Certificates; single project limitation.
42:1.0.1.1.3.0.1.7SECTION 2a.7
     2a.7 Effect of Confidentiality Certificate.
42:1.0.1.1.3.0.1.8SECTION 2a.8
     2a.8 Termination.
42:1.0.1.1.4PART 3
PART 3 - PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT
42:1.0.1.1.4.1SUBPART A
Subpart A - General Provisions
42:1.0.1.1.4.1.1.1SECTION 3.10
     3.10 Purpose.
42:1.0.1.1.4.1.1.2SECTION 3.20
     3.20 Definitions.
42:1.0.1.1.4.2SUBPART B
Subpart B - PSO Requirements and Agency Procedures
42:1.0.1.1.4.2.1.1SECTION 3.102
     3.102 Process and requirements for initial and continued listing of PSOs.
42:1.0.1.1.4.2.1.2SECTION 3.104
     3.104 Secretarial actions.
42:1.0.1.1.4.2.1.3SECTION 3.106
     3.106 Security requirements.
42:1.0.1.1.4.2.1.4SECTION 3.108
     3.108 Correction of deficiencies, revocation, and voluntary relinquishment.
42:1.0.1.1.4.2.1.5SECTION 3.110
     3.110 Assessment of PSO compliance.
42:1.0.1.1.4.2.1.6SECTION 3.112
     3.112 Submissions and forms.
42:1.0.1.1.4.3SUBPART C
Subpart C - Confidentiality and Privilege Protections of Patient Safety Work Product
42:1.0.1.1.4.3.1.1SECTION 3.204
     3.204 Privilege of patient safety work product.
42:1.0.1.1.4.3.1.2SECTION 3.206
     3.206 Confidentiality of patient safety work product.
42:1.0.1.1.4.3.1.3SECTION 3.208
     3.208 Continued protection of patient safety work product.
42:1.0.1.1.4.3.1.4SECTION 3.210
     3.210 Required disclosure of patient safety work product to the Secretary.
42:1.0.1.1.4.3.1.5SECTION 3.212
     3.212 Nonidentification of patient safety work product.
42:1.0.1.1.4.4SUBPART D
Subpart D - Enforcement Program
42:1.0.1.1.4.4.1.1SECTION 3.304
     3.304 Principles for achieving compliance.
42:1.0.1.1.4.4.1.2SECTION 3.306
     3.306 Complaints to the Secretary.
42:1.0.1.1.4.4.1.3SECTION 3.308
     3.308 Compliance reviews.
42:1.0.1.1.4.4.1.4SECTION 3.310
     3.310 Responsibilities of respondents.
42:1.0.1.1.4.4.1.5SECTION 3.312
     3.312 Secretarial action regarding complaints and compliance reviews.
42:1.0.1.1.4.4.1.6SECTION 3.314
     3.314 Investigational subpoenas and inquiries.
42:1.0.1.1.4.4.1.7SECTION 3.402
     3.402 Basis for a civil money penalty.
42:1.0.1.1.4.4.1.8SECTION 3.404
     3.404 Amount of a civil money penalty.
42:1.0.1.1.4.4.1.9SECTION 3.408
     3.408 Factors considered in determining the amount of a civil money penalty.
42:1.0.1.1.4.4.1.10SECTION 3.414
     3.414 Limitations.
42:1.0.1.1.4.4.1.11SECTION 3.416
     3.416 Authority to settle.
42:1.0.1.1.4.4.1.12SECTION 3.418
     3.418 Exclusivity of penalty.
42:1.0.1.1.4.4.1.13SECTION 3.420
     3.420 Notice of proposed determination.
42:1.0.1.1.4.4.1.14SECTION 3.422
     3.422 Failure to request a hearing.
42:1.0.1.1.4.4.1.15SECTION 3.424
     3.424 Collection of penalty.
42:1.0.1.1.4.4.1.16SECTION 3.426
     3.426 Notification of the public and other agencies.
42:1.0.1.1.4.4.1.17SECTION 3.504
     3.504 Hearings before an ALJ.
42:1.0.1.1.4.4.1.18SECTION 3.506
     3.506 Rights of the parties.
42:1.0.1.1.4.4.1.19SECTION 3.508
     3.508 Authority of the ALJ.
42:1.0.1.1.4.4.1.20SECTION 3.510
     3.510 Ex parte contacts.
42:1.0.1.1.4.4.1.21SECTION 3.512
     3.512 Prehearing conferences.
42:1.0.1.1.4.4.1.22SECTION 3.514
     3.514 Authority to settle.
42:1.0.1.1.4.4.1.23SECTION 3.516
     3.516 Discovery.
42:1.0.1.1.4.4.1.24SECTION 3.518
     3.518 Exchange of witness lists, witness statements, and exhibits.
42:1.0.1.1.4.4.1.25SECTION 3.520
     3.520 Subpoenas for attendance at hearing.
42:1.0.1.1.4.4.1.26SECTION 3.522
     3.522 Fees.
42:1.0.1.1.4.4.1.27SECTION 3.524
     3.524 Form, filing, and service of papers.
42:1.0.1.1.4.4.1.28SECTION 3.526
     3.526 Computation of time.
42:1.0.1.1.4.4.1.29SECTION 3.528
     3.528 Motions.
42:1.0.1.1.4.4.1.30SECTION 3.530
     3.530 Sanctions.
42:1.0.1.1.4.4.1.31SECTION 3.532
     3.532 Collateral estoppel.
42:1.0.1.1.4.4.1.32SECTION 3.534
     3.534 The hearing.
42:1.0.1.1.4.4.1.33SECTION 3.538
     3.538 Witnesses.
42:1.0.1.1.4.4.1.34SECTION 3.540
     3.540 Evidence.
42:1.0.1.1.4.4.1.35SECTION 3.542
     3.542 The record.
42:1.0.1.1.4.4.1.36SECTION 3.544
     3.544 Post hearing briefs.
42:1.0.1.1.4.4.1.37SECTION 3.546
     3.546 ALJ's decision.
42:1.0.1.1.4.4.1.38SECTION 3.548
     3.548 Appeal of the ALJ's decision.
42:1.0.1.1.4.4.1.39SECTION 3.550
     3.550 Stay of the Secretary's decision.
42:1.0.1.1.4.4.1.40SECTION 3.552
     3.552 Harmless error.
42:1.0.1.1.5PART 4
PART 4 - NATIONAL LIBRARY OF MEDICINE
42:1.0.1.1.5.0.1.1SECTION 4.1
     4.1 Programs to which these regulations apply.
42:1.0.1.1.5.0.1.2SECTION 4.2
     4.2 Definitions.
42:1.0.1.1.5.0.1.3SECTION 4.3
     4.3 Purpose of the Library.
42:1.0.1.1.5.0.1.4SECTION 4.4
     4.4 Use of Library facilities.
42:1.0.1.1.5.0.1.5SECTION 4.5
     4.5 Use of materials from the collections.
42:1.0.1.1.5.0.1.6SECTION 4.6
     4.6 Reference, bibliographic, reproduction, and consultation services.
42:1.0.1.1.5.0.1.7SECTION 4.7
     4.7 Fees.
42:1.0.1.1.5.0.1.8SECTION 4.8
     4.8 Publication of the Library and information about the Library.
42:1.0.1.1.6PART 5
PART 5 - DESIGNATION OF HEALTH PROFESSIONAL(S) SHORTAGE AREAS
42:1.0.1.1.6.0.1.1SECTION 5.1
     5.1 Purpose.
42:1.0.1.1.6.0.1.2SECTION 5.2
     5.2 Definitions.
42:1.0.1.1.6.0.1.3SECTION 5.3
     5.3 Procedures for designation of health professional(s) shortage areas.
42:1.0.1.1.6.0.1.4SECTION 5.4
     5.4 Notification and publication of designations and withdrawals.
42:1.0.1.1.6.0.1.5.1APPENDIX Appendix A
  Appendix A to Part 5 - Criteria for Designation of Areas Having Shortages of Primary Medical Care Professional(s)
42:1.0.1.1.6.0.1.5.2APPENDIX Appendix B
  Appendix B to Part 5 - Criteria for Designation of Areas Having Shortages of Dental Professional(s)
42:1.0.1.1.6.0.1.5.3APPENDIX Appendix C
  Appendix C to Part 5 - Criteria for Designation of Areas Having Shortages of Mental Health Professionals
42:1.0.1.1.6.0.1.5.4APPENDIX Appendix D
  Appendix D to Part 5 - Criteria for Designation of Areas Having Shortages of Vision Care Professional(s)
42:1.0.1.1.6.0.1.5.5APPENDIX Appendix E
  Appendix E to Part 5 - Criteria for Designation of Areas Having Shortages of Podiatric Professional(s)
42:1.0.1.1.6.0.1.5.6APPENDIX Appendix F
  Appendix F to Part 5 - Criteria for Designation of Areas Having Shortages of Pharmacy Professional(s)
42:1.0.1.1.6.0.1.5.7APPENDIX Appendix G
  Appendix G to Part 5 - Criteria for Designation of Areas Having Shortages of Veterinary Professional(s)
42:1.0.1.1.7PART 6
PART 6 - FEDERAL TORT CLAIMS ACT COVERAGE OF CERTAIN GRANTEES AND INDIVIDUALS
42:1.0.1.1.7.0.1.1SECTION 6.1
     6.1 Applicability.
42:1.0.1.1.7.0.1.2SECTION 6.2
     6.2 Definitions.
42:1.0.1.1.7.0.1.3SECTION 6.3
     6.3 Eligible entities.
42:1.0.1.1.7.0.1.4SECTION 6.4
     6.4 Covered individuals.
42:1.0.1.1.7.0.1.5SECTION 6.5
     6.5 Deeming process for eligible entities.
42:1.0.1.1.7.0.1.6SECTION 6.6
     6.6 Covered acts and omissions.
42:1.0.1.1.8PART 7
PART 7 - DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL PREPARATIONS
42:1.0.1.1.8.0.1.1SECTION 7.1
     7.1 Applicability.
42:1.0.1.1.8.0.1.2SECTION 7.2
     7.2 Establishment of a user charge.
42:1.0.1.1.8.0.1.3SECTION 7.3
     7.3 Definitions.
42:1.0.1.1.8.0.1.4SECTION 7.4
     7.4 Schedule of charges.
42:1.0.1.1.8.0.1.5SECTION 7.5
     7.5 Payment procedures.
42:1.0.1.1.8.0.1.6SECTION 7.6
     7.6 Exemptions.
42:1.0.1.1.9PART 8
PART 8 - MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDERS
42:1.0.1.1.9.1SUBPART A
Subpart A - General Provisions
42:1.0.1.1.9.1.1.1SECTION 8.1
     8.1 Scope.
42:1.0.1.1.9.1.1.2SECTION 8.2
     8.2 Definitions.
42:1.0.1.1.9.2SUBPART B
Subpart B - Accreditation of Opioid Treatment Programs
42:1.0.1.1.9.2.1.1SECTION 8.3
     8.3 Application for approval as an accreditation body.
42:1.0.1.1.9.2.1.2SECTION 8.4
     8.4 Accreditation body responsibilities.
42:1.0.1.1.9.2.1.3SECTION 8.5
     8.5 Periodic evaluation of accreditation bodies.
42:1.0.1.1.9.2.1.4SECTION 8.6
     8.6 Withdrawal of approval of accreditation bodies.
42:1.0.1.1.9.3SUBPART C
Subpart C - Certification and Treatment Standards for Opioid Treatment Programs
42:1.0.1.1.9.3.1.1SECTION 8.11
     8.11 Opioid treatment program certification.
42:1.0.1.1.9.3.1.2SECTION 8.12
     8.12 Federal opioid treatment standards.
42:1.0.1.1.9.3.1.3SECTION 8.13
     8.13 Revocation of accreditation and accreditation body approval.
42:1.0.1.1.9.3.1.4SECTION 8.14
     8.14 Suspension or revocation of certification.
42:1.0.1.1.9.3.1.5SECTION 8.15
     8.15 Forms.
42:1.0.1.1.9.4SUBPART 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
42:1.0.1.1.9.4.1.1SECTION 8.21
     8.21 Applicability.
42:1.0.1.1.9.4.1.2SECTION 8.22
     8.22 Definitions.
42:1.0.1.1.9.4.1.3SECTION 8.23
     8.23 Limitation on issues subject to review.
42:1.0.1.1.9.4.1.4SECTION 8.24
     8.24 Specifying who represents the parties.
42:1.0.1.1.9.4.1.5SECTION 8.25
     8.25 Informal review and the reviewing official's response.
42:1.0.1.1.9.4.1.6SECTION 8.26
     8.26 Preparation of the review file and written arguments.
42:1.0.1.1.9.4.1.7SECTION 8.27
     8.27 Opportunity for oral presentation.
42:1.0.1.1.9.4.1.8SECTION 8.28
     8.28 Expedited procedures for review of immediate suspension.
42:1.0.1.1.9.4.1.9SECTION 8.29
     8.29 Ex parte communications.
42:1.0.1.1.9.4.1.10SECTION 8.30
     8.30 Transmission of written communications by reviewing official and calculation of deadlines.
42:1.0.1.1.9.4.1.11SECTION 8.31
     8.31 Authority and responsibilities of the reviewing official.
42:1.0.1.1.9.4.1.12SECTION 8.32
     8.32 Administrative record.
42:1.0.1.1.9.4.1.13SECTION 8.33
     8.33 Written decision.
42:1.0.1.1.9.4.1.14SECTION 8.34
     8.34 Court review of final administrative action; exhaustion of administrative remedies.
42:1.0.1.1.9.5SUBPART E
Subpart E [Reserved]
42:1.0.1.1.9.6SUBPART F
Subpart F - Authorization To Increase Patient Limit to 275 Patients
42:1.0.1.1.9.6.1.1SECTION 8.610
     8.610 Which practitioners are eligible for a patient limit of 275
42:1.0.1.1.9.6.1.2SECTION 8.615
     8.615 What constitutes a qualified practice setting
42:1.0.1.1.9.6.1.3SECTION 8.620
     8.620 What is the process to request a patient limit of 275
42:1.0.1.1.9.6.1.4SECTION 8.625
     8.625 How will a Request for Patient Limit Increase be processed
42:1.0.1.1.9.6.1.5SECTION 8.630
     8.630 What must practitioners do in order to maintain their approval to treat up to 275 patients
42:1.0.1.1.9.6.1.6SECTION 8.635
     8.635 What are the reporting requirements for practitioners whose Request for Patient Limit Increase is approved
42:1.0.1.1.9.6.1.7SECTION 8.640
     8.640 What is the process for renewing a practitioner's Request for Patient Limit Increase approval
42:1.0.1.1.9.6.1.8SECTION 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
42:1.0.1.1.9.6.1.9SECTION 8.650
     8.650 Can SAMHSA's approval of a practitioner's Request for Patient Limit Increase be suspended or revoked
42:1.0.1.1.9.6.1.10SECTION 8.655
     8.655 Can a practitioner request to temporarily treat up to 275 patients in emergency situations
42:1.0.1.1.10PART 9
PART 9 - STANDARDS OF CARE FOR CHIMPANZEES HELD IN THE FEDERALLY SUPPORTED SANCTUARY SYSTEM
42:1.0.1.1.10.0.1.1SECTION 9.1
     9.1 Applicability and purpose.
42:1.0.1.1.10.0.1.2SECTION 9.2
     9.2 Definitions.
42:1.0.1.1.10.0.1.3SECTION 9.3
     9.3 Sanctuary policies and responsibilities.
42:1.0.1.1.10.0.1.4SECTION 9.4
     9.4 Physical facility policies and design.
42:1.0.1.1.10.0.1.5SECTION 9.5
     9.5 Chimpanzee ownership, fees, and studies.
42:1.0.1.1.10.0.1.6SECTION 9.6
     9.6 Animal care, well-being, husbandry, veterinary care, and euthanasia.
42:1.0.1.1.10.0.1.7SECTION 9.7
     9.7 Reproduction.
42:1.0.1.1.10.0.1.8SECTION 9.8
     9.8 Animal records.
42:1.0.1.1.10.0.1.9SECTION 9.9
     9.9 Facility staffing.
42:1.0.1.1.10.0.1.10SECTION 9.10
     9.10 Occupational Health and Safety Program (OHSP) and biosafety requirements.
42:1.0.1.1.10.0.1.11SECTION 9.11
     9.11 Animal transport.
42:1.0.1.1.10.0.1.12SECTION 9.12
     9.12 Compliance with the Standards of Care, and USDA and PHS policies and regulations.
42:1.0.1.1.10.0.1.13SECTION 9.13
     9.13 Other federal laws, regulations, and statutes that apply to the sanctuary.
42:1.0.1.1.11PART 10
PART 10 - 340B DRUG PRICING PROGRAM
42:1.0.1.1.11.1SUBPART A
Subpart A - General Provisions
42:1.0.1.1.11.1.1.1SECTION 10.1
     10.1 Purpose.
42:1.0.1.1.11.1.1.2SECTION 10.2
     10.2 Summary of 340B Drug Pricing Program.
42:1.0.1.1.11.1.1.3SECTION 10.3
     10.3 Definitions. \
42:1.0.1.1.11.2SUBPART B
Subpart B - 340B Ceiling Price
42:1.0.1.1.11.2.1.1SECTION 10.10
     10.10 Ceiling price for a covered outpatient drug.
42:1.0.1.1.11.2.1.2SECTION 10.11
     10.11 Manufacturer civil monetary penalties.
42:1.0.1.1.11.3SUBPART C
Subpart C - Administrative Dispute Resolution
42:1.0.1.1.11.3.1.1SECTION 10.20
     10.20 Administrative Dispute Resolution Panel.
42:1.0.1.1.11.3.1.2SECTION 10.21
     10.21 Claims.
42:1.0.1.1.11.3.1.3SECTION 10.22
     10.22 Information requests.
42:1.0.1.1.11.3.1.4SECTION 10.23
     10.23 Conduct of the ADR proceeding.
42:1.0.1.1.11.3.1.5SECTION 10.24
     10.24 Final agency decision.
42:1.0.1.1.12PART 11
PART 11 - CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION
42:1.0.1.1.12.1SUBPART A
Subpart A - General Provisions
42:1.0.1.1.12.1.1.1SECTION 11.2
     11.2 What is the purpose of this part
42:1.0.1.1.12.1.1.2SECTION 11.4
     11.4 To whom does this part apply
42:1.0.1.1.12.1.1.3SECTION 11.6
     11.6 What are the requirements for the submission of truthful information
42:1.0.1.1.12.1.1.4SECTION 11.8
     11.8 In what format must clinical trial information be submitted
42:1.0.1.1.12.1.1.5SECTION 11.10
     11.10 What definitions apply to this part
42:1.0.1.1.12.2SUBPART B
Subpart B - Registration
42:1.0.1.1.12.2.1.1SECTION 11.20
     11.20 Who must submit clinical trial registration information
42:1.0.1.1.12.2.1.2SECTION 11.22
     11.22 Which applicable clinical trials must be registered
42:1.0.1.1.12.2.1.3SECTION 11.24
     11.24 When must clinical trial registration information be submitted
42:1.0.1.1.12.2.1.4SECTION 11.28
     11.28 What constitutes clinical trial registration information
42:1.0.1.1.12.2.1.5SECTION 11.35
     11.35 By when will the NIH Director post clinical trial registration information submitted under § 11.28
42:1.0.1.1.12.3SUBPART C
Subpart C - Results Information Submission
42:1.0.1.1.12.3.1.1SECTION 11.40
     11.40 Who must submit clinical trial results information
42:1.0.1.1.12.3.1.2SECTION 11.42
     11.42 For which applicable clinical trials must clinical trial results information be submitted
42:1.0.1.1.12.3.1.3SECTION 11.44
     11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42
42:1.0.1.1.12.3.1.4SECTION 11.48
     11.48 What constitutes clinical trial results information
42:1.0.1.1.12.3.1.5SECTION 11.52
     11.52 By when will the NIH Director post submitted clinical trial results information
42:1.0.1.1.12.3.1.6SECTION 11.54
     11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission
42:1.0.1.1.12.4SUBPART D
Subpart D - Additional Submission of Clinical Trial Information
42:1.0.1.1.12.4.1.1SECTION 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
42:1.0.1.1.12.4.1.2SECTION 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
42:1.0.1.1.12.4.1.3SECTION 11.64
     11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected
42:1.0.1.1.12.5SUBPART E
Subpart E - Potential Legal Consequences of Non-Compliance
42:1.0.1.1.12.5.1.1SECTION 11.66
     11.66 What are potential legal consequences of not complying with the requirements of this part