| 21:1.0.1.1.24.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.24.1.63.1 | SECTION 58.1
| 58.1 Scope. | |
| 21:1.0.1.1.24.1.63.2 | SECTION 58.3
| 58.3 Definitions. | |
| 21:1.0.1.1.24.1.63.3 | SECTION 58.10
| 58.10 Applicability to studies performed under grants and contracts. | |
| 21:1.0.1.1.24.1.63.4 | SECTION 58.15
| 58.15 Inspection of a testing facility. | |
| 21:1.0.1.1.24.2 | SUBPART B
| Subpart B - Organization and Personnel | |
| 21:1.0.1.1.24.2.63.1 | SECTION 58.29
| 58.29 Personnel. | |
| 21:1.0.1.1.24.2.63.2 | SECTION 58.31
| 58.31 Testing facility management. | |
| 21:1.0.1.1.24.2.63.3 | SECTION 58.33
| 58.33 Study director. | |
| 21:1.0.1.1.24.2.63.4 | SECTION 58.35
| 58.35 Quality assurance unit. | |
| 21:1.0.1.1.24.3 | SUBPART C
| Subpart C - Facilities | |
| 21:1.0.1.1.24.3.63.1 | SECTION 58.41
| 58.41 General. | |
| 21:1.0.1.1.24.3.63.2 | SECTION 58.43
| 58.43 Animal care facilities. | |
| 21:1.0.1.1.24.3.63.3 | SECTION 58.45
| 58.45 Animal supply facilities. | |
| 21:1.0.1.1.24.3.63.4 | SECTION 58.47
| 58.47 Facilities for handling test and control articles. | |
| 21:1.0.1.1.24.3.63.5 | SECTION 58.49
| 58.49 Laboratory operation areas. | |
| 21:1.0.1.1.24.3.63.6 | SECTION 58.51
| 58.51 Specimen and data storage facilities. | |
| 21:1.0.1.1.24.4 | SUBPART D
| Subpart D - Equipment | |
| 21:1.0.1.1.24.4.63.1 | SECTION 58.61
| 58.61 Equipment design. | |
| 21:1.0.1.1.24.4.63.2 | SECTION 58.63
| 58.63 Maintenance and calibration of equipment. | |
| 21:1.0.1.1.24.5 | SUBPART E
| Subpart E - Testing Facilities Operation | |
| 21:1.0.1.1.24.5.63.1 | SECTION 58.81
| 58.81 Standard operating procedures. | |
| 21:1.0.1.1.24.5.63.2 | SECTION 58.83
| 58.83 Reagents and solutions. | |
| 21:1.0.1.1.24.5.63.3 | SECTION 58.90
| 58.90 Animal care. | |
| 21:1.0.1.1.24.6 | SUBPART F
| Subpart F - Test and Control Articles | |
| 21:1.0.1.1.24.6.63.1 | SECTION 58.105
| 58.105 Test and control article characterization. | |
| 21:1.0.1.1.24.6.63.2 | SECTION 58.107
| 58.107 Test and control article handling. | |
| 21:1.0.1.1.24.6.63.3 | SECTION 58.113
| 58.113 Mixtures of articles with carriers. | |
| 21:1.0.1.1.24.7 | SUBPART G
| Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study | |
| 21:1.0.1.1.24.7.63.1 | SECTION 58.120
| 58.120 Protocol. | |
| 21:1.0.1.1.24.7.63.2 | SECTION 58.130
| 58.130 Conduct of a nonclinical laboratory study. | |
| 21:1.0.1.1.24.8 | SUBPART H
| Subparts H-I [Reserved] | |
| 21:1.0.1.1.24.9 | SUBPART J
| Subpart J - Records and Reports | |
| 21:1.0.1.1.24.9.63.1 | SECTION 58.185
| 58.185 Reporting of nonclinical laboratory study results. | |
| 21:1.0.1.1.24.9.63.2 | SECTION 58.190
| 58.190 Storage and retrieval of records and data. | |
| 21:1.0.1.1.24.9.63.3 | SECTION 58.195
| 58.195 Retention of records. | |
| 21:1.0.1.1.24.10 | SUBPART K
| Subpart K - Disqualification of Testing Facilities | |
| 21:1.0.1.1.24.10.63.1 | SECTION 58.200
| 58.200 Purpose. | |
| 21:1.0.1.1.24.10.63.2 | SECTION 58.202
| 58.202 Grounds for disqualification. | |
| 21:1.0.1.1.24.10.63.3 | SECTION 58.204
| 58.204 Notice of and opportunity for hearing on proposed disqualification. | |
| 21:1.0.1.1.24.10.63.4 | SECTION 58.206
| 58.206 Final order on disqualification. | |
| 21:1.0.1.1.24.10.63.5 | SECTION 58.210
| 58.210 Actions upon disqualification. | |
| 21:1.0.1.1.24.10.63.6 | SECTION 58.213
| 58.213 Public disclosure of information regarding disqualification. | |
| 21:1.0.1.1.24.10.63.7 | SECTION 58.215
| 58.215 Alternative or additional actions to disqualification. | |
| 21:1.0.1.1.24.10.63.8 | SECTION 58.217
| 58.217 Suspension or termination of a testing facility by a sponsor. | |
| 21:1.0.1.1.24.10.63.9 | SECTION 58.219
| 58.219 Reinstatement of a disqualified testing facility. | |