|
Section 58.1
|
Definitions |
|
Section 58.3
|
Applicability to studies performed under grants and contracts |
|
Section 58.10
|
Inspection of a testing facility |
|
Section 58.15
|
Personnel |
|
Section 58.29
|
Testing facility management |
|
Section 58.31
|
Study director |
|
Section 58.33
|
Quality assurance unit |
|
Section 58.35
|
General |
|
Section 58.41
|
Animal care facilities |
|
Section 58.43
|
Animal supply facilities |
|
Section 58.45
|
Facilities for handling test and control articles |
|
Section 58.47
|
Laboratory operation areas |
|
Section 58.49
|
Specimen and data storage facilities |
|
Section 58.51
|
Equipment design |
|
Section 58.61
|
Maintenance and calibration of equipment |
|
Section 58.63
|
Standard operating procedures |
|
Section 58.81
|
Reagents and solutions |
|
Section 58.83
|
Animal care |
|
Section 58.90
|
Test and control article characterization |
|
Section 58.105
|
Test and control article handling |
|
Section 58.107
|
Mixtures of articles with carriers |
|
Section 58.113
|
Protocol |
|
Section 58.120
|
Conduct of a nonclinical laboratory study |
|
Section 58.130
|
Reporting of nonclinical laboratory study results |
|
Section 58.185
|
Storage and retrieval of records and data |
|
Section 58.190
|
Retention of records |
|
Section 58.195
|
Purpose |
|
Section 58.200
|
Grounds for disqualification |
|
Section 58.202
|
Notice of and opportunity for hearing on proposed disqualification |
|
Section 58.204
|
Final order on disqualification |
|
Section 58.206
|
Actions upon disqualification |
|
Section 58.210
|
Public disclosure of information regarding disqualification |
|
Section 58.213
|
Alternative or additional actions to disqualification |
|
Section 58.215
|
Suspension or termination of a testing facility by a sponsor |
|
Section 58.217
|
Reinstatement of a disqualified testing facility |
|
Section 58.219
|
Scope |