Subpart A - General Provisions

§ 58.1 - Scope.

§ 58.3 - Definitions.

§ 58.10 - Applicability to studies performed under grants and contracts.

§ 58.15 - Inspection of a testing facility.

Subpart B - Organization and Personnel

§ 58.29 - Personnel.

§ 58.31 - Testing facility management.

§ 58.33 - Study director.

§ 58.35 - Quality assurance unit.

Subpart C - Facilities

§ 58.41 - General.

§ 58.43 - Animal care facilities.

§ 58.45 - Animal supply facilities.

§ 58.47 - Facilities for handling test and control articles.

§ 58.49 - Laboratory operation areas.

§ 58.51 - Specimen and data storage facilities.

Subpart D - Equipment

§ 58.61 - Equipment design.

§ 58.63 - Maintenance and calibration of equipment.

Subpart E - Testing Facilities Operation

§ 58.81 - Standard operating procedures.

§ 58.83 - Reagents and solutions.

§ 58.90 - Animal care.

Subpart F - Test and Control Articles

§ 58.105 - Test and control article characterization.

§ 58.107 - Test and control article handling.

§ 58.113 - Mixtures of articles with carriers.

Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study

§ 58.120 - Protocol.

§ 58.130 - Conduct of a nonclinical laboratory study.

Subparts H--I - XXX

Subpart J - Records and Reports

§ 58.185 - Reporting of nonclinical laboratory study results.

§ 58.190 - Storage and retrieval of records and data.

§ 58.195 - Retention of records.

Subpart K - Disqualification of Testing Facilities

§ 58.200 - Purpose.

§ 58.202 - Grounds for disqualification.

§ 58.204 - Notice of and opportunity for hearing on proposed disqualification.

§ 58.206 - Final order on disqualification.

§ 58.210 - Actions upon disqualification.

§ 58.213 - Public disclosure of information regarding disqualification.

§ 58.215 - Alternative or additional actions to disqualification.

§ 58.217 - Suspension or termination of a testing facility by a sponsor.

§ 58.219 - Reinstatement of a disqualified testing facility.