Title 9

Volume 1 CHAPTER I SUBCHAP E

Subchapter E - Viruses, Serums, Toxins, And Analogous Products; Organisms And Vectors

9:1.0.1.5.41PART 101
PART 101 - DEFINITIONS
9:1.0.1.5.41.0.68.1SECTION 101.1
     101.1 Applicability.
9:1.0.1.5.41.0.68.2SECTION 101.2
     101.2 Administrative terminology.
9:1.0.1.5.41.0.68.3SECTION 101.3
     101.3 Biological products and related terms.
9:1.0.1.5.41.0.68.4SECTION 101.4
     101.4 Labeling terminology.
9:1.0.1.5.41.0.68.5SECTION 101.5
     101.5 Testing terminology.
9:1.0.1.5.41.0.68.6SECTION 101.6
     101.6 Cell cultures.
9:1.0.1.5.41.0.68.7SECTION 101.7
     101.7 Seed organisms.
9:1.0.1.5.42PART 102
PART 102 - LICENSES FOR BIOLOGICAL PRODUCTS
9:1.0.1.5.42.0.68.1SECTION 102.1
     102.1 Licenses issued by the Administrator.
9:1.0.1.5.42.0.68.2SECTION 102.2
     102.2 Licenses required.
9:1.0.1.5.42.0.68.3SECTION 102.3
     102.3 License applications.
9:1.0.1.5.42.0.68.4SECTION 102.4
     102.4 U.S. Veterinary Biologics Establishment License.
9:1.0.1.5.42.0.68.5SECTION 102.5
     102.5 U.S. Veterinary Biological Product License.
9:1.0.1.5.42.0.68.6SECTION 102.6
     102.6 Conditional licenses.
9:1.0.1.5.43PART 103
PART 103 - EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING
9:1.0.1.5.43.0.68.1SECTION 103.1
     103.1 Preparation of experimental biological products.
9:1.0.1.5.43.0.68.2SECTION 103.2
     103.2 Disposition of animals administered experimental biological products or live organisms.
9:1.0.1.5.43.0.68.3SECTION 103.3
     103.3 Shipment of experimental biological products.
9:1.0.1.5.44PART 104
PART 104 - PERMITS FOR BIOLOGICAL PRODUCTS
9:1.0.1.5.44.0.68.1SECTION 104.1
     104.1 Permit required.
9:1.0.1.5.44.0.68.2SECTION 104.2
     104.2 Permit authorized.
9:1.0.1.5.44.0.68.3SECTION 104.3
     104.3 Permit application.
9:1.0.1.5.44.0.68.4SECTION 104.4
     104.4 Products for research and evaluation.
9:1.0.1.5.44.0.68.5SECTION 104.5
     104.5 Products for distribution and sale.
9:1.0.1.5.44.0.68.6SECTION 104.6
     104.6 Products for transit shipment only.
9:1.0.1.5.44.0.68.7SECTION 104.7
     104.7 Product permit.
9:1.0.1.5.44.0.68.8SECTION 104.8
     104.8 Illegal shipments.
9:1.0.1.5.45PART 105
PART 105 - SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL LICENSES OR PERMITS
9:1.0.1.5.45.0.68.1SECTION 105.1
     105.1 Suspension or revocation.
9:1.0.1.5.45.0.68.2SECTION 105.2
     105.2 Notification of infractions.
9:1.0.1.5.45.0.68.3SECTION 105.3
     105.3 Notices re: worthless, contaminated, dangerous, or harmful biological products.
9:1.0.1.5.45.0.68.4SECTION 105.4
     105.4 Termination of licenses and permits for inactivity.
9:1.0.1.5.46PART 106
PART 106 - EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT PROGRAMS OR UNDER DEPARTMENT CONTROL OR SUPERVISION
9:1.0.1.5.46.0.68.1SECTION 106.1
     106.1 Biological products; exemption.
9:1.0.1.5.47PART 107
PART 107 - EXEMPTIONS FROM PREPARATION PURSUANT TO AN UNSUSPENDED AND UNREVOKED LICENSE
9:1.0.1.5.47.0.68.1SECTION 107.1
     107.1 Veterinary practitioners and animal owners.
9:1.0.1.5.47.0.68.2SECTION 107.2
     107.2 Products under State license.
9:1.0.1.5.48PART 108
PART 108 - FACILITY REQUIREMENTS FOR LICENSED ESTABLISHMENTS
9:1.0.1.5.48.0.68.1SECTION 108.1
     108.1 Applicability.
9:1.0.1.5.48.0.68.2SECTION 108.2
     108.2 Plot plans, blueprints, and legends required.
9:1.0.1.5.48.0.68.3SECTION 108.3
     108.3 Preparation of plot plans.
9:1.0.1.5.48.0.68.4SECTION 108.4
     108.4 Preparation of blueprints.
9:1.0.1.5.48.0.68.5SECTION 108.5
     108.5 Preparation of legends.
9:1.0.1.5.48.0.68.6SECTION 108.6
     108.6 Revision of plot plans, blueprints, and legends.
9:1.0.1.5.48.0.68.7SECTION 108.7
     108.7 Filing of plot plans, blueprints, and legends.
9:1.0.1.5.48.0.68.8SECTION 108.8
     108.8 Construction of buildings.
9:1.0.1.5.48.0.68.9SECTION 108.9
     108.9 Dressing rooms and other facilities.
9:1.0.1.5.48.0.68.10SECTION 108.10
     108.10 Outer premises and stables.
9:1.0.1.5.48.0.68.11SECTION 108.11
     108.11 Water quality requirements.
9:1.0.1.5.49PART 109
PART 109 - STERILIZATION AND PASTEURIZATION AT LICENSED ESTABLISHMENTS
9:1.0.1.5.49.0.68.1SECTION 109.1
     109.1 Equipment and the like.
9:1.0.1.5.49.0.68.2SECTION 109.2
     109.2 Sterilizers.
9:1.0.1.5.49.0.68.3SECTION 109.3
     109.3 Pasteurizers.
9:1.0.1.5.50PART 112
PART 112 - PACKAGING AND LABELING
9:1.0.1.5.50.0.68.1SECTION 112.1
     112.1 General.
9:1.0.1.5.50.0.68.2SECTION 112.2
     112.2 Final container label, carton label, and enclosure.
9:1.0.1.5.50.0.68.3SECTION 112.3
     112.3 Diluent labels.
9:1.0.1.5.50.0.68.4SECTION 112.4
     112.4 Subsidiaries, divisions, distributors, and permittees.
9:1.0.1.5.50.0.68.5SECTION 112.5
     112.5 Review and approval of labeling.
9:1.0.1.5.50.0.68.6SECTION 112.6
     112.6 Packaging biological products.
9:1.0.1.5.50.0.68.7SECTION 112.7
     112.7 Special additional requirements.
9:1.0.1.5.50.0.68.8SECTION 112.8
     112.8 For export only.
9:1.0.1.5.50.0.68.9SECTION 112.9
     112.9 Biological products imported for research and evaluation.
9:1.0.1.5.50.0.68.10SECTION 112.10
     112.10 Special packaging and labeling.
9:1.0.1.5.51PART 113
PART 113 - STANDARD REQUIREMENTS
9:1.0.1.5.51.0.68SUBJGRP 68
  Applicability
9:1.0.1.5.51.0.68.1SECTION 113.1
     113.1 Compliance.
9:1.0.1.5.51.0.68.2SECTION 113.2
     113.2 Testing aids.
9:1.0.1.5.51.0.68.3SECTION 113.3
     113.3 Sampling of biological products.
9:1.0.1.5.51.0.68.4SECTION 113.4
     113.4 Exemptions to tests.
9:1.0.1.5.51.0.68.5SECTION 113.5
     113.5 General testing.
9:1.0.1.5.51.0.68.6SECTION 113.6
     113.6 Animal and Plant Health Inspection Service testing.
9:1.0.1.5.51.0.68.7SECTION 113.7
     113.7 Multiple fractions.
9:1.0.1.5.51.0.68.8SECTION 113.8
     113.8 In vitro tests for serial release.
9:1.0.1.5.51.0.68.9SECTION 113.9
     113.9 New potency test.
9:1.0.1.5.51.0.68.10SECTION 113.10
     113.10 Testing of bulk material for export or for further manufacture.
9:1.0.1.5.51.0.69SUBJGRP 69
  Standard Procedures
9:1.0.1.5.51.0.69.11SECTION 113.25
     113.25 Culture media for detection of bacteria and fungi.
9:1.0.1.5.51.0.69.12SECTION 113.26
     113.26 Detection of viable bacteria and fungi except in live vaccine.
9:1.0.1.5.51.0.69.13SECTION 113.27
     113.27 Detection of extraneous viable bacteria and fungi in live vaccines.
9:1.0.1.5.51.0.69.14SECTION 113.28
     113.28 Detection of mycoplasma contamination.
9:1.0.1.5.51.0.69.15SECTION 113.29
     113.29 Determination of moisture content in desiccated biological products.
9:1.0.1.5.51.0.69.16SECTION 113.30
     113.30 Detection of Salmonella contamination.
9:1.0.1.5.51.0.69.17SECTION 113.31
     113.31 Detection of avian lymphoid leukosis.
9:1.0.1.5.51.0.69.18SECTION 113.32
     113.32 Detection of Brucella contamination.
9:1.0.1.5.51.0.69.19SECTION 113.33
     113.33 Mouse safety tests.
9:1.0.1.5.51.0.69.20SECTION 113.34
     113.34 Detection of hemagglutinating viruses.
9:1.0.1.5.51.0.69.21SECTION 113.35
     113.35 Detection of viricidal activity.
9:1.0.1.5.51.0.69.22SECTION 113.36
     113.36 Detection of pathogens by the chicken inoculation test.
9:1.0.1.5.51.0.69.23SECTION 113.37
     113.37 Detection of pathogens by the chicken embryo inoculation test.
9:1.0.1.5.51.0.69.24SECTION 113.38
     113.38 Guinea pig safety test.
9:1.0.1.5.51.0.69.25SECTION 113.39
     113.39 Cat safety tests.
9:1.0.1.5.51.0.69.26SECTION 113.40
     113.40 Dog safety tests.
9:1.0.1.5.51.0.69.27SECTION 113.41
     113.41 Calf safety test.
9:1.0.1.5.51.0.69.28SECTION 113.42
     113.42 Detection of lymphocytic choriomeningitis contamination.
9:1.0.1.5.51.0.69.29SECTION 113.43
     113.43 Detection of chlamydial agents.
9:1.0.1.5.51.0.69.30SECTION 113.44
     113.44 Swine safety test.
9:1.0.1.5.51.0.69.31SECTION 113.45
     113.45 Sheep safety test.
9:1.0.1.5.51.0.69.32SECTION 113.46
     113.46 Detection of cytopathogenic and/or hemadsorbing agents.
9:1.0.1.5.51.0.69.33SECTION 113.47
     113.47 Detection of extraneous viruses by the fluorescent antibody technique.
9:1.0.1.5.51.0.70SUBJGRP 70
  Ingredient Requirements
9:1.0.1.5.51.0.70.34SECTION 113.50
     113.50 Ingredients of biological products.
9:1.0.1.5.51.0.70.35SECTION 113.51
     113.51 Requirements for primary cells used for production of biologics.
9:1.0.1.5.51.0.70.36SECTION 113.52
     113.52 Requirements for cell lines used for production of biologics.
9:1.0.1.5.51.0.70.37SECTION 113.53
     113.53 Requirements for ingredients of animal origin used for production of biologics.
9:1.0.1.5.51.0.70.38SECTION 113.54
     113.54 Sterile diluent.
9:1.0.1.5.51.0.70.39SECTION 113.55
     113.55 Detection of extraneous agents in Master Seed Virus.
9:1.0.1.5.51.0.71SUBJGRP 71
  Live Bacterial Vaccines
9:1.0.1.5.51.0.71.40SECTION 113.64
     113.64 General requirements for live bacterial vaccines.
9:1.0.1.5.51.0.71.41SECTION 113.65
     113.65 Brucella Abortus Vaccine.
9:1.0.1.5.51.0.71.42SECTION 113.66
     113.66 Anthrax Spore Vaccine - Nonencapsulated.
9:1.0.1.5.51.0.71.43SECTION 113.67
     113.67 Erysipelothrix Rhusiopathiae Vaccine.
9:1.0.1.5.51.0.71.44SECTION 113.68
     113.68 Pasteurella Haemolytica Vaccine, Bovine.
9:1.0.1.5.51.0.71.45SECTION 113.69
     113.69 Pasteurella Multocida Vaccine, Bovine.
9:1.0.1.5.51.0.71.46SECTION 113.70
     113.70 Pasteurella Multocida Vaccine, Avian Isolate.
9:1.0.1.5.51.0.71.47SECTION 113.71
     113.71 Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia.
9:1.0.1.5.51.0.72SUBJGRP 72
  Inactivated Bacterial Products
9:1.0.1.5.51.0.72.48SECTION 113.100
     113.100 General requirements for inactivated bacterial products.
9:1.0.1.5.51.0.72.49SECTION 113.101
     113.101 Leptospira Pomona Bacterin.
9:1.0.1.5.51.0.72.50SECTION 113.102
     113.102 Leptospira Icterohaemorrhagiae Bacterin.
9:1.0.1.5.51.0.72.51SECTION 113.103
     113.103 Leptospira Canicola Bacterin.
9:1.0.1.5.51.0.72.52SECTION 113.104
     113.104 Leptospira Grippotyphosa Bacterin.
9:1.0.1.5.51.0.72.53SECTION 113.105
     113.105 Leptospira Hardjo Bacterin.
9:1.0.1.5.51.0.72.54SECTION 113.106
     113.106 Clostridium Chauvoei Bacterin.
9:1.0.1.5.51.0.72.55SECTION 113.107
     113.107 Clostridium Haemolyticum Bacterin.
9:1.0.1.5.51.0.72.56SECTION 113.108
     113.108 Clostridium Novyi Bacterin-Toxoid.
9:1.0.1.5.51.0.72.57SECTION 113.109
     113.109 Clostridium Sordellii Bacterin-Toxoid.
9:1.0.1.5.51.0.72.58SECTION 113.110
     113.110 Clostridium Botulinum Type C Bacterin-Toxoid.
9:1.0.1.5.51.0.72.59SECTION 113.111
     113.111 Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.
9:1.0.1.5.51.0.72.60SECTION 113.112
     113.112 Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid.
9:1.0.1.5.51.0.72.61SECTION 113.113
     113.113 Autogenous biologics.
9:1.0.1.5.51.0.72.62SECTION 113.114
     113.114 Tetanus Toxoid.
9:1.0.1.5.51.0.72.63SECTION 113.115
     113.115 Staphylococcus Aureus Bacterin-Toxoid.
9:1.0.1.5.51.0.72.64SECTION 113.116
     113.116 Pasteurella Multocida Bacterin, Avian Isolate, Type 4.
9:1.0.1.5.51.0.72.65SECTION 113.117
     113.117 Pasteurella Multocida Bacterin, Avian Isolate, Type 1.
9:1.0.1.5.51.0.72.66SECTION 113.118
     113.118 Pasteurella Multocida Bacterin, Avian Isolate, Type 3.
9:1.0.1.5.51.0.72.67SECTION 113.119
     113.119 Erysipelothrix Rhusiopathiae Bacterin.
9:1.0.1.5.51.0.72.68SECTION 113.120
     113.120 Salmonella Typhimurium Bacterin.
9:1.0.1.5.51.0.72.69SECTION 113.121
     113.121 Pasteurella Multocida Bacterin.
9:1.0.1.5.51.0.72.70SECTION 113.122
     113.122 Salmonella Choleraesuis Bacterin.
9:1.0.1.5.51.0.72.71SECTION 113.123
     113.123 Salmonella Dublin Bacterin.
9:1.0.1.5.51.0.73SUBJGRP 73
  Killed Virus Vaccines
9:1.0.1.5.51.0.73.72SECTION 113.200
     113.200 General requirements for killed virus vaccines.
9:1.0.1.5.51.0.73.73SECTION 113.201-113.203
     113.201-113.203 [Reserved]
9:1.0.1.5.51.0.73.74SECTION 113.204
     113.204 Mink Enteritis Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.75SECTION 113.205
     113.205 Newcastle Disease Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.76SECTION 113.206
     113.206 Wart Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.77SECTION 113.207
     113.207 Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.
9:1.0.1.5.51.0.73.78SECTION 113.208
     113.208 Avian Encephalomyelitis Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.79SECTION 113.209
     113.209 Rabies Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.80SECTION 113.210
     113.210 Feline Calicivirus Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.81SECTION 113.211
     113.211 [Reserved]
9:1.0.1.5.51.0.73.82SECTION 113.212
     113.212 Bursal Disease Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.83SECTION 113.213-113.214
     113.213-113.214 [Reserved]
9:1.0.1.5.51.0.73.84SECTION 113.215
     113.215 Bovine Virus Diarrhea Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.85SECTION 113.216
     113.216 Bovine Rhinotracheitis Vaccine, Killed Virus.
9:1.0.1.5.51.0.74SUBJGRP 74
  Live Virus Vaccines
9:1.0.1.5.51.0.74.86SECTION 113.300
     113.300 General requirements for live virus vaccines.
9:1.0.1.5.51.0.74.87SECTION 113.301
     113.301 Ovine Ecthyma Vaccine.
9:1.0.1.5.51.0.74.88SECTION 113.302
     113.302 Distemper Vaccine - Mink.
9:1.0.1.5.51.0.74.89SECTION 113.303
     113.303 Bluetongue Vaccine.
9:1.0.1.5.51.0.74.90SECTION 113.304
     113.304 Feline Panleukopenia Vaccine.
9:1.0.1.5.51.0.74.91SECTION 113.305
     113.305 Canine Hepatitis and Canine Adenovirus Type 2 Vaccine.
9:1.0.1.5.51.0.74.92SECTION 113.306
     113.306 Canine Distemper Vaccine.
9:1.0.1.5.51.0.74.93SECTION 113.308
     113.308 Encephalomyelitis Vaccine, Venezuelan.
9:1.0.1.5.51.0.74.94SECTION 113.309
     113.309 Bovine Parainfluenza3 Vaccine.
9:1.0.1.5.51.0.74.95SECTION 113.310
     113.310 Bovine Rhinotracheitis Vaccine.
9:1.0.1.5.51.0.74.96SECTION 113.311
     113.311 Bovine Virus Diarrhea Vaccine.
9:1.0.1.5.51.0.74.97SECTION 113.312
     113.312 Rabies Vaccine, Live Virus.
9:1.0.1.5.51.0.74.98SECTION 113.313
     113.313 Measles Vaccine.
9:1.0.1.5.51.0.74.99SECTION 113.314
     113.314 Feline Calicivirus Vaccine.
9:1.0.1.5.51.0.74.100SECTION 113.315
     113.315 Feline Rhinotracheitis Vaccine.
9:1.0.1.5.51.0.74.101SECTION 113.316
     113.316 Canine Parainfluenza Vaccine.
9:1.0.1.5.51.0.74.102SECTION 113.317
     113.317 Parvovirus Vaccine (Canine).
9:1.0.1.5.51.0.74.103SECTION 113.318
     113.318 Pseudorabies Vaccine.
9:1.0.1.5.51.0.74.104SECTION 113.319-113.324
     113.319-113.324 [Reserved]
9:1.0.1.5.51.0.74.105SECTION 113.325
     113.325 Avian Encephalomyelitis Vaccine.
9:1.0.1.5.51.0.74.106SECTION 113.326
     113.326 Avian Pox Vaccine.
9:1.0.1.5.51.0.74.107SECTION 113.327
     113.327 Bronchitis Vaccine.
9:1.0.1.5.51.0.74.108SECTION 113.328
     113.328 Fowl Laryngotracheitis Vaccine.
9:1.0.1.5.51.0.74.109SECTION 113.329
     113.329 Newcastle Disease Vaccine.
9:1.0.1.5.51.0.74.110SECTION 113.330
     113.330 Marek's Disease Vaccines.
9:1.0.1.5.51.0.74.111SECTION 113.331
     113.331 Bursal Disease Vaccine.
9:1.0.1.5.51.0.74.112SECTION 113.332
     113.332 Tenosynovitis Vaccine.
9:1.0.1.5.51.0.75SUBJGRP 75
  Diagnostics and Reagents
9:1.0.1.5.51.0.75.113SECTION 113.400-113.405
     113.400-113.405 [Reserved]
9:1.0.1.5.51.0.75.114SECTION 113.406
     113.406 Tuberculin, Intradermic.
9:1.0.1.5.51.0.75.115SECTION 113.407
     113.407 Pullorum antigen.
9:1.0.1.5.51.0.75.116SECTION 113.408
     113.408 Avian mycoplasma antigen.
9:1.0.1.5.51.0.75.117SECTION 113.409
     113.409 Tuberculin - PPD Bovis, Intradermic.
9:1.0.1.5.51.0.76SUBJGRP 76
  Antibody Products
9:1.0.1.5.51.0.76.118SECTION 113.450
     113.450 General requirements for antibody products.
9:1.0.1.5.51.0.76.119SECTION 113.451
     113.451 Tetanus Antitoxin.
9:1.0.1.5.51.0.76.120SECTION 113.452
     113.452 Erysipelothrix Rhusiopathiae Antibody.
9:1.0.1.5.51.0.76.121SECTION 113.453
     113.453 [Reserved]
9:1.0.1.5.51.0.76.122SECTION 113.454
     113.454 Clostridium Perfringens Type C Antitoxin.
9:1.0.1.5.51.0.76.123SECTION 113.455
     113.455 Clostridium Perfringens Type D Antitoxin.
9:1.0.1.5.51.0.76.124SECTION 113.456-113.498
     113.456-113.498 [Reserved]
9:1.0.1.5.51.0.76.125SECTION 113.499
     113.499 Products for treatment of failure of passive transfer.
9:1.0.1.5.52PART 114
PART 114 - PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS
9:1.0.1.5.52.0.77.1SECTION 114.1
     114.1 Applicability.
9:1.0.1.5.52.0.77.2SECTION 114.2
     114.2 Products not prepared under license.
9:1.0.1.5.52.0.77.3SECTION 114.3
     114.3 Separation of establishments.
9:1.0.1.5.52.0.77.4SECTION 114.4
     114.4 Identification of biological products.
9:1.0.1.5.52.0.77.5SECTION 114.5
     114.5 Micro-organisms used as seed.
9:1.0.1.5.52.0.77.6SECTION 114.6
     114.6 Mixing biological products.
9:1.0.1.5.52.0.77.7SECTION 114.7
     114.7 Personnel at licensed establishments.
9:1.0.1.5.52.0.77.8SECTION 114.8
     114.8 Outline of Production required.
9:1.0.1.5.52.0.77.9SECTION 114.9
     114.9 Outline of Production guidelines.
9:1.0.1.5.52.0.77.10SECTION 114.10
     114.10 Antibiotics as preservatives.
9:1.0.1.5.52.0.77.11SECTION 114.11
     114.11 Storage and handling.
9:1.0.1.5.52.0.77.12SECTION 114.12
     114.12 Expiration date required for a serial.
9:1.0.1.5.52.0.77.13SECTION 114.13
     114.13 Determination of the dating period of a product.
9:1.0.1.5.52.0.77.14SECTION 114.14
     114.14 Extension of expiration date for a serial or subserial.
9:1.0.1.5.52.0.77.15SECTION 114.15
     114.15 Disposal of unsatisfactory products and byproducts.
9:1.0.1.5.52.0.77.16SECTION 114.16
     114.16 Producing subsidiaries.
9:1.0.1.5.52.0.77.17SECTION 114.17
     114.17 Rebottling of biological products.
9:1.0.1.5.52.0.77.18SECTION 114.18
     114.18 Reprocessing of biological products.
9:1.0.1.5.53PART 115
PART 115 - INSPECTIONS
9:1.0.1.5.53.0.77.1SECTION 115.1
     115.1 Inspections of establishments.
9:1.0.1.5.53.0.77.2SECTION 115.2
     115.2 Inspections of biological products.
9:1.0.1.5.54PART 116
PART 116 - RECORDS AND REPORTS
9:1.0.1.5.54.0.77.1SECTION 116.1
     116.1 Applicability and general considerations.
9:1.0.1.5.54.0.77.2SECTION 116.2
     116.2 Inventory and disposition records.
9:1.0.1.5.54.0.77.3SECTION 116.3
     116.3 Label records.
9:1.0.1.5.54.0.77.4SECTION 116.4
     116.4 Sterilization and pasteurization records.
9:1.0.1.5.54.0.77.5SECTION 116.5
     116.5 Reports.
9:1.0.1.5.54.0.77.6SECTION 116.6
     116.6 Animal records.
9:1.0.1.5.54.0.77.7SECTION 116.7
     116.7 Test records.
9:1.0.1.5.54.0.77.8SECTION 116.8
     116.8 Completion and retention of records.
9:1.0.1.5.54.0.77.9SECTION 116.9
     116.9 Recording and reporting adverse events.
9:1.0.1.5.55PART 117
PART 117 - ANIMALS AT LICENSED ESTABLISHMENTS
9:1.0.1.5.55.0.77.1SECTION 117.1
     117.1 Applicability.
9:1.0.1.5.55.0.77.2SECTION 117.2
     117.2 Animal facilities.
9:1.0.1.5.55.0.77.3SECTION 117.3
     117.3 Admittance of animals.
9:1.0.1.5.55.0.77.4SECTION 117.4
     117.4 Test animals.
9:1.0.1.5.55.0.77.5SECTION 117.5
     117.5 Segregation of animals.
9:1.0.1.5.55.0.77.6SECTION 117.6
     117.6 Removal of animals.
9:1.0.1.5.56PART 118
PART 118 - DETENTION; SEIZURE AND CONDEMNATION
9:1.0.1.5.56.0.77.1SECTION 118.1
     118.1 Administrative detention.
9:1.0.1.5.56.0.77.2SECTION 118.2
     118.2 Method of detention; Notifications.
9:1.0.1.5.56.0.77.3SECTION 118.3
     118.3 Movement of detained biological products; Termination of detention.
9:1.0.1.5.56.0.77.4SECTION 118.4
     118.4 Seizure and condemnation.
9:1.0.1.5.57PART 121
PART 121 - POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
9:1.0.1.5.57.0.77.1SECTION 121.1
     121.1 Definitions.
9:1.0.1.5.57.0.77.2SECTION 121.2
     121.2 Purpose and scope.
9:1.0.1.5.57.0.77.3SECTION 121.3
     121.3 VS select agents and toxins.
9:1.0.1.5.57.0.77.4SECTION 121.4
     121.4 Overlap select agents and toxins.
9:1.0.1.5.57.0.77.5SECTION 121.5
     121.5 Exemptions for VS select agents and toxins.
9:1.0.1.5.57.0.77.6SECTION 121.6
     121.6 Exemptions for overlap select agents and toxins.
9:1.0.1.5.57.0.77.7SECTION 121.7
     121.7 Registration and related security risk assessments.
9:1.0.1.5.57.0.77.8SECTION 121.8
     121.8 Denial, revocation, or suspension of registration.
9:1.0.1.5.57.0.77.9SECTION 121.9
     121.9 Responsible official.
9:1.0.1.5.57.0.77.10SECTION 121.10
     121.10 Restricting access to select agents and toxins; security risk assessments.
9:1.0.1.5.57.0.77.11SECTION 121.11
     121.11 Security.
9:1.0.1.5.57.0.77.12SECTION 121.12
     121.12 Biosafety.
9:1.0.1.5.57.0.77.13SECTION 121.13
     121.13 Restricted experiments.
9:1.0.1.5.57.0.77.14SECTION 121.14
     121.14 Incident response. 12
9:1.0.1.5.57.0.77.15SECTION 121.15
     121.15 Training.
9:1.0.1.5.57.0.77.16SECTION 121.16
     121.16 Transfers.
9:1.0.1.5.57.0.77.17SECTION 121.17
     121.17 Records.
9:1.0.1.5.57.0.77.18SECTION 121.18
     121.18 Inspections.
9:1.0.1.5.57.0.77.19SECTION 121.19
     121.19 Notification of theft, loss, or release.
9:1.0.1.5.57.0.77.20SECTION 121.20
     121.20 Administrative review.
9:1.0.1.5.58PART 122
PART 122 - ORGANISMS AND VECTORS
9:1.0.1.5.58.0.77.1SECTION 122.1
     122.1 Definitions.
9:1.0.1.5.58.0.77.2SECTION 122.2
     122.2 Permits required.
9:1.0.1.5.58.0.77.3SECTION 122.3
     122.3 Application for permits.
9:1.0.1.5.58.0.77.4SECTION 122.4
     122.4 Suspension or revocation of permits.
9:1.0.1.5.59PART 123
PART 123 - RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE VIRUS-SERUM-TOXIN ACT
9:1.0.1.5.59.0.77.1SECTION 123.1
     123.1 Scope and applicability of rules of practice.
9:1.0.1.5.60PART 124
PART 124 - PATENT TERM RESTORATION
9:1.0.1.5.60.1SUBPART A
Subpart A - General Provisions
9:1.0.1.5.60.1.77.1SECTION 124.1
     124.1 Scope.
9:1.0.1.5.60.1.77.2SECTION 124.2
     124.2 Definitions.
9:1.0.1.5.60.2SUBPART B
Subpart B - Eligibility Assistance
9:1.0.1.5.60.2.77.1SECTION 124.10
     124.10 APHIS liaison with PTO.
9:1.0.1.5.60.3SUBPART C
Subpart C - Regulatory Review Period
9:1.0.1.5.60.3.77.1SECTION 124.20
     124.20 Patent term extension calculation.
9:1.0.1.5.60.3.77.2SECTION 124.21
     124.21 Regulatory review period determination.
9:1.0.1.5.60.3.77.3SECTION 124.22
     124.22 Revision of regulatory review period determination.
9:1.0.1.5.60.3.77.4SECTION 124.23
     124.23 Final action on regulatory review period determination.
9:1.0.1.5.60.4SUBPART D
Subpart D - Due Diligence Petitions
9:1.0.1.5.60.4.77.1SECTION 124.30
     124.30 Filing, format, and content of petitions.
9:1.0.1.5.60.4.77.2SECTION 124.31
     124.31 Applicant response to petition.
9:1.0.1.5.60.4.77.3SECTION 124.32
     124.32 APHIS action on petition.
9:1.0.1.5.60.4.77.4SECTION 124.33
     124.33 Standard of due diligence.
9:1.0.1.5.60.5SUBPART E
Subpart E - Due Diligence Hearing
9:1.0.1.5.60.5.77.1SECTION 124.40
     124.40 Request for hearing.
9:1.0.1.5.60.5.77.2SECTION 124.41
     124.41 Notice of hearing.
9:1.0.1.5.60.5.77.3SECTION 124.42
     124.42 Hearing procedure.
9:1.0.1.5.60.5.77.4SECTION 124.43
     124.43 Administrative decision.