| 21:1.0.1.1.1 | PART 1
| PART 1 - GENERAL ENFORCEMENT REGULATIONS | |
| 21:1.0.1.1.1.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.1.1.32.1 | SECTION 1.1
| 1.1 General. | |
| 21:1.0.1.1.1.1.32.2 | SECTION 1.3
| 1.3 Definitions. | |
| 21:1.0.1.1.1.1.32.3 | SECTION 1.4
| 1.4 Authority citations. | |
| 21:1.0.1.1.1.2 | SUBPART B
| Subpart B - General Labeling Requirements | |
| 21:1.0.1.1.1.2.32.1 | SECTION 1.20
| 1.20 Presence of mandatory label information. | |
| 21:1.0.1.1.1.2.32.2 | SECTION 1.21
| 1.21 Failure to reveal material facts. | |
| 21:1.0.1.1.1.2.32.3 | SECTION 1.23
| 1.23 Procedures for requesting variations and exemptions from required label statements. | |
| 21:1.0.1.1.1.2.32.4 | SECTION 1.24
| 1.24 Exemptions from required label statements. | |
| 21:1.0.1.1.1.3 | SUBPART C
| Subpart C [Reserved] | |
| 21:1.0.1.1.1.4 | SUBPART D
| Subpart D - Electronic Import Entries | |
| 21:1.0.1.1.1.4.32.1 | SECTION 1.70
| 1.70 Scope. | |
| 21:1.0.1.1.1.4.32.2 | SECTION 1.71
| 1.71 Definitions. | |
| 21:1.0.1.1.1.4.32.3 | SECTION 1.72
| 1.72 Data elements that must be submitted in ACE for articles regulated by FDA. | |
| 21:1.0.1.1.1.4.32.4 | SECTION 1.73
| 1.73 Food. | |
| 21:1.0.1.1.1.4.32.5 | SECTION 1.74
| 1.74 Human drugs. | |
| 21:1.0.1.1.1.4.32.6 | SECTION 1.75
| 1.75 Animal drugs. | |
| 21:1.0.1.1.1.4.32.7 | SECTION 1.76
| 1.76 Medical devices. | |
| 21:1.0.1.1.1.4.32.8 | SECTION 1.77
| 1.77 Radiation-emitting electronic products. | |
| 21:1.0.1.1.1.4.32.9 | SECTION 1.78
| 1.78 Biological products, HCT/Ps, and related drugs and medical devices. | |
| 21:1.0.1.1.1.4.32.10 | SECTION 1.79
| 1.79 Tobacco products. | |
| 21:1.0.1.1.1.4.32.11 | SECTION 1.80
| 1.80 Cosmetics. | |
| 21:1.0.1.1.1.4.32.12 | SECTION 1.81
| 1.81 Rejection of entry filing. | |
| 21:1.0.1.1.1.5 | SUBPART E
| Subpart E - Imports and Exports | |
| 21:1.0.1.1.1.5.32.1 | SECTION 1.83
| 1.83 Definitions. | |
| 21:1.0.1.1.1.5.32.2 | SECTION 1.90
| 1.90 Notice of sampling. | |
| 21:1.0.1.1.1.5.32.3 | SECTION 1.91
| 1.91 Payment for samples. | |
| 21:1.0.1.1.1.5.32.4 | SECTION 1.94
| 1.94 Hearing on refusal of admission or destruction. | |
| 21:1.0.1.1.1.5.32.5 | SECTION 1.95
| 1.95 Application for authorization to relabel and recondition. | |
| 21:1.0.1.1.1.5.32.6 | SECTION 1.96
| 1.96 Granting of authorization to relabel and recondition. | |
| 21:1.0.1.1.1.5.32.7 | SECTION 1.97
| 1.97 Bonds. | |
| 21:1.0.1.1.1.5.32.8 | SECTION 1.99
| 1.99 Costs chargeable in connection with relabeling and reconditioning inadmissible imports. | |
| 21:1.0.1.1.1.5.32.9 | SECTION 1.101
| 1.101 Notification and recordkeeping. | |
| 21:1.0.1.1.1.6 | SUBPART F
| Subparts F-G [Reserved] | |
| 21:1.0.1.1.1.7 | SUBPART H
| Subpart H - Registration of Food Facilities | |
| 21:1.0.1.1.1.7.32 | SUBJGRP 32
| General Provisions | |
| 21:1.0.1.1.1.7.32.1 | SECTION 1.225
| 1.225 Who must register under this subpart | |
| 21:1.0.1.1.1.7.32.2 | SECTION 1.226
| 1.226 Who does not have to register under this subpart | |
| 21:1.0.1.1.1.7.32.3 | SECTION 1.227
| 1.227 What definitions apply to this subpart | |
| 21:1.0.1.1.1.7.33 | SUBJGRP 33
| Procedures for Registration of Food Facilities | |
| 21:1.0.1.1.1.7.33.4 | SECTION 1.230
| 1.230 When must you register or renew your registration | |
| 21:1.0.1.1.1.7.33.5 | SECTION 1.231
| 1.231 How and where do you register or renew your registration | |
| 21:1.0.1.1.1.7.33.6 | SECTION 1.232
| 1.232 What information is required in the registration | |
| 21:1.0.1.1.1.7.33.7 | SECTION 1.233
| 1.233 Are there optional items included in the registration form | |
| 21:1.0.1.1.1.7.33.8 | SECTION 1.234
| 1.234 How and when do you update your facility's registration information | |
| 21:1.0.1.1.1.7.33.9 | SECTION 1.235
| 1.235 How and when do you cancel your facility's registration information | |
| 21:1.0.1.1.1.7.34 | SUBJGRP 34
| Additional Provisions | |
| 21:1.0.1.1.1.7.34.10 | SECTION 1.240
| 1.240 What other registration requirements apply | |
| 21:1.0.1.1.1.7.34.11 | SECTION 1.241
| 1.241 What are the consequences of failing to register, update, renew, or cancel your registration | |
| 21:1.0.1.1.1.7.34.12 | SECTION 1.242
| 1.242 What does assignment of a registration number mean | |
| 21:1.0.1.1.1.7.34.13 | SECTION 1.243
| 1.243 Is food registration information available to the public | |
| 21:1.0.1.1.1.7.34.14 | SECTION 1.245
| 1.245 Waiver request. | |
| 21:1.0.1.1.1.8 | SUBPART I
| Subpart I - Prior Notice of Imported Food | |
| 21:1.0.1.1.1.8.35 | SUBJGRP 35
| General Provisions | |
| 21:1.0.1.1.1.8.35.1 | SECTION 1.276
| 1.276 What definitions apply to this subpart | |
| 21:1.0.1.1.1.8.35.2 | SECTION 1.277
| 1.277 What is the scope of this subpart | |
| 21:1.0.1.1.1.8.36 | SUBJGRP 36
| Requirements To Submit Prior Notice of Imported Food | |
| 21:1.0.1.1.1.8.36.3 | SECTION 1.278
| 1.278 Who is authorized to submit prior notice | |
| 21:1.0.1.1.1.8.36.4 | SECTION 1.279
| 1.279 When must prior notice be submitted to FDA | |
| 21:1.0.1.1.1.8.36.5 | SECTION 1.280
| 1.280 How must you submit prior notice | |
| 21:1.0.1.1.1.8.36.6 | SECTION 1.281
| 1.281 What information must be in a prior notice | |
| 21:1.0.1.1.1.8.36.7 | SECTION 1.282
| 1.282 What must you do if information changes after you have received confirmation of a prior notice from FDA | |
| 21:1.0.1.1.1.8.37 | SUBJGRP 37
| Consequences | |
| 21:1.0.1.1.1.8.37.8 | SECTION 1.283
| 1.283 What happens to food that is imported or offered for import without adequate prior notice | |
| 21:1.0.1.1.1.8.37.9 | SECTION 1.284
| 1.284 What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart | |
| 21:1.0.1.1.1.8.37.10 | SECTION 1.285
| 1.285 What happens to food that is imported or offered for import from unregistered facilities that are required to register under subpart H of this part | |
| 21:1.0.1.1.1.9 | SUBPART J
| Subpart J - Establishment, Maintenance, and Availability of Records | |
| 21:1.0.1.1.1.9.38 | SUBJGRP 38
| General Provisions | |
| 21:1.0.1.1.1.9.38.1 | SECTION 1.326
| 1.326 Who is subject to this subpart | |
| 21:1.0.1.1.1.9.38.2 | SECTION 1.327
| 1.327 Who is excluded from all or part of the regulations in this subpart | |
| 21:1.0.1.1.1.9.38.3 | SECTION 1.328
| 1.328 What definitions apply to this subpart | |
| 21:1.0.1.1.1.9.38.4 | SECTION 1.329
| 1.329 Do other statutory provisions and regulations apply | |
| 21:1.0.1.1.1.9.38.5 | SECTION 1.330
| 1.330 Can existing records satisfy the requirements of this subpart | |
| 21:1.0.1.1.1.9.39 | SUBJGRP 39
| Requirements for Nontransporters To Establish and Maintain Records To Identify the Nontransporter and Transporter Immediate Previous Sources of Food | |
| 21:1.0.1.1.1.9.39.6 | SECTION 1.337
| 1.337 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food | |
| 21:1.0.1.1.1.9.40 | SUBJGRP 40
| Requirements for Nontransporters To Establish and Maintain Records To Identify the Nontransporter and Transporter Immediate Subsequent Recipients of Food | |
| 21:1.0.1.1.1.9.40.7 | SECTION 1.345
| 1.345 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food | |
| 21:1.0.1.1.1.9.41 | SUBJGRP 41
| Requirements for Transporters To Establish and Maintain Records | |
| 21:1.0.1.1.1.9.41.8 | SECTION 1.352
| 1.352 What information must transporters establish and maintain | |
| 21:1.0.1.1.1.9.42 | SUBJGRP 42
| General Requirements | |
| 21:1.0.1.1.1.9.42.9 | SECTION 1.360
| 1.360 What are the record retention requirements | |
| 21:1.0.1.1.1.9.42.10 | SECTION 1.361
| 1.361 What are the record availability requirements | |
| 21:1.0.1.1.1.9.42.11 | SECTION 1.362
| 1.362 What records are excluded from this subpart | |
| 21:1.0.1.1.1.9.42.12 | SECTION 1.363
| 1.363 What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart | |
| 21:1.0.1.1.1.9.43 | SUBJGRP 43
| Compliance Dates | |
| 21:1.0.1.1.1.9.43.13 | SECTION 1.368
| 1.368 What are the compliance dates for this subpart | |
| 21:1.0.1.1.1.10 | SUBPART K
| Subpart K - Administrative Detention of Food for Human or Animal Consumption | |
| 21:1.0.1.1.1.10.44 | SUBJGRP 44
| General Provisions | |
| 21:1.0.1.1.1.10.44.1 | SECTION 1.377
| 1.377 What definitions apply to this subpart | |
| 21:1.0.1.1.1.10.44.2 | SECTION 1.378
| 1.378 What criteria does FDA use to order a detention | |
| 21:1.0.1.1.1.10.44.3 | SECTION 1.379
| 1.379 How long may FDA detain an article of food | |
| 21:1.0.1.1.1.10.44.4 | SECTION 1.380
| 1.380 Where and under what conditions must the detained article of food be held | |
| 21:1.0.1.1.1.10.44.5 | SECTION 1.381
| 1.381 May a detained article of food be delivered to another entity or transferred to another location | |
| 21:1.0.1.1.1.10.44.6 | SECTION 1.382
| 1.382 What labeling or marking requirements apply to a detained article of food | |
| 21:1.0.1.1.1.10.44.7 | SECTION 1.383
| 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food | |
| 21:1.0.1.1.1.10.44.8 | SECTION 1.384
| 1.384 When does a detention order terminate | |
| 21:1.0.1.1.1.10.45 | SUBJGRP 45
| How Does FDA Order a Detention | |
| 21:1.0.1.1.1.10.45.9 | SECTION 1.391
| 1.391 Who approves a detention order | |
| 21:1.0.1.1.1.10.45.10 | SECTION 1.392
| 1.392 Who receives a copy of the detention order | |
| 21:1.0.1.1.1.10.45.11 | SECTION 1.393
| 1.393 What information must FDA include in the detention order | |
| 21:1.0.1.1.1.10.46 | SUBJGRP 46
| What Is the Appeal Process for a Detention Order | |
| 21:1.0.1.1.1.10.46.12 | SECTION 1.401
| 1.401 Who is entitled to appeal | |
| 21:1.0.1.1.1.10.46.13 | SECTION 1.402
| 1.402 What are the requirements for submitting an appeal | |
| 21:1.0.1.1.1.10.46.14 | SECTION 1.403
| 1.403 What requirements apply to an informal hearing | |
| 21:1.0.1.1.1.10.46.15 | SECTION 1.404
| 1.404 Who serves as the presiding officer for an appeal and for an informal hearing | |
| 21:1.0.1.1.1.10.46.16 | SECTION 1.405
| 1.405 When does FDA have to issue a decision on an appeal | |
| 21:1.0.1.1.1.10.46.17 | SECTION 1.406
| 1.406 How will FDA handle classified information in an informal hearing | |
| 21:1.0.1.1.1.11 | SUBPART L
| Subpart L - Foreign Supplier Verification Programs for Food Importers | |
| 21:1.0.1.1.1.11.47.1 | SECTION 1.500
| 1.500 What definitions apply to this subpart | |
| 21:1.0.1.1.1.11.47.2 | SECTION 1.501
| 1.501 To what foods do the requirements in this subpart apply | |
| 21:1.0.1.1.1.11.47.3 | SECTION 1.502
| 1.502 What foreign supplier verification program (FSVP) must I have | |
| 21:1.0.1.1.1.11.47.4 | SECTION 1.503
| 1.503 Who must develop my FSVP and perform FSVP activities | |
| 21:1.0.1.1.1.11.47.5 | SECTION 1.504
| 1.504 What hazard analysis must I conduct | |
| 21:1.0.1.1.1.11.47.6 | SECTION 1.505
| 1.505 What evaluation for foreign supplier approval and verification must I conduct | |
| 21:1.0.1.1.1.11.47.7 | SECTION 1.506
| 1.506 What foreign supplier verification and related activities must I conduct | |
| 21:1.0.1.1.1.11.47.8 | SECTION 1.507
| 1.507 What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation | |
| 21:1.0.1.1.1.11.47.9 | SECTION 1.508
| 1.508 What corrective actions must I take under my FSVP | |
| 21:1.0.1.1.1.11.47.10 | SECTION 1.509
| 1.509 How must the importer be identified at entry | |
| 21:1.0.1.1.1.11.47.11 | SECTION 1.510
| 1.510 How must I maintain records of my FSVP | |
| 21:1.0.1.1.1.11.47.12 | SECTION 1.511
| 1.511 What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation | |
| 21:1.0.1.1.1.11.47.13 | SECTION 1.512
| 1.512 What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers | |
| 21:1.0.1.1.1.11.47.14 | SECTION 1.513
| 1.513 What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system | |
| 21:1.0.1.1.1.11.47.15 | SECTION 1.514
| 1.514 What are some consequences of failing to comply with the requirements of this subpart | |
| 21:1.0.1.1.1.12 | SUBPART M
| Subpart M - Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | |
| 21:1.0.1.1.1.12.47 | SUBJGRP 47
| Recognition of Accreditation Bodies Under This Subpart | |
| 21:1.0.1.1.1.12.47.1 | SECTION 1.600
| 1.600 What definitions apply to this subpart | |
| 21:1.0.1.1.1.12.47.2 | SECTION 1.601
| 1.601 Who is subject to this subpart | |
| 21:1.0.1.1.1.12.47.3 | SECTION 1.610
| 1.610 Who is eligible to seek recognition | |
| 21:1.0.1.1.1.12.47.4 | SECTION 1.611
| 1.611 What legal authority must an accreditation body have to qualify for recognition | |
| 21:1.0.1.1.1.12.47.5 | SECTION 1.612
| 1.612 What competency and capacity must an accreditation body have to qualify for recognition | |
| 21:1.0.1.1.1.12.47.6 | SECTION 1.613
| 1.613 What protections against conflicts of interest must an accreditation body have to qualify for recognition | |
| 21:1.0.1.1.1.12.47.7 | SECTION 1.614
| 1.614 What quality assurance procedures must an accreditation body have to qualify for recognition | |
| 21:1.0.1.1.1.12.47.8 | SECTION 1.615
| 1.615 What records procedures must an accreditation body have to qualify for recognition | |
| 21:1.0.1.1.1.12.48 | SUBJGRP 48
| Requirements for Accreditation Bodies That Have Been Recognized Under This Subpart | |
| 21:1.0.1.1.1.12.48.9 | SECTION 1.620
| 1.620 How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation | |
| 21:1.0.1.1.1.12.48.10 | SECTION 1.621
| 1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited | |
| 21:1.0.1.1.1.12.48.11 | SECTION 1.622
| 1.622 How must a recognized accreditation body monitor its own performance | |
| 21:1.0.1.1.1.12.48.12 | SECTION 1.623
| 1.623 What reports and notifications must a recognized accreditation body submit to FDA | |
| 21:1.0.1.1.1.12.48.13 | SECTION 1.624
| 1.624 How must a recognized accreditation body protect against conflicts of interest | |
| 21:1.0.1.1.1.12.48.14 | SECTION 1.625
| 1.625 What records requirements must an accreditation body that has been recognized meet | |
| 21:1.0.1.1.1.12.49 | SUBJGRP 49
| Procedures for Recognition of Accreditation Bodies Under This Subpart | |
| 21:1.0.1.1.1.12.49.15 | SECTION 1.630
| 1.630 How do I apply to FDA for recognition or renewal of recognition | |
| 21:1.0.1.1.1.12.49.16 | SECTION 1.631
| 1.631 How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application | |
| 21:1.0.1.1.1.12.49.17 | SECTION 1.632
| 1.632 What is the duration of recognition | |
| 21:1.0.1.1.1.12.49.18 | SECTION 1.633
| 1.633 How will FDA monitor recognized accreditation bodies | |
| 21:1.0.1.1.1.12.49.19 | SECTION 1.634
| 1.634 When will FDA revoke recognition | |
| 21:1.0.1.1.1.12.49.20 | SECTION 1.635
| 1.635 What if I want to voluntarily relinquish recognition or do not want to renew recognition | |
| 21:1.0.1.1.1.12.49.21 | SECTION 1.636
| 1.636 How do I request reinstatement of recognition | |
| 21:1.0.1.1.1.12.50 | SUBJGRP 50
| Accreditation of Third-Party Certification Bodies Under This Subpart | |
| 21:1.0.1.1.1.12.50.22 | SECTION 1.640
| 1.640 Who is eligible to seek accreditation | |
| 21:1.0.1.1.1.12.50.23 | SECTION 1.641
| 1.641 What legal authority must a third-party certification body have to qualify for accreditation | |
| 21:1.0.1.1.1.12.50.24 | SECTION 1.642
| 1.642 What competency and capacity must a third-party certification body have to qualify for accreditation | |
| 21:1.0.1.1.1.12.50.25 | SECTION 1.643
| 1.643 What protections against conflicts of interest must a third-party certification body have to qualify for accreditation | |
| 21:1.0.1.1.1.12.50.26 | SECTION 1.644
| 1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation | |
| 21:1.0.1.1.1.12.50.27 | SECTION 1.645
| 1.645 What records procedures must a third-party certification body have to qualify for accreditation | |
| 21:1.0.1.1.1.12.51 | SUBJGRP 51
| Requirements for Third-Party Certification Bodies That Have Been Accredited Under This Subpart | |
| 21:1.0.1.1.1.12.51.28 | SECTION 1.650
| 1.650 How must an accredited third-party certification body ensure its audit agents are competent and objective | |
| 21:1.0.1.1.1.12.51.29 | SECTION 1.651
| 1.651 How must an accredited third-party certification body conduct a food safety audit of an eligible entity | |
| 21:1.0.1.1.1.12.51.30 | SECTION 1.652
| 1.652 What must an accredited third-party certification body include in food safety audit reports | |
| 21:1.0.1.1.1.12.51.31 | SECTION 1.653
| 1.653 What must an accredited third-party certification body do when issuing food or facility certifications | |
| 21:1.0.1.1.1.12.51.32 | SECTION 1.654
| 1.654 When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification | |
| 21:1.0.1.1.1.12.51.33 | SECTION 1.655
| 1.655 How must an accredited third-party certification body monitor its own performance | |
| 21:1.0.1.1.1.12.51.34 | SECTION 1.656
| 1.656 What reports and notifications must an accredited third-party certification body submit | |
| 21:1.0.1.1.1.12.51.35 | SECTION 1.657
| 1.657 How must an accredited third-party certification body protect against conflicts of interest | |
| 21:1.0.1.1.1.12.51.36 | SECTION 1.658
| 1.658 What records requirements must a third-party certification body that has been accredited meet | |
| 21:1.0.1.1.1.12.52 | SUBJGRP 52
| Procedures for Accreditation of Third-Party Certification Bodies Under This Subpart | |
| 21:1.0.1.1.1.12.52.37 | SECTION 1.660
| 1.660 Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application | |
| 21:1.0.1.1.1.12.52.38 | SECTION 1.661
| 1.661 What is the duration of accreditation by a recognized accreditation body | |
| 21:1.0.1.1.1.12.52.39 | SECTION 1.662
| 1.662 How will FDA monitor accredited third-party certification bodies | |
| 21:1.0.1.1.1.12.52.40 | SECTION 1.663
| 1.663 How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits | |
| 21:1.0.1.1.1.12.52.41 | SECTION 1.664
| 1.664 When would FDA withdraw accreditation | |
| 21:1.0.1.1.1.12.52.42 | SECTION 1.665
| 1.665 What if I want to voluntarily relinquish accreditation or do not want to renew accreditation | |
| 21:1.0.1.1.1.12.52.43 | SECTION 1.666
| 1.666 How do I request reaccreditation | |
| 21:1.0.1.1.1.12.53 | SUBJGRP 53
| Additional Procedures for Direct Accreditation of Third-Party Certification Bodies Under This Subpart | |
| 21:1.0.1.1.1.12.53.44 | SECTION 1.670
| 1.670 How do I apply to FDA for direct accreditation or renewal of direct accreditation | |
| 21:1.0.1.1.1.12.53.45 | SECTION 1.671
| 1.671 How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application | |
| 21:1.0.1.1.1.12.53.46 | SECTION 1.672
| 1.672 What is the duration of direct accreditation | |
| 21:1.0.1.1.1.12.54 | SUBJGRP 54
| Requirements for Eligible Entities Under This Subpart | |
| 21:1.0.1.1.1.12.54.47 | SECTION 1.680
| 1.680 How and when will FDA monitor eligible entities | |
| 21:1.0.1.1.1.12.54.48 | SECTION 1.681
| 1.681 How frequently must eligible entities be recertified | |
| 21:1.0.1.1.1.12.55 | SUBJGRP 55
| General Requirements of This Subpart | |
| 21:1.0.1.1.1.12.55.49 | SECTION 1.690
| 1.690 How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public | |
| 21:1.0.1.1.1.12.55.50 | SECTION 1.691
| 1.691 How do I request reconsideration of a denial by FDA of an application or a waiver request | |
| 21:1.0.1.1.1.12.55.51 | SECTION 1.692
| 1.692 How do I request internal agency review of a denial of an application or waiver request upon reconsideration | |
| 21:1.0.1.1.1.12.55.52 | SECTION 1.693
| 1.693 How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation | |
| 21:1.0.1.1.1.12.55.53 | SECTION 1.694
| 1.694 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter | |
| 21:1.0.1.1.1.12.55.54 | SECTION 1.695
| 1.695 Are the records obtained by FDA under this subpart subject to public disclosure | |
| 21:1.0.1.1.1.12.56 | SUBJGRP 56
| Requirements for User Fees Under This Subpart | |
| 21:1.0.1.1.1.12.56.55 | SECTION 1.700
| 1.700 Who is subject to a user fee under this subpart | |
| 21:1.0.1.1.1.12.56.56 | SECTION 1.705
| 1.705 What user fees are established under this subpart | |
| 21:1.0.1.1.1.12.56.57 | SECTION 1.710
| 1.710 How will FDA notify the public about the fee schedule | |
| 21:1.0.1.1.1.12.56.58 | SECTION 1.715
| 1.715 When must a user fee required by this subpart be submitted | |
| 21:1.0.1.1.1.12.56.59 | SECTION 1.720
| 1.720 Are user fees under this subpart refundable | |
| 21:1.0.1.1.1.12.56.60 | SECTION 1.725
| 1.725 What are the consequences of not paying a user fee under this subpart on time | |
| 21:1.0.1.1.1.13 | SUBPART N
| Subpart N [Reserved] | |
| 21:1.0.1.1.1.14 | SUBPART O
| Subpart O - Sanitary Transportation of Human and Animal Food | |
| 21:1.0.1.1.1.14.57 | SUBJGRP 57
| General Provisions | |
| 21:1.0.1.1.1.14.57.1 | SECTION 1.900
| 1.900 Who is subject to this subpart | |
| 21:1.0.1.1.1.14.57.2 | SECTION 1.902
| 1.902 How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act | |
| 21:1.0.1.1.1.14.57.3 | SECTION 1.904
| 1.904 What definitions apply to this subpart | |
| 21:1.0.1.1.1.14.58 | SUBJGRP 58
| Vehicles and Transportation Equipment | |
| 21:1.0.1.1.1.14.58.4 | SECTION 1.906
| 1.906 What requirements apply to vehicles and transportation equipment | |
| 21:1.0.1.1.1.14.59 | SUBJGRP 59
| Transportation Operations | |
| 21:1.0.1.1.1.14.59.5 | SECTION 1.908
| 1.908 What requirements apply to transportation operations | |
| 21:1.0.1.1.1.14.60 | SUBJGRP 60
| Training | |
| 21:1.0.1.1.1.14.60.6 | SECTION 1.910
| 1.910 What training requirements apply to carriers engaged in transportation operations | |
| 21:1.0.1.1.1.14.61 | SUBJGRP 61
| Records | |
| 21:1.0.1.1.1.14.61.7 | SECTION 1.912
| 1.912 What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations | |
| 21:1.0.1.1.1.14.62 | SUBJGRP 62
| Waivers | |
| 21:1.0.1.1.1.14.62.8 | SECTION 1.914
| 1.914 Under what circumstances will we waive a requirement of this subpart | |
| 21:1.0.1.1.1.14.62.9 | SECTION 1.916
| 1.916 When will we consider whether to waive a requirement of this subpart | |
| 21:1.0.1.1.1.14.62.10 | SECTION 1.918
| 1.918 What must be included in the Statement of Grounds in a petition requesting a waiver | |
| 21:1.0.1.1.1.14.62.11 | SECTION 1.920
| 1.920 What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available | |
| 21:1.0.1.1.1.14.62.12 | SECTION 1.922
| 1.922 Who will respond to a petition requesting a waiver | |
| 21:1.0.1.1.1.14.62.13 | SECTION 1.924
| 1.924 What process applies to a petition requesting a waiver | |
| 21:1.0.1.1.1.14.62.14 | SECTION 1.926
| 1.926 Under what circumstances may we deny a petition requesting a waiver | |
| 21:1.0.1.1.1.14.62.15 | SECTION 1.928
| 1.928 What process will we follow when waiving a requirement of this subpart on our own initiative | |
| 21:1.0.1.1.1.14.62.16 | SECTION 1.930
| 1.930 When will a waiver that we grant become effective | |
| 21:1.0.1.1.1.14.62.17 | SECTION 1.932
| 1.932 Under what circumstances may we modify or revoke a waiver | |
| 21:1.0.1.1.1.14.62.18 | SECTION 1.934
| 1.934 What procedures apply if we determine that a waiver should be modified or revoked | |
| 21:1.0.1.1.1.15 | SUBPART P
| Subpart P [Reserved] | |
| 21:1.0.1.1.1.16 | SUBPART Q
| Subpart Q - Administrative Detention of Drugs Intended for Human or Animal Use | |
| 21:1.0.1.1.1.16.63.1 | SECTION 1.980
| 1.980 Administrative detention of drugs. | |
| 21:1.0.1.1.2 | PART 2
| PART 2 - GENERAL ADMINISTRATIVE RULINGS AND DECISIONS | |
| 21:1.0.1.1.2.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.2.1.63.1 | SECTION 2.5
| 2.5 Imminent hazard to the public health. | |
| 21:1.0.1.1.2.1.63.2 | SECTION 2.10
| 2.10 Examination and investigation samples. | |
| 21:1.0.1.1.2.1.63.3 | SECTION 2.19
| 2.19 Methods of analysis. | |
| 21:1.0.1.1.2.2 | SUBPART B
| Subpart B - Human and Animal Foods | |
| 21:1.0.1.1.2.2.63.1 | SECTION 2.25
| 2.25 Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food. | |
| 21:1.0.1.1.2.2.63.2 | SECTION 2.35
| 2.35 Use of secondhand containers for the shipment or storage of food and animal feed. | |
| 21:1.0.1.1.2.3 | SUBPART C
| Subparts C-E [Reserved] | |
| 21:1.0.1.1.2.4 | SUBPART F
| Subpart F - Caustic Poisons | |
| 21:1.0.1.1.2.4.63.1 | SECTION 2.110
| 2.110 Definition of ammonia under Federal Caustic Poison Act. | |
| 21:1.0.1.1.2.5 | SUBPART G
| Subpart G - Provisions Applicable to Specific Products Subject to the Federal Food, Drug, and Cosmetic Act | |
| 21:1.0.1.1.2.5.63.1 | SECTION 2.125
| 2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics. | |
| 21:1.0.1.1.3 | PART 3
| PART 3 - PRODUCT JURISDICTION | |
| 21:1.0.1.1.3.1 | SUBPART A
| Subpart A - Assignment of Agency Component for Review of Premarket Applications | |
| 21:1.0.1.1.3.1.63.1 | SECTION 3.1
| 3.1 Purpose. | |
| 21:1.0.1.1.3.1.63.2 | SECTION 3.2
| 3.2 Definitions. | |
| 21:1.0.1.1.3.1.63.3 | SECTION 3.3
| 3.3 Scope. | |
| 21:1.0.1.1.3.1.63.4 | SECTION 3.4
| 3.4 Designated agency component. | |
| 21:1.0.1.1.3.1.63.5 | SECTION 3.5
| 3.5 Procedures for identifying the designated agency component. | |
| 21:1.0.1.1.3.1.63.6 | SECTION 3.6
| 3.6 Product jurisdiction officer. | |
| 21:1.0.1.1.3.1.63.7 | SECTION 3.7
| 3.7 Request for designation. | |
| 21:1.0.1.1.3.1.63.8 | SECTION 3.8
| 3.8 Letter of designation. | |
| 21:1.0.1.1.3.1.63.9 | SECTION 3.9
| 3.9 Effect of letter of designation. | |
| 21:1.0.1.1.3.1.63.10 | SECTION 3.10
| 3.10 Stay of review time. | |
| 21:1.0.1.1.3.2 | SUBPART B
| Subpart B [Reserved] | |
| 21:1.0.1.1.4 | PART 4
| PART 4 - REGULATION OF COMBINATION PRODUCTS | |
| 21:1.0.1.1.4.1 | SUBPART A
| Subpart A - Current Good Manufacturing Practice Requirements for Combination Products | |
| 21:1.0.1.1.4.1.63.1 | SECTION 4.1
| 4.1 What is the scope of this subpart | |
| 21:1.0.1.1.4.1.63.2 | SECTION 4.2
| 4.2 How does FDA define key terms and phrases in this subpart | |
| 21:1.0.1.1.4.1.63.3 | SECTION 4.3
| 4.3 What current good manufacturing practice requirements apply to my combination product | |
| 21:1.0.1.1.4.1.63.4 | SECTION 4.4
| 4.4 How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product | |
| 21:1.0.1.1.4.2 | SUBPART B
| Subpart B - Postmarketing Safety Reporting for Combination Products | |
| 21:1.0.1.1.4.2.63.1 | SECTION 4.100
| 4.100 What is the scope of this subpart | |
| 21:1.0.1.1.4.2.63.2 | SECTION 4.101
| 4.101 How does the FDA define key terms and phrases in this subpart | |
| 21:1.0.1.1.4.2.63.3 | SECTION 4.102
| 4.102 What reports must you submit to FDA for your combination product or constituent part | |
| 21:1.0.1.1.4.2.63.4 | SECTION 4.103
| 4.103 What information must you share with other constituent part applicants for the combination product | |
| 21:1.0.1.1.4.2.63.5 | SECTION 4.104
| 4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part | |
| 21:1.0.1.1.4.2.63.6 | SECTION 4.105
| 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part | |
| 21:1.0.1.1.5 | PART 5
| PART 5 - ORGANIZATION | |
| 21:1.0.1.1.5.1 | SUBPART A
| Subparts A-L [Reserved] | |
| 21:1.0.1.1.5.2 | SUBPART M
| Subpart M - Organization | |
| 21:1.0.1.1.5.2.63.1 | SECTION 5.1100
| 5.1100 Headquarters. | |
| 21:1.0.1.1.5.2.63.2 | SECTION 5.1105
| 5.1105 Chief Counsel, Food and Drug Administration. | |
| 21:1.0.1.1.5.2.63.3 | SECTION 5.1110
| 5.1110 FDA public information offices. | |
| 21:1.0.1.1.6 | PART 6
| PART 6 - XXX | |
| 21:1.0.1.1.7 | PART 7
| PART 7 - ENFORCEMENT POLICY | |
| 21:1.0.1.1.7.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.7.1.63.1 | SECTION 7.1
| 7.1 Scope. | |
| 21:1.0.1.1.7.1.63.2 | SECTION 7.3
| 7.3 Definitions. | |
| 21:1.0.1.1.7.1.63.3 | SECTION 7.12
| 7.12 Guaranty. | |
| 21:1.0.1.1.7.1.63.4 | SECTION 7.13
| 7.13 Suggested forms of guaranty. | |
| 21:1.0.1.1.7.2 | SUBPART B
| Subpart B [Reserved] | |
| 21:1.0.1.1.7.3 | SUBPART C
| Subpart C - Recalls (Including Product Corrections) - Guidance on Policy, Procedures, and Industry Responsibilities | |
| 21:1.0.1.1.7.3.63.1 | SECTION 7.40
| 7.40 Recall policy. | |
| 21:1.0.1.1.7.3.63.2 | SECTION 7.41
| 7.41 Health hazard evaluation and recall classification. | |
| 21:1.0.1.1.7.3.63.3 | SECTION 7.42
| 7.42 Recall strategy. | |
| 21:1.0.1.1.7.3.63.4 | SECTION 7.45
| 7.45 Food and Drug Administration-requested recall. | |
| 21:1.0.1.1.7.3.63.5 | SECTION 7.46
| 7.46 Firm-initiated recall. | |
| 21:1.0.1.1.7.3.63.6 | SECTION 7.49
| 7.49 Recall communications. | |
| 21:1.0.1.1.7.3.63.7 | SECTION 7.50
| 7.50 Public notification of recall. | |
| 21:1.0.1.1.7.3.63.8 | SECTION 7.53
| 7.53 Recall status reports. | |
| 21:1.0.1.1.7.3.63.9 | SECTION 7.55
| 7.55 Termination of a recall. | |
| 21:1.0.1.1.7.3.63.10 | SECTION 7.59
| 7.59 General industry guidance. | |
| 21:1.0.1.1.7.4 | SUBPART D
| Subpart D [Reserved] | |
| 21:1.0.1.1.7.5 | SUBPART E
| Subpart E - Criminal Violations | |
| 21:1.0.1.1.7.5.63.1 | SECTION 7.84
| 7.84 Opportunity for presentation of views before report of criminal violation. | |
| 21:1.0.1.1.7.5.63.2 | SECTION 7.85
| 7.85 Conduct of a presentation of views before report of criminal violation. | |
| 21:1.0.1.1.7.5.63.3 | SECTION 7.87
| 7.87 Records related to opportunities for presentation of views conducted before report of criminal violation. | |
| 21:1.0.1.1.8 | PART 10
| PART 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES | |
| 21:1.0.1.1.8.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.8.1.63.1 | SECTION 10.1
| 10.1 Scope. | |
| 21:1.0.1.1.8.1.63.2 | SECTION 10.3
| 10.3 Definitions. | |
| 21:1.0.1.1.8.1.63.3 | SECTION 10.10
| 10.10 Summaries of administrative practices and procedures. | |
| 21:1.0.1.1.8.1.63.4 | SECTION 10.19
| 10.19 Waiver, suspension, or modification of procedural requirements. | |
| 21:1.0.1.1.8.2 | SUBPART B
| Subpart B - General Administrative Procedures | |
| 21:1.0.1.1.8.2.63.1 | SECTION 10.20
| 10.20 Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure. | |
| 21:1.0.1.1.8.2.63.2 | SECTION 10.25
| 10.25 Initiation of administrative proceedings. | |
| 21:1.0.1.1.8.2.63.3 | SECTION 10.30
| 10.30 Citizen petition. | |
| 21:1.0.1.1.8.2.63.4 | SECTION 10.31
| 10.31 Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications. | |
| 21:1.0.1.1.8.2.63.5 | SECTION 10.33
| 10.33 Administrative reconsideration of action. | |
| 21:1.0.1.1.8.2.63.6 | SECTION 10.35
| 10.35 Administrative stay of action. | |
| 21:1.0.1.1.8.2.63.7 | SECTION 10.40
| 10.40 Promulgation of regulations for the efficient enforcement of the law. | |
| 21:1.0.1.1.8.2.63.8 | SECTION 10.45
| 10.45 Court review of final administrative action; exhaustion of administrative remedies. | |
| 21:1.0.1.1.8.2.63.9 | SECTION 10.50
| 10.50 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing. | |
| 21:1.0.1.1.8.2.63.10 | SECTION 10.55
| 10.55 Separation of functions; ex parte communications. | |
| 21:1.0.1.1.8.2.63.11 | SECTION 10.60
| 10.60 Referral by court. | |
| 21:1.0.1.1.8.2.63.12 | SECTION 10.65
| 10.65 Meetings and correspondence. | |
| 21:1.0.1.1.8.2.63.13 | SECTION 10.70
| 10.70 Documentation of significant decisions in administrative file. | |
| 21:1.0.1.1.8.2.63.14 | SECTION 10.75
| 10.75 Internal agency review of decisions. | |
| 21:1.0.1.1.8.2.63.15 | SECTION 10.80
| 10.80 Dissemination of draft Federal Register notices and regulations. | |
| 21:1.0.1.1.8.2.63.16 | SECTION 10.85
| 10.85 Advisory opinions. | |
| 21:1.0.1.1.8.2.63.17 | SECTION 10.90
| 10.90 Food and Drug Administration regulations, recommendations, and agreements. | |
| 21:1.0.1.1.8.2.63.18 | SECTION 10.95
| 10.95 Participation in outside standard-setting activities. | |
| 21:1.0.1.1.8.2.63.19 | SECTION 10.100
| 10.100 Public calendar. | |
| 21:1.0.1.1.8.2.63.20 | SECTION 10.105
| 10.105 Representation by an organization. | |
| 21:1.0.1.1.8.2.63.21 | SECTION 10.110
| 10.110 Settlement proposals. | |
| 21:1.0.1.1.8.2.63.22 | SECTION 10.115
| 10.115 Good guidance practices. | |
| 21:1.0.1.1.8.3 | SUBPART C
| Subpart C - Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures | |
| 21:1.0.1.1.8.3.63.1 | SECTION 10.200
| 10.200 Scope. | |
| 21:1.0.1.1.8.3.63.2 | SECTION 10.203
| 10.203 Definitions. | |
| 21:1.0.1.1.8.3.63.3 | SECTION 10.204
| 10.204 General. | |
| 21:1.0.1.1.8.3.63.4 | SECTION 10.205
| 10.205 Electronic media coverage of public administrative proceedings. | |
| 21:1.0.1.1.8.3.63.5 | SECTION 10.206
| 10.206 Procedures for electronic media coverage of agency public administrative proceedings. | |
| 21:1.0.1.1.9 | PART 11
| PART 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES | |
| 21:1.0.1.1.9.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.9.1.63.1 | SECTION 11.1
| 11.1 Scope. | |
| 21:1.0.1.1.9.1.63.2 | SECTION 11.2
| 11.2 Implementation. | |
| 21:1.0.1.1.9.1.63.3 | SECTION 11.3
| 11.3 Definitions. | |
| 21:1.0.1.1.9.2 | SUBPART B
| Subpart B - Electronic Records | |
| 21:1.0.1.1.9.2.63.1 | SECTION 11.10
| 11.10 Controls for closed systems. | |
| 21:1.0.1.1.9.2.63.2 | SECTION 11.30
| 11.30 Controls for open systems. | |
| 21:1.0.1.1.9.2.63.3 | SECTION 11.50
| 11.50 Signature manifestations. | |
| 21:1.0.1.1.9.2.63.4 | SECTION 11.70
| 11.70 Signature/record linking. | |
| 21:1.0.1.1.9.3 | SUBPART C
| Subpart C - Electronic Signatures | |
| 21:1.0.1.1.9.3.63.1 | SECTION 11.100
| 11.100 General requirements. | |
| 21:1.0.1.1.9.3.63.2 | SECTION 11.200
| 11.200 Electronic signature components and controls. | |
| 21:1.0.1.1.9.3.63.3 | SECTION 11.300
| 11.300 Controls for identification codes/passwords. | |
| 21:1.0.1.1.10 | PART 12
| PART 12 - FORMAL EVIDENTIARY PUBLIC HEARING | |
| 21:1.0.1.1.10.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.10.1.63.1 | SECTION 12.1
| 12.1 Scope. | |
| 21:1.0.1.1.10.2 | SUBPART B
| Subpart B - Initiation of Proceedings | |
| 21:1.0.1.1.10.2.63.1 | SECTION 12.20
| 12.20 Initiation of a hearing involving the issuance, amendment, or revocation of a regulation. | |
| 21:1.0.1.1.10.2.63.2 | SECTION 12.21
| 12.21 Initiation of a hearing involving the issuance, amendment, or revocation of an order. | |
| 21:1.0.1.1.10.2.63.3 | SECTION 12.22
| 12.22 Filing objections and requests for a hearing on a regulation or order. | |
| 21:1.0.1.1.10.2.63.4 | SECTION 12.23
| 12.23 Notice of filing of objections. | |
| 21:1.0.1.1.10.2.63.5 | SECTION 12.24
| 12.24 Ruling on objections and requests for hearing. | |
| 21:1.0.1.1.10.2.63.6 | SECTION 12.26
| 12.26 Modification or revocation of regulation or order. | |
| 21:1.0.1.1.10.2.63.7 | SECTION 12.28
| 12.28 Denial of hearing in whole or in part. | |
| 21:1.0.1.1.10.2.63.8 | SECTION 12.30
| 12.30 Judicial review after waiver of hearing on a regulation. | |
| 21:1.0.1.1.10.2.63.9 | SECTION 12.32
| 12.32 Request for alternative form of hearing. | |
| 21:1.0.1.1.10.2.63.10 | SECTION 12.35
| 12.35 Notice of hearing; stay of action. | |
| 21:1.0.1.1.10.2.63.11 | SECTION 12.37
| 12.37 Effective date of a regulation. | |
| 21:1.0.1.1.10.2.63.12 | SECTION 12.38
| 12.38 Effective date of an order. | |
| 21:1.0.1.1.10.3 | SUBPART C
| Subpart C - Appearance and Participation | |
| 21:1.0.1.1.10.3.63.1 | SECTION 12.40
| 12.40 Appearance. | |
| 21:1.0.1.1.10.3.63.2 | SECTION 12.45
| 12.45 Notice of participation. | |
| 21:1.0.1.1.10.3.63.3 | SECTION 12.50
| 12.50 Advice on public participation in hearings. | |
| 21:1.0.1.1.10.4 | SUBPART D
| Subpart D - Presiding Officer | |
| 21:1.0.1.1.10.4.63.1 | SECTION 12.60
| 12.60 Presiding officer. | |
| 21:1.0.1.1.10.4.63.2 | SECTION 12.62
| 12.62 Commencement of functions. | |
| 21:1.0.1.1.10.4.63.3 | SECTION 12.70
| 12.70 Authority of presiding officer. | |
| 21:1.0.1.1.10.4.63.4 | SECTION 12.75
| 12.75 Disqualification of presiding officer. | |
| 21:1.0.1.1.10.4.63.5 | SECTION 12.78
| 12.78 Unavailability of presiding officer. | |
| 21:1.0.1.1.10.5 | SUBPART E
| Subpart E - Hearing Procedures | |
| 21:1.0.1.1.10.5.63.1 | SECTION 12.80
| 12.80 Filing and service of submissions. | |
| 21:1.0.1.1.10.5.63.2 | SECTION 12.82
| 12.82 Petition to participate in forma pauperis. | |
| 21:1.0.1.1.10.5.63.3 | SECTION 12.83
| 12.83 Advisory opinions. | |
| 21:1.0.1.1.10.5.63.4 | SECTION 12.85
| 12.85 Disclosure of data and information by the participants. | |
| 21:1.0.1.1.10.5.63.5 | SECTION 12.87
| 12.87 Purpose; oral and written testimony; burden of proof. | |
| 21:1.0.1.1.10.5.63.6 | SECTION 12.89
| 12.89 Participation of nonparties. | |
| 21:1.0.1.1.10.5.63.7 | SECTION 12.90
| 12.90 Conduct at oral hearings or conferences. | |
| 21:1.0.1.1.10.5.63.8 | SECTION 12.91
| 12.91 Time and place of prehearing conference. | |
| 21:1.0.1.1.10.5.63.9 | SECTION 12.92
| 12.92 Prehearing conference procedure. | |
| 21:1.0.1.1.10.5.63.10 | SECTION 12.93
| 12.93 Summary decisions. | |
| 21:1.0.1.1.10.5.63.11 | SECTION 12.94
| 12.94 Receipt of evidence. | |
| 21:1.0.1.1.10.5.63.12 | SECTION 12.95
| 12.95 Official notice. | |
| 21:1.0.1.1.10.5.63.13 | SECTION 12.96
| 12.96 Briefs and arguments. | |
| 21:1.0.1.1.10.5.63.14 | SECTION 12.97
| 12.97 Interlocutory appeal from ruling of presiding officer. | |
| 21:1.0.1.1.10.5.63.15 | SECTION 12.98
| 12.98 Official transcript. | |
| 21:1.0.1.1.10.5.63.16 | SECTION 12.99
| 12.99 Motions. | |
| 21:1.0.1.1.10.6 | SUBPART F
| Subpart F - Administrative Record | |
| 21:1.0.1.1.10.6.63.1 | SECTION 12.100
| 12.100 Administrative record of a hearing. | |
| 21:1.0.1.1.10.6.63.2 | SECTION 12.105
| 12.105 Examination of record. | |
| 21:1.0.1.1.10.7 | SUBPART G
| Subpart G - Initial and Final Decisions | |
| 21:1.0.1.1.10.7.63.1 | SECTION 12.120
| 12.120 Initial decision. | |
| 21:1.0.1.1.10.7.63.2 | SECTION 12.125
| 12.125 Appeal from or review of initial decision. | |
| 21:1.0.1.1.10.7.63.3 | SECTION 12.130
| 12.130 Decision by Commissioner on appeal or review of initial decision. | |
| 21:1.0.1.1.10.7.63.4 | SECTION 12.139
| 12.139 Reconsideration and stay of action. | |
| 21:1.0.1.1.10.8 | SUBPART H
| Subpart H - Judicial Review | |
| 21:1.0.1.1.10.8.63.1 | SECTION 12.140
| 12.140 Review by the courts. | |
| 21:1.0.1.1.10.8.63.2 | SECTION 12.159
| 12.159 Copies of petitions for judicial review. | |
| 21:1.0.1.1.11 | PART 13
| PART 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY | |
| 21:1.0.1.1.11.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.11.1.63.1 | SECTION 13.1
| 13.1 Scope. | |
| 21:1.0.1.1.11.1.63.2 | SECTION 13.5
| 13.5 Notice of a hearing before a Board. | |
| 21:1.0.1.1.11.1.63.3 | SECTION 13.10
| 13.10 Members of a Board. | |
| 21:1.0.1.1.11.1.63.4 | SECTION 13.15
| 13.15 Separation of functions; ex parte communications; administrative support. | |
| 21:1.0.1.1.11.2 | SUBPART B
| Subpart B - Hearing Procedures | |
| 21:1.0.1.1.11.2.63.1 | SECTION 13.20
| 13.20 Submissions to a Board. | |
| 21:1.0.1.1.11.2.63.2 | SECTION 13.25
| 13.25 Disclosure of data and information by the participants. | |
| 21:1.0.1.1.11.2.63.3 | SECTION 13.30
| 13.30 Proceedings of a Board. | |
| 21:1.0.1.1.11.3 | SUBPART C
| Subpart C - Records of a Hearing Before a Board | |
| 21:1.0.1.1.11.3.63.1 | SECTION 13.40
| 13.40 Administrative record of a Board. | |
| 21:1.0.1.1.11.3.63.2 | SECTION 13.45
| 13.45 Examination of administrative record. | |
| 21:1.0.1.1.11.3.63.3 | SECTION 13.50
| 13.50 Record for administrative decision. | |
| 21:1.0.1.1.12 | PART 14
| PART 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | |
| 21:1.0.1.1.12.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.12.1.63.1 | SECTION 14.1
| 14.1 Scope. | |
| 21:1.0.1.1.12.1.63.2 | SECTION 14.5
| 14.5 Purpose of proceedings before an advisory committee. | |
| 21:1.0.1.1.12.1.63.3 | SECTION 14.7
| 14.7 Administrative remedies. | |
| 21:1.0.1.1.12.1.63.4 | SECTION 14.10
| 14.10 Applicability to Congress. | |
| 21:1.0.1.1.12.1.63.5 | SECTION 14.15
| 14.15 Committees working under a contract with FDA. | |
| 21:1.0.1.1.12.2 | SUBPART B
| Subpart B - Meeting Procedures | |
| 21:1.0.1.1.12.2.63.1 | SECTION 14.20
| 14.20 Notice of hearing before an advisory committee. | |
| 21:1.0.1.1.12.2.63.2 | SECTION 14.22
| 14.22 Meetings of an advisory committee. | |
| 21:1.0.1.1.12.2.63.3 | SECTION 14.25
| 14.25 Portions of advisory committee meetings. | |
| 21:1.0.1.1.12.2.63.4 | SECTION 14.27
| 14.27 Determination to close portions of advisory committee meetings. | |
| 21:1.0.1.1.12.2.63.5 | SECTION 14.29
| 14.29 Conduct of a hearing before an advisory committee. | |
| 21:1.0.1.1.12.2.63.6 | SECTION 14.30
| 14.30 Chairperson of an advisory committee. | |
| 21:1.0.1.1.12.2.63.7 | SECTION 14.31
| 14.31 Consultation by an advisory committee with other persons. | |
| 21:1.0.1.1.12.2.63.8 | SECTION 14.33
| 14.33 Compilation of materials for members of an advisory committee. | |
| 21:1.0.1.1.12.2.63.9 | SECTION 14.35
| 14.35 Written submissions to an advisory committee. | |
| 21:1.0.1.1.12.2.63.10 | SECTION 14.39
| 14.39 Additional rules for a particular advisory committee. | |
| 21:1.0.1.1.12.3 | SUBPART C
| Subpart C - Establishment of Advisory Committees | |
| 21:1.0.1.1.12.3.63.1 | SECTION 14.40
| 14.40 Establishment and renewal of advisory committees. | |
| 21:1.0.1.1.12.3.63.2 | SECTION 14.55
| 14.55 Termination of advisory committees. | |
| 21:1.0.1.1.12.4 | SUBPART D
| Subpart D - Records of Meetings and Hearings Before Advisory Committees | |
| 21:1.0.1.1.12.4.63.1 | SECTION 14.60
| 14.60 Minutes and reports of advisory committee meetings. | |
| 21:1.0.1.1.12.4.63.2 | SECTION 14.61
| 14.61 Transcripts of advisory committee meetings. | |
| 21:1.0.1.1.12.4.63.3 | SECTION 14.65
| 14.65 Public inquiries and requests for advisory committee records. | |
| 21:1.0.1.1.12.4.63.4 | SECTION 14.70
| 14.70 Administrative record of a public hearing before an advisory committee. | |
| 21:1.0.1.1.12.4.63.5 | SECTION 14.75
| 14.75 Examination of administrative record and other advisory committee records. | |
| 21:1.0.1.1.12.5 | SUBPART E
| Subpart E - Members of Advisory Committees | |
| 21:1.0.1.1.12.5.63.1 | SECTION 14.80
| 14.80 Qualifications for members of standing policy and technical advisory committees. | |
| 21:1.0.1.1.12.5.63.2 | SECTION 14.82
| 14.82 Nominations of voting members of standing advisory committees. | |
| 21:1.0.1.1.12.5.63.3 | SECTION 14.84
| 14.84 Nominations and selection of nonvoting members of standing technical advisory committees. | |
| 21:1.0.1.1.12.5.63.4 | SECTION 14.86
| 14.86 Rights and responsibilities of nonvoting members of advisory committees. | |
| 21:1.0.1.1.12.5.63.5 | SECTION 14.90
| 14.90 Ad hoc advisory committee members. | |
| 21:1.0.1.1.12.5.63.6 | SECTION 14.95
| 14.95 Compensation of advisory committee members. | |
| 21:1.0.1.1.12.6 | SUBPART F
| Subpart F - Standing Advisory Committees | |
| 21:1.0.1.1.12.6.63.1 | SECTION 14.100
| 14.100 List of standing advisory committees. | |
| 21:1.0.1.1.12.7 | SUBPART G
| Subpart G - Technical Electronic Products Radiation Safety Standards Committee | |
| 21:1.0.1.1.12.7.63.1 | SECTION 14.120
| 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). | |
| 21:1.0.1.1.12.7.63.2 | SECTION 14.122
| 14.122 Functions of TEPRSSC. | |
| 21:1.0.1.1.12.7.63.3 | SECTION 14.125
| 14.125 Procedures of TEPRSSC. | |
| 21:1.0.1.1.12.7.63.4 | SECTION 14.127
| 14.127 Membership of TEPRSSC. | |
| 21:1.0.1.1.12.7.63.5 | SECTION 14.130
| 14.130 Conduct of TEPRSSC meeting; availability of TEPRSSC records. | |
| 21:1.0.1.1.12.8 | SUBPART H
| Subpart H - Color Additive Advisory Committees | |
| 21:1.0.1.1.12.8.63.1 | SECTION 14.140
| 14.140 Establishment of a color additive advisory committee. | |
| 21:1.0.1.1.12.8.63.2 | SECTION 14.142
| 14.142 Functions of a color additive advisory committee. | |
| 21:1.0.1.1.12.8.63.3 | SECTION 14.145
| 14.145 Procedures of a color additive advisory committee. | |
| 21:1.0.1.1.12.8.63.4 | SECTION 14.147
| 14.147 Membership of a color additive advisory committee. | |
| 21:1.0.1.1.12.8.63.5 | SECTION 14.155
| 14.155 Fees and compensation pertaining to a color additive advisory committee. | |
| 21:1.0.1.1.12.9 | SUBPART I
| Subpart I - Advisory Committees for Human Prescription Drugs | |
| 21:1.0.1.1.12.9.63.1 | SECTION 14.160
| 14.160 Establishment of standing technical advisory committees for human prescription drugs. | |
| 21:1.0.1.1.12.9.63.2 | SECTION 14.171
| 14.171 Utilization of an advisory committee on the initiative of FDA. | |
| 21:1.0.1.1.12.9.63.3 | SECTION 14.172
| 14.172 Utilization of an advisory committee at the request of an interested person. | |
| 21:1.0.1.1.12.9.63.4 | SECTION 14.174
| 14.174 Advice and recommendations in writing. | |
| 21:1.0.1.1.13 | PART 15
| PART 15 - PUBLIC HEARING BEFORE THE COMMISSIONER | |
| 21:1.0.1.1.13.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.13.1.63.1 | SECTION 15.1
| 15.1 Scope. | |
| 21:1.0.1.1.13.2 | SUBPART B
| Subpart B - Procedures for Public Hearing Before the Commissioner | |
| 21:1.0.1.1.13.2.63.1 | SECTION 15.20
| 15.20 Notice of a public hearing before the Commissioner. | |
| 21:1.0.1.1.13.2.63.2 | SECTION 15.21
| 15.21 Notice of participation; schedule for hearing. | |
| 21:1.0.1.1.13.2.63.3 | SECTION 15.25
| 15.25 Written submissions. | |
| 21:1.0.1.1.13.2.63.4 | SECTION 15.30
| 15.30 Conduct of a public hearing before the Commissioner. | |
| 21:1.0.1.1.13.3 | SUBPART C
| Subpart C - Records of a Public Hearing Before the Commissioner | |
| 21:1.0.1.1.13.3.63.1 | SECTION 15.40
| 15.40 Administrative record. | |
| 21:1.0.1.1.13.3.63.2 | SECTION 15.45
| 15.45 Examination of administrative record. | |
| 21:1.0.1.1.14 | PART 16
| PART 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION | |
| 21:1.0.1.1.14.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.14.1.63.1 | SECTION 16.1
| 16.1 Scope. | |
| 21:1.0.1.1.14.1.63.2 | SECTION 16.5
| 16.5 Inapplicability and limited applicability. | |
| 21:1.0.1.1.14.2 | SUBPART B
| Subpart B - Initiation of Proceedings | |
| 21:1.0.1.1.14.2.63.1 | SECTION 16.22
| 16.22 Initiation of regulatory hearing. | |
| 21:1.0.1.1.14.2.63.2 | SECTION 16.24
| 16.24 Regulatory hearing required by the act or a regulation. | |
| 21:1.0.1.1.14.2.63.3 | SECTION 16.26
| 16.26 Denial of hearing and summary decision. | |
| 21:1.0.1.1.14.3 | SUBPART C
| Subpart C - Commissioner and Presiding Officer | |
| 21:1.0.1.1.14.3.63.1 | SECTION 16.40
| 16.40 Commissioner. | |
| 21:1.0.1.1.14.3.63.2 | SECTION 16.42
| 16.42 Presiding officer. | |
| 21:1.0.1.1.14.3.63.3 | SECTION 16.44
| 16.44 Communication to presiding officer and Commissioner. | |
| 21:1.0.1.1.14.4 | SUBPART D
| Subpart D - Procedures for Regulatory Hearing | |
| 21:1.0.1.1.14.4.63.1 | SECTION 16.60
| 16.60 Hearing procedure. | |
| 21:1.0.1.1.14.4.63.2 | SECTION 16.62
| 16.62 Right to counsel. | |
| 21:1.0.1.1.14.5 | SUBPART E
| Subpart E - Administrative Record and Decision | |
| 21:1.0.1.1.14.5.63.1 | SECTION 16.80
| 16.80 Administrative record of a regulatory hearing. | |
| 21:1.0.1.1.14.5.63.2 | SECTION 16.85
| 16.85 Examination of administrative record. | |
| 21:1.0.1.1.14.5.63.3 | SECTION 16.95
| 16.95 Administrative decision and record for decision. | |
| 21:1.0.1.1.14.6 | SUBPART F
| Subpart F - Reconsideration and Stay | |
| 21:1.0.1.1.14.6.63.1 | SECTION 16.119
| 16.119 Reconsideration and stay of action. | |
| 21:1.0.1.1.14.7 | SUBPART G
| Subpart G - Judicial Review | |
| 21:1.0.1.1.14.7.63.1 | SECTION 16.120
| 16.120 Judicial review. | |
| 21:1.0.1.1.15 | PART 17
| PART 17 - CIVIL MONEY PENALTIES HEARINGS | |
| 21:1.0.1.1.15.0.63.1 | SECTION 17.1
| 17.1 Scope. | |
| 21:1.0.1.1.15.0.63.2 | SECTION 17.2
| 17.2 Maximum penalty amounts. | |
| 21:1.0.1.1.15.0.63.3 | SECTION 17.3
| 17.3 Definitions. | |
| 21:1.0.1.1.15.0.63.4 | SECTION 17.5
| 17.5 Complaint. | |
| 21:1.0.1.1.15.0.63.5 | SECTION 17.7
| 17.7 Service of complaint. | |
| 21:1.0.1.1.15.0.63.6 | SECTION 17.9
| 17.9 Answer. | |
| 21:1.0.1.1.15.0.63.7 | SECTION 17.11
| 17.11 Default upon failure to file an answer. | |
| 21:1.0.1.1.15.0.63.8 | SECTION 17.13
| 17.13 Notice of hearing. | |
| 21:1.0.1.1.15.0.63.9 | SECTION 17.15
| 17.15 Parties to the hearing. | |
| 21:1.0.1.1.15.0.63.10 | SECTION 17.17
| 17.17 Summary decisions. | |
| 21:1.0.1.1.15.0.63.11 | SECTION 17.18
| 17.18 Interlocutory appeal from ruling of presiding officer. | |
| 21:1.0.1.1.15.0.63.12 | SECTION 17.19
| 17.19 Authority of the presiding officer. | |
| 21:1.0.1.1.15.0.63.13 | SECTION 17.20
| 17.20 Ex parte contacts. | |
| 21:1.0.1.1.15.0.63.14 | SECTION 17.21
| 17.21 Prehearing conferences. | |
| 21:1.0.1.1.15.0.63.15 | SECTION 17.23
| 17.23 Discovery. | |
| 21:1.0.1.1.15.0.63.16 | SECTION 17.25
| 17.25 Exchange of witness lists, witness statements, and exhibits. | |
| 21:1.0.1.1.15.0.63.17 | SECTION 17.27
| 17.27 Hearing subpoenas. | |
| 21:1.0.1.1.15.0.63.18 | SECTION 17.28
| 17.28 Protective order. | |
| 21:1.0.1.1.15.0.63.19 | SECTION 17.29
| 17.29 Fees. | |
| 21:1.0.1.1.15.0.63.20 | SECTION 17.30
| 17.30 Computation of time. | |
| 21:1.0.1.1.15.0.63.21 | SECTION 17.31
| 17.31 Form, filing, and service of papers. | |
| 21:1.0.1.1.15.0.63.22 | SECTION 17.32
| 17.32 Motions. | |
| 21:1.0.1.1.15.0.63.23 | SECTION 17.33
| 17.33 The hearing and burden of proof. | |
| 21:1.0.1.1.15.0.63.24 | SECTION 17.34
| 17.34 Determining the amount of penalties and assessments. | |
| 21:1.0.1.1.15.0.63.25 | SECTION 17.35
| 17.35 Sanctions. | |
| 21:1.0.1.1.15.0.63.26 | SECTION 17.37
| 17.37 Witnesses. | |
| 21:1.0.1.1.15.0.63.27 | SECTION 17.39
| 17.39 Evidence. | |
| 21:1.0.1.1.15.0.63.28 | SECTION 17.41
| 17.41 The administrative record. | |
| 21:1.0.1.1.15.0.63.29 | SECTION 17.43
| 17.43 Posthearing briefs. | |
| 21:1.0.1.1.15.0.63.30 | SECTION 17.45
| 17.45 Initial decision. | |
| 21:1.0.1.1.15.0.63.31 | SECTION 17.47
| 17.47 Appeals. | |
| 21:1.0.1.1.15.0.63.32 | SECTION 17.48
| 17.48 Harmless error. | |
| 21:1.0.1.1.15.0.63.33 | SECTION 17.51
| 17.51 Judicial review. | |
| 21:1.0.1.1.15.0.63.34 | SECTION 17.54
| 17.54 Deposit in the Treasury of the United States. | |
| 21:1.0.1.1.16 | PART 19
| PART 19 - STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST | |
| 21:1.0.1.1.16.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.16.1.63.1 | SECTION 19.1
| 19.1 Scope. | |
| 21:1.0.1.1.16.1.63.2 | SECTION 19.5
| 19.5 Reference to Department regulations. | |
| 21:1.0.1.1.16.1.63.3 | SECTION 19.6
| 19.6 Code of ethics for government service. | |
| 21:1.0.1.1.16.1.63.4 | SECTION 19.10
| 19.10 Food and Drug Administration Conflict of Interest Review Board. | |
| 21:1.0.1.1.16.2 | SUBPART B
| Subpart B - Reporting of Violations | |
| 21:1.0.1.1.16.2.63.1 | SECTION 19.21
| 19.21 Duty to report violations. | |
| 21:1.0.1.1.16.3 | SUBPART C
| Subpart C - Disqualification Conditions | |
| 21:1.0.1.1.16.3.63.1 | SECTION 19.45
| 19.45 Temporary disqualification of former employees. | |
| 21:1.0.1.1.16.3.63.2 | SECTION 19.55
| 19.55 Permanent disqualification of former employees. | |
| 21:1.0.1.1.17 | PART 20
| PART 20 - PUBLIC INFORMATION | |
| 21:1.0.1.1.17.1 | SUBPART A
| Subpart A - Official Testimony and Information | |
| 21:1.0.1.1.17.1.63.1 | SECTION 20.1
| 20.1 Testimony by Food and Drug Administration employees. | |
| 21:1.0.1.1.17.1.63.2 | SECTION 20.2
| 20.2 Production of records by Food and Drug Administration employees. | |
| 21:1.0.1.1.17.1.63.3 | SECTION 20.3
| 20.3 Certification and authentication of Food and Drug Administration records. | |
| 21:1.0.1.1.17.2 | SUBPART B
| Subpart B - General Policy | |
| 21:1.0.1.1.17.2.63.1 | SECTION 20.20
| 20.20 Policy on disclosure of Food and Drug Administration records. | |
| 21:1.0.1.1.17.2.63.2 | SECTION 20.21
| 20.21 Uniform access to records. | |
| 21:1.0.1.1.17.2.63.3 | SECTION 20.22
| 20.22 Partial disclosure of records. | |
| 21:1.0.1.1.17.2.63.4 | SECTION 20.23
| 20.23 Request for existing records. | |
| 21:1.0.1.1.17.2.63.5 | SECTION 20.24
| 20.24 Preparation of new records. | |
| 21:1.0.1.1.17.2.63.6 | SECTION 20.25
| 20.25 Retroactive application of regulations. | |
| 21:1.0.1.1.17.2.63.7 | SECTION 20.26
| 20.26 Indexes of certain records. | |
| 21:1.0.1.1.17.2.63.8 | SECTION 20.27
| 20.27 Submission of records marked as confidential. | |
| 21:1.0.1.1.17.2.63.9 | SECTION 20.28
| 20.28 Food and Drug Administration determinations of confidentiality. | |
| 21:1.0.1.1.17.2.63.10 | SECTION 20.29
| 20.29 Prohibition on withdrawal of records from Food and Drug Administration files. | |
| 21:1.0.1.1.17.2.63.11 | SECTION 20.30
| 20.30 Food and Drug Administration Division of Freedom of Information. | |
| 21:1.0.1.1.17.2.63.12 | SECTION 20.31
| 20.31 Retention schedule of requests for Food and Drug Administration records. | |
| 21:1.0.1.1.17.2.63.13 | SECTION 20.32
| 20.32 Disclosure of Food and Drug Administration employee names. | |
| 21:1.0.1.1.17.2.63.14 | SECTION 20.33
| 20.33 Form or format of response. | |
| 21:1.0.1.1.17.2.63.15 | SECTION 20.34
| 20.34 Search for records. | |
| 21:1.0.1.1.17.3 | SUBPART C
| Subpart C - Procedures and Fees | |
| 21:1.0.1.1.17.3.63.1 | SECTION 20.40
| 20.40 Filing a request for records. | |
| 21:1.0.1.1.17.3.63.2 | SECTION 20.41
| 20.41 Time limitations. | |
| 21:1.0.1.1.17.3.63.3 | SECTION 20.42
| 20.42 Aggregation of certain requests. | |
| 21:1.0.1.1.17.3.63.4 | SECTION 20.43
| 20.43 Multitrack processing. | |
| 21:1.0.1.1.17.3.63.5 | SECTION 20.44
| 20.44 Expedited processing. | |
| 21:1.0.1.1.17.3.63.6 | SECTION 20.45
| 20.45 Fees to be charged. | |
| 21:1.0.1.1.17.3.63.7 | SECTION 20.46
| 20.46 Waiver or reduction of fees. | |
| 21:1.0.1.1.17.3.63.8 | SECTION 20.47
| 20.47 Situations in which confidentiality is uncertain. | |
| 21:1.0.1.1.17.3.63.9 | SECTION 20.48
| 20.48 Judicial review of proposed disclosure. | |
| 21:1.0.1.1.17.3.63.10 | SECTION 20.49
| 20.49 Denial of a request for records. | |
| 21:1.0.1.1.17.3.63.11 | SECTION 20.50
| 20.50 Nonspecific and overly burdensome requests. | |
| 21:1.0.1.1.17.3.63.12 | SECTION 20.51
| 20.51 Referral to primary source of records. | |
| 21:1.0.1.1.17.3.63.13 | SECTION 20.52
| 20.52 Availability of records at National Technical Information Service. | |
| 21:1.0.1.1.17.3.63.14 | SECTION 20.53
| 20.53 Use of private contractor for copying. | |
| 21:1.0.1.1.17.3.63.15 | SECTION 20.54
| 20.54 Request for review without copying. | |
| 21:1.0.1.1.17.3.63.16 | SECTION 20.55
| 20.55 Indexing trade secrets and confidential commercial or financial information. | |
| 21:1.0.1.1.17.4 | SUBPART D
| Subpart D - Exemptions | |
| 21:1.0.1.1.17.4.63.1 | SECTION 20.60
| 20.60 Applicability of exemptions. | |
| 21:1.0.1.1.17.4.63.2 | SECTION 20.61
| 20.61 Trade secrets and commercial or financial information which is privileged or confidential. | |
| 21:1.0.1.1.17.4.63.3 | SECTION 20.62
| 20.62 Inter- or intra-agency memoranda or letters. | |
| 21:1.0.1.1.17.4.63.4 | SECTION 20.63
| 20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy. | |
| 21:1.0.1.1.17.4.63.5 | SECTION 20.64
| 20.64 Records or information compiled for law enforcement purposes. | |
| 21:1.0.1.1.17.4.63.6 | SECTION 20.65
| 20.65 National defense and foreign policy. | |
| 21:1.0.1.1.17.4.63.7 | SECTION 20.66
| 20.66 Internal personnel rules and practices. | |
| 21:1.0.1.1.17.4.63.8 | SECTION 20.67
| 20.67 Records exempted by other statutes. | |
| 21:1.0.1.1.17.5 | SUBPART E
| Subpart E - Limitations on Exemptions | |
| 21:1.0.1.1.17.5.63.1 | SECTION 20.80
| 20.80 Applicability of limitations on exemptions. | |
| 21:1.0.1.1.17.5.63.2 | SECTION 20.81
| 20.81 Data and information previously disclosed to the public. | |
| 21:1.0.1.1.17.5.63.3 | SECTION 20.82
| 20.82 Discretionary disclosure by the Commissioner. | |
| 21:1.0.1.1.17.5.63.4 | SECTION 20.83
| 20.83 Disclosure required by court order. | |
| 21:1.0.1.1.17.5.63.5 | SECTION 20.84
| 20.84 Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees. | |
| 21:1.0.1.1.17.5.63.6 | SECTION 20.85
| 20.85 Disclosure to other Federal government departments and agencies. | |
| 21:1.0.1.1.17.5.63.7 | SECTION 20.86
| 20.86 Disclosure in administrative or court proceedings. | |
| 21:1.0.1.1.17.5.63.8 | SECTION 20.87
| 20.87 Disclosure to Congress. | |
| 21:1.0.1.1.17.5.63.9 | SECTION 20.88
| 20.88 Communications with State and local government officials. | |
| 21:1.0.1.1.17.5.63.10 | SECTION 20.89
| 20.89 Communications with foreign government officials. | |
| 21:1.0.1.1.17.5.63.11 | SECTION 20.90
| 20.90 Disclosure to contractors. | |
| 21:1.0.1.1.17.5.63.12 | SECTION 20.91
| 20.91 Use of data or information for administrative or court enforcement action. | |
| 21:1.0.1.1.17.6 | SUBPART F
| Subpart F - Availability of Specific Categories of Records | |
| 21:1.0.1.1.17.6.63.1 | SECTION 20.100
| 20.100 Applicability; cross-reference to other regulations. | |
| 21:1.0.1.1.17.6.63.2 | SECTION 20.101
| 20.101 Administrative enforcement records. | |
| 21:1.0.1.1.17.6.63.3 | SECTION 20.102
| 20.102 Court enforcement records. | |
| 21:1.0.1.1.17.6.63.4 | SECTION 20.103
| 20.103 Correspondence. | |
| 21:1.0.1.1.17.6.63.5 | SECTION 20.104
| 20.104 Summaries of oral discussions. | |
| 21:1.0.1.1.17.6.63.6 | SECTION 20.105
| 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration. | |
| 21:1.0.1.1.17.6.63.7 | SECTION 20.106
| 20.106 Studies and reports prepared by or with funds provided by the Food and Drug Administration. | |
| 21:1.0.1.1.17.6.63.8 | SECTION 20.107
| 20.107 Food and Drug Administration manuals. | |
| 21:1.0.1.1.17.6.63.9 | SECTION 20.108
| 20.108 Agreements between the Food and Drug Administration and other departments, agencies, and organizations. | |
| 21:1.0.1.1.17.6.63.10 | SECTION 20.109
| 20.109 Data and information obtained by contract. | |
| 21:1.0.1.1.17.6.63.11 | SECTION 20.110
| 20.110 Data and information about Food and Drug Administration employees. | |
| 21:1.0.1.1.17.6.63.12 | SECTION 20.111
| 20.111 Data and information submitted voluntarily to the Food and Drug Administration. | |
| 21:1.0.1.1.17.6.63.13 | SECTION 20.112
| 20.112 Voluntary drug experience reports submitted by physicians and hospitals. | |
| 21:1.0.1.1.17.6.63.14 | SECTION 20.113
| 20.113 Voluntary product defect reports. | |
| 21:1.0.1.1.17.6.63.15 | SECTION 20.114
| 20.114 Data and information submitted pursuant to cooperative quality assurance agreements. | |
| 21:1.0.1.1.17.6.63.16 | SECTION 20.115
| 20.115 Product codes for manufacturing or sales dates. | |
| 21:1.0.1.1.17.6.63.17 | SECTION 20.116
| 20.116 Drug and device registration and listing information. | |
| 21:1.0.1.1.17.6.63.18 | SECTION 20.117
| 20.117 New drug information. | |
| 21:1.0.1.1.17.6.63.19 | SECTION 20.118
| 20.118 Advisory committee records. | |
| 21:1.0.1.1.17.6.63.20 | SECTION 20.119
| 20.119 Lists of names and addresses. | |
| 21:1.0.1.1.17.6.63.21 | SECTION 20.120
| 20.120 Records available in Food and Drug Administration Public Reading Rooms. | |
| 21:1.0.1.1.18 | PART 21
| PART 21 - PROTECTION OF PRIVACY | |
| 21:1.0.1.1.18.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.18.1.63.1 | SECTION 21.1
| 21.1 Scope. | |
| 21:1.0.1.1.18.1.63.2 | SECTION 21.3
| 21.3 Definitions. | |
| 21:1.0.1.1.18.1.63.3 | SECTION 21.10
| 21.10 Policy concerning records about individuals. | |
| 21:1.0.1.1.18.2 | SUBPART B
| Subpart B - Food and Drug Administration Privacy Act Record Systems | |
| 21:1.0.1.1.18.2.63.1 | SECTION 21.20
| 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record Systems. | |
| 21:1.0.1.1.18.2.63.2 | SECTION 21.21
| 21.21 Changes in systems and new systems. | |
| 21:1.0.1.1.18.3 | SUBPART C
| Subpart C - Requirements for Specific Categories of Records | |
| 21:1.0.1.1.18.3.63.1 | SECTION 21.30
| 21.30 Records of contractors. | |
| 21:1.0.1.1.18.3.63.2 | SECTION 21.31
| 21.31 Records stored by the National Archives and Records Administration. | |
| 21:1.0.1.1.18.3.63.3 | SECTION 21.32
| 21.32 Personnel records. | |
| 21:1.0.1.1.18.3.63.4 | SECTION 21.33
| 21.33 Medical records. | |
| 21:1.0.1.1.18.4 | SUBPART D
| Subpart D - Procedures for Notification of and Access to Records in Privacy Act Record Systems | |
| 21:1.0.1.1.18.4.63.1 | SECTION 21.40
| 21.40 Procedures for submitting requests for notification and access. | |
| 21:1.0.1.1.18.4.63.2 | SECTION 21.41
| 21.41 Processing of requests. | |
| 21:1.0.1.1.18.4.63.3 | SECTION 21.42
| 21.42 Responses to requests. | |
| 21:1.0.1.1.18.4.63.4 | SECTION 21.43
| 21.43 Access to requested records. | |
| 21:1.0.1.1.18.4.63.5 | SECTION 21.44
| 21.44 Verification of identity. | |
| 21:1.0.1.1.18.4.63.6 | SECTION 21.45
| 21.45 Fees. | |
| 21:1.0.1.1.18.5 | SUBPART E
| Subpart E - Procedures for Requests for Amendment of Records | |
| 21:1.0.1.1.18.5.63.1 | SECTION 21.50
| 21.50 Procedures for submitting requests for amendment of records. | |
| 21:1.0.1.1.18.5.63.2 | SECTION 21.51
| 21.51 Responses to requests for amendment of records. | |
| 21:1.0.1.1.18.5.63.3 | SECTION 21.52
| 21.52 Administrative appeals of refusals to amend records. | |
| 21:1.0.1.1.18.5.63.4 | SECTION 21.53
| 21.53 Notation and disclosure of disputed records. | |
| 21:1.0.1.1.18.5.63.5 | SECTION 21.54
| 21.54 Amended or disputed records received from other agencies. | |
| 21:1.0.1.1.18.6 | SUBPART F
| Subpart F - Exemptions | |
| 21:1.0.1.1.18.6.63.1 | SECTION 21.60
| 21.60 Policy. | |
| 21:1.0.1.1.18.6.63.2 | SECTION 21.61
| 21.61 Exempt systems. | |
| 21:1.0.1.1.18.6.63.3 | SECTION 21.65
| 21.65 Access to records in exempt systems. | |
| 21:1.0.1.1.18.7 | SUBPART G
| Subpart G - Disclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject Individual | |
| 21:1.0.1.1.18.7.63.1 | SECTION 21.70
| 21.70 Disclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required. | |
| 21:1.0.1.1.18.7.63.2 | SECTION 21.71
| 21.71 Disclosure of records in Privacy Act Record Systems; accounting required. | |
| 21:1.0.1.1.18.7.63.3 | SECTION 21.72
| 21.72 Individual consent to disclosure of records to other persons. | |
| 21:1.0.1.1.18.7.63.4 | SECTION 21.73
| 21.73 Accuracy, completeness, timeliness, and relevance of records disclosed from Privacy Act Record Systems. | |
| 21:1.0.1.1.18.7.63.5 | SECTION 21.74
| 21.74 Providing notice that a record is disputed. | |
| 21:1.0.1.1.18.7.63.6 | SECTION 21.75
| 21.75 Rights of legal guardians. | |
| 21:1.0.1.1.19 | PART 25
| PART 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS | |
| 21:1.0.1.1.19.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.19.1.63.1 | SECTION 25.1
| 25.1 Purpose. | |
| 21:1.0.1.1.19.1.63.2 | SECTION 25.5
| 25.5 Terminology. | |
| 21:1.0.1.1.19.1.63.3 | SECTION 25.10
| 25.10 Policies and NEPA planning. | |
| 21:1.0.1.1.19.2 | SUBPART B
| Subpart B - Agency Actions Requiring Environmental Consideration | |
| 21:1.0.1.1.19.2.63.1 | SECTION 25.15
| 25.15 General procedures. | |
| 21:1.0.1.1.19.2.63.2 | SECTION 25.16
| 25.16 Public health and safety emergencies. | |
| 21:1.0.1.1.19.2.63.3 | SECTION 25.20
| 25.20 Actions requiring preparation of an environmental assessment. | |
| 21:1.0.1.1.19.2.63.4 | SECTION 25.21
| 25.21 Extraordinary circumstances. | |
| 21:1.0.1.1.19.2.63.5 | SECTION 25.22
| 25.22 Actions requiring the preparation of an environmental impact statement. | |
| 21:1.0.1.1.19.3 | SUBPART C
| Subpart C - Categorical Exclusions | |
| 21:1.0.1.1.19.3.63.1 | SECTION 25.30
| 25.30 General. | |
| 21:1.0.1.1.19.3.63.2 | SECTION 25.31
| 25.31 Human drugs and biologics. | |
| 21:1.0.1.1.19.3.63.3 | SECTION 25.32
| 25.32 Foods, food additives, and color additives. | |
| 21:1.0.1.1.19.3.63.4 | SECTION 25.33
| 25.33 Animal drugs. | |
| 21:1.0.1.1.19.3.63.5 | SECTION 25.34
| 25.34 Devices and electronic products. | |
| 21:1.0.1.1.19.3.63.6 | SECTION 25.35
| 25.35 Tobacco product applications. | |
| 21:1.0.1.1.19.4 | SUBPART D
| Subpart D - Preparation of Environmental Documents | |
| 21:1.0.1.1.19.4.63.1 | SECTION 25.40
| 25.40 Environmental assessments. | |
| 21:1.0.1.1.19.4.63.2 | SECTION 25.41
| 25.41 Findings of no significant impact. | |
| 21:1.0.1.1.19.4.63.3 | SECTION 25.42
| 25.42 Environmental impact statements. | |
| 21:1.0.1.1.19.4.63.4 | SECTION 25.43
| 25.43 Records of decision. | |
| 21:1.0.1.1.19.4.63.5 | SECTION 25.44
| 25.44 Lead and cooperating agencies. | |
| 21:1.0.1.1.19.4.63.6 | SECTION 25.45
| 25.45 Responsible agency official. | |
| 21:1.0.1.1.19.5 | SUBPART E
| Subpart E - Public Participation and Notification of Environmental Documents | |
| 21:1.0.1.1.19.5.63.1 | SECTION 25.50
| 25.50 General information. | |
| 21:1.0.1.1.19.5.63.2 | SECTION 25.51
| 25.51 Environmental assessments and findings of no significant impact. | |
| 21:1.0.1.1.19.5.63.3 | SECTION 25.52
| 25.52 Environmental impact statements. | |
| 21:1.0.1.1.19.6 | SUBPART F
| Subpart F - Other Requirements | |
| 21:1.0.1.1.19.6.63.1 | SECTION 25.60
| 25.60 Environmental effects abroad of major agency actions. | |
| 21:1.0.1.1.20 | PART 26
| PART 26 - MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY | |
| 21:1.0.1.1.20.0.63.1 | SECTION 26.0
| 26.0 General. | |
| 21:1.0.1.1.20.1 | SUBPART A
| Subpart A - Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices | |
| 21:1.0.1.1.20.1.63.1 | SECTION 26.1
| 26.1 Definitions. | |
| 21:1.0.1.1.20.1.63.2 | SECTION 26.2
| 26.2 Purpose. | |
| 21:1.0.1.1.20.1.63.3 | SECTION 26.3
| 26.3 Scope. | |
| 21:1.0.1.1.20.1.63.4 | SECTION 26.4
| 26.4 Product coverage. | |
| 21:1.0.1.1.20.1.63.5 | SECTION 26.5
| 26.5 Length of transition period. | |
| 21:1.0.1.1.20.1.63.6 | SECTION 26.6
| 26.6 Equivalence assessment. | |
| 21:1.0.1.1.20.1.63.7 | SECTION 26.7
| 26.7 Participation in the equivalence assessment and determination. | |
| 21:1.0.1.1.20.1.63.8 | SECTION 26.8
| 26.8 Other transition activities. | |
| 21:1.0.1.1.20.1.63.9 | SECTION 26.9
| 26.9 Equivalence determination. | |
| 21:1.0.1.1.20.1.63.10 | SECTION 26.10
| 26.10 Regulatory authorities not listed as currently equivalent. | |
| 21:1.0.1.1.20.1.63.11 | SECTION 26.11
| 26.11 Start of operational period. | |
| 21:1.0.1.1.20.1.63.12 | SECTION 26.12
| 26.12 Nature of recognition of inspection reports. | |
| 21:1.0.1.1.20.1.63.13 | SECTION 26.13
| 26.13 Transmission of postapproval inspection reports. | |
| 21:1.0.1.1.20.1.63.14 | SECTION 26.14
| 26.14 Transmission of preapproval inspection reports. | |
| 21:1.0.1.1.20.1.63.15 | SECTION 26.15
| 26.15 Monitoring continued equivalence. | |
| 21:1.0.1.1.20.1.63.16 | SECTION 26.16
| 26.16 Suspension. | |
| 21:1.0.1.1.20.1.63.17 | SECTION 26.17
| 26.17 Role and composition of the Joint Sectoral Committee. | |
| 21:1.0.1.1.20.1.63.18 | SECTION 26.18
| 26.18 Regulatory collaboration. | |
| 21:1.0.1.1.20.1.63.19 | SECTION 26.19
| 26.19 Information relating to quality aspects. | |
| 21:1.0.1.1.20.1.63.20 | SECTION 26.20
| 26.20 Alert system. | |
| 21:1.0.1.1.20.1.63.21 | SECTION 26.21
| 26.21 Safeguard clause. | |
| 21:1.0.1.1.20.1.63.22.1 | APPENDIX Appendix A
| Appendix A to Subpart A of Part 26 - List of Applicable Laws, Regulations, and Administrative Provisions | |
| 21:1.0.1.1.20.1.63.22.2 | APPENDIX Appendix B
| Appendix B to Subpart A of Part 26 - List of Authorities | |
| 21:1.0.1.1.20.1.63.22.3 | APPENDIX Appendix C
| Appendix C to Subpart A of Part 26 - Indicative List of Products Covered by Subpart A | |
| 21:1.0.1.1.20.1.63.22.4 | APPENDIX Appendix D
| Appendix D to Subpart A of Part 26 - Criteria for Assessing Equivalence for Post- and Preapproval | |
| 21:1.0.1.1.20.1.63.22.5 | APPENDIX Appendix E
| Appendix E to Subpart A of Part 26 - Elements To Be Considered in Developing a Two-Way Alert System | |
| 21:1.0.1.1.20.2 | SUBPART B
| Subpart B - Specific Sector Provisions for Medical Devices | |
| 21:1.0.1.1.20.2.63.1 | SECTION 26.31
| 26.31 Purpose. | |
| 21:1.0.1.1.20.2.63.2 | SECTION 26.32
| 26.32 Scope. | |
| 21:1.0.1.1.20.2.63.3 | SECTION 26.33
| 26.33 Product coverage. | |
| 21:1.0.1.1.20.2.63.4 | SECTION 26.34
| 26.34 Regulatory authorities. | |
| 21:1.0.1.1.20.2.63.5 | SECTION 26.35
| 26.35 Length and purpose of transition period. | |
| 21:1.0.1.1.20.2.63.6 | SECTION 26.36
| 26.36 Listing of CAB's. | |
| 21:1.0.1.1.20.2.63.7 | SECTION 26.37
| 26.37 Confidence building activities. | |
| 21:1.0.1.1.20.2.63.8 | SECTION 26.38
| 26.38 Other transition period activities. | |
| 21:1.0.1.1.20.2.63.9 | SECTION 26.39
| 26.39 Equivalence assessment. | |
| 21:1.0.1.1.20.2.63.10 | SECTION 26.40
| 26.40 Start of the operational period. | |
| 21:1.0.1.1.20.2.63.11 | SECTION 26.41
| 26.41 Exchange and endorsement of quality system evaluation reports. | |
| 21:1.0.1.1.20.2.63.12 | SECTION 26.42
| 26.42 Exchange and endorsement of product evaluation reports. | |
| 21:1.0.1.1.20.2.63.13 | SECTION 26.43
| 26.43 Transmission of quality system evaluation reports. | |
| 21:1.0.1.1.20.2.63.14 | SECTION 26.44
| 26.44 Transmission of product evaluation reports. | |
| 21:1.0.1.1.20.2.63.15 | SECTION 26.45
| 26.45 Monitoring continued equivalence. | |
| 21:1.0.1.1.20.2.63.16 | SECTION 26.46
| 26.46 Listing of additional CAB's. | |
| 21:1.0.1.1.20.2.63.17 | SECTION 26.47
| 26.47 Role and composition of the Joint Sectoral Committee. | |
| 21:1.0.1.1.20.2.63.18 | SECTION 26.48
| 26.48 Harmonization. | |
| 21:1.0.1.1.20.2.63.19 | SECTION 26.49
| 26.49 Regulatory cooperation. | |
| 21:1.0.1.1.20.2.63.20 | SECTION 26.50
| 26.50 Alert system and exchange of postmarket vigilance reports. | |
| 21:1.0.1.1.20.2.63.21.6 | APPENDIX Appendix A
| Appendix A to Subpart B of Part 26 - Relevant Legislation, Regulations, and Procedures. | |
| 21:1.0.1.1.20.2.63.21.7 | APPENDIX Appendix B
| Appendix B to Subpart B of Part 26 - Scope of Product Coverage | |
| 21:1.0.1.1.20.2.63.21.8 | APPENDIX
| Appendixes C-F to Subpart B of Part 26 [Reserved] | |
| 21:1.0.1.1.20.3 | SUBPART C
| Subpart C - “Framework” Provisions | |
| 21:1.0.1.1.20.3.63.1 | SECTION 26.60
| 26.60 Definitions. | |
| 21:1.0.1.1.20.3.63.2 | SECTION 26.61
| 26.61 Purpose of this part. | |
| 21:1.0.1.1.20.3.63.3 | SECTION 26.62
| 26.62 General obligations. | |
| 21:1.0.1.1.20.3.63.4 | SECTION 26.63
| 26.63 General coverage of this part. | |
| 21:1.0.1.1.20.3.63.5 | SECTION 26.64
| 26.64 Transitional arrangements. | |
| 21:1.0.1.1.20.3.63.6 | SECTION 26.65
| 26.65 Designating authorities. | |
| 21:1.0.1.1.20.3.63.7 | SECTION 26.66
| 26.66 Designation and listing procedures. | |
| 21:1.0.1.1.20.3.63.8 | SECTION 26.67
| 26.67 Suspension of listed conformity assessment bodies. | |
| 21:1.0.1.1.20.3.63.9 | SECTION 26.68
| 26.68 Withdrawal of listed conformity assessment bodies. | |
| 21:1.0.1.1.20.3.63.10 | SECTION 26.69
| 26.69 Monitoring of conformity assessment bodies. | |
| 21:1.0.1.1.20.3.63.11 | SECTION 26.70
| 26.70 Conformity assessment bodies. | |
| 21:1.0.1.1.20.3.63.12 | SECTION 26.71
| 26.71 Exchange of information. | |
| 21:1.0.1.1.20.3.63.13 | SECTION 26.72
| 26.72 Sectoral contact points. | |
| 21:1.0.1.1.20.3.63.14 | SECTION 26.73
| 26.73 Joint Committee. | |
| 21:1.0.1.1.20.3.63.15 | SECTION 26.74
| 26.74 Preservation of regulatory authority. | |
| 21:1.0.1.1.20.3.63.16 | SECTION 26.75
| 26.75 Suspension of recognition obligations. | |
| 21:1.0.1.1.20.3.63.17 | SECTION 26.76
| 26.76 Confidentiality. | |
| 21:1.0.1.1.20.3.63.18 | SECTION 26.77
| 26.77 Fees. | |
| 21:1.0.1.1.20.3.63.19 | SECTION 26.78
| 26.78 Agreements with other countries. | |
| 21:1.0.1.1.20.3.63.20 | SECTION 26.79
| 26.79 Territorial application. | |
| 21:1.0.1.1.20.3.63.21 | SECTION 26.80
| 26.80 Entry into force, amendment, and termination. | |
| 21:1.0.1.1.20.3.63.22 | SECTION 26.81
| 26.81 Final provisions. | |
| 21:1.0.1.1.21 | PART 50
| PART 50 - PROTECTION OF HUMAN SUBJECTS | |
| 21:1.0.1.1.21.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.21.1.63.1 | SECTION 50.1
| 50.1 Scope. | |
| 21:1.0.1.1.21.1.63.2 | SECTION 50.3
| 50.3 Definitions. | |
| 21:1.0.1.1.21.2 | SUBPART B
| Subpart B - Informed Consent of Human Subjects | |
| 21:1.0.1.1.21.2.63.1 | SECTION 50.20
| 50.20 General requirements for informed consent. | |
| 21:1.0.1.1.21.2.63.2 | SECTION 50.23
| 50.23 Exception from general requirements. | |
| 21:1.0.1.1.21.2.63.3 | SECTION 50.24
| 50.24 Exception from informed consent requirements for emergency research. | |
| 21:1.0.1.1.21.2.63.4 | SECTION 50.25
| 50.25 Elements of informed consent. | |
| 21:1.0.1.1.21.2.63.5 | SECTION 50.27
| 50.27 Documentation of informed consent. | |
| 21:1.0.1.1.21.3 | SUBPART C
| Subpart C [Reserved] | |
| 21:1.0.1.1.21.4 | SUBPART D
| Subpart D - Additional Safeguards for Children in Clinical Investigations | |
| 21:1.0.1.1.21.4.63.1 | SECTION 50.50
| 50.50 IRB duties. | |
| 21:1.0.1.1.21.4.63.2 | SECTION 50.51
| 50.51 Clinical investigations not involving greater than minimal risk. | |
| 21:1.0.1.1.21.4.63.3 | SECTION 50.52
| 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects. | |
| 21:1.0.1.1.21.4.63.4 | SECTION 50.53
| 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition. | |
| 21:1.0.1.1.21.4.63.5 | SECTION 50.54
| 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. | |
| 21:1.0.1.1.21.4.63.6 | SECTION 50.55
| 50.55 Requirements for permission by parents or guardians and for assent by children. | |
| 21:1.0.1.1.21.4.63.7 | SECTION 50.56
| 50.56 Wards. | |
| 21:1.0.1.1.22 | PART 54
| PART 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS | |
| 21:1.0.1.1.22.0.63.1 | SECTION 54.1
| 54.1 Purpose. | |
| 21:1.0.1.1.22.0.63.2 | SECTION 54.2
| 54.2 Definitions. | |
| 21:1.0.1.1.22.0.63.3 | SECTION 54.3
| 54.3 Scope. | |
| 21:1.0.1.1.22.0.63.4 | SECTION 54.4
| 54.4 Certification and disclosure requirements. | |
| 21:1.0.1.1.22.0.63.5 | SECTION 54.5
| 54.5 Agency evaluation of financial interests. | |
| 21:1.0.1.1.22.0.63.6 | SECTION 54.6
| 54.6 Recordkeeping and record retention. | |
| 21:1.0.1.1.23 | PART 56
| PART 56 - INSTITUTIONAL REVIEW BOARDS | |
| 21:1.0.1.1.23.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.23.1.63.1 | SECTION 56.101
| 56.101 Scope. | |
| 21:1.0.1.1.23.1.63.2 | SECTION 56.102
| 56.102 Definitions. | |
| 21:1.0.1.1.23.1.63.3 | SECTION 56.103
| 56.103 Circumstances in which IRB review is required. | |
| 21:1.0.1.1.23.1.63.4 | SECTION 56.104
| 56.104 Exemptions from IRB requirement. | |
| 21:1.0.1.1.23.1.63.5 | SECTION 56.105
| 56.105 Waiver of IRB requirement. | |
| 21:1.0.1.1.23.2 | SUBPART B
| Subpart B - Organization and Personnel | |
| 21:1.0.1.1.23.2.63.1 | SECTION 56.106
| 56.106 Registration. | |
| 21:1.0.1.1.23.2.63.2 | SECTION 56.107
| 56.107 IRB membership. | |
| 21:1.0.1.1.23.3 | SUBPART C
| Subpart C - IRB Functions and Operations | |
| 21:1.0.1.1.23.3.63.1 | SECTION 56.108
| 56.108 IRB functions and operations. | |
| 21:1.0.1.1.23.3.63.2 | SECTION 56.109
| 56.109 IRB review of research. | |
| 21:1.0.1.1.23.3.63.3 | SECTION 56.110
| 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. | |
| 21:1.0.1.1.23.3.63.4 | SECTION 56.111
| 56.111 Criteria for IRB approval of research. | |
| 21:1.0.1.1.23.3.63.5 | SECTION 56.112
| 56.112 Review by institution. | |
| 21:1.0.1.1.23.3.63.6 | SECTION 56.113
| 56.113 Suspension or termination of IRB approval of research. | |
| 21:1.0.1.1.23.3.63.7 | SECTION 56.114
| 56.114 Cooperative research. | |
| 21:1.0.1.1.23.4 | SUBPART D
| Subpart D - Records and Reports | |
| 21:1.0.1.1.23.4.63.1 | SECTION 56.115
| 56.115 IRB records. | |
| 21:1.0.1.1.23.5 | SUBPART E
| Subpart E - Administrative Actions for Noncompliance | |
| 21:1.0.1.1.23.5.63.1 | SECTION 56.120
| 56.120 Lesser administrative actions. | |
| 21:1.0.1.1.23.5.63.2 | SECTION 56.121
| 56.121 Disqualification of an IRB or an institution. | |
| 21:1.0.1.1.23.5.63.3 | SECTION 56.122
| 56.122 Public disclosure of information regarding revocation. | |
| 21:1.0.1.1.23.5.63.4 | SECTION 56.123
| 56.123 Reinstatement of an IRB or an institution. | |
| 21:1.0.1.1.23.5.63.5 | SECTION 56.124
| 56.124 Actions alternative or additional to disqualification. | |
| 21:1.0.1.1.24 | PART 58
| PART 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES | |
| 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. | |
| 21:1.0.1.1.25 | PART 60
| PART 60 - PATENT TERM RESTORATION | |
| 21:1.0.1.1.25.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.25.1.63.1 | SECTION 60.1
| 60.1 Scope. | |
| 21:1.0.1.1.25.1.63.2 | SECTION 60.2
| 60.2 Purpose. | |
| 21:1.0.1.1.25.1.63.3 | SECTION 60.3
| 60.3 Definitions. | |
| 21:1.0.1.1.25.2 | SUBPART B
| Subpart B - Eligibility Assistance | |
| 21:1.0.1.1.25.2.63.1 | SECTION 60.10
| 60.10 FDA assistance on eligibility. | |
| 21:1.0.1.1.25.3 | SUBPART C
| Subpart C - Regulatory Review Period Determinations | |
| 21:1.0.1.1.25.3.63.1 | SECTION 60.20
| 60.20 FDA action on regulatory review period determinations. | |
| 21:1.0.1.1.25.3.63.2 | SECTION 60.22
| 60.22 Regulatory review period determinations. | |
| 21:1.0.1.1.25.3.63.3 | SECTION 60.24
| 60.24 Revision of regulatory review period determinations. | |
| 21:1.0.1.1.25.3.63.4 | SECTION 60.26
| 60.26 Final action on regulatory review period determinations. | |
| 21:1.0.1.1.25.3.63.5 | SECTION 60.28
| 60.28 Time frame for determining regulatory review periods. | |
| 21:1.0.1.1.25.4 | SUBPART D
| Subpart D - Due Diligence Petitions | |
| 21:1.0.1.1.25.4.63.1 | SECTION 60.30
| 60.30 Filing, format, and content of petitions. | |
| 21:1.0.1.1.25.4.63.2 | SECTION 60.32
| 60.32 Applicant response to petition. | |
| 21:1.0.1.1.25.4.63.3 | SECTION 60.34
| 60.34 FDA action on petitions. | |
| 21:1.0.1.1.25.4.63.4 | SECTION 60.36
| 60.36 Standard of due diligence. | |
| 21:1.0.1.1.25.5 | SUBPART E
| Subpart E - Due Diligence Hearings | |
| 21:1.0.1.1.25.5.63.1 | SECTION 60.40
| 60.40 Request for hearing. | |
| 21:1.0.1.1.25.5.63.2 | SECTION 60.42
| 60.42 Notice of hearing. | |
| 21:1.0.1.1.25.5.63.3 | SECTION 60.44
| 60.44 Hearing procedures. | |
| 21:1.0.1.1.25.5.63.4 | SECTION 60.46
| 60.46 Administrative decision. | |
| 21:1.0.1.1.26 | PART 70
| PART 70 - COLOR ADDITIVES | |
| 21:1.0.1.1.26.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.26.1.63.1 | SECTION 70.3
| 70.3 Definitions. | |
| 21:1.0.1.1.26.1.63.2 | SECTION 70.5
| 70.5 General restrictions on use of color additives. | |
| 21:1.0.1.1.26.1.63.3 | SECTION 70.10
| 70.10 Color additives in standardized foods and new drugs. | |
| 21:1.0.1.1.26.1.63.4 | SECTION 70.11
| 70.11 Related substances. | |
| 21:1.0.1.1.26.1.63.5 | SECTION 70.19
| 70.19 Fees for listing. | |
| 21:1.0.1.1.26.2 | SUBPART B
| Subpart B - Packaging and Labeling | |
| 21:1.0.1.1.26.2.63.1 | SECTION 70.20
| 70.20 Packaging requirements for straight colors (other than hair dyes). | |
| 21:1.0.1.1.26.2.63.2 | SECTION 70.25
| 70.25 Labeling requirements for color additives (other than hair dyes). | |
| 21:1.0.1.1.26.3 | SUBPART C
| Subpart C - Safety Evaluation | |
| 21:1.0.1.1.26.3.63.1 | SECTION 70.40
| 70.40 Safety factors to be considered. | |
| 21:1.0.1.1.26.3.63.2 | SECTION 70.42
| 70.42 Criteria for evaluating the safety of color additives. | |
| 21:1.0.1.1.26.3.63.3 | SECTION 70.45
| 70.45 Allocation of color additives. | |
| 21:1.0.1.1.26.3.63.4 | SECTION 70.50
| 70.50 Application of the cancer clause of section 721 of the act. | |
| 21:1.0.1.1.26.3.63.5 | SECTION 70.51
| 70.51 Advisory committee on the applicability of the anticancer clause. | |
| 21:1.0.1.1.26.3.63.6 | SECTION 70.55
| 70.55 Request for scientific studies. | |
| 21:1.0.1.1.27 | PART 71
| PART 71 - COLOR ADDITIVE PETITIONS | |
| 21:1.0.1.1.27.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.27.1.63.1 | SECTION 71.1
| 71.1 Petitions. | |
| 21:1.0.1.1.27.1.63.2 | SECTION 71.2
| 71.2 Notice of filing of petition. | |
| 21:1.0.1.1.27.1.63.3 | SECTION 71.4
| 71.4 Samples; additional information. | |
| 21:1.0.1.1.27.1.63.4 | SECTION 71.6
| 71.6 Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice. | |
| 21:1.0.1.1.27.1.63.5 | SECTION 71.15
| 71.15 Confidentiality of data and information in color additive petitions. | |
| 21:1.0.1.1.27.1.63.6 | SECTION 71.18
| 71.18 Petition for exemption from certification. | |
| 21:1.0.1.1.27.2 | SUBPART B
| Subpart B - Administrative Action on Petitions | |
| 21:1.0.1.1.27.2.63.1 | SECTION 71.20
| 71.20 Publication of regulation. | |
| 21:1.0.1.1.27.2.63.2 | SECTION 71.22
| 71.22 Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued. | |
| 21:1.0.1.1.27.2.63.3 | SECTION 71.25
| 71.25 Condition for certification. | |
| 21:1.0.1.1.27.2.63.4 | SECTION 71.26
| 71.26 Revocation of exemption from certification. | |
| 21:1.0.1.1.27.2.63.5 | SECTION 71.27
| 71.27 Listing and exemption from certification on the Commissioner's initiative. | |
| 21:1.0.1.1.27.2.63.6 | SECTION 71.30
| 71.30 Procedure for filing objections to regulations. | |
| 21:1.0.1.1.27.2.63.7 | SECTION 71.37
| 71.37 Exemption of color additives for investigational use. | |
| 21:1.0.1.1.28 | PART 73
| PART 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | |
| 21:1.0.1.1.28.1 | SUBPART A
| Subpart A - Foods | |
| 21:1.0.1.1.28.1.63.1 | SECTION 73.1
| 73.1 Diluents in color additive mixtures for food use exempt from certification. | |
| 21:1.0.1.1.28.1.63.2 | SECTION 73.30
| 73.30 Annatto extract. | |
| 21:1.0.1.1.28.1.63.3 | SECTION 73.35
| 73.35 Astaxanthin. | |
| 21:1.0.1.1.28.1.63.4 | SECTION 73.37
| 73.37 Astaxanthin dimethyldisuccinate. | |
| 21:1.0.1.1.28.1.63.5 | SECTION 73.40
| 73.40 Dehydrated beets (beet powder). | |
| 21:1.0.1.1.28.1.63.6 | SECTION 73.50
| 73.50 Ultramarine blue. | |
| 21:1.0.1.1.28.1.63.7 | SECTION 73.70
| 73.70 Calcium carbonate. | |
| 21:1.0.1.1.28.1.63.8 | SECTION 73.75
| 73.75 Canthaxanthin. | |
| 21:1.0.1.1.28.1.63.9 | SECTION 73.85
| 73.85 Caramel. | |
| 21:1.0.1.1.28.1.63.10 | SECTION 73.90
| 73.90 β-Apo-8′-carotenal. | |
| 21:1.0.1.1.28.1.63.11 | SECTION 73.95
| 73.95 β-Carotene. | |
| 21:1.0.1.1.28.1.63.12 | SECTION 73.100
| 73.100 Cochineal extract; carmine. | |
| 21:1.0.1.1.28.1.63.13 | SECTION 73.125
| 73.125 Sodium copper chlorophyllin. | |
| 21:1.0.1.1.28.1.63.14 | SECTION 73.140
| 73.140 Toasted partially defatted cooked cottonseed flour. | |
| 21:1.0.1.1.28.1.63.15 | SECTION 73.160
| 73.160 Ferrous gluconate. | |
| 21:1.0.1.1.28.1.63.16 | SECTION 73.165
| 73.165 Ferrous lactate. | |
| 21:1.0.1.1.28.1.63.17 | SECTION 73.169
| 73.169 Grape color extract. | |
| 21:1.0.1.1.28.1.63.18 | SECTION 73.170
| 73.170 Grape skin extract (enocianina). | |
| 21:1.0.1.1.28.1.63.19 | SECTION 73.185
| 73.185 Haematococcus algae meal. | |
| 21:1.0.1.1.28.1.63.20 | SECTION 73.200
| 73.200 Synthetic iron oxide. | |
| 21:1.0.1.1.28.1.63.21 | SECTION 73.250
| 73.250 Fruit juice. | |
| 21:1.0.1.1.28.1.63.22 | SECTION 73.260
| 73.260 Vegetable juice. | |
| 21:1.0.1.1.28.1.63.23 | SECTION 73.275
| 73.275 Dried algae meal. | |
| 21:1.0.1.1.28.1.63.24 | SECTION 73.295
| 73.295 Tagetes (Aztec marigold) meal and extract. | |
| 21:1.0.1.1.28.1.63.25 | SECTION 73.300
| 73.300 Carrot oil. | |
| 21:1.0.1.1.28.1.63.26 | SECTION 73.315
| 73.315 Corn endosperm oil. | |
| 21:1.0.1.1.28.1.63.27 | SECTION 73.340
| 73.340 Paprika. | |
| 21:1.0.1.1.28.1.63.28 | SECTION 73.345
| 73.345 Paprika oleoresin. | |
| 21:1.0.1.1.28.1.63.29 | SECTION 73.350
| 73.350 Mica-based pearlescent pigments. | |
| 21:1.0.1.1.28.1.63.30 | SECTION 73.352
| 73.352 Paracoccus pigment. | |
| 21:1.0.1.1.28.1.63.31 | SECTION 73.355
| 73.355 Phaffia yeast. | |
| 21:1.0.1.1.28.1.63.32 | SECTION 73.450
| 73.450 Riboflavin. | |
| 21:1.0.1.1.28.1.63.33 | SECTION 73.500
| 73.500 Saffron. | |
| 21:1.0.1.1.28.1.63.34 | SECTION 73.520
| 73.520 Soy leghemoglobin. | |
| 21:1.0.1.1.28.1.63.35 | SECTION 73.530
| 73.530 Spirulina extract. | |
| 21:1.0.1.1.28.1.63.36 | SECTION 73.575
| 73.575 Titanium dioxide. | |
| 21:1.0.1.1.28.1.63.37 | SECTION 73.585
| 73.585 Tomato lycopene extract; tomato lycopene concentrate. | |
| 21:1.0.1.1.28.1.63.38 | SECTION 73.600
| 73.600 Turmeric. | |
| 21:1.0.1.1.28.1.63.39 | SECTION 73.615
| 73.615 Turmeric oleoresin. | |
| 21:1.0.1.1.28.2 | SUBPART B
| Subpart B - Drugs | |
| 21:1.0.1.1.28.2.63.1 | SECTION 73.1001
| 73.1001 Diluents in color additive mixtures for drug use exempt from certification. | |
| 21:1.0.1.1.28.2.63.2 | SECTION 73.1010
| 73.1010 Alumina (dried aluminum hydroxide). | |
| 21:1.0.1.1.28.2.63.3 | SECTION 73.1015
| 73.1015 Chromium-cobalt-aluminum oxide. | |
| 21:1.0.1.1.28.2.63.4 | SECTION 73.1025
| 73.1025 Ferric ammonium citrate. | |
| 21:1.0.1.1.28.2.63.5 | SECTION 73.1030
| 73.1030 Annatto extract. | |
| 21:1.0.1.1.28.2.63.6 | SECTION 73.1070
| 73.1070 Calcium carbonate. | |
| 21:1.0.1.1.28.2.63.7 | SECTION 73.1075
| 73.1075 Canthaxanthin. | |
| 21:1.0.1.1.28.2.63.8 | SECTION 73.1085
| 73.1085 Caramel. | |
| 21:1.0.1.1.28.2.63.9 | SECTION 73.1095
| 73.1095 β-Carotene. | |
| 21:1.0.1.1.28.2.63.10 | SECTION 73.1100
| 73.1100 Cochineal extract; carmine. | |
| 21:1.0.1.1.28.2.63.11 | SECTION 73.1125
| 73.1125 Potassium sodium copper chloropyhllin (chlorophyllin-copper complex). | |
| 21:1.0.1.1.28.2.63.12 | SECTION 73.1150
| 73.1150 Dihydroxyacetone. | |
| 21:1.0.1.1.28.2.63.13 | SECTION 73.1162
| 73.1162 Bismuth oxychloride. | |
| 21:1.0.1.1.28.2.63.14 | SECTION 73.1200
| 73.1200 Synthetic iron oxide. | |
| 21:1.0.1.1.28.2.63.15 | SECTION 73.1298
| 73.1298 Ferric ammonium ferrocyanide. | |
| 21:1.0.1.1.28.2.63.16 | SECTION 73.1299
| 73.1299 Ferric ferrocyanide. | |
| 21:1.0.1.1.28.2.63.17 | SECTION 73.1326
| 73.1326 Chromium hydroxide green. | |
| 21:1.0.1.1.28.2.63.18 | SECTION 73.1327
| 73.1327 Chromium oxide greens. | |
| 21:1.0.1.1.28.2.63.19 | SECTION 73.1329
| 73.1329 Guanine. | |
| 21:1.0.1.1.28.2.63.20 | SECTION 73.1350
| 73.1350 Mica-based pearlescent pigments. | |
| 21:1.0.1.1.28.2.63.21 | SECTION 73.1375
| 73.1375 Pyrogallol. | |
| 21:1.0.1.1.28.2.63.22 | SECTION 73.1400
| 73.1400 Pyrophyllite. | |
| 21:1.0.1.1.28.2.63.23 | SECTION 73.1410
| 73.1410 Logwood extract. | |
| 21:1.0.1.1.28.2.63.24 | SECTION 73.1496
| 73.1496 Mica. | |
| 21:1.0.1.1.28.2.63.25 | SECTION 73.1530
| 73.1530 Spirulina extract. | |
| 21:1.0.1.1.28.2.63.26 | SECTION 73.1550
| 73.1550 Talc. | |
| 21:1.0.1.1.28.2.63.27 | SECTION 73.1575
| 73.1575 Titanium dioxide. | |
| 21:1.0.1.1.28.2.63.28 | SECTION 73.1645
| 73.1645 Aluminum powder. | |
| 21:1.0.1.1.28.2.63.29 | SECTION 73.1646
| 73.1646 Bronze powder. | |
| 21:1.0.1.1.28.2.63.30 | SECTION 73.1647
| 73.1647 Copper powder. | |
| 21:1.0.1.1.28.2.63.31 | SECTION 73.1991
| 73.1991 Zinc oxide. | |
| 21:1.0.1.1.28.3 | SUBPART C
| Subpart C - Cosmetics | |
| 21:1.0.1.1.28.3.63.1 | SECTION 73.2030
| 73.2030 Annatto. | |
| 21:1.0.1.1.28.3.63.2 | SECTION 73.2085
| 73.2085 Caramel. | |
| 21:1.0.1.1.28.3.63.3 | SECTION 73.2087
| 73.2087 Carmine. | |
| 21:1.0.1.1.28.3.63.4 | SECTION 73.2095
| 73.2095 β-Carotene. | |
| 21:1.0.1.1.28.3.63.5 | SECTION 73.2110
| 73.2110 Bismuth citrate. | |
| 21:1.0.1.1.28.3.63.6 | SECTION 73.2120
| 73.2120 Disodium EDTA-copper. | |
| 21:1.0.1.1.28.3.63.7 | SECTION 73.2125
| 73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex). | |
| 21:1.0.1.1.28.3.63.8 | SECTION 73.2150
| 73.2150 Dihydroxyacetone. | |
| 21:1.0.1.1.28.3.63.9 | SECTION 73.2162
| 73.2162 Bismuth oxychloride. | |
| 21:1.0.1.1.28.3.63.10 | SECTION 73.2180
| 73.2180 Guaiazulene. | |
| 21:1.0.1.1.28.3.63.11 | SECTION 73.2190
| 73.2190 Henna. | |
| 21:1.0.1.1.28.3.63.12 | SECTION 73.2250
| 73.2250 Iron oxides. | |
| 21:1.0.1.1.28.3.63.13 | SECTION 73.2298
| 73.2298 Ferric ammonium ferrocyanide. | |
| 21:1.0.1.1.28.3.63.14 | SECTION 73.2299
| 73.2299 Ferric ferrocyanide. | |
| 21:1.0.1.1.28.3.63.15 | SECTION 73.2326
| 73.2326 Chromium hydroxide green. | |
| 21:1.0.1.1.28.3.63.16 | SECTION 73.2327
| 73.2327 Chromium oxide greens. | |
| 21:1.0.1.1.28.3.63.17 | SECTION 73.2329
| 73.2329 Guanine. | |
| 21:1.0.1.1.28.3.63.18 | SECTION 73.2396
| 73.2396 Lead acetate. | |
| 21:1.0.1.1.28.3.63.19 | SECTION 73.2400
| 73.2400 Pyrophyllite. | |
| 21:1.0.1.1.28.3.63.20 | SECTION 73.2496
| 73.2496 Mica. | |
| 21:1.0.1.1.28.3.63.21 | SECTION 73.2500
| 73.2500 Silver. | |
| 21:1.0.1.1.28.3.63.22 | SECTION 73.2575
| 73.2575 Titanium dioxide. | |
| 21:1.0.1.1.28.3.63.23 | SECTION 73.2645
| 73.2645 Aluminum powder. | |
| 21:1.0.1.1.28.3.63.24 | SECTION 73.2646
| 73.2646 Bronze powder. | |
| 21:1.0.1.1.28.3.63.25 | SECTION 73.2647
| 73.2647 Copper powder. | |
| 21:1.0.1.1.28.3.63.26 | SECTION 73.2725
| 73.2725 Ultramarines. | |
| 21:1.0.1.1.28.3.63.27 | SECTION 73.2775
| 73.2775 Manganese violet. | |
| 21:1.0.1.1.28.3.63.28 | SECTION 73.2991
| 73.2991 Zinc oxide. | |
| 21:1.0.1.1.28.3.63.29 | SECTION 73.2995
| 73.2995 Luminescent zinc sulfide. | |
| 21:1.0.1.1.28.4 | SUBPART D
| Subpart D - Medical Devices | |
| 21:1.0.1.1.28.4.63.1 | SECTION 73.3100
| 73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers. | |
| 21:1.0.1.1.28.4.63.2 | SECTION 73.3105
| 73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione. | |
| 21:1.0.1.1.28.4.63.3 | SECTION 73.3106
| 73.3106 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers. | |
| 21:1.0.1.1.28.4.63.4 | SECTION 73.3107
| 73.3107 Carbazole violet. | |
| 21:1.0.1.1.28.4.63.5 | SECTION 73.3110
| 73.3110 Chlorophyllin-copper complex, oil soluble. | |
| 21:1.0.1.1.28.4.63.6 | SECTION 73.3110a
| 73.3110a Chromium-cobalt-aluminum oxide. | |
| 21:1.0.1.1.28.4.63.7 | SECTION 73.3111
| 73.3111 Chromium oxide greens. | |
| 21:1.0.1.1.28.4.63.8 | SECTION 73.3112
| 73.3112 C.I. Vat Orange 1. | |
| 21:1.0.1.1.28.4.63.9 | SECTION 73.3115
| 73.3115 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol. | |
| 21:1.0.1.1.28.4.63.10 | SECTION 73.3117
| 73.3117 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone. | |
| 21:1.0.1.1.28.4.63.11 | SECTION 73.3118
| 73.3118 N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide. | |
| 21:1.0.1.1.28.4.63.12 | SECTION 73.3119
| 73.3119 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone. | |
| 21:1.0.1.1.28.4.63.13 | SECTION 73.3120
| 73.3120 16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione. | |
| 21:1.0.1.1.28.4.63.14 | SECTION 73.3121
| 73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers. | |
| 21:1.0.1.1.28.4.63.15 | SECTION 73.3122
| 73.3122 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one. | |
| 21:1.0.1.1.28.4.63.16 | SECTION 73.3123
| 73.3123 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one. | |
| 21:1.0.1.1.28.4.63.17 | SECTION 73.3124
| 73.3124 Phthalocyanine green. | |
| 21:1.0.1.1.28.4.63.18 | SECTION 73.3125
| 73.3125 Iron oxides. | |
| 21:1.0.1.1.28.4.63.19 | SECTION 73.3126
| 73.3126 Titanium dioxide. | |
| 21:1.0.1.1.28.4.63.20 | SECTION 73.3127
| 73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products. | |
| 21:1.0.1.1.28.4.63.21 | SECTION 73.3128
| 73.3128 Mica-based pearlescent pigments. | |
| 21:1.0.1.1.28.4.63.22 | SECTION 73.3129
| 73.3129 Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate. | |
| 21:1.0.1.1.29 | PART 74
| PART 74 - LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | |
| 21:1.0.1.1.29.1 | SUBPART A
| Subpart A - Foods | |
| 21:1.0.1.1.29.1.63.1 | SECTION 74.101
| 74.101 FD&C Blue No. 1. | |
| 21:1.0.1.1.29.1.63.2 | SECTION 74.102
| 74.102 FD&C Blue No. 2. | |
| 21:1.0.1.1.29.1.63.3 | SECTION 74.203
| 74.203 FD&C Green No. 3. | |
| 21:1.0.1.1.29.1.63.4 | SECTION 74.250
| 74.250 Orange B. | |
| 21:1.0.1.1.29.1.63.5 | SECTION 74.302
| 74.302 Citrus Red No. 2. | |
| 21:1.0.1.1.29.1.63.6 | SECTION 74.303
| 74.303 FD&C Red No. 3. | |
| 21:1.0.1.1.29.1.63.7 | SECTION 74.340
| 74.340 FD&C Red No. 40. | |
| 21:1.0.1.1.29.1.63.8 | SECTION 74.705
| 74.705 FD&C Yellow No. 5. | |
| 21:1.0.1.1.29.1.63.9 | SECTION 74.706
| 74.706 FD&C Yellow No. 6. | |
| 21:1.0.1.1.29.2 | SUBPART B
| Subpart B - Drugs | |
| 21:1.0.1.1.29.2.63.1 | SECTION 74.1101
| 74.1101 FD&C Blue No. 1 | |
| 21:1.0.1.1.29.2.63.2 | SECTION 74.1102
| 74.1102 FD&C Blue No. 2. | |
| 21:1.0.1.1.29.2.63.3 | SECTION 74.1104
| 74.1104 D&C Blue No. 4. | |
| 21:1.0.1.1.29.2.63.4 | SECTION 74.1109
| 74.1109 D&C Blue No. 9. | |
| 21:1.0.1.1.29.2.63.5 | SECTION 74.1203
| 74.1203 FD&C Green No. 3. | |
| 21:1.0.1.1.29.2.63.6 | SECTION 74.1205
| 74.1205 D&C Green No. 5. | |
| 21:1.0.1.1.29.2.63.7 | SECTION 74.1206
| 74.1206 D&C Green No. 6. | |
| 21:1.0.1.1.29.2.63.8 | SECTION 74.1208
| 74.1208 D&C Green No. 8. | |
| 21:1.0.1.1.29.2.63.9 | SECTION 74.1254
| 74.1254 D&C Orange No. 4. | |
| 21:1.0.1.1.29.2.63.10 | SECTION 74.1255
| 74.1255 D&C Orange No. 5. | |
| 21:1.0.1.1.29.2.63.11 | SECTION 74.1260
| 74.1260 D&C Orange No. 10. | |
| 21:1.0.1.1.29.2.63.12 | SECTION 74.1261
| 74.1261 D&C Orange No. 11. | |
| 21:1.0.1.1.29.2.63.13 | SECTION 74.1303
| 74.1303 FD&C Red No. 3. | |
| 21:1.0.1.1.29.2.63.14 | SECTION 74.1304
| 74.1304 FD&C Red No. 4. | |
| 21:1.0.1.1.29.2.63.15 | SECTION 74.1306
| 74.1306 D&C Red No. 6. | |
| 21:1.0.1.1.29.2.63.16 | SECTION 74.1307
| 74.1307 D&C Red No. 7. | |
| 21:1.0.1.1.29.2.63.17 | SECTION 74.1317
| 74.1317 D&C Red No. 17. | |
| 21:1.0.1.1.29.2.63.18 | SECTION 74.1321
| 74.1321 D&C Red No. 21. | |
| 21:1.0.1.1.29.2.63.19 | SECTION 74.1322
| 74.1322 D&C Red No. 22. | |
| 21:1.0.1.1.29.2.63.20 | SECTION 74.1327
| 74.1327 D&C Red No. 27. | |
| 21:1.0.1.1.29.2.63.21 | SECTION 74.1328
| 74.1328 D&C Red No. 28. | |
| 21:1.0.1.1.29.2.63.22 | SECTION 74.1330
| 74.1330 D&C Red No. 30. | |
| 21:1.0.1.1.29.2.63.23 | SECTION 74.1331
| 74.1331 D&C Red No. 31. | |
| 21:1.0.1.1.29.2.63.24 | SECTION 74.1333
| 74.1333 D&C Red No. 33. | |
| 21:1.0.1.1.29.2.63.25 | SECTION 74.1334
| 74.1334 D&C Red No. 34. | |
| 21:1.0.1.1.29.2.63.26 | SECTION 74.1336
| 74.1336 D&C Red No. 36. | |
| 21:1.0.1.1.29.2.63.27 | SECTION 74.1339
| 74.1339 D&C Red No. 39. | |
| 21:1.0.1.1.29.2.63.28 | SECTION 74.1340
| 74.1340 FD&C Red No. 40. | |
| 21:1.0.1.1.29.2.63.29 | SECTION 74.1602
| 74.1602 D&C Violet No. 2. | |
| 21:1.0.1.1.29.2.63.30 | SECTION 74.1705
| 74.1705 FD&C Yellow No. 5. | |
| 21:1.0.1.1.29.2.63.31 | SECTION 74.1706
| 74.1706 FD&C Yellow No. 6. | |
| 21:1.0.1.1.29.2.63.32 | SECTION 74.1707
| 74.1707 D&C Yellow No. 7. | |
| 21:1.0.1.1.29.2.63.33 | SECTION 74.1707a
| 74.1707a Ext. D&C Yellow No. 7. | |
| 21:1.0.1.1.29.2.63.34 | SECTION 74.1708
| 74.1708 D&C Yellow No. 8. | |
| 21:1.0.1.1.29.2.63.35 | SECTION 74.1710
| 74.1710 D&C Yellow No. 10. | |
| 21:1.0.1.1.29.2.63.36 | SECTION 74.1711
| 74.1711 D&C Yellow No. 11. | |
| 21:1.0.1.1.29.3 | SUBPART C
| Subpart C - Cosmetics | |
| 21:1.0.1.1.29.3.63.1 | SECTION 74.2052
| 74.2052 D&C Black No. 2. | |
| 21:1.0.1.1.29.3.63.2 | SECTION 74.2053
| 74.2053 D&C Black No. 3. | |
| 21:1.0.1.1.29.3.63.3 | SECTION 74.2101
| 74.2101 FD&C Blue No. 1. | |
| 21:1.0.1.1.29.3.63.4 | SECTION 74.2104
| 74.2104 D&C Blue No. 4. | |
| 21:1.0.1.1.29.3.63.5 | SECTION 74.2151
| 74.2151 D&C Brown No. 1. | |
| 21:1.0.1.1.29.3.63.6 | SECTION 74.2203
| 74.2203 FD&C Green No. 3. | |
| 21:1.0.1.1.29.3.63.7 | SECTION 74.2205
| 74.2205 D&C Green No. 5. | |
| 21:1.0.1.1.29.3.63.8 | SECTION 74.2206
| 74.2206 D&C Green No. 6. | |
| 21:1.0.1.1.29.3.63.9 | SECTION 74.2208
| 74.2208 D&C Green No. 8. | |
| 21:1.0.1.1.29.3.63.10 | SECTION 74.2254
| 74.2254 D&C Orange No. 4. | |
| 21:1.0.1.1.29.3.63.11 | SECTION 74.2255
| 74.2255 D&C Orange No. 5. | |
| 21:1.0.1.1.29.3.63.12 | SECTION 74.2260
| 74.2260 D&C Orange No. 10. | |
| 21:1.0.1.1.29.3.63.13 | SECTION 74.2261
| 74.2261 D&C Orange No. 11. | |
| 21:1.0.1.1.29.3.63.14 | SECTION 74.2304
| 74.2304 FD&C Red No. 4. | |
| 21:1.0.1.1.29.3.63.15 | SECTION 74.2306
| 74.2306 D&C Red No. 6. | |
| 21:1.0.1.1.29.3.63.16 | SECTION 74.2307
| 74.2307 D&C Red No. 7 | |
| 21:1.0.1.1.29.3.63.17 | SECTION 74.2317
| 74.2317 D&C Red No. 17. | |
| 21:1.0.1.1.29.3.63.18 | SECTION 74.2321
| 74.2321 D&C Red No. 21. | |
| 21:1.0.1.1.29.3.63.19 | SECTION 74.2322
| 74.2322 D&C Red No. 22. | |
| 21:1.0.1.1.29.3.63.20 | SECTION 74.2327
| 74.2327 D&C Red No. 27. | |
| 21:1.0.1.1.29.3.63.21 | SECTION 74.2328
| 74.2328 D&C Red No. 28. | |
| 21:1.0.1.1.29.3.63.22 | SECTION 74.2330
| 74.2330 D&C Red No. 30. | |
| 21:1.0.1.1.29.3.63.23 | SECTION 74.2331
| 74.2331 D&C Red No. 31. | |
| 21:1.0.1.1.29.3.63.24 | SECTION 74.2333
| 74.2333 D&C Red No. 33. | |
| 21:1.0.1.1.29.3.63.25 | SECTION 74.2334
| 74.2334 D&C Red No. 34. | |
| 21:1.0.1.1.29.3.63.26 | SECTION 74.2336
| 74.2336 D&C Red No. 36. | |
| 21:1.0.1.1.29.3.63.27 | SECTION 74.2340
| 74.2340 FD&C Red No. 40. | |
| 21:1.0.1.1.29.3.63.28 | SECTION 74.2602
| 74.2602 D&C Violet No. 2. | |
| 21:1.0.1.1.29.3.63.29 | SECTION 74.2602a
| 74.2602a Ext. D&C Violet No. 2. | |
| 21:1.0.1.1.29.3.63.30 | SECTION 74.2705
| 74.2705 FD&C Yellow No. 5. | |
| 21:1.0.1.1.29.3.63.31 | SECTION 74.2706
| 74.2706 FD&C Yellow No. 6. | |
| 21:1.0.1.1.29.3.63.32 | SECTION 74.2707
| 74.2707 D&C Yellow No. 7. | |
| 21:1.0.1.1.29.3.63.33 | SECTION 74.2707a
| 74.2707a Ext. D&C Yellow No. 7. | |
| 21:1.0.1.1.29.3.63.34 | SECTION 74.2708
| 74.2708 D&C Yellow No. 8. | |
| 21:1.0.1.1.29.3.63.35 | SECTION 74.2710
| 74.2710 D&C Yellow No. 10. | |
| 21:1.0.1.1.29.3.63.36 | SECTION 74.2711
| 74.2711 D&C Yellow No. 11. | |
| 21:1.0.1.1.29.4 | SUBPART D
| Subpart D - Medical Devices | |
| 21:1.0.1.1.29.4.63.1 | SECTION 74.3045
| 74.3045 [Phthalocyaninato(2-)] copper. | |
| 21:1.0.1.1.29.4.63.2 | SECTION 74.3054
| 74.3054 D&C Black No. 4. | |
| 21:1.0.1.1.29.4.63.3 | SECTION 74.3102
| 74.3102 FD&C Blue No. 2. | |
| 21:1.0.1.1.29.4.63.4 | SECTION 74.3106
| 74.3106 D&C Blue No. 6. | |
| 21:1.0.1.1.29.4.63.5 | SECTION 74.3206
| 74.3206 D&C Green No. 6. | |
| 21:1.0.1.1.29.4.63.6 | SECTION 74.3230
| 74.3230 D&C Red No. 17. | |
| 21:1.0.1.1.29.4.63.7 | SECTION 74.3602
| 74.3602 D&C Violet No. 2. | |
| 21:1.0.1.1.29.4.63.8 | SECTION 74.3708
| 74.3708 D&C Yellow No. 8. | |
| 21:1.0.1.1.29.4.63.9 | SECTION 74.3710
| 74.3710 D&C Yellow No. 10. | |
| 21:1.0.1.1.30 | PART 80
| PART 80 - COLOR ADDITIVE CERTIFICATION | |
| 21:1.0.1.1.30.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.30.1.63.1 | SECTION 80.10
| 80.10 Fees for certification services. | |
| 21:1.0.1.1.30.2 | SUBPART B
| Subpart B - Certification Procedures | |
| 21:1.0.1.1.30.2.63.1 | SECTION 80.21
| 80.21 Request for certification. | |
| 21:1.0.1.1.30.2.63.2 | SECTION 80.22
| 80.22 Samples to accompany requests for certification. | |
| 21:1.0.1.1.30.2.63.3 | SECTION 80.31
| 80.31 Certification. | |
| 21:1.0.1.1.30.2.63.4 | SECTION 80.32
| 80.32 Limitations of certificates. | |
| 21:1.0.1.1.30.2.63.5 | SECTION 80.34
| 80.34 Authority to refuse certification service. | |
| 21:1.0.1.1.30.2.63.6 | SECTION 80.35
| 80.35 Color additive mixtures; certification and exemption from certification. | |
| 21:1.0.1.1.30.2.63.7 | SECTION 80.37
| 80.37 Treatment of batch pending certification. | |
| 21:1.0.1.1.30.2.63.8 | SECTION 80.38
| 80.38 Treatment of batch after certification. | |
| 21:1.0.1.1.30.2.63.9 | SECTION 80.39
| 80.39 Records of distribution. | |
| 21:1.0.1.1.31 | PART 81
| PART 81 - GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS | |
| 21:1.0.1.1.31.0.63.1 | SECTION 81.1
| 81.1 Provisional lists of color additives. | |
| 21:1.0.1.1.31.0.63.2 | SECTION 81.10
| 81.10 Termination of provisional listings of color additives. | |
| 21:1.0.1.1.31.0.63.3 | SECTION 81.30
| 81.30 Cancellation of certificates. | |
| 21:1.0.1.1.32 | PART 82
| PART 82 - LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS | |
| 21:1.0.1.1.32.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:1.0.1.1.32.1.63.1 | SECTION 82.3
| 82.3 Definitions. | |
| 21:1.0.1.1.32.1.63.2 | SECTION 82.5
| 82.5 General specifications for straight colors. | |
| 21:1.0.1.1.32.1.63.3 | SECTION 82.6
| 82.6 Certifiable mixtures. | |
| 21:1.0.1.1.32.2 | SUBPART B
| Subpart B - Foods, Drugs, and Cosmetics | |
| 21:1.0.1.1.32.2.63.1 | SECTION 82.50
| 82.50 General. | |
| 21:1.0.1.1.32.2.63.2 | SECTION 82.51
| 82.51 Lakes (FD&C). | |
| 21:1.0.1.1.32.2.63.3 | SECTION 82.101
| 82.101 FD&C Blue No. 1. | |
| 21:1.0.1.1.32.2.63.4 | SECTION 82.102
| 82.102 FD&C Blue No. 2. | |
| 21:1.0.1.1.32.2.63.5 | SECTION 82.203
| 82.203 FD&C Green No. 3. | |
| 21:1.0.1.1.32.2.63.6 | SECTION 82.304
| 82.304 FD&C Red No. 4. | |
| 21:1.0.1.1.32.2.63.7 | SECTION 82.705
| 82.705 FD&C Yellow No. 5. | |
| 21:1.0.1.1.32.2.63.8 | SECTION 82.706
| 82.706 FD&C Yellow No. 6. | |
| 21:1.0.1.1.32.3 | SUBPART C
| Subpart C - Drugs and Cosmetics | |
| 21:1.0.1.1.32.3.63.1 | SECTION 82.1050
| 82.1050 General. | |
| 21:1.0.1.1.32.3.63.2 | SECTION 82.1051
| 82.1051 Lakes (D&C). | |
| 21:1.0.1.1.32.3.63.3 | SECTION 82.1104
| 82.1104 D&C Blue No. 4. | |
| 21:1.0.1.1.32.3.63.4 | SECTION 82.1205
| 82.1205 D&C Green No. 5. | |
| 21:1.0.1.1.32.3.63.5 | SECTION 82.1206
| 82.1206 D&C Green No. 6. | |
| 21:1.0.1.1.32.3.63.6 | SECTION 82.1254
| 82.1254 D&C Orange No. 4. | |
| 21:1.0.1.1.32.3.63.7 | SECTION 82.1255
| 82.1255 D&C Orange No. 5. | |
| 21:1.0.1.1.32.3.63.8 | SECTION 82.1260
| 82.1260 D&C Orange No. 10. | |
| 21:1.0.1.1.32.3.63.9 | SECTION 82.1261
| 82.1261 D&C Orange No. 11. | |
| 21:1.0.1.1.32.3.63.10 | SECTION 82.1306
| 82.1306 D&C Red No. 6. | |
| 21:1.0.1.1.32.3.63.11 | SECTION 82.1307
| 82.1307 D&C Red No. 7. | |
| 21:1.0.1.1.32.3.63.12 | SECTION 82.1317
| 82.1317 D&C Red No. 17. | |
| 21:1.0.1.1.32.3.63.13 | SECTION 82.1321
| 82.1321 D&C Red No. 21. | |
| 21:1.0.1.1.32.3.63.14 | SECTION 82.1322
| 82.1322 D&C Red No. 22. | |
| 21:1.0.1.1.32.3.63.15 | SECTION 82.1327
| 82.1327 D&C Red No. 27. | |
| 21:1.0.1.1.32.3.63.16 | SECTION 82.1328
| 82.1328 D&C Red No. 28. | |
| 21:1.0.1.1.32.3.63.17 | SECTION 82.1330
| 82.1330 D&C Red No. 30. | |
| 21:1.0.1.1.32.3.63.18 | SECTION 82.1331
| 82.1331 D&C Red No. 31. | |
| 21:1.0.1.1.32.3.63.19 | SECTION 82.1333
| 82.1333 D&C Red No. 33. | |
| 21:1.0.1.1.32.3.63.20 | SECTION 82.1334
| 82.1334 D&C Red No. 34. | |
| 21:1.0.1.1.32.3.63.21 | SECTION 82.1336
| 82.1336 D&C Red No. 36. | |
| 21:1.0.1.1.32.3.63.22 | SECTION 82.1602
| 82.1602 D&C Violet No. 2. | |
| 21:1.0.1.1.32.3.63.23 | SECTION 82.1707
| 82.1707 D&C Yellow No. 7. | |
| 21:1.0.1.1.32.3.63.24 | SECTION 82.1708
| 82.1708 D&C Yellow No. 8. | |
| 21:1.0.1.1.32.3.63.25 | SECTION 82.1710
| 82.1710 D&C Yellow No. 10. | |
| 21:1.0.1.1.32.4 | SUBPART D
| Subpart D - Externally Applied Drugs and Cosmetics | |
| 21:1.0.1.1.32.4.63.1 | SECTION 82.2050
| 82.2050 General. | |
| 21:1.0.1.1.32.4.63.2 | SECTION 82.2051
| 82.2051 Lakes (Ext. D&C). | |
| 21:1.0.1.1.32.4.63.3 | SECTION 82.2707a
| 82.2707a Ext. D&C Yellow No. 7. | |
| 21:1.0.1.1.33 | PART 83-98
| PARTS 83-98 [RESERVED] | |
| 21:1.0.1.1.34 | PART 99
| PART 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES | |
| 21:1.0.1.1.34.1 | SUBPART A
| Subpart A - General Information | |
| 21:1.0.1.1.34.1.63.1 | SECTION 99.1
| 99.1 Scope. | |
| 21:1.0.1.1.34.1.63.2 | SECTION 99.3
| 99.3 Definitions. | |
| 21:1.0.1.1.34.2 | SUBPART B
| Subpart B - Information To Be Disseminated | |
| 21:1.0.1.1.34.2.63.1 | SECTION 99.101
| 99.101 Information that may be disseminated. | |
| 21:1.0.1.1.34.2.63.2 | SECTION 99.103
| 99.103 Mandatory statements and information. | |
| 21:1.0.1.1.34.2.63.3 | SECTION 99.105
| 99.105 Recipients of information. | |
| 21:1.0.1.1.34.3 | SUBPART C
| Subpart C - Manufacturer's Submissions, Requests, and Applications | |
| 21:1.0.1.1.34.3.63.1 | SECTION 99.201
| 99.201 Manufacturer's submission to the agency. | |
| 21:1.0.1.1.34.3.63.2 | SECTION 99.203
| 99.203 Request to extend the time for completing planned studies. | |
| 21:1.0.1.1.34.3.63.3 | SECTION 99.205
| 99.205 Application for exemption from the requirement to file a supplemental application. | |
| 21:1.0.1.1.34.4 | SUBPART D
| Subpart D - FDA Action on Submissions, Requests, and Applications | |
| 21:1.0.1.1.34.4.63.1 | SECTION 99.301
| 99.301 Agency action on a submission. | |
| 21:1.0.1.1.34.4.63.2 | SECTION 99.303
| 99.303 Extension of time for completing planned studies. | |
| 21:1.0.1.1.34.4.63.3 | SECTION 99.305
| 99.305 Exemption from the requirement to file a supplemental application. | |
| 21:1.0.1.1.34.5 | SUBPART E
| Subpart E - Corrective Actions and Cessation of Dissemination | |
| 21:1.0.1.1.34.5.63.1 | SECTION 99.401
| 99.401 Corrective actions and cessation of dissemination of information. | |
| 21:1.0.1.1.34.5.63.2 | SECTION 99.403
| 99.403 Termination of approvals of applications for exemption. | |
| 21:1.0.1.1.34.5.63.3 | SECTION 99.405
| 99.405 Applicability of labeling, adulteration, and misbranding authority. | |
| 21:1.0.1.1.34.6 | SUBPART F
| Subpart F - Recordkeeping and Reports | |
| 21:1.0.1.1.34.6.63.1 | SECTION 99.501
| 99.501 Recordkeeping and reports. | |