| 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. | |