Title 21

CHAPTER I SUBCHAP A

Subchapter A - General

21:1.0.1.1.1PART 1
PART 1 - GENERAL ENFORCEMENT REGULATIONS
21:1.0.1.1.1.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.1.1.32.1SECTION 1.1
     1.1 General.
21:1.0.1.1.1.1.32.2SECTION 1.3
     1.3 Definitions.
21:1.0.1.1.1.1.32.3SECTION 1.4
     1.4 Authority citations.
21:1.0.1.1.1.2SUBPART B
Subpart B - General Labeling Requirements
21:1.0.1.1.1.2.32.1SECTION 1.20
     1.20 Presence of mandatory label information.
21:1.0.1.1.1.2.32.2SECTION 1.21
     1.21 Failure to reveal material facts.
21:1.0.1.1.1.2.32.3SECTION 1.23
     1.23 Procedures for requesting variations and exemptions from required label statements.
21:1.0.1.1.1.2.32.4SECTION 1.24
     1.24 Exemptions from required label statements.
21:1.0.1.1.1.3SUBPART C
Subpart C [Reserved]
21:1.0.1.1.1.4SUBPART D
Subpart D - Electronic Import Entries
21:1.0.1.1.1.4.32.1SECTION 1.70
     1.70 Scope.
21:1.0.1.1.1.4.32.2SECTION 1.71
     1.71 Definitions.
21:1.0.1.1.1.4.32.3SECTION 1.72
     1.72 Data elements that must be submitted in ACE for articles regulated by FDA.
21:1.0.1.1.1.4.32.4SECTION 1.73
     1.73 Food.
21:1.0.1.1.1.4.32.5SECTION 1.74
     1.74 Human drugs.
21:1.0.1.1.1.4.32.6SECTION 1.75
     1.75 Animal drugs.
21:1.0.1.1.1.4.32.7SECTION 1.76
     1.76 Medical devices.
21:1.0.1.1.1.4.32.8SECTION 1.77
     1.77 Radiation-emitting electronic products.
21:1.0.1.1.1.4.32.9SECTION 1.78
     1.78 Biological products, HCT/Ps, and related drugs and medical devices.
21:1.0.1.1.1.4.32.10SECTION 1.79
     1.79 Tobacco products.
21:1.0.1.1.1.4.32.11SECTION 1.80
     1.80 Cosmetics.
21:1.0.1.1.1.4.32.12SECTION 1.81
     1.81 Rejection of entry filing.
21:1.0.1.1.1.5SUBPART E
Subpart E - Imports and Exports
21:1.0.1.1.1.5.32.1SECTION 1.83
     1.83 Definitions.
21:1.0.1.1.1.5.32.2SECTION 1.90
     1.90 Notice of sampling.
21:1.0.1.1.1.5.32.3SECTION 1.91
     1.91 Payment for samples.
21:1.0.1.1.1.5.32.4SECTION 1.94
     1.94 Hearing on refusal of admission or destruction.
21:1.0.1.1.1.5.32.5SECTION 1.95
     1.95 Application for authorization to relabel and recondition.
21:1.0.1.1.1.5.32.6SECTION 1.96
     1.96 Granting of authorization to relabel and recondition.
21:1.0.1.1.1.5.32.7SECTION 1.97
     1.97 Bonds.
21:1.0.1.1.1.5.32.8SECTION 1.99
     1.99 Costs chargeable in connection with relabeling and reconditioning inadmissible imports.
21:1.0.1.1.1.5.32.9SECTION 1.101
     1.101 Notification and recordkeeping.
21:1.0.1.1.1.6SUBPART F
Subparts F-G [Reserved]
21:1.0.1.1.1.7SUBPART H
Subpart H - Registration of Food Facilities
21:1.0.1.1.1.7.32SUBJGRP 32
  General Provisions
21:1.0.1.1.1.7.32.1SECTION 1.225
     1.225 Who must register under this subpart
21:1.0.1.1.1.7.32.2SECTION 1.226
     1.226 Who does not have to register under this subpart
21:1.0.1.1.1.7.32.3SECTION 1.227
     1.227 What definitions apply to this subpart
21:1.0.1.1.1.7.33SUBJGRP 33
  Procedures for Registration of Food Facilities
21:1.0.1.1.1.7.33.4SECTION 1.230
     1.230 When must you register or renew your registration
21:1.0.1.1.1.7.33.5SECTION 1.231
     1.231 How and where do you register or renew your registration
21:1.0.1.1.1.7.33.6SECTION 1.232
     1.232 What information is required in the registration
21:1.0.1.1.1.7.33.7SECTION 1.233
     1.233 Are there optional items included in the registration form
21:1.0.1.1.1.7.33.8SECTION 1.234
     1.234 How and when do you update your facility's registration information
21:1.0.1.1.1.7.33.9SECTION 1.235
     1.235 How and when do you cancel your facility's registration information
21:1.0.1.1.1.7.34SUBJGRP 34
  Additional Provisions
21:1.0.1.1.1.7.34.10SECTION 1.240
     1.240 What other registration requirements apply
21:1.0.1.1.1.7.34.11SECTION 1.241
     1.241 What are the consequences of failing to register, update, renew, or cancel your registration
21:1.0.1.1.1.7.34.12SECTION 1.242
     1.242 What does assignment of a registration number mean
21:1.0.1.1.1.7.34.13SECTION 1.243
     1.243 Is food registration information available to the public
21:1.0.1.1.1.7.34.14SECTION 1.245
     1.245 Waiver request.
21:1.0.1.1.1.8SUBPART I
Subpart I - Prior Notice of Imported Food
21:1.0.1.1.1.8.35SUBJGRP 35
  General Provisions
21:1.0.1.1.1.8.35.1SECTION 1.276
     1.276 What definitions apply to this subpart
21:1.0.1.1.1.8.35.2SECTION 1.277
     1.277 What is the scope of this subpart
21:1.0.1.1.1.8.36SUBJGRP 36
  Requirements To Submit Prior Notice of Imported Food
21:1.0.1.1.1.8.36.3SECTION 1.278
     1.278 Who is authorized to submit prior notice
21:1.0.1.1.1.8.36.4SECTION 1.279
     1.279 When must prior notice be submitted to FDA
21:1.0.1.1.1.8.36.5SECTION 1.280
     1.280 How must you submit prior notice
21:1.0.1.1.1.8.36.6SECTION 1.281
     1.281 What information must be in a prior notice
21:1.0.1.1.1.8.36.7SECTION 1.282
     1.282 What must you do if information changes after you have received confirmation of a prior notice from FDA
21:1.0.1.1.1.8.37SUBJGRP 37
  Consequences
21:1.0.1.1.1.8.37.8SECTION 1.283
     1.283 What happens to food that is imported or offered for import without adequate prior notice
21:1.0.1.1.1.8.37.9SECTION 1.284
     1.284 What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart
21:1.0.1.1.1.8.37.10SECTION 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
21:1.0.1.1.1.9SUBPART J
Subpart J - Establishment, Maintenance, and Availability of Records
21:1.0.1.1.1.9.38SUBJGRP 38
  General Provisions
21:1.0.1.1.1.9.38.1SECTION 1.326
     1.326 Who is subject to this subpart
21:1.0.1.1.1.9.38.2SECTION 1.327
     1.327 Who is excluded from all or part of the regulations in this subpart
21:1.0.1.1.1.9.38.3SECTION 1.328
     1.328 What definitions apply to this subpart
21:1.0.1.1.1.9.38.4SECTION 1.329
     1.329 Do other statutory provisions and regulations apply
21:1.0.1.1.1.9.38.5SECTION 1.330
     1.330 Can existing records satisfy the requirements of this subpart
21:1.0.1.1.1.9.39SUBJGRP 39
  Requirements for Nontransporters To Establish and Maintain Records To Identify the Nontransporter and Transporter Immediate Previous Sources of Food
21:1.0.1.1.1.9.39.6SECTION 1.337
     1.337 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food
21:1.0.1.1.1.9.40SUBJGRP 40
  Requirements for Nontransporters To Establish and Maintain Records To Identify the Nontransporter and Transporter Immediate Subsequent Recipients of Food
21:1.0.1.1.1.9.40.7SECTION 1.345
     1.345 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food
21:1.0.1.1.1.9.41SUBJGRP 41
  Requirements for Transporters To Establish and Maintain Records
21:1.0.1.1.1.9.41.8SECTION 1.352
     1.352 What information must transporters establish and maintain
21:1.0.1.1.1.9.42SUBJGRP 42
  General Requirements
21:1.0.1.1.1.9.42.9SECTION 1.360
     1.360 What are the record retention requirements
21:1.0.1.1.1.9.42.10SECTION 1.361
     1.361 What are the record availability requirements
21:1.0.1.1.1.9.42.11SECTION 1.362
     1.362 What records are excluded from this subpart
21:1.0.1.1.1.9.42.12SECTION 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
21:1.0.1.1.1.9.43SUBJGRP 43
  Compliance Dates
21:1.0.1.1.1.9.43.13SECTION 1.368
     1.368 What are the compliance dates for this subpart
21:1.0.1.1.1.10SUBPART K
Subpart K - Administrative Detention of Food for Human or Animal Consumption
21:1.0.1.1.1.10.44SUBJGRP 44
  General Provisions
21:1.0.1.1.1.10.44.1SECTION 1.377
     1.377 What definitions apply to this subpart
21:1.0.1.1.1.10.44.2SECTION 1.378
     1.378 What criteria does FDA use to order a detention
21:1.0.1.1.1.10.44.3SECTION 1.379
     1.379 How long may FDA detain an article of food
21:1.0.1.1.1.10.44.4SECTION 1.380
     1.380 Where and under what conditions must the detained article of food be held
21:1.0.1.1.1.10.44.5SECTION 1.381
     1.381 May a detained article of food be delivered to another entity or transferred to another location
21:1.0.1.1.1.10.44.6SECTION 1.382
     1.382 What labeling or marking requirements apply to a detained article of food
21:1.0.1.1.1.10.44.7SECTION 1.383
     1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food
21:1.0.1.1.1.10.44.8SECTION 1.384
     1.384 When does a detention order terminate
21:1.0.1.1.1.10.45SUBJGRP 45
  How Does FDA Order a Detention
21:1.0.1.1.1.10.45.9SECTION 1.391
     1.391 Who approves a detention order
21:1.0.1.1.1.10.45.10SECTION 1.392
     1.392 Who receives a copy of the detention order
21:1.0.1.1.1.10.45.11SECTION 1.393
     1.393 What information must FDA include in the detention order
21:1.0.1.1.1.10.46SUBJGRP 46
  What Is the Appeal Process for a Detention Order
21:1.0.1.1.1.10.46.12SECTION 1.401
     1.401 Who is entitled to appeal
21:1.0.1.1.1.10.46.13SECTION 1.402
     1.402 What are the requirements for submitting an appeal
21:1.0.1.1.1.10.46.14SECTION 1.403
     1.403 What requirements apply to an informal hearing
21:1.0.1.1.1.10.46.15SECTION 1.404
     1.404 Who serves as the presiding officer for an appeal and for an informal hearing
21:1.0.1.1.1.10.46.16SECTION 1.405
     1.405 When does FDA have to issue a decision on an appeal
21:1.0.1.1.1.10.46.17SECTION 1.406
     1.406 How will FDA handle classified information in an informal hearing
21:1.0.1.1.1.11SUBPART L
Subpart L - Foreign Supplier Verification Programs for Food Importers
21:1.0.1.1.1.11.47.1SECTION 1.500
     1.500 What definitions apply to this subpart
21:1.0.1.1.1.11.47.2SECTION 1.501
     1.501 To what foods do the requirements in this subpart apply
21:1.0.1.1.1.11.47.3SECTION 1.502
     1.502 What foreign supplier verification program (FSVP) must I have
21:1.0.1.1.1.11.47.4SECTION 1.503
     1.503 Who must develop my FSVP and perform FSVP activities
21:1.0.1.1.1.11.47.5SECTION 1.504
     1.504 What hazard analysis must I conduct
21:1.0.1.1.1.11.47.6SECTION 1.505
     1.505 What evaluation for foreign supplier approval and verification must I conduct
21:1.0.1.1.1.11.47.7SECTION 1.506
     1.506 What foreign supplier verification and related activities must I conduct
21:1.0.1.1.1.11.47.8SECTION 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
21:1.0.1.1.1.11.47.9SECTION 1.508
     1.508 What corrective actions must I take under my FSVP
21:1.0.1.1.1.11.47.10SECTION 1.509
     1.509 How must the importer be identified at entry
21:1.0.1.1.1.11.47.11SECTION 1.510
     1.510 How must I maintain records of my FSVP
21:1.0.1.1.1.11.47.12SECTION 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
21:1.0.1.1.1.11.47.13SECTION 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
21:1.0.1.1.1.11.47.14SECTION 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
21:1.0.1.1.1.11.47.15SECTION 1.514
     1.514 What are some consequences of failing to comply with the requirements of this subpart
21:1.0.1.1.1.12SUBPART M
Subpart M - Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
21:1.0.1.1.1.12.47SUBJGRP 47
  Recognition of Accreditation Bodies Under This Subpart
21:1.0.1.1.1.12.47.1SECTION 1.600
     1.600 What definitions apply to this subpart
21:1.0.1.1.1.12.47.2SECTION 1.601
     1.601 Who is subject to this subpart
21:1.0.1.1.1.12.47.3SECTION 1.610
     1.610 Who is eligible to seek recognition
21:1.0.1.1.1.12.47.4SECTION 1.611
     1.611 What legal authority must an accreditation body have to qualify for recognition
21:1.0.1.1.1.12.47.5SECTION 1.612
     1.612 What competency and capacity must an accreditation body have to qualify for recognition
21:1.0.1.1.1.12.47.6SECTION 1.613
     1.613 What protections against conflicts of interest must an accreditation body have to qualify for recognition
21:1.0.1.1.1.12.47.7SECTION 1.614
     1.614 What quality assurance procedures must an accreditation body have to qualify for recognition
21:1.0.1.1.1.12.47.8SECTION 1.615
     1.615 What records procedures must an accreditation body have to qualify for recognition
21:1.0.1.1.1.12.48SUBJGRP 48
  Requirements for Accreditation Bodies That Have Been Recognized Under This Subpart
21:1.0.1.1.1.12.48.9SECTION 1.620
     1.620 How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation
21:1.0.1.1.1.12.48.10SECTION 1.621
     1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited
21:1.0.1.1.1.12.48.11SECTION 1.622
     1.622 How must a recognized accreditation body monitor its own performance
21:1.0.1.1.1.12.48.12SECTION 1.623
     1.623 What reports and notifications must a recognized accreditation body submit to FDA
21:1.0.1.1.1.12.48.13SECTION 1.624
     1.624 How must a recognized accreditation body protect against conflicts of interest
21:1.0.1.1.1.12.48.14SECTION 1.625
     1.625 What records requirements must an accreditation body that has been recognized meet
21:1.0.1.1.1.12.49SUBJGRP 49
  Procedures for Recognition of Accreditation Bodies Under This Subpart
21:1.0.1.1.1.12.49.15SECTION 1.630
     1.630 How do I apply to FDA for recognition or renewal of recognition
21:1.0.1.1.1.12.49.16SECTION 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
21:1.0.1.1.1.12.49.17SECTION 1.632
     1.632 What is the duration of recognition
21:1.0.1.1.1.12.49.18SECTION 1.633
     1.633 How will FDA monitor recognized accreditation bodies
21:1.0.1.1.1.12.49.19SECTION 1.634
     1.634 When will FDA revoke recognition
21:1.0.1.1.1.12.49.20SECTION 1.635
     1.635 What if I want to voluntarily relinquish recognition or do not want to renew recognition
21:1.0.1.1.1.12.49.21SECTION 1.636
     1.636 How do I request reinstatement of recognition
21:1.0.1.1.1.12.50SUBJGRP 50
  Accreditation of Third-Party Certification Bodies Under This Subpart
21:1.0.1.1.1.12.50.22SECTION 1.640
     1.640 Who is eligible to seek accreditation
21:1.0.1.1.1.12.50.23SECTION 1.641
     1.641 What legal authority must a third-party certification body have to qualify for accreditation
21:1.0.1.1.1.12.50.24SECTION 1.642
     1.642 What competency and capacity must a third-party certification body have to qualify for accreditation
21:1.0.1.1.1.12.50.25SECTION 1.643
     1.643 What protections against conflicts of interest must a third-party certification body have to qualify for accreditation
21:1.0.1.1.1.12.50.26SECTION 1.644
     1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation
21:1.0.1.1.1.12.50.27SECTION 1.645
     1.645 What records procedures must a third-party certification body have to qualify for accreditation
21:1.0.1.1.1.12.51SUBJGRP 51
  Requirements for Third-Party Certification Bodies That Have Been Accredited Under This Subpart
21:1.0.1.1.1.12.51.28SECTION 1.650
     1.650 How must an accredited third-party certification body ensure its audit agents are competent and objective
21:1.0.1.1.1.12.51.29SECTION 1.651
     1.651 How must an accredited third-party certification body conduct a food safety audit of an eligible entity
21:1.0.1.1.1.12.51.30SECTION 1.652
     1.652 What must an accredited third-party certification body include in food safety audit reports
21:1.0.1.1.1.12.51.31SECTION 1.653
     1.653 What must an accredited third-party certification body do when issuing food or facility certifications
21:1.0.1.1.1.12.51.32SECTION 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
21:1.0.1.1.1.12.51.33SECTION 1.655
     1.655 How must an accredited third-party certification body monitor its own performance
21:1.0.1.1.1.12.51.34SECTION 1.656
     1.656 What reports and notifications must an accredited third-party certification body submit
21:1.0.1.1.1.12.51.35SECTION 1.657
     1.657 How must an accredited third-party certification body protect against conflicts of interest
21:1.0.1.1.1.12.51.36SECTION 1.658
     1.658 What records requirements must a third-party certification body that has been accredited meet
21:1.0.1.1.1.12.52SUBJGRP 52
  Procedures for Accreditation of Third-Party Certification Bodies Under This Subpart
21:1.0.1.1.1.12.52.37SECTION 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
21:1.0.1.1.1.12.52.38SECTION 1.661
     1.661 What is the duration of accreditation by a recognized accreditation body
21:1.0.1.1.1.12.52.39SECTION 1.662
     1.662 How will FDA monitor accredited third-party certification bodies
21:1.0.1.1.1.12.52.40SECTION 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
21:1.0.1.1.1.12.52.41SECTION 1.664
     1.664 When would FDA withdraw accreditation
21:1.0.1.1.1.12.52.42SECTION 1.665
     1.665 What if I want to voluntarily relinquish accreditation or do not want to renew accreditation
21:1.0.1.1.1.12.52.43SECTION 1.666
     1.666 How do I request reaccreditation
21:1.0.1.1.1.12.53SUBJGRP 53
  Additional Procedures for Direct Accreditation of Third-Party Certification Bodies Under This Subpart
21:1.0.1.1.1.12.53.44SECTION 1.670
     1.670 How do I apply to FDA for direct accreditation or renewal of direct accreditation
21:1.0.1.1.1.12.53.45SECTION 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
21:1.0.1.1.1.12.53.46SECTION 1.672
     1.672 What is the duration of direct accreditation
21:1.0.1.1.1.12.54SUBJGRP 54
  Requirements for Eligible Entities Under This Subpart
21:1.0.1.1.1.12.54.47SECTION 1.680
     1.680 How and when will FDA monitor eligible entities
21:1.0.1.1.1.12.54.48SECTION 1.681
     1.681 How frequently must eligible entities be recertified
21:1.0.1.1.1.12.55SUBJGRP 55
  General Requirements of This Subpart
21:1.0.1.1.1.12.55.49SECTION 1.690
     1.690 How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public
21:1.0.1.1.1.12.55.50SECTION 1.691
     1.691 How do I request reconsideration of a denial by FDA of an application or a waiver request
21:1.0.1.1.1.12.55.51SECTION 1.692
     1.692 How do I request internal agency review of a denial of an application or waiver request upon reconsideration
21:1.0.1.1.1.12.55.52SECTION 1.693
     1.693 How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation
21:1.0.1.1.1.12.55.53SECTION 1.694
     1.694 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter
21:1.0.1.1.1.12.55.54SECTION 1.695
     1.695 Are the records obtained by FDA under this subpart subject to public disclosure
21:1.0.1.1.1.12.56SUBJGRP 56
  Requirements for User Fees Under This Subpart
21:1.0.1.1.1.12.56.55SECTION 1.700
     1.700 Who is subject to a user fee under this subpart
21:1.0.1.1.1.12.56.56SECTION 1.705
     1.705 What user fees are established under this subpart
21:1.0.1.1.1.12.56.57SECTION 1.710
     1.710 How will FDA notify the public about the fee schedule
21:1.0.1.1.1.12.56.58SECTION 1.715
     1.715 When must a user fee required by this subpart be submitted
21:1.0.1.1.1.12.56.59SECTION 1.720
     1.720 Are user fees under this subpart refundable
21:1.0.1.1.1.12.56.60SECTION 1.725
     1.725 What are the consequences of not paying a user fee under this subpart on time
21:1.0.1.1.1.13SUBPART N
Subpart N [Reserved]
21:1.0.1.1.1.14SUBPART O
Subpart O - Sanitary Transportation of Human and Animal Food
21:1.0.1.1.1.14.57SUBJGRP 57
  General Provisions
21:1.0.1.1.1.14.57.1SECTION 1.900
     1.900 Who is subject to this subpart
21:1.0.1.1.1.14.57.2SECTION 1.902
     1.902 How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act
21:1.0.1.1.1.14.57.3SECTION 1.904
     1.904 What definitions apply to this subpart
21:1.0.1.1.1.14.58SUBJGRP 58
  Vehicles and Transportation Equipment
21:1.0.1.1.1.14.58.4SECTION 1.906
     1.906 What requirements apply to vehicles and transportation equipment
21:1.0.1.1.1.14.59SUBJGRP 59
  Transportation Operations
21:1.0.1.1.1.14.59.5SECTION 1.908
     1.908 What requirements apply to transportation operations
21:1.0.1.1.1.14.60SUBJGRP 60
  Training
21:1.0.1.1.1.14.60.6SECTION 1.910
     1.910 What training requirements apply to carriers engaged in transportation operations
21:1.0.1.1.1.14.61SUBJGRP 61
  Records
21:1.0.1.1.1.14.61.7SECTION 1.912
     1.912 What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations
21:1.0.1.1.1.14.62SUBJGRP 62
  Waivers
21:1.0.1.1.1.14.62.8SECTION 1.914
     1.914 Under what circumstances will we waive a requirement of this subpart
21:1.0.1.1.1.14.62.9SECTION 1.916
     1.916 When will we consider whether to waive a requirement of this subpart
21:1.0.1.1.1.14.62.10SECTION 1.918
     1.918 What must be included in the Statement of Grounds in a petition requesting a waiver
21:1.0.1.1.1.14.62.11SECTION 1.920
     1.920 What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available
21:1.0.1.1.1.14.62.12SECTION 1.922
     1.922 Who will respond to a petition requesting a waiver
21:1.0.1.1.1.14.62.13SECTION 1.924
     1.924 What process applies to a petition requesting a waiver
21:1.0.1.1.1.14.62.14SECTION 1.926
     1.926 Under what circumstances may we deny a petition requesting a waiver
21:1.0.1.1.1.14.62.15SECTION 1.928
     1.928 What process will we follow when waiving a requirement of this subpart on our own initiative
21:1.0.1.1.1.14.62.16SECTION 1.930
     1.930 When will a waiver that we grant become effective
21:1.0.1.1.1.14.62.17SECTION 1.932
     1.932 Under what circumstances may we modify or revoke a waiver
21:1.0.1.1.1.14.62.18SECTION 1.934
     1.934 What procedures apply if we determine that a waiver should be modified or revoked
21:1.0.1.1.1.15SUBPART P
Subpart P [Reserved]
21:1.0.1.1.1.16SUBPART Q
Subpart Q - Administrative Detention of Drugs Intended for Human or Animal Use
21:1.0.1.1.1.16.63.1SECTION 1.980
     1.980 Administrative detention of drugs.
21:1.0.1.1.2PART 2
PART 2 - GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
21:1.0.1.1.2.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.2.1.63.1SECTION 2.5
     2.5 Imminent hazard to the public health.
21:1.0.1.1.2.1.63.2SECTION 2.10
     2.10 Examination and investigation samples.
21:1.0.1.1.2.1.63.3SECTION 2.19
     2.19 Methods of analysis.
21:1.0.1.1.2.2SUBPART B
Subpart B - Human and Animal Foods
21:1.0.1.1.2.2.63.1SECTION 2.25
     2.25 Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food.
21:1.0.1.1.2.2.63.2SECTION 2.35
     2.35 Use of secondhand containers for the shipment or storage of food and animal feed.
21:1.0.1.1.2.3SUBPART C
Subparts C-E [Reserved]
21:1.0.1.1.2.4SUBPART F
Subpart F - Caustic Poisons
21:1.0.1.1.2.4.63.1SECTION 2.110
     2.110 Definition of ammonia under Federal Caustic Poison Act.
21:1.0.1.1.2.5SUBPART G
Subpart G - Provisions Applicable to Specific Products Subject to the Federal Food, Drug, and Cosmetic Act
21:1.0.1.1.2.5.63.1SECTION 2.125
     2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.
21:1.0.1.1.3PART 3
PART 3 - PRODUCT JURISDICTION
21:1.0.1.1.3.1SUBPART A
Subpart A - Assignment of Agency Component for Review of Premarket Applications
21:1.0.1.1.3.1.63.1SECTION 3.1
     3.1 Purpose.
21:1.0.1.1.3.1.63.2SECTION 3.2
     3.2 Definitions.
21:1.0.1.1.3.1.63.3SECTION 3.3
     3.3 Scope.
21:1.0.1.1.3.1.63.4SECTION 3.4
     3.4 Designated agency component.
21:1.0.1.1.3.1.63.5SECTION 3.5
     3.5 Procedures for identifying the designated agency component.
21:1.0.1.1.3.1.63.6SECTION 3.6
     3.6 Product jurisdiction officer.
21:1.0.1.1.3.1.63.7SECTION 3.7
     3.7 Request for designation.
21:1.0.1.1.3.1.63.8SECTION 3.8
     3.8 Letter of designation.
21:1.0.1.1.3.1.63.9SECTION 3.9
     3.9 Effect of letter of designation.
21:1.0.1.1.3.1.63.10SECTION 3.10
     3.10 Stay of review time.
21:1.0.1.1.3.2SUBPART B
Subpart B [Reserved]
21:1.0.1.1.4PART 4
PART 4 - REGULATION OF COMBINATION PRODUCTS
21:1.0.1.1.4.1SUBPART A
Subpart A - Current Good Manufacturing Practice Requirements for Combination Products
21:1.0.1.1.4.1.63.1SECTION 4.1
     4.1 What is the scope of this subpart
21:1.0.1.1.4.1.63.2SECTION 4.2
     4.2 How does FDA define key terms and phrases in this subpart
21:1.0.1.1.4.1.63.3SECTION 4.3
     4.3 What current good manufacturing practice requirements apply to my combination product
21:1.0.1.1.4.1.63.4SECTION 4.4
     4.4 How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product
21:1.0.1.1.4.2SUBPART B
Subpart B - Postmarketing Safety Reporting for Combination Products
21:1.0.1.1.4.2.63.1SECTION 4.100
     4.100 What is the scope of this subpart
21:1.0.1.1.4.2.63.2SECTION 4.101
     4.101 How does the FDA define key terms and phrases in this subpart
21:1.0.1.1.4.2.63.3SECTION 4.102
     4.102 What reports must you submit to FDA for your combination product or constituent part
21:1.0.1.1.4.2.63.4SECTION 4.103
     4.103 What information must you share with other constituent part applicants for the combination product
21:1.0.1.1.4.2.63.5SECTION 4.104
     4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part
21:1.0.1.1.4.2.63.6SECTION 4.105
     4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part
21:1.0.1.1.5PART 5
PART 5 - ORGANIZATION
21:1.0.1.1.5.1SUBPART A
Subparts A-L [Reserved]
21:1.0.1.1.5.2SUBPART M
Subpart M - Organization
21:1.0.1.1.5.2.63.1SECTION 5.1100
     5.1100 Headquarters.
21:1.0.1.1.5.2.63.2SECTION 5.1105
     5.1105 Chief Counsel, Food and Drug Administration.
21:1.0.1.1.5.2.63.3SECTION 5.1110
     5.1110 FDA public information offices.
21:1.0.1.1.6PART 7
PART 7 - ENFORCEMENT POLICY
21:1.0.1.1.6.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.6.1.63.1SECTION 7.1
     7.1 Scope.
21:1.0.1.1.6.1.63.2SECTION 7.3
     7.3 Definitions.
21:1.0.1.1.6.1.63.3SECTION 7.12
     7.12 Guaranty.
21:1.0.1.1.6.1.63.4SECTION 7.13
     7.13 Suggested forms of guaranty.
21:1.0.1.1.6.2SUBPART B
Subpart B [Reserved]
21:1.0.1.1.6.3SUBPART C
Subpart C - Recalls (Including Product Corrections) - Guidance on Policy, Procedures, and Industry Responsibilities
21:1.0.1.1.6.3.63.1SECTION 7.40
     7.40 Recall policy.
21:1.0.1.1.6.3.63.2SECTION 7.41
     7.41 Health hazard evaluation and recall classification.
21:1.0.1.1.6.3.63.3SECTION 7.42
     7.42 Recall strategy.
21:1.0.1.1.6.3.63.4SECTION 7.45
     7.45 Food and Drug Administration-requested recall.
21:1.0.1.1.6.3.63.5SECTION 7.46
     7.46 Firm-initiated recall.
21:1.0.1.1.6.3.63.6SECTION 7.49
     7.49 Recall communications.
21:1.0.1.1.6.3.63.7SECTION 7.50
     7.50 Public notification of recall.
21:1.0.1.1.6.3.63.8SECTION 7.53
     7.53 Recall status reports.
21:1.0.1.1.6.3.63.9SECTION 7.55
     7.55 Termination of a recall.
21:1.0.1.1.6.3.63.10SECTION 7.59
     7.59 General industry guidance.
21:1.0.1.1.6.4SUBPART D
Subpart D [Reserved]
21:1.0.1.1.6.5SUBPART E
Subpart E - Criminal Violations
21:1.0.1.1.6.5.63.1SECTION 7.84
     7.84 Opportunity for presentation of views before report of criminal violation.
21:1.0.1.1.6.5.63.2SECTION 7.85
     7.85 Conduct of a presentation of views before report of criminal violation.
21:1.0.1.1.6.5.63.3SECTION 7.87
     7.87 Records related to opportunities for presentation of views conducted before report of criminal violation.
21:1.0.1.1.7PART 10
PART 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES
21:1.0.1.1.7.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.7.1.63.1SECTION 10.1
     10.1 Scope.
21:1.0.1.1.7.1.63.2SECTION 10.3
     10.3 Definitions.
21:1.0.1.1.7.1.63.3SECTION 10.10
     10.10 Summaries of administrative practices and procedures.
21:1.0.1.1.7.1.63.4SECTION 10.19
     10.19 Waiver, suspension, or modification of procedural requirements.
21:1.0.1.1.7.2SUBPART B
Subpart B - General Administrative Procedures
21:1.0.1.1.7.2.63.1SECTION 10.20
     10.20 Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure.
21:1.0.1.1.7.2.63.2SECTION 10.25
     10.25 Initiation of administrative proceedings.
21:1.0.1.1.7.2.63.3SECTION 10.30
     10.30 Citizen petition.
21:1.0.1.1.7.2.63.4SECTION 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.
21:1.0.1.1.7.2.63.5SECTION 10.33
     10.33 Administrative reconsideration of action.
21:1.0.1.1.7.2.63.6SECTION 10.35
     10.35 Administrative stay of action.
21:1.0.1.1.7.2.63.7SECTION 10.40
     10.40 Promulgation of regulations for the efficient enforcement of the law.
21:1.0.1.1.7.2.63.8SECTION 10.45
     10.45 Court review of final administrative action; exhaustion of administrative remedies.
21:1.0.1.1.7.2.63.9SECTION 10.50
     10.50 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
21:1.0.1.1.7.2.63.10SECTION 10.55
     10.55 Separation of functions; ex parte communications.
21:1.0.1.1.7.2.63.11SECTION 10.60
     10.60 Referral by court.
21:1.0.1.1.7.2.63.12SECTION 10.65
     10.65 Meetings and correspondence.
21:1.0.1.1.7.2.63.13SECTION 10.70
     10.70 Documentation of significant decisions in administrative file.
21:1.0.1.1.7.2.63.14SECTION 10.75
     10.75 Internal agency review of decisions.
21:1.0.1.1.7.2.63.15SECTION 10.80
     10.80 Dissemination of draft Federal Register notices and regulations.
21:1.0.1.1.7.2.63.16SECTION 10.85
     10.85 Advisory opinions.
21:1.0.1.1.7.2.63.17SECTION 10.90
     10.90 Food and Drug Administration regulations, recommendations, and agreements.
21:1.0.1.1.7.2.63.18SECTION 10.95
     10.95 Participation in outside standard-setting activities.
21:1.0.1.1.7.2.63.19SECTION 10.100
     10.100 Public calendar.
21:1.0.1.1.7.2.63.20SECTION 10.105
     10.105 Representation by an organization.
21:1.0.1.1.7.2.63.21SECTION 10.110
     10.110 Settlement proposals.
21:1.0.1.1.7.2.63.22SECTION 10.115
     10.115 Good guidance practices.
21:1.0.1.1.7.3SUBPART C
Subpart C - Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures
21:1.0.1.1.7.3.63.1SECTION 10.200
     10.200 Scope.
21:1.0.1.1.7.3.63.2SECTION 10.203
     10.203 Definitions.
21:1.0.1.1.7.3.63.3SECTION 10.204
     10.204 General.
21:1.0.1.1.7.3.63.4SECTION 10.205
     10.205 Electronic media coverage of public administrative proceedings.
21:1.0.1.1.7.3.63.5SECTION 10.206
     10.206 Procedures for electronic media coverage of agency public administrative proceedings.
21:1.0.1.1.8PART 11
PART 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
21:1.0.1.1.8.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.8.1.63.1SECTION 11.1
     11.1 Scope.
21:1.0.1.1.8.1.63.2SECTION 11.2
     11.2 Implementation.
21:1.0.1.1.8.1.63.3SECTION 11.3
     11.3 Definitions.
21:1.0.1.1.8.2SUBPART B
Subpart B - Electronic Records
21:1.0.1.1.8.2.63.1SECTION 11.10
     11.10 Controls for closed systems.
21:1.0.1.1.8.2.63.2SECTION 11.30
     11.30 Controls for open systems.
21:1.0.1.1.8.2.63.3SECTION 11.50
     11.50 Signature manifestations.
21:1.0.1.1.8.2.63.4SECTION 11.70
     11.70 Signature/record linking.
21:1.0.1.1.8.3SUBPART C
Subpart C - Electronic Signatures
21:1.0.1.1.8.3.63.1SECTION 11.100
     11.100 General requirements.
21:1.0.1.1.8.3.63.2SECTION 11.200
     11.200 Electronic signature components and controls.
21:1.0.1.1.8.3.63.3SECTION 11.300
     11.300 Controls for identification codes/passwords.
21:1.0.1.1.9PART 12
PART 12 - FORMAL EVIDENTIARY PUBLIC HEARING
21:1.0.1.1.9.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.9.1.63.1SECTION 12.1
     12.1 Scope.
21:1.0.1.1.9.2SUBPART B
Subpart B - Initiation of Proceedings
21:1.0.1.1.9.2.63.1SECTION 12.20
     12.20 Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.
21:1.0.1.1.9.2.63.2SECTION 12.21
     12.21 Initiation of a hearing involving the issuance, amendment, or revocation of an order.
21:1.0.1.1.9.2.63.3SECTION 12.22
     12.22 Filing objections and requests for a hearing on a regulation or order.
21:1.0.1.1.9.2.63.4SECTION 12.23
     12.23 Notice of filing of objections.
21:1.0.1.1.9.2.63.5SECTION 12.24
     12.24 Ruling on objections and requests for hearing.
21:1.0.1.1.9.2.63.6SECTION 12.26
     12.26 Modification or revocation of regulation or order.
21:1.0.1.1.9.2.63.7SECTION 12.28
     12.28 Denial of hearing in whole or in part.
21:1.0.1.1.9.2.63.8SECTION 12.30
     12.30 Judicial review after waiver of hearing on a regulation.
21:1.0.1.1.9.2.63.9SECTION 12.32
     12.32 Request for alternative form of hearing.
21:1.0.1.1.9.2.63.10SECTION 12.35
     12.35 Notice of hearing; stay of action.
21:1.0.1.1.9.2.63.11SECTION 12.37
     12.37 Effective date of a regulation.
21:1.0.1.1.9.2.63.12SECTION 12.38
     12.38 Effective date of an order.
21:1.0.1.1.9.3SUBPART C
Subpart C - Appearance and Participation
21:1.0.1.1.9.3.63.1SECTION 12.40
     12.40 Appearance.
21:1.0.1.1.9.3.63.2SECTION 12.45
     12.45 Notice of participation.
21:1.0.1.1.9.3.63.3SECTION 12.50
     12.50 Advice on public participation in hearings.
21:1.0.1.1.9.4SUBPART D
Subpart D - Presiding Officer
21:1.0.1.1.9.4.63.1SECTION 12.60
     12.60 Presiding officer.
21:1.0.1.1.9.4.63.2SECTION 12.62
     12.62 Commencement of functions.
21:1.0.1.1.9.4.63.3SECTION 12.70
     12.70 Authority of presiding officer.
21:1.0.1.1.9.4.63.4SECTION 12.75
     12.75 Disqualification of presiding officer.
21:1.0.1.1.9.4.63.5SECTION 12.78
     12.78 Unavailability of presiding officer.
21:1.0.1.1.9.5SUBPART E
Subpart E - Hearing Procedures
21:1.0.1.1.9.5.63.1SECTION 12.80
     12.80 Filing and service of submissions.
21:1.0.1.1.9.5.63.2SECTION 12.82
     12.82 Petition to participate in forma pauperis.
21:1.0.1.1.9.5.63.3SECTION 12.83
     12.83 Advisory opinions.
21:1.0.1.1.9.5.63.4SECTION 12.85
     12.85 Disclosure of data and information by the participants.
21:1.0.1.1.9.5.63.5SECTION 12.87
     12.87 Purpose; oral and written testimony; burden of proof.
21:1.0.1.1.9.5.63.6SECTION 12.89
     12.89 Participation of nonparties.
21:1.0.1.1.9.5.63.7SECTION 12.90
     12.90 Conduct at oral hearings or conferences.
21:1.0.1.1.9.5.63.8SECTION 12.91
     12.91 Time and place of prehearing conference.
21:1.0.1.1.9.5.63.9SECTION 12.92
     12.92 Prehearing conference procedure.
21:1.0.1.1.9.5.63.10SECTION 12.93
     12.93 Summary decisions.
21:1.0.1.1.9.5.63.11SECTION 12.94
     12.94 Receipt of evidence.
21:1.0.1.1.9.5.63.12SECTION 12.95
     12.95 Official notice.
21:1.0.1.1.9.5.63.13SECTION 12.96
     12.96 Briefs and arguments.
21:1.0.1.1.9.5.63.14SECTION 12.97
     12.97 Interlocutory appeal from ruling of presiding officer.
21:1.0.1.1.9.5.63.15SECTION 12.98
     12.98 Official transcript.
21:1.0.1.1.9.5.63.16SECTION 12.99
     12.99 Motions.
21:1.0.1.1.9.6SUBPART F
Subpart F - Administrative Record
21:1.0.1.1.9.6.63.1SECTION 12.100
     12.100 Administrative record of a hearing.
21:1.0.1.1.9.6.63.2SECTION 12.105
     12.105 Examination of record.
21:1.0.1.1.9.7SUBPART G
Subpart G - Initial and Final Decisions
21:1.0.1.1.9.7.63.1SECTION 12.120
     12.120 Initial decision.
21:1.0.1.1.9.7.63.2SECTION 12.125
     12.125 Appeal from or review of initial decision.
21:1.0.1.1.9.7.63.3SECTION 12.130
     12.130 Decision by Commissioner on appeal or review of initial decision.
21:1.0.1.1.9.7.63.4SECTION 12.139
     12.139 Reconsideration and stay of action.
21:1.0.1.1.9.8SUBPART H
Subpart H - Judicial Review
21:1.0.1.1.9.8.63.1SECTION 12.140
     12.140 Review by the courts.
21:1.0.1.1.9.8.63.2SECTION 12.159
     12.159 Copies of petitions for judicial review.
21:1.0.1.1.10PART 13
PART 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
21:1.0.1.1.10.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.10.1.63.1SECTION 13.1
     13.1 Scope.
21:1.0.1.1.10.1.63.2SECTION 13.5
     13.5 Notice of a hearing before a Board.
21:1.0.1.1.10.1.63.3SECTION 13.10
     13.10 Members of a Board.
21:1.0.1.1.10.1.63.4SECTION 13.15
     13.15 Separation of functions; ex parte communications; administrative support.
21:1.0.1.1.10.2SUBPART B
Subpart B - Hearing Procedures
21:1.0.1.1.10.2.63.1SECTION 13.20
     13.20 Submissions to a Board.
21:1.0.1.1.10.2.63.2SECTION 13.25
     13.25 Disclosure of data and information by the participants.
21:1.0.1.1.10.2.63.3SECTION 13.30
     13.30 Proceedings of a Board.
21:1.0.1.1.10.3SUBPART C
Subpart C - Records of a Hearing Before a Board
21:1.0.1.1.10.3.63.1SECTION 13.40
     13.40 Administrative record of a Board.
21:1.0.1.1.10.3.63.2SECTION 13.45
     13.45 Examination of administrative record.
21:1.0.1.1.10.3.63.3SECTION 13.50
     13.50 Record for administrative decision.
21:1.0.1.1.11PART 14
PART 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
21:1.0.1.1.11.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.11.1.63.1SECTION 14.1
     14.1 Scope.
21:1.0.1.1.11.1.63.2SECTION 14.5
     14.5 Purpose of proceedings before an advisory committee.
21:1.0.1.1.11.1.63.3SECTION 14.7
     14.7 Administrative remedies.
21:1.0.1.1.11.1.63.4SECTION 14.10
     14.10 Applicability to Congress.
21:1.0.1.1.11.1.63.5SECTION 14.15
     14.15 Committees working under a contract with FDA.
21:1.0.1.1.11.2SUBPART B
Subpart B - Meeting Procedures
21:1.0.1.1.11.2.63.1SECTION 14.20
     14.20 Notice of hearing before an advisory committee.
21:1.0.1.1.11.2.63.2SECTION 14.22
     14.22 Meetings of an advisory committee.
21:1.0.1.1.11.2.63.3SECTION 14.25
     14.25 Portions of advisory committee meetings.
21:1.0.1.1.11.2.63.4SECTION 14.27
     14.27 Determination to close portions of advisory committee meetings.
21:1.0.1.1.11.2.63.5SECTION 14.29
     14.29 Conduct of a hearing before an advisory committee.
21:1.0.1.1.11.2.63.6SECTION 14.30
     14.30 Chairperson of an advisory committee.
21:1.0.1.1.11.2.63.7SECTION 14.31
     14.31 Consultation by an advisory committee with other persons.
21:1.0.1.1.11.2.63.8SECTION 14.33
     14.33 Compilation of materials for members of an advisory committee.
21:1.0.1.1.11.2.63.9SECTION 14.35
     14.35 Written submissions to an advisory committee.
21:1.0.1.1.11.2.63.10SECTION 14.39
     14.39 Additional rules for a particular advisory committee.
21:1.0.1.1.11.3SUBPART C
Subpart C - Establishment of Advisory Committees
21:1.0.1.1.11.3.63.1SECTION 14.40
     14.40 Establishment and renewal of advisory committees.
21:1.0.1.1.11.3.63.2SECTION 14.55
     14.55 Termination of advisory committees.
21:1.0.1.1.11.4SUBPART D
Subpart D - Records of Meetings and Hearings Before Advisory Committees
21:1.0.1.1.11.4.63.1SECTION 14.60
     14.60 Minutes and reports of advisory committee meetings.
21:1.0.1.1.11.4.63.2SECTION 14.61
     14.61 Transcripts of advisory committee meetings.
21:1.0.1.1.11.4.63.3SECTION 14.65
     14.65 Public inquiries and requests for advisory committee records.
21:1.0.1.1.11.4.63.4SECTION 14.70
     14.70 Administrative record of a public hearing before an advisory committee.
21:1.0.1.1.11.4.63.5SECTION 14.75
     14.75 Examination of administrative record and other advisory committee records.
21:1.0.1.1.11.5SUBPART E
Subpart E - Members of Advisory Committees
21:1.0.1.1.11.5.63.1SECTION 14.80
     14.80 Qualifications for members of standing policy and technical advisory committees.
21:1.0.1.1.11.5.63.2SECTION 14.82
     14.82 Nominations of voting members of standing advisory committees.
21:1.0.1.1.11.5.63.3SECTION 14.84
     14.84 Nominations and selection of nonvoting members of standing technical advisory committees.
21:1.0.1.1.11.5.63.4SECTION 14.86
     14.86 Rights and responsibilities of nonvoting members of advisory committees.
21:1.0.1.1.11.5.63.5SECTION 14.90
     14.90 Ad hoc advisory committee members.
21:1.0.1.1.11.5.63.6SECTION 14.95
     14.95 Compensation of advisory committee members.
21:1.0.1.1.11.6SUBPART F
Subpart F - Standing Advisory Committees
21:1.0.1.1.11.6.63.1SECTION 14.100
     14.100 List of standing advisory committees.
21:1.0.1.1.11.7SUBPART G
Subpart G - Technical Electronic Products Radiation Safety Standards Committee
21:1.0.1.1.11.7.63.1SECTION 14.120
     14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).
21:1.0.1.1.11.7.63.2SECTION 14.122
     14.122 Functions of TEPRSSC.
21:1.0.1.1.11.7.63.3SECTION 14.125
     14.125 Procedures of TEPRSSC.
21:1.0.1.1.11.7.63.4SECTION 14.127
     14.127 Membership of TEPRSSC.
21:1.0.1.1.11.7.63.5SECTION 14.130
     14.130 Conduct of TEPRSSC meeting; availability of TEPRSSC records.
21:1.0.1.1.11.8SUBPART H
Subpart H - Color Additive Advisory Committees
21:1.0.1.1.11.8.63.1SECTION 14.140
     14.140 Establishment of a color additive advisory committee.
21:1.0.1.1.11.8.63.2SECTION 14.142
     14.142 Functions of a color additive advisory committee.
21:1.0.1.1.11.8.63.3SECTION 14.145
     14.145 Procedures of a color additive advisory committee.
21:1.0.1.1.11.8.63.4SECTION 14.147
     14.147 Membership of a color additive advisory committee.
21:1.0.1.1.11.8.63.5SECTION 14.155
     14.155 Fees and compensation pertaining to a color additive advisory committee.
21:1.0.1.1.11.9SUBPART I
Subpart I - Advisory Committees for Human Prescription Drugs
21:1.0.1.1.11.9.63.1SECTION 14.160
     14.160 Establishment of standing technical advisory committees for human prescription drugs.
21:1.0.1.1.11.9.63.2SECTION 14.171
     14.171 Utilization of an advisory committee on the initiative of FDA.
21:1.0.1.1.11.9.63.3SECTION 14.172
     14.172 Utilization of an advisory committee at the request of an interested person.
21:1.0.1.1.11.9.63.4SECTION 14.174
     14.174 Advice and recommendations in writing.
21:1.0.1.1.12PART 15
PART 15 - PUBLIC HEARING BEFORE THE COMMISSIONER
21:1.0.1.1.12.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.12.1.63.1SECTION 15.1
     15.1 Scope.
21:1.0.1.1.12.2SUBPART B
Subpart B - Procedures for Public Hearing Before the Commissioner
21:1.0.1.1.12.2.63.1SECTION 15.20
     15.20 Notice of a public hearing before the Commissioner.
21:1.0.1.1.12.2.63.2SECTION 15.21
     15.21 Notice of participation; schedule for hearing.
21:1.0.1.1.12.2.63.3SECTION 15.25
     15.25 Written submissions.
21:1.0.1.1.12.2.63.4SECTION 15.30
     15.30 Conduct of a public hearing before the Commissioner.
21:1.0.1.1.12.3SUBPART C
Subpart C - Records of a Public Hearing Before the Commissioner
21:1.0.1.1.12.3.63.1SECTION 15.40
     15.40 Administrative record.
21:1.0.1.1.12.3.63.2SECTION 15.45
     15.45 Examination of administrative record.
21:1.0.1.1.13PART 16
PART 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
21:1.0.1.1.13.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.13.1.63.1SECTION 16.1
     16.1 Scope.
21:1.0.1.1.13.1.63.2SECTION 16.5
     16.5 Inapplicability and limited applicability.
21:1.0.1.1.13.2SUBPART B
Subpart B - Initiation of Proceedings
21:1.0.1.1.13.2.63.1SECTION 16.22
     16.22 Initiation of regulatory hearing.
21:1.0.1.1.13.2.63.2SECTION 16.24
     16.24 Regulatory hearing required by the act or a regulation.
21:1.0.1.1.13.2.63.3SECTION 16.26
     16.26 Denial of hearing and summary decision.
21:1.0.1.1.13.3SUBPART C
Subpart C - Commissioner and Presiding Officer
21:1.0.1.1.13.3.63.1SECTION 16.40
     16.40 Commissioner.
21:1.0.1.1.13.3.63.2SECTION 16.42
     16.42 Presiding officer.
21:1.0.1.1.13.3.63.3SECTION 16.44
     16.44 Communication to presiding officer and Commissioner.
21:1.0.1.1.13.4SUBPART D
Subpart D - Procedures for Regulatory Hearing
21:1.0.1.1.13.4.63.1SECTION 16.60
     16.60 Hearing procedure.
21:1.0.1.1.13.4.63.2SECTION 16.62
     16.62 Right to counsel.
21:1.0.1.1.13.5SUBPART E
Subpart E - Administrative Record and Decision
21:1.0.1.1.13.5.63.1SECTION 16.80
     16.80 Administrative record of a regulatory hearing.
21:1.0.1.1.13.5.63.2SECTION 16.85
     16.85 Examination of administrative record.
21:1.0.1.1.13.5.63.3SECTION 16.95
     16.95 Administrative decision and record for decision.
21:1.0.1.1.13.6SUBPART F
Subpart F - Reconsideration and Stay
21:1.0.1.1.13.6.63.1SECTION 16.119
     16.119 Reconsideration and stay of action.
21:1.0.1.1.13.7SUBPART G
Subpart G - Judicial Review
21:1.0.1.1.13.7.63.1SECTION 16.120
     16.120 Judicial review.
21:1.0.1.1.14PART 17
PART 17 - CIVIL MONEY PENALTIES HEARINGS
21:1.0.1.1.14.0.63.1SECTION 17.1
     17.1 Scope.
21:1.0.1.1.14.0.63.2SECTION 17.2
     17.2 Maximum penalty amounts.
21:1.0.1.1.14.0.63.3SECTION 17.3
     17.3 Definitions.
21:1.0.1.1.14.0.63.4SECTION 17.5
     17.5 Complaint.
21:1.0.1.1.14.0.63.5SECTION 17.7
     17.7 Service of complaint.
21:1.0.1.1.14.0.63.6SECTION 17.9
     17.9 Answer.
21:1.0.1.1.14.0.63.7SECTION 17.11
     17.11 Default upon failure to file an answer.
21:1.0.1.1.14.0.63.8SECTION 17.13
     17.13 Notice of hearing.
21:1.0.1.1.14.0.63.9SECTION 17.15
     17.15 Parties to the hearing.
21:1.0.1.1.14.0.63.10SECTION 17.17
     17.17 Summary decisions.
21:1.0.1.1.14.0.63.11SECTION 17.18
     17.18 Interlocutory appeal from ruling of presiding officer.
21:1.0.1.1.14.0.63.12SECTION 17.19
     17.19 Authority of the presiding officer.
21:1.0.1.1.14.0.63.13SECTION 17.20
     17.20 Ex parte contacts.
21:1.0.1.1.14.0.63.14SECTION 17.21
     17.21 Prehearing conferences.
21:1.0.1.1.14.0.63.15SECTION 17.23
     17.23 Discovery.
21:1.0.1.1.14.0.63.16SECTION 17.25
     17.25 Exchange of witness lists, witness statements, and exhibits.
21:1.0.1.1.14.0.63.17SECTION 17.27
     17.27 Hearing subpoenas.
21:1.0.1.1.14.0.63.18SECTION 17.28
     17.28 Protective order.
21:1.0.1.1.14.0.63.19SECTION 17.29
     17.29 Fees.
21:1.0.1.1.14.0.63.20SECTION 17.30
     17.30 Computation of time.
21:1.0.1.1.14.0.63.21SECTION 17.31
     17.31 Form, filing, and service of papers.
21:1.0.1.1.14.0.63.22SECTION 17.32
     17.32 Motions.
21:1.0.1.1.14.0.63.23SECTION 17.33
     17.33 The hearing and burden of proof.
21:1.0.1.1.14.0.63.24SECTION 17.34
     17.34 Determining the amount of penalties and assessments.
21:1.0.1.1.14.0.63.25SECTION 17.35
     17.35 Sanctions.
21:1.0.1.1.14.0.63.26SECTION 17.37
     17.37 Witnesses.
21:1.0.1.1.14.0.63.27SECTION 17.39
     17.39 Evidence.
21:1.0.1.1.14.0.63.28SECTION 17.41
     17.41 The administrative record.
21:1.0.1.1.14.0.63.29SECTION 17.43
     17.43 Posthearing briefs.
21:1.0.1.1.14.0.63.30SECTION 17.45
     17.45 Initial decision.
21:1.0.1.1.14.0.63.31SECTION 17.47
     17.47 Appeals.
21:1.0.1.1.14.0.63.32SECTION 17.48
     17.48 Harmless error.
21:1.0.1.1.14.0.63.33SECTION 17.51
     17.51 Judicial review.
21:1.0.1.1.14.0.63.34SECTION 17.54
     17.54 Deposit in the Treasury of the United States.
21:1.0.1.1.15PART 19
PART 19 - STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
21:1.0.1.1.15.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.15.1.63.1SECTION 19.1
     19.1 Scope.
21:1.0.1.1.15.1.63.2SECTION 19.5
     19.5 Reference to Department regulations.
21:1.0.1.1.15.1.63.3SECTION 19.6
     19.6 Code of ethics for government service.
21:1.0.1.1.15.1.63.4SECTION 19.10
     19.10 Food and Drug Administration Conflict of Interest Review Board.
21:1.0.1.1.15.2SUBPART B
Subpart B - Reporting of Violations
21:1.0.1.1.15.2.63.1SECTION 19.21
     19.21 Duty to report violations.
21:1.0.1.1.15.3SUBPART C
Subpart C - Disqualification Conditions
21:1.0.1.1.15.3.63.1SECTION 19.45
     19.45 Temporary disqualification of former employees.
21:1.0.1.1.15.3.63.2SECTION 19.55
     19.55 Permanent disqualification of former employees.
21:1.0.1.1.16PART 20
PART 20 - PUBLIC INFORMATION
21:1.0.1.1.16.1SUBPART A
Subpart A - Official Testimony and Information
21:1.0.1.1.16.1.63.1SECTION 20.1
     20.1 Testimony by Food and Drug Administration employees.
21:1.0.1.1.16.1.63.2SECTION 20.2
     20.2 Production of records by Food and Drug Administration employees.
21:1.0.1.1.16.1.63.3SECTION 20.3
     20.3 Certification and authentication of Food and Drug Administration records.
21:1.0.1.1.16.2SUBPART B
Subpart B - General Policy
21:1.0.1.1.16.2.63.1SECTION 20.20
     20.20 Policy on disclosure of Food and Drug Administration records.
21:1.0.1.1.16.2.63.2SECTION 20.21
     20.21 Uniform access to records.
21:1.0.1.1.16.2.63.3SECTION 20.22
     20.22 Partial disclosure of records.
21:1.0.1.1.16.2.63.4SECTION 20.23
     20.23 Request for existing records.
21:1.0.1.1.16.2.63.5SECTION 20.24
     20.24 Preparation of new records.
21:1.0.1.1.16.2.63.6SECTION 20.25
     20.25 Retroactive application of regulations.
21:1.0.1.1.16.2.63.7SECTION 20.26
     20.26 Indexes of certain records.
21:1.0.1.1.16.2.63.8SECTION 20.27
     20.27 Submission of records marked as confidential.
21:1.0.1.1.16.2.63.9SECTION 20.28
     20.28 Food and Drug Administration determinations of confidentiality.
21:1.0.1.1.16.2.63.10SECTION 20.29
     20.29 Prohibition on withdrawal of records from Food and Drug Administration files.
21:1.0.1.1.16.2.63.11SECTION 20.30
     20.30 Food and Drug Administration Division of Freedom of Information.
21:1.0.1.1.16.2.63.12SECTION 20.31
     20.31 Retention schedule of requests for Food and Drug Administration records.
21:1.0.1.1.16.2.63.13SECTION 20.32
     20.32 Disclosure of Food and Drug Administration employee names.
21:1.0.1.1.16.2.63.14SECTION 20.33
     20.33 Form or format of response.
21:1.0.1.1.16.2.63.15SECTION 20.34
     20.34 Search for records.
21:1.0.1.1.16.3SUBPART C
Subpart C - Procedures and Fees
21:1.0.1.1.16.3.63.1SECTION 20.40
     20.40 Filing a request for records.
21:1.0.1.1.16.3.63.2SECTION 20.41
     20.41 Time limitations.
21:1.0.1.1.16.3.63.3SECTION 20.42
     20.42 Aggregation of certain requests.
21:1.0.1.1.16.3.63.4SECTION 20.43
     20.43 Multitrack processing.
21:1.0.1.1.16.3.63.5SECTION 20.44
     20.44 Expedited processing.
21:1.0.1.1.16.3.63.6SECTION 20.45
     20.45 Fees to be charged.
21:1.0.1.1.16.3.63.7SECTION 20.46
     20.46 Waiver or reduction of fees.
21:1.0.1.1.16.3.63.8SECTION 20.47
     20.47 Situations in which confidentiality is uncertain.
21:1.0.1.1.16.3.63.9SECTION 20.48
     20.48 Judicial review of proposed disclosure.
21:1.0.1.1.16.3.63.10SECTION 20.49
     20.49 Denial of a request for records.
21:1.0.1.1.16.3.63.11SECTION 20.50
     20.50 Nonspecific and overly burdensome requests.
21:1.0.1.1.16.3.63.12SECTION 20.51
     20.51 Referral to primary source of records.
21:1.0.1.1.16.3.63.13SECTION 20.52
     20.52 Availability of records at National Technical Information Service.
21:1.0.1.1.16.3.63.14SECTION 20.53
     20.53 Use of private contractor for copying.
21:1.0.1.1.16.3.63.15SECTION 20.54
     20.54 Request for review without copying.
21:1.0.1.1.16.3.63.16SECTION 20.55
     20.55 Indexing trade secrets and confidential commercial or financial information.
21:1.0.1.1.16.4SUBPART D
Subpart D - Exemptions
21:1.0.1.1.16.4.63.1SECTION 20.60
     20.60 Applicability of exemptions.
21:1.0.1.1.16.4.63.2SECTION 20.61
     20.61 Trade secrets and commercial or financial information which is privileged or confidential.
21:1.0.1.1.16.4.63.3SECTION 20.62
     20.62 Inter- or intra-agency memoranda or letters.
21:1.0.1.1.16.4.63.4SECTION 20.63
     20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.
21:1.0.1.1.16.4.63.5SECTION 20.64
     20.64 Records or information compiled for law enforcement purposes.
21:1.0.1.1.16.4.63.6SECTION 20.65
     20.65 National defense and foreign policy.
21:1.0.1.1.16.4.63.7SECTION 20.66
     20.66 Internal personnel rules and practices.
21:1.0.1.1.16.4.63.8SECTION 20.67
     20.67 Records exempted by other statutes.
21:1.0.1.1.16.5SUBPART E
Subpart E - Limitations on Exemptions
21:1.0.1.1.16.5.63.1SECTION 20.80
     20.80 Applicability of limitations on exemptions.
21:1.0.1.1.16.5.63.2SECTION 20.81
     20.81 Data and information previously disclosed to the public.
21:1.0.1.1.16.5.63.3SECTION 20.82
     20.82 Discretionary disclosure by the Commissioner.
21:1.0.1.1.16.5.63.4SECTION 20.83
     20.83 Disclosure required by court order.
21:1.0.1.1.16.5.63.5SECTION 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.
21:1.0.1.1.16.5.63.6SECTION 20.85
     20.85 Disclosure to other Federal government departments and agencies.
21:1.0.1.1.16.5.63.7SECTION 20.86
     20.86 Disclosure in administrative or court proceedings.
21:1.0.1.1.16.5.63.8SECTION 20.87
     20.87 Disclosure to Congress.
21:1.0.1.1.16.5.63.9SECTION 20.88
     20.88 Communications with State and local government officials.
21:1.0.1.1.16.5.63.10SECTION 20.89
     20.89 Communications with foreign government officials.
21:1.0.1.1.16.5.63.11SECTION 20.90
     20.90 Disclosure to contractors.
21:1.0.1.1.16.5.63.12SECTION 20.91
     20.91 Use of data or information for administrative or court enforcement action.
21:1.0.1.1.16.6SUBPART F
Subpart F - Availability of Specific Categories of Records
21:1.0.1.1.16.6.63.1SECTION 20.100
     20.100 Applicability; cross-reference to other regulations.
21:1.0.1.1.16.6.63.2SECTION 20.101
     20.101 Administrative enforcement records.
21:1.0.1.1.16.6.63.3SECTION 20.102
     20.102 Court enforcement records.
21:1.0.1.1.16.6.63.4SECTION 20.103
     20.103 Correspondence.
21:1.0.1.1.16.6.63.5SECTION 20.104
     20.104 Summaries of oral discussions.
21:1.0.1.1.16.6.63.6SECTION 20.105
     20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration.
21:1.0.1.1.16.6.63.7SECTION 20.106
     20.106 Studies and reports prepared by or with funds provided by the Food and Drug Administration.
21:1.0.1.1.16.6.63.8SECTION 20.107
     20.107 Food and Drug Administration manuals.
21:1.0.1.1.16.6.63.9SECTION 20.108
     20.108 Agreements between the Food and Drug Administration and other departments, agencies, and organizations.
21:1.0.1.1.16.6.63.10SECTION 20.109
     20.109 Data and information obtained by contract.
21:1.0.1.1.16.6.63.11SECTION 20.110
     20.110 Data and information about Food and Drug Administration employees.
21:1.0.1.1.16.6.63.12SECTION 20.111
     20.111 Data and information submitted voluntarily to the Food and Drug Administration.
21:1.0.1.1.16.6.63.13SECTION 20.112
     20.112 Voluntary drug experience reports submitted by physicians and hospitals.
21:1.0.1.1.16.6.63.14SECTION 20.113
     20.113 Voluntary product defect reports.
21:1.0.1.1.16.6.63.15SECTION 20.114
     20.114 Data and information submitted pursuant to cooperative quality assurance agreements.
21:1.0.1.1.16.6.63.16SECTION 20.115
     20.115 Product codes for manufacturing or sales dates.
21:1.0.1.1.16.6.63.17SECTION 20.116
     20.116 Drug and device registration and listing information.
21:1.0.1.1.16.6.63.18SECTION 20.117
     20.117 New drug information.
21:1.0.1.1.16.6.63.19SECTION 20.118
     20.118 Advisory committee records.
21:1.0.1.1.16.6.63.20SECTION 20.119
     20.119 Lists of names and addresses.
21:1.0.1.1.16.6.63.21SECTION 20.120
     20.120 Records available in Food and Drug Administration Public Reading Rooms.
21:1.0.1.1.17PART 21
PART 21 - PROTECTION OF PRIVACY
21:1.0.1.1.17.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.17.1.63.1SECTION 21.1
     21.1 Scope.
21:1.0.1.1.17.1.63.2SECTION 21.3
     21.3 Definitions.
21:1.0.1.1.17.1.63.3SECTION 21.10
     21.10 Policy concerning records about individuals.
21:1.0.1.1.17.2SUBPART B
Subpart B - Food and Drug Administration Privacy Act Record Systems
21:1.0.1.1.17.2.63.1SECTION 21.20
     21.20 Procedures for notice of Food and Drug Administration Privacy Act Record Systems.
21:1.0.1.1.17.2.63.2SECTION 21.21
     21.21 Changes in systems and new systems.
21:1.0.1.1.17.3SUBPART C
Subpart C - Requirements for Specific Categories of Records
21:1.0.1.1.17.3.63.1SECTION 21.30
     21.30 Records of contractors.
21:1.0.1.1.17.3.63.2SECTION 21.31
     21.31 Records stored by the National Archives and Records Administration.
21:1.0.1.1.17.3.63.3SECTION 21.32
     21.32 Personnel records.
21:1.0.1.1.17.3.63.4SECTION 21.33
     21.33 Medical records.
21:1.0.1.1.17.4SUBPART D
Subpart D - Procedures for Notification of and Access to Records in Privacy Act Record Systems
21:1.0.1.1.17.4.63.1SECTION 21.40
     21.40 Procedures for submitting requests for notification and access.
21:1.0.1.1.17.4.63.2SECTION 21.41
     21.41 Processing of requests.
21:1.0.1.1.17.4.63.3SECTION 21.42
     21.42 Responses to requests.
21:1.0.1.1.17.4.63.4SECTION 21.43
     21.43 Access to requested records.
21:1.0.1.1.17.4.63.5SECTION 21.44
     21.44 Verification of identity.
21:1.0.1.1.17.4.63.6SECTION 21.45
     21.45 Fees.
21:1.0.1.1.17.5SUBPART E
Subpart E - Procedures for Requests for Amendment of Records
21:1.0.1.1.17.5.63.1SECTION 21.50
     21.50 Procedures for submitting requests for amendment of records.
21:1.0.1.1.17.5.63.2SECTION 21.51
     21.51 Responses to requests for amendment of records.
21:1.0.1.1.17.5.63.3SECTION 21.52
     21.52 Administrative appeals of refusals to amend records.
21:1.0.1.1.17.5.63.4SECTION 21.53
     21.53 Notation and disclosure of disputed records.
21:1.0.1.1.17.5.63.5SECTION 21.54
     21.54 Amended or disputed records received from other agencies.
21:1.0.1.1.17.6SUBPART F
Subpart F - Exemptions
21:1.0.1.1.17.6.63.1SECTION 21.60
     21.60 Policy.
21:1.0.1.1.17.6.63.2SECTION 21.61
     21.61 Exempt systems.
21:1.0.1.1.17.6.63.3SECTION 21.65
     21.65 Access to records in exempt systems.
21:1.0.1.1.17.7SUBPART G
Subpart G - Disclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject Individual
21:1.0.1.1.17.7.63.1SECTION 21.70
     21.70 Disclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required.
21:1.0.1.1.17.7.63.2SECTION 21.71
     21.71 Disclosure of records in Privacy Act Record Systems; accounting required.
21:1.0.1.1.17.7.63.3SECTION 21.72
     21.72 Individual consent to disclosure of records to other persons.
21:1.0.1.1.17.7.63.4SECTION 21.73
     21.73 Accuracy, completeness, timeliness, and relevance of records disclosed from Privacy Act Record Systems.
21:1.0.1.1.17.7.63.5SECTION 21.74
     21.74 Providing notice that a record is disputed.
21:1.0.1.1.17.7.63.6SECTION 21.75
     21.75 Rights of legal guardians.
21:1.0.1.1.18PART 25
PART 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS
21:1.0.1.1.18.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.18.1.63.1SECTION 25.1
     25.1 Purpose.
21:1.0.1.1.18.1.63.2SECTION 25.5
     25.5 Terminology.
21:1.0.1.1.18.1.63.3SECTION 25.10
     25.10 Policies and NEPA planning.
21:1.0.1.1.18.2SUBPART B
Subpart B - Agency Actions Requiring Environmental Consideration
21:1.0.1.1.18.2.63.1SECTION 25.15
     25.15 General procedures.
21:1.0.1.1.18.2.63.2SECTION 25.16
     25.16 Public health and safety emergencies.
21:1.0.1.1.18.2.63.3SECTION 25.20
     25.20 Actions requiring preparation of an environmental assessment.
21:1.0.1.1.18.2.63.4SECTION 25.21
     25.21 Extraordinary circumstances.
21:1.0.1.1.18.2.63.5SECTION 25.22
     25.22 Actions requiring the preparation of an environmental impact statement.
21:1.0.1.1.18.3SUBPART C
Subpart C - Categorical Exclusions
21:1.0.1.1.18.3.63.1SECTION 25.30
     25.30 General.
21:1.0.1.1.18.3.63.2SECTION 25.31
     25.31 Human drugs and biologics.
21:1.0.1.1.18.3.63.3SECTION 25.32
     25.32 Foods, food additives, and color additives.
21:1.0.1.1.18.3.63.4SECTION 25.33
     25.33 Animal drugs.
21:1.0.1.1.18.3.63.5SECTION 25.34
     25.34 Devices and electronic products.
21:1.0.1.1.18.3.63.6SECTION 25.35
     25.35 Tobacco product applications.
21:1.0.1.1.18.4SUBPART D
Subpart D - Preparation of Environmental Documents
21:1.0.1.1.18.4.63.1SECTION 25.40
     25.40 Environmental assessments.
21:1.0.1.1.18.4.63.2SECTION 25.41
     25.41 Findings of no significant impact.
21:1.0.1.1.18.4.63.3SECTION 25.42
     25.42 Environmental impact statements.
21:1.0.1.1.18.4.63.4SECTION 25.43
     25.43 Records of decision.
21:1.0.1.1.18.4.63.5SECTION 25.44
     25.44 Lead and cooperating agencies.
21:1.0.1.1.18.4.63.6SECTION 25.45
     25.45 Responsible agency official.
21:1.0.1.1.18.5SUBPART E
Subpart E - Public Participation and Notification of Environmental Documents
21:1.0.1.1.18.5.63.1SECTION 25.50
     25.50 General information.
21:1.0.1.1.18.5.63.2SECTION 25.51
     25.51 Environmental assessments and findings of no significant impact.
21:1.0.1.1.18.5.63.3SECTION 25.52
     25.52 Environmental impact statements.
21:1.0.1.1.18.6SUBPART F
Subpart F - Other Requirements
21:1.0.1.1.18.6.63.1SECTION 25.60
     25.60 Environmental effects abroad of major agency actions.
21:1.0.1.1.19PART 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
21:1.0.1.1.19.0.63.1SECTION 26.0
     26.0 General.
21:1.0.1.1.19.1SUBPART A
Subpart A - Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices
21:1.0.1.1.19.1.63.1SECTION 26.1
     26.1 Definitions.
21:1.0.1.1.19.1.63.2SECTION 26.2
     26.2 Purpose.
21:1.0.1.1.19.1.63.3SECTION 26.3
     26.3 Scope.
21:1.0.1.1.19.1.63.4SECTION 26.4
     26.4 Product coverage.
21:1.0.1.1.19.1.63.5SECTION 26.5
     26.5 Length of transition period.
21:1.0.1.1.19.1.63.6SECTION 26.6
     26.6 Equivalence assessment.
21:1.0.1.1.19.1.63.7SECTION 26.7
     26.7 Participation in the equivalence assessment and determination.
21:1.0.1.1.19.1.63.8SECTION 26.8
     26.8 Other transition activities.
21:1.0.1.1.19.1.63.9SECTION 26.9
     26.9 Equivalence determination.
21:1.0.1.1.19.1.63.10SECTION 26.10
     26.10 Regulatory authorities not listed as currently equivalent.
21:1.0.1.1.19.1.63.11SECTION 26.11
     26.11 Start of operational period.
21:1.0.1.1.19.1.63.12SECTION 26.12
     26.12 Nature of recognition of inspection reports.
21:1.0.1.1.19.1.63.13SECTION 26.13
     26.13 Transmission of postapproval inspection reports.
21:1.0.1.1.19.1.63.14SECTION 26.14
     26.14 Transmission of preapproval inspection reports.
21:1.0.1.1.19.1.63.15SECTION 26.15
     26.15 Monitoring continued equivalence.
21:1.0.1.1.19.1.63.16SECTION 26.16
     26.16 Suspension.
21:1.0.1.1.19.1.63.17SECTION 26.17
     26.17 Role and composition of the Joint Sectoral Committee.
21:1.0.1.1.19.1.63.18SECTION 26.18
     26.18 Regulatory collaboration.
21:1.0.1.1.19.1.63.19SECTION 26.19
     26.19 Information relating to quality aspects.
21:1.0.1.1.19.1.63.20SECTION 26.20
     26.20 Alert system.
21:1.0.1.1.19.1.63.21SECTION 26.21
     26.21 Safeguard clause.
21:1.0.1.1.19.1.63.22.1APPENDIX Appendix A
  Appendix A to Subpart A of Part 26 - List of Applicable Laws, Regulations, and Administrative Provisions
21:1.0.1.1.19.1.63.22.2APPENDIX Appendix B
  Appendix B to Subpart A of Part 26 - List of Authorities
21:1.0.1.1.19.1.63.22.3APPENDIX Appendix C
  Appendix C to Subpart A of Part 26 - Indicative List of Products Covered by Subpart A
21:1.0.1.1.19.1.63.22.4APPENDIX Appendix D
  Appendix D to Subpart A of Part 26 - Criteria for Assessing Equivalence for Post- and Preapproval
21:1.0.1.1.19.1.63.22.5APPENDIX Appendix E
  Appendix E to Subpart A of Part 26 - Elements To Be Considered in Developing a Two-Way Alert System
21:1.0.1.1.19.2SUBPART B
Subpart B - Specific Sector Provisions for Medical Devices
21:1.0.1.1.19.2.63.1SECTION 26.31
     26.31 Purpose.
21:1.0.1.1.19.2.63.2SECTION 26.32
     26.32 Scope.
21:1.0.1.1.19.2.63.3SECTION 26.33
     26.33 Product coverage.
21:1.0.1.1.19.2.63.4SECTION 26.34
     26.34 Regulatory authorities.
21:1.0.1.1.19.2.63.5SECTION 26.35
     26.35 Length and purpose of transition period.
21:1.0.1.1.19.2.63.6SECTION 26.36
     26.36 Listing of CAB's.
21:1.0.1.1.19.2.63.7SECTION 26.37
     26.37 Confidence building activities.
21:1.0.1.1.19.2.63.8SECTION 26.38
     26.38 Other transition period activities.
21:1.0.1.1.19.2.63.9SECTION 26.39
     26.39 Equivalence assessment.
21:1.0.1.1.19.2.63.10SECTION 26.40
     26.40 Start of the operational period.
21:1.0.1.1.19.2.63.11SECTION 26.41
     26.41 Exchange and endorsement of quality system evaluation reports.
21:1.0.1.1.19.2.63.12SECTION 26.42
     26.42 Exchange and endorsement of product evaluation reports.
21:1.0.1.1.19.2.63.13SECTION 26.43
     26.43 Transmission of quality system evaluation reports.
21:1.0.1.1.19.2.63.14SECTION 26.44
     26.44 Transmission of product evaluation reports.
21:1.0.1.1.19.2.63.15SECTION 26.45
     26.45 Monitoring continued equivalence.
21:1.0.1.1.19.2.63.16SECTION 26.46
     26.46 Listing of additional CAB's.
21:1.0.1.1.19.2.63.17SECTION 26.47
     26.47 Role and composition of the Joint Sectoral Committee.
21:1.0.1.1.19.2.63.18SECTION 26.48
     26.48 Harmonization.
21:1.0.1.1.19.2.63.19SECTION 26.49
     26.49 Regulatory cooperation.
21:1.0.1.1.19.2.63.20SECTION 26.50
     26.50 Alert system and exchange of postmarket vigilance reports.
21:1.0.1.1.19.2.63.21.6APPENDIX Appendix A
  Appendix A to Subpart B of Part 26 - Relevant Legislation, Regulations, and Procedures.
21:1.0.1.1.19.2.63.21.7APPENDIX Appendix B
  Appendix B to Subpart B of Part 26 - Scope of Product Coverage
21:1.0.1.1.19.2.63.21.8APPENDIX
  Appendixes C-F to Subpart B of Part 26 [Reserved]
21:1.0.1.1.19.3SUBPART C
Subpart C - “Framework” Provisions
21:1.0.1.1.19.3.63.1SECTION 26.60
     26.60 Definitions.
21:1.0.1.1.19.3.63.2SECTION 26.61
     26.61 Purpose of this part.
21:1.0.1.1.19.3.63.3SECTION 26.62
     26.62 General obligations.
21:1.0.1.1.19.3.63.4SECTION 26.63
     26.63 General coverage of this part.
21:1.0.1.1.19.3.63.5SECTION 26.64
     26.64 Transitional arrangements.
21:1.0.1.1.19.3.63.6SECTION 26.65
     26.65 Designating authorities.
21:1.0.1.1.19.3.63.7SECTION 26.66
     26.66 Designation and listing procedures.
21:1.0.1.1.19.3.63.8SECTION 26.67
     26.67 Suspension of listed conformity assessment bodies.
21:1.0.1.1.19.3.63.9SECTION 26.68
     26.68 Withdrawal of listed conformity assessment bodies.
21:1.0.1.1.19.3.63.10SECTION 26.69
     26.69 Monitoring of conformity assessment bodies.
21:1.0.1.1.19.3.63.11SECTION 26.70
     26.70 Conformity assessment bodies.
21:1.0.1.1.19.3.63.12SECTION 26.71
     26.71 Exchange of information.
21:1.0.1.1.19.3.63.13SECTION 26.72
     26.72 Sectoral contact points.
21:1.0.1.1.19.3.63.14SECTION 26.73
     26.73 Joint Committee.
21:1.0.1.1.19.3.63.15SECTION 26.74
     26.74 Preservation of regulatory authority.
21:1.0.1.1.19.3.63.16SECTION 26.75
     26.75 Suspension of recognition obligations.
21:1.0.1.1.19.3.63.17SECTION 26.76
     26.76 Confidentiality.
21:1.0.1.1.19.3.63.18SECTION 26.77
     26.77 Fees.
21:1.0.1.1.19.3.63.19SECTION 26.78
     26.78 Agreements with other countries.
21:1.0.1.1.19.3.63.20SECTION 26.79
     26.79 Territorial application.
21:1.0.1.1.19.3.63.21SECTION 26.80
     26.80 Entry into force, amendment, and termination.
21:1.0.1.1.19.3.63.22SECTION 26.81
     26.81 Final provisions.
21:1.0.1.1.20PART 50
PART 50 - PROTECTION OF HUMAN SUBJECTS
21:1.0.1.1.20.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.20.1.63.1SECTION 50.1
     50.1 Scope.
21:1.0.1.1.20.1.63.2SECTION 50.3
     50.3 Definitions.
21:1.0.1.1.20.2SUBPART B
Subpart B - Informed Consent of Human Subjects
21:1.0.1.1.20.2.63.1SECTION 50.20
     50.20 General requirements for informed consent.
21:1.0.1.1.20.2.63.2SECTION 50.23
     50.23 Exception from general requirements.
21:1.0.1.1.20.2.63.3SECTION 50.24
     50.24 Exception from informed consent requirements for emergency research.
21:1.0.1.1.20.2.63.4SECTION 50.25
     50.25 Elements of informed consent.
21:1.0.1.1.20.2.63.5SECTION 50.27
     50.27 Documentation of informed consent.
21:1.0.1.1.20.3SUBPART C
Subpart C [Reserved]
21:1.0.1.1.20.4SUBPART D
Subpart D - Additional Safeguards for Children in Clinical Investigations
21:1.0.1.1.20.4.63.1SECTION 50.50
     50.50 IRB duties.
21:1.0.1.1.20.4.63.2SECTION 50.51
     50.51 Clinical investigations not involving greater than minimal risk.
21:1.0.1.1.20.4.63.3SECTION 50.52
     50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
21:1.0.1.1.20.4.63.4SECTION 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.
21:1.0.1.1.20.4.63.5SECTION 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.
21:1.0.1.1.20.4.63.6SECTION 50.55
     50.55 Requirements for permission by parents or guardians and for assent by children.
21:1.0.1.1.20.4.63.7SECTION 50.56
     50.56 Wards.
21:1.0.1.1.21PART 54
PART 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
21:1.0.1.1.21.0.63.1SECTION 54.1
     54.1 Purpose.
21:1.0.1.1.21.0.63.2SECTION 54.2
     54.2 Definitions.
21:1.0.1.1.21.0.63.3SECTION 54.3
     54.3 Scope.
21:1.0.1.1.21.0.63.4SECTION 54.4
     54.4 Certification and disclosure requirements.
21:1.0.1.1.21.0.63.5SECTION 54.5
     54.5 Agency evaluation of financial interests.
21:1.0.1.1.21.0.63.6SECTION 54.6
     54.6 Recordkeeping and record retention.
21:1.0.1.1.22PART 56
PART 56 - INSTITUTIONAL REVIEW BOARDS
21:1.0.1.1.22.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.22.1.63.1SECTION 56.101
     56.101 Scope.
21:1.0.1.1.22.1.63.2SECTION 56.102
     56.102 Definitions.
21:1.0.1.1.22.1.63.3SECTION 56.103
     56.103 Circumstances in which IRB review is required.
21:1.0.1.1.22.1.63.4SECTION 56.104
     56.104 Exemptions from IRB requirement.
21:1.0.1.1.22.1.63.5SECTION 56.105
     56.105 Waiver of IRB requirement.
21:1.0.1.1.22.2SUBPART B
Subpart B - Organization and Personnel
21:1.0.1.1.22.2.63.1SECTION 56.106
     56.106 Registration.
21:1.0.1.1.22.2.63.2SECTION 56.107
     56.107 IRB membership.
21:1.0.1.1.22.3SUBPART C
Subpart C - IRB Functions and Operations
21:1.0.1.1.22.3.63.1SECTION 56.108
     56.108 IRB functions and operations.
21:1.0.1.1.22.3.63.2SECTION 56.109
     56.109 IRB review of research.
21:1.0.1.1.22.3.63.3SECTION 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.
21:1.0.1.1.22.3.63.4SECTION 56.111
     56.111 Criteria for IRB approval of research.
21:1.0.1.1.22.3.63.5SECTION 56.112
     56.112 Review by institution.
21:1.0.1.1.22.3.63.6SECTION 56.113
     56.113 Suspension or termination of IRB approval of research.
21:1.0.1.1.22.3.63.7SECTION 56.114
     56.114 Cooperative research.
21:1.0.1.1.22.4SUBPART D
Subpart D - Records and Reports
21:1.0.1.1.22.4.63.1SECTION 56.115
     56.115 IRB records.
21:1.0.1.1.22.5SUBPART E
Subpart E - Administrative Actions for Noncompliance
21:1.0.1.1.22.5.63.1SECTION 56.120
     56.120 Lesser administrative actions.
21:1.0.1.1.22.5.63.2SECTION 56.121
     56.121 Disqualification of an IRB or an institution.
21:1.0.1.1.22.5.63.3SECTION 56.122
     56.122 Public disclosure of information regarding revocation.
21:1.0.1.1.22.5.63.4SECTION 56.123
     56.123 Reinstatement of an IRB or an institution.
21:1.0.1.1.22.5.63.5SECTION 56.124
     56.124 Actions alternative or additional to disqualification.
21:1.0.1.1.23PART 58
PART 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
21:1.0.1.1.23.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.23.1.63.1SECTION 58.1
     58.1 Scope.
21:1.0.1.1.23.1.63.2SECTION 58.3
     58.3 Definitions.
21:1.0.1.1.23.1.63.3SECTION 58.10
     58.10 Applicability to studies performed under grants and contracts.
21:1.0.1.1.23.1.63.4SECTION 58.15
     58.15 Inspection of a testing facility.
21:1.0.1.1.23.2SUBPART B
Subpart B - Organization and Personnel
21:1.0.1.1.23.2.63.1SECTION 58.29
     58.29 Personnel.
21:1.0.1.1.23.2.63.2SECTION 58.31
     58.31 Testing facility management.
21:1.0.1.1.23.2.63.3SECTION 58.33
     58.33 Study director.
21:1.0.1.1.23.2.63.4SECTION 58.35
     58.35 Quality assurance unit.
21:1.0.1.1.23.3SUBPART C
Subpart C - Facilities
21:1.0.1.1.23.3.63.1SECTION 58.41
     58.41 General.
21:1.0.1.1.23.3.63.2SECTION 58.43
     58.43 Animal care facilities.
21:1.0.1.1.23.3.63.3SECTION 58.45
     58.45 Animal supply facilities.
21:1.0.1.1.23.3.63.4SECTION 58.47
     58.47 Facilities for handling test and control articles.
21:1.0.1.1.23.3.63.5SECTION 58.49
     58.49 Laboratory operation areas.
21:1.0.1.1.23.3.63.6SECTION 58.51
     58.51 Specimen and data storage facilities.
21:1.0.1.1.23.4SUBPART D
Subpart D - Equipment
21:1.0.1.1.23.4.63.1SECTION 58.61
     58.61 Equipment design.
21:1.0.1.1.23.4.63.2SECTION 58.63
     58.63 Maintenance and calibration of equipment.
21:1.0.1.1.23.5SUBPART E
Subpart E - Testing Facilities Operation
21:1.0.1.1.23.5.63.1SECTION 58.81
     58.81 Standard operating procedures.
21:1.0.1.1.23.5.63.2SECTION 58.83
     58.83 Reagents and solutions.
21:1.0.1.1.23.5.63.3SECTION 58.90
     58.90 Animal care.
21:1.0.1.1.23.6SUBPART F
Subpart F - Test and Control Articles
21:1.0.1.1.23.6.63.1SECTION 58.105
     58.105 Test and control article characterization.
21:1.0.1.1.23.6.63.2SECTION 58.107
     58.107 Test and control article handling.
21:1.0.1.1.23.6.63.3SECTION 58.113
     58.113 Mixtures of articles with carriers.
21:1.0.1.1.23.7SUBPART G
Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study
21:1.0.1.1.23.7.63.1SECTION 58.120
     58.120 Protocol.
21:1.0.1.1.23.7.63.2SECTION 58.130
     58.130 Conduct of a nonclinical laboratory study.
21:1.0.1.1.23.8SUBPART H
Subparts H-I [Reserved]
21:1.0.1.1.23.9SUBPART J
Subpart J - Records and Reports
21:1.0.1.1.23.9.63.1SECTION 58.185
     58.185 Reporting of nonclinical laboratory study results.
21:1.0.1.1.23.9.63.2SECTION 58.190
     58.190 Storage and retrieval of records and data.
21:1.0.1.1.23.9.63.3SECTION 58.195
     58.195 Retention of records.
21:1.0.1.1.23.10SUBPART K
Subpart K - Disqualification of Testing Facilities
21:1.0.1.1.23.10.63.1SECTION 58.200
     58.200 Purpose.
21:1.0.1.1.23.10.63.2SECTION 58.202
     58.202 Grounds for disqualification.
21:1.0.1.1.23.10.63.3SECTION 58.204
     58.204 Notice of and opportunity for hearing on proposed disqualification.
21:1.0.1.1.23.10.63.4SECTION 58.206
     58.206 Final order on disqualification.
21:1.0.1.1.23.10.63.5SECTION 58.210
     58.210 Actions upon disqualification.
21:1.0.1.1.23.10.63.6SECTION 58.213
     58.213 Public disclosure of information regarding disqualification.
21:1.0.1.1.23.10.63.7SECTION 58.215
     58.215 Alternative or additional actions to disqualification.
21:1.0.1.1.23.10.63.8SECTION 58.217
     58.217 Suspension or termination of a testing facility by a sponsor.
21:1.0.1.1.23.10.63.9SECTION 58.219
     58.219 Reinstatement of a disqualified testing facility.
21:1.0.1.1.24PART 60
PART 60 - PATENT TERM RESTORATION
21:1.0.1.1.24.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.24.1.63.1SECTION 60.1
     60.1 Scope.
21:1.0.1.1.24.1.63.2SECTION 60.2
     60.2 Purpose.
21:1.0.1.1.24.1.63.3SECTION 60.3
     60.3 Definitions.
21:1.0.1.1.24.2SUBPART B
Subpart B - Eligibility Assistance
21:1.0.1.1.24.2.63.1SECTION 60.10
     60.10 FDA assistance on eligibility.
21:1.0.1.1.24.3SUBPART C
Subpart C - Regulatory Review Period Determinations
21:1.0.1.1.24.3.63.1SECTION 60.20
     60.20 FDA action on regulatory review period determinations.
21:1.0.1.1.24.3.63.2SECTION 60.22
     60.22 Regulatory review period determinations.
21:1.0.1.1.24.3.63.3SECTION 60.24
     60.24 Revision of regulatory review period determinations.
21:1.0.1.1.24.3.63.4SECTION 60.26
     60.26 Final action on regulatory review period determinations.
21:1.0.1.1.24.3.63.5SECTION 60.28
     60.28 Time frame for determining regulatory review periods.
21:1.0.1.1.24.4SUBPART D
Subpart D - Due Diligence Petitions
21:1.0.1.1.24.4.63.1SECTION 60.30
     60.30 Filing, format, and content of petitions.
21:1.0.1.1.24.4.63.2SECTION 60.32
     60.32 Applicant response to petition.
21:1.0.1.1.24.4.63.3SECTION 60.34
     60.34 FDA action on petitions.
21:1.0.1.1.24.4.63.4SECTION 60.36
     60.36 Standard of due diligence.
21:1.0.1.1.24.5SUBPART E
Subpart E - Due Diligence Hearings
21:1.0.1.1.24.5.63.1SECTION 60.40
     60.40 Request for hearing.
21:1.0.1.1.24.5.63.2SECTION 60.42
     60.42 Notice of hearing.
21:1.0.1.1.24.5.63.3SECTION 60.44
     60.44 Hearing procedures.
21:1.0.1.1.24.5.63.4SECTION 60.46
     60.46 Administrative decision.
21:1.0.1.1.25PART 70
PART 70 - COLOR ADDITIVES
21:1.0.1.1.25.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.25.1.63.1SECTION 70.3
     70.3 Definitions.
21:1.0.1.1.25.1.63.2SECTION 70.5
     70.5 General restrictions on use of color additives.
21:1.0.1.1.25.1.63.3SECTION 70.10
     70.10 Color additives in standardized foods and new drugs.
21:1.0.1.1.25.1.63.4SECTION 70.11
     70.11 Related substances.
21:1.0.1.1.25.1.63.5SECTION 70.19
     70.19 Fees for listing.
21:1.0.1.1.25.2SUBPART B
Subpart B - Packaging and Labeling
21:1.0.1.1.25.2.63.1SECTION 70.20
     70.20 Packaging requirements for straight colors (other than hair dyes).
21:1.0.1.1.25.2.63.2SECTION 70.25
     70.25 Labeling requirements for color additives (other than hair dyes).
21:1.0.1.1.25.3SUBPART C
Subpart C - Safety Evaluation
21:1.0.1.1.25.3.63.1SECTION 70.40
     70.40 Safety factors to be considered.
21:1.0.1.1.25.3.63.2SECTION 70.42
     70.42 Criteria for evaluating the safety of color additives.
21:1.0.1.1.25.3.63.3SECTION 70.45
     70.45 Allocation of color additives.
21:1.0.1.1.25.3.63.4SECTION 70.50
     70.50 Application of the cancer clause of section 721 of the act.
21:1.0.1.1.25.3.63.5SECTION 70.51
     70.51 Advisory committee on the applicability of the anticancer clause.
21:1.0.1.1.25.3.63.6SECTION 70.55
     70.55 Request for scientific studies.
21:1.0.1.1.26PART 71
PART 71 - COLOR ADDITIVE PETITIONS
21:1.0.1.1.26.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.26.1.63.1SECTION 71.1
     71.1 Petitions.
21:1.0.1.1.26.1.63.2SECTION 71.2
     71.2 Notice of filing of petition.
21:1.0.1.1.26.1.63.3SECTION 71.4
     71.4 Samples; additional information.
21:1.0.1.1.26.1.63.4SECTION 71.6
     71.6 Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice.
21:1.0.1.1.26.1.63.5SECTION 71.15
     71.15 Confidentiality of data and information in color additive petitions.
21:1.0.1.1.26.1.63.6SECTION 71.18
     71.18 Petition for exemption from certification.
21:1.0.1.1.26.2SUBPART B
Subpart B - Administrative Action on Petitions
21:1.0.1.1.26.2.63.1SECTION 71.20
     71.20 Publication of regulation.
21:1.0.1.1.26.2.63.2SECTION 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.
21:1.0.1.1.26.2.63.3SECTION 71.25
     71.25 Condition for certification.
21:1.0.1.1.26.2.63.4SECTION 71.26
     71.26 Revocation of exemption from certification.
21:1.0.1.1.26.2.63.5SECTION 71.27
     71.27 Listing and exemption from certification on the Commissioner's initiative.
21:1.0.1.1.26.2.63.6SECTION 71.30
     71.30 Procedure for filing objections to regulations.
21:1.0.1.1.26.2.63.7SECTION 71.37
     71.37 Exemption of color additives for investigational use.
21:1.0.1.1.27PART 73
PART 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
21:1.0.1.1.27.1SUBPART A
Subpart A - Foods
21:1.0.1.1.27.1.63.1SECTION 73.1
     73.1 Diluents in color additive mixtures for food use exempt from certification.
21:1.0.1.1.27.1.63.2SECTION 73.30
     73.30 Annatto extract.
21:1.0.1.1.27.1.63.3SECTION 73.35
     73.35 Astaxanthin.
21:1.0.1.1.27.1.63.4SECTION 73.37
     73.37 Astaxanthin dimethyldisuccinate.
21:1.0.1.1.27.1.63.5SECTION 73.40
     73.40 Dehydrated beets (beet powder).
21:1.0.1.1.27.1.63.6SECTION 73.50
     73.50 Ultramarine blue.
21:1.0.1.1.27.1.63.7SECTION 73.70
     73.70 Calcium carbonate.
21:1.0.1.1.27.1.63.8SECTION 73.75
     73.75 Canthaxanthin.
21:1.0.1.1.27.1.63.9SECTION 73.85
     73.85 Caramel.
21:1.0.1.1.27.1.63.10SECTION 73.90
     73.90 β-Apo-8′-carotenal.
21:1.0.1.1.27.1.63.11SECTION 73.95
     73.95 β-Carotene.
21:1.0.1.1.27.1.63.12SECTION 73.100
     73.100 Cochineal extract; carmine.
21:1.0.1.1.27.1.63.13SECTION 73.125
     73.125 Sodium copper chlorophyllin.
21:1.0.1.1.27.1.63.14SECTION 73.140
     73.140 Toasted partially defatted cooked cottonseed flour.
21:1.0.1.1.27.1.63.15SECTION 73.160
     73.160 Ferrous gluconate.
21:1.0.1.1.27.1.63.16SECTION 73.165
     73.165 Ferrous lactate.
21:1.0.1.1.27.1.63.17SECTION 73.169
     73.169 Grape color extract.
21:1.0.1.1.27.1.63.18SECTION 73.170
     73.170 Grape skin extract (enocianina).
21:1.0.1.1.27.1.63.19SECTION 73.185
     73.185 Haematococcus algae meal.
21:1.0.1.1.27.1.63.20SECTION 73.200
     73.200 Synthetic iron oxide.
21:1.0.1.1.27.1.63.21SECTION 73.250
     73.250 Fruit juice.
21:1.0.1.1.27.1.63.22SECTION 73.260
     73.260 Vegetable juice.
21:1.0.1.1.27.1.63.23SECTION 73.275
     73.275 Dried algae meal.
21:1.0.1.1.27.1.63.24SECTION 73.295
     73.295 Tagetes (Aztec marigold) meal and extract.
21:1.0.1.1.27.1.63.25SECTION 73.300
     73.300 Carrot oil.
21:1.0.1.1.27.1.63.26SECTION 73.315
     73.315 Corn endosperm oil.
21:1.0.1.1.27.1.63.27SECTION 73.340
     73.340 Paprika.
21:1.0.1.1.27.1.63.28SECTION 73.345
     73.345 Paprika oleoresin.
21:1.0.1.1.27.1.63.29SECTION 73.350
     73.350 Mica-based pearlescent pigments.
21:1.0.1.1.27.1.63.30SECTION 73.352
     73.352 Paracoccus pigment.
21:1.0.1.1.27.1.63.31SECTION 73.355
     73.355 Phaffia yeast.
21:1.0.1.1.27.1.63.32SECTION 73.450
     73.450 Riboflavin.
21:1.0.1.1.27.1.63.33SECTION 73.500
     73.500 Saffron.
21:1.0.1.1.27.1.63.34SECTION 73.520
     73.520 Soy leghemoglobin.
21:1.0.1.1.27.1.63.35SECTION 73.530
     73.530 Spirulina extract.
21:1.0.1.1.27.1.63.36SECTION 73.575
     73.575 Titanium dioxide.
21:1.0.1.1.27.1.63.37SECTION 73.585
     73.585 Tomato lycopene extract; tomato lycopene concentrate.
21:1.0.1.1.27.1.63.38SECTION 73.600
     73.600 Turmeric.
21:1.0.1.1.27.1.63.39SECTION 73.615
     73.615 Turmeric oleoresin.
21:1.0.1.1.27.2SUBPART B
Subpart B - Drugs
21:1.0.1.1.27.2.63.1SECTION 73.1001
     73.1001 Diluents in color additive mixtures for drug use exempt from certification.
21:1.0.1.1.27.2.63.2SECTION 73.1010
     73.1010 Alumina (dried aluminum hydroxide).
21:1.0.1.1.27.2.63.3SECTION 73.1015
     73.1015 Chromium-cobalt-aluminum oxide.
21:1.0.1.1.27.2.63.4SECTION 73.1025
     73.1025 Ferric ammonium citrate.
21:1.0.1.1.27.2.63.5SECTION 73.1030
     73.1030 Annatto extract.
21:1.0.1.1.27.2.63.6SECTION 73.1070
     73.1070 Calcium carbonate.
21:1.0.1.1.27.2.63.7SECTION 73.1075
     73.1075 Canthaxanthin.
21:1.0.1.1.27.2.63.8SECTION 73.1085
     73.1085 Caramel.
21:1.0.1.1.27.2.63.9SECTION 73.1095
     73.1095 β-Carotene.
21:1.0.1.1.27.2.63.10SECTION 73.1100
     73.1100 Cochineal extract; carmine.
21:1.0.1.1.27.2.63.11SECTION 73.1125
     73.1125 Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).
21:1.0.1.1.27.2.63.12SECTION 73.1150
     73.1150 Dihydroxyacetone.
21:1.0.1.1.27.2.63.13SECTION 73.1162
     73.1162 Bismuth oxychloride.
21:1.0.1.1.27.2.63.14SECTION 73.1200
     73.1200 Synthetic iron oxide.
21:1.0.1.1.27.2.63.15SECTION 73.1298
     73.1298 Ferric ammonium ferrocyanide.
21:1.0.1.1.27.2.63.16SECTION 73.1299
     73.1299 Ferric ferrocyanide.
21:1.0.1.1.27.2.63.17SECTION 73.1326
     73.1326 Chromium hydroxide green.
21:1.0.1.1.27.2.63.18SECTION 73.1327
     73.1327 Chromium oxide greens.
21:1.0.1.1.27.2.63.19SECTION 73.1329
     73.1329 Guanine.
21:1.0.1.1.27.2.63.20SECTION 73.1350
     73.1350 Mica-based pearlescent pigments.
21:1.0.1.1.27.2.63.21SECTION 73.1375
     73.1375 Pyrogallol.
21:1.0.1.1.27.2.63.22SECTION 73.1400
     73.1400 Pyrophyllite.
21:1.0.1.1.27.2.63.23SECTION 73.1410
     73.1410 Logwood extract.
21:1.0.1.1.27.2.63.24SECTION 73.1496
     73.1496 Mica.
21:1.0.1.1.27.2.63.25SECTION 73.1530
     73.1530 Spirulina extract.
21:1.0.1.1.27.2.63.26SECTION 73.1550
     73.1550 Talc.
21:1.0.1.1.27.2.63.27SECTION 73.1575
     73.1575 Titanium dioxide.
21:1.0.1.1.27.2.63.28SECTION 73.1645
     73.1645 Aluminum powder.
21:1.0.1.1.27.2.63.29SECTION 73.1646
     73.1646 Bronze powder.
21:1.0.1.1.27.2.63.30SECTION 73.1647
     73.1647 Copper powder.
21:1.0.1.1.27.2.63.31SECTION 73.1991
     73.1991 Zinc oxide.
21:1.0.1.1.27.3SUBPART C
Subpart C - Cosmetics
21:1.0.1.1.27.3.63.1SECTION 73.2030
     73.2030 Annatto.
21:1.0.1.1.27.3.63.2SECTION 73.2085
     73.2085 Caramel.
21:1.0.1.1.27.3.63.3SECTION 73.2087
     73.2087 Carmine.
21:1.0.1.1.27.3.63.4SECTION 73.2095
     73.2095 β-Carotene.
21:1.0.1.1.27.3.63.5SECTION 73.2110
     73.2110 Bismuth citrate.
21:1.0.1.1.27.3.63.6SECTION 73.2120
     73.2120 Disodium EDTA-copper.
21:1.0.1.1.27.3.63.7SECTION 73.2125
     73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex).
21:1.0.1.1.27.3.63.8SECTION 73.2150
     73.2150 Dihydroxyacetone.
21:1.0.1.1.27.3.63.9SECTION 73.2162
     73.2162 Bismuth oxychloride.
21:1.0.1.1.27.3.63.10SECTION 73.2180
     73.2180 Guaiazulene.
21:1.0.1.1.27.3.63.11SECTION 73.2190
     73.2190 Henna.
21:1.0.1.1.27.3.63.12SECTION 73.2250
     73.2250 Iron oxides.
21:1.0.1.1.27.3.63.13SECTION 73.2298
     73.2298 Ferric ammonium ferrocyanide.
21:1.0.1.1.27.3.63.14SECTION 73.2299
     73.2299 Ferric ferrocyanide.
21:1.0.1.1.27.3.63.15SECTION 73.2326
     73.2326 Chromium hydroxide green.
21:1.0.1.1.27.3.63.16SECTION 73.2327
     73.2327 Chromium oxide greens.
21:1.0.1.1.27.3.63.17SECTION 73.2329
     73.2329 Guanine.
21:1.0.1.1.27.3.63.18SECTION 73.2396
     73.2396 Lead acetate.
21:1.0.1.1.27.3.63.19SECTION 73.2400
     73.2400 Pyrophyllite.
21:1.0.1.1.27.3.63.20SECTION 73.2496
     73.2496 Mica.
21:1.0.1.1.27.3.63.21SECTION 73.2500
     73.2500 Silver.
21:1.0.1.1.27.3.63.22SECTION 73.2575
     73.2575 Titanium dioxide.
21:1.0.1.1.27.3.63.23SECTION 73.2645
     73.2645 Aluminum powder.
21:1.0.1.1.27.3.63.24SECTION 73.2646
     73.2646 Bronze powder.
21:1.0.1.1.27.3.63.25SECTION 73.2647
     73.2647 Copper powder.
21:1.0.1.1.27.3.63.26SECTION 73.2725
     73.2725 Ultramarines.
21:1.0.1.1.27.3.63.27SECTION 73.2775
     73.2775 Manganese violet.
21:1.0.1.1.27.3.63.28SECTION 73.2991
     73.2991 Zinc oxide.
21:1.0.1.1.27.3.63.29SECTION 73.2995
     73.2995 Luminescent zinc sulfide.
21:1.0.1.1.27.4SUBPART D
Subpart D - Medical Devices
21:1.0.1.1.27.4.63.1SECTION 73.3100
     73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers.
21:1.0.1.1.27.4.63.2SECTION 73.3105
     73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.
21:1.0.1.1.27.4.63.3SECTION 73.3106
     73.3106 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.
21:1.0.1.1.27.4.63.4SECTION 73.3107
     73.3107 Carbazole violet.
21:1.0.1.1.27.4.63.5SECTION 73.3110
     73.3110 Chlorophyllin-copper complex, oil soluble.
21:1.0.1.1.27.4.63.6SECTION 73.3110a
     73.3110a Chromium-cobalt-aluminum oxide.
21:1.0.1.1.27.4.63.7SECTION 73.3111
     73.3111 Chromium oxide greens.
21:1.0.1.1.27.4.63.8SECTION 73.3112
     73.3112 C.I. Vat Orange 1.
21:1.0.1.1.27.4.63.9SECTION 73.3115
     73.3115 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol.
21:1.0.1.1.27.4.63.10SECTION 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.
21:1.0.1.1.27.4.63.11SECTION 73.3118
     73.3118 N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.
21:1.0.1.1.27.4.63.12SECTION 73.3119
     73.3119 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.
21:1.0.1.1.27.4.63.13SECTION 73.3120
     73.3120 16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione.
21:1.0.1.1.27.4.63.14SECTION 73.3121
     73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers.
21:1.0.1.1.27.4.63.15SECTION 73.3122
     73.3122 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.
21:1.0.1.1.27.4.63.16SECTION 73.3123
     73.3123 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one.
21:1.0.1.1.27.4.63.17SECTION 73.3124
     73.3124 Phthalocyanine green.
21:1.0.1.1.27.4.63.18SECTION 73.3125
     73.3125 Iron oxides.
21:1.0.1.1.27.4.63.19SECTION 73.3126
     73.3126 Titanium dioxide.
21:1.0.1.1.27.4.63.20SECTION 73.3127
     73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products.
21:1.0.1.1.27.4.63.21SECTION 73.3128
     73.3128 Mica-based pearlescent pigments.
21:1.0.1.1.27.4.63.22SECTION 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.
21:1.0.1.1.28PART 74
PART 74 - LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
21:1.0.1.1.28.1SUBPART A
Subpart A - Foods
21:1.0.1.1.28.1.63.1SECTION 74.101
     74.101 FD&C Blue No. 1.
21:1.0.1.1.28.1.63.2SECTION 74.102
     74.102 FD&C Blue No. 2.
21:1.0.1.1.28.1.63.3SECTION 74.203
     74.203 FD&C Green No. 3.
21:1.0.1.1.28.1.63.4SECTION 74.250
     74.250 Orange B.
21:1.0.1.1.28.1.63.5SECTION 74.302
     74.302 Citrus Red No. 2.
21:1.0.1.1.28.1.63.6SECTION 74.303
     74.303 FD&C Red No. 3.
21:1.0.1.1.28.1.63.7SECTION 74.340
     74.340 FD&C Red No. 40.
21:1.0.1.1.28.1.63.8SECTION 74.705
     74.705 FD&C Yellow No. 5.
21:1.0.1.1.28.1.63.9SECTION 74.706
     74.706 FD&C Yellow No. 6.
21:1.0.1.1.28.2SUBPART B
Subpart B - Drugs
21:1.0.1.1.28.2.63.1SECTION 74.1101
     74.1101 FD&C Blue No. 1
21:1.0.1.1.28.2.63.2SECTION 74.1102
     74.1102 FD&C Blue No. 2.
21:1.0.1.1.28.2.63.3SECTION 74.1104
     74.1104 D&C Blue No. 4.
21:1.0.1.1.28.2.63.4SECTION 74.1109
     74.1109 D&C Blue No. 9.
21:1.0.1.1.28.2.63.5SECTION 74.1203
     74.1203 FD&C Green No. 3.
21:1.0.1.1.28.2.63.6SECTION 74.1205
     74.1205 D&C Green No. 5.
21:1.0.1.1.28.2.63.7SECTION 74.1206
     74.1206 D&C Green No. 6.
21:1.0.1.1.28.2.63.8SECTION 74.1208
     74.1208 D&C Green No. 8.
21:1.0.1.1.28.2.63.9SECTION 74.1254
     74.1254 D&C Orange No. 4.
21:1.0.1.1.28.2.63.10SECTION 74.1255
     74.1255 D&C Orange No. 5.
21:1.0.1.1.28.2.63.11SECTION 74.1260
     74.1260 D&C Orange No. 10.
21:1.0.1.1.28.2.63.12SECTION 74.1261
     74.1261 D&C Orange No. 11.
21:1.0.1.1.28.2.63.13SECTION 74.1303
     74.1303 FD&C Red No. 3.
21:1.0.1.1.28.2.63.14SECTION 74.1304
     74.1304 FD&C Red No. 4.
21:1.0.1.1.28.2.63.15SECTION 74.1306
     74.1306 D&C Red No. 6.
21:1.0.1.1.28.2.63.16SECTION 74.1307
     74.1307 D&C Red No. 7.
21:1.0.1.1.28.2.63.17SECTION 74.1317
     74.1317 D&C Red No. 17.
21:1.0.1.1.28.2.63.18SECTION 74.1321
     74.1321 D&C Red No. 21.
21:1.0.1.1.28.2.63.19SECTION 74.1322
     74.1322 D&C Red No. 22.
21:1.0.1.1.28.2.63.20SECTION 74.1327
     74.1327 D&C Red No. 27.
21:1.0.1.1.28.2.63.21SECTION 74.1328
     74.1328 D&C Red No. 28.
21:1.0.1.1.28.2.63.22SECTION 74.1330
     74.1330 D&C Red No. 30.
21:1.0.1.1.28.2.63.23SECTION 74.1331
     74.1331 D&C Red No. 31.
21:1.0.1.1.28.2.63.24SECTION 74.1333
     74.1333 D&C Red No. 33.
21:1.0.1.1.28.2.63.25SECTION 74.1334
     74.1334 D&C Red No. 34.
21:1.0.1.1.28.2.63.26SECTION 74.1336
     74.1336 D&C Red No. 36.
21:1.0.1.1.28.2.63.27SECTION 74.1339
     74.1339 D&C Red No. 39.
21:1.0.1.1.28.2.63.28SECTION 74.1340
     74.1340 FD&C Red No. 40.
21:1.0.1.1.28.2.63.29SECTION 74.1602
     74.1602 D&C Violet No. 2.
21:1.0.1.1.28.2.63.30SECTION 74.1705
     74.1705 FD&C Yellow No. 5.
21:1.0.1.1.28.2.63.31SECTION 74.1706
     74.1706 FD&C Yellow No. 6.
21:1.0.1.1.28.2.63.32SECTION 74.1707
     74.1707 D&C Yellow No. 7.
21:1.0.1.1.28.2.63.33SECTION 74.1707a
     74.1707a Ext. D&C Yellow No. 7.
21:1.0.1.1.28.2.63.34SECTION 74.1708
     74.1708 D&C Yellow No. 8.
21:1.0.1.1.28.2.63.35SECTION 74.1710
     74.1710 D&C Yellow No. 10.
21:1.0.1.1.28.2.63.36SECTION 74.1711
     74.1711 D&C Yellow No. 11.
21:1.0.1.1.28.3SUBPART C
Subpart C - Cosmetics
21:1.0.1.1.28.3.63.1SECTION 74.2052
     74.2052 D&C Black No. 2.
21:1.0.1.1.28.3.63.2SECTION 74.2053
     74.2053 D&C Black No. 3.
21:1.0.1.1.28.3.63.3SECTION 74.2101
     74.2101 FD&C Blue No. 1.
21:1.0.1.1.28.3.63.4SECTION 74.2104
     74.2104 D&C Blue No. 4.
21:1.0.1.1.28.3.63.5SECTION 74.2151
     74.2151 D&C Brown No. 1.
21:1.0.1.1.28.3.63.6SECTION 74.2203
     74.2203 FD&C Green No. 3.
21:1.0.1.1.28.3.63.7SECTION 74.2205
     74.2205 D&C Green No. 5.
21:1.0.1.1.28.3.63.8SECTION 74.2206
     74.2206 D&C Green No. 6.
21:1.0.1.1.28.3.63.9SECTION 74.2208
     74.2208 D&C Green No. 8.
21:1.0.1.1.28.3.63.10SECTION 74.2254
     74.2254 D&C Orange No. 4.
21:1.0.1.1.28.3.63.11SECTION 74.2255
     74.2255 D&C Orange No. 5.
21:1.0.1.1.28.3.63.12SECTION 74.2260
     74.2260 D&C Orange No. 10.
21:1.0.1.1.28.3.63.13SECTION 74.2261
     74.2261 D&C Orange No. 11.
21:1.0.1.1.28.3.63.14SECTION 74.2304
     74.2304 FD&C Red No. 4.
21:1.0.1.1.28.3.63.15SECTION 74.2306
     74.2306 D&C Red No. 6.
21:1.0.1.1.28.3.63.16SECTION 74.2307
     74.2307 D&C Red No. 7
21:1.0.1.1.28.3.63.17SECTION 74.2317
     74.2317 D&C Red No. 17.
21:1.0.1.1.28.3.63.18SECTION 74.2321
     74.2321 D&C Red No. 21.
21:1.0.1.1.28.3.63.19SECTION 74.2322
     74.2322 D&C Red No. 22.
21:1.0.1.1.28.3.63.20SECTION 74.2327
     74.2327 D&C Red No. 27.
21:1.0.1.1.28.3.63.21SECTION 74.2328
     74.2328 D&C Red No. 28.
21:1.0.1.1.28.3.63.22SECTION 74.2330
     74.2330 D&C Red No. 30.
21:1.0.1.1.28.3.63.23SECTION 74.2331
     74.2331 D&C Red No. 31.
21:1.0.1.1.28.3.63.24SECTION 74.2333
     74.2333 D&C Red No. 33.
21:1.0.1.1.28.3.63.25SECTION 74.2334
     74.2334 D&C Red No. 34.
21:1.0.1.1.28.3.63.26SECTION 74.2336
     74.2336 D&C Red No. 36.
21:1.0.1.1.28.3.63.27SECTION 74.2340
     74.2340 FD&C Red No. 40.
21:1.0.1.1.28.3.63.28SECTION 74.2602
     74.2602 D&C Violet No. 2.
21:1.0.1.1.28.3.63.29SECTION 74.2602a
     74.2602a Ext. D&C Violet No. 2.
21:1.0.1.1.28.3.63.30SECTION 74.2705
     74.2705 FD&C Yellow No. 5.
21:1.0.1.1.28.3.63.31SECTION 74.2706
     74.2706 FD&C Yellow No. 6.
21:1.0.1.1.28.3.63.32SECTION 74.2707
     74.2707 D&C Yellow No. 7.
21:1.0.1.1.28.3.63.33SECTION 74.2707a
     74.2707a Ext. D&C Yellow No. 7.
21:1.0.1.1.28.3.63.34SECTION 74.2708
     74.2708 D&C Yellow No. 8.
21:1.0.1.1.28.3.63.35SECTION 74.2710
     74.2710 D&C Yellow No. 10.
21:1.0.1.1.28.3.63.36SECTION 74.2711
     74.2711 D&C Yellow No. 11.
21:1.0.1.1.28.4SUBPART D
Subpart D - Medical Devices
21:1.0.1.1.28.4.63.1SECTION 74.3045
     74.3045 [Phthalocyaninato(2-)] copper.
21:1.0.1.1.28.4.63.2SECTION 74.3054
     74.3054 D&C Black No. 4.
21:1.0.1.1.28.4.63.3SECTION 74.3102
     74.3102 FD&C Blue No. 2.
21:1.0.1.1.28.4.63.4SECTION 74.3106
     74.3106 D&C Blue No. 6.
21:1.0.1.1.28.4.63.5SECTION 74.3206
     74.3206 D&C Green No. 6.
21:1.0.1.1.28.4.63.6SECTION 74.3230
     74.3230 D&C Red No. 17.
21:1.0.1.1.28.4.63.7SECTION 74.3602
     74.3602 D&C Violet No. 2.
21:1.0.1.1.28.4.63.8SECTION 74.3708
     74.3708 D&C Yellow No. 8.
21:1.0.1.1.28.4.63.9SECTION 74.3710
     74.3710 D&C Yellow No. 10.
21:1.0.1.1.29PART 80
PART 80 - COLOR ADDITIVE CERTIFICATION
21:1.0.1.1.29.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.29.1.63.1SECTION 80.10
     80.10 Fees for certification services.
21:1.0.1.1.29.2SUBPART B
Subpart B - Certification Procedures
21:1.0.1.1.29.2.63.1SECTION 80.21
     80.21 Request for certification.
21:1.0.1.1.29.2.63.2SECTION 80.22
     80.22 Samples to accompany requests for certification.
21:1.0.1.1.29.2.63.3SECTION 80.31
     80.31 Certification.
21:1.0.1.1.29.2.63.4SECTION 80.32
     80.32 Limitations of certificates.
21:1.0.1.1.29.2.63.5SECTION 80.34
     80.34 Authority to refuse certification service.
21:1.0.1.1.29.2.63.6SECTION 80.35
     80.35 Color additive mixtures; certification and exemption from certification.
21:1.0.1.1.29.2.63.7SECTION 80.37
     80.37 Treatment of batch pending certification.
21:1.0.1.1.29.2.63.8SECTION 80.38
     80.38 Treatment of batch after certification.
21:1.0.1.1.29.2.63.9SECTION 80.39
     80.39 Records of distribution.
21:1.0.1.1.30PART 81
PART 81 - GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
21:1.0.1.1.30.0.63.1SECTION 81.1
     81.1 Provisional lists of color additives.
21:1.0.1.1.30.0.63.2SECTION 81.10
     81.10 Termination of provisional listings of color additives.
21:1.0.1.1.30.0.63.3SECTION 81.30
     81.30 Cancellation of certificates.
21:1.0.1.1.30.0.63.4SECTION 81.32
     81.32 Limitation of certificates.
21:1.0.1.1.31PART 82
PART 82 - LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
21:1.0.1.1.31.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.31.1.63.1SECTION 82.3
     82.3 Definitions.
21:1.0.1.1.31.1.63.2SECTION 82.5
     82.5 General specifications for straight colors.
21:1.0.1.1.31.1.63.3SECTION 82.6
     82.6 Certifiable mixtures.
21:1.0.1.1.31.2SUBPART B
Subpart B - Foods, Drugs, and Cosmetics
21:1.0.1.1.31.2.63.1SECTION 82.50
     82.50 General.
21:1.0.1.1.31.2.63.2SECTION 82.51
     82.51 Lakes (FD&C).
21:1.0.1.1.31.2.63.3SECTION 82.101
     82.101 FD&C Blue No. 1.
21:1.0.1.1.31.2.63.4SECTION 82.102
     82.102 FD&C Blue No. 2.
21:1.0.1.1.31.2.63.5SECTION 82.203
     82.203 FD&C Green No. 3.
21:1.0.1.1.31.2.63.6SECTION 82.304
     82.304 FD&C Red No. 4.
21:1.0.1.1.31.2.63.7SECTION 82.705
     82.705 FD&C Yellow No. 5.
21:1.0.1.1.31.2.63.8SECTION 82.706
     82.706 FD&C Yellow No. 6.
21:1.0.1.1.31.3SUBPART C
Subpart C - Drugs and Cosmetics
21:1.0.1.1.31.3.63.1SECTION 82.1050
     82.1050 General.
21:1.0.1.1.31.3.63.2SECTION 82.1051
     82.1051 Lakes (D&C).
21:1.0.1.1.31.3.63.3SECTION 82.1104
     82.1104 D&C Blue No. 4.
21:1.0.1.1.31.3.63.4SECTION 82.1205
     82.1205 D&C Green No. 5.
21:1.0.1.1.31.3.63.5SECTION 82.1206
     82.1206 D&C Green No. 6.
21:1.0.1.1.31.3.63.6SECTION 82.1254
     82.1254 D&C Orange No. 4.
21:1.0.1.1.31.3.63.7SECTION 82.1255
     82.1255 D&C Orange No. 5.
21:1.0.1.1.31.3.63.8SECTION 82.1260
     82.1260 D&C Orange No. 10.
21:1.0.1.1.31.3.63.9SECTION 82.1261
     82.1261 D&C Orange No. 11.
21:1.0.1.1.31.3.63.10SECTION 82.1306
     82.1306 D&C Red No. 6.
21:1.0.1.1.31.3.63.11SECTION 82.1307
     82.1307 D&C Red No. 7.
21:1.0.1.1.31.3.63.12SECTION 82.1317
     82.1317 D&C Red No. 17.
21:1.0.1.1.31.3.63.13SECTION 82.1321
     82.1321 D&C Red No. 21.
21:1.0.1.1.31.3.63.14SECTION 82.1322
     82.1322 D&C Red No. 22.
21:1.0.1.1.31.3.63.15SECTION 82.1327
     82.1327 D&C Red No. 27.
21:1.0.1.1.31.3.63.16SECTION 82.1328
     82.1328 D&C Red No. 28.
21:1.0.1.1.31.3.63.17SECTION 82.1330
     82.1330 D&C Red No. 30.
21:1.0.1.1.31.3.63.18SECTION 82.1331
     82.1331 D&C Red No. 31.
21:1.0.1.1.31.3.63.19SECTION 82.1333
     82.1333 D&C Red No. 33.
21:1.0.1.1.31.3.63.20SECTION 82.1334
     82.1334 D&C Red No. 34.
21:1.0.1.1.31.3.63.21SECTION 82.1336
     82.1336 D&C Red No. 36.
21:1.0.1.1.31.3.63.22SECTION 82.1602
     82.1602 D&C Violet No. 2.
21:1.0.1.1.31.3.63.23SECTION 82.1707
     82.1707 D&C Yellow No. 7.
21:1.0.1.1.31.3.63.24SECTION 82.1708
     82.1708 D&C Yellow No. 8.
21:1.0.1.1.31.3.63.25SECTION 82.1710
     82.1710 D&C Yellow No. 10.
21:1.0.1.1.31.4SUBPART D
Subpart D - Externally Applied Drugs and Cosmetics
21:1.0.1.1.31.4.63.1SECTION 82.2050
     82.2050 General.
21:1.0.1.1.31.4.63.2SECTION 82.2051
     82.2051 Lakes (Ext. D&C).
21:1.0.1.1.31.4.63.3SECTION 82.2707a
     82.2707a Ext. D&C Yellow No. 7.
21:1.0.1.1.32PART 83-98
PARTS 83-98 [RESERVED]
21:1.0.1.1.33PART 99
PART 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
21:1.0.1.1.33.1SUBPART A
Subpart A - General Information
21:1.0.1.1.33.1.63.1SECTION 99.1
     99.1 Scope.
21:1.0.1.1.33.1.63.2SECTION 99.3
     99.3 Definitions.
21:1.0.1.1.33.2SUBPART B
Subpart B - Information To Be Disseminated
21:1.0.1.1.33.2.63.1SECTION 99.101
     99.101 Information that may be disseminated.
21:1.0.1.1.33.2.63.2SECTION 99.103
     99.103 Mandatory statements and information.
21:1.0.1.1.33.2.63.3SECTION 99.105
     99.105 Recipients of information.
21:1.0.1.1.33.3SUBPART C
Subpart C - Manufacturer's Submissions, Requests, and Applications
21:1.0.1.1.33.3.63.1SECTION 99.201
     99.201 Manufacturer's submission to the agency.
21:1.0.1.1.33.3.63.2SECTION 99.203
     99.203 Request to extend the time for completing planned studies.
21:1.0.1.1.33.3.63.3SECTION 99.205
     99.205 Application for exemption from the requirement to file a supplemental application.
21:1.0.1.1.33.4SUBPART D
Subpart D - FDA Action on Submissions, Requests, and Applications
21:1.0.1.1.33.4.63.1SECTION 99.301
     99.301 Agency action on a submission.
21:1.0.1.1.33.4.63.2SECTION 99.303
     99.303 Extension of time for completing planned studies.
21:1.0.1.1.33.4.63.3SECTION 99.305
     99.305 Exemption from the requirement to file a supplemental application.
21:1.0.1.1.33.5SUBPART E
Subpart E - Corrective Actions and Cessation of Dissemination
21:1.0.1.1.33.5.63.1SECTION 99.401
     99.401 Corrective actions and cessation of dissemination of information.
21:1.0.1.1.33.5.63.2SECTION 99.403
     99.403 Termination of approvals of applications for exemption.
21:1.0.1.1.33.5.63.3SECTION 99.405
     99.405 Applicability of labeling, adulteration, and misbranding authority.
21:1.0.1.1.33.6SUBPART F
Subpart F - Recordkeeping and Reports
21:1.0.1.1.33.6.63.1SECTION 99.501
     99.501 Recordkeeping and reports.