2005 CFR Title 21, Volume 1

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 1--GENERAL ENFORCEMENT REGULATIONS
	1.1	General.
	1.3	Definitions.
	1.4	Authority citations.
	1.20	Presence of mandatory label information.
	1.21	Failure to reveal material facts.
	1.23	Procedures for requesting variations and exemptions from required label statements.
	1.24	Exemptions from required label statements.
	1.83	Definitions.
	1.90	Notice of sampling.
	1.91	Payment for samples.
	1.94	Hearing on refusal of admission.
	1.95	Application for authorization to relabel and recondition.
	1.96	Granting of authorization to relabel and recondition.
	1.97	Bonds.
	1.99	Costs chargeable in connection with relabeling and reconditioning inadmissible imports.
	1.101	Notification and recordkeeping.
	1.225	Who must register under this subpart?
	1.226	Who does not have to register under this subpart?
	1.227	What definitions apply to this subpart?
	1.230	When must you register?
	1.231	How and where do you register?
	1.232	What information is required in the registration?
	1.233	What optional items are included in the registration form?
	1.234	How and when do you update your facility's registration information?
	1.235	How and when do you cancel your facility's registration information?
	1.240	What other registration requirements apply?
	1.241	What are the consequences of failing to register, update, or cancel your registration?
	1.242	What does assignment of a registration number mean?
	1.243	Is food registration information available to the public?
	1.276	What definitions apply to this subpart?
	1.277	What is the scope of this subpart?
	1.278	Who is authorized to submit prior notice?
	1.279	When must prior notice be submitted to FDA?
	1.280	How must you submit prior notice?
	1.281	What information must be in a prior notice?
	1.282	What must you do if information changes after you have received confirmation of a prior notice from FDA?
	1.283	What happens to food that is imported or offered for import without adequate prior notice?
	1.284	What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?
	1.285	What happens to food that is imported or offered for import from unregistered facilities that are required to register under 21 CFR part 1, subpart H?
	1.326	Who is subject to this subpart?
	1.327	Who is excluded from all or part of the regulations in this subpart?
	1.328	What definitions apply to this subpart?
	1.329	Do other statutory provisions and regulations apply?
	1.330	Can existing records satisfy the requirements of this subpart?
	1.337	What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food?
	1.345	What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?
	1.352	What information must transporters establish and maintain?
	1.360	What are the record retention requirements?
	1.361	What are the record availability requirements?
	1.362	What records are excluded from this subpart?
	1.363	What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?
	1.368	What are the compliance dates for this subpart?
	1.377	What definitions apply to this subpart?
	1.378	What criteria does FDA use to order a detention?
	1.379	How long may FDA detain an article of food?
	1.380	Where and under what conditions must the detained article of food be held?
	1.381	May a detained article of food be delivered to another entity or transferred to another location?
	1.382	What labeling or marking requirements apply to a detained article of food?
	1.383	What expedited procedures apply when FDA initiates a seizure action against a detained perishable food?
	1.384	When does a detention order terminate?
	1.391	Who approves a detention order?
	1.392	Who receives a copy of the detention order?
	1.393	What information must FDA include in the detention order?
	1.401	Who is entitled to appeal?
	1.402	What are the requirements for submitting an appeal?
	1.403	What requirements apply to an informal hearing?
	1.404	Who serves as the presiding officer for an appeal, and for an informal hearing?
	1.405	When does FDA have to issue a decision on an appeal?
	1.406	How will FDA handle classified information in an informal hearing?