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Chapter 5 Administrative Actions
NOTE: The district compliance officer (or, the center CSO/Scientist, if the action was center-initiated) assigned to the administrative action should diligently pursue and actively monitor the progress of the case through the Agency review process to its conclusion. The Office of Enforcement (Division of Compliance Management and Operations) can assist in situations where significant delays are experienced or assistance is needed to resolve technical, scientific, or policy issues. (Also, see section on Ad Hoc Committees in Chapter 10.)
This chapter contains the following sections.
5-1 - CITATIONS
5-1-1 - Purpose
5-1-2 - Legal Authority
5-1-3 - Citation Under Multiple Laws
5-1-4 - Criteria For Citation
5-1-5 - Determining the Need for Citation
5-1-6 - Time Frames
5-1-7 - Field Office Citation Procedures
5-1-8 - Determination Of Citees
5-1-9 - Setting Date For Meeting
5-1-10 - Preparation Of Citation Documents
5-1-11 - Distribution of Citation Documents
5-1-12 - Transfer of Meeting
5-1-13 - Correspondence with Attorneys
5-1-14 - Drug Advertising Citations
5-2 - SECTION 305 MEETING
5-2-1 - Purpose
5-2-2 - Authority
5-2-3 - Preparation
5-2-4 - Respondents' Request for Special Information
5-2-5 - Conducting the 305 Meeting
5-2-6 - Procedures after Meeting
5-3 - ADMINISTRATIVE DETENTION OF FOOD
5-3-1 - Purpose
5-3-2 - Background
5-3-3 - Issuing and Terminating Detention Orders
5-3-4 - Appeal of a Detention Order
5-3-5 - Informal Hearing on Appeal of a Detention Order
5-3-6 - Issuing the Decision on an Appeal and Requirements After a Hearing on an Appeal of a Detention Order
5-4 - DETENTION OF FOODS – OTHER STATUTORY AUTHORITY
5-4-1 - Purpose
5-4-2 - Authority
5-4-3 - Criteria For Effecting And Terminating Detentions
5-5 - ADMINISTRATIVE DETENTION OF DEVICES
5-5-1 - Purpose
5-5-2 - Detention Of Devices
5-5-3 - Appeal Of A Detention Order
5-5-4 - Informal Hearing On Appeal Of A Detention Order
5-5-5 - Requirements After A Hearing On Appeal Of A Detention Order
5-6 - LICENSE REVOCATION OR SUSPENSION
5-6-1 - Purpose
5-6-2 - General
5-6-3 - General Considerations For Revocation
5-6-4 - Issues Not Supporting License Revocation
5-6-5 - Revocation Procedures
5-6-6 - General Considerations For Suspension
5-6-7 - Suspension Procedures
5-7 - ORDERS OF RETENTION, RECALL, DESTRUCTION, AND CESSATION OF MANUFACTURING RELATED TO HUMAN CELL, TISSUE, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)
5-7-1 - Purpose
5-7-2 - Background
5-7-3 - General Considerations
5-7-4 - Procedures for Orders of Retention, Recall, or Destruction of HCT/Ps
5-7-5 - Follow-Up for Orders of Retention, Recall, or Destruction
5-7-6 - Procedures for Orders of Cessation of Manufacturing
5-7-7 - Follow Up for Orders of Cessation of Manufacturing
5-7-8 - Part 16 Hearing
5-8 - CIVIL MONEY PENALTIES
5-8-1 - Civil Money Penalty Authorities
5-8-2 - Reduction Of Civil Money Penalties For Small Entities
5-8-3 - Civil Money Penalty Recommendations
5-9 - EXHIBITS
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