FDA/ORA Regulatory Procedures Manual Contents

August 1997*

(*Includes RPM Updates Through: 01.01.2003)

 CHAPTER 1 - REGULATORY ORGANIZATION (Updated/Replaced January 2003)

Office of Regulatory Affairs
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Enforcement Policy Directory

Entire Chapter Content in PDF , 189kb; in Word ; 351kb

CHAPTER 2 - FDA AUTHORITY

Selected Amendments to the Federal Food, Drug, and Cosmetic Act
Other Laws 

CHAPTER 3 - OTHER REGULATORY AGENCIES

Commissioning State and Local Officials
Work Sharing Agreements
Exhibits, Chapter 3

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CHAPTER 4 - ADVISORY ACTIONS

Warning Letters
Untitled Letters

CHAPTER 5 - ADMINISTRATIVE ACTIONS

Citations
Detentions
Administrative Detentions of Devices
License Revocation and Suspension
Section 305 Meeting
Order for Retention, Recall, and/or Destruction of Human Tissue
Civil Money Penalties:
  Reduction of, for Small Entities 03/21/2001

CHAPTER 6 - JUDICIAL ACTIONS

Seizure
Injunctions
Inspection Warrants
Search Warrants
Prosecutions
Civil Penalties - Electronic Product Radiation Control

CHAPTER 7 - RECALL AND EMERGENCY PROCEDURES

Recall Procedures
Emergency Procedures

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CHAPTER 8 - INFORMATION DISCLOSURE

Expert Witness
Testimony
FOIA
Sharing Non-Public Information with Federal Government Officials
Sharing Non-Public Information with State and Local Government Officials
Sharing Non-Public Information with Foreign Government Officials

CHAPTER 9 - IMPORT OPERATIONS/ACTIONS (Revised May 12, 1998)

Import Procedures (Revised)
Coverage of Personal Importations
Importation of Biological Products
FDA National Import Procedure Regarding Warehouse Entries
Release Notices
Automatic Detention
Notice of Detention and Hearing
Response to Notice of Detention and Hearing
Notice of Refusal of Admission
Reconditioning
Supervisory Charges (revised)
Bond Actions
Import Information Directives
Priority Enforcement Strategy for Problem Importers (revised)
Import For Export (revised)
Importations for Trade Shows/Fairs, Exhibits and Special Events (new)
Secured Storage (Temporary Removal Due to Pending Revision)
Communication Concerning Assessment of Civil Monetary Penalties
by U.S. Customs Service in cases involving Imported Food (new)
Notice of Sampling (new)
Granting and Denying Transportation and Exportation (T&E) Entries
Chapter 9 Exhibits 1 through 12 (revised)
Chapter 9 Exhibit  13 (New)

CHAPTER 10 - OTHER PROCEDURES

Prior Notice
EIR Conclusions and Decisions
ITS and Support Facilities- Classifications and Administrative Actions
Reporting and Monitoring
Ad Hoc Committee
Appeal Process
Application Integrity Policy Update number 1 to RPM August 1997, March 5, 1998

CHAPTER 11 - GLOSSARY

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Page updated: January, 2003