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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2011 Revision and Updates

  • 12/07/2011:  Chapter 4 of the Regulatory Procedures Manual (RPM) has been revised and updated, as detailed below.
    • Chapter 4 - Advisory Actions
      • 4-1-10 Warning Letter Format, Item 13, - is being revised to reflect the heightened interest in drug shortages and the October 31, 2011 Executive Order from President Obama.  Adding a reminder of the availability of FDA resources to prevent or reduce the impact of shortages explicitly in WLs would directly support the early notification step in the Executive Order.
  • 11/16/2011: Revised Debarment List - Scott S. Reuben added.
  • 11/15/2011: Revised Debarment List - Gayle Rothenberg added.
  • 11/15/2011: Revised Debarment List - Albert Ronald Cioffi added.
  • 10/5/2011: Revised Debarment List - Deborah Martinez-Seldon added.
  • 9/21/2011: 

Compliance Policy Guide Sec. 440.100 Marketed New Drugs without Approved NDAs and ANDAs was revised.  Federal Register notice of availability published on September 21, 2011 (76 FR 58398) @ http://www.gpo.gov/fdsys/pkg/FR-2011-09-21/html/2011-24316.htm.

 

  • 9/7/2011:  Chapters 3, 7, 10, and Appendix A of the Regulatory Procedures Manual (RPM) have been revised and updated, as detailed below.
    • Chapter 3 - Commissioning and Work Sharing
      • 3-3-3 - Background Investigation, 3-3-6 - Contacting the Candidate - Item f., and Exhibit 3-8 -Form - Basic Information from Candidate - are each being revised to include United States nationals.  The scope of commissioning is being broadened to include United States nationals.  This revision is consistent with the provisions of the FD&C Act.
      • 3-5-2 - Conflict of Interest Considerations Before Commissioning - the last paragraph was inadvertently missing from the previous Internet version of the RPM.
      • Exhibit 3-6 - Model Letter Offering a Commission to an Agency Head - the word "territory" is being added.
    • Chapter 7 - Recall Procedures
      • 7-8-2 - Managing FDA's Audit Program - revised to incorporate GAO recommendations regarding recalls affecting the school lunch program.
    • Chapter 10 - Other Procedures 
      • Updated the following sections with current address, phone or fax information:  10-1-3  -Debarment - Notification Responsibilities of FDA Employees - Item 2.b.ii; 10-10-6 - Obtaining and Paying for Expert Support - Item 2.c.ii; 10-11-1 - Requests for Testimony - Item 1.a; and 10-11-6 - Congressional Requests - Instructions for ORA Staff.
      • Deleted mail codes on Pages 10-15 and 10-23.
    • Appendix A - RPM Change Request Form - Updated OE/DCP phone number.
  • 6-2 Injunctions - Streamline process for concurrent review.
  • 6-3 Inspection Warrants; 6-3-3 Responsibilities - Updated DCMO address and phone number; clarified that "potential or suspect" adulteration and/or misbranding charges should be identified prior to submitting the action in CMS; and added "Any situation that may result in a refusal or delay of an inspection conducted under a warrant" to the list of what should be included in a memorandum requesting an inspection warrant.  
  • Exhibit 6-10 Procedures & Models for Issuing Press Releases - Clarified ORA Executive Operations Staff's role and responsibilities and the procedures in general.
  • Chapter 10 - Other Procedures 
  • 10-8 Ad Hoc Committee - Added Seizure/Injunction as separate appeal.  
  • 10-9 Appeal Process (DCMO) is unchanged and still available for other types of decisions.
  • 03/17/2011:  The Regulatory Procedures Manual (RPM) has been revised and updated, as detailed below.
    Chapter 4 - Advisory Actions
    • Exhibit 4-1 Procedures for Clearing FDA Warning Letters and Untitled Letters - Updated to reflect the August 2009 shift in review policy. 
  • 03/10/2011: Revised Debarment List - Mark E. Van Wormer added.
  • 03/09/2011: Revised Debarment List - Anastasios Pappas added.
  • 03/09/2011: Revised Debarment List¹ - David E. Berman added.
  • 03/03/2011: Revised Debarment List - Albert Poet added.
  • 01/26/2011: The Regulatory Procedures Manual (RPM) has been revised and updated, as detailed below.
    Chapter 6 - Judicial Actions, Section 5 Prosecution
    • 6-5-3 Special Procedures and Considerations for Park Doctrine Prosecutions - this new section added.
    • 6-5-4 Communication Between OCI and Other FDA Components - this new section added.
    • 6-5-2 Office of Criminal Investigations (now titled Referral of Criminal Matters to the Office of Criminal Investigation) - updated to include instructions regarding communications between OCI and other FDA components.
    • 6-5-8 Contempt of Court; Violation of Probation (previously 6-5-6) - updated to add CMS instructions.
    • Editorial changes made to the following sections:
      • 6-5-5 Processing a Summary and Recommendation (previously 6-5-3);
      • 6-5-10 Referrals for Criminal Investigation (previously 6-5-8);
      • 6-5-12 Grand Jury Investigations and Secrecy (previously 6-5-10); and
      • 6-5-13 Preparation of Summary and Recommendation (previously 6-5-12) paragraph 6.  Prior Notice.
      • Moved information from previous 6-5-11 Format for Summary & Recommendation to 6-5-13.