12/7/2011

Chapter 4 of the Regulatory Procedures Manual (RPM) was revised, as detailed below.

Chapter 4 - Advisory Actions

• 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.

9/7/2011

Chapters 3, 7, 10, and Appendix A of the Regulatory Procedures Manual (RPM) were revised, as detailed below.

Chapter 3 - Commissioning and Work Sharing

• 3-3 - Background Investigation, 3-6 - Contacting the Candidate, Item f., and Exhibit 3-8 - Form - Basic Information from Candidate - are 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. 
• 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 -added the word "territory."

Chapter 7 - Recall Procedures

• 8-2 - Managing FDA's Audit Program - revised to incorporate GAO recommendations regarding recalls affecting the school lunch program.
   

Chapter 10 - Other Procedures

• 1-3 - Debarment - Notification Responsibilities of FDA employees - Item 2.b.ii.
• 10-6 - Obtaining and Paying for Expert Support - Item 2.c.ii.
• 11-1 - Requests for Testimony- Item 1.a.
• 11-6 - Congressional Requests - Instructions for ORA Staff
• Deleted mail codes on pages 10-15 and 10-23.

5/20/2011

Chapters 6 and 10 of the Regulatory Procedures Manual (RPM) were revised, as detailed below.

Chapter 6 - Judicial Actions

• 6-1 Seizure - Streamline process for concurrent review.
• 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.

3/17/2011

Chapter 4 of the Regulatory Procedures Manual (RPM) was revised, 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.  

1/26/2011        

Chapter 6 of the Regulatory Procedures Manual (RPM) was revised, 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) - CMS instructions added.
• 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 & Recommendation (previously 6-5-12) paragraph 6. Prior Notice.
  • Moved information from previous 6-5-11 Format for Summary & Recommendation to 6-5-13.