2010 Revisions and Updates

• 1/10/2011:  Revised Debarment List - Ehigiator O. Akhigbe added.
• 12/23/2010: 
  • Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs revised with date extension to December 31, 2012.   Federal Register notice of availability published on December 23, 2010 (75 FR 80827) @ http://edocket.access.gpo.gov/2010/pdf/2010-32274.pdf.  
• 12/07/2010:

  Compliance Policy Guide Sec. 390.500 Definition of High Voltage Vacuum Switch  was withdrawn.  Federal Register notice of availability published on December 7, 2010 (75 FR 48180) @ http://www.gpo.gov/fdsys/pkg/FR-2010-12-07/pdf/2010-30677.pdf.

     

• 12/1/2010:  Chapter 6 of the Regulatory Procedures Manual (RPM) was revised, as detailed below.
  • Chapter 6 - Judicial Actions -
    • 6-2 Injunctions - Streamlined the agency's processing of injunctions by eliminating legal documents from recommendations and reducing the preparation of duplicate information.
• 10/1/2010:  Chapters 3, 5, & 8 of the Regulatory Procedures Manual (RPM) were revised, as detailed below.
  • Chapter 3 - Commissioning and Work Sharing - Revised/Updated Sections and Exhibits:
    • 3-3-3 Background Investigation - Shows background investigations are mandatory for all commission candidates seeking pocket credentials.
    • 3-3-4 Program Areas; Commissioning Activities - Includes tobacco and egg program areas.
    • 3-4-3 Pocket Credentials - Includes more streamlined approach for reporting lost or stolen pocket credentials.
    • 3-7-4 Renewal of a Commission - Reflects new process for renewing pocket credentials.
    • 3-7-6 Revocation of a Commission - Strengthens process for revoking a commission.
    • 3-10 Work Sharing - Reflects use of program in emergency situations only.
    • Exhibits: 3-3 State Credential Record; 3-4 Model State Credential Card; 3-8 Basic Info From A Candidate For An FDA Commission; 3-9 E-QIP Initiation Form; 3-10 Instructions to Candidate For An FDA Commission; and 3-12 Form FDA 2081:  Commissioned Officer's Record.
  • Chapter 5 - Administrative Actions; 5-9-7 The Notice of Opportunity Of Hearing (NOOH)
    • Revised review process.
  • Chapter 8 - Emergency Operations; 8-5-5 Reporting
    • Updated addresses.
• 08/26/2010:  Revised Debarment List - Su Van Ho added.
• 08/18/2010:  Revised Debarment List - Seth M. Yoser added.
• 04/08/2010:  Revised Debarment List - Kevin Xu added.
• 03/31/2010:  March 2010 edition of the Regulatory Procedures Manual (RPM) published; Chapters 1, 2, 4, and 10 updated as below.
  • Chapter 1 - Regulatory Organization; 1-8-1 Office of Regulatory Affairs - Headquarters and 1-8-2 Office of Regulatory Affairs - Field.
    • Updated phone numbers. 
  • Chapter 2 - FDA Authority; 2-2 Selected Amendments to the [Act]and 2-3 Others Laws
    • Updated and corrected the following summaries:  2-2-1 FDA Amendments Act of 2007, 2-2-4 Minor Use and Minor Species Animal Health Act of 2004, 2-2-11 FDA Modernization Act of 1997, 2-2-18 Medical Device Amendments of 1992, 2-2-19 Safe Medical Devices Act of 1990, 2-2-24 (prev. 2-2-25) Prescription Drug Marketing Act of 1987, 2-3-4 Federal Anti-Tampering Act -1983, 2-3-6 Electronic Freedom of Information Amendments of 1996, 2-3-15 (prev. 2-3-17) Crimes and Criminal Procedure - Section 1001 - Statements and entries generally and Section 1505 - Obstruction of proceedings before departments, agencies, and committees.
    • Deleted the following summaries:  2-3-7 Sanitary Food Transportation Act of 1990 and 2-3-15 Equal Access to Justice Act -1980.
  • Chapter 4 - Advisory Actions
    • 4-1-4 Center Concurrence and Letters Issued by Centers
      • 2.  (CDER) - Updated contact information.
      • 3.  (CBER) - Revised to require center concurrence for "Violations relating to HIV and HCV lookback."
    • 4-1-6 Multiple Center Review
      • Added instructions for using CMS.
    • 4-1-8 Warning Letter Follow-up...1. Acknowledgment of Response to a Warning Letter -
      • Added instructions for using CMS.
    • 4-1-9 Firm Profile Updates in FACTS and 4-2-3 Tracking - 
      • Simplified instructions.
    • 4-1-15 (CDER)...3.  Standard CDER charges...h. For information regarding health fraud issues...
      • Updated phone number for internet and health fraud team.
    • 4-3 Use of State Evidence for FDA Warning Letters and Untitled Letters     
      • New section; describes the factors FDA will consider in determining whether to issue a Warning or Untitled Letter based on evidence obtained by state personnel, and the process for issuing these letters.
  • Chapter 10 - Other Procedures
    •  10-10-6 Obtaining and Paying for Expert Support
      • Updated phone numbers.
    • 10-11-1 Requests for Testimony - 
      • Added the following instruction to paragraph 1.a.:  To expedite processing, a scanned copy of the testimony request should also be sent to:  Testimony-FDA-wide@fda.hhs.gov
      • Updated phone numbers
    • 10-11-6 Congressional Requests - Instructions for ORA Staff -
      • New section; provides instructions for ORA Staff to use when responding to Congressional requests.
  • Various chapters - Updated broken Web links (URLs). 
• 03/22/2010:
  • Compliance Policy Guide Sec. 540.375 Canned Salmon -- Adulteration Involving Decomposition is obsolete and was withdrawn March 22, 2010.   See 75 FR 13555, March 22, 2010.  
• 03/05/2010:  Revised Debarment List - James A. Holland added.
• 02/23/2010:  Revised Debarment List - Patrick J. Lais added.
• 02/02/2010:  Revised Debarment List - Brian Ullom added.
• 01/12/2010:  Revised Debarment List - Jason Vale added.