• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

2010 Revisions and Updates

  • 1/10/2011:  Revised Debarment List - Ehigiator O. Akhigbe added.
  • 12/23/2010
  • 12/07/2010:
  • 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.