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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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RPM News 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3/31/2010

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 for Hearing

  • Revised review process.

Chapter 8 - Emergency Operations; 8-5-5 Reporting

  • Updated addresses.

 

March 2010 edition of the Regulatory Procedures Manual  (RPM) published; Chapters 1, 2, 4, and 10 updated, as detailed 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 Other Laws  

  • Updated/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, Section 1505 - Obstruction of proceedings before departments, agencies, and committees
  • Deleted the following summaries:  2-3-7 Sanitary Food Transportation Act of 1990, 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 instructions 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).