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