2004 Revisions and Updates

• 12/07/2004
  Revised Debarment List, 12/07/2004 - One person added. Published 12/02/2004.
• 11/18/2004
  Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated November 18, 2004
• 11/16/2004
  New CPG Sec. 400.210- Radiofrequency Identification Feasibility Studies and Pilot Programs
• 11/03/2004
  Revised CPG Sec. 110.300 - Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
• 11/02/2004
  Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
• 10/29/2004
  Draft CPG (Not for Implementation), Sec. 560.400 "Imported Milk and Cream--Federal Import Milk Act (CPG 7119.05)." When finalized it will replace the existing CPG at Sec. 560.400. Comments due 30 days after date of publication in the Federal Register dated October 29, 2004
• 10/03/2004
  Revised list to add 1 new member, Disqualified/Totally Restricted List for Clinical Investigators
• 08/31/2004
  Edited Debarment List - at Uddin, Mohammad, added "NMI" to indicate that FDA records show no middle initial for this person.
• 08/16/2004
  Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
• 07/29/2004
  Revised CPG Sec. 394.500 - Importation of Television Products, Microwave Ovens, and Inherent Class I Laser Products for Investigation and Evaluation
• 07/29/2004
  Replaced/Retitled CPG Sec. 560.750 Guidance Levels for Radionuclides in Domestic and Imported Foods (CPG 7119.14)
• 07/23/2004
  Updated links to FDA Regulations (2004) on the Bioresearch Monitoring Information Page;
  links to laws enforced by FDA and related regulation on the Welcome to Compliance References page
• 06/24/2004
  Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
  
• 06/16/2004
  AIP Procedures - procedures March 5, 1998
  
• 06/10/2004
  Revised to update citations Sec. 690.300 Canned Pet Food (CPG 7126.18)
  
• 06/15/2004
  Correction in classification (Class) - Charles River Laboratories, West Chester, OH
  
• 05/12/2004
  John B. Najarian on Restricted List for Clinical Investigators
  
• 05/06/2004
  March 2004 edition of the Regulatory Procedures Manual (RPM) published. New edition of FDA RPM is effective May 6^th, 2004. All chapters have been changed except Chapter 9 "Import Operations/Actions."
  
• 04/09/2004
  Corrected entry for Arthur Riba on Restricted List for Clinical Investigators
  
• 04/05/2004
  Revised Application Integrity Policy List to add Plus Orthopedics, San Diego, California.
  
• 3/12/2004
  Revised to update content of August 2000 paper edition:
  Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval CPG 7132c.08
  
• 02/23/2004
  Revised list to add 1 new member, 02/23/2004: Restricted List for Clinical Investigators;
  Revised list to add 1 new member, 02/23/2004: Disqualified/Totally Restricted List for Clinical Investigators
  
• 02/13/2004
  Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated February 9, 2004
  
• 2/9/2004
  Edited two pages to conform text (reference) on Internet pages to August 2000 paper edition: CPG Sec. 515.700 Chocolate & Chocolate Liquor - Adulteration with Insect and Rodent Filth CPG 7105.11
  CPG Sec. 515.775 Cocoa Powder, Press Cake - Adulteration with Insect and Rodent Filth CPG 7105.13
• Draft CPG 1/14/2004
  Draft CPG (Not for Implementation), Sec. 560.750 "Guidance Levels for Radionuclides in Domestic and Imported Foods, Availability; and Draft Supporting Document, Supporting Document for Guidance Levels for Radionuclides in Domestic and Imported Foods." [TXT] [PDF (39kb)] When finalized it will replace the existing CPG. Comments due March 15, 2004
  --The Draft Guidance Word version (39.5kb)
  --The Draft Guidance PDF (17.2kb)
  --Supporting Statement for Guidance Levels - Word version (151kb)
  --Supporting Statement for Guidance Levels - PDF (59.3kb)
• Revoked 1/5/2004
  Sec. 370.200 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse CPG 7124.06