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2005 ORA Web Site Update Log

Updates and changes made to the ORA Web Pages for the year 2005

From most recent to oldest...

• Fall, 2005
• Summer, 2005
• Winter/Spring, 2005

Fall, 2005

• Update: (December 30, 2005)
  Revised the Public Affairs Specialists page for Federal State Relations
• Update: (December 29, 2005)
  Revised Restricted List for Clinical Investigators to add 1 new member
  Revised the Directory of State and Local Officials 2005 Edition for the following states:
  Alabama
  Alaska
  Arizona
  Arkansas
  California
  Colorado
  Connecticut
  Delaware
  District of Columbia
  Florida
  Georgia
  Hawaii
  Idaho
  Illinois
  Indiana
  Iowa
  Kansas
  Kentucky
  Louisiana
  Maine
• Update: (December 21, 2005)
  Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990. Updated December 09, 2005
  Edited list to correct typographical error in the initial of Dr. Farber on Disqualified/Totally Restricted List for Clinical Investigators
  Updated "FDA AIP Contacts List" (December 2005) on the Application Integrity Policy Information page
• Obsolete: (December 16, 2005) Reinvention Initiative and Hammer awards pages removed.
• Update: (December 13, 2005)
  Within the ORA Laboratory Manual 2004, updated volumes I, II and III:
  Volume I: All sections (PDF, 381 kb)
  Volume 2: Nine sections
  ORA-LAB 4.3 (PDF, 169 kb)
  ORA-LAB 4.6 (PDF, 116 kb)
  ORA-LAB 4.11 (PDF, 74 kb)
  ORA-LAB 5.2 (PDF, 144 kb)
  ORA-LAB 5.5 (PDF, 188 kb)
  ORA-LAB 5.5.1 (PDF, 100 kb)
  ORA-LAB 5.6 (PDF, 107 kb)
  ORA-LAB 5.8 (PDF, 132 kb)
  ORA-LAB 5.10 (PDF, 139 kb)
  Volume 3: Two Sections:
  ORA-LAB 4 (PDF, 346 kb)
  ORA-LAB 7 (PDF, 183 kb)
• Update: (December 12, 2005)
  Revised CPG Sec. 230.150 - Blood Donor Classification Statement, Paid or Volunteer Donor
  Revised CPG Sec. 300.750 - Class III Devices Subject to 515(b) Requirements (CPG 7124.18)
  Revoked CPG Sec. 460.700 - Controlled Release Dosage Form Drugs - Rate of Release of Active Ingredients (CPG 7132a.02)
• Update: (December 6, 2005)
  Updated list to remove restriction for 1 member, 11/23/2005: Restricted List for Clinical Investigators
• Update: (December 02, 2005) in Federal State Relations: Updated Federalism Outreach letters for 5/29/2005 and 11/16/2005 in Proposed Regulations.
• Update: (December 1, 2005)
  Updated "FDA AIP Contacts List" (August 2005) on the Application Integrity Policy Information page
• Update: (November 29, 2005) in Compliance Reference: Edited Compliance Policy Guides Sec. 160.100 and 118 pages in Chapter 5 to reflect FDA organization and contact changes.
• Update: (November 18, 2005) in Compliance Reference: Updated Compliance Program Manual (CPGM) in Devices section added on-line link for compliance program 7385.014, Mammography Facility Inspections.
  Update: In Disqualified/Totally Restricted List for Clinical Investigators: Revised list to add 1 new member.
• Update: (November 18, 2005) in Compliance Reference: Updated Compliance Program Manual (CPGM) in Devices section added on-line link for compliance program 7385.014, Mammography Facility Inspections.
  Update: In Disqualified/Totally Restricted List for Clinical Investigators: Revised list to add 1 new member.
• Update: (November 17, 2005) in Federal State Relations: Updated contact information has been published in Directory of State and Local Officials.
• Update: (November 14, 2005)
  Revised list to add 1 new member, Disqualified/Totally Restricted List for Clinical Investigators
• Update: (November 10, 2005
  Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
• Update: (November 3, 2005) in Import Program: refusal reports for October have been published on Import Refusals.
  Revised list to remove one member from the Application Integrity Policy List
• Update: (November 2, 2005) in Science Ref: updated  Table of Contents of the Laboratory Manual: to show the associated SOP or ISO clause for Volume II.

  And in Inspect_Ref: updated Field Management Directives for contact person name and phone number in FMD 37 Procedures for Arranging Foreign Visitor Program Activities.

• Update: (October 31, 2005)
  Revised http://www.fda.gov/ora/compliance_ref/bimo/disqlist.htm to add one person and update the list contact person. Also, the contact person was updated on:
  http://www.fda.gov/ora/compliance_ref/bimo/asurlist.htm
  http://www.fda.gov/ora/compliance_ref/bimo/restlist.htm
• Update: (Oct 3, 2005) in Compliance Reference: Chapter 5 Administrative Actions of the Regulatory Procedures Manual (PDF) has been revised as follows:
  • New Section, 5-3 ,"Administrative Detention of Food" was added.
  • Section 5-7,“Orders for Retention, Recall, and/or Destruction related to human cell, tissue, and cellular and tissue-based products (HCT/Ps)” , was updated to address provisions in 21 CFR Part 1271, including Orders of Cessation of Manufacturing.
  • Exhibits were revised, deleted, added, and re-numbered, as follows:
    1. Material in (old) Exhibit 5-6, Model General Summary of Information, is now covered in Exhibit 5-14, Model General Summary of Information Administrative Detention of Devices (AD of Devices)
    2. Material in (old) Exhibit 5-7, Model Comprehensive Statement, is now covered in Exhibits 5-11 (for administrative detention of food), and 5-15, (for administrative detention of devices.)
    3. Material in (old) Exhibit 5-8, Examples of Detailed Statements, is now covered under Exhibit 5-16 for administrative detention of devices.
    4. Material in (old) Exhibit 5-9, Model Hearing Confirmation Letter, is now covered in Exhibits 5-12, for administrative detention of foods, and 5-17, for administrative detention of devices.
    5. Material in Exhibit 5-10, Model Order, is now covered in Exhibits 5-13, Short Form Administrative Detention of Food, and 5-18, administrative detention of devices.
    6. Exhibit 5-11, Summary Format - Section 305 Meeting, is now designated Exhibit 5-6.
    7. Exhibit 5-12, Notification of Non-Prosecution, is now designated Exhibit 5-7.
    8. Exhibit 5-13, Model Letter For Voluntary Corrective Action, was deleted.
    9. Exhibit 5-14, Model Order For Retention, Recall, And/Or Destruction, is now designated Exhibit 5-19.
  • Finally, throughout this chapter content was reformatted and restructured to improve clarity and consistency. As other RPM chapters are updated, they will be converted to this new format and structure, as well.

     

• Update: (Sept 27, 2005) in Compliance Reference: Chapter 6 of the RPM (PDF) was modified as follows:
  • In Sub-Section 6-2-4 Injunctions "General Considerations" - added new procedures for multi-district injunctions.
  • In Sub-Sections 6-1-15 and 6-2-19 added "Issuing Press Releases"- Procedures and Models for Issuing Press Releases on Enforcement Actions.
  • In Section 6-3 "Inspection Warrants" - updated addresses and phone numbers.
  • In Exhibit 29 "Rule 6. The Grand Jury" - updated Rule 6 to include a Dec. 2004 amendment.
  • Inserted two new exhibits into the roster of exhibits, and renumbered some others, as follows:
  • The two new exhibits are designated 6-10, covering procedures and models for press releases, and 6-11, covering multi-district injunctions. Incremented by two the numbers used for all the“old” exhibits that had been published as 6-10 thru 6-29. They are now 6-12 thru 6-31, respectively.
  • Finally, throughout this chapter reformatted and restructured most of the content to improve clarity and consistency. As the other RPM chapters are updated, they will be converted to this new format and structure, as well.

   

• Correction: (Sept 23, 2005) corrected links to Evans-Chiron FDA 483 Inspectional Observations PDF file in 7 pages beginning at Evans-Chiron HTML.

   

• New: (Sept 22, 2005) in Frequently Requested FOI Reading Room FDA 483 Inspectional Observations regarding Guidant Corp., Saint Paul, MN,
  FDA 483 Inspectional Observations, 08/22/2005 - 09/01/2005
  [HTML] PDF size 542 KB

   

• New: (Sept 12, 2005) Responding to the needs of the Hurricane Katrina State of Emergency, ORA has published a links page for Food Emergency and Salvage Information intended for ORA inspectors, State/Local/Tribal Public Health Officers and the public.

   

• Update: (Sept 12, 2005) in Science Ref: updated one PDF section of the Laboratory Manual: Volume II, Section 2 Test Methods & Validation Methods, 5.04.05 Method Verification and Validation (PDF, size 180KB).

   

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Summer, 2005

• Update: (August 9, 2005) in Import: Added link to Import start page for information on CFSAN pages for Cosmetics Importers to address confusion regarding voluntary registration for the importation of cosmetics.

   

• New: (July 29, 2005) in Inspection Reference: in Guides to Inspections added Guide to Inspection of Aseptic Processing and Packaging for the Food Industry, published in February 2001 and now available on the web.

   

• Update: (July 26, 2005) in Compliance Reference CPG pages updated CPG Sec. 315.100 "Illegal Interstate Commercial Shipment of Dentures (CPG 7124.07)" and updates to Revisions, CPG TOC and CPG Devices TOC pages.) (7-28-2005 Editorial changes to section wording and dates/numbers in Background sub section.)
• Update: (July 22, 2005) in Federal State Relations Activities updated the Aids Health Fraud Task Force page.
• New: (July 22, 2005) in Inspection Reference: in Field Management Directives added FMD 151, Compliance Review & District Conclusion for BSE Samples
• Update: (July 13, 2005) in Science Ref: updated PDF sections of the Laboratory Manual: Vol 1 (all), Volume II, Section 5.5, Volume III, Sections 6 and 7
• New: (July 13, 2005) in Frequently Requested ORA Documents and FDA 483s: American National Red Cross/Biomedical Services, Washington, D.C., Modified Adverse Determination Letter [HTML] PDF (size 899 KB) Attachment [HTML]

  and link to Able Laboratories, Inc., Cranberry, NJ, FDA 483 Inspectional Observations, dated 05/02-07/01/2005

• Correction: (June 30, 2005) in This page (Whatsnew): corrected links for June 10 entries for Evans-Chiron FDA 483 Inspectional Observations PDF files.

   

• Update: (June 21, 2005) in Compliance Reference: updates to the Regulatory Procedures Manual:
  • Chapter 1 (PDF, 202KB) was updated with respect to organizational information about all the centers, ORA Headquarters Offices (OE, and ORO/DIOP), Regional Offices in the Pacific, Southwest, and Central Regions, and District Offices in Los Angeles, San Francisco, New England, Atlanta, Florida, and Minneapolis.
  • Chapter 2 (PDF, 225KB) was revised to add descriptions of two new Acts:
    • The Animal Drug User Fee Act of 2003; and
    • The National Defense Authorization Act for Fiscal Year 2004.

    And, to add clarifying language to the descriptions of the following Acts:

    • FDA Modernization Act of 1997- re Pharmacy Compounding;
    • Dietary Supplement Health and Education Act of 1994 - to note that DSHEA does not apply to products for animal use;
    • Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) - re information disclosure and commissioning of Federal officials; and
    • Health Insurance Portability and Accountability Act of 1996 - re information disclosure.
  • Chapter 3 (PDF, 661KB), was revised to more succinctly describe the commissioning authorities under the Bioterrorism Act.
  • Chapter 7 (PDF, 347KB) was revised to refer to Staff Manual Guide 1410.412, that delegates authority to perform recall functions under section 518(e) of the Food, Drug and Cosmetic Act to certain Center officials in CDRH, CDER, and CBER.
  • Chapter 8 (PDF, 114KB) was updated with respect to RPM internal chapter section references.
  • Chapter 10 (PDF, 252KB) was revised:
    • regarding the functions of various types of ad hoc committees, to cross reference the Appeal Process.
    • to request that principles designate a "compliance" official if they are unable to attend a scheduled ad hoc meeting.
    • To add a new section on Multi-issue Subpoena, to describe the procedure for handling a subpoena or request that seeks FDA records, testimony, and actual samples.

   

• Update: (June 16, 2005) in Compliance Reference: editorial change to remove out of date position names and update contact information in the CPG Forward

   

• New: (June 10, 2005) in Frequently Requested FOI Reading Room HTML versions of previously posted PDF (EIR and 483s) regarding Evans Vaccine, Ltd., affiliate of Chiron Corp., Liverpool, UK:
  
  • FDA 483 Inspectional Observations, dated 06/02-10/2003 (link corrected 6/30/2005)
    
  • FDA 483 Inspectional Observations, dated 10/10-15/2004 (link corrected 6/30/2005)

   

• Correction: (June 8, 2005) in Compliance Reference: Restricted list for Clinical Investigators remove duplicate entry for Briggs
  

   

• Update: (June 1, 2005) in Compliance Reference: Restricted list for Clinical Investigators add 1 Todd V. Swanson
  
  • bimo/restlist.htm
  • revisions.htm

   

 

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Winter/Spring, 2005

• New: (May 23, 2005) in Federal State Relations Electronic State Access to FACTS published the ESAF V1.1 Release Notes.

 

• New: (May 19, 2005) in Frequently Requested ORA Documents and FDA 483s: American National Red Cross/Biomedical Services, Washington, D.C., May 16, 2005 Adverse Determination Letter (HTML) PDF (36KB) and Attachment(HTML) PDF (282KB)

   

• Update: (May 13, 2005) in CPGM: minor editorial changes, updated redirect links for 42_006.PDF and 45_001.PDF superceded by 7345.848 "Inspection of Biological Drug Products" linked from CBER page http://www.fda.gov/cber/cpg/cpg.htm

   

• New: (April 29, 2005) in Inspection Reference: in Field Management Directives added FMD 150 Review of Human Subject Research

   

• Update: (April 25, 2005) in Compliance Reference: Restricted list for Clinical Investigators (add 3) Batshaw; Raper; Wilson
  • bimo/restlist.htm
  • revisions.htm

   

• Update: (April 20, 2005) in Compliance Reference CPG pages updated CPG Sec. 300.500 "Reprocessing of Single Use Devices (CPG 7124.16) ” formerly "Reuse of Medical Disposable Devices " (changes in name to Revisions, CPG TOC and CPG Devices TOC pages.)

 

• New: (April 8, 2005) in Frequently Requested ORA Documents and FDA 483s: American National Red Cross/Biomedical Services, Washington, D.C., March 28, 2005, Adverse Determination Letter [html], PDF 114KB

   

• Update: (April 1, 2005) in Science Reference updated two volumes of the Laboratory Manual 2004 (LM) replacing:
  • Volume II, Section 5.4.6
    Procedure, ORA-LAB.5.4.6, revised to be in accordance with the A2LA policy on Measurement Uncertainty and the Life Sciences Annex issued 02/08/05. The annex lists only three measurement uncertainty categories: Qualitative, Well-recognized Methods, and Other.
  • Volume III, Section 3
    Procedure: Vol III, Section 3, 3.7 Title - 704 (d) removed. This section did not address 704(d) letters. This topic is addressed in ORA-LAB. 5.10, Section H. 3.

 

• Correction: (Mar 29, 2005) in Training/ORAU minor correction to the Food Security Awareness Course to remove reference to "Coop milk inspectors".

 

• Updated: (March 22, 2005) in Compliance Reference updated Chapter 4 of the Regulatory Procedures Manual.

 

• New: (March 7, 2005) in Inspection Reference published the Investigations Operations Manual (IOM) 2005 Edition.

 

• Update: (March 3, 2005) in Compliance Reference updated 3 pages for PN Revised CPG Sec. 110.310 Prior Notice of Imported Food...rev5 March 2005:
  • Compliance revisions page
  • CPG Start page
  • Chapter 1: General

 

• Update: (March 2, 2005) in Federal State Relations updated the Events page for the Public Workshop "FDA Drug Education Forum" on May 11, 2005.

 

• Update: (Feb 23, 2005) in Compliance Reference updated 4 chapters (PDF) of the Regulatory Procedures Manual.
  • Chapter 4
  • Chapter 6
  • Chapter 10
  • Chapter 11

 

• New: (Feb 22, 2005) in Training/ORAU published the Food Security Awareness Course.
  • State Courses
  • Course Overview
  • Course Startpage

 

• New: (Feb 18, 2005) in Compliance Reference posted draft guidance Sec. 310.210 Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy (CPG 7124.23).

   

• Refreshed: (Feb 14, 2005) in About ORA refreshed the ORA Overview pages. (Content in revision, only updated page layout.)

 

• Refreshed: (Feb 14, 2005) in Guides to Inspections: Foods updated navigation in TOC pages to provide cross links to Parts 1, 2, and 3. (No change to content, only updated page links.)

 

• New: (Jan 19, 2005) in Federal State Relations published the ESAF FAQ.

 

• Update: (Jan 7, 2005) in Federal State Relations published the Calendar of State Meetings FY2005.

 

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