FDA/ORA 2004 Web Pages Updates and Changes

Reviewed: 2006-01-12 2004 ORA Web Site Update Log Updates and changes made to the ORA Web Pages for the year 2004 From most recent to oldest... 2004 Updates Fall, 2004 Summer, 2004 Spring, 2004
Annual Index:	Current	2005	2004	2003
	2002	2001	2000	1999
				1998

Fall, 2004

New: (December 15, 2004) in Science Reference published the Laboratory Manual 2004 (LM) replacing the Laboratory Procedures Manual.

Withdrawn: (December 15, 2004) in Inspection Reference Inspectors Technical Guide (ITG) page withdrawn for revision ITG Subject: "Package-Unit" Italian Flour Mills.

Update: (November 23, 2004) in Compliance Reference updated Application Integrity Policy Information.

Update: (November 23, 2004) in Import Program: updated OASIS start page.

New: (November 17, 2004) in Frequently Requested FOI Reading Room
Three PDF documents (EIR and 483s) regarding Evans Vaccine, Ltd., affiliate of Chiron Corp., Liverpool, UK:
Establishment Inspection Report (EIR), dated 06/02-10/2003
FDA 483 Inspectional Observations, dated 06/02-10/2003
FDA 483 Inspectional Observations, dated 10/10-15/2004

New: (November 17, 2004) in Recalls pages New Model Recall Press Release for Medical Device

New: (November 16, 2004) in Compliance Reference New CPG Sec. 400.210 - Radiofrequency Identification Feasibility Studies and Pilot Programs
- Revisions tracking page added links to reflect new CPG.
- CPG Update history page updated for 400.210

Update: (November 8, 2004) in Compliance Reference updated CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (CPG 7150.13).

Updates: (November 3, 2004) in Compliance Reference:
- Revisions tracking page added links to 11/03/2004 110.300 Food Facilities Registration updates.
- CPG Update history page updated for 110.300 and 110.310 link changes
- Updated links in CPG Chapter 1, Import/Export TOC section: Registration of Food Facilities (110.300) and Prior Notice (110.310) entries
- Editorial correction to table of contents entry in Chapter 5 for "560 - Imports"

Update: (November 2, 2004) in Compliance Reference: CPG start page added links to 11/03/2004 110.300 Food Facilities Registration update.

Update: (November 2, 2004) in Compliance Reference: Revisions page added links to 10/29/2004 560.400 Milk/Cream Imports Federal Register and Prior Notice updates.

Update: (October 1, 2004) in About ORA: The Enforcement Story, 2003 Edition

Update: (September 3, 2004) in Compliance Reference:
- revisions.htm
- debar/default.htm

Summer, 2004

Update: (August 24, 2004) in Compliance Reference:
Update: (August 20, 2004) in Training, one page, /computer/eLexnet/default.htm
Update: (August 17, 2004) in Compliance Reference:

Update: (August 4, 2004) in Compliance Reference:

New: (August 4, 2004) in Frequently Requested ORA Documents and FDA 483s: American National Red Cross/Biomedical Services, Washington, D.C., July 13, 2004 Consent Decree Correspondence, [html], PDF 29KB
Update: (July 30, 2004) in Inspection Reference:
- Updated the IOM Directory: SOUTHWEST REGION:Dallas District, (DAL-DO)
New: (July 21, 2004) in Compliance Reference: BIMO
- New pages regarding Comparison Chart - FDA/EPA & OECD (HTML)
  PDF 1.79MB
Update: (July 20, 2004) in Inspection Reference:
- Updated pages in the IOM
  - Streamlined reconciliation examination guidance in 530.04
  - Line 24, Registration requirement text changed to " NO " - applies to both domestic and foreign firms for Devices covered by an Investigational Device Exemption (IDE) in Exhibit 550
  - tracked updates on Changes Page
Update: (July 19, 2004) in Import Program: one page, Import Program System Information.

Correction: (July 13, 2004) in Compliance Reference:
- Corrected page bimo/glp/wh_list_intro.htm
Update: (June 12, 2004) in Federal State Relations: Partnership Agreements, State Contracts Inspections, Pacific Region Audit Report.
Refreshed: (July 9, 2004) in Inspection Reference pages republished using standard FDA layout without changing content for folders: FMD, IGS, GIIT, and ITG.
Revised: (June 30, 2004) in Compliance Reference CPG revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 updated Revisions page
New: (June 24, 2004) in Compliance Reference, added AIP Procedures, (HTML) ( PDF 153 kb) - Application Integrity Policy procedures March 5, 1998 and updated Revisions page
Update: (June 22, 2004) in Inspection Reference IOM, update to Section 454.03 and IOM Changes page.
Update: (June 17, 2004) in Compliance Reference:
- revisions.htm
- bimo/glp/wh_list_intro.htm
Corrections: (June 16, 2004) in Compliance Reference, corrections to BIMO Start page.
Update: (June 15, 2004) in Compliance Reference:
Update: (June 14, 2004) in Compliance Reference:
- revisions.htm
- aip_contacts.htm
Update: (June 10, 2004) in Compliance Reference:
- revisions.htm
- bimo/disqlist.htm
Update: (June 10, 2004) in Training:
- ORAU/ceu.htm
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Winter/Spring, 2004

Update: (May 28, 2004) in Compliance Reference:
- revisions.htm
- bimo/disqlist.htm
- bimo/glp/default.htm
- bimo/glp/wh_list_intro.htm
- bimo/glp/wh_list_univers.htm
- bimo/glp/wh_list_foreign.htm
- bimo/glp/wh_list_inact.htm
Update: (May 24, 2004) in Federal State Relations:
- dfsr_staff.htm
- fdapas.html
- milk_specialists.htm
- radiological_health_specialists.htm
- shellfish_specialists.htm
Update: (May 20, 2004) in Compliance Reference, an update to Application Integrity Policy Information.
Update: (May 17, 2004) in Compliance Reference, an update to Restricted List for Clinical Investigators.
Update: (May 11, 2004) in Federal-State Relations:
- /DFSR_Activities/state_meetings.htm
- directorytable.htm
- alabama.html
- alaska.html
- arizona.html
- arkansas.html
- calif.html
- connecticut.html
- delaware.html
- district_of_columbia.html
- florida.html
- hawaii.html
- idaho.html
- illinois.html
- indiana.html
- kansas.html
- kentucky.html
- maine.html
- maryland.html
- minnesota.html
- missouri.html
- nevada.html
- newmexico.html
- northcarolina.html
- ohio.html
- oklahoma.html
- pennsylvania.html
- puerto_rico.html
- southcarolina.html
- southdakota.html
- utah.html
- virginislands.html
- westvirginia.html

Update: (May 6, 2004) in Regulatory Procedures Manual (RPM), March 2004 Edition (all chapters, except Chapter 9, are revised) in PDF format while HTML versions are being prepared.

Update: (April 23, 2004) in IOM 2004 Edition updates to pages:
- section 610
- section 620_50
- exhibits x311
- section 510part2
- ORA Directory part 3
- ORA Directory part 5
- monitors list
- section 700
- sections 750 60
- 770 part 1
- 770 part 2
- exhibits x550
Update/New: (April 22, 2004) in Frequently Requested EFOIA American National Red Cross/Biomedical Services, Washington, D.C., April 2, 2004, Adverse Determination Letter:
- default.htm
- letters/ARC_20040402_ADLetter.html (New)
- letters/ARC_20040402_ADLetter_att1.html (New)
- letters/ARC_20040402_ADLetter_att2.html (New)
- letters/ARC_20040402_ADLetter.pdf (New) ( PDF, 33 KB)
- letters/ARC_20040402_ADLetter_att1.pdf (New) ( PDF, 26 KB)
- letters/ARC_20040402_ADLetter_att2.pdf (New) ( PDF, 11 KB)
Update: (April 22, 2004) Training:
- /computer/eLexnet/default.htm
Update: (April 16, 2004) in Federal State Relations: Small Business Guide pages
- default.htm
- intro.html
- fedreg.html
- howtoreg.html
- getfddoc.html
- howto.html
- petit.html
- decision.html
- whattodo.htm
- whocont.html
- smbusrep.html
- regions.htm
- centerco.htm
- assistan.html
- freqcall.htm
- small_business_guide.doc
- small_business_guide.pdf ( PDF, 71 KB)
Update/New: (April 15, 2004) in Inspection Reference:
- igs/iglist.html
- igs/lacfpt3/default.htm (New)
- igs/lacfpt3/content.html (New)
- igs/lacfpt3/attachments.html (New)
- igs/lacfpt3/lacfpt3.doc (New)
- igs/lacfpt3/lacfpt3.pdf (New) ( PDF size 7.5 MB)
- igs/lacfpt3/attachments/1.html (New)
- igs/lacfpt3/attachments/2.html (New)
- igs/lacfpt3/attachments/3.html (New)
- igs/lacfpt3/attachments/4.html (New)
- igs/lacfpt3/attachments/5.html (New)
- igs/lacfpt3/attachments/6.html (New)
- igs/lacfpt3/attachments/7.html (New)
- igs/lacfpt3/attachments/8.html (New)
- igs/lacfpt3/attachments/9.html (New)
- igs/lacfpt3/attachments/10.html (New)
- igs/lacfpt3/attachments/11.html (New)
- igs/lacfpt3/attachments/12.html (New)
- igs/lacfpt3/attachments/13.html (New)
- igs/lacfpt3/attachments/14.html (New)
- igs/lacfpt3/attachments/15.html (New)
- igs/lacfpt3/attachments/16.html (New)
- igs/lacfpt3/attachments/17.html (New)
- igs/lacfpt3/attachments/18.html (New)
- igs/lacfpt3/attachments/19.html (New)
- igs/lacfpt3/attachments/20.html (New)
- igs/lacfpt3/attachments/21.html (New)
- igs/lacfpt3/attachments/22.html (New)
- igs/lacfpt3/attachments/23.html (New)
- igs/lacfpt3/attachments/24.html (New)
- igs/lacfpt3/attachments/25.html (New)
- igs/lacfpt3/attachments/26.html (New)
- igs/lacfpt3/attachments/27.html (New)
Update: (April 9, 2004) in Compliance Reference:
- bimo/restlist.htm
- revisions.htm
- aiplist.html
Update/New: (March 22, 2004) in Federal-State Relations:
- DFSR_Activities/radiological_health_specialists.htm
- DFSR_Activities/shellfish_specialists.htm
- default.htm
- retail_food.html (New)
- rfst/default.htm (New)
- rfst/prog_over.html (New)
- rfst/roles_res.html (New)
- rfst/chall_exfacts.html (New)
- rfst/prog_out.html (New)
- rfst/preform_goals.html (New)
- rfst/prog_admin.html (New)
- rfst/annex1.html (New)
- rfst/annex2.html (New)
- rfst/annex3.html (New)
- rfst/annex4.html (New)
- rfst/annex5.html (New)
- rfst/annex5_work.html (New)
Update: (March 22, 2004) in Inspection Reference:
- igs/epigde/epigde.html
- igs/epigde/epigde_content.html
Update: (March 22, 2004) Training:
- state/welcome.htm
- state/navigate.htm
- stt/stt04_schedule.html
Update: (March 17, 2004) in Compliance Reference:
- revisions.htm
- cpg/default.htm
- cpg/cpgdrg/default.htm
- cpg/cpgdrg/cpg490-100.html

New: (March 15, 2004) in Frequently Requested EFOIA American National Red Cross/Biomedical Services, Washington, D.C., March 8, 2004, Consent Decree Correspondence [HTML], PDF size 20 KB

New/Update: (March 12, 2004) in ORAU Web Based Courses:
- state/intro.htm
- state/gegletter.htm
- state/online_eval.htm (new)
- state/online_eval.doc (new)
- state/online_eval.pdf (new) ( PDF size 112 KB)
New/Refresh: (March 11, 2004) in Inspection Reference: in the Investigations Operations Manual (IOM) 2004 Edition added new PDF versions for each chapter, refreshed the HTML pages to include title, description, and keyword metatags. Added new IOM Search page.
Update: (March 2, 2004) in Compliance Reference: the Regulatory Procedures Manual (RPM) Chapter 7 Headquarters Emergency Procedures telephone contact number change.
Update: (March 1, 2004) in Inspection Reference: the Investigations Operations Manual (IOM) 2004 Edition
Update: (February 18, 2004) in Compliance Reference:
- revisions.htm
- bimo/glp/default.htm
- bimo/glp/wh_list_intro.htm
- bimo/glp/wh_list_univers.htm
- bimo/glp/wh_list_foreign.htm
- bimo/glp/wh_list_inact.htm
Update: (February 12, 2004) in Federal State Relations, Activities & Staff Directory section, Regional Food Specialists

New: (February 12, 2004) in Frequently Requested EFOIA American National Red Cross/Biomedical Services, Washington, D.C., February 11, 2004, Adverse Determination Letter [HTML], PDF size 191 KB

Update: (February 11, 2004) in Compliance Reference:
- revisions.htm
- cpg/default.htm
- cpg/cpgfod/cpg515-700.html
- cpg/cpgfod/cpg515-775.html

Refresh/New (February 10, 2004) of Training/ORAU Pages. Refreshed the page layout of all pages. While most page content was not changed, new pages were added for State, Local and Tribal Regulatory Partners training.
Update: (February 9, 2004) in Partnership Agreements:
- contracts/audits_central_rpt.htm
- contracts/audits_northeast_rpt.html
- contracts/audits_pacific_rpt.html
- contracts/audits_southeast_rpt.html
- contracts/audits_southwest_rpt.html

Refresh (February 9, 2004) of Science Reference. Refreshed the page layout of all pages, content was not changed.
Update: (February 9, 2004) in Compliance Reference: corrected the link to CPG400.700 on page CPGM Chapter 4 (Human Drugs)

Update: (January 28, 2004) in Federal State Relations: Small Business Guide pages
- default.htm
- intro.html
- fedreg.html
- howtoreg.html
- getfddoc.html
- howto.html
- petit.html
- decision.html
- whattodo.htm
- whocont.html
- smbusrep.html
- regions.htm
- centerco.htm
- assistan.html
- freqcall.htm
- small_business_guide.pdf ( PDF, 71 KB)
New/Update (January 21, 2004) in Inspection Reference updated list of Guides to Inspections for New Salmonella Enteritidis Guide to Traceback in Eggs (7/03) with links to PDF and MS Word formats available.
Refresh (January 16, 2004) of Compliance Reference and Import Program. Refreshed the page layout of all pages, content was not changed.
Update: (January 15, 2004) in Compliance Reference:
- revisions.htm
- cpg/default.htm
- cpg/cpgdev/default.htm
- cpg/cpgdev/cpg370-200.html
Update: (January 15, 2004) in Federal-State Relations: one file, DFSR_Activities/fdapas.html
New (January 13, 2004): in Federal-State Relations:
- sail/default.htm
- sail/SAILFall03.html
- sail/SAILfall03.pdf (PDF size 512 KB)

Updated (January 5, 2004): in Training:
- stt/default.htm
- stt/STT04_Schedule.html
- stt/sttregform.htm
- stt/sttregformtext.htm

Update: (January 2, 2004) in Federal-State Relations:
- directorytable.htm
- alabama.html
- alaska.html
- arizona.html
- arkansas.html
- calif.html
- colorado.html
- connecticut.html
- delaware.html
- florida.html
- georgia.html
- hawaii.html
- idaho.html
- illinois.html
- iowa.html
- kansas.html
- kentucky.html
- louisiana.html
- maine.html
- maryland.html
- massachusetts.html
- michigan.html
- minnesota.html
- missouri.html
- mississippi.html
- montana.html
- nebraska.html
- nevada.html
- newhampshire.html
- newjersey.html
- newmexico.html
- northcarolina.html
- northdakota.html
- newyork.html
- ohio.html
- oklahoma.html
- oregon.html
- pennsylvania.html
- rhodeisland.html
- southcarolina.html
- southdakota.html
- tennessee.html
- texas.html
- utah.html
- vermont.html
- virginia.html
- washington.html
- westvirginia.html
- wisconsin.html
- wyoming.html
- district_of_columbia.html
- puerto_rico.html
- guam.html
- mariana.html
- amersamo.html
- virginislands.html
- trust.html
Update: (January 28, 2004) in Federal State Relations: Small Business Guide pages
- default.htm
- intro.html
- fedreg.html
- howtoreg.html
- getfddoc.html
- howto.html
- petit.html
- decision.html
- whattodo.htm
- whocont.html
- smbusrep.html
- regions.htm
- centerco.htm
- assistan.html
- freqcall.htm
- small_business_guide.pdf ( PDF, 71 KB)
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