FDA/ORA Web Pages Updates and Changes

Office of Regulatory Affairs, U.S. Food and Drug Administration

What's new and changed on the ORA pages... Updated: November 3, 2004

		Updates and changes made to the ORA Web Pages... Not seeing an updated page? Please be sure to check that your browser is updating from the FDA web site and not from its local cache. To do this with Internet Explorer hold down the shift key while selecting the refresh button.
Index		Current Summer, 2004 Spring, 2004 Logs for Previous Years 2003 Updates Fall/Winter, 2003 Summer, 2003 Spring, 2003 2002 Updates Fall, 2002 Summer, 2002 Spring, 2002 2001 Updates Fall, 2001 Summer, 2001 Spring, 2001 2000 Updates Fall, 2000 Summer, 2000 Spring, 2000 1999 Updates Fall, 1999 Summer, 1999 Spring, 1999 1998

Recent Updates, Changes, New Pages, Web Site Log		Fall, 2004 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: 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: (August 20, 2004) in Training, one page, /computer/eLexnet/default.htm Update: (August 17, 2004) in Compliance Reference: revisions.htm cpg/default.htm cpg/cpggenl/default.htm cpg/cpgdev/default.htm cpg/cpggenl/cpg110_310.pdf 118KB Update: (August 4, 2004) in Compliance Reference: default.htm bimo/default.htm revisions.htm cpg/default.htm cpg/cpgfod/default.htm cpg/cpgfod/cpg560-750.html 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: revisions.htm cpg/default.htm cpg/cpgvet/cpg690-300.html 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 Page Top

Previous Updates, Changes, New Pages, Web Site Log		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 References: 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 References: 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 References: 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 References: 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) Page Top

Index to Logs		Logs for Current Year Current (Summer, 2004) Spring, 2004 Logs for Previous Years 2003 Updates Fall/Winter, 2003 Summer, 2003 Spring, 2003 2002 Updates Fall, 2002 Summer, 2002 Spring, 2002 2001 Updates Fall, 2001 Summer, 2001 Spring, 2001 2000 Updates Fall, 2000 Summer, 2000 Spring, 2000 1999 Updates Fall, 1999 Summer, 1999 Spring, 1999 1998 Page Top

Return to: Page Top | About ORA Start