FDA/ORA 2002 Web Pages Updates and Changes

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

2002 ORA Web Site Update Log

Web Site Log		Updates and changes made to the ORA Web Pages for the year 2002

		Fall, 2002 Summer, 2002 Spring, 2002 Link to Current site log Logs for Next Year Fall, 2003 Summer, 2003 Spring, 2003 Logs for Earlier Years Fall, 2001 Summer, 2001 Spring, 2001 Fall, 2000 Summer, 2000 Spring, 2000 Fall, 1999 Summer, 1999 Spring, 1999 1998

2002 Updates, Changes, New Pages		Update: (December 31, 2002) in Federal State Relations: small_business/sbrtext.htm small_business/swest.htm small_business/sb_guide/smbusrep.html New: (December 20, 2002) on Frequently Requested ORA documents and 483s new Inspectional Observations report: American National Red Cross/Biomedical Services, Arlington, Virginia (12/20/2002) PDF version (1845 KB) HTML version Updated Compliance Reference revisions page for link tonew FDA 483 Updated Frequently Requested default page for link to new FDA 483 Update: (December 18, 2002) in Compliance Reference: revisions.htm bimo/glp/wh_list_inact.htm bimo/glp/wh_list_intro.htm Update: (December 16, 2002) in Training: stt/abstracts/FD2007.html stt/STT03_Schedule.html Update: (December 9, 2002) in Compliance Reference: revisions.htm debar/default.htm Update/New: (December 6, 2002) in Federal-State Relations, 3 pages in DFSR Activities: sail/default.htm sail/SAILFall02.htm (new) sail/SAILFall02.pdf (new) (PDF , 442 kb) Update: (December 6, 2002) in Training, 3 pages updated in ORA U: Technical_Courses.htm Technical_Requirements.htm Web_Based_Courses.htm Update/New: (December 5, 2002) in Training: default.htm forward.htm policy2000.htm standard2000.htm CEU.html (new) Index of State Training Team Course Abstracts (new) Risk Communication, CM2004 (new) Low Acid Canned Foods, FD1003 (new) Food Processing & Distribution, FD1004 (new) Effective Enforcement, FD1006 (new) Temporary Food Establishments, FD1008 (new) Food Code, FD1012 (new) Fundamentals of Foodborne Illness Investigations, FD1025 (new) Basic Shellfish Plant Sanitation, FD1040 (new) Acidified Foods, FD2002 (new) Vacuuming Packaging, FD2005 (new) Plan Review, FD2007 (new) Food Code Train the Trainer, FD2013 (new) Managing Retail Food Safety, FD2015 (new) Integrated Pest Management, FD2030 (new) Plumbing & Cross-Connection Control Applications, FD2031 (new) Shellfish State Standardization, FD2041 (new) Applied Concepts In Sanitation Surveys Of Shellfish Growing Areas, FD2042 (new) Food Preservation, FD3009 (new) Preparation For Retail Food Standardization, FD3016 (new) Milk Pasteurization Controls And Tests, FD3101 (new) Milk Plant Sanitation And Inspection, FD3102 (new) State Milk Laboratory Evaluation Officer’s Workshop (Leo), FD3103 (new) Laboratory Examination Of Dairy Products, FD3104 (new) Dairy Farm Sanitation And Inspection, FD3105 (new) Special Problems In Milk Protection, FD5107 (new) Advanced Milk Processing, FD5108 (new) Update: (December 4, 2002) in Compliance Reference: cpg/default.htm debar/default.htm Corrections: (November 27, 2002) in Compliance Reference: corrections to pages: Revisions Page Part 11: Dockets Index CPG Chapter 5: section 515-350 CPG Chapter 5: section 555-425 CPG Chapter 5: section 555-600 BIMO: GLP default page In ORA Home Page, recent publications, correction to Laboratory Information Bulletin - Detection, Quantification and Confirmation of Myclobutanil (Systhane) by Ion Trap Technology to remove "Strawberries". Update: (November 19, 2002) in About ORA: new pages: Start Page updated, contact information, etc. The Enforcement Story, new web publication Site Map Site Index Update/New: (November 18, 2002) in Compliance Reference: nine pages updated, 3 new: Compliance Refs Revisions/Update page CPG Revision/Update page CPG Chapter 3 Contents page CPG Sec. 398.475 Revoked FDA Debarment List (3 new) Linked Debarment List PDF files (3): ../compliance_ref/debar/dbarfedreg/fiddes2002.pdf (PDF , 33 kb) or text ../compliance_ref/debar/dbarfedreg/hernandez2002.pdf (PDF , 33 kb) or text ../compliance_ref/debar/dbarfedreg/lai02.pdf (PDF , 34 kb) or text Non-clinical Laboratory Inspections "GLP" Pages (4): ../compliance_ref/bimo/glp/wh_list_intro.htm ../compliance_ref/bimo/glp/wh_list_univers.htm ../compliance_ref/bimo/glp/wh_list_foreign.htm ../compliance_ref/bimo/glp/wh_list_inact.htm Update: (November 15, 2002) in Partnership Agreements Contracts: five pages updated: ../Partnership_Agreements/contracts/central_region.htm ../Partnership_Agreements/contracts/northeast_region.htm ../Partnership_Agreements/contracts/pacific_region.htm ../Partnership_Agreements/contracts/southeast_region.htm ../Partnership_Agreements/contracts/southwest_region.htm Updated: (November 14, 2002) in Training: updated State Training Team Courses & Training Material, 2003 Course Schedule. Update: (November 8, 2002) in Federal-State Relations: four pages updated: small_business/neast.htm small_business/sbrtext.htm small_business/sb_guide/smbusrep.html small_business/sb_guide/Small_Business_Guide.pdf (PDF , 319 kb) Update: (November 3, 2002) in Federal-State Relations: one page, DFSR Public Affairs Specialists Update: (October 30, 2002) New Traveler's Alert link on Import Program Page to "Looks can be deceiving" brochure on CDER Updated/New: (October 29, 2002) in Federal-State Relations: food_safety/default.htm /food_safety/state_ProgressReports.htm (new) /food_safety/state_progressreports_page2.htm (new) /food_safety/state_progressreports_page3.htm (new) Updated: (October 29, 2002) in Federal-State Relations, in the Directory Table of States: Directory_of_State_Local_Officials.pdf (PDF , 871 kb) alabama.html alaska.html amersamo.html arizona.html calif.html colorado.html connecticut.html delaware.html district_of_columbia.html florida.html georgia.html guam.html hawaii.html idaho.html illinois.html kansas.html louisiana.html mariana.html maryland.html massachusetts.html michigan.html mississippi.html missouri.html montana.html nevada.html newjersey.html newyork.html oklahoma.html oregon.html pennsylvania.html puerto_rico.html rhodeisland.html southcarolina.html southdakota.html texas.html utah.html vermont.html virginia.html virginislands.html washington.html wyoming.html emergency_contacts.htm indian_contacts.html Updated/New: (October 28, 2002) in Training: updated State Training Team Courses & Training Material, 2003 Course Schedule (new) Updated: (October 25, 2002) in Compliance Reference: /revisions.htm /cpg/default.htm /cpg/cpgdev/default.htm /cpg/cpgdev/cpg300-700.html /bimo/disqlist.htm /bimo/restlist.htm Updated/New: (October 24, 2002) in Training: one update, 6 new pages in Broadcast & Video Announcements: /satmain.htm /juice/default.htm (new) /juice/exercise.htm (new) /juice/juice_eval.htm (new) /juice/juice_registration.htm (new) /juice/juice_sign_in.htm (new) /juice/JuiceHACCPExercise.pdf (PDF , 10kb) (new) Updated: (October 23, 2002) Central Region contacts in Small Business Guide: in Central Region page Updated: (October 22, 2002) in Training: /course_ora.html /ORAU/Web_Based_Courses.htm /Library/library.htm /Library/request_form.html /Library/index.html Updated: (October 10, 2002) New Food Security and Recalls Event in Federal-State Relations: in Events pages, also an update to Regional Milk Specialists:: /20021119_announce.html /20021119_agenda.html /20021119_regform.html /DFSR_Activities/milk_specialists.htm /DFSR_Activities/shellfish_specialists.htm Updated: (September 30, 2002) in Inspection Reference: two pages in the Investigations Operations Manual: contents/ch5_TOC.html ChapterText/510part3.html#518 Updated/New: (September 27, 2002) in Federal-State Relations: DFSR_Activities/State_Meetings.htm events/default.htm events/20021025_agenda.htm (new) Updated: (September 26, 2002) in Imports: one page Import for Export Information Reformat/Link Check: (September 18, 2002) Partnership_Agreements: All of the pages in this section of the ORA Web have been updated with a new page layout and navigation structure without modification of the information content. Hyperlinks have been checked and corrected where necessary. Updated: (September 13, 2002) in Compliance Reference specifically in the Regulatory Procedures Manual: revisions.htm rpm_new2/default.htm rpm_new2/ch9impex.html Updated: (September 4, 2002) in Inspection Reference: one page in the Investigations Operations Manual, Chapter 2 Organization Directory for Headquarters. New/Updated: (August 30, 2002) in Federal-State Relations: indust_assit/default.htm events/default.htm events/20021025_announcement.htm (new) events/20021025_regform.htm (new) New/Updated: (August 28, 2002) in Compliance Reference: revisions.htm bimo/glp/default.htm bimo/glp/wh_list_intro.htm (new) bimo/glp/wh_list_univers.htm (new) bimo/glp/wh_list_foreign.htm (new) bimo/glp/wh_list_inact.htm (new) bimo/glp/84proposedrule.htm (new) bimo/glp/87finalrule.htm (new) Updated: (August 28, 2002) in Inspection Reference: one page in the Investigations Operations Manual, Chapter 1 Administration Subchapter 140 (Safety) New/Updated: (August 27, 2002) in Federal-State Relations: default.htm dfsr_staff.htm nfss/NFSS-statusRpt99-02-Final2.html rfs/default.htm (new) rfs/Retail_Food_SafetyQA.htm (new) New/Updated: (August 26, 2002) in Compliance Reference: revisions.htm bimo/disqlist.htm cpg/default.htm cpg/cpgdev/default.htm cpg/cpgdev/cpg315-200.html frequent/default.htm frequent/cryolife_order.htm (new) frequent/cryolife_order20020813.pdf (new) Reformat/Link Check: (July 26, 2002) Federal-State Section: All of the pages in this section of the ORA Web have been updated with a new page layout and navigation structure without modification of the information content. Hyperlinks have been checked and corrected where necessary. New: (July 15, 2002) on Frequently Requested ORA documents and 483s new Inspectional Observations report: Greater Chesapeake & Potomac Blood Service Region, American Red Cross (Baltimore)(06/21/2001) HTML version Updated: (July 10, 2002) in Inspection Reference, two pages of the Investigations Operations Manual: Chapter 2 Organization: Directory for the Central Region, and Chapter 2 Organization: ORA Field Program Monitors. New: (July 2, 2002) Federal-State Events Food Bio-Security/Recall Workshops (July 25, 2002; August 28, 2002; September 24, 2002), announcement, brochure, and updated links to this page from the Industry Assistance page. Update: (June 28, 2002) in Compliance Reference Bioresearch Monitoring (BIMO): updated Disqualified/Totally Restricted List for Clinical Investigators (added LaHaye, CDRH); updated Restricted List for Clinical Investigators (added Faxon, formatted comments on Morton); updated Revisions and Update List Update: (June 24, 2002) Federal-State Notice: Grant Funds/Innovative Food Safety Projects, Innovative Food Safety Grants: Inspections, Innovative Food Safety Grants: Education and Health Information Dissemination, Model Grant Application Table of Contents, and Model Grant Application. Update: (June 21, 2002) Compliance Reference CPG Chapter 3 CPGDEV revocation/deletion status of 391-100 page and 396-100 page and update to CPG Chapter 3 TOC. In addition, a redirect of an incorrectly named Chapter 3 TOC to the correct page. New: (June 6, 2002) Federal-State Events Medical Device Workshop, Dallas, TX, July 19, 2002 and updated links to this page from the Industry Assistance page. Update: (June 6, 2002) Compliance Reference CPG Chapter 4 TOC: for CPG 460-200 Drug Compounding reissue update New: (June 5, 2002) Federal-State Notice: Grant Funds/Innovative Food Safety Projects copy of Federal Register Notice dated May 21, 2002 Volume 67 Number 98. Update: (June 5, 2002) Compliance Reference Compliance Policy Guides: reissue CPG 460-200 Drug Compounding for Supreme Court decision, and Revisions tracking page. Part 11 Dockets Index page updated to provide new links. Update: (May 24, 2002) Compliance Reference Compliance Policy Guides Manual start page updated for recent updates to CPG 230-150 and 575-100. Updated CPG Biologics Chapter contents page. Correction: (May 17, 2002) In Compliance Reference Revisions page corrected links to CPG page cpg230-150final.htm and CPG page Sec 575.100 Pesticide Residues Updated/New/Correction: (May 16, 2002) in Compliance Reference , page Revisions updated with links to: Revised 87fr-glpamendment.pdf - missing page added; New CPG page cpg230-150final.htm and Correction to CPG page Sec 575.100 Pesticide Residues...Heptachlor table Updated: (May 9, 2002) in Compliance Program Guidance Manual: CPGM, publication of the link to Drug Manufacturing Inspections Program 7356.002 . Revised Debarment List - person added; revisions.htm, petrik-dbr02.htm, and petrik_order.pdf Revised Training: web_based_courses Updated: (May 8, 2002) in Inspection Reference, publication of the Investigations Operations Manual, 2002 edition. New: (May 7, 2002) in Import, the new Import Refusals Report (IRR) has replaced the Import Detentions Report (IDR). See IRR Introduction for an explanation. New: (April 17, 2002) in Federal State Relations Events, new section with information on upcoming FDA Public Workshop on Food Labeling and Allergen Declaration, Announcement and Registration (, 21KB, PDF version) pages, linked from both the Federal State Relations start page and the Industry Assistance page Update: (April 10, 2002) in Compliance Reference Debarment List, updated debarment list ("NMI" was added to list member Shulman, Robert) Update/New: (April 9, 2002) in Compliance Reference BIMO, updated document aip_page.html, Application Integrity Policy Information, to remove certain obsolete dates and updated document revisions.htm for changes to disqlist.htm, disqualified or "totally restricted" clinical investigators to add Vriescendorp. Updated default.htm, for new draft document: cpg345-100_draft.html Sec. 345.100 Male Condom Defects (CPG 7124.21) Update: (April 8, 2002) in Fed_State Activities, updated file shellfish_specialists.htm and in Small Business Guide, updated files: centerco.htm regions.htm smbusrep.html whocont.html Update: (March 27, 2002) in Fed_State Small Business Guide, updated file whocont.html Update: (February 20, 2002) in Compliance Reference two updated files: aiplist.html revisions.htm New: In News the site update log file (this page) has been broken up into 4 sections: whatsnew.html site_log_2001.html site_log_2000.html site_log_1999.html Update/New: (February 15, 2002) in Training & Human Resource Development Programs 1 updated and 3 new files: /safety/default.htm /safety/tips.htm (new) /safety/evaluation.PDF (, 13KB) (new) /safety/registration.PDF (, 12KB) (new) New: (February 11, 2001) Federal-State Relations SAIL Newsletter, Winter 2002 Issue Update: (February 5, 2002) in Federal-State Relations 5 files under the Small Business Guide to FDA: /centerco.htm /freqcall.htm /intro.html /regions.htm /whocont.html Update/New: (February 4, 2002) in Training & Human Resource Development Programs 6 updated and 8 new files: /Satellite/satmain.htm /Satellite/Announcements/safety/default.htm (new) /ORAU/Technical_Courses.htm /ORAU/Technical_Requirements.htm /ORAU/Web_Based_Courses.htm /stt/Lending_Library2000.htm /course_ora.html /wbref/default.htm (new) /wbref/Dotterweich.PDF (, 323KB) (new) /wbref/hata.pdf (, 228KB) (new) /wbref/kaadt.pdf (, 397KB) (new) /wbref/parfait.pdf (, 139KB) (new) /wbref/park.pdf (, 341KB) (new) /wbref/starr.pdf (, 194KB) (new) /wbref/Wiesenfeld.PDF (, 420KB) (new) Update: (January 23, 2002) Federal-State Relations, Directory of State Officials: arizona.html colorado.html delaware.html Directory_of_State_Local_Officials.pdf florida.html hawaii.html idaho.html illinois.html indiana.html iowa.html kentucky.html louisiana.html maine.html maryland.html massachusetts.html michigan.html mississippi.html missouri.html montana.html nebraska.html nevada.html newhampshire.html newjersey.html newmexico.html northcarolina.html northdakota.html oregon.html rhodeisland.html southcarolina.html texas.html virginia.html washington.html westvirginia.html wisconsin.html virginislands.html Update: (January 15, 2002) in Compliance Reference three updated files: /revisions.htm /bimo/disqlist.htm /bimo/restlist.htm Update: in Federal/State Relations, two pages: /DFSR_Activities/State_Meetings.htm /DFSR_Activities/fdapas.html

		Fall, 2002 Summer, 2002 Spring, 2002 Link to Current site log Logs for Previous Years Fall, 2001 Summer, 2001 Spring, 2001 Fall, 2000 Summer, 2000 Spring, 2000 Fall, 1999 Summer, 1999 Spring, 1999 1998

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