Fall, 2000
- New (Dec 29, 2000) Compliance Reference, Compliance Program guides,
updated files Revisions, Drafts Page and Blood Donor Incentives (draft)
- Correction (Dec 29, 2000) Compliance Reference, Compliance Program
guides, corrected links on CPG Manual Page
to pages: CPG230-110, CPG280-100 and CPG280-110
- Updated (Dec 21, 2000) Federal State Relations, updated files MISSION.HTML, DFSR Activities start page
- Updated (Dec 8, 2000) Inspection Reference, Inspections Operations
Manual IOM
- Updated/New: (Nov 22, 2000) to Compliance Reference, Bioresearch
Monitoring (BIMO):
Compliance Programs Section:
/ora/compliance_ref/bimo/default.htm
/ora/compliance_ref/bimo/7348_001/default.htm
/ora/compliance_ref/bimo/7348_001/foi48001.pdf
/ora/compliance_ref/bimo/7348_808A/Default.htm
/ora/compliance_ref/bimo/7346_808A/cp7348-808a.pdf
/ora/compliance_ref/bimo/7348_811/Default.htm
/ora/ftparea/compliance/48_811.pdf
GLP Reference Section:
/ora/compliance_ref/bimo/GLP/78fr-glpfinalrule.pdf
/ora/compliance_ref/bimo/GLP/87fr-glpamendment.pdf
/ora/compliance_ref/bimo/GLP/81GLP-qanda.htm
/ora/compliance_ref/bimo/GLP/81GLP-qanda.pdf
Redirect Files:
/ora/compliance_ref/bimo/7348_808/default.htm
(replaced default.html which is now a redirect page)
/ora/compliance_ref/bimo/7348_810/default.htm
(replaced default.html which is now a redirect page)
- Updated: (Nov 21, 2000) to Federal-State directory files:
colorado.html
connecticut.html
district_of_columbia.html
florida.html
illinois.html
indiana.html
iowa.html
kansas.html
massachusetts.html
michigan.html
minnesota.html
missouri.html
montana.html
newhampshire.html
newjersey.html
newmexico.html
newyork.html
northcarolina.html
oklahoma.html
oregon.html
pennsylvania.html
southcarolina.html
tennessee.html
texas.html
- Updated: (Nov 20, 2000) corrections to Compliance Reference, CPG
575-100 Pesticide Residues in
Food and Feed - Enforcement Criteria (CPG 7141.01)
- New: (Nov 17, 2000) CPGM Compliance Program Manual, Field Compliance
Testing of Diagnostic (Medical) X-ray Equipment Compliance Program (MS Word and PDF
versions) /ora/cpgm/default.htm
- Updated: (Nov 15, 2000) Compliance Reference, CPG 540-650 revised
uneviserated fish products, salt-cured, dried, or smoked, CPG 7108.17 /ora/compliance_ref/cpg/cpgfod/cpg540-650.htm
- New: (Nov 7, 2000) FDA 483, Bioport Corporation, Lansing, MI,
10/10-26/2000, 17 pages /ora/frequent/bioport483.pdf
- Updated: (Nov 2, 2000) Compliance Reference, guidance documents
concerning 21 CFR Part 11: /ora/compliance_ref/part11/default.htm,
/ora/compliance_ref/part11/dockets_index.htm,
and /ora/compliance_ref/part11/PDA-conf-sum.htm.
- New: (Oct 26, 2000) Federal - State Relations, Small Business Guide: 15
pages beginning with /ora/fed_state/Small_Business/sb_guide/default.htm
- Updated: (Oct 26, 2000) Federal - State Relations, Small Business
pages: /ora/fed_state/Small_Business/swest.htm
and /ora/fed_state/Small_Business/sbrtext.htm
- Updated: (Oct 25, 2000) ORA Field Contacts page /ora/inspect_ref/iom/IOMORADIR.html and
Field Monitors contacts page /ora/inspect_ref/iom/iomoradir_monitors.html
- New (Oct 24, 2000) Federal State relations: Food Safety Task Force
page: /ora/fed_state/State_FoodSafetyTaskForces.htm
- Updated: (Oct 20,2000) Federal State relations: /ora/fed_state/DFSR_Activities/State_Meetings.htm
- Updated: (Oct 17, 2000) IGS Guide
to the Inspection of Pharmaceutical Quality Control Laboratories page.
- Updated: (Oct 5, 2000) Performance Results Staff pages: /ora/ora21/default.htm, Hammer awards list, /ora/ora21/hammerlist.htm, and FY00 goals /ora/ora21/fy00goal.html
- New: (Oct 4, 2000) added 2 links to Debarment List
Compliance Reference /ora/compliance_ref/debar/default.htm
for supporting Federal Register WAIS files: /ora/compliance_ref/debar/dbarfedreg/perkal98.htm
and (PDF document) /ora/compliance_ref/debar/dbarfedreg/perkal98.pdf
- Updated/New: (Oct 3, 2000) Debarment List Compliance
Reference: 3 new entries in Debarment List; /ora/compliance_ref/debar/default.htm and
new supporting Federal Register WAIS pages: /ora/compliance_ref/debar/dbarfedreg/elsh-dbr00.htm,
/ora/compliance_ref/debar/dbarfedreg/marc-dbr00.htm,
/ora/compliance_ref/debar/dbarfedreg/uddi-dbr00.htm
and 3 corresponding PDF documents.
- New: (Sep 26, 2000) Federal State relations: /ora/fed_state/DFSR_Activities/State_Meetings.htm
- Updated: (Sep 22, 2000) Compliance Reference; aiplist.html FDA Application Integrity Policy
- New: (Sep 11, 2000) Compliance Reference; CPG 100-950 FDA compliance
partnership agreements with foreign government agencies,
foreign or domestic trade associations, other organizations.
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Summer, 2000
- New: (Aug 31, 2000) State Contracts pages (8)
- New: (July 26, 2000) Federal - State relations State Action
Information Letter, Summer 2000 edition:
/ora/fed_state/DFSR_Activities/sail/SAILSpring00.htm
and PDF version:
/ora/fed_state/DFSR_Activities/sail/SAILSpring00.pdf
- Update: (July 26, 2000) Imports start page /ora/import/default.htm, Automated
Manufacturer/Shipper Continuous documents pages /ora/import/AutomatedSystem.html,
/ora/import/FDAmanufacturer.html and
/ora/import/FDAmanufacturer.PDF pages.
- New/Update: (July 20, 2000) Imports start page /ora/import/default.htm updated with link to new
Automated Manufacturer/Shipper Continuous documents page /ora/import/AutomatedSystem.html which links
to web and PDF doc versions. These documents are revisions
to the Manufacturer and Shipper data transmissions requirements documents.
- Update: (July 20, 2000) Federal - State Relations Small Business pages:
previous start page
"/ora/fed_state/small_business/default.htm" replaced with redirect to:
/opacom/morechoices/moreindu.html.
Small Business regional contacts pages updated:
/ora/fed_state/Small_Business/regional.htm,
and /ora/fed_state/Small_Business/sbrtext.htm
- Update: (July 20, 2000) Federal - State relations Directory of State
and Local Officials pages referenced from: /ora/fed_state/directorytable.htm
and obsolete files deleted: PUERTO.HTML, ALLSTATES.ZIP and DIRECTORY.ZIP.
- Update: (June 26, 2000) Compliance Reference; CPG Chapter 6 Veterinary Medicine and
section /ora/compliance_ref/cpg/cpgvet/cpg651-100.html
- Update: (June 26, 2000) Industry Assistance page, /ora/indust_assit/default.htm, updated link to Regional Small Business Representatives
page.
- Reformat: (June 26, 2000) Import Program start page: /ora/import/ora_import_program.html
- Reformat: (June 26, 2000) Consumer Information link page, /ora/consumer_info/default.htm
- Update/New: (June 20, 2000) Compliance Reference; DEBAR: list of firms
or persons debarred pursuant to sections 306(a) and (b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 335(a) and (b)) as published in the Federal Register /ora/compliance_ref/debar/default.htm and
two new attachment files matkar2000.htm,
matkar2000.pdf
- Update: (June 13, 2000) Compliance Reference; BIMO:
Disqualified/Restricted/Assurances List for Clinical Investigators /ora/compliance_ref/bimo/dis_res_assur.htm
- Update: (June 8, 2000) Fed-State Partnership pages (10) linked from: /ora/partnership_agreements/default.htm
- Reformat (June 8, 2000) Guidance Document: Exception from Informed
Consent Requirements for Emergency Research. /ora/compliance_ref/bimo/err_guide.htm
returned after format change.
- Revised (June 8, 2000) Virginia State and Local Officials directory: virginia.html
- Update (June 7, 2000) State and Local Officials directory files (61)
referenced from page: /ora/fed_state/directorytable.htm
Jump to: Page Top
Spring, 2000
- New (May 30, 2000) Science Reference, Total Diet and Pesticide Research
Center (TDPRC) publications for 1999: /ora/science_ref/tdprc/td99pub.htm
- Update (May 30, 2000) Inspection Reference, Investigations Operations
Manual, ORA contact information: /ora/inspect_ref/iom/iomoradir.html;
and ORA Field Monitors contact information: /ora/inspect_ref/iom/iomoradir_monitors.html
- New (May 15, 2000) Federal-State Relations, Small Business Assistance
pages: /ora/fed_state/Small_Business/default.htm,
locator map: /ora/fed_state/Small_Business/regional.htm,
five regional contact information pages: /ora/fed_state/Small_Business/neast.htm,
Northeast, /ora/fed_state/Small_Business/central.htm,
Central, /ora/fed_state/Small_Business/seast.htm,
Southeast, /ora/fed_state/Small_Business/swest.htm,
Southwest, /ora/fed_state/Small_Business/pacific.htm,
Pacific, and /ora/fed_state/Small_Business/sbrtext.htm,
combined text listing of all regions.
- Update (May 12, 2000) Import Program product code builder files: /ora/import/prodbldr/default.htm:
Installation Instructions: /ora/import/prodbldr/produc1.html,
Data files: /ora/import/prodbldr/Dat_file1.html,
and two downloadable executables: "Complete.exe"
and "PCBinstl.exe"
- New: (May 3, 2000) PDF version of Guidance Document: Exception from
Informed Consent Requirements for Emergency Research: /ora/compliance_ref/bimo/emrfinal.pdf
- Withdrawn (May 3, 2000) for reformat: Guidance Document: Exception from
Informed Consent Requirements for Emergency Research. /ora/compliance_ref/bimo/err_guide.htm
- Update (Apr 28, 2000) Federal-State regional public affairs contact
page: /ora/fed_state/DFSR_Activities/fdapas.html
- Update (Apr 28, 2000) Compliance Reference: outdated page deleted:Sec.
215.100 IND Filings /ora/compliance_ref/cpg/cpgbio/cpg215-100.html.
and matching change to table of contents page: /ora/compliance_ref/cpg/cpgbio/Default.htm.
- New (Apr 6, 2000) Compliance Refs Page: /ora/compliance_ref/part11/default.htm
Electronic Signatures
- Updated (Apr 6, 2000) Compliance Refs Page: /ora/compliance_ref/bimo/revisions.htm
- Updated (Apr 6, 2000): Bioresearch Monitoring Pages: /ora/compliance_ref/bimo/default.htm
- Updated: (Apr 3, 2000): Bioresearch Monitoring Pages:. /ora/compliance_ref/frn/fraud_ill_grat.html
final policy on "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal
Gratuities" (fraud policy)
- New (Mar 31, 2000) 21 CFR Part 11 /ora/compliance_ref/Part11/Default.htm
(collection of background and update documents)
- Updated (Mar 31, 2000) Compliance Reference: Volume Limits for
Automated Collection of Source Plasma /ora/compliance_ref/cpg/cpgbio/cpg252-110.html
and Deferral of source plasma donors: /ora/compliance_ref/cpg/cpgbio/cpg257-100.html
- New (Mar 31, 2000) Guidance Document: Exception from Informed Consent
Requirements for Emergency Research. /ora/compliance_ref/bimo/err_guide.htm
- Updated (Feb 17, 2000) Fed-State Directory: emergency_contacts.htm
and virginia.html
- Updated (Feb 15, 2000) Fed-State Activities: state_associations.htm, directorytable.htm and state_contracts.htm
- Added (Feb 8, 2000) links to QSIT Workshop information and minor
reformat on QSIT page: /ora/inspect_ref/igs/qsit/default.htm.
- Reformatted (Feb 8, 2000) of the Whatsnew (this) page.
- Update (Feb 03, 2000): State Training Team Course Descriptions and
Contacts: STT_Courses2000.htm
Update/New: Federal-State Relations: new link on Health Fraud
page to new page: Aids
Health Fraud Task Force Network.
- Update: Performance Results Staff revised and updated several pages: Hammers.htm, Hammerlist.htm,
Centhams.htm, NEhams.htm,
Quotes.htm (Jan 07, 2000)
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