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Newly Published Information

Veterinary Biologics Information Published in the Last 90 Days

CVB Draft Guidance Documents for Comment
Title ID COMMENTS DUE DATE Posted Date
Guidelines for Autogenous Biologics
638
Jun 08, 2020
extended to July 15, 2020
May 14, 2020
Name Change for Biologicals containing Glaesserella parasuis, formerly Haemophilus parasuis, and Clostridioides difficile, formerly Clostridium difficile 660
July 13, 2020
Jun 18, 2020
CVB Notices
Title ID Publication Date Posted Date
NCAH Portal Functionality: Electronic Labeling Submission Revision 20-02 Mar 25, 2020 Mar 31, 2020
Issuance of Licenses 20-03 May 15, 2020 May 21, 2020
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date




Rulemaking
Title FR Citation Effective Date Posted Date
       
Proposed Rulemaking
Title Federal Register Vol/Page Comments Due Date Posted Date

 

Notices of Availability
Title Federal Register Vol/Page Comments Due Date Posted Date




Supplemental Assay Methods (SAMs)
Title ID Document Date Posted Date




Testing Protocols (PROs)
Title ID Document Date Posted Date




Reagent Data Sheets (DATs)
Title Lot ID Publication Date Posted Date
Leptospira grippotyphosa Reference Bacterin
IRP 523 (05)
Apr 01, 2020
Apr 03, 2020
Leptospira icterohaemorrhagiae Reference Bacterin
IRP 542 (06)
Apr 01, 2020
Apr 03, 2020
Leptospira pomona Master Reference Bacterin
IRP 524 (05)
Apr 01, 2020
Apr 03, 2020
Leptospira canicola Master Reference Bacterin
IRP 555 (07)
Apr 01, 2020
Apr 03, 2020
Other
Title ID Publication Date Posted Date
NCAH Portal User Guide #11 - Submitting Labels to Policy, Evaluation and Licensing (PEL) 11 Mar 27, 2020 Mar 31, 2020
Current Veterinary Biologics Product Catalog -- Apr 01, 2020 Apr 03, 2020
Single Tier Label Claim Guidance - Example Study Summaries -- Apr 8, 2020 Apr 16, 2020
Organizational Chart - CVB Management -- Mar 07, 2020 May 04, 2020
NCAH Portal User Guide #13 - Using the CVB template for a label mounting sheet 13 Jun 02, 2020 Jun 02, 2020
NCAH Portal User Template A - Word Label Template A Jun 02, 2020 Jun 02, 2020
NCAH Portal User Template C - PDF Label Template C Jun 02, 2020 Jun 02, 2020
Policy, Evaluation and Licensing (PEL) Reviewer Manual Chapter - Outlines of Production and Special Outlines CVB-SOP-0067 Jun 12, 2020 Jun 16, 2020
NCAH Portal User Guide #18 - Creating and Revising Electronic Outlines 18 Jun 18, 2020 Jun 18, 2020
NCAH Portal User Template B - Outline Templates B Jun 18, 2020 Jun 18, 2020
Organizational Chart - Policy, Evaluation and Licensing -- Jun 21, 2020 Jun 26, 2020
Organizational Chart - Inspection and Compliance -- Jun 21, 2020 Jun 26, 2020
Organizational Chart - Assistant Director -- Jun 21, 2020 Jun 26, 2020
Organizational Chart - Administration -- Jun 21, 2020 Jun 26, 2020
NCAH Portal User Guide #15 - Formatting Documents for Policy, Evaluation and Licensing (PEL) Submissions 15 Jun 18, 2020 Jun 26, 2020

 

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