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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CVB Draft Guidance Documents for Comment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
Availability of New Inactivated Veterinary Rabies Reference
Draft 636
extended to Nov 01, 2019
Sep 09, 2019
Determination of Regulatory Review Period for Purposes of Patent Extension; Porcine Circovirus Vaccine, Type 1-Type 2 Chimera, Killed Virus, Mycoplasma Hyopneumoniae Bacterin
Docket No. APHIS-2019-0039
Nov 04, 2019
Oct 07, 2019
Preparation and Submission of Adverse Event Reports for Biological Products by Licensees and Permittees
Draft 637
Nov 12, 2019
Oct 18, 2019
CVB Notices
Title ID Publication Date Posted Date
Discontinued Availability of Pasteurella multocida 169 (Porcine) Bacterin 19-07 Jul 19, 2019 Jul 22, 2019
Availability of Newcastle Disease Isolate and Sequence Information 19-09 Sep 05, 2019 Sep 09, 2019
Expanded NCAH Portal Functionality: APHIS Form 2005 Applications for Sale and Distribution 19-10 Sep 09, 2019 Sep 09, 2019
Expanded NCAH Portal Functionality: APHIS Form 2005 Applications for Research and Evaluation, and Transit Shipment Permits 19-11 Sep 09, 2019 Sep 09, 2019
Issuance of a Conditional License for Avian Reovirus Vaccine, Killed Virus Permits 19-12 Sep 19, 2019 Oct 07, 2019
Issuance of Licenses 19-13 Oct 02, 2019 Oct 07, 2019
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
Diagnostic Test Kit Validation
800.73
Sep 24, 2019
Sep 24, 2019
Preparation and Submission of Facilities Documents
800.78
Sep 24, 2019
Sep 24, 2019
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
Master Seed Testing in the Virology Section CVB-SOP-0149
Jul 30, 2019 Aug 08, 2019
Hematoxylin and Eosin Staining Procedure for Detection of Cytopathic Extraneous Agents in Master Seeds CVB-PRO-0038
Jul 11, 2019 Aug 08, 2019
Fluorescent Antibody Staining Procedure for Detection of Viral Antigens CVB-PRO-0040
Jul 11, 2019 Aug 08, 2019
Reverse Transcription (RT)-PCR Assay Using Qiagen OneStep CVB-PRO-0033
Oct 10, 2019 Oct 15, 2019
Reagent Data Sheets (DATs)
Title Lot ID Publication Date Posted Date
Pasteurella multocida (bovine) Challenge Culture IRP 610 Jul 30, 2019 Aug 08, 2019
Veterinary Rabies Reference Vaccine, killed virus Lot 08-14 Aug 15, 2019 Aug 28, 2019
Other
Title ID Publication Date Posted Date
Organizational Chart - Administration -- Jul 07, 2019 Aug 28, 2019
Organizational Chart - Inspection and Compliance -- Jul 07, 2019 Aug 28, 2019
Organizational Chart - Information Management Unit -- Jul 07, 2019 Aug 28, 2019
Organizational Chart - Safety and Security Unit -- Jul 07, 2019 Aug 28, 2019
NCAH Portal User Guide - Application for United States Veterinary Biological Product Permit - RESEARCH AND EVALUATION *functionality will be available in NCAH Portal on 9/26/2019 27 Sep 11, 2019 Sep 12, 2019
NCAH Portal User Guide - Application for United States Veterinary Biological Product Permit - TRANSIT SHIPMENT ONLY *functionality will be available in NCAH Portal on 9/26/2019 28 Sep 11, 2019 Sep 12, 2019
NCAH Portal User Guide - Application for United States Veterinary Biological Product Permit - SALES AND DISTRIBUTION *functionality will be available in NCAH Portal on 9/26/2019 29 Sep 11, 2019 Sep 12, 2019
Inspection and Compliance Manual - Scheduling and Approval of Inspections in LSRTIS CVB-WI-0119 Jul 12, 2019 Sep 12, 2019
Hold-over Information from Veterinary Services Memorandum No. 800.90 -- Sep 13, 2019 Sep 13, 2019
NCAH Portal User Guide - General Guide for Submission of Veterinary Biologics Production and Test Report 5 Sep 13, 2019 Sep 13, 2019
Inspection and Compliance Manual - Workload Indicator Calculations for Compliance CVB-WI-0149 Aug 20, 2019 Sep 16, 2019
PEL Reviewer Manual - Validating Alternate Techniques for the Detection of Mycoplasmas CVB-WI-0181 Aug 20, 2019 Sep 16, 2019
PEL Reviewer Manual - Dilution of Preservative Studies CVB-WI-0182 Aug 20, 2019 Sep 16, 2019
PEL Reviewer Manual - Quarterly Submission Acknowledgement Summaries CVB-SOP-0064 Aug 30, 2019 Sep 16, 2019
Inspection and Compliance Manual - CVB Inspection and Compliance Procedure for Generating Case Summaries from PV Works System CVB-WI-0127 Sep 05, 2019 Sep 24, 2019
Current Veterinary Biologics Product Catalog -- Oct 01, 2019 Oct 07, 2019
NCAH Portal User Guide - Requirements for Electronic Outline of Production and Special Outline Templates 17 Oct 16, 2019 Oct 16, 2019
Inspection and Compliance Manual - Processes for Evaluating Compliance with Requirements of VS Memo 800.210 and VS Memo 800.57 CVB-WI-5218 Oct 01, 2019 Oct 18, 2019
Inspection and Compliance Manual - Facility Documents; Specialist Review, including Electronic Processing CVB-WI-0115 Oct 03, 2019 Oct 21, 2019
NCAH Portal User Guide - General Guide for E-Submissions to CVB-Policy, Evaluation and Licensing 10 Oct 18, 2019 Oct 21, 2019

 

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