Newly Published Information

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CVB Draft Guidance Documents for Comment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
General Licensing Considerations: Preparing Outlines of Production for Vaccines, Bacterins, Antigens, Toxoids, and Diagnostic Test Kits 584 Jun 25, 2018 Jun 1, 2018
Guidelines Regarding the Revision to APHIS’ Implementing Procedures for the National Environmental Policy Act 608 Jul 02, 2018 Jun 11, 2018
Shipment of Experimental Veterinary Biological Products 586 Jul 02, 2018 Jun 11, 2018
Diagnostic Test Kit Validation 561 Jul 16, 2018 Jun 21, 2018
CVB Notices
Title ID Publication Date Posted Date
Expanded NCAH Portal Functionality: Submission of Export Documents 18-04 Mar 29, 2018 Mar 29, 2018
Detection of Senecavirus A in Veterinary Biological Products 18-05 Mar 30, 2018 Apr 03, 2018
Issuance of Licenses 18-06 Apr 06, 2018 Apr 11, 2018
Digital Signatures on Microsoft Word Documents 18-07 May 17, 2018 May 18, 2018
Expanded NCAH Portal Functionality: Submission of Facility Documents 18-08 May 30, 2018 Jun 01, 2018
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
Basic License Requirements and Guidelines for Submission of Materials in Support of Licensure 800.50 Apr 02, 2018 Apr 13, 2018
Manufacturing Deviations Identified Prior to Marketing Release 800.210 May 31, 2018 Jun 12, 2018
Market Suspensions and Post Marketing Temperature Deviations 800.57 Jun 11, 2018 Jun 12, 2018
Rulemaking
Title FR Citation Effective Date Posted Date
VSTA Records and Reports Specific to International Standards for Pharmacovigilance APHIS-2014-0063 May 17, 2018 May 17, 2018
Proposed Rulemaking
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
Amplification of Extraneous Senecavirus Through Cell Culture VIRPRO0129 Jul 24, 2017 Mar 29, 2018
Real-time Reverse Transcription Polymerase Chain Reaction Assay for the Detection of Senecavirus A RNA VIRPRO0130 Dec 06, 2017 Mar 29, 2018
Detection of Pathogens by the Inoculation Test in Embryonated Chicken Eggs VIRPRO1017 Apr 17, 2018 May 04, 2018
Reagent Data Sheets (DATs)
Title Lot # Publication Date Posted Date
Clostridium tetani Toxin IRP 648 May 04, 2018 May 21, 2018
Multiple BB DATs were recently updated with expiration dates or contact information. Visit the BB Reagent Data Sheet page to see them all. -- Mar 29, 2018 and Apr 3, 2018 Apr 11, 2018
Leptospira pomona Monoclonal Antibody (LP MAb) IRP 04-504 Apr 26, 2018 Jun 11, 2018
Other
Title ID Publication Date Posted Date
STATS Work Instruction - Non-parametric Estimation of Median Effective Dose STATWI0001 Mar 23, 2018 Mar 29, 2018
STATS Work Instruction - Technical Notes for Estimating Diagnostic Sensitivity and Specificity STATWI0002 Mar 23, 2018 Mar 29, 2018
Current Veterinary Biologics Product Catalogue -- Apr 05, 2018 Apr 11, 2018
PEL Reviewer Manual List of Standard License Restrictions Chapter 2.2.1 Mar 23, 2018 Apr 11, 2018
PEL Reviewer Manual Outlines of Production & Special Outlines Chapter 4.1 Mar 23, 2018 Apr 11, 2018
PEL Reviewer Manual True Names, Product Codes and Establishment Codes Chapter 1.3 Mar 26, 2018 Apr 11, 2018
NCAH Portal User Guide #25 - Versioning Electronic Outlines 19 Apr 16, 2018 Apr 16, 2018
NCAH Portal Newletter - Announcement of Expansion of NCAH Portal to Include Export Certificates vol. 3, issue 1 Mar 20, 2018 Apr 16, 2018
Organization Chart (Inspection and Compliance) -- Apr 01, 2018 Apr 16, 2018
Inspection and Compliance Manual Mail Log Work Flow for Correspondence for Inspection and Compliance: Biologics Specialist Review (Sec. 15.3.7) ICWI0236 Apr 11, 2018 Apr 18, 2018
Organization Chart (Policy, Evaluation and Licensing) -- Apr 01, 2018 Apr 27, 2018
Organization Chart (Safety and Security Unit) -- Apr 28, 2018 May 04, 2018
Inspection and Compliance Manual Processing United States Veterinary Permits for Importation and Transportation of Controlled Materials and Organisms and Vectors (VS Form 16-6A MAR 95) ICSOP0032 Mar 22, 2018 May 17, 2018
Inspection and Compliance Manual Review, Electronic Filing, and Disposal of United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors (VS Form 16-6A) ICWI0032 Mar 23, 2018 May 17, 2018
NCAH Portal User Guide #13 - Using the CVB Template for a Label Mounting Sheet 13 May 21, 2018 May 21, 2018
NCAH Portal User Guide #26 - Submitting Facility Documents to Inspection and Compliance (IC) 26 Jun 01, 2018 Jun 01, 2018

 

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