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CVB Draft Guidance Documents for Comment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
Diagnostic Test Kit Validation 561 Jul 16, 2018 extended to July 23, 2018 Jun 21, 2018
Policy for Long-Term Recognition of CVB Digital Signatures in Microsoft Word documents 623 Jul 30, 2018 Jul 05, 2018
CVB Notices
Title ID Publication Date Posted Date
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
Implementation Period for the Submission of Adverse Event Reports 18-09 Jun 25, 2018 Jun 26, 2018
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
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
National Environmental Policy Act Implementing Procedures APHIS-2013-0049 Jun 25, 2018 Jun 25, 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
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
Veterinary Rabies Reference Vaccine, killed virus 08-14 Jul 02, 2018 Jul 03, 2018
Clostridium perfringens type C (beta) toxin IRP 624 Jul 06, 2018 Jul 19, 2018
Other
Title ID Publication Date Posted Date
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 (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
Inspection and Compliance Manual Inspection and Compliance Correspondence (LSRTIS, Mail Log Procedures) (Sec. 15.3) ICSOP0045 Apr 13, 2018 Jun 26, 2018
Organization Chart (Policy, Evaluation and Licensing) -- Jun 24, 2018 Jul 05, 2018
Current Veterinary Biologics Product Catalogue -- Jul 05, 2018 Jul 05, 2018

 

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