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CVB Draft Guidance Documents for Comment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
Potency and Safety Testing by Unlicensed Facilities (VS Memo) 545 Aug 20, 2018 Jul 27, 2018
Proposal to Change the Regulation of Veterinary Allergenic Extracts (CVB Notice) 610 Aug 20, 2018 Jul 27, 2018
Labeling of Vaccines Containing Porcine Circovirus Type 2 (CVB Notice) 621 Aug 20, 2018 Jul 27, 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
Issuance of Licenses 18-10 Aug 09, 2018 Aug 10, 2018
Policy for Long-Term Recognition of CVB Digital Signatures in Microsoft Word documents 18-11 Aug 08, 2018 Aug 10, 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
Reissuance of Product Licenses for Autogenous Products and Guidance Concerning Restrictions on the Production and Use of Veterinary Biologics 800.103 Jul 18, 2018 Jul 23, 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
Sterility Testing of Preparations Other Than Live Vaccines 906 Jul 26, 2018 Aug 03, 2018
Sterility Testing of Live Viral Vaccines and Master Seed Virus Samples 908 Jul 26, 2018 Aug 03, 2018
Sterility Testing of Live Viral Vaccines of Chicken Embryo Origin Recommended for Nonparenteral Injection 909 Jul 26, 2018 Aug 03, 2018
Detection of Extraneous Bacteria and Fungi in Live Bacterial Vaccines and Master Seed Bacteria Samples 928 Jul 26, 2018 Aug 03, 2018
Testing Protocols (PROs)
Title ID Document Date Posted Date
Modified Potency Testing Protocol for Purified Protein Derivative (PPD) Tuberculins BBPRO0002 Jul 17, 2018 Aug 01, 2018
Master Seed Testing in the Virology Section VIRSOP2007 Mar 27, 2018 Aug 03, 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
Clostridium perfringens type D (epsilon) toxin IRP 632 Apr 03, 2018 Aug 07, 2018
Other
Title ID Publication Date Posted Date
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
Inspection and Compliance Manual Inspection and Compliance Correspondence (LSRTIS, Mail Log Procedures) (Sec. 15.3) ICSOP0045 Apr 13, 2018 Jun 26, 2018
Current Veterinary Biologics Product Catalogue -- Jul 05, 2018 Jul 05, 2018
PEL (Reviewer) Manual Labels 4.2 Jul 05, 2018 Jul 27, 2018
NCAH Portal User Guide #26 - Submitting Facility Documents to Inspection and Compliance (IC) 26 Aug 01, 2018 Aug 01, 2018
NCAH Portal Video - Using the NCAH Portal for Submission of an APHIS Form 2017 -- -- Aug 01, 2018
NCAH Portal Video - Using the NCAH Portal for Submission of APHIS Forms 2046 or 2046-S -- -- Aug 01, 2018
NCAH Portal Video - Using the NCAH Portal for Submission of APHIS Forms 2047 or 2047-S -- -- Aug 01, 2018
NCAH Portal Video - Using the NCAH Portal for Submission of Attestations and Ingredients of Animal Origin -- -- Aug 01, 2018
Organization Chart (Policy, Evaluation and Licensing) -- Aug 01, 2018 Aug 03, 2018
Current SAMs list -- Aug 02, 2018 Aug 03, 2018
Printable Version of Guidance to Industry Preparing Supporting Summaries for Single Tier (Single Label Claim) Effectiveness Statements -- Aug 01, 2018 Aug 03, 2018
Inspection and Compliance Manual Preliminary Review of Facility Documents (BCA) (Sec. 9.1) ICWI0081 Jun 25, 2018 Aug 07, 2018
Inspection and Compliance Manual Finalization of Facility Document Submission (Sec. 9.3) ICWI0084 Jul 03, 2018 Aug 07, 2018
Inspection and Compliance Manual Export Certificates and Certificates of Licensing and Inspection (Sec. 18.1) ICSOP0044 Jul 05, 2018 Aug 07, 2018
Inspection and Compliance Manual Entry and Primary Review of Export Documents (APHIS Form 2017 and Certificates of Licensing and Inspection) (Sec. 18.2) ICWI0068 Jul 06, 2018 Aug 07, 2018
Inspection and Compliance Manual Secondary Review of Export Documents (APHIS Form 2017 and Certificates of Licensing and Inspection) (Sec. 18.3) ICWI0069 Jul 06, 2018 Aug 07, 2018
Organization Chart (Administration Unit) -- Jun 24, 2018 Aug 10, 2018