Newly Published Information

Newly Published Information

Veterinary Biologics Information Published in the Last 90 Days

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
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
Licensing Guidelines for Production Platform-Based, Non-Replicating, Nonviable Products 800.213 Mar 12, 2018 Mar 14, 2018
Prescription Platform Product Biologics 800.214 Mar 12, 2018 Mar 14, 2018
Basic License Requirements and Guidelines for Submission of Materials in Support of Licensure 800.50 Apr 02, 2018 Apr 13, 2018
Rulemaking
Title FR Citation Effective Date Posted Date
Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serial and Subserials and Determination of Expiration Date of Product APHIS-2009-0028 Apr 13, 2018 Mar 19, 2018
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
Titration of Newcastle Disease Vaccine, Infectious Bronchitis Vaccine, and Combination Newcastle Disease-Infectious Bronchitis Vaccine in Chicken Embryos 411 Jan 10, 2018 Mar 14, 2018
Testing Protocols (PROs)
Title ID Document Date Posted Date
Testing Protocol for Enzyme Linked Immunosorbent Assay (ELISA) for Extraneous Avian Leukosis Virus (ALV) *author update only VIRPRO0123 Jan 31, 2018 Feb 20, 2018
Preparation of Cryopreserved Challenge Cultures for Leptospira Serogroups Canicola, Pomona, Grippotyphosa, and Icterohaemorrhaghiae BBAPP0011 Feb 01, 2018 Mar 19, 2018
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
Erysipelothrix rhusiopathiae Reference Bacterin IRP 609 Mar 02, 2018 Mar 09, 2018
Clostridium botulinum Type C Antitoxin IRP 428 Feb 27, 2018 Mar 14, 2018
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
Other
Title ID Publication Date Posted Date
User Guide #1 - Logging In and IT Security Awareness Training 1 Feb 22, 2018 Feb 27, 2018
Inspection and Compliance Manual Items to Consider in Evaluating Electronic Records and Digital Data (Sec. 3.3.9.1) ICWI0146 Dec 01, 2017 Mar 09, 2018
Inspection and Compliance Manual Instructions for Completing the Center for Veterinary Biologics Inspection and Compliance Facility Document Submission Worksheet (Sec. 9.5.3) ICWI0134 Dec 26, 2017 Mar 09, 2018
Inspection and Compliance Manual Workload Indicator Calculations for Policy Documents (Sec. 19.2.6) ICWI0927 Apr 12, 2016 Mar 09, 2018
Examples of a variety of Individual Study Summaries Single Tier Label Claim Guidance Document -- Mar 14, 2018 Mar 14, 2018
Center for Veterinary Biologics Reagent Catalog -- Feb 27, 2018 Mar 14, 2018
Inspection and Compliance Manual BCA Work Instructions for Processing/Finalizing Inspection Reports (Sec. 3.5.1) ICWI0115 Feb 23, 2018 Mar 19, 2018
NCAH Portal User Guide #2 - Description of Portal Roles and Privileges 2 Mar 16, 2018 Mar 21, 2018
NCAH Portal User Guide #22 - Biologics Export Certification - APHIS Form 2017 22 Mar 15, 2018 Mar 21, 2018
NCAH Portal User Guide #23 - Biologics Export Certification - APHIS Form 2046 and 2046-S 23 Mar 15, 2018 Mar 21, 2018
NCAH Portal User Guide #24 - Biologics Export Certification - APHIS Form 2047 and 2047-S 24 Mar 15, 2018 Mar 21, 2018
NCAH Portal User Guide #25 - Biologics Export Certification - Stand Alone Attestations and Ingredients of Animal Origin (English and Spanish) 25 Mar 15, 2018 Mar 21, 2018
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

 

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