Newly Published Information

Newly Published Information

Veterinary Biologics Information Published in the Last 90 Days

CVB Notices
Title ID Publication Date Posted Date
Facility Documents Processing Changes – Pilot Project
Draft of the FDS and instructions for use
17-11 Sep 13, 2017 Sep 14, 2017
Issuance of Licenses 17-12 Oct 05, 2017 Oct 06, 2017
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
Target Animal Safety Testing Exemption 800.116 Aug 14, 2017 Aug 28, 2017
Preparation and Submission of Facilities Documents 800.78 Aug 18, 2017 Aug 30, 2017
Rulemaking
Title FR Citation Effective Date Posted Date
       
Proposed Rulemaking
Title Federal Register Vol/Page Comments Due Date Posted Date
       
Supplemental Assay Methods (SAMs)
Title ID Document Date Posted Date
Supplemental Assay Method for Titration of Parainfluenza 3 Neutralizing Antibody (Constant Virus - Varying Serum Method) 113 May 12, 2017 Jul 25, 2017
Testing Protocols (PROs)
Title ID Document Date Posted Date
Fluorescent Antibody Staining Procedure for Detection of Viral Antigens VIRPRO1014 Jul 11, 2017 Jul 25, 2017
Reagent Data Sheets (DATs)
Title Lot # Publication Date Posted Date
Veterinary Rabies Reference Vaccine, killed virus 08-14 Apr 11, 2017 Sep 11, 2017
Erysipelothrix rhusiopathiae Reference Bacterin IRP 609 May 02, 2016 Oct 04, 2017
Other
Title ID Publication Date Posted Date
Inspection and Compliance Manual Product Sampling - ICSOP0022 (Section 7) -- Jul 05, 2017 Jul 20, 2017
Current SAMs -- Jul 14, 2017 Jul 25, 2017
PEL (Reviewer) Manual Using Software to Estimate Relative Potency (Section 4.6.2) -- Jul 20, 2017 Jul 28, 2017
PEL (Reviewer) Manual True Names and Product Codes (Section 1.3) -- Jul 19, 2017 Aug 04, 2017
PEL (Reviewer) Manual Labels (Section 4.2) -- Jul 07, 2017 Aug 04, 2017
PEL (Reviewer) Manual Efficacy Studies (Section 4.4) -- Jun 30, 2017 Aug 04, 2017
Inspection and Compliance Manual Delegation of Authority for Center for Veterinary Biologics - ICSOP0001 (Sec. 2.3) -- Jul 27, 2017 Aug 09, 2017
Inspection and Compliance Manual APHIS Dispositions and Associated Information on Form 2008s - ICWI0130 (Section 6.2.18) -- Jul 05, 2017 Aug 09, 2017
Inspection and Compliance Manual BCA Ready for Approval - ICWI1410 (Section 6.7) -- Jul 05, 2017 Aug 09, 2017
NCAH Portal User Guide #21 - Requesting Confirmatory Testing of Product Serials (Prelicense, Outline Change, or Technology Transfer) -- Aug 09, 2017 Aug 09, 2017
NCAH Portal Newsletter - vol. 2, issue 5 - Notification of Changes Made in Version 1.2.0 -- Jun 28, 2017 Aug 28, 2017
Inspection and Compliance Manual VBI Procedures - ICWI0016 (Sec. 4.1) -- Aug 03, 2017 Aug 29, 2017
Inspection and Compliance Manual Investigation Procedures Following a Report of Potential Lack of Efficacy Report for a Rabies Vaccine - ICWI0006 (Sec. 4.2) -- Aug 04, 2017 Aug 29, 2017
Inspection and Compliance Manual LSRTIS Special Test Request Procedures for Inspection and Compliance - ICSOP0043 (Sec. 6.3) -- Jul 10, 2017 Aug 29, 2017
Inspection and Compliance Manual Preliminary Review of Facility Documents (BCA) - ICWI0081 (Sec. 9.1) -- Aug 11, 2017 Aug 29, 2017
NCAH Portal User Guide #3 - Submission History (CVB) and Account Details -- Aug 29, 2017 Aug 30, 2017
Org. Chart (Information Management Unit) -- Sep 01, 2017 Sep 08, 2017
NCAH Portal Newsletter - vol. 2, issue 6 - Announcement of Change to Allow for an Additional Email Address for NCAH Portal Notification Emails -- Aug 29, 2017 Sep 14, 2017
NCAH Portal User Guide #18 - Creating and Revising Electronic Outlines -- Sep 27, 2017 Sep 27, 2017
User Guide #16 - CVB Data Guide (how to submit data to PEL) -- Sep 26, 2017 Oct 04, 2017
Individual Study Summary (ISS) Template Single Tier Label Claim Guidance Document -- Oct 04, 2017 Oct 05, 2017
Individual Study Summary (ISS) Template line-wise instructions Single Tier Label Claim Guidance Document -- Oct 04, 2017 Oct 05, 2017
Center for Veterinary Biologics Reagent Catalog -- Sep 22, 2017 Oct 05, 2017
VS 800 series Memoranda and CVB Notices - Historical Summary of Proposed Documents -- Oct 05, 2017 Oct 05, 2017
Current Veterinary Biologics Product Catalogue -- Oct 04, 2017 Oct 06, 2017
Inspection and Compliance Manual Items to Consider Regarding Facility Documents for Autologous Therapeutic Biologics - ICWI0082 (Section 9.4.4) -- Sep 29, 2017 Oct 11, 2017
Inspection and Compliance Manual Inspection, Requested Document Worksheet - ICFRM0027 (Section 3.3.3.3) -- Aug 18, 2017 Oct 11, 2017
Inspection and Compliance Manual Inspection Tools – Requested Documents and Observations - ICWI0035 (Section 3.3.3.1) -- Aug 18, 2017 Oct 11, 2017
Inspection and Compliance Manual Preparation of Administrative Inspection Reviews - ICWI0242 (Section 3.6.1) -- Sep 29, 2017 Oct 11, 2017
Inspection and Compliance Manual Processing Incoming Administrative Inspection Review (AIR) Documents by CVB - ICWI0241 (Section 3.6.2) -- Sep 29, 2017 Oct 11, 2017
Inspection and Compliance Manual Facility Document Form Plot Plan/Plot Plan Legend - Preliminary Review (BCA) - ICFRM0018 (Section 9.1.1) -- Aug 30, 2017 Oct 13, 2017
Inspection and Compliance Manual Facility Document Form Blueprint/Blueprint Legend - Preliminary Review (BCA) - ICFRM0019 (Section 9.1.2) -- Aug 30, 2017 Oct 13, 2017

 

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