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
Revised Scope of Eligibility for Studies Requiring Single-Tier Summaries 17-13 Nov 03, 2017 Nov 03, 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
Electronic Recordkeeping and Compliance with 9 CFR Part 116 800.122 Nov 03, 2017 Nov 08, 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
       
Testing Protocols (PROs)
Title ID Document Date Posted Date
       
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
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
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
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
NCAH Portal User Guide #19 - Versioning Electronic Outlines -- Oct 17, 2017 Oct 17, 2017
Org. Chart (CVB Management) -- Oct 01, 2017 Oct 31, 2017
Org. Chart (Assistant Director) -- Oct 01, 2017 Oct 31, 2017
Org. Chart (Administration Unit) -- Oct 01, 2017 Oct 31, 2017
NCAH Portal User Guide B - Outline Templates -- Oct 25, 2017 Oct 31, 2017
NCAH Portal User Guide #12 - Working with Digital Signatures -- Oct 25, 2017 Oct 31, 2017
Inspection and Compliance Manual Facility Documents: Specialist Review and Outgoing Correspondence - ICWI0083 (Section 9.2) -- Oct 11, 2017 Oct 31, 2017
Inspection and Compliance Manual Facility Document Correspondence - ICTEM0045 (Section 9.2.1) -- Oct 12, 2017 Oct 31, 2017
Inspection and Compliance Manual Processing Facility Documents - ICSOP0018 (Sec. 9) -- Oct 06, 2017 Oct 31, 2017
Inspection and Compliance Manual Preliminary Review of Facility Documents (BCA) - ICWI0081 (Sec. 9.1) -- Oct 12, 2017 Oct 31, 2017
Individual Study Summary (ISS) Procedure Data RequirementsSingle Tier Label Claim Guidance Document -- Oct 31, 2017 Nov 03, 2017
Examples of a variety of Individual Study SummariesSingle Tier Label Claim Guidance Document -- Nov 03, 2017 Nov 03, 2017
Scope of Studies Requiring Single-Tier SummariesSingle Tier Label Claim Guidance Document -- Oct 31, 2017 Nov 03, 2017
Center for Veterinary Biologics Reagent Catalog -- Oct 27, 2017 Nov 03, 2017
Inspection and Compliance Manual Finalization of Facility Document Submission - ICWI0084 (Sec. 9.3) -- Oct 31, 2017 Nov 13, 2017

 

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