Historical Summary Report of CVB Policy Management for: 9 CFR Regulation / C

Routine Notice / Veterinary Services Memorandum

Item # Working Title Type Current Status Final 11354 Product Stability Studies (Draft 155) - Date Originated:

22FEB2007 - Version: 10

Veterinary ServicesMemorandum

Completed 800.

11395 Guidelines for Determining Release and ThroughoutDating Potency Specifications VSM 800.124 (Draft 440) -

Date Originated: 10FEB2011 - Version: 15

Veterinary ServicesMemorandum

Completed 800.

11435 revision of 9CFR 113.53 (Draft 535) - Date Originated:

23MAR2015 - Version: 1

9 CFR Regulation Completed 

11734 USDA Review of Special Export Use and "For exportonly" labeling (Draft 640) - Date Originated:

30AUG2019 - Version: 3

CVB Public NoticeCVB Completed 22-0

11774 Record Audit Inspections CVB Public NoticeCVB Completed 11794 VSM 800.52 Draft Doc 635 Veterinary Services

Memorandum

Completed 

11854 In vitro References and Market Release (Draft Doc 619

in previous database) - Date Originated: 05/21/2018 -Version: 1

CVB Public NoticeCVB Completed 

11856 Marek's Disease Vaccine potency tests - (Draft doc 634

from previous database) - Date Originated: 5/6/2019 -Version: 1

CVB Public NoticeCVB Completed 

11874 Veterinary Biological Products in Licensed

Establishments Produced and Destroyed 01/01/2020through 12/31/2020

Routine Notice Completed 

11894 Biologics Products in Licensed Establishments Produced

and Destroyed 01/01/98 through 12/31/98

Routine Notice Completed CVB 

11895 Issuance of New of Revised Supplemental Assay

Methods

Routine Notice Completed CVB 

11896 Issuance of Licenses Aug 1998 Routine Notice Completed CVB 11897 Issuance of Licenses Oct 1998 Routine Notice Completed CVB 11898 Issuance of Licenses Nov 1998 Routine Notice Completed CVB 11900 CVB Notice 98-15 How to Complete Part I of the

Outline of Production for Vaccines, Bacterins, Antigensand Toxoids

CVB Public NoticeCVB Completed CVB 

11901 CVB Notice 98-17 Issuance of New or Revised

Supplemental Assay Methods

CVB Public NoticeCVB Completed CVB 

11915 Guidelines for Autogenous Biologics Veterinary Services

Memorandum

Completed 

Last Updated: 02/01/2024 FOR OFFICIAL USE ONLY 
Item # Working Title Type Current Status Final 

11916 CVB Notice 98-12 Issuance of New or Revised

Supplemental Assay Methods

Routine Notice Completed CVB 

11917 CVB Notice 98-16 Issuance of New or Revised

Supplemental Assay Methods

Routine Notice Completed CVB 

11954 VSM 800.101 U.S. Veterinary Biological Product

Permits for Distribution and Sale

Veterinary ServicesMemorandum

Completed 

11955 Requirement for original certificate to accompany

shipments of permitted products

CVB Public NoticeCVB Completed 

11974 Coccidiosis Vaccines Veterinary Services

Memorandum

Completed 800.

11994 Request for Exemption to Laboratory Animal Batch

safety testing

CVB Public NoticeCVB Completed 

12054 Issuance of Certificates of Inspection CVB Public NoticeCVB Completed 12095 Title 9 Code of Federal Regulations Part 113.28 9 CFR Regulation Completed 12135 VSM 800.211 Rewrite Veterinary Services

Memorandum

Completed 

12174 Issuance of Licenses Q2 FY2021 Routine Notice Completed 12214 Label Warnings Concerning Bovine Rhinotracheitis

Vaccine, Modified Live Virus, and Bovine VirusDiarrhea Vaccine, Modified Live Virus, for PregnantCows or Calves Nursing Pregnant Cows

Veterinary ServicesMemorandum

Completed 

12234 Basic License Requirements and Guidelines for

Submission of Materials in Support of Licensure

Veterinary ServicesMemorandum

Completed 

12235 Guidance Document for Veterinary Biologics Derived

from Bioengineered Plants

CVB Public NoticeCVB Completed 

12236 Exemption to Sterility Test Requirement for Allergenic

Extract Prescription Product

Veterinary ServicesMemorandum

Completed 

12255 Reissuance of Product Licenses for Products Under

Conditional Licenses

Veterinary ServicesMemorandum

Completed 

12494 Supply Chain Disruptions associated with the COVID19 Pandemic CVB Public NoticeCVB Completed 21-012495 Updated Process for Video Submission for Virtual

Inspections related to Remodeled or New Facilities forExisting Licensed Establishments CVB Notice 21-07

CVB Public NoticeCVB Completed 21-0

12554 Relabeling, Rebottling, and Reprocessing Veterinary

Biological Products

Veterinary ServicesMemorandum

Completed 

12555 Issuance of Licenses Q3 FY2021 Routine Notice Completed 12615 Parking lot for VSM 800.53 - addition of Allergenic

Extract information

Veterinary ServicesMemorandum

Completed 

12677 Issuance of Licenses Q4 FY2021 Routine Notice Completed 21-012734 Update to Notice 20-11: Documenting Appropriate

Details for Potency Tests

CVB Public NoticeCVB Completed 23-0

FOR OFFICIAL USE ONLY 
Item # Working Title Type Current Status Final 

12814 Shipment of Experimental Veterinary Biological

Products

Veterinary ServicesMemorandum

Completed 

12854 Issuance of Licenses Q1 FY2022 Routine Notice Completed CVB 12914 Extended use of currently approved, non-Single Tier

compliant domestic labels

CVB Public NoticeCVB Completed 22-0

12934 Availability of Avian Influenza Isolate and Sequence

Information

CVB Public NoticeCVB Completed 

12954 CVB Notice 89 Routine Notice Completed CVB 12974 Discontinued Availability of Erysipelothrix

rhusiopathiae Rabbit Polycolonal Antibody (DetectionAntibody)

CVB Public NoticeCVB Completed 22-0

13015 Issuance of a Conditional License for Mink Coronavirus CVB Public NoticeCVB Completed 22-013037 Issuance of Licenses Q2 FY2022 Routine Notice Completed 22-013194 Issue of Licenses Q3 FY2022 Routine Notice Completed CVB 13274 Policy Regarding Presence of Antimicrobial Resistance

Genes in Regulated Veterinary Biological Products

CVB Public NoticeCVB Completed 23-0

13294 Issuance of Licenses Q4 FY2022 Routine Notice Completed CVB 13334 Change of True Name for antivenin products CVB Public NoticeCVB Completed 23-013354 Issuance of a Conditional License for American

Foulbrood

CVB Public NoticeCVB Completed CVB 

13355 CVB Notice No. 90 for Doses Produced & Destroyed in

CY2022

Routine Notice Completed CVB 

13356 CVB Notice 23-01, Issuance of Licenses Q1 FY2023 Routine Notice Completed CVB 13374 Availability of Duck Atadenovirus 1 (DAdV-1; aka Egg

drop 76, adenovirus 127, duck adenovirus) geneticsequence and isolate

CVB Public NoticeCVB Completed 23-0

13394 Notice to firms requesting additional copies of Master

Seed and Master Cell labels with submissions to theCVB laboratory

CVB Public NoticeCVB Completed 23-1

13414 Sale of unlicensed autologous therapeutic biologics CVB Public NoticeCVB Completed 23-013454 CVB Notice for FAD Diagnostics Sources Sought Notice CVB Public NoticeCVB Completed 23-0105601 Killed/Non-viable Veterinary Vaccines and Veterinary

Diagnostic Products Targeting Egg Drop Syndrome inChickens

CVB Public NoticeCVB Completed 23-1

105845 Issuance of Licenses Q2 FY2023 Routine Notice Completed CVB 105996 Issuance of a Conditional License for Canine Parvovirus

Monoclonal Antibody

CVB Public NoticeCVB Completed CVB 

106306 Issuance of Licenses Q3 FY2023 Routine Notice Completed CVB 

FOR OFFICIAL USE ONLY