Release Date: 08 Mar 2021 

Title: Submission Compliance Guide 

Author: ■■l■I Document Number: CVB-SOP-5106.01 

CONTROLLED//PROPIN//BASIC 

Amended or Added Pages - 9 CFR 114.9(a)(4) 

CVB-SOP-5106.01 

Page 6 of 15 

Amended pages are numbered the same as those being superseded. They shall bear the date prepared 

and refer to the date of the pages being superseded. Inserting a page, designated with a number and a 

letter, is acceptable to accommodate overflow of text due to changes. As an example, if an addition 

causes page 3 to overflow, a page 3a may be added. 

Every amended page needs a signature (see details under Signature listed below) 

Do not submit a new cover page when pages are amended. 

Original Signatures - 9 CFR 114.9(a)(5) 

The last page of completed Outlines of Production and each page amended separately shall be 

signed in the lower left corner by the authorized representative of the licensee or permittee. 

Stamped or facsimile signatures are not acceptable. 

Signatures completed in blue ink allow distinction between original signatures from those that 

are photocopied. 

Summary of Changes - 9 CFR 114.9(a)(6) 

A summary of changes shall appear as an attached page(s), preferably behind the Outline, and refer 

to each page, paragraph, or subparagraph being changed and the reason for the change. 

The summary of changes is separate from the Outline of Production; it is not a continuation of the 

Outline. It (if numbered) has its own set of numbers when consisting of more than one page. 

Transmittal Form-APHIS Form 2015 (full instructions on back of form) 

A single transmittal form shall be used for each new or subsequent submission. 

This form is available as a fillable document found on the CVB website at: 

https:/ /www.aphis.usda.gov/aphis/ ourfocus/animalhealth/veterinarybiologics/sa bio forms/ct vb forms 

If the product has not been licensed at the time of the submission, place an "X" in Block 7. This 

will serve as a priority flag for review. 

Block 10 - "Complete Revision" is checked only if an entire Outline of Production is being 

submitted to replace the Outline of Production currently on file with APHIS. 

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100 








Title: Submis�iance Guide 

Release Date: 08 Mar 2021 Author: - Document Number: CVB-SOP-5106.01 

CONTROLLED//PROPIN//BASIC 

Contact Information 

CVB-SOP-5106.01 

Page 15 of 15 

Contact us if you have any questions regarding format, regulations, memorandums, notices, or the 

status of your submissions. 

Request priorities through your assigned the CVB-PEL Reviewer. 

Legal Instruments Examiners: 

Aimee Losee 

E-mail: Aimee.M.Losee@usda.gov

Phone No.: (515) 337-7935

Address: 

USDA APHIS VS 

Center for Veterinary Biologics 

Policy, Evaluation, and Licensing 

1920 Dayton A venue 

P.O. Box 844 

Ames, Iowa 50010 

CVB Phone: (515) 337-6100 

CVB Fax: (515) 337-6120 

CVB Home Web Site: 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinazybiologics 

To reach the current the CVB Notices, VS Memos, and 9 CFR from our Home 

Page, click on Veterinary Biologics and Biologics Regulations & Guidance. 

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100