INSTRUCTIONS FOR COMPLETING THE CENTER FOR VETERINARY BIOLOGICS INSPECTION 

 AND COMPLIANCE FACILTY DOCUMENT SUBMISSION WORKSHEET

ICWI0134.01 Page 1 of 2 

Author: David Mattocks 

Issue Date: 26Dec17 

Source Document: CVB Notice 17-11, Facility Documents Processing Changes

BACKGROUND: 

One outcome from the Facility Document Business Process Improvement project of FY2017 was the use 

of the Center for Veterinary Biologics Inspection and Compliance Facility Document Submission 

Worksheet (FDS). It is not required for licensee/permittees to use the FDS. But this form streamlines the 

review and response process, so if the licensee/permittee does not submit facility documents using this 

form, the Export Document Examiner (EDE) will be filling out this form for the submission. 

The FDS will be document type “Outgoing Correspondence”. 

PROCESS 

A. The form can be found , CompleteDraftFormFDS 

 This is a fillable pdf form. 

B. The EDE fills out the FDS Form based on the submission. 

NOTE: Use a separate FDS form for each establishment site submission. This is relevant to 

establishments with multiple licensed premises and permittees regarding the international 

manufacturing site and the permittee/quarantine site. A site is not equal to an address. For 

example, Biomune has one site in Lenexa and one site in Anniston. An FDS form would be 

required for the Lenexa site, not each individual address listed on the establishment license for 

Lenexa. Another FDS form would be needed for the Anniston site. 

Block - Required information 

1. The U.S Veterinary Biologics Establishment number 

 

2. The Establishment Site Address related to the submission 

[A] Establishment name for the site 

[B] Establishment site street address 

[C] Establishment site City 

[D] Establishment site State 

[E] Establishment site Country (international submissions) 

[F] Establishment site Zip Code (domestic submissions) 

3. The date the facility documents were submitted to the CVB (cover letter) 

4. Documents Submitted 

[A] Type of Document 

This column has a pick list of different types of facility documents. Please choose the type that 

fits the document being submitted. Several documents may be submitted for one establishment 

site in a single submission. If you need to make more entries than one worksheet allows, use an 

additional worksheet. 

[B] Comments 

This column is free text of up to 49 characters. Enter the identity of the building/floor/area 

related to the document listed in A. For legends, addendums, and summary of changes, include 
INSTRUCTIONS FOR COMPLETING THE CENTER FOR VETERINARY BIOLOGICS INSPECTION 

 AND COMPLIANCE FACILTY DOCUMENT SUBMISSION WORKSHEET

ICWI0134.01 Page 2 of 2 

Author: David Mattocks 

Issue Date: 26Dec17 

Source Document: CVB Notice 17-11, Facility Documents Processing Changes

the page numbers. For example, a Blueprint Legend identified in column A would be further 

identified in column B as Building X, pages 1-10. 

[C] CVB USE ONLY 

For use by Biologics Compliance Assistants (BCAs) to review submission against the FDS form. 

 

5. Miscellaneous Document Type 

This is for documents that don’t match one of the types listed in the pick list under Section 4[A]

or for listing extra documents if you run out of room (rather than opening a new FDS). The type 

of document is entered in the left side block and further identification is entered in the right 

side block. If additional room is needed, use an additional form and place “Page x/y” in the 

comments of each form. 

6. Comments 

Type “Form not submitted by establishment – cover letter signed by (name)”

7. Submitter Signature 

[A] Signature left blank 

[B] Date – same as date submitted, see Block 3 

 

8. Enter Mail Log (ML) Number 

C. The EDE saves the completed FDS folder as EST FDS ML 

XXXXXX. 

NOTE: If more than one form is used due to space constraints, append “part X” to the name of 

the saved forms. 

D. The EDE prints a hard copy of the FDS and files with the facility document submission in the pending 

drawer. 

E. The EDE attaches the FDS to the ML as Document Type “Incoming Submission” (along with the 

scanned cover letter). 

F. The EDE fills out a reference slip using ICTEM0048 Word document. 

1. Replace “(date)” with the submission date and “(number)” with the corresponding ML number. 

2. The liaison address should be placed in the “To:” field. 

3. Save the completed reference slip in the same folder with corresponding FDS Form as EST 

ICTEM0048 ML XXXXXX. 

G. The EDE attaches the reference slip to the ML as Document Type “Internally Routed” and moves it 

forward to Initial Facility Document Review Pool. 

H. The BCA self-assigns ML – See ICWI0081, Preliminary Review of Facility Documents (BCA).