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ICSOP0011.03

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United States Department of Agriculture

Center for Veterinary Biologics

Standard Operating Policy/Procedure

Outgoing Correspondence

Date: April 28, 2017

Number: ICSOP0011.03

Supersedes: ICSOP0011.02, February 1, 2010

Contact: Becky R. Rasmussen, (515) 337-6138

Approvals:

/s/Steven A. Karli Date: 24May17

Steven A. Karli, Director

Inspection and Compliance

Center for Veterinary Biologics

United States Department of Agriculture

Animal and Plant Health Inspection Service

P. O. Box 844

Ames, IA 50010

INTERNAL USE ONLY

Mention of trademark or proprietary product does not constitute a guarantee or warranty of the product by USDA 

and does not imply its approval to the exclusion of other products that may be suitable.

Entered into CVB Quality Management System

by: /s/Linda S. Snavely 25May17 

 Linda S. Snavely Date

 Quality Management Program Assistant
Center for Veterinary Biologics ICSOP0011.03

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Table of Contents

1. Purpose and Scope

2. General Instructions

3. Instructions for All Draft Stage Correspondence from Biologics Specialists in 

Training (or whenever a second opinion is required or desired by a trained 

Biologics Specialist)

4. Instructions for All Finalized Correspondence

5. Summary of Revisions
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1. Purpose and Scope

This document provides work instructions to facilitate the movement of correspondence from 

origination to finalization. 

2. General Instructions

Current templates are to be used. See the Inspection and Compliance Manual located on the CVB 

Quality Management SharePoint site for the current template. (Documents not on current 

templates will be returned to the author for revision.)

The author drafts the document for finalizing and includes distribution by email (em) and/or 

hardcopy (cc). All Center for Veterinary Biologics (CVB) recipients will be emailed. 

Drafted correspondence should be prepared by the author to conform to acceptable standards for 

format, readability, consistency, grammar, and punctuation. 

Any incoming correspondence and any other related/relevant information (i.e., phone logs, 

emails) is to accompany the correspondence-in-progress. 

The Biologics Compliance Assistant (BCA) will review the document for format, readability and 

consistency in word usage, checking for grammar and punctuation, and finalize for signature. All 

content changes suggested are discussed with the author or supervisor prior to incorporation.

Regulatory letters with financial impact on licensees or permittees (such as mandated stop 

distribution and sale, infraction notices) are to be signed by the Compliance Section Leader or 

other designated person (see the current version of ICSOP0002, The Inspection and Compliance 

Development Process for Veterinary Biologics Program Documentation Intended for 

Publication).

3. Instructions for All Draft Stage Correspondence from Biologics Specialists in 

Training (or whenever a second opinion is required or desired by a trained Biologics 

Specialist)

3.1 Author

All outgoing correspondence is submitted through the supervisor for review, Section 

Leader Review (LSRTIS Mail Log).
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3.2 Supervisor 

The supervisor reads the document for content and adherence to program policies and 

may make suggestions and corrections to the draft document.

If significant changes are to be made, the supervisor may return the document to the 

author for revision before applying initials.

Draft correspondence that has been initialed and dated will be submitted for finalization

after revision according to the supervisor’s comments. 

4. Instructions for All Finalized Correspondence

The draft document is placed in the appropriate inbox, if needed, or to the electronic CVB IC

Inbox within the Mail Log system.

4.1 The BCA will make any needed corrections/revisions to the document.

Any changes other than spelling or format are to be reviewed with the author prior to 

finalizing.

The BCA finalizes the document for signature and returns the document and 

accompanying documentation to the author. If the outgoing correspondence is electronic, 

the BCA will PDF the document prior to signature.

4.2 The signee (author or other designated person) signs the original (white) copy of 

the finalized document, if needed. Otherwise the signee electronically signs the document 

with the appropriate USDA signature block.

The signee ensures the yellow copy is initialed above the legend line by the supervisor or 

CVB-IC management, indicating that the document has been reviewed and is acceptable, 

if needed. Otherwise, the signee sends the electronic document to the Section Leader Final 

Authorization for final review within the Mail Log. 

If the outgoing document was hard copy, the documentation is returned to the appropriate 

BCA. If the outgoing document was electronic, the documentation is sent directly to 

Records Management. Records Management employees perform a quality inspection of 

outgoing documents prior to being pushed to the NCAH Portal.

4.3 If the outgoing documentation is hard copy, the BCA completes the processing, 

converts the final version to PDF format, and files it in the appropriate electronic folder.

The word document is deleted after the yellow is initialed off by the supervisor or 
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management and the hard copy of the letter is sent out. The PDF electronic copy is the 

official electronic copy. 

The BCA designates the physical file location in the upper right-hand corner of the hard 

copy of the yellow. This information should include Establishment number, Specialist last 

name and the physical designation for the hard copy. The electronic path must include 

author/person formatting letter/path/main folder/# of licensed establishment subfolder 

under establishment folder/yymmdd (for example –

). 

4.4 Prior to mail being sealed, a secondary review of contents is performed to verify 

the correspondence is being mailed to the correct address/addressee. 

The Serial Release BCA or other designee performs this review and initials and dates in 

the left margin by the legend line on the yellow copy. 

5. Summary of Revisions 

Version .03

 Updated to include NCAH Portal processes. 

Version .02

 The Contact information has been updated. 

 4.3: This section has been updated for clarification