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United States Department of Agriculture 

Center for Veterinary Biologics 

Standard Operating Policy/Procedure 

General Inspection and Compliance Correspondence Guidance 

Date: 

Number: 

Supersedes: 

Contact: 

April 4, 2016 

ICSOP0042.02 

ICSOP0042.01, June 20, 2012 

Patti C. Woo (515) 337-6127 (updated 24Jan18)

Approvals: 

/s/Steven A. Karli Date: 06Apr16 

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 06Apr16

Linda S. Snavely Date

Quality Management Program Assistant
Center for Veterinary Biologics ICSOP0042.02

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General Inspection and Compliance Correspondence Guidance

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Table of Contents

1. Purpose

2. Correspondence

3. Templates for Inspection and Compliance Correspondence

4. Common Conventions used in the Veterinary Biologics Program

5. Summary of Revisions
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1. Purpose 

1.1 The purpose of this document is to set forth the various procedures established for 

correspondence not covered elsewhere in the Inspection and Compliance Manual. 

General Office Guidelines are listed in Chapter 15 of the Inspection and Compliance 

Manual. Additional guidance is located in ICSOP0011, Outgoing Correspondence, and 

ICWI0011, Outgoing Correspondence. 

1.2 For purposes of this document, the term Specialist refers to individuals 

performing “Biologic Specialist” activities. 

 

2. Correspondence 

2.1 Style, form, and standard nomenclature are determined for this office by the 

Inspection and Compliance (IC) Program Support Assistant (PSA) based on guidance 

from the VS Correspondence Manual. The VS Correspondence Manual is located at: 

. Templates for IC correspondence, letters, 

memorandums, and policy documents are located in the Center for Veterinary Biologics 

(CVB) Quality Management SharePoint site under templates. 

Additional helpful links are: 

 

U.S. Government Style Manual (2008): 

https://www.gpo.gov/fdsys/search/pagedetails.action?granuleId=&packageId=GPOSTYLEMANUAL-2008

Plain Writing Act: 

http://www.plainlanguage.gov/index.cfm 

2.2 Correspondence is received in many different forms (i.e., verbal, e-mail, etc.). 

However, all official CVB correspondence is by letter. Letters are used for 

correspondence going outside the department. Letters (carbon copy (cc) or original) sent 

to an establishment are addressed to the official liaison. In certain instances, the author 

may choose to include a visible cc: so the recipient of the letter knows that the cc: was 

done. 

2.3 Memorandums are used for internal and intra-departmental correspondence only. 

Memorandum types include Standard, Decision, Informational, and Briefing. 

Memorandums which will be sent outside of the CVB are sent through the applicable 

Section Leader, the IC Director, and the CVB Director. An em (email) copy may be sent 

to other persons mentioned in the memorandum. Just as in letters, the memorandums may 

describe who should receive an em copy. Unlike letters, the em distribution is shown on 

the original of the memorandum. Memorandums to CVB-Policy, Evaluation, and 
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Licensing (PEL) are written to the PEL Director (unless responding to a specific request 

by a Reviewer). For current templates see the Quality Management SharePoint site, CVB 

Manual, CVB Templates (CVBTEM).

3. Templates for Inspection and Compliance Correspondence

3.1 IC Templates for correspondence are located in the Inspection and Compliance 

Manual or on the CVB Quality Management SharePoint site. The templates are labeled as 

ICTEM followed by a number. All IC staff members are responsible for keeping the PSA 

informed of any problems, changes, updates, or new templates needed. See

QMSOP0001, Section 7, Templates, Center for Veterinary Biologics Quality 

Management System Documents, for further information.

If a new template or template change is identified, it is to be brought to the PSA. The 

PSA brings the change to the staff member, usually a Section Leader, assigned to that 

template. The Section Leader decides whether the change is necessary or not. 

3.2 Work Instructions which contain examples of various regulatory actions/activities 

for reporting the Weekly Activity Report for the President are in the CVB Quality 

Management SharePoint site as ICWI0121, Inspection and Compliance Weekly Report to 

the President Examples.

3.3 All authors of letters are required to obtain a “clean” template for their outgoing 

correspondence. Do not work from previous letters.

4. Common Conventions used in the Veterinary Biologics Program

 Only one space after a period or colon. 

 Est. No. or Est. may be abbreviated everywhere.

 Est., License Number, Product Code, Code, Serial are all capitalized when referring

to a specific number.

 Computer entry in a database: remove all dashes, slashes, periods or other marks in 

serial and license numbers or test and product codes. 

 The dashes, slashes, dots or other marks should be left in the numbers in all 

correspondence and reports (exactly as shown on the APHIS Form 2008).

 In APHIS correspondence and reports persons are usually referred to by first name, 

middle initial, last name and working title: John A. Doe, Biologics Specialist.
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 The types of inspections are: in-depth (Inspection), follow-up (Inspection), and 

special (Investigations, etc.). When used in a sentence, they are not capitalized.

 Master Seed (Virus or Bacteria) is usually capitalized.

 Product names and scientific names of organisms are handled differently:

 Product Organism

Clostridium Chauvoei Bacterin Clostridium chauvoei

Canine Parvovirus Vaccine canine parvovirus

Use italics for scientific words; underline if italics is not available.

 When listing the product code in a sentence, place it after the product name. Unless 

needed for clarification, just use the term "Code" with the product number: 

Autogenous Bacterin, Code 2051.00.

 In letters, refer to either “veterinary biological products” or “veterinary biologics”, 

not “veterinary biologic products”.

 For letters that are addressed to an audience that is familiar with the CVB, the letter 

does not have to spell out the Center for Veterinary Biologics prior to use of the 

acronym.

 Use of the possessive tense. Instead of writing: This is in response to Mr. Zamboni’s

letter dated November 18, 2011, concerning......

Rearrange to: This is in response to the letter dated November 18, 2011, from Mr. 

Zamboni concerning......

 Letters or memorandums that are only one paragraph long and less than 10 lines 

should be double spaced.

 To cite the Code of Federal Regulations: For the first use of the Code of Federal 

Regulations, refer to and format as follows: title 9, Code of Federal Regulations (9 

CFR), section 94.2. Note that Code of Federal Regulations is italicized and that 

“title” and “section” are lowercase. If you are referring to a part (e.g., part 94), “part” 

would also be lowercase. If you only refer to the CFR once, than you do not need the 

acronym. For subsequent use, omit the words “section” or “part” if 9 CFR is used: 9 

CFR 94.2 or 9 CFR 94; if 9 CFR is not used then cite section 94.2 or part 94.
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5. Summary of Revisions

Version .02

 The document was updated to reflect current correspondence procedures.