An Equal Opportunity Provider and Employer

VETERINARY SERVICES MEMORANDUM NO. 800.63

TO: Veterinary Services Leadership Team

Directors, Center for Veterinary Biologics

Biologics Licensees, Permittees, and Applicants

FROM: Jack A. Shere

Deputy Administrator

SUBJECT: Personnel at Licensed Establishments

I. PURPOSE

This memorandum provides guidance concerning the official liaison and biographical 

summaries required under title 9, Code of Federal Regulations (9 CFR), section

114.7(a). 

II. REPLACEMENT

This memorandum replaces Veterinary Services (VS) Memorandum No. 800.63 dated 

October 1, 1999. It is being updated to include guidance for designated roles within the 

National Centers for Animal Health (NCAH) Portal for electronic submissions to the 

Center for Veterinary Biologics (CVB).

III. BACKGROUND

A. Personnel responsible for any phase of development, manufacture, or 

distribution of a veterinary biological product must provide evidence to the 

CVB that they are competent to produce a consistent quality product that is 

pure, safe, potent, and effective. Competency may be supported by education, 

training, and/or experience. 

B. For the purpose of this memorandum, the following definitions apply:

1. Biographical Summaries: Information submitted to the CVB to support 

personnel competency. “Contact and Qualifications of Veterinary 

Biologics Personnel,” APHIS Form 2007, meets the requirement. 

2. NCAH Portal: Web-based submission system. The NCAH Portal Website

address is https://ncahappspub.aphis.usda.gov/NCAHPortal/public/.

Animal and Plant

Health Inspection

Service

Veterinary Services

1400 Independence

Ave, SW

Washington, DC

20250
VETERINARY SERVICES MEMORANDUM NO. 800.63

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 An Equal Opportunity Provider and Employer

IV. GUIDELINES FOR QUALIFICATION OF VETERINARY BIOLOGICS 

PERSONNEL

A. Official Liaison and Alternate(s)

1. Each licensee or permittee must designate a person to act as his or her official 

liaison for formal communication with the CVB, as provided under 9 CFR 

114.7(a). 

a. The liaison is considered to be responsible for communicating the 

licensee/permittee’s regulatory needs to the CVB to obtain and maintain 

the establishment license and product licenses or permits. 

b. The liaison may designate alternates. The number of alternate liaisons 

should accurately reflect the need of the firm and not be excessive. 

Liaisons must periodically review the list of alternate liaisons and adjust 

the number as needed.

c. Prior to engaging in formal communication on behalf of the regulated 

entity, the CVB will acknowledge the role of liaison and alternate liaison.

d. The liaison must have adequate knowledge of the day-to-day activities of 

the licensee or permittee.

e. Liaisons and alternate liaisons must reside in the United States. Site 

contacts may be named for international manufacturing sites or multiple 

domestic sites if needed.

f. Liaisons and alternate liaisons must have a physical address represented 

on the establishment license.

g. Typically, consultants are not appropriate to be named as the liaison. 

2. Official correspondence from the CVB will be sent to the liaison at the official 

mail address as listed on the U.S. Veterinary Biologics Establishment License or 

returned via the NCAH Portal. 

Liaisons do not need to reside at the physical location of the official mail 

address, as long as there are processes in place to timely route correspondence 

to the liaison. 

3. The biographical summary included on the APHIS Form 2007 for the liaison, or 

alternate liaison must be filled out completely, including information related to 

employee education. Employee education may include degrees obtained at 
VETERINARY SERVICES MEMORANDUM NO. 800.63

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 An Equal Opportunity Provider and Employer

secondary educational institutions, as well as formal training certificates 

relevant to the liaison function. 

4. The official liaison or the alternate is responsible for signing the following 

documents:

a. Official correspondence initiated by the licensee or permittee.

b. Requests for exemptions, exceptions, or authorizations.

c. Responses to official letters from the CVB.

B. Other Biographical Summaries. An APHIS Form 2007 used to obtain the 

qualifications of supervisory personnel must be submitted for each employee who has 

final responsibility for one or more of the following functions in a licensed 

establishment. These employees may or may not have portal access. An APHIS Form 

2007 should be filed for employees involved in the following functions:

1. Research and product development.

2. Product manufacture including, but not limited to:

a. Management of seed and cell cultures.

b. Incoming review of raw ingredients.

c. Inoculation through harvest processes, including in-process testing.

d. Downstream processing.

e. Batching/blending of serials.

f. Filling.

g. Labeling and packaging.

h. Storage and distribution.

3. Quality control.

4. Acquisition, maintenance, use, and disposal of animals.

5. Authorized sampler (see VS Memorandum No. 800.59 for further information), 

including:

a. Selection, shipment, and retention of samples.

b. Personnel signing and submitting APHIS Form 2020, “Shipment and Receipt 

of Biologics Samples.”

6. Serial Release (see VS Memorandum No. 800.53 for further information), 

including:

a. Personnel signing and submitting APHIS Form 2008, “Veterinary Biologics 

Production and Test Report.”
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 An Equal Opportunity Provider and Employer

V. NCAH PORTAL REQUIREMENTS 

The NCAH Portal is used to electronically submit data to and receive responses from the 

CVB.

A. Each employee must have USDA Level 2 eAuthentication. Detailed instructions are 

located at https://www.eauth.usda.gov.

B. Each employee must have an APHIS Form 2007 on file with the CVB.

C. Once employees have provided the CVB with a USDA Level 2 eAuthentication ID 

and have an APHIS Form 2007 on file with the CVB, they may enter and edit 

information regarding their own APHIS Form 2007.

D. Additional NCAH Portal roles and authorities related to the CVB may be found at 

www.aphis.usda.gov/animal_health/vet_biologics/publications/2-PortalRoles.pdf.

VI. IMPLEMENTATION/APPLICABILITY

A. Instructions for completing a hard-copy APHIS Form 2007 can be found on page 2 of 

the form. 

B. Submit all APHIS Forms 2007 to CVB-Inspection and Compliance (IC). The CVBIC will be responsible for routing forms within the CVB, whether submitted by hard

copy or through the NCAH Portal. 

C. The changes contained in this memorandum are effective immediately.