CVB-WI-5236.01 Page 1 of 7

New Firm Informational Packet for Diagnostic Test Kits

Background Information

The purpose of this packet is to give an overview of the licensing process to new firms 

unfamiliar with the process of licensing a diagnostic test kit. The information should be viewed 

only as an introduction, and not a list of all possible requirements. Each product will have unique 

characteristics that may require its own unique studies to assure the final licensed product is safe 

and effective. 

Veterinary biologics producers in the United States must have both a U.S. Veterinary Biologics 

Establishment License for their facility and a U.S. Veterinary Biological Product License for 

each product produced in their facility. To qualify for an Establishment License, an applicant 

must qualify for at least one Product License. The Establishment and Product Licenses are issued 

simultaneously.

The Center for Veterinary Biologics (CVB) consists of two operational units: Policy, Evaluation, 

and Licensing (PEL) and Inspection and Compliance (IC). These units closely interact during the 

prelicensing stage of new products as well as after licensing. The PEL unit is responsible for 

licensing of new products and maintenance of products once licensed. Licensing of new products 

consists of review of Outlines of Production, review of study protocols and associated 

reports/data, laboratory testing, and issuing Establishment and Product licenses. The IC unit is 

responsible for inspections of new facilities (including review of blueprints, plot plans, and 

legends), product marketing release, initiating investigations when appropriate, conducting 

periodic firm inspections, responding to issues related to product performance, and implementing 

our pharmacovigilance program.

Please be aware that CVB relies on formal, signed paper copy documents to be submitted by 

your firm. Email, meetings, and phone conversations are considered informal and non-binding 

communication. CVB will formally respond with our decisions and recommendations 

concerning licensure by paper copy. There is a specific process for communicating with CVB 

which also contains an introduction to the licensing process described in Veterinary Service 

Memorandum (VSM ) 800.50: Basic License requirements and guidelines for submitting 

materials in support of licensure: 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_vs_memos

A complete set of biologics-related guidelines, memorandums, notices, and related forms are 

available online at the Veterinary Biologics website:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics
CVB-WI-5236.01 Page 2 of 7

APHIS Forms 2001, 2003, 2005, 2007, 2008, 2015, 2071, and 2072 are located at the site below:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinarybiologics/sa_bio_forms/ct_vb_forms

The Submission Compliance Guide: Submitting Complete and Accurate Paper License 

Applications, Outlines, and Labels provides step wise directions on making these submissions.

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_regs_guidance

The CVB website describes the thorough and extensive licensing process in detail. One informal 

resource that helps bring together the overlapping guidance documents is the CVB Policy, 

Evaluation and Licensing - Reviewer Manual and is available on the CVB website at: 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_pelmanual_toc

There are also several organizations outside of the USDA that may be used to assist in the 

licensing process. Two professional organizations, Animal Health Institute (AHI) and 

Association of Veterinary Biologics Companies (AVBC), have members from biologics firms 

and consultants which may be able to assist new firms through the licensure process.

Additionally, the Institute for International Cooperation in Animal Biologics (IICAB) in 

cooperation with the CVB provides week-long training annually on U.S. veterinary biologics 

licensing requirements.

The following list is general guidance for all veterinary biologics and should not be 

considered an all-inclusive list. In addition to these general requirements there are also

diagnostic test kits specific requirements listed later in this document. Formal 

communication between your firm and your CVB Reviewer will determine the appropriate 

licensing pathway for your unique product. However, it is the firm’s obligation to 

understand and meet all the licensing requirements.

I. The initial submission to the CVB is an introduction of your company and product. The 

goal is to determine if your product falls within CVB regulatory jurisdiction. The 

submission should include:

• A cover letter with the following information: 

 Brief description of the product including mechanism of action of the test

 Animal species and sample type the kit is designed for

 Proposed label claim (what you propose the product will do)

 Names and addresses of all legal entities (not individual persons) involved in the 

manufacture of the product

 Supporting publications

• If it is determined your product falls under CVB jurisdiction an individual Reviewer will be 

assigned to your firm. See the Memorandum of Understanding between the APHIS and the FDA

for additional details on jurisdiction: 
CVB-WI-5236.01 Page 3 of 7

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_regs_guidance

II. Core documents required prior to any study submissions

• APHIS Form 2001 Application for United States Veterinary Biologics Establishment License:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinarybiologics/sa_bio_forms/ct_vb_forms

 Articles of Incorporation

The following documents associated with the APHIS Form 2001 may be submitted at a later 

date:

 Water Quality Statement verifying the effluent waste for the facility meets local 

regulatory standards

 Facility documents; see VSM 800.78 Preparation and Submission of Facilities 

Documents:

https://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo800-78.pdf

• APHIS Form 2003 Application for United States Veterinary Biological Product License:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinarybiologics/sa_bio_forms/ct_vb_forms

• For imported test kits, an APHIS Form 2005 for “General Sale and Distribution,” is used in place 

of the APHIS Form 2001 and 2003. This is because the test kit will be “permitted” and not 

“licensed.”

See more detailed information in 9 CFR 104 PERMITS FOR BIOLOGICAL PRODUCTS and 9 

CFR 104.5 Products for distribution and sale

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_cfr

https://www.aphis.usda.gov/library/forms/pdf/APHIS2005.pdf

It is important to realize that a separate “Research and Evaluation” permit which also uses the 

APHIS Form 2005 is required before bringing test kits into the US for evaluation. Information on 

how to obtain an importation permit is found at 9CFR 104.4 Products for research and 

evaluation
CVB-WI-5236.01 Page 4 of 7

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_cfr

An importation SIF is required prior to bringing the test kits into the US. This information is 

found in: Summary Information Format for the Importation of Veterinary Biological Products 

into the United States.

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_sifs

• APHIS Form 2007 Qualifications of Veterinary Biologics Personnel: 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinarybiologics/sa_bio_forms/ct_vb_forms

Identify persons who will act as Liaison and Alternate Liaison(s), which should be reflected on 

APHIS Form 2007. This is the person who will represent your company to CVB on all 

correspondence, see VSM 800.63 Personnel at Licensed Establishments: 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_vs_memos

• An Outline of Production submitted with APHIS Form 2015 Transmittal of Labeling or Outlines:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinarybiologics/sa_bio_forms/ct_vb_forms

This key document describes how you make your product. See Veterinary Services 

Memorandum (VSM) 800.206 General Licensing Considerations: Preparing Outlines of 

Production for Vaccines, Bacterins, Antigens, and Toxoids and Diagnostic Test Kits:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_vs_memos

9 CFR 114.8: Outline of Production required and 9 CFR 114.9(f): Outline of Production 

guidelines:

https://www.ecfr.gov/cgi-bin/textidx?gp=&SID=4b71249719aef16788f85e60ab1873fe&mc=true&tpl=/ecfrbrowse/Title09/9CIsu

bchapE.tpl

Reviewer manual Chapter 4 Outlines of Production and Special Outlines:
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https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_pelmanual_toc

The safety of the components of the kit must meet VSM 800.51: Additives in Administered 

Animal Biological Products

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_vs_memos

III. The following are the core scientific submissions and their associated guidance documents. 

Pivotal studies required below typically begin with the submission of a protocol as 

described in VSM 800.200 General Licensing Considerations: Study Practices and 

Documentation. The final reports for these studies will need to be accompanied by properly 

formatted electronic data (CVB Data Guide).

https://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_200.pdf

https://www.aphis.usda.gov/animal_health/vet_biologics/publications/16-CVBDataGuide

• Core guidance on developing a diagnostic test is found in VSM 800.73 Diagnostic Test Kit 

Validation and within the Reviewer Manual

https://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo800-73.pdf

Reviewer Manual Chapter 4 Diagnostic Test Kits:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_pelmanual_toc

IV. Shipment of your experimental biologic

Because the unlicensed product is considered to be experimental in nature, authorization to ship 

the product for conduct of efficacy, safety, or other studies must be authorized by the CVB. 

Guidance for shipment of product for these studies is under 9 CFR 103.3. Shipment of 

Experimental Biological Products. 

https://www.ecfr.gov/cgi-bin/textidx?gp=&SID=4b71249719aef16788f85e60ab1873fe&mc=true&tpl=/ecfrbrowse/Title09/9CIsu

bchapE.tpl

See VSM 800.67 Shipment of Experimental Biological Products:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_vs_memos
CVB-WI-5236.01 Page 6 of 7

Additional guidance regarding shipment of experimental product may be found at:

Reviewer Manual Chapter 6 Shipping Experimental Product:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_pelmanual_toc

An APHIS Form 2071 Application for Authorization to Ship Experimental Veterinary Biological 

Products may be used to request authorization to ship experimental product and may be accessed 

at:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinarybiologics/sa_bio_forms/ct_vb_forms

Note: if the product is a recombinant product, an evaluation of your SIF is required well before 

any movement of the product outside of containment would be allowed. 

V. Prelicense serial testing

• CVB will require confirmatory testing of your three prelicense serials. 

VSM 800.50: Basic License requirements and guidelines for submitting materials in support of 

licensure: 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_vs_memos

APHIS 2072 Application for Authorization to Ship Biological Product Samples for Confirmatory 

Testing by APHIS

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinarybiologics/sa_bio_forms/ct_vb_forms

VI. Prelicense facility inspection 

• Guidance regarding the CVB-IC prelicensing inspections process which is initiated by your 

reviewer is at:

Inspection and Compliance Manual Chapter 3 Process for Prelicense Inspection Requests

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_icmanual_toc

VSM 800.91 Categories of Inspection for Licensed Veterinary Biologics Establishments 

describes important categories evaluated during the inspection process:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_vs_memos
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General guidance on the authority for inspections and record keeping requirements are found in 9 

CFR 115 Inspections and 9 CFR 116 Records and Reports

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_cfr

Note: a prelicensing inspection must be completed by CVB-IC prior to issuance of an 

establishment license or permit. If it has been longer than two years since the prelicensing 

inspection, a second prelicensing inspection will most likely need to be completed prior to 

issuance of the establishment license or permit. 

VII. Becoming Portal Enabled

• The NCAH Portal is a valuable communication tool for both the firm and CVB. However, the 

CVB receives numerous inquiries from new establishments each year, with only a subset of 

those proceeding beyond the initial inquiry, so initial communication is via paper letters and not 

via the electronic Portal. Access to submit submissions via the NCAH Portal Guidance for CVB 

Submitters may be considered for prelicense firms, as described below:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_regs_guidance

VIII. Final submissions prior to licensure

• Final labeling materials guidance:

See 9 CFR 112 Packaging and labeling: 

https://www.ecfr.gov/cgi-bin/textidx?gp=&SID=4b71249719aef16788f85e60ab1873fe&mc=true&tpl=/ecfrbrowse/Title09/9CIsu

bchapE.tpl

See VSM 800.54 Guidelines for the Preparation and Review of Labeling Materials:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_vs_memos

Reviewer Manual Chapter 4 Labels:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologicsregulations-and-guidance/ct_vb_pelmanual_toc

See information on advertising that is not part of labeling in VSM 800.95 Advertising and 

Promotional Materials

https://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_98.pdf