National Animal Identification System - Business

Manufacturer Application – AIN RFID Injectable Transponders

Manufacturer Application

AIN RFID Injectable Transponders

January 2, 2007

I. Contact Information

Business Information

Company Name      	Contact Person Name      
Address      	Contact Person Email      
	Phone      
City, State, ZIP      	FAX      
Nonproducer Participant Number (NPN)      	Company Website (URL)      

Manufacturing Plant Information (if different from above)

Company Name      	Contact Person Name      
Address      	Contact Person Email      
	Phone      
City, State/Province, ZIP      	FAX      
Country (if other than US)      

Information Technology (IT) Contact Information

(Designated person for the NAIS IT Team to contact regarding system issues)

IT Contact Person Name      	Phone      
IT Contact Person Email      	FAX      

II. Manufacturing, Description and Technology Standards

Manufacturing

What is the company’s role regarding the tag being applied for? Manufacturing and encoding Encoding only	Do you plan to be an AIN device/tag manager? Yes No
Manufacturer Product Name      	Manufacturer Product Code Number      
What is the bi-weekly production capacity for this transponder?      	What is the anticipated inventory for this transponder?      

Physical Description and Characteristics

Glass Encapsulated
Other than Glass Encapsulated Please describe:      
Weight (grams)      	Length (mm)      		Diameter (mm)      

Technology Standards

ISO 11784/85 (required, unless other ISO or US based technology standards are applicable)

Manufacturer Number assigned by ICAR      	Transponder Read Type HDX FDX
ICAR Product Code (for device being applied for)      	Activation Frequency      

III. Performance and Quality Controls

Performance

Clearly explain how the device being applied for meets or exceeds the following criteria (either enter the response in the text box below or submit on a separate attachment). When appropriate, include other reference documentation (charts, summaries, etc.) with the application and note such your explanations.

• Read Range: The transponder must have a minimum read range of 4 inches with a handheld transceiver (reader).

 

• Anti-migration: The transponder shall be constructed to prevent migration after implantation.

 

• Transponder security: The AIN encoded within each transponder shall not be alterable (changed to represent a different AIN than what was initially encoded in the transponder).

 

• Expected tag life: The minimum time that a tag shall be expected to remain functional (electronically) is for the expected life of the animal. (20 years for horses)

 

• Transponder failure rates: The transponder shall be reliable and machine-readable for the expected lifetime of the animal with a failure rate of less than 1% per annum.

 

• Breakage: The transponder, under normal animal husbandry conditions, shall not break.

 

• Harmless to the animal: The implant, when injected and maintained as an implanted device, shall not cause harm to the animal.

 

Quality Control

Explain your control measures and ability to produce the transponder consistently according to the specifications. Include procedures that will ensure the uniqueness of the AIN is maintained. If applicable, enclose your company’s quality control plan.

 

IV. Species and Use of Device in other National ID Programs

Species

Species for which the applied for implant is being recommended

Note: The use of injectable transponders in food animals is regulated by FDA¹.

Bison Cattle Deer/Elk Horses Sheep/Goats Pigs Alpaca/Llama

Other:

Official Identification for Other Countries (Optional)

Please list the National Identification Programs of other countries in which this implant is currently an approved device.

Country	Date Approved	Country	Date Approved
     	     	     	     
     	     	     	     
     	     	     	     
     	     	     	     

V. Additional Content with the Application

Packaging, Applicator, and Instructions

Provide at least 10 samples of the applied for transponder in the planned package for distribution (individual sterile packaging, bulk, etc.). Provide manufacturer’s recommendation for sterile handling and administration of Injectable transponder with the application.

Provide 3 injection devices used to implant the transponder being applied for with manufacturer instructions for proper use of the applicator.

Please encode the following number in the transponders as the AIN: 840003123456789. (This number has been designated for use in sample AIN devices.)

Submit Manufacturer Application
and sample transponders and injection applicator devices to:

USDA APHIS Veterinary Services
c/o Vince Chapman, NAIS Program Staff
4700 River Road, Unit #200
Riverdale, Maryland 20737

Direct Questions To:

Email: [email protected]

Tel: 301-734-0739

Fax: 301-734-7964

Table 1 — AIN/RF Implants Performance Criteria and Characteristics

Read Range	The transponder must have a minimum read range of 4 inches with a handheld transceiver (reader). Note: USDA APHIS will use an inventoried transceiver that reads ISO compliant transponders to test the read distance. Applicants submitting non-ISO transponders must also provide a reader with their application.
Anti-migration	The transponder shall be constructed to prevent migration after implantation.
Transponder security	The AIN encoded within each transponder shall not be alterable (changed to represent a different AIN than what was initially encoded in the transponder).
Expected tag life	The minimum time that a tag shall be expected to remain functional (electronically) is for the expected life of the animal. (20 years for horses)
Transponder failure rates	The transponder shall be reliable and machine-readable for the expected lifetime of the animal with a failure rate of less than 1% per annum.
Breakage	The transponder, under normal animal husbandry conditions, shall not break.
Harmless to the animal	The implant, when injected and maintained as an implanted device, shall not cause harm to the animal.

1 The manufacturer is required to include the FDA and FSIS requirements regarding the use of injectable transponders in the packaging container of all AIN Injectable Transponder shipments.

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