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pdfAccording to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a valid OMB control number. The OMB control number for this information collection is 0579-0327. The time required to complete this information collection is
estimated to average 15 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information.
OMB Approved
0579-0327
EXP: 02/2022
MANUFACTURER APPLICATION
FOR APPROVAL OF
OFFICIAL ANIMAL IDENTIFICATION DEVICES
UNITED STATES DEPARTMENT OF AGRICULTURE
ANIMAL AND PLANT HEALTH INSPECTION SERVICE
VETERINARY SERVICES
Submission of this form by a device manufacturer indicates that they agree to follow the procedures for approval of official animal
identification methods and devices contained in the Animal Disease Traceability (ADT) General Standards document and submit all required
supporting documentation (see ADT General Standards Part C. Approval of Official Identification Methods and Devices for Animals and the
associated appendices, and 9 CFR 79.3(k) for sheep and goats). For more information on ADT and official identification devices visit the ADT
Website at http://www.aphis.usda.gov/traceability/.
PURPOSE OF APPLICATION
Initial
(Proposed field trial protocol attached)
Final
Modification of an approved device
(Device approval and sales data from other
(Original and proposed specifications, field trial
countries OR field trial summary report attached) data and/or approval and sales data from other
countries (as applicable) attached)
DEVICE APPLICANT INFORMATION
Name:
Nonproducer Participant Number (NPN):
Street Address:
Street Address 2:
City:
State:
Phone:
Email:
Primary Contact First Name:
Last Name:
Phone:
Phone 2:
Postal Code:
Email:
Do you plan to be a device/tag manager? (Distribute the approved device)
Yes
No
What is the company’s role regarding this device?
Complete manufacturing, imprinting, and encoding
(radio frequency identification (RFID) only)
Encoding and/or Imprinting only
U.S. Device Manager only (foreign manufacturer)
What is the bi-weekly production capacity for this device?
What is the anticipated inventory for this device?
MANUFACTURING PLANT INFORMATION (if different than above)
(If more than one manufacturer, provide additional contact information and locations on a separate sheet)
Business Name:
Nonproducer Participant Number (NPN):
Street Address:
Street Address 2:
City:
State:
Phone:
Email:
Primary Contact First Name:
Last Name:
Phone:
Phone 2:
What is the bi-weekly production capacity for this device?
What is the anticipated inventory for this device?
VS FORM 1-64
APR 2020
Email:
Postal Code:
Country:
DEVICE INFORMATION
(If requesting a modification to an existing approved identification device, complete the information below with the new device specifications.)
Device Name:
Manufacturer Product Code:
Required International Committee for Animal Recording (ICAR) Conformance and Performance certifications attached?
ICAR Product Code:
Device Format:
Physical Characteristics:
Shape:
Yes
No
Yes
No
ICAR Approval Date:
Eartag
Injectable Transponder
One Piece
Two Piece
Round
Rectangle
Other (describe):
Strip
Other (describe):
Primary Material:
High resolution pictures and diagrams showing all aspects of the device including materials used in each component and
measurements (including pictures of all print formats and colors for which approval is requested for sheep and goats tags)
emailed to traceability@usda.gov?
SPECIES
(USDA reserves the right to approve methods of identification specific to each species. Additionally, the use of injectable transponders in food animals is subject to FDA and FSIS regulations.
Injectable transponders are not an approved official identification method for bison and cattle.)
Alpaca/Llama
Cattle/Bison
Deer/Elk
Horses
Sheep/Goats
Swine
DEVICE DETAILS
Low Frequency (LF) 134.2 kHz (must conform to ISO 11784 and 11785)
Technology type:
HDX
FDX
UHF
Numbering Format:
Animal Identification Number (AIN)
National Uniform Eartagging System (NUES)
Dual (combined low and ultra-high) Frequency Eartag (AIN Numbering format only)
Visual Only
For technologies other than RFID, please contact ADT Program Staff at traceability@usda.gov.
PERFORMANCE AND QUALITY CONTROLS
I certify that the identification device submitted for approval meets all performance and conformance
requirements as defined in the ADT General Standards.
Yes
No
Description of the quality control measures detailing the ability to produce and distribute the device
consistently and according to the specifications contained in the ADT General Standards, including
the full quality control plan and flow diagram for this identification device from manufacturing of all
components, encoding and/or imprinting, shipment and addressing consumer complaints, is attached.
If more than one company is involved with the manufacturing of the device components, a full quality
control plan is attached for the entity that performs each step and their location.
Yes
No
If requesting approval for a sheep and goat identification device, a signed Company Agreement for
Approval to Produce Official Eartags for Sheep and Goats is attached.
Yes
No
SIGNATURE
Applicant Signature
Date
File Type | application/pdf |
File Title | Contact Information |
Author | Hammerschmidt, Neil E - APHIS |
File Modified | 2020-04-23 |
File Created | 2020-04-23 |