SOP for SAFE TraQ data use by CDC Registered ACF

Standard Operating Procedures for SAFE TraQ data use

Updated November 21 ,2023

Form Approved
OMB Co. No. 0920-1383
Expiration 05/31/2027

Standard Operating Procedures for SAFE TraQ data use by CDC-registered Animal Care Facilities Participating in Public Health Evaluations of Imported Animals

CDC recognizes the benefit that public health evaluations of imported animals at animal care facilities (ACF) may advance our understanding of the spread of zoonotic and foreign animal diseases of concern among imported animals. However, the health and safety of imported animals is of the utmost importance to CDC, as is ensuring importers understand any implications of study participation. 

 

CDC requires any ACF participating in animal evaluations or assessments to notify the CDC Zoonoses Prevention and Import Regulations Team Lead (Dr. Emily Pieracci, cdcanimalimports@cdc.gov) of proposed evaluations prior to beginning the evaluation. 

 

The ACF and principal investigator (PI) should submit to CDC: 

1. The names and affiliations of the PI and any collaborators 

2. The proposed protocol which should include objectives of the study, intended outcomes, methods and sample collection, proposed analysis, and timeline. 

3. An Institutional Animal Care and Use Committee (IACUC)-approved protocol (approved by CDC or other equivalent institution) 

4. If project will include human subjects, an Institutional Review Board (IRB)-approved protocol or a determination made by an authorized reviewer (not the PI or ACF) that IRB review is not needed (approved by CDC or other equivalent institution) 

5. Clear instructions for importers to opt into or out of the evaluation and clear messaging that highlights participation is voluntary and will not impact an animal’s importation status with CDC. The dog may be subject to other local, state, or federal agency requirements based on the results of the evaluation. 

6. Clear instructions for how an importer may obtain results from the evaluation (if applicable) and how the results will be used. 

 

Proposed evaluations should be submitted to Dr. Pieracci as early as possible to allow for adequate planning and coordination, but no later than 90 days prior to the intended start date. This will help to ensure any evaluations conducted on imported animals while under the care of the ACF are in line with CDC IACUC guidelines and to ensure animals are not enrolled in multiple studies at one time which could lead to unintentional mistreatment of animals.  

 

Requests for data maintained within SAFE TraQ must be directed to CDC (Dr. Emily Pieracci cdcanimalimports@cdc.gov) and should include the purpose of the request. Additionally, a data use agreement must be established with CDC prior to release of any information. ACF may not disseminate or share any information maintained within SAFE TraQ without express written permission from CDC. This includes importer information (such as address, phone or email), dog demographic data (such as age, breed, sex), results of exam findings, illness or death reports, country of origin data, airline carrier data, or any other information collected by the ACF and stored in SAFE TraQ.  

 

For each approved evaluation, CDC will require quarterly updates from the PI and may request additional updates at any time before, during or after the evaluation has occurred. Failure to provide updates within 5 business days of the request may result in immediate termination of the evaluation. 

 

Acknowledgement of Requirements for CDC-Registered Animal Care Facilities

Participating in Public Health Evaluations of Imported Animals

I acknowledge that I have read and understand the Guidance for CDC-Registered Animal Care Facilities Participating in Public Health Evaluations of Imported Animals. I understand that failure to adhere to the standards set forth in this document may result in suspension or revocation of the Animal Care Facility’s status by CDC.

Name: ______________________________________________________

Title:________________________________________________________

Date: _______________________________________________________

Signature: ___________________________________________________

Public reporting burden of this collection of information is estimated to average 10 minutes 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. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB Control Number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road NE, MS H16-4, Atlanta, Georgia 30333; ATTN: PRA 0920-1383.