On May 17, 2021, the Center for Veterinary Medicine’s (CVM) Office of New Animal Drug Evaluation (ONADE) began this voluntary pilot program to allow sponsors of pioneer animal drugs to propose a list of raw data and documents to be submitted with the final study report for a pivotal target animal safety study. A pivotal study is one that is intended to support an original or supplemental new animal drug approval. The pilot period will continue for 6 months, during which time ONADE will monitor and evaluate experiences regarding the utility and costs associated with the program to both ONADE and the drug sponsor to determine if the pilot should be continued and possibly extended to other protocol types. 

Historically, ONADE has requested that sponsors submit a copy of raw data and other documents intended to support their pivotal safety and effectiveness studies when they submit their final study report for review. Under this pilot program, sponsors have the option of requesting that ONADE review and agree with their proposed raw data elements and documents list at the protocol review stage. These requests are submitted as an H submission with a SP subclass code using eSubmitter. ONADE will review the proposed list and either agree with the list as proposed or provide feedback regarding additional elements or documents that should be submitted, or proposed elements or documents that do not need to be submitted, with the final study report.

The goal of review of these H submissions is for ONADE to evaluate the sponsor’s proposed list of raw data elements and documents to determine what modifications (if any) would be needed to make the list acceptable. ONADE will then communicate our findings to the sponsor in an acknowledgement letter. 

Any sponsor of a pioneer investigational new animal drug (i.e., an animal drug being developed and reviewed towards original or supplemental approval under an Investigational New Animal Drug (INAD) file) may participate, if they are seeking ONADE’s concurrence with a pivotal target animal safety study protocol.

No. This pilot program is entirely voluntary. If you choose to not submit an H submission for review of a proposed list of raw data elements and documents, you should submit a copy of the raw data elements and documents intended to support your study when you submit the final study report to ONADE for review.

ONADE will only review this type of H submission for any pivotal target animal safety study conducted under Good Laboratory Practices (GLP) intended to support an original or supplemental new animal drug approval. 

ONADE will only review this type of H submission if:

• the associated protocol has been submitted for review in advance of conducting the study (E submission), 
• ONADE has not completed the review of the associated protocol submission, 
• the associated protocol is for a GLP target animal safety study intended to support an original or supplemental new animal drug application, and 
• the associated protocol’s submission ID is clearly identified in the H submission (in the cover letter).

ONADE will generally refuse to review this type of H submission if the above criteria are not met (rare exceptions may apply during the pilot program period).

You should submit your H submission after the associated protocol has been submitted; however, you may submit your H submission on the same day. You should submit your H submission before ONADE has completed review of the associated protocol submission. You should submit your H submission to the same division that is reviewing your protocol (i.e., either the Division of Companion Animal Drugs (HFV-110) or the Division of Food Animal Drugs (HFV-130)).

You should submit your H submission using eSubmitter and select the SP subclass code. You should include the following in your H submission:

• the associated protocol’s submission ID
• your proposed list of raw data elements and documents to be submitted with the final study report.

You should not include additional information or questions with this type of H submission, other than any information necessary to justify inclusion or exclusion of raw data elements and documents from the proposed list.

An H submission with a SP subclass code (I-H-SP) is a submission that contains information to assist in the review of a protocol (E submission). Evaluation of a proposed list of raw data elements and documents to be submitted inherently depends upon review of the associated protocol.

No. Because ONADE will only review these requests if the associated protocol is under review, and because protocols are submitted to INAD files, you should submit these requests for review to the same INAD under which the protocol is being reviewed.

You may submit your H submission at any time during ONADE’s review of the associated protocol (E) submission (I-E-TS). Because you will need to reference the submission ID for the associated protocol in your request, you should submit your H submission after the associated protocol has been submitted; however, you may submit your H submission on the same day.

You should include the associated protocol’s submission ID and your proposed list of raw data elements and documents to be submitted with the final study report. You should not include additional information or questions with this type of H submission, other than any information necessary to justify inclusion or exclusion of data elements from the proposed list.

The review time for an H submission is 100 days.

Upon receipt of the H submission, ONADE will evaluate the submission to ensure that it meets the criteria for review. If it does not meet the criteria for review or does not contain a proposed list of raw data elements and documents to be submitted, ONADE will refuse to review the H submission.

ONADE will assess the associated protocol submission to determine if it is acceptable for review. ONADE will begin review of the H submission only when the protocol is determined to be acceptable for review. If ONADE refuses to review the associated protocol, ONADE will also refuse to review the H submission.

If the H submission is acceptable for review, ONADE will evaluate the proposed list of raw data elements and documents to be submitted in consideration of the purpose of the study and the data that will be collected according to the associated protocol. If the H submission includes additional information or questions beyond any information needed to justify inclusion or exclusion of raw data elements or documents from the proposed list, ONADE will not review that additional information, and will advise you to resubmit it in a separate submission if you want ONADE to review it.

When ONADE completes review of both the associated protocol and the H submission, we will issue an acknowledgement letter for the H submission.

• If ONADE issued a concurrence letter for the associated protocol (or a nonconcurrence letter with shortened review time (SRT) offered, where revisions will not impact the raw data or documents being collected in the study), then the acknowledgement letter will convey that ONADE either agrees or does not agree with your proposed list of raw data elements and documents to be submitted.
  
  If ONADE does not agree with your proposed raw data and documents list, the acknowledgement letter will also describe modifications that would make the list acceptable, along with our justification for those modifications. 
  
  The letter will state that if you submit the raw data elements and documents in this list (as modified, if applicable), no additional elements of raw data or documents need to be initially submitted with the final study report. The letter will also state that CVM reserves the right to request additional raw data elements or documents if questions arise during review of the study and final study report.
• If ONADE issued a nonconcurrence letter for the associated protocol (or a nonconcurrence letter with SRT offered, where revisions may impact the raw data or documents being collected in the study), the acknowledgement letter will convey that ONADE was unable to review the proposed list of raw data elements and documents because we did not concur with the associated protocol.
• If the H submission included information or questions beyond that necessary to justify inclusion or exclusion of raw data elements and documents from the proposed list, the letter will inform you that the additional information or questions were not reviewed under this H submission.  

Yes. You should collect and retain all raw data and documents during the study in accordance with the applicable standard of conduct for the study and relevant regulations.

Yes. ONADE reserves the right to request additional raw data elements or documents if questions arise during review of the study and final study report.

You may contact the ONADE project manager assigned to your firm if you have any additional process or H submission timing questions. Firms who do not have an assigned PM may contact CCVM.ONADE.PM@fda.hhs.gov.