On this page:

What is the Informal Written Response process?
Who may participate? Under which types of files and applications can I submit my questions?
Why should I use this process?
Am I required to participate?
What kinds of questions qualify?
When should I not use this process?
What information should I include in the submission?
How do I submit my question(s)?
Why was the Z submission type chosen for this process?
What can I expect from ONADE after submitting my question?
How long it will take to receive a response to my question(s)?
What will happen if ONADE decides if a meeting is needed?
Who should I contact if I have additional questions?

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What is the Informal Written Response process?

The process outlined here is intended to be an efficient, secure, and well documented way for you to ask ONADE a wide range of questions during your drug’s development process. The process uses the eSubmitter software system, which provides a secure environment to transmit proprietary and trade secret information and ensures that the questions you ask and ONADE’s responses are documented in the administrative record. 

Who may participate? Under which types of files and applications can I submit my questions? 

Anyone with an eSubmitter account may use this process. Questions may be submitted under ONADE Communication for new animal drug applications (NADA), abbreviated new animal drug applications (ANADA), investigational new animal drug (INAD) files, generic investigational new animal drug (JINAD) files, general correspondence (GC) files, and veterinary master files (VMF).

Why should I use this process?

First, the process provides a secure method of communicating with CVM instead of email. Email is not considered a secure means of communication and using it to transmit sensitive information is at your risk. Second, by submitting your questions via eSubmitter, you receive confirmation that CVM has received them and a submission number that can be referenced in future communications. Your questions and CVM’s responses become part of the administrative record for the applicable file. Finally, this process provides you with a way to get answers to some of your more complex questions in a shorter timeline than the existing meeting request route. 

Am I required to participate?

No. However, your participation is highly encouraged. In addition to the immediate benefits discussed above, using this process will help ONADE and sponsors better understand what makes for an efficient electronic communications process, information that can be used to develop more effective tools for the future. If for some reason you choose not to use this process, you may still use existing means of contacting ONADE.

What questions qualify?

You may use this process for questions that require time and deliberation for ONADE to adequately address, but for which a meeting with ONADE may not be needed. The process is ideal for questions that fall between those warranting a brief clarifying e-mail and a formal meeting.

Examples include:

• Policy questions related to regulations and legal requirements, patents, marketing status, or controlled substances.
• Issues that occur immediately before or during a study such as: need for amendments and deviations, product quality issues, interim analysis, unmasking, addressing serious adverse events, or addition of study sites.
• Scientific questions such as clarification of non-concurrence or incomplete (technical section or supplement) comments, questions on non-pivotal studies (pilot studies, dose characterization, palatability, etc.), or limited study design questions in advance of protocol submission/revision.
• Specific administrative questions related to the content and format of a proposed submission, or inquiries related to submitting a post-approval change.
• Other questions requiring consultation with other FDA Centers, or questions requiring input from multiple teams or divisions to fully answer.
• Requests for pre- and post-review feedback for drugs designated as Priority Zoonotic Animal Drugs (PZAD).

Please note that this list is not exhaustive, but it should help you gauge the type of questions appropriate for this process.

When should I not use this process?

The process should not be used for:

• Questions that require an answer from ONADE within 48 hours
• Informal data review
• Amending an existing submission
• Informal protocol concurrence
• Speculative or overly broad questions
• Official reporting of serious adverse events (SAEs) during a study 
• Presenting Early Information
• Seeking agreements usually covered by P&P 1243.3050 (Pre-Submission Conferences) (type and number of studies required, etc.)
• Process related questions and routine communications with the CVM Project Managers. 

A basic rule of thumb is that if there is an existing official process for submitting particular information, you should follow that process rather than use this process. 

What information should I include in the submission?

While there is no set list of what must be included in your submission, you should ensure that you provide sufficient information for ONADE to understand your specific questions and provide an answer. If ONADE determines that more information is needed, you may receive a request to submit an amendment, which may delay the response time.

You should limit the information you include in the submission to what ONADE needs to formulate a response, as extraneous information may also delay the response time.

How do I submit my question(s)?

First, you will need to update your eSubmitter templates to use this process. If you do not have an appropriate file/application already established, you can open a GC file to submit your question(s). 

You will then create a submission through eSubmitter under ONADE Communication. You will enter your specific question(s) into the template as part of the eSubmitter submission process. 

Why do these submissions receive a Z submission type?

Using the Z submission provides flexibility in situations where ONADE determines that a meeting is necessary to provide an adequate response. By using this submission type, should this happen, you will not need to submit a new meeting request.* Rather, ONADE can transition the submission to a meeting and schedule it under the same submission. You would only have to submit additional information (i.e., attendees, agenda) that might be needed as an amendment.  

*Note: Informal communications submissions cannot be converted to a Pre-Submission Conference (PSC). If the submitted question(s) is applicable to a PSC, re-submission using a PSC processes will be required. 

What can I expect from ONADE after submitting my question?

ONADE will determine if the submission is acceptable for review under the process.

• If the submission is acceptable and sufficient information is present, ONADE will start the review process and a tentative due date will be established. 
• If the submission is acceptable, but additional information is needed, ONADE will request that you submit an amendment to provide the needed information and the submission due date will be updated once ONADE has received the amendment.
• If ONADE determines that the question(s) would be better addressed by meeting with you, ONADE will contact you to discuss the option to schedule a meeting.*

When ONADE completes review of the submission, you will receive an acknowledgement letter with the response(s) to your question(s).

*Note: Informal communications submissions cannot be converted to a Pre-Submission Conference (PSC). If the submitted question(s) is applicable to a PSC, re-submission using a PSC processes will be required. 

How long will it take to receive a response to my question(s)?

Response times will vary depending on the nature of the question(s) presented. The typical time for a written response is 14 days or less. If ONADE needs additional time beyond 14 days, we will notify you with the expected response date.

If additional information is needed to answer your question(s), it may affect the response time. If a meeting is scheduled rather than providing a written response, established ONADE meeting timelines will apply. 

Please Note: The ‘CVM Due Date’ on the eSubmitter receipt will not reflect the actual due date to receive a response to your question(s).

What will happen if ONADE decides a meeting is needed to discuss your question(s)?

If ONADE determines that a meeting is needed to provide an adequate answer, you will be contacted to discuss changing your written response request to a meeting.* If your submission is changed to a meeting you will not need to re-submit the information. ONADE will contact you if additional information/materials are needed to schedule the meeting. Submissions changed to a meeting will follow the established ONADE meeting timelines.

*Note: Informal communications submissions cannot be converted to a Pre-Submission Conference (PSC). If the submitted question(s) is applicable to a PSC, re-submission using a PSC processes will be required. 

Who should I contact if I have additional questions?

If you have additional questions regarding the process, please contact your assigned ONADE project manager (for pioneer products) or relevant Team Leader (for generic products). If you do not know who your project manager is, send an email to CVM.ONADE.PM@fda.hhs.gov.