Meetings with Industry and Investigators on the Research and Development of Tobacco Products
Guidance for Industry and Investigators: Meetings with Industry and Investigators on the Research and Development of Tobacco Products (Revised*)
- What is the scope of this guidance?
- Which FDA staff would likely attend this meeting?
- How do I request a meeting?
- When should I submit my meeting request?
- What should I include in my meeting request?
- How will FDA to respond to my request?
- If FDA denies my initial meeting request, can I resubmit my request?
- Could FDA decide that a face-to-face meeting or teleconference is unnecessary?
- Who will be my point of contact for the meeting?
- Is there any additional information that I should submit prior to the scheduled meeting?
- What should I include in my meeting information package?
- Where do I send my meeting requests and meeting information packages?
- What if I am unable to provide adequate supporting documentation in my meeting information package no later than 45 days prior to the scheduled meeting?
- If my initial meeting request is postponed or canceled, can I resubmit my request?
- What, if anything, should I bring to the meeting?
- How will the meeting be conducted?
- Will FDA provide any documentation to summarize the meeting?
- What should I do if I have a question or concern regarding the official meeting minutes?
- Can I submit or discuss confidential information with FDA prior to, during, or after the meeting?
This guidance is intended to assist tobacco manufacturers, importers, researchers, and/or investigators who seek meetings with the Office of Science within the Center for Tobacco Products regarding their research and development plans related to tobacco products.
Any tobacco product manufacturer, researcher, importer, or investigator involved in the research, development or marketing of a tobacco product, or their representatives, should submit a written meeting request to the Director, Office of Science, CTP, at FDA. The request should be prominently identified as “OS Meeting Request” and can either be securely transmitted electronically via the FDA Electronic Submissions Gateway (“ESG”) using the eSubmitter tool* or sent by mail or courier. Please refer to discussion section III.L. in this document for the mailing address.
A meeting request should be submitted prior to submission of a tobacco product application because the purpose of the meeting is to answer questions about the design and conduct of investigations intended to support an application. In most circumstances, FDA does not intend to grant meetings to discuss the content of applications under review. Occasionally, however, a meeting request is submitted during the review of an application. For example, an applicant can request a meeting to discuss the appropriate design of post-marketing studies during the review of a pending modified risk tobacco product application.
A meeting request should include adequate information for FDA to determine the potential utility of the meeting and to identify appropriate FDA staff to discuss the proposed agenda items. A meeting request should include the following information:
- Product name and FDA-assigned Submission Tracking Number (if applicable);
- Product category, e.g., cigarettes, smokeless tobacco (if applicable);
- Product use (indicate for consumer use or for further manufacturing);
- Contact information for an authorized point of contact for the company requesting the meeting;
- The topic of the meeting being requested, e.g., a new tobacco product application, an application for authorization to market an MRTP, or proposed investigational use of a new tobacco product;
- A brief statement of the purpose of the meeting, which could include a discussion of the types of studies or data to be discussed at the meeting, the general nature of the primary questions to be asked, and where the meeting fits in the overall product development plans;
- A preliminary list of the specific objectives/outcomes expected from the meeting;
- A preliminary proposed agenda, including an estimate of the time needed and a designated speaker for each agenda item;
- A preliminary list of specific questions, grouped by discipline, e.g., chemistry, clinical, nonclinical;
- A list of all individuals who will attend meeting on your behalf, including titles and responsibilities;
- When you expect to submit the meeting information package, described below;
- Suggested format of the meeting, e.g., conference call, in person meeting at FDA offices, video conference, or written response, and suggested dates and times for the meeting. Meetings are usually scheduled for 1 hour.
In general, FDA intends to respond to meeting requests in writing within 21 calendar days of receipt. If FDA agrees to the meeting, the written response should include the following:
- The date, time, format, and location of the meeting;
- The expected FDA participants;
- Instructions for submitting the meeting information package.
If a meeting request is denied, the response should include a clear explanation of the reason(s) for the denial (e.g., the meeting request did not provide enough information for FDA to determine the utility of the meeting).
Yes. If FDA denies your initial request, you may submit another request. A subsequent request should include any information that was lacking in your initial request, and otherwise address the stated reasons for FDA’s denial of the initial request. FDA will consider a subsequent meeting request to be a new request.
Yes. FDA may determine that a face-to-face meeting or teleconference is unnecessary, and instead provide written responses to the questions raised in the meeting request. If you believe that the written responses are insufficient, you may submit a subsequent request for a meeting.
FDA’s response to your meeting request should list the name and contact information for an employee of the Office of Science, who will likely be a Regulatory Health Project Manager. This employee will be your point of contact for additional questions regarding the meeting.
If FDA schedules the meeting, we recommend that you submit a “meeting information package” at least 45 days prior to the scheduled meeting. You can also submit this package with the meeting request. However, if this information changes prior to the scheduled meeting, you should update the information accordingly. If these changes are voluminous and/or complex, FDA may choose to reevaluate whether a meeting or a written response is appropriate and/or postpone the meeting to give staff appropriate time to review the new materials.
Your meeting information package should include summary information relevant to your product(s) and the proposed agenda. Full study reports or detailed data generally are not appropriate for meeting packages; the summarized material should describe the design, conduct, analysis, and results of relevant studies and clinical trials with some degree of quantification. The pre-specified study endpoints should be stated, as should whether endpoints were altered or analyses changed. Also, merely describing a result as significant does not provide enough information for FDA to give good advice or identify important problems the requestor may have missed.
To facilitate FDA’s review of your meeting information package, we suggest you organize the contents according to the proposed agenda. The meeting information package should be a sequentially paginated document (individual sections can be numbered separately) with a table of contents, appropriate indices, appendices, cross references or hyperlinking, and tabs differentiating sections. The meeting information package should support the intended meeting objectives. Although the contents of the meeting information package will vary based on the product, phase of tobacco product development, and issues to be discussed, the meeting information package should generally include (as applicable):
- Product name and FDA-assigned Submission Tracking Number;
- Product category;
- Product use (indicate for consumer use or further manufacturing);
- Product type, e.g., finished tobacco product or component, part, accessory;
- A brief statement of the purpose of the meeting, which could include a discussion of the types of studies or data that you intend to discuss at the meeting, the general nature of your critical questions, and where the meeting fits in overall development plans;
- A list of the specific objectives/outcomes expected from the meeting;
- An agenda, including estimated amounts of time needed for each agenda item and designated speaker(s);
- A list of specific questions grouped by issue/study;
- Product composition and design data summary;
- Manufacturing and process control data summary;
- Nonclinical data summary;
- Clinical data summary;
- Behavioral and product use data summary;
- User and non-user perception data summary;
- Investigational plans for studies and surveillance of the tobacco product, including a summary of proposed study protocols containing the following information:
- Study objective(s);
- Study hypotheses;
- Study design;
- Study population (inclusion/exclusion criteria, comparison group(s));
- Human subject protection information, including Institutional Review Board (IRB) information;
- Primary and secondary endpoints (definition and success criteria);
- Sample size calculation;
- Data collection procedures;
- Duration of follow-up and baseline and follow-up assessments;
- Data analysis plan(s).
The content of your meeting information package should include any information necessary to support your meeting purpose and objectives. Although the request for a meeting should include items 1 through 8 above (as applicable), these items should be updated in the meeting information package where appropriate to reflect the most current and accurate information available to you. For specific guidance regarding the contents of the meeting information package, contact the point-of-contact person listed on FDA’s response to your meeting request.
You should submit your meeting request to the Director, Office of Science, CTP, at FDA. The request should be prominently identified as “OS Meeting Request” and can be securely transmitted via the FDA Electronic Submissions Gateway (ESG) using the eSubmitter tool.**
Alternatively, you may send your meeting request via U.S. Mail or courier to the following address:
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
We encourage you to submit the meeting information package electronically. To facilitate the meeting process, we strongly suggest that copies of meeting information packages provided in electronic format also be provided in paper format. Your CTP point of contact will advise you on the number of paper copies you should submit for the planned FDA meeting attendees.
What if I am unable to provide adequate supporting documentation in my meeting information package no later than 45 days prior to the scheduled meeting?
FDA may decide to postpone or cancel a meeting if we have not received adequate supporting documentation for a productive meeting within this timeframe. You should contact your CTP point of contact as soon as possible if you will not be able to meet this deadline.
FDA intends to take reasonable steps to avoid postponing or canceling a scheduled meeting. If you cancel a previously scheduled meeting, FDA will consider a subsequent meeting request to be a new request.
At least two business days prior to the scheduled meeting, you should provide your point of contact with an electronic copy of your presentation. Alternatively, you can bring paper copies to the meeting for all attendees. Your CTP point of contact will advise you on the number of paper copies you should submit for the planned FDA meeting attendees.
Your presentations should be limited to information included in the meeting information package. FDA staff may not be able to provide comments on data or information not previously submitted in the meeting information package. Before the end of the meeting, attendees should summarize the important discussion points, agreements, clarifications, and action items. FDA intends to ask the meeting participant(s) to present the summary to ensure that there is mutual understanding of meeting outcomes and actions. FDA staff should then add or further clarify any important points not covered in the summary. The summary can be done at the end of the meeting or after the discussion of each question.
Documentation of meeting outcomes, agreements, disagreements, and action items is often helpful to ensure this information is preserved for meeting attendees and future reference. FDA generally intends to provide the official minutes of the meeting to summarize the important discussion points, decisions, recommendations, agreements, disagreements, issues for further discussion, and action items. We intend to send you the official minutes within 45 days of the meeting.
If you have a question or concern regarding the meeting minutes, you should get in touch with your CTP point of contact. If you disagree with the accuracy of FDA’s minutes, you should send your comments and suggested changes, including your recommendations and rationale, to your point of contact for our consideration. If FDA deems it appropriate to change the official minutes, the Agency intends to document this change in an addendum to the official minutes. FDA also intends to include any areas of continued objection to the accuracy of the minutes in such an addendum.
You may choose to submit nonpublic, trade secret, or confidential commercial information prior to a meeting or to discuss such information prior to, during, or after the meeting. FDA abides by the federal laws governing confidentiality, including sections 301(j) and 906(c) of the FD&C Act (21 U.S.C. 331(j) and 387f(c)), the Trade Secrets Act (18 U.S.C. 1905), and the Freedom of Information Act (5 U.S.C. 552), as well as FDA’s implementing regulations.
* Please refer to the ESG website instructions for setting up a WebTrader account. More information about the eSubmitter tool.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.