Meetings with Industry and Investigators 
on the Research and Development 
of Tobacco Products (Revised)* 
Guidance for Industry and Investigators 
Comments may be submitted at any time for Agency consideration. Electronic comments may 
be submitted to http://www.regulations.gov. Alternatively, submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, Rockville, MD 20852. All comments should be identified with Docket No. 
FDA-2012-D-0429. 
For questions regarding this guidance, contact the Center for Tobacco Products at: 
(Tel) 1-877-CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m.  4 p.m. ET. 
Additional copies are available online at https://www.fda.gov/tobacco-products/rules-regulations-
and-guidance/guidance. You may send an e-mail request to SmallBiz.Tobacco@fda.hhs.gov to 
receive an electronic copy of this guidance. You may send a request for hard copies to U.S. Food 
and Drug Administration, Center for Tobacco Products, Attn: Office of Small Business 
Assistance, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-2000. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
September 2022 
OMB Control No. 0910-0731  
Current expiration date available at https://www.reginfo.gov 
See additional PRA statement on page 8 of this guidance. 
*This is a revision to the third edition of this guidance, which issued in June 2020.  
Contains Nonbinding Recommendations 
 
Table of Contents 
I.  INTRODUCTION ......................................................................................................................... 1 
II.  BACKGROUND .................................................................................................................... 1 
III.  DISCUSSION ....................................................................................................................... 3 
A.  What is the scope of this guidance? ................................................................................................. 3 
B.  Which FDA staff would likely attend this meeting? ....................................................................... 3 
C.  How do I request a meeting? ................................................................................................................. 3 
D.  When should I submit my meeting request? ................................................................................... 3 
E.  What should I include in my meeting request? ............................................................................... 3 
F.  How will FDA to respond to my request? ............................................................................................ 4 
G.  If FDA denies my initial meeting request, can I resubmit my request? .......................................... 4 
H.  Could FDA decide that a face-to-face meeting or teleconference is unnecessary? ........................ 4 
I.  Who will be my point of contact for the meeting? ............................................................................... 5 
J. Is there any additional information that I should submit prior to the scheduled meeting? .......... 5 
K.  What should I include in my meeting information package? ........................................................ 5 
L.  Where do I send my meeting requests and meeting information packages? ............................... 6 
M.  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? ....................................... 7 
N.  If my initial meeting request is postponed or canceled, can I resubmit my request?.................... 7 
O.  What, if anything, should I bring to the meeting? ............................................................................. 7 
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P.  How will the meeting be conducted? ................................................................................................ 7 
Q.  Will FDA provide any documentation to summarize the meeting? ................................................. 7 
R.  What should I do if I have a question or concern regarding the official meeting minutes? ......... 8 
S.  Can I submit or discuss confidential information with FDA prior to, during, or after the 
meeting? .......................................................................................................................................................... 8 
IV.  PAPERWORK REDUCTION ACT OF 1995 .................................................................... 8 
 
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Contains Nonbinding Recommendations 
Meetings with Industry and Investigators 
on the Research and Development 
of Tobacco Products 
 
Guidance for Industry and Investigators1 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic. It does not establish any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 
To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the 
title page. 
I.  INTRODUCTION 
 
This guidance is intended to assist tobacco manufacturers, importers, researchers, and/or 
investigators who seek meetings with staff of FDAs Center for Tobacco Products (CTP), 
relating to their plans to conduct research to inform the regulation of tobacco products or support 
the development or marketing of tobacco products. This guidance document discusses, among 
other things: 
 
  What information FDA recommends you include in a meeting request 
  How and when to submit a request 
  What information FDA recommends you submit prior to the meeting 
This guidance does not pertain to other types of meetings or meeting requests other than those 
described throughout this document. In general, FDAs guidance documents do not establish 
legally enforceable responsibilities. Instead, guidances describe the Agencys current thinking 
on a topic and should be viewed only as recommendations, unless specific regulatory or 
statutory requirements are cited. The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required. 
 
II.  BACKGROUND 
The manufacture, sale, and distribution of tobacco products are subject to the Food, Drug, and 
Cosmetic Act (FD&C Act or the Act), as amended by the Family Smoking Prevention and 
Tobacco Control Act (the Tobacco Control Act or TCA).2 Among other things, the Act sets 
forth requirements for authorization to market a new tobacco product through one of three 
pathways: 
 
1 This guidance was prepared by the Office of Science and the Office of Regulations in the Center for Tobacco 
Products at FDA. 
2 Unless otherwise stated, references to statutory sections (identified with ) in this guidance are to sections of the 
FD&C Act. 
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  An application to market a new tobacco product under  910(b) (premarket tobacco 
application or PMTA)3 
  A report showing the product is substantially equivalent to a predicate tobacco product that 
(i) was commercially marketed (other than for test markets) in the United States as of 
February 15, 2007, or (ii) FDA has issued an order of substantial equivalence under             
 910(a)(2)(A)(i)4 
  A request for exemption from substantial equivalence requirements, which requires a report 
showing the product meets the requirements for exemption5 
The Act also sets forth requirements for authorization to market a modified-risk tobacco product 
(MRTP) ( 911).6 
In support of a PMTA, a report showing substantial equivalence, a request for exemption from 
substantial equivalence requirements, or an application to market a MRTP, a manufacturer may 
undertake research studies (investigations).7 Such investigations may utilize tobacco products 
intended for investigational use (investigational tobacco products).8 Manufacturers and 
investigators who undertake investigations may have questions about FDA requirements, or 
about the use of investigational tobacco products.9 
FDA staff intends to participate in many meetings with industry and investigators who seek 
information relating to the research and development of tobacco products, including studies 
involving investigational tobacco products. Because these meetings often represent important 
opportunities in the regulatory process, it is important that there are efficient, consistent 
procedures for the timely and effective conduct of such meetings. This guidance is intended to 
provide consistent principles and procedures to promote well-managed meetings pertaining to 
tobacco product research and development. 
 
 
3 For information on how to submit a PMTA, see FDAs final rule, Premarket Tobacco Product Applications and 
Recordkeeping Requirements, (86 FR 55300, October 10, 2021) available at https://www.govinfo.gov/content/pkg/FR-
2021-10-05/pdf/2021-21011.pdf, and Guidance for Industry, Premarket Tobacco Product Applications for Electronic 
Nicotine Delivery Systems (ENDS) (June 2019). This and all guidances cited in this document are available at 
https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance 
4 See  905(j)(1) and  910(a). For additional information regarding how to submit a substantial equivalence report, 
See FDAs final rule, Content and Format of Substantial Equivalence Reports; Food and Drug Administration 
Actions on Substantial Equivalence Reports, (86 FR 55224, October 5, 2021) available at 
https://www.govinfo.gov/content/pkg/FR-2021-10-05/pdf/2021-21009.pdf. Also see Guidance for Industry, 
Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products (January 2011) and 
Guidance for Industry, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to 
Frequently Asked Questions (December 2016). 
5 See  905(j)(3) and 21 CFR 1107.1, Exemptions. Also, after receiving a Found Exempt order, applicants 
seeking exemption from substantial equivalence must submit a report under  905(j)(1)(A)(ii) at least 90 days prior 
to the introduction or delivery for introduction of the new tobacco product into interstate commerce. 
6 For information about the MRTP application process, see Draft Guidance for Industry, Modified Risk Tobacco 
Product Applications (March 2012). 
7 For example, see  910(c)(5)(A), which reads: For purposes of [the determination under] paragraph (2)(A), 
whether permitting a tobacco product to be marketed would be appropriate for the protection of the public health 
shall, when appropriate, be determined on the basis of well-controlled investigations, which may include 1 or more 
clinical investigations by experts qualified by training and experience to evaluate the tobacco product. 
8 For more information about investigational tobacco products, see Draft Guidance for Industry and Investigators, Use 
of Investigational Tobacco Products (February 2019). 
9 However, in most circumstances, FDA does not intend to meet with manufacturers or investigators to discuss 
submissions that are currently under review. See section III.D., below. 
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Contains Nonbinding Recommendations 
III.  DISCUSSION 
 
A.  What is the scope of this guidance? 
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. 
 
B.  Which FDA staff would likely attend this meeting? 
Staff from CTPs Office of Science would attend this meeting. Staff from other parts of CTP 
and FDA may also participate as appropriate, e.g., CTPs Office of Compliance and 
Enforcement or FDAs Office of Chief Counsel. 
 
C.  How do I request a meeting? 
 
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 CTP Portal using the eSubmitter tool10 or sent by mail or courier. Please refer 
to discussion section III.L. in this document for the mailing address. 
 
D.  When should I submit my meeting request? 
 
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 currently 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 MRTP application. 
 
E.  What should I include in my meeting request? 
 
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 
  FDA-assigned Submission Tracking Number(s) of prior FDA submissions for the product 
and relevant product version(s) (if applicable) 
  Product category, e.g., cigarettes, smokeless tobacco (if applicable) 
  Product use (indicate for consumer use or for further manufacturing) 
 
10 Information about the CTP Portal can be found at: https://www.fda.gov/tobacco-products/manufacturing/submit-
documents-ctp-portal. Additional information about the eSubmitter tool can be found at:  
https://www.fda.gov/industry/fda-esubmitter/esubmitter-tutorial-videos. Alternatively, the FDAs Electronic 
Submission Gateway (ESG) is still available as an option to the CTP Portal. Please refer to the ESG website 
instructions for setting up a WebTrader account at https://www.fda.gov/industry/create-esg-account/setting-
webtrader-account-checklist 
  
  3   
Contains Nonbinding Recommendations 
  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 critical 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 
 
F.  How will FDA to respond to my request? 
In general, FDA intends to respond to meeting requests in writing within 21 calendar days of 
receipt. If FDA agrees to the meeting, the letter should include the following: 
  The date, time, format, and location of the meeting 
  The expected FDA disciplines 
  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, the answers to questions have previously been made available in public 
materials or through previous communication). 
 
G.  If FDA denies my initial meeting request, can I resubmit my request? 
 
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 FDAs denial of the initial request. FDA will consider a subsequent meeting 
request to be a new request. 
 
H.  Could FDA decide that a face-to-face meeting or teleconference is unnecessary? 
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. 
 
 
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I.  Who will be my point of contact for the meeting? 
 
FDAs 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. 
 
J.  Is there any additional information that I should submit prior to the scheduled 
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. If the information in the meeting package 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. 
 
K.  What should I include in my meeting information package? 
 
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, such as during the study or after study completion, as well as an explanation 
for the changes. 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 FDAs 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): 
 
1.  Product name 
2.  FDA-assigned Submission Tracking Number (s) of prior FDA submissions for 
the product and relevant product version(s) 
3.  Product category 
4.  Product use (indicate for consumer use or further manufacturing) 
5.  Product type, e.g., finished tobacco product or component, part, accessory 
6.  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 
7.  A list of the specific objectives/outcomes expected from the meeting 
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8.  An agenda, including estimated amounts of time needed for each agenda item and 
designated speaker(s) 
9.  A list of specific critical questions grouped by issue/study 
10.   Product composition and design data summary 
11.  Manufacturing and process control data summary 
12.  Nonclinical data summary 
13.  Clinical data summary 
14.  Behavioral and product use data summary 
15.  User and non-user perception data summary 
16.  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 FDAs response to your meeting request. 
 
L.  Where do I send my meeting requests and meeting information packages? 
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 CTP Portal using the eSubmitter tool.11  We highly encourage you to 
submit the meeting information package electronically via the CTP Portal using the 
eSubmitter tool.
 
11 Information about the CTP Portal can be found at: https://www.fda.gov/tobacco-products/manufacturing/submit-
documents-ctp-portal.  Additional information about the eSubmitter tool can be found at:  
https://www.fda.gov/industry/fda-esubmitter/esubmitter-tutorial-videos. Alternatively, the FDAs Electronic 
Submission Gateway (ESG) is still available as an option to the CTP Portal. Please refer to the ESG website 
instructions for setting up a WebTrader account at https://www.fda.gov/industry/create-esg-account/setting-
webtrader-account-checklist 
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Alternatively, you may send your meeting request and meeting information package 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 
 
M.  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. 
 
N.  If my initial meeting request is postponed or canceled, can I resubmit my 
request? 
 
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. 
 
O.  What, if anything, should I bring to the meeting? 
 
At least two business days prior to the scheduled meeting, you should provide your point of 
contact with an electronic copy of your presentation (if applicable). 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. 
 
P.  How will the meeting be conducted? 
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. 
 
Q.  Will FDA provide any documentation to summarize the meeting? 
 
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. 
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R.  What should I do if I have a question or concern regarding the official meeting 
minutes? 
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 FDAs 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. 
 
S.  Can I submit or discuss confidential information with FDA prior to, during, or 
after the meeting? 
 
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 FDAs implementing regulations. 
 
IV.  PAPERWORK REDUCTION ACT OF 1995 
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). 
 
The time required to complete this information collection is estimated to average 10 hours per 
response, including the time to review instructions, search existing data sources, gather the data 
needed, and complete and review the information collection. Send comments regarding this 
burden estimate or suggestions for reducing this burden to: 
 
Food and Drug Administration 
Center for Tobacco Products 
Document Control Center 
Building 71, Room G335 
10903 New Hampshire Avenue 
Silver Spring, MD 20993-0002 
 
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. The OMB control number 
for this information collection is 0910-0731 (To find the current expiration date, search for this 
OMB control number available at https://www.reginfo.gov). 
 
 
 
 
 
 
 
 
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Document History 
May 2012  Guidance is published. 
 
July 2016  This is a revision to the May 2012 edition of this guidance. Revisions include: 
  The background section of this guidance was updated to reflect the publication of Draft 
Guidance for Industry and Investigators, Use of Investigational Tobacco Products 
(9/24/2015) and Guidance for Industry, Demonstrating the Substantial Equivalence of a 
New Tobacco Product: Responses to Frequently Asked Questions (9/8/2015). The 
background section was also shortened to replace brief background information about  
905, 910, and 911 with citations to the current guidances that provide detailed 
information about each provision. The definitions section was removed, as the terms 
listed in the previous version were relevant to the removed text. 
 
  Additional line items were added to the list of information one should include in the 
meeting package: (1) product composition and design data summary, and (2) 
manufacturing and process control data. These line items take the place of Chemistry, 
manufacturing, and control data summary, which was removed. Finally, the line item, 
preclinical data summary was changed to nonclinical data summary. 
 
June 2020  This is a revision to the July 2016 edition of this guidance. Revisions include: 
 
  Footnotes in the background section of this guidance were updated to reflect 
finalization and date of Guidance for Industry, Premarket Tobacco Product 
Applications for Electronic Nicotine Delivery Systems (ENDS) and date of Guidance 
for Industry, Demonstrating the Substantial Equivalence of a New Tobacco Product: 
Responses to Frequently Asked Questions. 
 
  Changed FDA would respond to a meeting request by written response to letter 
and the letter should include the expected FDA disciplines which was previously 
participants. 
 
  CTP Portal was added as an alternative method to transmit meeting requests 
electronically. 
 
September 2022  This is a revision to the June 2020 edition of this guidance. Revisions 
include: 
 
  Addition of clarifying text to the suggested content of meeting submission packages, 
e.g., Submission Tracking Numbers for previous submissions of related or relevant 
product versions. 
 
  Additional clarification on circumstances for possible FDA denial of meeting requests. 
 
  Updates to footnotes, including: the addition of reference to Premarket Tobacco 
Product Application (PMTA) and Substantial Equivalence Report (SE) final rules; 
removal of a withdrawn PMTA draft guidance (Draft Guidance for Industry, 
Application for Premarket Review of New Tobacco Products (September 2011); 
reference to the most recent version of Draft Guidance for Industry and Investigators, 
  9   
Contains Nonbinding Recommendations 
Use of Investigational Tobacco Products (February 2019; replaces the September 
2015 version). 
 
  Additional recommendations for meeting requestors to submit meeting requests and 
meeting packages electronically through the CTP Portal (eSubmitter tool). Electronic 
submittals are consistent with PMTA, SE Report, and Exemption Request submission 
requirements. 
 
  Updates to the OMB control number expiration date on the cover page and section IV, 
Paperwork Reduction Act of 1995, of this guidance. 
 
  Minor edits to improve consistency and readability. 
 
  10