Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products

Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products

0731_Guidance_2022

Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products

OMB: 0910-0731

Document [pdf]
Download: pdf | pdf
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-regulationsand-guidance/guidance. You may send an e-mail request to [email protected] 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
xxxx 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

i

Contains Nonbinding Recommendations
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

ii

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 FDA’s 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. FDA’s guidance documents, including this guidance, do
not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s
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.

1

Contains Nonbinding Recommendations
•
•

•

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 FDA’s final rule, Premarket Tobacco Product Applications and
Recordkeeping Requirements, (86 FR 55300, October 10, 2021) available at https://www.govinfo.gov/content/pkg/FR2021-10-05/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 FDA’s 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.

2

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 CTP’s Office of Science would attend this meeting. Staff from other parts of CTP
and FDA may also participate as appropriate, e.g., CTP’s Office of Compliance and
Enforcement or FDA’s 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/submitdocuments-ctp-portal. Additional information about the eSubmitter tool can be found at:
https://www.fda.gov/industry/fda-esubmitter/esubmitter-tutorial-videos. Alternatively, the FDA’s 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/settingwebtrader-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 FDA’s 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.

4

Contains Nonbinding Recommendations
I. Who will be my point of contact for the 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.
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 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):
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
5

Contains Nonbinding Recommendations
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 FDA’s 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/submitdocuments-ctp-portal. Additional information about the eSubmitter tool can be found at:
https://www.fda.gov/industry/fda-esubmitter/esubmitter-tutorial-videos. Alternatively, the FDA’s 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/settingwebtrader-account-checklist

6

Contains Nonbinding Recommendations
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.
7

Contains Nonbinding Recommendations
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 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.
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 FDA’s 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).

8

Contains Nonbinding Recommendations
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.

xxxx 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


File Typeapplication/pdf
File TitleMeetings with Industry and Investigators on the Research and Development of Tobacco Products
SubjectGuidance for Industry
AuthorFDA/CTP
File Modified2022-05-18
File Created2022-05-18

© 2022 OMB.report | Privacy Policy