[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Pages 25062-25063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11225]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0429]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance on Meetings 
With Industry and Investigators on the Research and Development of 
Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by July 1, 
2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0731. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

OMB Control Number 0910-0731--Extension

    The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) offers tobacco product manufacturers several pathways to obtain an 
order from FDA to authorize the marketing of a new tobacco product 
before it may be introduced or delivered into interstate commerce. To 
provide assistance with these pathways to market products, FDA will 
meet with tobacco product manufacturers, importers, researchers, and 
investigators (or their representatives) when appropriate as described 
in Guidance on Meetings with Industry and Investigators on the Research 
and Development of Tobacco Products. This guidance is intended to 
assist persons who seek meetings with FDA relating to their research to 
inform the regulation of tobacco products, or to support the 
development or marketing of tobacco products. The original guidance 
issued in 2012 was revised for updating and clarity in July 2016.
    In the guidance, the Agency discusses, among other things:
     What information FDA recommends persons include in a 
meeting request;
     How and when to submit a request; and
     What information FDA recommends persons submit prior to a 
meeting.
    This guidance describes two collections of information: (1) The 
submission of a meeting request containing certain information and (2) 
the submission of an information package in advance of the meeting. The 
purpose of this proposed information collection is to allow FDA to 
conduct meetings with tobacco manufacturers, importers, researchers, 
and investigators in an effective and efficient manner. FDA issued this 
guidance and the revisions consistent with FDA's good guidance 
practices regulations (21 CFR 10.115).
    Meeting Requests: The guidance sets forth FDA's recommendations for 
materials to be included in a request for a meeting with FDA to discuss 
the research and development of tobacco products. In the guidance, FDA 
recommends that the following information be included in the meeting 
request:
    1. Product name and FDA-assigned Submission Tracking Number (if 
applicable);
    2. Product category (e.g., cigarettes, smokeless tobacco) (if 
applicable);
    3. Product use (indicate for consumer use or for further 
manufacturing);
    4. Contact information for the authorized point of contact for the 
company requesting the meeting;
    5. The topic of the meeting being requested (e.g., a new tobacco 
product application, an application for permission to market a modified 
risk tobacco product, or investigational use of a new tobacco product);
    6. 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;
    7. A preliminary list of the specific objectives/outcomes expected 
from the meeting;
    8. A preliminary proposed agenda, including an estimate of the time 
needed and a designated speaker for each agenda item;
    9. A preliminary list of specific questions, grouped by discipline 
(e.g., chemistry, clinical, nonclinical);
    10. A list of all individuals who will attend the meeting on behalf 
of the tobacco product manufacturer, importer, researcher, or 
investigator, including titles and responsibilities;
    11. The date on which the meeting information package will be 
received by FDA; and
    12. 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.
    This information will be used by the Agency to: (1) Determine the 
utility of the meeting, (2) identify Agency staff necessary to discuss 
proposed agenda items, and (3) schedule the meeting.
    Meeting Information Packages: An individual submitting a meeting 
information package to FDA in advance of a meeting should provide 
summary information relevant to the product and supplementary 
information pertaining to any issue raised by the individual or FDA to 
be discussed at the meeting. As stated in the guidance, FDA recommends 
that meeting information packages generally include updates of 
information that was submitted with the meeting request and, as 
applicable:
    1. Product composition and design data summary;
    2. Manufacturing and process control data summary;
    3. Nonclinical data summary;
    4. Clinical data summary;
    5. Behavioral and product use data summary;

[[Page 25063]]

    6. User and nonuser perception data summary; and
    7. Investigational plans for studies and surveillance of the 
tobacco product, including a summary of proposed study protocols 
containing the following information (as applicable):
    a. Study objective(s);
    b. Study hypotheses;
    c. Study design;
    d. Study population (inclusion/exclusion criteria, comparison 
group(s));
    e. Human subject protection information, including Institutional 
Review Board information;
    f. Primary and secondary endpoints (definition and success 
criteria);
    g. Sample size calculation;
    h. Data collection procedures;
    i. Duration of follow up and baseline and follow up assessments, 
and
    j. Data analysis plan(s).
    The purpose of the information package is to provide Agency staff 
the opportunity to adequately prepare for the meeting, including the 
review of relevant data concerning the product. In the Agency's 
experience, reviewing such information is critical to achieving a 
productive meeting. If the information package was previously submitted 
in the meeting request, it should be revised, as applicable, so that 
the information reflects the most current and accurate information 
available.
    In the Federal Register of September 12, 2018 (83 FR 46174), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Three comments were received; however, none 
were PRA related.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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                                                Meeting Requests
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Combining and Sending Meeting                 83               1              83              10             830
 Request Letters for
 Manufacturers, Importers, and
 Researchers....................
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                                          Meeting Information Packages
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Combining and Submitting Meeting              83               1              83              18           1,494
 Information Packages for
 Manufacturers, Importers, and
 Researchers....................
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    Total.......................  ..............  ..............  ..............  ..............           2,324
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's estimate of the number of respondents for meeting requests in 
table 1 is based on the number of meeting requests received and 
projected over the next 3 years. FDA estimates that 83 preapplication 
meetings will be requested.
    The hours per response for combining and sending meeting request 
letters are estimated at 10 hours each, and the total burden hours for 
meeting requests are expected to be 830 hours. Based on FDA's 
experience, the Agency expects it will take respondents this amount of 
time to prepare, gather, copy, and submit brief statements about the 
product and a description of the purpose and details of the meeting.
    FDA estimates that 83 respondents will compile meeting information 
packages and submit to FDA at 18 hours per response. Based on FDA's 
experience, the Agency expects that it will take respondents, 
collectively, 1,494 hours (83 respondents x 18 hours) to gather, copy, 
and submit brief statements about the product, a description of the 
details of the anticipated meeting, and data and information that 
generally would already have been generated for the planned research 
and/or product development.
    The total number of burden hours for this collection of information 
is estimated to be 2,324 hours (830 hours to prepare and submit meeting 
requests and 1,494 hours to prepare and submit information packages).
    Our estimated burden for the information collection reflects an 
overall increase of 16 respondents and 448 hours. We attribute this 
adjustment to an increase in the number of industry meetings as the 
premarket tobacco application compliance deadlines will come due in the 
next 3 years.

    Dated: May 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11225 Filed 5-29-19; 8:45 am]
 BILLING CODE 4164-01-P