[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Notices]
[Pages 46174-46176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19743]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on ``Guidance on Meetings with Industry and 
Investigators on the Research and Development of Tobacco Products.''

DATES: Submit either electronic or written comments on the collection 
of information by November 13, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 13, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2012-D-0429 for ``Guidance on Meetings with Industry and 
Investigators on the Research and Development of Tobacco Products.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,

[[Page 46175]]

Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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. 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;
    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).

[[Page 46176]]

    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.
    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....................
                                 -------------------------------------------------------------------------------
    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's 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 
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: September 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19743 Filed 9-11-18; 8:45 am]
 BILLING CODE 4164-01-P


