[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Notices]
[Pages 55855-55857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23332]


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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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 FDA's meetings with tobacco 
manufacturers, importers, researchers, and/or investigators relating to 
their plans to conduct research to inform the regulation of tobacco 
products, or support the development or marketing of tobacco products.

DATES: Submit either electronic or written comments on the collection 
of information by November 16, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the 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 docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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

[[Page 55856]]

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 tobacco product before 
it may be introduced or delivered into interstate commerce. To provide 
assistance with these pathways to market particular 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. 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 as a level 2 guidance consistent with FDA's good guidance 
practices regulations (21 CFR 10.115).
    Meeting Requests: Section IV.E of 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;
    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 draft list of the specific objectives/outcomes expected from 
the meeting;
    8. A preliminary proposed agenda, including estimated amounts of 
time needed for each agenda item and designated speaker(s);
    9. A draft list of specific questions, grouped by discipline (e.g., 
chemistry, clinical, nonclinical);
    10. A list of all individuals (including titles and 
responsibilities) who will attend the meeting on behalf of the tobacco 
product manufacturer, importer, researcher, or investigator;
    11. The approximate date on which supporting documentation (i.e., 
the meeting information package) will likely be received by FDA; and
    12. Suggested dates and times for the meeting (note that generally 
a meeting will be 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 section IV.K of the guidance, 
FDA recommends that meeting information packages generally include 
updated information from the meeting request (see items 1 through 8 in 
section III.A of this document) and:
    1. Product composition and design (as applicable);
    2. Manufacturing and process control data summary (as applicable);
    3. Nonclinical data summary (as applicable);
    4. Clinical data summary (as applicable);
    5. Behavioral and product use data summary (as applicable);
    6. User and nonuser perception data summary (as applicable); 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. For the information that was previously submitted 
in the meeting request, the information package should provide updated 
information that reflects the most current and accurate information 
available.
    Description of Respondents: The respondents to this collection of 
information are manufacturers, importers, researchers, and 
investigators of tobacco products who seek to meet with FDA to discuss 
their plans regarding the development or marketing of a tobacco 
product.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 55857]]



                                 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                 67               1              67              10             670
 Request Letters for
 Manufacturers, Importers, and
 Researchers....................
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                                          Meeting Information Packages
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Combining and Submitting Meeting              67               1              67              18           1,206
 Information Packages for
 Manufacturers, Importers, and
 Researchers....................
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    Total.......................  ..............  ..............  ..............  ..............           1,876
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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 of this document is based on the number of meeting requests to 
be received over the next 3 years.
    In the next three years of this collection, FDA estimates that 67 
pre-application meetings will be requested. The number is not expected 
to change, as the public is more experienced in submitting applications 
for substantial equivalence, requests for non-substantial equivalence, 
etc.
    Thus, FDA estimates the number of manufacturers, importers, 
researchers, and investigators who are expected to submit meeting 
requests in Table 1 of this document to be 67 (50 year 1 requests + 100 
year 2 requests + 50 year 3 requests divided by 3). The hours per 
response, which is the estimated number of hours that a respondent 
would spend preparing the information recommended by this guidance to 
be submitted with a meeting request is estimated to be approximately 10 
hours each, and the total burden hours are 670 hours (10 hours 
preparation/mailing times 67 average respondents per year). 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 estimate of the number of respondents for compiling meeting 
information packages in Table 1 of this document is based on 67 
respondents each preparing copies of their information package and 
submitting them to FDA, for a total of 1,206 hours annually. The hours 
per response, which is the estimated number of hours that a respondent 
would spend preparing the information package as recommended by the 
guidance, is estimated to be approximately 18 hours per information 
package. Based on FDA's experience, the Agency expects that it will 
take respondents 1,206 hours of time (67 respondents times 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 1,876 hours (67 hours to prepare and submit meeting requests and 
1,206 hours to prepare and submit information packages).

    Dated: September 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23332 Filed 9-16-15; 8:45 am]
BILLING CODE 4164-01-P