[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Pages 5758-5760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02000]


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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) 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.

DATES: Fax written comments on the collection of information by March 
4, 2016.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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. 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 guidance has been revised to provide clarity.
    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: 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 an 
MRTP, 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;

[[Page 5759]]

    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).

    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.
    In the Federal Register of September 17, 2015 (80 FR 55855), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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....................
                                 -------------------------------------------------------------------------------
    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 3 years of this collection, FDA estimates that 67 
preapplication 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 nonsubstantial 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 / 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 for meeting requests are expected to be 670 
hours (10 hours preparation/mailing x 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

[[Page 5760]]

that it will take respondents 1,206 hours of time (67 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 1,876 hours (670 hours to prepare and submit meeting requests and 
1,206 hours to prepare and submit information packages).

     Dated: January 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02000 Filed 2-2-16; 8:45 am]
BILLING CODE 4164-01-P