[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Notices]
[Pages 31368-31371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12775]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Meetings with 
Industry and Investigators on the Research and Development of Tobacco 
Products.'' This guidance describes FDA's current policies and 
recommendations with respect to Agency 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. 
The guidance is intended to assist persons seeking a meeting with FDA 
to discuss the research and development of tobacco products. This 
guidance does not pertain to other types of meetings or meeting 
requests with Center for Tobacco Products (CTP) staff.

DATES: Submit either electronic or written comments on this guidance at 
any time. Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 (the PRA) by July 24, 2012 (see section 
III. Paperwork Reduction Act of 1995 in this document).

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Meetings with Industry and Investigators on the Research and 
Development of Tobacco Products'' to the Center for Tobacco Products, 
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850-3229. Send one self-addressed adhesive label to assist that 
office in processing your request or include a fax number to which the 
guidance document may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments, including comments on the 
proposed collection of information, to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to the guidance: Gerie 
Voss, Center for Tobacco Products, 9200 Corporate Blvd., Rockville, MD 
20850,

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1-877-287-1373, [email protected].
    With regard to the proposed collection of information: Daniel 
Gittleson, Office of Information Management, Food and Drug 
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-5156, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Meetings with Industry and Investigators on the Research and 
Development of Tobacco Products.'' This guidance is intended to assist 
tobacco manufacturers, importers, researchers, and investigators, and 
their representatives who seek meetings with staff of FDA's 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 does not pertain to other types of meetings or 
meeting requests with CTP staff.
    The Family Smoking Prevention and Tobacco Control Act (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) where appropriate.
    This guidance is intended to assist persons who seek guidance 
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 such a 
meeting request,
     How and when to submit such a request, and
     What information FDA recommends persons submit prior to 
such a meeting.

II. Significance of Guidance

    FDA is issuing this guidance as a level 2 guidance consistent with 
FDA's good guidance practices regulations (21 CFR 10.115). The guidance 
represents the Agency's current thinking on ``Meetings with Industry 
and Investigators on the Research and Development of Tobacco 
Products.'' It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Paperwork Reduction Act of 1995

    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 that they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320(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 before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing this 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 on 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 for Industry: Meetings With Industry and Investigators on the 
Research and Development of Tobacco Products

    This guidance is intended to assist persons seeking to have a 
meeting with FDA on the research and development of tobacco products. 
This guidance document discusses, among other things: What information 
FDA recommends that persons include in a meeting request, how and when 
to submit a request, and what information FDA recommends that persons 
submit prior to the 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.
A. 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. Under 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, etc.) (if 
applicable);
    3. Product use (indicate for consumer use or for further 
manufacturing);
    4. Contact information for individual or company requesting the 
meeting;
    5. The type of 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;
    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) likely will be received by FDA; and
    12. Suggested dates and times for the meeting (note that generally 
a meeting will be scheduled for approximately 1 to 1.5 hours).
    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.
B. 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

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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. Chemistry, manufacturing, and control data summary (as 
applicable);
    2. Preclinical data summary (as applicable);
    3. Clinical data summary (as applicable);
    4. Behavioral and product use data summary (as applicable);
    5. User and nonuser perception data summary (as applicable); and
    6. 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 followup and baseline and followup 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.
C. 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:

                                   Table 1--Estimated Annual Reporting Burden1
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                                                     Number of                    Average burden
Meeting requests and information     Number of     responses per   Total annual    per response     Total hours
            packages                respondents     respondent       responses      (in hours)
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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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    Collection Totals...........  ..............  ..............  ..............  ..............           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 first year of this 
collection, FDA estimates that 50 preapplication meetings will be 
requested. In year 2, FDA estimates that 100 meetings will be 
requested, especially as applications and reports for substantial 
equivalence, etc., are received and acted upon. Once the public knows 
more about submitting these applications in year 3, the request for 
meetings is expected to drop back to the year 1 rate of 50 per year. 
Thus, FDA estimates the number of manufacturers, importers, 
researchers, and investigators who are expected to submit meeting 
request 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).

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division

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of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of this guidance document at http://www.regulations.gov or 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12775 Filed 5-24-12; 8:45 am]
BILLING CODE 4160-01-P