[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Notices]
[Pages 31368-31371]
From the Federal Register Online via the Government Printing 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, gerie.voss@fda.hhs.gov.
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, daniel.gittleson@fda.hhs.gov.
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]
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