[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Pages 74194-74195]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30057]


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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 January 
14, 2013.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Guidance on Meetings With Industry and Investigators on the 
Research and Development of Tobacco Products.'' Also, include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: 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: 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-NEW)

    This guidance is intended to assist tobacco manufacturers, 
importers, researchers, and investigators, and their representatives 
who seek meetings with staff of FDA's Center for Tobacco Products (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 DA 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.
    In the Federal Register of May 25, 2012 (77 FR 31368), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one response containing PRA-
related comments.. The comment indicated that the guidance should 
clarify that meeting request times will vary depending on the type of 
submission to be discussed and the meeting information package 
requirements should be tailored to the submission type.
    In response, the estimated burden hours for both meeting requests 
and meeting information package requirements have been calculated by 
FDA and are based on an average number of hours for each type of 
submission over a 3-year period. The meeting information requirements 
are also averaged together and are not individually split into 
submission types

[[Page 74195]]

for this collection. The commenter also provided comments that were not 
PRA-related and are beyond the scope of this document.
    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 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 three years. In year 1 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 three, the request for meetings is 
expected to drop back to the year 1 one rate of 50 per year. 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 the 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 (670 hours to 
prepare and submit meeting requests and 1,206 hours to prepare and 
submit information packages).

    Dated: December 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30057 Filed 12-12-12; 8:45 am]
BILLING CODE 4160-01-P