[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]
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