[Federal Register Volume 75, Number 205 (Monday, October 25, 2010)]
[Notices]
[Pages 65490-65491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26830]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0542]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Information Request Regarding Dissolvable Tobacco
Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on an information request regarding the use of
dissolvable tobacco products.
DATES: Submit either electronic or written comments on the collection
of information by December 27, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr. PI50-400B,
Rockville, MD 20850, 301-796-3794, [email protected].
SUPPLEMENTARY INFORMATION: 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 they conduct or sponsor.
``Collection of Information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(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 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 of 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.
Information Request Regarding Dissolvable Tobacco Products
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act) by adding a new chapter granting FDA
important new authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect the public health generally
and to reduce tobacco use by minors.
Section 917 of the Tobacco Control Act required the Secretary of
Health and Human Services (the Secretary) to establish a Tobacco
Products Scientific Advisory Committee (TPSAC). Section 907(f) of the
Tobacco Control Act requires the TPSAC to submit a report and
recommendations to the Secretary on the impact of the use of
dissolvable tobacco products on the public health, including such use
among children. To ensure a comprehensive review of this issue, FDA is
requesting tobacco industry documents and information to support the
work of TPSAC. Under section 907(f), TPSAC must submit its report and
recommendations to the Secretary within 2 years of its formation, or
March 23, 2012.
In order to provide TPSAC with the information it needs to carry
out its statutory obligation, FDA is requesting that tobacco companies
submit information under section 904(b) of the Tobacco Control Act
pertaining to documents and underlying scientific and financial
information relating to research, and research findings, conducted,
supported, or possessed by the manufacturer (or agents thereof) on a
specified set of topics. For the purposes of this request, ``research''
may include, but is not limited to, focus groups, surveys, experimental
clinical studies, post-marketing surveillance, toxicological and
biochemical assays, taste panels, and assessments of the effectiveness
of product marketing practices. Topics for which information relating
to dissolvable tobacco products is requested are marketing research;
marketing practices; effectiveness of marketing practices; and health,
toxicological, behavioral, and physiological effects. FDA's request for
documents related to dissolvable tobacco products includes, but is not
limited to products for research, investigational use, developmental
studies, test marketing, and/or commercial marketing, and also to the
components, parts, or accessories of such products.
[[Page 65491]]
FDA estimates the burden for this collection of information as
follows:
Table 1--Estimate of One-Time Reporting Burden\1\
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Annual Total average
Activity Number of frequency per annual Hours per Total hours
respondents response responses response
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Providing negative response to 110 1 110 0.50 55
request for dissolvable tobacco
product documents..............
Submission of dissolvable 10 1 10 230 2,300
tobacco products...............
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Total....................... 120 .............. 120 .............. 2,355
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These burden estimates were derived by taking into consideration
FDA's experience with document production, experience with submissions
pertaining to other tobacco product-related information collections,
and comments received in response to other tobacco product-related
information collections. FDA is limiting the burden on respondents by
only requesting documents on specific topics that will have utility for
FDA. FDA is requesting the final version of documents or the most
recent draft in the absence of a final document. Also, publically
available published abstracts, editorials, letters, and manuscripts are
not being requested, although FDA would appreciate a list of such
publications. Information responsive to this section 904(b) information
request that has been previously provided to FDA under the FD&C Act or
other letter requests does not have to be resubmitted as long as the
document is fully referenced. FDA believes that the number of documents
being requested in this information collection will be limited due to
the estimated small number of respondents and the relatively shorter
amount of time these tobacco products have been in existence compared
to other tobacco products.
FDA estimates that there are approximately 120 tobacco product
manufacturers who may be affected by this collection of information. Of
the total number of manufacturers, FDA estimates that most
manufacturers (110) will not have documents which will be responsive to
this section 904(b) request and that they will only need to send a
letter notifying the FDA's Center for Tobacco Products that they have
no documents to report. FDA anticipates it should take no longer than
30 minutes to draft such a response and send to FDA. The total one-time
hourly burden to submit this letter to FDA is estimated to be 55 hours
(30 minutes x 110 manufacturers).
FDA estimates that there are approximately 10 tobacco product
manufacturers who may have documents meeting the criteria of this
information collection request. Because the volume of responsive
documents each of these respondents may have will likely vary, the
corresponding time burden for each respondent to satisfy this
information collection request will also vary. Therefore, FDA estimates
that these 10 respondents will average approximately 230 hours each to
satisfy the requirements of this section 904(b) request. The total one-
time hourly burden to locate and send documents meeting the
requirements of this request is estimated to be 2,300 hours (230 hours
x 10 manufacturers). The total one-time hourly burden for this
collection of information is 2,355 hours (55 hours + 2,300 hours).
Dated: October 19, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26830 Filed 10-22-10; 8:45 am]
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