Document ID: FDA-2010-N-0542-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Dissolvable Tobacco Products
Posted Date: 2010-10-25T04:00Z

[Federal Register: October 25, 2010 (Volume 75, Number 205)]
[Notices]               
[Page 65490-65491]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25oc10-65]                         

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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, Jonnalynn.Capezzuto@fda.hhs.gov.

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]
BILLING CODE 4160-01-P