Document ID: FDA-2010-N-0367-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Menthol in Cigarettes
Posted Date: 2010-07-20T04:00Z

[Federal Register: July 20, 2010 (Volume 75, Number 138)]
[Notices]               
[Page 42093-42094]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jy10-55]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0367]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Information Request Regarding Menthol in Cigarettes

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, 
including each proposed extension of an existing 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 menthol in cigarettes.

DATES: Submit either electronic or written comments on the collection 
of information by September 20, 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, including 
each proposed extension of an existing 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 Menthol in Cigarettes--(OMB Control 
Number 0910-0662)--Extension

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (the Tobacco Control Act) (Public 
Law 111-31) into law. The Tobacco Control Act amended the Federal Food, 
Drug, and Cosmetic 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 requires the Secretary of 
Health and Human Services (the Secretary) to establish a Tobacco 
Products Scientific Advisory Committee (TPSAC). Section 907(e) of the 
Tobacco Control Act requires the TPSAC to submit a report and 
recommendations to the Secretary on the impact of the use of menthol in 
cigarettes on the public health, including such use among children, 
African-Americans, Hispanics, and other racial and ethnic minorities. 
To ensure a comprehensive review of this issue, the Center for Tobacco 
Products is requesting tobacco industry data and information to support 
the work of TPSAC. Under section 907(e) of the Tobacco Control Act, 
TPSAC must submit its report and recommendations to the Secretary 
within 1 year of its formation, or March 23, 2011.
    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. OMB 
granted emergency processing and approved the information collection on 
May 12, 2010. In a letter dated May 26, 2010, FDA asked tobacco 
manufacturers to submit documents containing scientific, marketing, and 
health-related information pertaining to the use of menthol in 
cigarettes.
    FDA has requested that tobacco manufacturers submit all documents 
and underlying scientific information relating to research activities, 
and research findings, conducted, supported, or possessed by the 
manufacturer (or agents thereof) on a specified set of topics. 
``Research activities'' may include, but are not limited to, focus 
groups, surveys, experimental clinical studies, toxicological and 
biochemical assays, taste panels, and assessments of the effectiveness 
of product marketing practices. Scientific and health-related 
information FDA has requested include

[[Page 42094]]

dose-response relationships for physiologic effects and chemosensory 
effects of mentholated tobacco smoke. FDA also requested information on 
the impact of menthol on the neurobiology of tobacco dependence and 
information on dose-related interactions between menthol and nicotine, 
including on the uptake and metabolism of nicotine and on various 
consumer perceptions of the product.
    FDA has also requested tobacco companies to submit consumer 
research data and marketing information pertaining to menthol 
cigarettes. FDA requested consumer research data pertaining to use, 
cessation, and consumer perception of menthol cigarettes. FDA's request 
for documents and underlying scientific information related to 
marketing information includes data and information on marketing 
strategies for each brand or subbrand of menthol cigarettes, including 
strategies targeted to particular demographic groups, strategies aimed 
at tobacco-na[iuml]ve consumers, and strategies aimed at recruitment of 
former tobacco users.
    FDA estimates the burden of this collection of information as 
follows:

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                                                 No. of        Annual Frequency     Total Annual        Hours per                         Total Capital
                 Activity                      Respondents       per Response         Responses         Response         Total Hours          Costs
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Submission of Menthol Documents                          116                   1               116               140            16,240            $1,940
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    The capital costs associated with this collection pertain to the 
postage for mailing documents in electronic format. Estimating these 
costs is problematic because the costs would vary depending on the size 
of the document production (e.g. one binder of documents vs. numerous 
boxes of paper) and the media type (e.g., compact disk (CD) or digital 
video disk (DVD)) chosen to submit documents. Currently, we cannot 
identify how many documents will be submitted per response.
    Some sample postage costs are shown for different types of 
packages:
     10 CDs in a flat envelope weighing 30 ounces: 
Approximately $8 using first class business mail,
     Five-pound parcel containing paper documents: 
Approximately $12 using business parcel post mail and delivering to the 
furthest delivery zone,
     Ten-pound parcel containing paper documents: Approximately 
$17 using business parcel mail and delivering to the furthest delivery 
zone, and
     Fifty-pound parcel containing paper documents: 
Approximately $52 using business parcel post mail and delivering to the 
furthest delivery zone.
    This estimate is based upon: (1) Ninety three submissions (80% of 
116 submissions) being submitted by mailing an average of 10 CDs per 
envelope (93 x $8 = $744) and (2) Twenty three submissions (20% of the 
116 submissions) being submitted by mailing a package of paper 
documents weighing an average of 50 pounds (23 x $52 = $1,196.) 
Therefore, we estimate the total capital costs associated with this 
document submission to be $1,940.

    Dated: July 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17607 Filed 7-19-10; 8:45 am]
BILLING CODE 4160-01-S