[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7279-7281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3036]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0496]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Tobacco Product 
Standard on Flavored Cigarettes

AGENCY: Food and Drug Administration, HHS.

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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 March 
22, 2010.

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 e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0647. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Tobacco Product Standard on Flavored Cigarettes--(OMB Control Number 
0910-0647)--Extension

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 
111-31) into law. The Tobacco Control Act amended the Federal Food, 
Drug, and Cosmetic Act (the 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.
    FDA is requesting an extension of an existing collection of 
information pertaining to section 907(a)(1)(A) of the act (21 U.S.C. 
397(a)(1)(A), as amended by the Tobacco Control Act, which provides a 
general tobacco standard special rule for cigarettes that became 
effective on September 22, 2009. This special rule for cigarettes 
states in part that ``* * * a cigarette or any of its component parts 
(including the tobacco, filter, or paper) shall not contain, as a 
constituent (including a smoke constituent) or additive, an artificial 
or natural flavor (other than tobacco or menthol) or an herb or spice, 
including strawberry, grape, orange, clove, cinnamon, pineapple, 
vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that 
is a characterizing flavor of the tobacco product or tobacco smoke.''
    As part of our enforcement strategy, FDA created a Tobacco Call 
Center (with a toll-free number) to accept information from the public 
about violations of this provision, known as the cigarette flavor ban. 
Callers are able to report violations of the cigarette flavor ban and 
FDA will determine whether to conduct targeted followup investigations 
based on information the agency receives. Members of the public who 
wish to report a violation will be asked for certain information: Name 
and contact information, which are optional, date that the caller 
observed or purchased the alleged violative product, description of the 
tobacco product, and address of the retail outlet or Internet address 
where the violative product was available. FDA developed a form (FDA 
Form 3734) that Tobacco Call Center representatives use to record this 
information. Additionally, this form is posted on FDA's Internet at 
http://www.accessdata.fda.gov/scripts/email/TobaccoProducts/flavoredCigarettes.cfm) which allows the public to report violations of 
the cigarette flavor ban by filling out the form online. Others may 
simply choose to send a letter to FDA. (Information about how to 
contact FDA's Center for Tobacco Products is posted at http://www.fda.gov/TobaccoProducts/default.htm).
    FDA described how to report information about possible violations 
in a Federal Register notice reminding regulated industry of the 
effective date of the ban on certain flavored cigarettes (74 FR 48974, 
September 25, 2009). FDA also included this information in the 
following outreach materials:
     Letter to our tobacco control partners announcing the 
cigarette flavor ban and soliciting information on possible violations,
     Press release announcing the effective date of the 
cigarette flavor ban,
     Flavored tobacco products fact sheet, and
     Flavored tobacco products parental advisory.
    In the Federal Register of October 26, 2009 (74 FR 55050), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment in response to the 
60-day notice soliciting public comment on the extension of OMB 
approval for this information collection generally supporting ``the 
extension of this collection of information regarding the enforcement 
of the cigarette flavor ban and submits that the extension of data 
collection is critical to the `proper performance of FDA's functions' 
and that it will have great `practical utility'.'' Although FDA did not 
receive comment on the estimated number of respondents, FDA is 
adjusting this estimate based on current reporting experience to 170 
respondents.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                           No. of        Annual Frequency  per      Total Annual       Minutes Per
             Activity and Form FDA 3734                 Respondents             Response             Responses           Response         Total Hours
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Reporting violations of section 907(a)(1)(A) of the                170                        1                170   10 (0.167 hours)                 28
 act
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 7281]]

    Dated: February 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3036 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S