[Federal Register Volume 74, Number 205 (Monday, October 26, 2009)]
[Notices]
[Pages 55050-55051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25604]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Tobacco Product Standard for Flavored Cigarettes

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

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 the proposed extension of an 
existing collection of information pertaining to the tobacco product 
standard for flavored cigarettes under the Family Smoking Prevention 
and Tobacco Control Act (FSPTCA).

DATES:  Submit written or electronic comments on the collection of 
information by December 28, 2009.

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 (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 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, 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 extension of 
an existing 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.

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

    On June 22, 2009, the President signed the FSPTCA (Public Law 111-
31) into law. The FSPTCA amended the Federal Food, Drug, and Cosmetic 
Act (FDCA) 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 FDCA, as amended 
by the FSPTCA, 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 Call Center representatives use to record this 
information. Additionally, this form is posted on FDA's Internet 
(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 on-line. 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 (September 25, 2009; 74 FR 48974). 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,

[[Page 55051]]

     Press release announcing the effective date of the 
cigarette flavor ban,
     Flavored tobacco products fact sheet, and
     Flavored tobacco products parental advisory.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1.--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        No. of         Annual Frequency        Total Annual           Minutes per
           Activity and Form  FDA 3734               Respondents         per Response            Responses             Response           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting violations of section 907(a)(1)(A) of               1,700                     1                 1,700                    10                283
 the FDCA
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: October 15, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25604 Filed 10-23-09; 8:45 am]
BILLING CODE 4160-01-S