
[Federal Register Volume 76, Number 162 (Monday, August 22, 2011)]
[Notices]
[Pages 52333-52334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21381]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0553]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Tobacco Product Reporting Violation Form

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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the collection of information contained in 
FDA's Tobacco Product Reporting Violation Form.

DATES: Submit either electronic or written comments on the collection 
of information by October 21, 2011.

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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@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.

[[Page 52334]]

Tobacco Product Reporting Violation Form (OMB Control Number 0910-NEW)

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 
111-31) into law. The Tobacco Control Act amended the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321 et seq.) 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 OMB approval for a new collection of information 
to accept consumer and other stakeholder feedback and notification of 
potential violations of the FD&C Act, as amended by the Tobacco Control 
Act.
    As part of its enforcement strategy, FDA created a Tobacco Call 
Center (with a toll-free number: 1-877-CTP-1373) to accept information 
from the public about violations of the Tobacco Control Act. Callers 
are able to report potential violations of the Tobacco Control Act and 
FDA will conduct targeted followup investigation based on information 
received. When callers report a violation, the caller will be asked to 
provide as much certain information as they can recall, including: The 
date the potential violation happened, the product type (e.g., 
cigarette, smokeless, roll-your-own, etc.), tobacco brand, type of 
potentially violative promotional materials, potential violation type, 
who potentially violated, and the name, address, phone number, and e-
mail address of the potential violator. The caller will also be asked 
to list the potential violator's Web site (if available), describe the 
potential violation, and provide any additional files or information 
pertinent to the potential violation. FDA has developed a form that 
will be used to solicit this information from the caller (FDA Form 
3779, Tobacco Product Violations Reporting), which is expected to 
eventually replace current form FDA Form 3734 for Cigarette Flavor Ban 
Violations. This new form will be posted on FDA's Web site, and 
information may be submitted by filling out the form online (or the 
public can request a copy of Form 3779 by contacting the Center for 
Tobacco Products (CTP)). In addition, FDA has developed a smartphone 
application for use with iPhones, Android, etc. to allow consumers to 
report potential violations to FDA via their smartphone. Others may 
simply choose to send a letter to FDA with their information. In 
summary, the public will be able to report information regarding 
possible violations of the Tobacco Control Act through the following 
methods: calling the Tobacco Call Center using CTP's toll-free number; 
using a fill-able form found on FDA's Web site; using FDA's tobacco 
violation reporting smartphone application, and sending a letter to 
FDA's Center for Tobacco Products.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                     Activity and FDA Form 3779                         Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting violations of the FD&C Act, as amended by the Tobacco               1,000                1            1,000            0.167              167
 Control Act by telephone, Internet form, smartphone application,
 or mail...........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that submitting the information (by phone, Internet 
form, smartphone application, or mail) will take 10 minutes. Since a 
similar type of reporting went into effect for the cigarette flavor 
ban, FDA has received several reports via the Internet or e-mail. 
Judging from the rate of reporting for the cigarette flavor ban, FDA 
estimates the number of respondents will be 1,000 who will submit 1 
report each annually by phone, Internet form, smartphone application, 
or mail. Because of the variety of products regulated by FDA under the 
authority of the FD&C Act, as amended by the Tobacco Control Act, FDA 
expects the rate of calls and reports received to remain steady over 
the next 3 years.

    Dated: August 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21381 Filed 8-19-11; 8:45 am]
BILLING CODE 4160-01-P


