[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9216-9217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03381]



[[Page 9216]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0086]


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

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 the collection of information 
contained in FDA's Tobacco Product Violations Reporting Form.

DATES: Submit either electronic or written comments on the collection 
of information by April 21, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [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 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.

Potential Tobacco Product Violations Reporting Form--(OMB Control 
Number 0910-0716)--Extension

    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 section 201 et seq. 
of the Federal Food, Drug, and Cosmetic Act (the 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 an extension of OMB approval 
for the 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.
    FDA created a Tobacco Call Center (with a toll-free number: 1-877-
CTP-1373). Callers are able to report potential violations of the 
Tobacco Control Act, and FDA will conduct targeted followup 
investigations 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 occurred; product type (e.g., cigarette, smokeless, roll-
your-own); tobacco brand; potential violation type; type of potentially 
violative promotional materials; who potentially violated; and the 
name, address, phone number, and email 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 currently provides a form that may be used to solicit this 
information from the caller (Form FDA 3779, Potential Tobacco Product 
Violations Report), and seeks renewal of Form FDA 3779. This form is 
posted on FDA's Web site. The public and interested stakeholders are 
also able to report information regarding possible violations of the 
Tobacco Control Act through the following methods: Calling the Tobacco 
Call Center using the Center for Tobacco Products' (CTP) toll-free 
number; using a fillable Form FDA 3779 found on FDA's Web site; 
downloading a PDF version of the form to send via email or mail to FDA; 
requesting a copy of Form FDA 3779 by contacting CTP and sending by 
mail to FDA; and sending a letter to FDA's CTP. The public and 
interested stakeholders will also be able to report information 
regarding possible violations of the Tobacco Control Act in the future 
using FDA's tobacco violation reporting smartphone application.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 9217]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                    No. of
  Activity and Form FDA 3779        No. of       Responses per   Total annual    Average burden     Total hours
                                  Respondents     respondent       responses      per response
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Reporting violations of the                400               2             800  0.25 (15                     200
 FD&C Act, as amended by the                                                     minutes).
 Tobacco Control Act, by
 telephone, Internet form,
 mail, smartphone application,
 or email..
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that submitting the information (by telephone, 
Internet, mail, smartphone application, or email) will take 0.25 hours 
(i.e., 15 minutes) per response. FDA estimates the number of annual 
respondents to this collection of information will be 400, who will 
each submit 2 reports by telephone, Internet, mail, smartphone 
application, or email. This estimate is based on the rate of reporting 
through Form FDA 3779, reports received from FDA's toll-free telephone 
number and email address, and FDA experience. Each report is expected 
to take 0.25 hours to complete and submit; therefore, total burden 
hours for this collection of information is estimated to be 200 hours 
(800 responses x 0.25 hours per response). The total burden hours for 
this collection have decreased by 50 hours (from 250 to 200) because 
the number of estimated respondents decreased from 1,000 to 400, and 
the annual responses are expected to drop from 1,000 to 800 annually. 
Based on past submissions to FDA, the number of estimated annual 
respondents is expected to decrease from 1,000 to 400 and each 
respondent's number of submissions is expected to increase from 1 to 2 
annually. Therefore, the number of responses are expected to decrease 
from 1,000 to 800 annually (400 respondents x 2 responses).

    Dated: February 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03381 Filed 2-14-14; 8:45 am]
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