[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:
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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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