Document ID: FDA-2014-N-0086-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Potential Tobacco
Product Violations Reporting Form
Posted Date: 2014-05-09T04:00Z

[Federal Register Volume 79, Number 90 (Friday, May 9, 2014)]
[Notices]
[Pages 26765-26766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10657]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 June 9, 
2014.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0716. 
Also include the FDA 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, PRAStaff@fda.hhs.gov.

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.

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.
    In the Federal Register of February 18, 2014 (79 FR 9216), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                     Activity and Form FDA 3779                         Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Reporting violations of the FD&C Act, as amended by the Tobacco                 400                2              800         \2\ 0.25              200
 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.
\2\ 15 minutes.

    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-

[[Page 26766]]

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. 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 is expected to decrease 
from 1,000 to 800 annually (400 respondents x 2 responses).

    Dated: May 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10657 Filed 5-8-14; 8:45 am]
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