[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Notices]
[Pages 14018-14020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5634]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 (the PRA).

DATES: Fax written comments on the collection of information by April 
9, 2012.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Potential Tobacco Product Violations Reporting Form.'' Also 
include the FDA 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, 
[email protected].

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-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 (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 OMB approval for a new collection of information 
to accept consumer and other stakeholder feedback and notification of 
potential tobacco 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 may conduct targeted followup investigation based on information 
received. When callers report a violation, the caller will be asked to 
provide as much 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 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 has developed a form that 
will be used to solicit this information from the caller (Form FDA 
3779, Potential Tobacco Product Violations Reporting), which is 
expected to eventually replace current Form FDA 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 FDA 3779 by contacting the Center for 
Tobacco Products (CTP)). In addition, FDA has developed a smartphone 
application for use with mobile devices (i.e., iPhones, Android) 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 and interested stakeholders 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.
    In the Federal Register of August 22, 2011 (76 FR 52333), FDA 
published a 60-day notice requesting public comment on this proposed 
collection of information. FDA received 24 comment submissions, which 
included over 60

[[Page 14019]]

comments embedded. The comments have been summarized into four PRA-
related areas as follows.
    (Comment 1) FDA received several comments that said the Tobacco 
Control Act does not include a provision directing FDA to request or 
accept information on potential tobacco product violations from the 
public and other stakeholder groups. The comments stated that the 
public and other stakeholder groups have not been trained to inspect 
retail tobacco operations, have not been trained to recognize or report 
tobacco product violations, and are not able to verify what does or 
does not constitute compliance with the Tobacco Control Act. Commenters 
also stated that a retailer of tobacco products could be targeted by 
overzealous stakeholders and unfairly earmarked by FDA for future 
inspections.
    (Response) FDA disagrees with this comment. The Tobacco Control Act 
amended the FD&C Act by adding a new chapter granting FDA important new 
authority to regulate the manufacture, marketing, and distribution of 
tobacco products to protect public health generally and to reduce 
tobacco use by minors. This includes broad authority to enforce the 
provisions of the Tobacco Control Act.
    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 (TCA). This collection of information falls under FDA's 
responsibilities to monitor compliance with and enforce the TCA.
    In addition, the proposed tobacco violation form does not require 
respondents to verify compliance with or violations of the TCA. 
Instead, the submitted information will be one source of information to 
help FDA identify potential areas for further Agency inquiry.
    (Comment 2) FDA received several comments that stated that the form 
is contrary to and may violate Executive Order 13563, ``Improving 
Regulation and Regulatory Review,'' the intent of which is to eliminate 
unnecessary and wasteful government regulations.
    (Response) FDA disagrees with this comment. Executive Order 13563 
pertains to unnecessary and wasteful regulations. This form is not a 
regulation but an extension of the means that the public and 
stakeholders have to voluntarily report potential tobacco violations 
and events to FDA. Current methods of reporting are FDA's toll-free 
hotline number (1-877-CTP-1373), email ([email protected]), and Form 
FDA 3734. This form is not an inspection reporting form but is another, 
perhaps easier, way for the public and stakeholders to report 
information to FDA. No information received from the form will be 
forwarded to inspectors unless the information is deemed credible by 
FDA.
    (Comment 3) Several comments questioned the burden to complete the 
form and the methodology used to compute total responses expected 
through the use of this form. Commenters also stated that the form is 
overly broad and includes some categories of tobacco products currently 
not regulated by FDA under the Tobacco Control Act. Commenters also 
stated that the form was redundant in places, while one commenter liked 
the form and encouraged FDA to make the public aware that the form 
exists.
    (Response) FDA generally agrees with these comments, except with 
regard to the redundancy of the form. The time to gather information 
and complete the form has been tested internally to take no longer than 
10 minutes. However, due to the comments received, FDA is revising the 
burden estimate upward to indicate that the form or mobile application 
will take 15 minutes to complete.
    With regard to the form being overly broad, the Potential Tobacco 
Product Violations Reporting Form has been revised to ensure that it 
only lists currently regulated tobacco products and possible violations 
under the TCA for those products. Most notably, the word ``other'' has 
been removed from some of the questions on the form to reduce confusion 
about which tobacco products are regulated by FDA. The layout of the 
form has also been adjusted to make it easier for the public to 
voluntarily submit information to FDA. The intent of the form is not to 
gather establishment inspection information like that collected by 
Federal, State, or local inspectors of tobacco facilities but to offer 
another means of contacting FDA about tobacco-related events and 
potential violations, such as that offered by the 1-877-CTP-1373 toll-
free hotline and the [email protected] email address. The use of the 
form is voluntary and is not designed to target specific establishments 
or deputize the public as inspectors for identifying specific 
violations of the TCA.
    With regard to the comments addressing the methodology for 
computing the burden, FDA has based this estimate on information 
received from several flavored cigarette reports, reports currently 
received from FDA's toll-free hotline and email address, and FDA 
experience. If the number of actual reports received is either too high 
or low, FDA will either correct the collection via a revision of the 
information collection or during its next renewal submission to OMB. 
Upon receiving OMB approval for the form and the collection of 
information, FDA will place the form on its complaint Web site and will 
advertise its location to the public.
    With regard to the redundancy of fields of information on the form, 
FDA has reviewed all aspects of the form and mobile application 
carefully and has eliminated any redundant fields on the form.
    (Comment 4) Several comments indicated that they thought the form 
is being used by the public and stakeholders as an inspection report to 
police or target tobacco retailers and the public, and that 
stakeholders have not been thoroughly or extensively trained with the 
training provided to FDA's Federal, State, and local inspectors. In 
addition to the lack of training, commenters also wondered what type of 
corrective action would or could be taken against a person or entity 
who files a false or inaccurate report against a retailer.
    (Response) FDA's intent in creating this form and mobile 
application is not to target retailers but to provide the public and 
stakeholders with another means to report tobacco-related events, 
concerns, or potential violations, much like the information that is 
currently collected using the existing Center for Tobacco Products 
toll-free hotline telephone number, email address, and Form FDA 3774. 
The Web-based, paper, and mobile application form may allow the Agency 
to become better informed about certain tobacco-related topics and will 
provide the public and other stakeholders with an easier and possibly 
more efficient way to submit potential violation and event information 
to FDA. Information received by FDA from this form will not be 
forwarded to an inspector unless FDA deems the information is credible 
and worth further investigation. The information provided by this form 
will also help FDA more efficiently use its inspection resources, based 
on credible information provided by the public and stakeholders on 
potential events.
    With regard to the type of corrective action taken against persons 
falsifying information submitted on these forms, FDA will scrutinize 
each submission carefully. Only forms containing information which are 
determined to be worthy of further investigation will be submitted to 
investigators for further review. Because this form is voluntary,

[[Page 14020]]

submission of the information by the public and stakeholders does not 
guarantee that an investigation against a retailer will be triggered, 
and FDA will work to ensure that no specific retailer or supplier is 
unfairly targeted.
    To clarify that Form FDA 3779 is not an inspection report, FDA is 
amending the title of Form FDA 3779 to ``Potential Tobacco Product 
Violations Reporting.'' FDA is making this change to reflect that the 
form is voluntary, that the form is intended to be a means for the 
public to submit information to FDA regarding possible violations of 
the laws that it enforces, and that a Form FDA 3779 submission is not, 
by itself, enough to warrant further FDA action.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                              Annual
                       Activity and Form FDA 3779                            Number of     frequency per   Total annual   Average burden    Total hours
                                                                            respondents      response        responses     per response
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Reporting potential violations of the FD&C Act, as amended by the                  1,000               1           1,000            0.25             250
 Tobacco Control Act, by telephone, Internet or paper form, smartphone
 application or email...................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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, paper form by mail, smartphone application, or email) will take 
15 minutes per response. Since a similar type of reporting went into 
effect for the cigarette flavor ban, FDA has received several reports 
via the Internet or email. Based on the rate of reporting for the 
cigarette flavor ban, reports received from FDA's toll-free telephone 
number and email address, and FDA experience, FDA estimates the number 
of annual respondents to this collection of information will be 1,000, 
who will each submit 1 report by phone, Internet form, paper form, 
smartphone application, or email. Each report is expected to take 15 
minutes to complete and submit, therefore, total burden hours for this 
collection of information is estimated to be 250 hours (1,000 responses 
x 0.25 hours per response). 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 constant over the next 3 years.

    Dated: March 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5634 Filed 3-7-12; 8:45 am]
BILLING CODE 4160-01-P