Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form, 14018-14020 [2012-5634]
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14018
Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total
burden hours
Information Collections ....................................................................................
2,700
1
2
5,400
Estimated Total Annual Burden
Hours: 5,400.
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project. Fax: 202–395–7285,
Email: OIRA_SUBMISSION@OMB.EOP.
GOV. Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–5600 Filed 3–7–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
wreier-aviles on DSK5TPTVN1PROD with NOTICES
[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.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
SUMMARY:
VerDate Mar<15>2010
15:20 Mar 07, 2012
Jkt 226001
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 oira_
submission@omb.eop.gov. 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, daniel.gittleson@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–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–
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
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
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Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices
comments embedded. The comments
have been summarized into four PRArelated 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 (AskCTP@fda.hhs.gov), and Form
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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 tobaccorelated events and potential violations,
such as that offered by the 1–877–CTP–
1373 toll-free hotline and the AskCTP@
fda.hhs.gov 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
PO 00000
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14019
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,
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Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices
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
Number of
respondents
Activity and Form FDA 3779
Reporting potential violations of the FD&C Act, as amended by the Tobacco Control Act, by telephone, Internet or
paper form, smartphone application or email ..................
1 There
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
wreier-aviles on DSK5TPTVN1PROD with NOTICES
1,000
Total annual
responses
1
1,000
Average
burden per
response
0.25
Total
hours
250
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 × 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.
[Docket No. FDA–2012–N–0197]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Emergency
Shortages Data Collection System
AGENCY:
Annual
frequency
per response
Food and Drug Administration,
HHS.
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ACTION:
Notice.
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 Emergency Shortages Data
Collection System.
DATES: Submit either electronic or
written comments on the collection of
information by May 7, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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
SUMMARY:
PO 00000
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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.
Emergency Shortages Data Collection
System—Section 903(d)(2) of the
Federal Food, Drug, and Cosmetic Act
(OMB Control Number 0910–0491)—
Extension
Under section 903(d)(2) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 393(d)(2)), the
Commissioner of Food and Drugs is
authorized to implement general powers
(including conducting research) to carry
out effectively the mission of FDA.
Subsequent to the events of September
11, 2001, and as part of broader
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[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Notices]
[Pages 14018-14020]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5634]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 oira_submission@omb.eop.gov. 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,
daniel.gittleson@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-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 (AskCTP@fda.hhs.gov), 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 AskCTP@fda.hhs.gov 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Activity and Form FDA 3779 Number of frequency per Total annual Average burden Total hours
respondents response responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
