[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36597-36598]
[FR Doc No: 2020-13071]

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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 or the Agency) 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 (PRA).

DATES: Submit written comments (including recommendations) on the
collection of information by July 17, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0716. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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

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 (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.
    The public is crucial in helping FDA enforce tobacco regulations to
protect America's youth. FDA created the Tobacco Call Center (with a
toll-free number: 1-877-CTP-1373) to assist the public with reporting
potential violations of the Tobacco Control Act. FDA will evaluate any
information reported and may conduct followup investigations if
necessary. 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, cigar, e-cigarette, hookah, pipe tobacco);
tobacco brand; potential violation type; type of potentially violative
promotional materials; who potentially violated, including the name,
address, phone number, and email address of the potential violator. The
caller will also be asked to list the potential violator's website (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 public (Form FDA 3779, Potential Tobacco Product
Violations Report) and seeks renewal of Form FDA 3779. The public and
interested stakeholders are able to report information regarding
possible violations of the Tobacco Control Act by submitting
information online, via email, postal mail, or by calling FDA's Tobacco
Call Center. Instructions on how to report possible violations of the
Tobacco Control Act can be found at (https://www.fda.gov/tobacco-products/compliance-enforcement-training/report-potential-tobacco-product-violation).
    In the Federal Register of October 15, 2019 (84 FR 55161), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two PRA related comments were received.
    (Comment 1) FDA received a comment urging the Agency to publicize
the availability of the Potential Tobacco Product Violations Report
(PTVR) form more broadly. The comment further urged that if FDA does
not already have a dissemination plan for this information collection
actively, it must create one because it is important that consumers,
retailers, and other stakeholders are aware of this form in order to be
most helpful. The comment indicated that it is important that FDA
disseminate the violations reporting form more broadly to the public so
people are aware of how they can report the various types of
violations.
    (Response) There are multiple options available for industry and
the public to report potential violations of the Tobacco Control Act,
and FDA has publicized the form on multiple occasions, including when
the FDA Commissioner issued public statements regarding the youth
vaping epidemic and potential electronic nicotine delivery systems-
related seizures. FDA's website (https://www.fda.gov/tobacco-products/compliance-enforcement-training/report-potential-tobacco-product-violation) has a link to submit the online PTVR form (https://www.accessdata.fda.gov/scripts/ptvr/index.cfm).
    As referenced previously in this notice, there are many additional
options for submission, which can be found at https://www.fda.gov/tobacco-products/compliance-enforcement-training/report-potential-tobacco-product-violation.
    (Comment 2) FDA received a comment which stated that the original

burden of this collection of information of 1,500 hours was too low and
that the commenter believes more violations occur than 1,500. The
commenter pointed to the number of Warning Letters and Civil Money
Penalties FDA issued in 2019 to support this statement.
    (Response) After reviewing the PTVR submissions again over the past
5 years we have made an adjustment to our burden estimate. The number
of complaints submitted by the public is not reflective of the total
number of reported violations of the FD&C Act and implementing
regulations. In 2019, FDA received over 3,000 annual PTVR complaint
reports and issued over 14,600 Warning Letters, 4,700 Civil Money
Penalties, and 17 No-Tobacco-Sale-Orders. Reports of potential
violations from the public are critical in helping FDA enforce tobacco
regulations to protect America's youth. The PTVR form was designed to
provide the public with a means of reporting violations of the FD&C Act
to the Center for Tobacco Products. FDA conducts our own investigations
and inspections to followup on complaints that may be submitted through
PTVR submissions. FDA evaluates each report submitted to determine if
the activity is a potential violation of the FD&C Act or related
regulations before deciding what followup action, if any, is necessary.
FDA now estimates we will receive 5,370 reports annually.
    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 per response       Total hours
                                                    respondents       respondent       responses
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Reporting violations of the FD&C Act, as amended           2,685                2            5,370   0.25 (15 minutes).................           1,343
 by the Tobacco Control Act via telephone,
 online form, mail 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, online
form, mail or email) will take 0.25 hour (i.e., 15 minutes) per
response. This estimate is based on the type and rate of reporting that
has been submitted through the Potential Tobacco Violation Report Form
in the past.
    FDA estimates the number of annual respondents to this collection
of information will be 2,685, who will each submit 2 reports by
telephone, online form, mail or email. Each report is expected to take
0.25 hour to complete and submit; therefore, total burden hours for
this collection of information is estimated to be 1,343 hours (5,370
responses x 0.25 hour per response).
    We have adjusted our burden estimate based on the updated number of
reports received to approximately 5,370 forms annually, which more
accurately reflects the projected number of submissions based on
current trends. Using these new figures, our estimated burden for the
information collection signifies an overall increase to reflect 2,685
respondents per year and 1,343 hours.

    Dated: June 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13071 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P