Notice2026-03771
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Retailer Training Programs
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 25, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 37 (Wednesday, February 25, 2026)</title>
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[Federal Register Volume 91, Number 37 (Wednesday, February 25, 2026)]
[Notices]
[Pages 9290-9292]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03771]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0350]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tobacco Retailer
Training Programs
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: Submit written comments (including recommendations) on the
collection of information by March 27, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0745. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Barrett, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#37676576644356515177515356195f5f4419505841"><span class="__cf_email__" data-cfemail="06565447557267606046606267286e6e7528616970">[email protected]</span></a>.
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.
Tobacco Retailer Training Programs
OMB Control Number 0910-0745--Extension
Tobacco products are governed by chapter IX of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (sections 900 through 920) (21 U.S.C.
387 through 21 U.S.C. 387u). FDA intends to issue regulations
establishing standards for approved tobacco retailer training programs
under section 906(d) of the FD&C Act (21 U.S.C. 387f(d)). In the
interim, FDA published a guidance document entitled ``Tobacco Retailer
Training Programs (Revised)'' (2018) that can be downloaded at <a href="https://www.fda.gov/media/79013/download">https://www.fda.gov/media/79013/download</a>. The guidance is intended to assist
tobacco retailers to voluntarily implement effective training programs
for employees.
The guidance discusses recommended elements that should be covered
in a training program, such as: (1) Federal laws restricting the access
to, and the advertising and promotion of, cigarettes, smokeless, and
covered tobacco products; (2) the health and economic effects of
tobacco use, especially when the tobacco use begins at a young age; (3)
written company policies against sales to youth and other restrictions
on the access to, and the advertising and promotion of, tobacco
products; (4) identification of the tobacco products sold in the retail
establishment that are subject to the Federal laws and regulations
prohibiting their sale to underage persons; (5) age verification
methods; (6) practical guidelines for refusing sales; and (7) testing
to ensure that employees have the required
[[Page 9291]]
knowledge. The guidance recommends that retailers require current and
new employees to take a written test prior to selling tobacco products
and that refresher training be provided at least annually and more
frequently as needed. The guidance recommends that retailers maintain
certain written records documenting that all individual employees have
been trained and that retailers retain these records for 4 years in
order to be able to provide evidence of a training program during the
48-month time period covered by the civil money penalty schedules
outlined in the law.
The guidance also recommends that retailers implement certain
hiring and management practices as part of an effective retailer
training program. The guidance suggests that applicants and current
employees be notified both verbally and in writing of the importance of
complying with laws prohibiting the sales of tobacco products to
underage persons. In addition, FDA recommends that retailers implement
an internal compliance check program and document the procedures and
corrective actions for the program. In the Federal Register of August
22, 2025 (90 FR 41081), FDA published a 60-day notice requesting public
comment on the proposed collection of information. FDA received two
comments that were PRA related.
Both comments agreed that the proposed information collection is
necessary and has practical utility. One of the comments explained that
the retailer training program recommendations are linked to preventing
youth access to tobacco products and improving compliance. The other
comment explained that retailer training programs are a critical
component of preventing youth access to tobacco products and ensuring
compliance with federal law. FDA agrees with these comments.
One of the comments requested that FDA provide materials to the
public for the development of retail training programs, such as
retailer checklists covering the guidance recommendations, model
nonbinding templates for written policies and standard operating
procedures, and minimal data fields for employee records, to improve
uniformity. The same comment suggested that FDA could leverage specific
automation and information technology tools to minimize the burden on
respondents. FDA disagrees with the comment. The guidance provides
recommendations for elements to be included in retailer training
programs and recommended hiring and management practices to assist
retailers in complying with Federal tobacco laws and regulations.
Retailers who want to train employees about Federal requirements may
incorporate the elements described in the guidance into their existing
training programs, as appropriate. The guidance also encourages the
inclusion of training related to specific age verification techniques
using point of sale scanning systems and electronic age verification
devices. Additionally, FDA has provided several resources, such as
webinars and downloadable materials through FDA's ``This is Our Watch''
Program, to assist retailers in complying with the requirements under
the law.
Both comments suggested that FDA approve or otherwise explicitly
recognize that certain existing retailer training programs and
certifications satisfy recommended elements of the guidance. The
comments suggest that FDA approval or recognition of these programs and
certifications will improve the quality and usefulness of the collected
information. FDA disagrees with this comment. The Tobacco Control Act
does not require retailers to implement retailer training programs, and
retailers are under no obligation to submit their training programs for
FDA review because this is a voluntary program. Additionally, the
guidance establishes non-binding recommendations for the elements that
should be included in a retailer training program, it does not
establish requirements. To do so, FDA must first promulgate regulations
establishing standards for approved retailer training programs. FDA has
not yet promulgated these regulations, and currently FDA is not in a
position to recognize any program or certification as an approved
retailer training program.
With respect to the burden estimates, one comment indicated that
FDA may have overestimated the number of retailers that would need to
develop a training program as many may already have training programs
in place or may adopt existing programs. The same comment suggested
that FDA may have underestimated the burden per recordkeeper in Tables
1 and 2, but its estimates may be reasonable if FDA evaluates the
burden by retailer size and type. The other comment indicated that
FDA's burden estimates are likely reasonable. FDA agrees that it may
have overestimated the number of retailers that would develop new
retailer training programs and has adjusted the number of recordkeepers
in Table 1 as described below. FDA is not adjusting the average burden
values, as both commentors agree that those estimates could be
reasonable. While one comment noted that the burden may change per size
and sophistication of the retailer, the recommendations of the guidance
are not retail size or type specific. Additionally, FDA considered the
availability of online support resources provided by FDA to assist all
retail establishments in developing training programs and internal
compliance check programs in determining the average burden per
recordkeeper.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated One Time Annual Recordreporting Burden\1\
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Average burden
Number of Number of Total annual per
Activity (guidance section IV) recordkeepers records per records recordkeeper Total hours
recordkeeper in hours
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Develop training program........ 18,969 1 18,969 16 303,504
Develop written policy against 18,969 1 18,969 1 18,969
sales to minors and employee
acknowledgement................
Develop internal compliance 18,969 1 18,969 8 151,752
check program..................
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Total....................... .............. 3 .............. 25 474,225
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity (guidance section IV) Number of records per Total annual per recordkeeper Total hours
recordkeepers recordkeeper records in hours
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Training program.............. 237,113 4 948,452 0.25 (15 237,113
minutes).
Written policy against sales 237,113 4 948,452 0.10 (6 minutes) 94,845
to minors and employee
acknowledgement.
Internal compliance check 237,113 2 474,226 0.5 (30 minutes) 237,113
program.
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Total..................... .............. .............. .............. ................ 569,071
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
As explained above, FDA is adjusting its burden calculations based
on more recently available retailer data. FDA's estimate of the number
of respondents in tables 1 and 2 is based on 2022 data from the Census
Bureau's Economic Census,\1\ Statistics of U.S. Businesses (SUSB),\2\
and Business Dynamics Statistics (BDS).\3\
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\1\ <a href="http://www.census.gov/programs-surveys/economic-census/year/2022/news-updates/ecdata-releases.html">www.census.gov/programs-surveys/economic-census/year/2022/news-updates/ecdata-releases.html</a>. (EC2200NAPCSINDPRD Industry by
Product and EC2200NAPCSPRDIND
\2\ <a href="http://www.census.gov/data/tables/2022/econ/susb/2022-susb-annual.html">www.census.gov/data/tables/2022/econ/susb/2022-susb-annual.html</a>.
\3\ <a href="http://www.census.gov/data/data-tools/bds-explorer.html">www.census.gov/data/data-tools/bds-explorer.html</a>.
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We use SUSB and Economic Census data to estimate the counts of
retail establishments that sell tobacco products,\4\ resulting in a
count of 237,113 total tobacco product retail establishments who keep
records of training programs, written policies, and internal compliance
check programs (Table 2) annually. From the 2022 Business Dynamics
Statistics, we calculate establishment entry and exit rate of
approximately 8 percent, on average, for NAICS industry codes 4451
(Grocery and Convenience Retailers) and 4471 (Gasoline Stations)--these
two categories represent more than 60% of our estimated total count of
tobacco product retail establishments. In Table 1, we estimate 18,969
tobacco retail establishments (= 237,113 total establishments x 8
percent) may newly develop retailer training programs, written
policies, and internal compliance check programs annually.
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\4\ NAICS codes--44511 (Supermarkets and Other Grocery (except
Convenience) Stores), 44512 (Convenience Stores), 44530 (Beer, Wine,
and Liquor Stores), 44611 (Pharmacies and Drug Stores), 44711
(Gasoline Stations with Convenience Stores), 44719 (Other Gasoline
Stations), 452311 (Warehouse Clubs and Supercenters), 452319 (All
Other General Merchandise Stores), and 453991 (Tobacco Stores).
Economic Census data were used to determine the percent of
establishments within each NAICS code that sell tobacco products.
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In Table 1, FDA estimates that developing a training program will
require 16 hours, creating a written procedure may take 1 hour, and
developing an internal compliance check program will require 8 hours
for a total of 25 hours per respondent.
For Table 2, the guidance recommends retailers periodically review
and update their established training program, written policies, and
internal compliance checks. Annually, we assume training programs and
written policies will be reviewed and updated quarterly and therefore
estimate 4 records per recordkeeper, taking 21 minutes per quarter (=
15 minutes + 6 minutes). Following the guidance, we assume retailers
will conduct internal compliance checks every 6 months and therefore
estimate 2 records per recordkeeper annually, taking 30 minutes per
record.
FDA has updated the counts of tobacco product retail establishments
in Table 1 and Table 2 using more recent data from Census Bureau on the
number of retail establishments that sell tobacco products and retail
establishment entry and exit rates. FDA considered the availability of
online support resources provided by FDA to assist retail
establishments in developing training programs and internal compliance
check programs, and believe that the average burden values are
appropriate
Since publication of the 60-day notice, FDA has updated the
estimated annual burden for this information collection in response to
a public comment received during the 60-day comment period. Based on
further review of the assumptions used to calculate burden, the total
estimated annual hours have changed from 2,183,780 hours to 1,043,296
hours, an overall decrease of 1,140,484 hours.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03771 Filed 2-24-26; 8:45 am]
BILLING CODE 4164-01-P
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