Document ID: FDA-2010-D-0350-0011
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Tobacco Retailer Training Programs
Posted Date: 2013-03-27T04:00Z

[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18609-18611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06982]

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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; Guidance for Industry 
on 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: Fax written comments on the collection of information by April 
26, 2013.

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 ``Guidance for Industry on Tobacco Retailer Training Programs.'' 
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.

Guidance for Industry on Tobacco Retailer Training Programs--(OMB 
Control Number 0910-NEW)

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act grants FDA important authority to 
regulate the manufacture, marketing, and distribution of tobacco 
products to protect the public health generally and to reduce tobacco 
use by minors.
    The Tobacco Control Act provides for lower civil money penalties 
for violations of sale and distribution, including youth access, and 
advertising and promotion restrictions issued under section 906(d) of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
387f(d)), as amended by the Tobacco Control Act, for retailers who have 
implemented a training program that complies with standards developed 
by FDA for such programs (section 103(q)(2) of the Tobacco Control 
Act). FDA intends to issue regulations establishing standards for 
approved retailer training programs. In the interim, the guidance is 
intended to assist tobacco retailers in implementing training programs 
for employees.
    The guidance discusses the elements that should be covered in a 
training program, such as: (1) Federal laws restricting the sale and 
distribution, including youth access to, and the advertising and 
promotion of, cigarettes and smokeless 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 the sale of 
cigarettes and smokeless tobacco to minors; (4) identification of the 
cigarettes and smokeless tobacco sold in the retail establishment that 
are subject to the Federal laws prohibiting their sale to persons under 
the age of 18; and (5) age verification methods.
    The guidance recommends that retailers train current employees as 
soon as practicable and that new employees be trained prior to selling 
cigarettes and smokeless tobacco. Refresher training should be provided 
at least annually and more frequently, as needed. In addition, the 
guidance recommends that retailers review and update their training 
program, as needed, and take appropriate corrective action after any 
violation of the regulations restricting sale and distribution, 
including youth access, and advertising and promotion of cigarettes and 
smokeless tobacco. The guidance recommends that retailers document any 
modifications to the training program following such a review.
    The guidance recommends that retailers maintain certain 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 in section 103(q)(2)(A) of 
the Tobacco Control Act. The guidance also recommends that retailers 
implement certain hiring and management practices as part of a retailer 
training program.
    In the Federal Register of July 16, 2010 (75 FR 41498), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received seven comments in response to 
the notice, with four comments on the information collection. In the 
Federal Register of November 25, 2011 (76 FR 72710), FDA republished 
notice of the proposed collection of information in order to comply 
with section 3506(c)(2)(A) of the Paperwork Reduction Act. FDA received 
two comments that were beyond the scope of the information request 
(e.g., raising fines will be more successful than retailer training, 
support for educating retail employees about the negative effects of 
using tobacco products). Comments relevant to the information request 
are addressed in this document.
    (Comment 1) Several comments stated that it would be burdensome and 
costly to keep training records for 4 years due to the high turnover in 
the retail industry.
    (Response) The Tobacco Control Act does not require retailers to 
implement retailer training programs. However, it provides for two 
schedules of civil money penalties for violations of restrictions 
issued under section 906(d) of the FD&C Act pertaining to the sale and 
distribution of tobacco products, including access, advertising, and 
promotion restrictions--a schedule of lower penalties for retailers who 
have implemented a training program that complies with the standards 
set by FDA and a schedule of higher penalties for those who have not. 
Until FDA issues regulations establishing standards for approved 
retailer training programs, the Agency intends to seek penalties within 
the range provided by section 103(q)(2)(A)(i) of the Tobacco Control 
Act (for retailers with an approved retailer training program) whether 
or not the retailer has implemented a training program. FDA may 
consider further reducing the civil money penalty for retailers who 
have implemented a

[[Page 18610]]

training program. Retailers who wish to implement training programs 
should retain their records for 4 years to be able to provide evidence 
of a training program during the 48-month time period covered by the 
civil money penalty schedules in section 103(q)(2)(A) of the Tobacco 
Control Act.
    (Comment 2) Several comments suggested that retailers be allowed to 
keep electronic and/or written records of their training programs.
    (Response) We agree. The guidance provides that retailers may 
determine the format of the records to be maintained (e.g., paper, 
electronic).
    (Comment 3) Several comments suggested that, due to the high 
employee turnover in the retail industry, it would be burdensome for 
retailers to have job applicants sign an acknowledgment stating that 
they have read and understand the importance of complying with laws 
prohibiting the sale of cigarettes and smokeless tobacco.
    (Response) We agree with these comments and revised the guidance 
accordingly. However, we do not believe these changes will affect the 
burden for this information collection. In light of the comments' 
statements about the high turnover in the retail industry, it is 
possible that we underestimated the annual frequency for this 
recordkeeping. Therefore, we invite comments on the burden for employee 
acknowledgments to assist FDA in determining more accurate burden 
estimates in the future.
    (Comment 4) One comment suggested that retailers who receive a 
Complaint for Civil Money Penalties from FDA and who seek to have their 
penalty reduced because they have a training program should show that 
all staff involved in the violation had received the initial training 
and that remedial action was taken after the violation.
    (Response) We agree with this comment and revised the guidance to 
provide recommendations regarding when retailers should review and 
update their training program. Table 2 of this document includes our 
burden estimates for reviewing and updating retailer training programs. 
We estimate that retailers will review and update their training 
programs, on average, once a year. We invite comment on this burden 
estimate to assist FDA in determining a more accurate burden estimate 
in the future.
    As discussed in this document, FDA has adjusted the burden for this 
information collection based on public comments received for this 
collection of information. FDA's estimate of the number of respondents 
in tables 1 and 2 is based on data reported to the U.S. Department of 
Health and Human Services Substance Abuse and Mental Health Services 
Administration. According to the fiscal year 2009 Annual Synar Report, 
there are 372,677 total retail tobacco outlets in the 50 States, 
District of Columbia, and 8 U.S. territories that are accessible to 
youth (meaning that there is no State law restricting access to these 
outlets to individuals older than age 18). Inflating this number by 
about 10 percent to account for outlets in States that sell tobacco but 
are, by law, inaccessible to minors, results in an estimated total 
number of tobacco outlets of 410,000. We assume that 75 percent of 
tobacco retailers already have some sort of training program for age 
and identification verification. We expect that some of those retailer 
training programs already meet the elements in the guidance, some 
retailers would update their training program to meet the elements in 
the guidance, and other retailers would develop a training program for 
the first time. Thus, we estimate that two-thirds of tobacco retailers 
would develop a training program on a one-time basis that meets the 
elements in the guidance (66 percent of 410,000 = 270,600).
    With regard to reporting burden, we expect that all 270,600 
retailers would develop a training program on a one-time basis. Table 1 
estimates the one-time burden for retailers. In addition, we expect 
that all 270,600 retailers would maintain records. Table 2 estimates 
the recordkeeping burden for retailers.
    FDA estimates the burden of this collection of information as 
follows:

                                                    Table 1--Estimated One-Time Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of       Annual frequency     Total annual        Hours per
                         Activity                             respondents        per response        responses           response         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Develop training program.................................            270,600                  1            270,600                 16          4,329,600
Develop written policy against sales to minors & employee            270,600                  1            270,600                  1            270,600
 acknowledgment..........................................
Develop internal compliance check program................            270,600                  1            270,600                  8          2,164,800
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................         6,765,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Because the reporting burden in this table is for one-time activities only, the annualized burden for this table is estimated to be 2,255,000
  (6,765,000 one-time burden hours divided by 3 years expected OMB approval).

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of       Annual frequency     Total annual
                         Activity                            recordkeepers    per recordkeeping       records        Hours per record     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Training program.........................................            270,600                  4          1,082,400               0.25            270,600
                                                                                                                         (15 minutes)
Review and update training program.......................            270,600                  1            270,600                0.5            135,300
                                                                                                                         (30 minutes)
Written policy against sales to minors & employee                    270,600                  4          1,082,400               0.10            108,240
 acknowledgment..........................................                                                                 (6 minutes)
Internal compliance check program........................            270,600                  2            541,200                0.5            270,600
                                                                                                                         (30 minutes)
                                                          ----------------------------------------------------------------------------------------------

[[Page 18611]]

 
    Total................................................  .................  .................  .................  .................           784,740
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: March 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06982 Filed 3-26-13; 8:45 am]
BILLING CODE 4160-01-P