[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Notices]
[Pages 72710-72712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30327]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0350]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Draft Guidance for Tobacco Retailers on Tobacco 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 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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection provisions of 
the draft guidance entitled ``Tobacco Retailer Training Programs.''

DATES: Submit written or electronic comments on the collection of 
information by January 24, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://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. Identify comments 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, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 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 before submitting the 
collection to OMB for approval. To comply with this requirement, in the 
Federal Register of July 16, 2010 (75 FR 41498), FDA published a notice 
of availability of the draft guidance document providing a 60-day 
public comment period on the collection of information provisions. An 
electronic version of the guidance document is available on the 
Internet at http://www.regulations.gov (Docket No. FDA-2010-D-0350) and 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. FDA received seven 
comments in response to the notice of availability, with four comments 
pertaining to the information collection.
    FDA is republishing notice of the proposed collection of 
information in order to comply with section 3506(c)(2)(A) of the PRA. 
We invite comments only on the proposed collection of information set 
forth in this document. FDA will respond to comments on the collection 
of information provisions received in response to this notice and to 
the July 16, 2010, notice in a 30-day notice announcing that a proposed 
collection of information has been submitted to OMB for review and 
clearance under the PRA.
    With respect to the collection of information associated with the 
draft guidance, 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.

Information Request Regarding Draft Guidance for Tobacco Retailers on 
Tobacco Retailer Training Programs (OMB Control Number 0910-New)

    The Tobacco Control Act does not require retailers to implement 
retailer training programs. However, the statute does provide for 
lesser civil money penalties for violations of access, advertising, and 
promotion restrictions of regulations promulgated under section 906(d) 
of the Federal Food,

[[Page 72711]]

Drug, and Cosmetic Act, as amended by the Tobacco Control Act, for 
retailers who have implemented a training program that complies with 
standards developed by the FDA for such programs. The FDA intends to 
promulgate regulations establishing standards for approved retailer 
training programs. In the interim, the draft guidance is intended to 
assist tobacco retailers in implementing effective training programs 
for employees.
    The draft guidance discusses the 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 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 sales to minors; (4) identification of the 
tobacco products 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 draft 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 draft 
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 in section 103(q)(2)(A) of 
the Tobacco Control Act.
    The draft guidance also recommends that retailers implement certain 
hiring and management practices as part of an effective retailer 
training program. The draft 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 persons under the age of 18 and that they should be 
required to sign an acknowledgement stating that they have read and 
understand the information. In addition, FDA recommends that retailers 
implement an internal compliance check program and document the 
procedures and corrective actions for the program.
    FDA's estimate of the number of respondents in tables 1 and 2 of 
this document is based on data reported to the U.S. Department of 
Health and Human Services Substance Abuse and Mental Health Services 
Administration (SAMHSA). 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 draft 
guidance, some retailers would update their training program to meet 
the elements in the draft 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 that meets the 
elements in the draft guidance (66 percent of 410,000 = 270,600).
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated One Time Reporting Burden\1\
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                                                      Annual
            Activity                 Number of    frequency  per   Total annual      Hours per      Total hours
                                    Respondents       response       responses       response
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Develop training program........         270,600               1         270,600              16       4,329,600
Develop written policy against           270,600               1         270,600               1         270,600
 sales to minors & employee
 acknowledgment.................
Develop internal compliance              270,600               1         270,600               8       2,164,800
 check program..................
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    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.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                     Number of        Annual
            Activity                  Record-      frequency per   Total annual      Hours per      Total hours
                                      keepers     record-keeping      records         record
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Training program................         270,600               4       1,082,400             .25         270,600
Written policy against sales to          270,600               4       1,082,400             .10         108,240
 minors & employee
 acknowledgment.................
Internal compliance check                270,600               2         541,200              .5         270,600
 program........................
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    Total.......................  ..............  ..............  ..............  ..............         649,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 72712]]

    Dated: November 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30327 Filed 11-23-11; 8:45 am]
BILLING CODE 4160-01-P