81 FR 9862 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Tobacco Retailers on Tobacco Retailer Training Programs

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 38 (February 26, 2016)

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 information collection provisions of the guidance entitled ``Tobacco Retailer Training Programs.''

[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Pages 9862-9864]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04176]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Tobacco Retailers on Tobacco Retailer 
Training Programs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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, 
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 information collection 
provisions of the guidance entitled ``Tobacco Retailer Training 
Programs.''

DATES: Submit either electronic or written comments on the collection 
of information by April 26, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-D-0350 for ``Guidance for Tobacco Retailers on Tobacco 
Retailer Training Programs.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts

[[Page 9863]]

and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 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.

Information Request Regarding Guidance for Tobacco Retailers on Tobacco 
Retailer Training Programs--OMB Control Number 0910-0745--Extension

    The Family Smoking Prevention and Tobacco Control Act (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 issued under section 906(d) of the Federal 
Food, Drug, and Cosmetic 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. 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 effective training 
programs for employees.
    The 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; 
(5) age verification methods; (6) practical guidelines for refusing 
sales; and (7) testing to ensure that employees have the required 
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 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 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 
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 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 that meets the elements in 
the guidance (66 percent of 410,000 = 270,600).
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
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 and employee
 acknowledgement................

[[Page 9864]]

 
Develop internal compliance              270,600               1         270,600               8       2,164,800
 check program..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       6,765,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Number of
                 Activity                     Number of      records per    Total annual          Average burden per  recordkeeper          Total hours
                                            recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Training program.........................         270,600               4       1,082,400  0.25 (15 minutes)............................         270,600
Written policy against sales to minors            270,600               4       1,082,400  0.10 (6 minutes).............................         108,240
 and employee acknowledgement.
Internal compliance check program........         270,600               2         541,200  0.5 (30 minutes).............................         270,600
                                          ------------------------------------------------                                               ---------------
    Total................................  ..............  ..............  ..............  .............................................         649,440
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04176 Filed 2-25-16; 8:45 am]
 BILLING CODE 4164-01-P