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)

Page Range		9862-9864
FR Document		2016-04176

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 Issue 38 (Friday, February 26, 2016)

[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]


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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; 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

Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices 9863

and/or go to the Division of Dockets Information Request Regarding money penalty schedules in section
Management, 5630 Fishers Lane, rm. Guidance for Tobacco Retailers on 103(q)(2)(A) of the Tobacco Control Act.
1061, Rockville, MD 20852. Tobacco Retailer Training Programs— The guidance also recommends that
OMB Control Number 0910–0745— retailers implement certain hiring and
FOR FURTHER INFORMATION CONTACT: FDA Extension
PRA Staff, Office of Operations, Food management practices as part of an
and Drug Administration, 8455 The Family Smoking Prevention and effective retailer training program. The
Tobacco Control Act (Tobacco Control guidance suggests that applicants and
Colesville Rd., COLE–14526, Silver
Act) does not require retailers to current employees be notified both
Spring, MD 20993–0002, PRAStaff@
implement retailer training programs. verbally and in writing of the
fda.hhs.gov. However, the statute does provide for importance of complying with laws
SUPPLEMENTARY INFORMATION: Under the lesser civil money penalties for prohibiting the sales of tobacco products
PRA (44 U.S.C. 3501–3520), Federal violations of access, advertising, and to persons under the age of 18 and that
Agencies must obtain approval from the promotion restrictions of regulations they should be required to sign an
Office of Management and Budget issued under section 906(d) of the acknowledgement stating that they have
Federal Food, Drug, and Cosmetic Act read and understand the information. In
(OMB) for each collection of
(21 U.S.C. 387f(d)), as amended by the addition, FDA recommends that
information they conduct or sponsor.
Tobacco Control Act, for retailers who retailers implement an internal
‘‘Collection of information’’ is defined have implemented a training program compliance check program and
in 44 U.S.C. 3502(3) and 5 CFR that complies with standards developed document the procedures and corrective
1320.3(c) and includes Agency requests by FDA for such programs. FDA intends actions for the program.
or requirements that members of the to issue regulations establishing
public submit reports, keep records, or FDA’s estimate of the number of
standards for approved retailer training respondents in tables 1 and 2 of this
provide information to a third party. programs. In the interim, the guidance document is based on data reported to
Section 3506(c)(2)(A) of the PRA (44 is intended to assist tobacco retailers in the U.S. Department of Health and
U.S.C. 3506(c)(2)(A)) requires Federal implementing effective training Human Services Substance Abuse and
Agencies to provide a 60-day notice in programs for employees. Mental Health Services Administration
the Federal Register concerning each The guidance discusses the elements
(SAMHSA). According to the fiscal year
proposed collection of information, that should be covered in a training
2009 Annual Synar Report, there are
including each proposed extension of an program, such as: (1) Federal laws
372,677 total retail tobacco outlets in
existing collection of information, restricting the access to, and the
the 50 States, District of Columbia, and
before submitting the collection to OMB advertising and promotion of, cigarettes
8 U.S. territories that are accessible to
for approval. To comply with this and smokeless tobacco products; (2) the
youth (meaning that there is no State
requirement, FDA is publishing notice health and economic effects of tobacco
law restricting access to these outlets to
use, especially when the tobacco use
of the proposed collection of individuals older than age 18). Inflating
begins at a young age; (3) written
information set forth in this document. this number by about 10 percent to
company policies against sales to
With respect to the following minors; (4) identification of the tobacco account for outlets in States that sell
collection of information, FDA invites products sold in the retail establishment tobacco but are, by law, inaccessible to
comments on these topics: (1) Whether that are subject to the Federal laws minors results in an estimated total
the proposed collection of information prohibiting their sale to persons under number of tobacco outlets of 410,000.
is necessary for the proper performance the age of 18; (5) age verification We assume that 75 percent of tobacco
methods; (6) practical guidelines for retailers already have some sort of
of FDA’s functions, including whether
refusing sales; and (7) testing to ensure training program for age and
the information will have practical
that employees have the required identification verification. We expect
utility; (2) the accuracy of FDA’s that some of those retailer training
estimate of the burden of the proposed knowledge. The guidance recommends
that retailers require current and new programs already meet the elements in
collection of information, including the the guidance, some retailers would
validity of the methodology and employees to take a written test prior to
selling tobacco products and that update their training program to meet
assumptions used; (3) ways to enhance the elements in the guidance, and other
refresher training be provided at least
the quality, utility, and clarity of the retailers would develop a training
annually and more frequently as
information to be collected; and (4) program for the first time. Thus, we
needed. The guidance recommends that
ways to minimize the burden of the retailers maintain certain written estimate that two-thirds of tobacco
collection of information on records documenting that all individual retailers would develop a training
respondents, including through the use employees have been trained and that program that meets the elements in the
of automated collection techniques, retailers retain these records for 4 years guidance (66 percent of 410,000 =
when appropriate, and other forms of in order to be able to provide evidence 270,600).
information technology. of a training program during the 48- FDA estimates the burden of this
month time period covered by the civil collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
mstockstill on DSK4VPTVN1PROD with NOTICES

Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Develop training program .................................................... 270,600 1 270,600 16 4,329,600
Develop written policy against sales to minors and em-
ployee acknowledgement ................................................. 270,600 1 270,600 1 270,600

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9864 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Develop internal compliance check program ...................... 270,600 1 270,600 8 2,164,800

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
Number of Total annual Average burden per
Activity records per Total hours
recordkeepers records recordkeeper
recordkeeper

Training program ............................................. 270,600 4 1,082,400 0.25 (15 minutes) ............... 270,600
Written policy against sales to minors and 270,600 4 1,082,400 0.10 (6 minutes) ................. 108,240
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. Ave., Bldg. 31, Rm. 2417, Silver Spring, or designee, who is identified with
Leslie Kux, MD 20993–0002, 301–796–9001, email: consumer interests and is recommended
Associate Commissioner for Policy. GIDAC@fda.hhs.gov. by either a consortium of consumer-
[FR Doc. 2016–04176 Filed 2–25–16; 8:45 am] SUPPLEMENTARY INFORMATION: Under 41 oriented organizations or other
BILLING CODE 4164–01–P CFR 102–3.65 and approval by the interested persons. In addition to the
Department of Health and Human voting members, the Committee may
Services under 45 CFR part 11 and by include one non-voting member who is
DEPARTMENT OF HEALTH AND the General Services Administration, identified with industry interests.
HUMAN SERVICES FDA is announcing the renewal of the
Gastrointestinal Drugs Advisory Further information regarding the
Food and Drug Administration Committee. The Committee is a most recent charter and other
discretionary Federal advisory information can be found at http://
[Docket No. FDA–2016–N–0001] www.fda.gov/AdvisoryCommittees/
committee established to provide advice
Advisory Committee; Gastrointestinal to the Commissioner. CommitteesMeetingMaterials/Drugs/
Drugs Advisory Committee, Renewal The Committee advises the GastrointestinalDrugsAdvisory
Commissioner or designee in Committee/default.htm or by contacting
AGENCY: Food and Drug Administration, discharging responsibilities as they the Designated Federal Officer (see FOR
HHS. relate to helping to ensure safe and FURTHER INFORMATION CONTACT). In light
ACTION:Notice; renewal of advisory effective drugs for human use and, as of the fact that no change has been made
committee. required, any other product for which to the committee name or description of
the Food and Drug Administration has duties, no amendment will be made to
SUMMARY: The Food and Drug regulatory responsibility.
Administration (FDA) is announcing the 21 CFR 14.100.
The Committee reviews and evaluates
renewal of the Gastrointestinal Drugs available data concerning the safety and This document is issued under the
Advisory Committee by the effectiveness of marketed and Federal Advisory Committee Act (5
Commissioner of Food and Drugs (the investigational human drug products for U.S.C. app.). For general information
Commissioner). The Commissioner has use in the treatment of gastrointestinal related to FDA advisory committees,
determined that it is in the public diseases and makes appropriate please visit us at http://www.fda.gov/
interest to renew the Gastrointestinal recommendations to the Commissioner. AdvisoryCommittees/default.htm.
Drugs Advisory Committee for an The Committee shall consist of a core Dated: February 22, 2016.
additional 2 years beyond the charter of 11 voting members including the
expiration date. The new charter will be Leslie Kux,
Chair. Members and the Chair are
in effect until March 3, 2018. selected by the Commissioner or Associate Commissioner for Policy.
DATES: Authority for the Gastrointestinal designee from among authorities [FR Doc. 2016–04093 Filed 2–25–16; 8:45 am]
Drugs Advisory Committee will expire knowledgeable in the fields of BILLING CODE 4164–01–P
on March 3, 2018, unless the gastroenterology, endocrinology,
Commissioner formally determines that
mstockstill on DSK4VPTVN1PROD with NOTICES

surgery, clinical pharmacology,
renewal is in the public interest. physiology, pathology, liver function,
FOR FURTHER INFORMATION CONTACT: motility, esophagitis, and statistics.
Cindy Hong, Division of Advisory Almost all non-Federal members of this
Committee and Consultant committee serve as Special Government
Management, Office of Executive Employees. The core of voting members
Programs, Food and Drug may include one technically qualified
Administration, 10903 New Hampshire member, selected by the Commissioner

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Document Created: 2018-02-02 14:37:23
Document Modified: 2018-02-02 14:37:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by April 26, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 9862

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 SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration