81 FR 50522 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 147 (August 1, 2016)

Page Range		50522-50523
FR Document		2016-18092

The Food and Drug Administration (FDA or we) 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.

Federal Register, Volume 81 Issue 147 (Monday, August 1, 2016)

[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)]
[Notices]
[Pages 50522-50523]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18092]


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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 Tobacco 
Retailers on Tobacco Retailer Training Programs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) 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 August 
31, 2016.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0745. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, FDA PRA Staff, Office of Operations, Food 
and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20851, [email protected].

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 Tobacco Retailers on Tobacco Retailer Training Programs 
OMB Control Number 0910-0745--Extension

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) 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 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).
    The Tobacco Control Act gave FDA the authority to issue a 
regulation deeming all other products that meet the statutory 
definition of a tobacco product as subject to FDA regulatory authority 
(``deeming'') (section 901(b) of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act). On May 10, 2016, FDA issued the deeming rule, extending 
FDA's tobacco product authority to other tobacco products (81 FR 
28973). In the Federal Register of February, 26, 2016 (81 FR 9862), FDA 
published the 60-day notice requesting public comment on the proposed 
collection of information. Since FDA published the 60-day notice before 
the deeming rule, FDA has adjusted the burdens in this information 
collection to reflect the expected increase in the number of affected 
retail establishments based on the publication of the deeming rule, as 
detailed below. We also estimate that there are approximately 5,000 to 
10,000 vape shops; we assume that 66 percent

[[Page 50523]]

of them, or 3,300 (= 66% x 5,000) of the low estimate, currently engage 
in retailing activities (Ref. 1) Two PRA related comments were received 
in response to the 60-day notice.
    The two comments both identified additional training options that 
could be used to provide further educational opportunities for tobacco 
retailers. These comments primarily relate more to the content and 
method of a retailer training program rather than the proposed 
collection of information associated with the current guidance 
document. At the same time, one comment was supportive of the 
information collection activities associated with the current guidance 
document. FDA is supportive of training programs that assist retailers 
in complying with the tobacco control laws.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Develop training program........         273,900               1         273,900              16       4,382,400
Develop written policy against           273,900               1         273,900               1         273,900
 sales to minors and employee
 acknowledgement................
Develop internal compliance              273,900               1         273,900               8       2,191,200
 check program..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       6,847,500
----------------------------------------------------------------------------------------------------------------
\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..............................         273,900               4       1,095,600  .25 (15 minutes)........................         279,300
Written policy against sales to minors and             273,900               4       1,095,600  .10 (6 minutes).........................         109,560
 employee acknowledgement.
Internal compliance check program.............         273,900               2         547,800  .5 (30 minutes).........................         279,300
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................         668,160
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that the total burden for this collection will be 
7,515,660 hours (6,847,500 reporting + 668,160 recordkeeping).

Reference

    1. Burke, Don, ``Trends & Insights in the Nicotine Delivery 
Category.'' Management Science Associates, Inc. Presentation at NATO 
Show, April 23, 2015. Accessed June 2015.

    Dated: July 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18092 Filed 7-29-16; 8:45 am]
 BILLING CODE 4164-01-P

50522 Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Notices

Estimated Total Annual Burden Guidance for Tobacco Retailers on to persons under the age of 18 and that
Hours: 20,552. Tobacco Retailer Training Programs they should be required to sign an
Dated: July 25, 2016.
OMB Control Number 0910–0745— acknowledgement stating that they have
Extension read and understand the information. In
Kathy Greenlee, addition, FDA recommends that
Administrator and Assistant Secretary for
The Family Smoking Prevention and
Tobacco Control Act (Tobacco Control retailers implement an internal
Aging. compliance check program and
Act) (Pub. L. 111–31) does not require
[FR Doc. 2016–18177 Filed 7–29–16; 8:45 am]
retailers to implement retailer training document the procedures and corrective
BILLING CODE 4154–01–P
programs. However, the statute does actions for the program.
FDA’s estimate of the number of
provide for lesser civil money penalties
respondents in tables 1 and 2 is based
for violations of access, advertising, and
DEPARTMENT OF HEALTH AND on data reported to the U.S. Department
promotion restrictions of regulations
HUMAN SERVICES of Health and Human Services
issued under section 906(d) of the
Substance Abuse and Mental Health
Federal Food, Drug, and Cosmetic Act
Food and Drug Administration Services Administration (SAMHSA).
(21 U.S.C. 387f(d)), as amended by the According to the fiscal year 2009
Tobacco Control Act, for retailers who Annual Synar Report, there are 372,677
[Docket No. FDA–2010–D–0350] have implemented a training program total retail tobacco outlets in the 50
that complies with standards developed States, District of Columbia, and 8 U.S.
Agency Information Collection by FDA for such programs. FDA intends
Activities; Submission for Office of territories that are accessible to youth
to issue regulations establishing (meaning that there is no State law
Management and Budget Review; standards for approved retailer training
Comment Request; Guidance for restricting access to these outlets to
programs. In the interim, the guidance individuals older than age 18). Inflating
Tobacco Retailers on Tobacco Retailer is intended to assist tobacco retailers in
Training Programs this number by about 10 percent to
implementing effective training account for outlets in States that sell
programs for employees. tobacco but are, by law, inaccessible to
AGENCY: Food and Drug Administration, The guidance discusses the elements
HHS. minors, results in an estimated total
that should be covered in a training number of tobacco outlets of 410,000.
ACTION: Notice. program, such as: (1) Federal laws We assume that 75 percent of tobacco
restricting the access to, and the retailers already have some sort of
SUMMARY: The Food and Drug advertising and promotion of, cigarettes training program for age and
Administration (FDA or we) is and smokeless tobacco products; (2) the identification verification. We expect
announcing that a proposed collection health and economic effects of tobacco that some of those retailer training
of information has been submitted to the use, especially when the tobacco use programs already meet the elements in
Office of Management and Budget begins at a young age; (3) written the guidance, some retailers would
(OMB) for review and clearance under company policies against sales to update their training program to meet
the Paperwork Reduction Act of 1995. minors; (4) identification of the tobacco the elements in the guidance, and other
products sold in the retail establishment retailers would develop a training
DATES: Fax written comments on the that are subject to the Federal laws program for the first time. Thus, we
collection of information by August 31, prohibiting their sale to persons under estimate that two-thirds of tobacco
2016. the age of 18; (5) age verification retailers would develop a training
methods; (6) practical guidelines for program that meets the elements in the
ADDRESSES: To ensure that comments on
refusing sales; and (7) testing to ensure guidance (66 percent of 410,000 =
the information collection are received,
that employees have the required 270,600).
OMB recommends that written
knowledge. The guidance recommends The Tobacco Control Act gave FDA
comments be faxed to the Office of
that retailers require current and new the authority to issue a regulation
Information and Regulatory Affairs,
employees to take a written test prior to deeming all other products that meet the
OMB, Attn: FDA Desk Officer, FAX:
selling tobacco products and that statutory definition of a tobacco product
202–395–7285, or emailed to oira_
refresher training be provided at least as subject to FDA regulatory authority
submission@omb.eop.gov. All
annually and more frequently as (‘‘deeming’’) (section 901(b) of the
comments should be identified with the needed. The guidance recommends that Federal Food, Drug, and Cosmetic Act
OMB control number 0910–0745. Also retailers maintain certain written (FD&C Act). On May 10, 2016, FDA
include the FDA docket number found records documenting that all individual issued the deeming rule, extending
in brackets in the heading of this employees have been trained and that FDA’s tobacco product authority to
document. retailers retain these records for 4 years other tobacco products (81 FR 28973). In
FOR FURTHER INFORMATION CONTACT: FDA in order to be able to provide evidence the Federal Register of February, 26,
PRA Staff, Office of Operations, Food of a training program during the 48- 2016 (81 FR 9862), FDA published the
and Drug Administration, FDA PRA month time period covered by the civil 60-day notice requesting public
Staff, Office of Operations, Food and money penalty schedules in section comment on the proposed collection of
Drug Administration, Three White Flint 103(q)(2)(A) of the Tobacco Control Act. information. Since FDA published the
North, 10A63, 11601 Landsdown St., The guidance also recommends that 60-day notice before the deeming rule,
retailers implement certain hiring and
sradovich on DSK3GMQ082PROD with NOTICES

North Bethesda, MD 20851, PRAStaff@ FDA has adjusted the burdens in this
fda.hhs.gov. management practices as part of an information collection to reflect the
effective retailer training program. The expected increase in the number of
SUPPLEMENTARY INFORMATION: In guidance suggests that applicants and affected retail establishments based on
compliance with 44 U.S.C. 3507, FDA current employees be notified both the publication of the deeming rule, as
has submitted the following proposed verbally and in writing of the detailed below. We also estimate that
collection of information to OMB for importance of complying with laws there are approximately 5,000 to 10,000
review and clearance. prohibiting the sales of tobacco products vape shops; we assume that 66 percent

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Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Notices 50523

of them, or 3,300 (= 66% × 5,000) of the opportunities for tobacco retailers. information collection activities
low estimate, currently engage in These comments primarily relate more associated with the current guidance
retailing activities (Ref. 1) Two PRA to the content and method of a retailer document. FDA is supportive of training
related comments were received in training program rather than the programs that assist retailers in
response to the 60-day notice. proposed collection of information complying with the tobacco control
The two comments both identified associated with the current guidance laws.
additional training options that could be document. At the same time, one FDA estimates the burden of this
used to provide further educational comment was supportive of the collection of information as follows:

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

Develop training program .................................................... 273,900 1 273,900 16 4,382,400
Develop written policy against sales to minors and em-
ployee acknowledgement ................................................. 273,900 1 273,900 1 273,900
Develop internal compliance check program ...................... 273,900 1 273,900 8 2,191,200

Total .............................................................................. ........................ ........................ ........................ ........................ 6,847,500
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 Average
Number of Total annual
Activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeper

Training program .......................................................... 273,900 4 1,095,600 .25 (15 minutes) .... 279,300
Written policy against sales to minors and employee 273,900 4 1,095,600 .10 (6 minutes) ...... 109,560
acknowledgement.
Internal compliance check program ............................. 273,900 2 547,800 .5 (30 minutes) ...... 279,300

Total ...................................................................... ........................ ........................ ........................ ............................... 668,160
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates that the total burden DEPARTMENT OF HEALTH AND OMB recommends that written
for this collection will be 7,515,660 HUMAN SERVICES comments be faxed to the Office of
hours (6,847,500 reporting + 668,160 Information and Regulatory Affairs,
recordkeeping). Food and Drug Administration OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
Reference [Docket No. FDA–2013–N–1428] submission@omb.eop.gov. All
1. Burke, Don, ‘‘Trends & Insights in the Agency Information Collection comments should be identified with the
Nicotine Delivery Category.’’ Management Activities; Submission for Office of title. Also include the FDA docket
Science Associates, Inc. Presentation at Management and Budget Review; number found in brackets in the
NATO Show, April 23, 2015. Accessed June Comment Request; Guidance for heading of this document.
2015. Industry on Electronic Drug Product FOR FURTHER INFORMATION CONTACT: FDA
Dated: July 26, 2016. Reporting of Human Drug PRA Staff, Office of Operations, Food
Leslie Kux, Compounding Outsourcing Facilities and Drug Administration, Three White
Under Section 503B of the Federal Flint North, 10A63, 11601 Landsdown
Associate Commissioner for Policy. Street, North Bethesda, MD 20852,
Food, Drug, and Cosmetic Act
[FR Doc. 2016–18092 Filed 7–29–16; 8:45 am] PRAStaff@fda.hhs.gov.
BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: In
HHS. compliance with 44 U.S.C. 3507, FDA
ACTION: Notice. has submitted the following proposed
collection of information to OMB for
SUMMARY: The Food and Drug
review and clearance.
Administration (FDA) is announcing
that a proposed collection of Guidance for Industry: Electronic
information has been submitted to the Product Reporting for Human Drug
Office of Management and Budget Compounding Outsourcing Facilities
sradovich on DSK3GMQ082PROD with NOTICES

(OMB) for review and clearance under Under Section 503B of the Federal
the Paperwork Reduction Act of 1995. Food, Drug, and Cosmetic Act;
DATES: Fax written comments on the Availability—OMB Control Number
collection of information by August 31, 0910—(NEW)
2016. On November 27, 2013, the President
ADDRESSES: To ensure that comments on signed the Drug Quality and Security
the information collection are received, Act (DQSA) into law (Pub. L. 113–54).

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Document Created: 2016-07-30 06:25:27
Document Modified: 2016-07-30 06:25:27

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		Fax written comments on the collection of information by August 31, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20851, [email protected]
FR Citation		81 FR 50522

81 FR 50522 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 147 (August 1, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration