[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Notices]
[Pages 80781-80783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32558]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of
information are necessary for the proper performance of the functions
of the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
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Proposed Project: Substance Abuse Prevention and Treatment Block Grant
Synar Report Format, FFY 2017-2019--(OMB No. 0930-0222)--Revision
Section 1926 of the Public Health Service Act [42 U.S.C. 300x-26]
stipulates that funding Substance Abuse Prevention and Treatment Block
Grant (SABG) agreements for alcohol and drug abuse programs for fiscal
year 1994 and subsequent fiscal years require states to have in effect
a law providing that it is unlawful for any manufacturer, retailer, or
distributor of tobacco products to sell or distribute any such product
to any individual under the age of 18. This section further requires
that states conduct annual, random, unannounced inspections to ensure
compliance with the law; that the state submit annually a report
describing the results of the inspections, the activities carried out
by the state to enforce the required law, the success the state has
achieved in reducing the availability of tobacco products to
individuals under the age of 18, and the strategies to be utilized by
the state for enforcing such law during the fiscal year for which the
grant is sought.
Before making an award to a State under the SABG, the Secretary
must make a determination that the state has maintained compliance with
these requirements. If a determination is made that the state is not in
compliance, penalties shall be applied. Penalties ranged from 10
percent of the Block Grant in applicable year 1 (FFY 1997 SABG
Applications) to 40 percent in applicable year 4 (FFY 2000 SABG
Applications) and subsequent years. Respondents include the 50 states,
the District of Columbia, the Commonwealth of Puerto Rico, the U.S.
Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern
Mariana Islands, Palau, Micronesia, and the Marshall Islands.
Regulations that implement this legislation are at 45 CFR 96.130,
are approved by OMB under control number 0930-0163, and require that
each state submit an annual Synar report to the Secretary describing
their progress in complying with section 1926 of the PHS Act. The Synar
report, due December 31 following the fiscal year for which the state
is reporting, describes the results of the inspections and the
activities carried out by the state to enforce the required law; the
success the state has achieved in reducing the availability of tobacco
products to individuals under the age of 18; and the strategies to be
utilized by the state for enforcing such law during the fiscal year for
which the grant is sought. SAMHSA's Center for Substance Abuse
Prevention will request OMB approval of revisions to the current report
format associated with Section 1926 (42 U.S.C. 300x-26). The report
format is not changing significantly. Any changes in either formatting
or content are being made to simplify the reporting process for the
states and to clarify the information as the states report it; both
outcomes will facilitate consistent, credible, and efficient monitoring
of Synar compliance across the states. All of the information required
in the new report format is already being collected by the states.
Specific changes are listed below:
Clarification Changes
To decrease the need for supplemental questions and reporting,
additional instruction has been included in 3 portions of the report.
In Section I (Compliance Progress), the following clarification
changes are being made with respect to the Annual Synar Report:
Question 1b: Changes to state law--This question asks about changes
in state laws that impact the state's protocol for conducting Synar
inspections and has been edited to include an option for changes to
state law concerning changes in the definition of tobacco products.
Many states are changing the definition of tobacco products in their
state laws to include electronic nicotine delivery systems, which would
impact the types of products that could be included in Synar surveys.
Question 1c: Changes to state law--This question asks about changes
to state youth access to tobacco laws and has been edited to include an
option for changes to state law concerning additional product
categories to their youth tobacco access law. While some states have
changed the definition in the state law to include electronic nicotine
delivery systems, smokeless tobacco, and other tobacco products, other
states have added these products as additional product categories in
addition to tobacco products.
Question 2: Describe how the Annual Synar Report and the state plan
were made public prior to submission of the ASR. This question asks
states to describe how they make their ASR public prior to submission.
States have been asked to provide a Web address and the date the ASR
was posted to that Web address if they choose to post the ASR on an
agency Web site. The ASR format has been clarified to provide a
separate text box to enter both of these pieces of information.
Questions 4d-f--Coordination with Agency that Receives the FDA
State Enforcement Contract - These close-ended questions ask the state
to list the agency that is under contract to the FDA to enforce federal
youth access laws, to describe the relationship between the state's
Synar program and this agency, and to identify if the state uses data
from the FDA enforcement inspections for the Synar survey. This
question has been edited to include skip logic and response options if
a state does not have a current contract with the FDA.
Questions 5b, 5c, 5d, 5e, 5f: Enforcement Agencies, Evidence of
Enforcement and Frequency of Enforcement--These questions have been
clarified so it is clear that they refer to enforcement of state youth
access laws, and not federal or local youth access laws. In addition,
these questions have been re-ordered (but the wording has not been
changed) to improve logical flow of the questions. In addition,
question 5e has been edited to include separate response options to
allow states to describe each of the additional activities listed in
the question stem to encourage states to describe each of those
activities fully.
In Section II (Intended Use), the following clarification change is
being made:
Question 3--State Challenges: This question asks states to identify
and describe their challenges in implementing the Synar program. This
question has been edited to include separate response options to allow
states to describe each of the challenges listed in the question stem
to encourage states to describe each of the challenges fully and to
make targeted technical assistance requests.
In Appendix C (Synar Survey Inspection Protocol Summary), the
following change is being made:
Title: The title of this Appendix has been edited to reflect that
it is the summary of the state's inspection protocol and that the
Appendix itself is not detailed enough to serve as the entirety of the
state's inspection protocol.
Questions 4--Type of Tobacco Products--These questions, which ask
the state to define the type of tobacco products requested during Synar
inspections and to describe the protocol for tobacco type selection,
have been edited to separate the options of including small cigars and
cigarillos and to add the option of including electronic nicotine
delivery systems or electronic cigarettes.
Questions 5a and b--The previous question 5 has been separated into
two sections to provide ensure states are
[[Page 80783]]
able to fully describe the methods used to recruit, select and train
adult supervisors for the survey separately from the methods used to
recruit, select, and train youth inspectors.
Content Changes
The content of the Synar Report has changed little. The content
changes that have been made address the need to (1) clarify the intent
of information requested via the addition of clarifying questions, (2)
reduce the need for State Project Officers to ask additional questions
to supplement the originally submitted Report. These additions and
changes are essential to SAMHSA's ability to adequately assess state
and jurisdictional compliance with the Synar regulation.
In Section I (Compliance Progress), the following changes are being
made with respect to the Annual Synar Report:
Question 6: Changes to the sampling methodology--This question asks
states if their sampling methodology has changed from the previous
year. If there has been a change, a sub-question has been added to
document how that change was communicated to SAMHSA. Since this change
requires prior approval, a state who has not received prior approval
will have the opportunity to discuss the process that was used to
determine a change needed to be made.
Question 9: Changes to the inspection protocol--This question asks
states if their inspection protocol has changed from the previous year.
If there has been a change, a sub-question has been added to document
how that change was communicated to SAMHSA. Since this change requires
prior approval, a state who has not received prior approval will have
the opportunity to discuss the process that was used to determine a
change needed to be made. Existing questions 9a, 9b, and 9c have been
renumbered to account for this new sub-question.
In Appendix B (Synar Survey Sampling Methodology), the following
changes are being made:
Question 4--Vending machine inclusion in Synar Survey--This
question, which asks if vending machines are included in the Synar
survey and the reasons for their elimination if they are not included.
Because many states have a contract with the FDA and is actively
enforcing the vending machine requirements of the Family Smoking
Prevention and Tobacco Control Act, some states that include vending
machines in their sampling protocols do not sample any because there
are few eligible vending machines remaining on their list frame. A
second part has been added to this question to determine how vending
machines are sampled.
There are no changes to Forms 1-5 or Appendix D.
Annual Reporting Burden
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Number of
45 CFR Citation respondents Responses per Total number Hours per Total hour
\1\ respondents of responses response burden
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Annual Report (Section 1--States 59 1 59 15 885
and Territories) 96.130(e)(1-3)
State Plan (Section II--States 59 1 59 3 177
and Territories) 96.130(e)(4,5)
96.130(g)......................
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Total....................... 59 .............. .............. .............. 1,062
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\1\ Red Lake Indian Tribe is not subject to tobacco requirements.
Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 2-
1057, One Choke Cherry Road, Rockville, MD 20857 OR email a copy to
[email protected]. Written comments should be received by
February 26, 2016.
Summer King,
Statistician.
[FR Doc. 2015-32558 Filed 12-24-15; 8:45 am]
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