[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.

[[Page 80782]]

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]
 BILLING CODE 4162-20-P