This PDF is the current document as it appeared on Public Inspection on 12/03/2012 at 08:45 am.
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.
Proposed Project: Substance Abuse Prevention and Treatment Block Grant Synar Report Format, FFY 2014-2016—(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, the Republic of Palau, the Federated States of Micronesia, and the Republic of 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:
To decrease the need for supplemental questions and reporting, additional instruction has been included in 4 portions of the report.
In Section I (Compliance Progress), the following clarification changes are being made with respect to the Annual Synar Report:
Question 1c: Changes to State law—This question, which was formerly Question 1d, asks about changes to state youth access to tobacco laws and has been edited to include an option for changes to state law concerning vending machines. The former Question 1c, which contained detailed information about types of changes to vending machine laws has been eliminated due to the fact that the Family Smoking Prevention and Tobacco Control Act, which gives the Food and Drug Administration (FDA) the authority to regulate tobacco products, banned vending machines in youth accessible locations as of June 2010, making it unlikely that states that have not done so already will enact similar state laws. However, there are three U.S. jurisdictions not subject to federal law that may still enact vending machine restrictions and can report this information in the new Question 1c.
Questions 5a, 5b, and 5d: 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 youth access laws.
In Section II (Intended Use), the following clarification change is being made:
Question 3—State Challenges: This question includes a new response option (“Issues regarding the age or gender balance of youth inspectors”) since this is a common challenge reported by states.
In Appendix B (Synar Survey Sampling Methodology), the following clarification is 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, includes a new response option (“State has a contract with the FDA and is actively enforcing the vending machine requirements of the Family Smoking Prevention and Tobacco Control Act”). This new option is included because federal law bans vending machines in youth accessible locations and states that are contracted with the FDA to enforce this provision are not required to include vending machines in their Synar surveys.
In Appendix C (Synar Survey Inspection Protocol), the following change is being made:
Question 1—Synar Survey Protocol— This question, which asks about aspects of the state's Synar survey protocol (including whether buys are consummated or unconsummated, whether youth inspectors carry identification, whether adult inspectors enter the outlet with the youth, and whether youth inspectors are compensated), has been edited to remove the option for “Not specified in protocol” since all states are required to submit Synar protocols that include these items. Additionally, a requirement for states to provide a narrative explanation has been included for those states who choose the response option “Permitted under specified circumstances.”
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 Government 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:
Questions 4d-g—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. They have been added to replace the previously open-ended Question 5g, which required a narrative response. These close-ended questions will focus state responses.
In Appendix B (Synar Survey Sampling Methodology), the following changes are being made:
Questions 9a-b—Synar Survey Estimation System Sample Size (SSES) Calculator— These questions, which ask if the state used the SSES sample size calculator and if so, if they used the state or stratum level calculator, will eliminate the need for Government Project Officers to ask these clarifying questions during the review process. This revision also eliminates the need for those states who use the SSES sample size calculator to manually list the sample size formulas.
Question 10b—Stratum Level Information— This question, which asks states who used the stratum level calculator to provide the stratum level information, eliminates the need for Government Project Officers to ask this clarifying question during the review process.
In Appendix C (Synar Survey Inspection Protocol), the following change is being made:
Questions 4a-b—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 added to Appendix C. They have been added to provide additional information about state Synar protocols, which is frequently requested by partner agencies and can also be used to target technical assistance.
There are no changes to Forms 1-5 or Appendix D.
|45 CFR Citation||Number of respondents 1||Responses per respondents||Total number of responses||Hours per response||Total hour burden|
|Annual Report (Section 1—States and Territories) 96.130(e)(1-3)||59||1||59||15||885|
|State Plan (Section II—States and Territories) 96.130(e)(4,5)96.130(g)||59||1||59||3||177|
|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 Summer.King@samhsa.hhs.gov. Written comments must be received before 60 days after the date of the publication in the Federal Register.
[FR Doc. 2012-29199 Filed 12-3-12; 8:45 am]
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