81 FR 18632 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration

Federal Register Volume 81, Issue 62 (March 31, 2016)

Page Range		18632-18634
FR Document		2016-07223
Federal Register, Volume 81 Issue 62 (Thursday, March 31, 2016)
[Federal Register Volume 81, Number 62 (Thursday, March 31, 2016)]
[Notices]
[Pages 18632-18634]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-07223]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Substance Abuse and Mental Health Services 
Administration (SAMHSA) will publish a summary of information 
collection requests under OMB review, in compliance with the Paperwork 
Reduction Act (44 U.S.C. chapter 35). To request a copy of these 
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.

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

[[Page 18633]]

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. The 
time frame was corrected per the comments.
    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. The timeframe for this question was corrected per the 
comments.
    Questions 8a and 8b: Sampling Frame Coverage Study--Language was 
changed in these questions to emphasize the word sampling regarding the 
frame coverage study as requested during the comment period.
    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 changes are 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 ensure states are 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, and 
(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 that had not received prior approval 
will have the opportunity to discuss the process used to determine the 
need for a change. Language in the report format and the instructions 
was adjusted to reflect the comments. The time period was also 
corrected per the comments.
    Question 9: Changes to the inspection protocol--This question asks 
states if its 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 that had not received prior approval will have 
the opportunity to discuss the process used to determine the need for

[[Page 18634]]

a change. Existing questions 9a, 9b, and 9c have been renumbered to 
account for this new sub-question. Language in the report format and 
the instructions was adjusted to reflect the comments.
    In Appendix B (Synar Survey Sampling Methodology), the following 
changes are being made:
    Question 4--Vending machine inclusion in Synar Survey--This 
question, whether asks 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 are 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
----------------------------------------------------------------------------------------------------------------
                                           Number of                      Total number
            45 CFR Citation               respondents     Responses per         of       Hours per    Total hour
                                              \1\          respondents      responses     response      burden
----------------------------------------------------------------------------------------------------------------
Annual Report (Section 1--States and                59                 1            59           15          885
 Territories) 96.130(e)(1-3)..........
State Plan (Section II--States and                  59                 1            59            3          177
 Territories) 96.130(e)(4,5)96.130(g).
                                       -------------------------------------------------------------------------
    Total.............................              59  ................  ............  ...........        1,062
----------------------------------------------------------------------------------------------------------------
\1\ Red Lake Indian Tribe is not subject to tobacco requirements.

    Written comments and recommendations concerning the proposed 
information collection should be sent by May 2, 2016 to the SAMHSA Desk 
Officer at the Office of Information and Regulatory Affairs, Office of 
Management and Budget (OMB). To ensure timely receipt of comments, and 
to avoid potential delays in OMB's receipt and processing of mail sent 
through the U.S. Postal Service, commenters are encouraged to submit 
their comments to OMB via email to: [email protected]. 
Although commenters are encouraged to send their comments via email, 
commenters may also fax their comments to: 202-395-7285. Commenters may 
also mail them to: Office of Management and Budget, Office of 
Information and Regulatory Affairs, New Executive Office Building, Room 
10102, Washington, DC 20503.

Summer King,
Statistician.
[FR Doc. 2016-07223 Filed 3-30-16; 8:45 am]
BILLING CODE 4162-20-P
18632 Federal Register / Vol. 81, No. 62 / Thursday, March 31, 2016 / Notices

Colorectal Cancer Screening’’ (CDC– limited number of individuals aged 50– The information collection will
RFA–DP15–1502). CRCCP grantees 64 in the program’s priority population enable CDC to gauge progress in meeting
include state governments or bona-fide who are asymptomatic, at average risk CRCCP program goals and to monitor
agents, universities, and tribal for CRC, have inadequate or no health implementation activities, evaluate
organizations. The purpose of the new insurance for CRC screening, and are outcomes, and identify grantee technical
cooperative agreement program is to low income. assistance needs. In addition, findings
increase CRC screening rates among an Based on the redesigned CRCCP, the will inform program improvement and
applicant defined target population of information collection plan has also help identify successful activities that
persons 50–75 years of age within a been redesigned to address the two need to be maintained, replicated, or
partner health system serving a defined program components. The new expanded.
geographical area or disparate cooperative agreement program (CDC–
population. RFA–DP15–1502) requires that CDC OMB approval is requested for three
The CRCCP was significantly monitor and evaluate the CRCCP and years. Participation is required for
redesigned in 2015 and has two individual grantee performance using CRCCP awardees. In the pilot test for the
components. Under Component 1, all 31 both process and outcome evaluation. CRCCP annual grantee survey, the
CRCCP grantees receive funding to Two forms are proposed. First, the average time to complete the instrument
support partnerships with health CRCCP grantee survey was redesigned was approximately 45 minutes. In the
systems to implement up to four priority to align with new CRCCP goals. The pilot test for the CRCCP clinic-level
evidence-based interventions (EBIs) grantee survey will be submitted to CDC information collection, the average time
described in the Guide to Community annually. Second, CDC proposes to to complete the instrument was
Preventive Services, as well as other collect clinic-level information to assess approximately 30 minutes. CDC
supporting strategies. Grantees must changes in CDC’s primary outcome of estimates an average of 12 responses per
implement at least two EBIs in each interest, i.e., CRC screening rates within grantee annually to correspond with the
partnering health system. Under partner health systems. Each grantee number of health system partners. The
Component 2, 6 of the 31 CRCCP will complete a clinic-level collection total estimated annualized burden hours
grantees will provide direct screening template once per year. All information are 209. There are no costs to
and follow-up clinical services for a will be reported to CDC electronically. respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hr)

CRCCP Grantees ........................................... CRCCP Annual Grantee Survey .................... 31 1 45/60
CRCCP Clinic-level Information Collection 31 12 30/60
Template.

Leroy A. Richardson, Project: Substance Abuse Prevention the fiscal year for which the grant is
Chief, Information Collection Review Office, and Treatment Block Grant Synar sought.
Office of Scientific Integrity, Office of the Report Format, FFY 2017–2019—(OMB Before making an award to a State
Associate Director for Science, Office of the No. 0930–0222)—Revision under the SABG, the Secretary must
Director, Centers for Disease Control and make a determination that the state has
Prevention. Section 1926 of the Public Health maintained compliance with these
[FR Doc. 2016–07225 Filed 3–30–16; 8:45 am] Service Act [42 U.S.C. 300x–26] requirements. If a determination is made
BILLING CODE 4163–18–P stipulates that funding Substance Abuse that the state is not in compliance,
Prevention and Treatment Block Grant penalties shall be applied. Penalties
(SABG) agreements for alcohol and drug ranged from 10 percent of the Block
DEPARTMENT OF HEALTH AND abuse programs for fiscal year 1994 and Grant in applicable year 1 (FFY 1997
HUMAN SERVICES subsequent fiscal years require states to SABG Applications) to 40 percent in
have in effect a law providing that it is applicable year 4 (FFY 2000 SABG
Substance Abuse and Mental Health unlawful for any manufacturer, retailer, Applications) and subsequent years.
Services Administration or distributor of tobacco products to sell Respondents include the 50 states, the
or distribute any such product to any District of Columbia, the
Agency Information Collection Commonwealth of Puerto Rico, the U.S.
individual under the age of 18. This
Activities: Submission for OMB Virgin Islands, Guam, American Samoa,
section further requires that states
Review; Comment Request the Commonwealth of the Northern
conduct annual, random, unannounced
Mariana Islands, Palau, Micronesia, and
inspections to ensure compliance with the Marshall Islands.
Periodically, the Substance Abuse and
the law; that the state submit annually Regulations that implement this
Mental Health Services Administration
a report describing the results of the
mstockstill on DSK4VPTVN1PROD with NOTICES

(SAMHSA) will publish a summary of legislation are at 45 CFR 96.130, are
inspections, the activities carried out by approved by OMB under control
information collection requests under the state to enforce the required law, the
OMB review, in compliance with the number 0930–0163, and require that
success the state has achieved in each state submit an annual Synar
Paperwork Reduction Act (44 U.S.C. reducing the availability of tobacco report to the Secretary describing their
chapter 35). To request a copy of these products to individuals under the age of progress in complying with section 1926
documents, call the SAMHSA Reports 18, and the strategies to be utilized by of the PHS Act. The Synar report, due
Clearance Officer on (240) 276–1243. the state for enforcing such law during December 31 following the fiscal year

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18634 Federal Register / Vol. 81, No. 62 / Thursday, March 31, 2016 / Notices

a change. Existing questions 9a, 9b, and question, whether asks vending include vending machines in their
9c have been renumbered to account for machines are included in the Synar sampling protocols do not sample any
this new sub-question. Language in the survey and the reasons for their because there are few eligible vending
report format and the instructions was elimination if they are not included. machines remaining on their list frame.
adjusted to reflect the comments. Because many states have a contract A second part has been added to this
In Appendix B (Synar Survey with the FDA and are actively enforcing question to determine how vending
Sampling Methodology), the following the vending machine requirements of machines are sampled.
changes are being made: the Family Smoking Prevention and
Question 4—Vending machine There are no changes to Forms 1–5 or
Tobacco Control Act, some states that Appendix D.
inclusion in Synar Survey—This

ANNUAL REPORTING BURDEN
Number of Responses per Total number Hours per Total hour
45 CFR Citation respondents 1 respondents of responses response 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

Total .................................................................................... 59 ............................ ...................... .................... 1,062
1 Red Lake Indian Tribe is not subject to tobacco requirements.

Written comments and DEPARTMENT OF HOMELAND Office of International Trade, at
recommendations concerning the SECURITY josephine.baiamonte@cbp.dhs.gov.
proposed information collection should FOR FURTHER INFORMATION CONTACT: For
be sent by May 2, 2016 to the SAMHSA U.S. Customs and Border Protection CBP-related questions, contact Jeffrey
Desk Officer at the Office of Information Nii, Director, Inter-Agency
Cessation of National Customs
and Regulatory Affairs, Office of Collaboration Division, Office of
Automation Program (NCAP) Test
Management and Budget (OMB). To International Trade, at jeffrey.c.nii@
Concerning the Submission of Certain
ensure timely receipt of comments, and Data Required by the Food and Drug cbp.dhs.gov. For FDA-related questions,
to avoid potential delays in OMB’s Administration (FDA) Using the Partner contact Sandra Abbott at sandra.abbott@
receipt and processing of mail sent Government Agency (PGA) Message fda.hhs.gov.
through the U.S. Postal Service, Set Through the Automated SUPPLEMENTARY INFORMATION:
commenters are encouraged to submit Commercial Environment (ACE)
their comments to OMB via email to: Background
OIRA_Submission@omb.eop.gov. AGENCY: U.S. Customs and Border The National Customs Automation
Although commenters are encouraged to Protection, Department of Homeland Program (NCAP) was established by
send their comments via email, Security. Subtitle B of Title VI—Customs
commenters may also fax their ACTION: General notice. Modernization, in the North American
comments to: 202–395–7285. Free Trade Agreement Implementation
SUMMARY: U.S. Customs and Border
Commenters may also mail them to: Act (Pub. L. 103–182, 107 Stat. 2057,
Protection (CBP) and the Food and Drug
Office of Management and Budget, December 8, 1993) (Customs
Administration (FDA) have determined
Office of Information and Regulatory Modernization Act). See 19 U.S.C. 1411.
that the National Customs Automation
Affairs, New Executive Office Building, Through NCAP, the thrust of customs
Program (NCAP) test concerning the
Room 10102, Washington, DC 20503. modernization was on trade compliance
electronic transmission of certain
and the development of the Automated
import data for all FDA-regulated
Summer King, Commercial Environment (ACE), the
commodities through the Automated
Statistician. planned successor to the legacy
Commercial Environment (ACE) has
[FR Doc. 2016–07223 Filed 3–30–16; 8:45 am] Customs Automated Commercial
been a success as ACE is capable of
System (ACS). ACE is an automated and
BILLING CODE 4162–20–P accepting FDA-regulated electronic
electronic system for commercial trade
entries. Accordingly, this document
processing. ACE will streamline
announces that the pilot is ending and
business processes, facilitate growth in
CBP encourages all importers of
trade, ensure cargo security, and foster
merchandise regulated by the FDA to
participation in global commerce, while
now use ACE for their electronic filings.
ensuring compliance with U.S. laws and
In the near future ACE will be the sole
regulations and reducing costs for CBP
CBP-authorized Electronic Data
and all its communities of interest. The
Interchange (EDI) system for these
mstockstill on DSK4VPTVN1PROD with NOTICES

ability to meet these objectives depends
filings.
upon successfully modernizing CBP’s
DATES: The FDA test will end on May business functions and the information
2, 2016. technology that supports those
ADDRESSES: Comments concerning this functions. CBP’s modernization efforts
notice and any aspect of this test may are accomplished through phased
be submitted via email to Josephine releases of ACE component
Baiamonte, ACE Business Office (ABO), functionality, designed to introduce a

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Document Created: 2016-03-31 00:56:08
Document Modified: 2016-03-31 00:56:08
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
FR Citation		81 FR 18632
81 FR 18632 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESSubstance Abuse and Mental Health Services Administration

Federal Register Volume 81, Issue 62 (March 31, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
