Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Notices 16013 

vehicle sold by respondent. Part V 

requires dissemination of the order, now 

and in the future, to persons with 

responsibilities relating to the MINI 

Division and the subject matter of the 

order. Part VI ensures notification to the 

FTC of changes in corporate status. Part 

VII mandates that respondent submit an 

initial compliance report to the FTC, 

and make subsequent reports available 

to the FTC, upon request. Part VIII is a 

provision ‘‘sunsetting’’ the order after 

twenty (20) years, within certain 

exceptions. 

The purpose of this analysis is to 

facilitate public comment on the 

proposed order. It is not intended to 

constitute an official interpretation of 

the proposed order or to modify its 

terms in any way. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2015–06903 Filed 3–25–15; 8:45 am] 

BILLING CODE 6750–01–P 

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: Community Mental Health 

Services Block Grant and Substance 

Abuse and Prevention Treatment Block 

Grant FY 2016–2017 Plan and Report 

Guidance and Instructions (OMB No. 

0930–0168)—Revision 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), is requesting approval from 

the Office of Management and Budget 

(OMB) for a revision of the 2016 and 

2017 Community Mental Health 

Services Block Grant (MHBG) and 

Substance Abuse Prevention and 

Treatment Block Grant (SABG) Plan and 

Report Guidance and Instructions. 

Currently, the SABG and the MHBG 

differ on a number of their practices 

(e.g., data collection at individual or 

aggregate levels) and statutory 

authorities (e.g., method of calculating 

MOE, stakeholder input requirements 

for planning, set asides for specific 

populations or programs, etc.). 

Historically, the Centers within 

SAMHSA that administer these block 

grants have had different approaches to 

application requirements and reporting. 

To compound this variation, states have 

different structures for accepting, 

planning, and accounting for the block 

grants and the prevention set aside 

within the SABG. As a result, how these 

dollars are spent and what is known 

about the services and clients that 

receive these funds varies by block grant 

and by state. 

Increasingly, under the Affordable 

Care Act, more individuals are eligible 

for Medicaid and private insurance. 

This expansion of health insurance 

coverage will continue to have a 

significant impact on how State Mental 

Health Authorities (SMHAs) and Single 

State Agencies (SSAs) use their limited 

resources. In 2009, more than 39 percent 

of individuals with serious mental 

illnesses (SMI) or serious emotional 

disturbances (SED) were uninsured. 

Sixty percent of individuals with 

substance use disorders whose 

treatment and recovery support services 

were supported wholly or in part by 

SAMHSA block grant funds were also 

uninsured. A substantial proportion of 

this population, as many as six million 

people, will gain health insurance 

coverage in 2014 and will have various 

outpatient and other services covered 

through Medicaid, Medicare, or private 

insurance. However, these plans will 

not provide access to the full range of 

support services necessary to achieve 

and maintain recovery for most of these 

individuals and their families. 

Given these changes, SAMHSA has 

conveyed that block grant funds be 

directed toward four purposes: (1) To 

fund priority treatment and support 

services for individuals without 

insurance or who cycle in and out of 

health insurance coverage; (2) to fund 

those priority treatment and support 

services not covered by Medicaid, 

Medicare or private insurance offered 

through the exchanges and that 

demonstrate success in improving 

outcomes and/or supporting recovery; 

(3) to fund universal, selective and 

targeted prevention activities and 

services; and (4) to collect performance 

and outcome data to determine the 

ongoing effectiveness of behavioral 

health prevention, treatment and 

recovery support services and to plan 

the implementation of new services on 

a nationwide basis. 

To help states meet the challenges of 

2016 and beyond, and to foster the 

implementation of an integrated 

physical health and mental health and 

addiction service system, SAMHSA 

must establish standards and 

expectations that will lead to an 

improved system of care for individuals 

with or at risk of mental and substance 

use disorders. Therefore, this 

application package includes fully 

exercising SAMHSA’s existing authority 

regarding states’, territories’ and the Red 

Lake Band of the Chippewa Tribe’s 

(subsequently referred to as ‘‘states’’) 

use of block grant funds, and a shift in 

SAMHSA staff functions to support and 

provide technical assistance for states 

receiving block grant funds as they fully 

integrate behavioral health services into 

health care. 

Consistent with previous 

applications, the FY 2016–2017 

application has sections that are 

required and other sections where 

additional information is requested. The 

FY 2016–2017 application requires 

states to submit a face sheet, a table of 

contents, a behavioral health assessment 

and plan, reports of expenditures and 

persons served, an executive summary, 

and funding agreements and 

certifications. In addition, SAMHSA is 

requesting information on key areas that 

are critical to the states success in 

addressing health care integration. 

Therefore, as part of this block grant 

planning process, SAMHSA is asking 

states to identify their technical 

assistance needs to implement the 

strategies they identify in their plans for 

FY 2016 and 2017. 

To facilitate an efficient application 

process for states in FY 2016–2017, 

SAMHSA convened an internal 

workgroup to develop the application 

for the block grant planning section. In 

addition, SAMHSA consulted with 

representatives from SMHAs and SSAs 

to receive input regarding proposed 

changes to the block grant. Based on 

these discussions with states, SAMHSA 

is proposing several changes to the 

block grant programs, discussed in 

greater detail below. 

Changes to Assessment and Planning 

Activities 

The revisions reflect changes within 

the planning section of the application. 

The most significant of these changes 

relate to evidenced based practice for 

early intervention for the MHBG, 

participant directed care, medication 

assisted treatment for the SABG, crisis 

services, pregnant women and women 

with dependent children, community 

living and the implementation of 

Olmstead, and quality and data 

readiness collection. 

The FY 2014–2015 application 

sections on the Affordable Care Act, 

health insurance marketplace, 

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16014 Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Notices 

enrollment and primary and behavioral 

health care integration have been 

consolidated into a Health Care System 

and Integration section moving the 

emphasis to implementation of health 

care systems rather than preparation of 

the Affordable Care Act. Additionally, 

the FY 2014–2015 Quality, Data and 

Information Technology sections have 

been consolidated into one section in 

the FY 2016–2017 application. 

SAMHSA has provided a set of guiding 

questions to stimulate and direct the 

dialogue that states may engage in to 

determine the various approaches used 

to develop their responses to each of the 

focus areas. 

The proposed revisions are described 

below: 

• Health Care System and 

Integration—This section is a 

consolidation of the FY 2014–2015 

sections on the Affordable Care Act, 

health insurance marketplace, 

enrollment and primary and behavioral 

health care integration. It is vital that 

SMHAs and SSAs programming and 

planning reflect the strong connection 

between behavioral and physical health. 

Fragmented or discontinuous care may 

result in inadequate diagnosis and 

treatment of both physical and 

behavioral conditions, including cooccurring disorders. Health care 

professionals, consumers of mental, 

substance use disorders, co-occurring 

mental, and substance use disorders 

treatment recognize the need for 

improved coordination of care and 

integration of primary and behavioral 

health care. Health information 

technology, including electronic health 

records (EHRs) and telehealth are 

examples of important strategies to 

promote integrated care. Use of EHRs— 

in full compliance with applicable legal 

requirements—may allow providers to 

share information, coordinate care and 

improve billing practices. 

Implementation by SMHAs, SSAs and 

their partners of the Affordable Care Act 

is an important part of efforts to ensure 

access to care and better integrate care. 

In a recent report, the Congressional 

Budget Office estimates that by 2018, 25 

million persons will have enrolled in 

the Affordable Care Act Marketplace 

and 12 million in Medicaid and the 

State Children’s Health Insurance 

Program (SCHIP). The Department of 

Health and Human Services Assistant 

Secretary for Planning and Evaluation 

(ASPE) estimates that 32 million 

Americans will acquire coverage for 

mental and substance use disorder 

treatment as a result of the Affordable 

Care Act, including both previously 

uninsured persons and those enrolled in 

plans that lacked adequate coverage. In 

2014, non-grandfathered health plans 

sold in the individual or the small group 

health insurance markets offered 

coverage for mental and substance use 

disorders as an essential health benefit. 

• Evidenced-Based Practices for Early 

Intervention for the MHBG—In its FY 

2014 appropriation, SAMHSA was 

directed to require that states set aside 

5 percent of their MHBG allocation to 

support evidence-based programs that 

provide treatment to those with early 

SMI including but not limited to 

psychosis at any age. SAMHSA worked 

collaboratively with the National 

Institutes of Health, National Institute 

on Mental Health (NIMH) to review 

evidence showing efficacy of specific 

practices in ameliorating SMI and 

promoting improved functioning. NIMH 

has released information on 

Components of Coordinated Specialty 

Care (CSC) for First Episode Psychosis. 

Results from the NIMH funded Recovery 

After an Initial Schizophrenia Episode 

(RAISE) initiative, a research project of 

the NIMH, suggest that mental health 

providers across multiple disciplines 

can learn the principles of CSC for First 

Episode of Psychosis (FEP), and apply 

these skills to engage and treat persons 

in the early stages of psychotic illness. 

States can implement models across a 

continuum, which have demonstrated 

efficacy, including the range of services 

and principles identified by NIMH. 

Utilizing these principles, regardless of 

the amount of investment, and with 

leveraging funds through inclusion of 

services reimbursed by Medicaid or 

private insurance, every state will be 

able to begin to move their system 

toward earlier intervention, or enhance 

the services already being implemented. 

• Participant Directed Care—As 

states implement policies that support 

self-determination and improve personcentered service delivery, one option 

that states can consider is the role that 

vouchers may play in their overall 

financing strategy. Many states have 

implemented voucher and self-directed 

care programs to help individuals gain 

expanded access to care and to enable 

individuals to play a more significant 

role in the development of their 

prevention, treatment and recovery 

services. The major goal of a voucher 

program is to ensure individuals have a 

genuine, free, and independent choice 

among a network of eligible providers. 

The implementation of a voucher 

program expands mental and substance 

use disorder treatment capacity and 

promotes choice among clinical 

treatment and recovery support 

providers, providing individuals with 

the ability to secure the best treatment 

options available to meet their specific 

needs. A voucher program facilitates 

linking clinical treatment with critical 

recovery support services, such as care 

coordination, childcare, motivational 

development, early/brief intervention, 

outpatient treatment, medical services, 

housing support, employment/

education support, peer resources, 

family/parenting services or 

transportation. 

States interested in utilizing a 

voucher system should create or 

maintain a voucher management system 

to support vouchering and the reporting 

of data to enhance accountability by 

measuring outcomes. Meeting these 

voucher program challenges by creating 

and coordinating a wide array of service 

providers, leading them though the 

innovations and inherent system change 

processes results in the building of an 

integrated system that provides holistic 

care to individuals recovering from 

mental and substance use disorders. 

• Medication Assisted Treatment 

(MAT)—There is a voluminous 

literature on the efficacy of Food and 

Drug Administration (FDA)-approved 

medications for the treatment of 

substance use disorders. However, many 

treatment programs in the U.S. still offer 

only abstinence-based treatment for 

these conditions. The evidence base for 

medication assisted treatment of these 

disorders is described in several of 

SAMHSA’s Treatment Improvement 

Protocol Series (TIPS) publications 

numbered 40, 43, 45, and 49. SAMHSA 

strongly encourages the states to require 

that treatment facilities providing 

clinical care to those with substance use 

disorders be required to either have the 

capacity and staff expertise to utilize 

MAT or have collaborative relationships 

with other providers such that these 

MATs can be accessed as clinically 

indicated for patient need. Individuals 

with substance use disorders who have 

a disorder for which there is an FDAapproved medication treatment should 

have access to those treatments. 

• Crisis Services—In the on-going 

development of efforts to build an 

evidence-based robust system of care for 

adults diagnosed with an SMI, children 

with a serious emotional disturbance 

(SED) and persons with addictive 

disorders and their families via a 

coordinated continuum of treatments, 

services and supports, growing attention 

is being paid across the country to how 

states and local communities identify 

and effectively respond to behavioral 

health crises. SAMHSA has taken a 

leadership role in deepening the 

understanding of what it means to be in 

crisis and how to effectively respond to 

crisis as experienced by people with 

behavioral health conditions. 

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Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Notices 16015 

• A crisis response system will have 

the capacity to recognize and respond to 

crises across a continuum, from crisis 

planning, to early stages of support and 

respite, to crisis stabilization and 

intervention, to post-crisis follow-up 

and support for the individual and their 

family. SAMHSA expects that states 

will build on the emerging and growing 

body of evidence for effective 

community-based crisis response 

systems. Given the multi-system 

involvement of many individuals with 

behavioral health issues, the crisis 

response system approach provides the 

infrastructure to improve care 

coordination and outcomes, manage 

costs and better invest resources. 

• Pregnant Women and Women With 

Dependent Children—Substanceabusing pregnant women have been a 

leading priority population throughout 

the history of the SABG (Section 1922(b) 

of Title XIX, Part B, Subpart II, of the 

PHS Act (42 U.S.C. 300x–22(b)). The 

authorizing legislation required states to 

expend not less than 5 percent of the FY 

1993 and FY 1994 SABG to increase the 

availability of treatment services 

designed for pregnant women and 

women with dependent children. The 

purpose of these programs is to expand 

the availability of comprehensive, 

residential substance use disorder 

treatment, and recovery support services 

for pregnant and postpartum women 

and their minor children, including 

services for non-residential family 

members. This population continues to 

be of utmost concern, since by helping 

such women along their recovery 

journey, additional benefits may result: 

Fetal alcohol spectrum disorder may be 

prevented; a normal birth-weight may 

be achieved; and intergenerational 

transmission of addiction may be 

interrupted. Women with dependent 

children are also identified as a priority 

for specialized treatment (as opposed to 

treatment as usual) in the implementing 

regulations governing the SABG. In 

1995 and subsequent fiscal years states 

are required to expend no less than an 

amount equal to that spent by the state 

in prior fiscal years for treatment 

services designed for pregnant women 

and women with dependent children. 

• Community Living and the 

Implementation of Olmstead—The 

community living and Olmsted section 

was included in the environmental 

factors/background section of the FY 

2014–2015 application and has been 

added to the planning section of the FY 

2016–2017 application. The integration 

mandate in Title II of the Americans 

with Disabilities Act (ADA) and the 

Supreme Court’s decision in Olmstead 

v. L.C., 527 U.S. 581 (1999), provide 

legal requirements that are consistent 

with SAMHSA’s mission to reduce the 

impact of substance abuse and mental 

illness on America’s communities. 

Being an active member of a community 

is an important part of recovery for 

persons with behavioral health 

conditions. Title II of the ADA and the 

regulations promulgated for its 

enforcement require that states provide 

services in the most integrated 

arrangement appropriate and prohibit 

needless institutionalization and 

segregation in work, living, and other 

settings. In response to the tenth 

anniversary of the Supreme Court’s 

Olmstead decision, then HHS Secretary 

Sebelius directed the creation of the 

Coordinating Council on Community 

Living at the HHS. SAMHSA has been 

a key member of the Coordinating 

Council on Community Living and has 

funded a number of technical assistance 

opportunities to promote integrated 

services for people with behavioral 

health needs, including a policy 

academy to share effective practices 

with states. 

Community living has been a priority 

across the federal government with 

recent changes to Section 811 and other 

housing programs operated by the 

Department of Housing and Urban 

Development (HUD). HUD and HHS 

collaborate to support housing 

opportunities for persons with 

disabilities, including persons with 

mental/substance use disorders. The 

Department of Justice (DOJ) and HHS 

Office of Civil Rights (OCR) cooperate 

on enforcement and compliance 

measures. DOJ and HHS OCR have 

expressed concern about some aspects 

of state mental health systems including 

use of traditional institutions and other 

settings that have institutional 

characteristics to serve persons whose 

needs could be better met in community 

settings. More recently, there has been 

litigation regarding certain employment 

services such as sheltered workshops. 

States should ensure Block Grant funds 

are allocated to support treatment and 

recovery services in community settings 

whenever feasible and remain 

committed, as SAMHSA is, to ensuring 

services are implemented in accordance 

with Olmstead and Title II of the ADA. 

• Quality and Data Collection—The 

FY 2014–2015 Quality, Data and 

Information Technology sections have 

been consolidated into one section in 

the FY 2016–2017 application and is 

part of the planning section. SAMHSA 

is moving forward on the task of 

advancing a system for the collection of 

client level substance abuse and mental 

health treatment data. As such, 

SAMHSA is undertaking a series of 

efforts designed to develop a set of 

common core performance, quality, and 

cost measures to demonstrate the impact 

of SAMHSA’s discretionary and block 

grant programs and guide SAMHSA’s 

evaluation activities. 

The foundation of this effort is 

National Quality Behavioral Health 

Framework, which derives from the 

National Quality Strategy and seeks to 

improve the delivery of health care 

services, individual patient health 

outcomes, and the overall health of the 

population. The overarching goals are to 

ensure that services are evidence-based 

and effective; that they are person/

family-centered; that care is coordinated 

across systems; that services promote 

healthy living; and that they are safe, 

accessible and affordable. 

For the FY 2016–2017 MHBG and 

SABG reports, achieving these goals will 

result in a more coordinated behavioral 

health data collection program that 

complements other existing systems 

(e.g., Medicaid administrative and 

billing data systems; and state mental 

health and substance abuse data 

systems), ensures consistency in the use 

of measures that are harmonized across 

various agencies and reporting systems, 

and provides a more complete 

understanding of the delivery of mental 

health and substance abuse services. 

Both goals can only be achieved through 

continuous collaboration with and 

feedback from SAMHSA’s state 

partners. 

SAMHSA anticipates this movement 

is consistent with the current state 

authority’s movement toward system 

integration and will minimize 

challenges associated with changing 

operational logistics of data collection 

and reporting. SAMHSA understands 

some modifications to data collection 

systems may be necessary, but will work 

with the states to minimize the impact 

of these changes. 

Other Changes 

The overall format has been 

streamlined to integrate the 

environmental factors throughout the 

behavioral health assessment and plan 

narrative. This has reduced the length of 

the application by 10 pages. 

While the statutory deadlines and 

block grant award periods remain 

unchanged, SAMHSA encourages states 

to turn in their application as early as 

possible to allow for a full discussion 

and review by SAMHSA. Applications 

for the MHBG-only is due no later than 

September 1, 2015. 

The application for SABG-only is due 

no later than October 1, 2015. A single 

application for MHBG and SABG is due 

no later than September 1, 2015. 

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16016 Federal Register / Vol. 80, No. 58 / Thursday, March 26, 2015 / Notices 

Estimates of Annualized Hour Burden 

The estimated annualized burden for 

a uniform application is 37,429 hours. 

Burden estimates are broken out in the 

following tables showing burden 

separately for Year 1 and Year 2. Year 

1 includes the estimates of burden for 

the uniform application and annual 

reporting. Year 2 includes the estimates 

of burden for the application update and 

annual reporting. The reporting burden 

remains constant for both years. 

TABLE 1—ESTIMATES OF APPLICATION AND REPORTING BURDEN FOR YEAR 1 

Application element Number respondents Responses/ 

respondents 

Burden/ 

response 

(hours) 

Total burden 

Application Burden 

Yr One Plan (separate submissions) .............. 30 (CMHS) .....................................................

30 (SAPT) ......................................................

1 282 16,920 

Yr One Plan (combined submission ............... 30 ................................................................... 1 282 8,460

Application Sub-total ................................ 60 ................................................................... ........................ ........................ 25,380 

Reporting Burden 

MHBG Report ................................................. 59 ................................................................... 1 186 10,974 

URS Tables ..................................................... 59 ................................................................... 1 35 2,065 

SAPTBG Report .............................................. 60 1 ................................................................. 1 186 11,160 

Table 5 ............................................................ 15 2 ................................................................. 1 4 60 

Reporting Subtotal ................................... 60 ................................................................... ........................ ........................ 24,259 

Total .................................................. 119 ................................................................. ........................ ........................ 49,639 

1 Redlake Band of the Chippewa Indians from MN receives a grant. 

2Only 15 States have a management information system to complete Table 5. 

TABLE 2—ESTIMATES OF APPLICATION AND REPORTING BURDEN FOR YEAR 2 

Application element Number respondents Responses/ 

respondents 

Burden/ 

response 

(hours) 

Total burden 

Application Burden 

Yr Two Plan .................................................... 24 ................................................................... 1 40 960 

Application Sub-total ................................ 24 ................................................................... ........................ ........................ 960 

Reporting Burden 

MHBG Report ................................................. 59 ................................................................... 1 186 10,974 

URS Tables ..................................................... 59 ................................................................... 1 35 2,065 

SAPTBG Report .............................................. 60 ................................................................... 1 186 11,160 

Table 5 ............................................................ 15 ................................................................... 1 4 60 

Reporting Subtotal ................................... 60 ................................................................... ........................ ........................ 24,259 

Total .................................................. 119 ................................................................. ........................ ........................ 25,219 

The total annualized burden for the 

application and reporting is 37,429 

hours (49,639 + 25,219 = 74,858/2 years 

= 37,429). 

Link for the application: http://www.

samhsa.gov/grants/block-grants. 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by April 27, 2015 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: 

OIRA_Submission@omb.eop.gov. 

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. 2015–06915 Filed 3–25–15; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–15–0963] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

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