[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Pages 61608-61610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19272]


=======================================================================
-----------------------------------------------------------------------

SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION


Request for Information; Potential Changes to its Evidence-Based 
Practices Resource Center

AGENCY: Substance Abuse and Mental Health Services Administration 
(SAMHSA), Department of Health and Human Services (HHS).

ACTION: Notice of request for information (RFI).

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

SUMMARY: SAMHSA is issuing this RFI to gather expert and public 
feedback to determine how to best satisfy Sec. 7002, subsections (b), 
(c), or (d) of the 21st Century Cures Act, which are explained below. 
Input from the public and experts will help SAMHSA identify the optimal 
ways to identify, evaluate, and disseminate programs and practices, 
based on their intended audiences, the nature of the evidence 
supporting the program or practice, and the type of product deemed best 
suited to the content. SAMHSA seeks input from members of the public on 
potential changes to its Evidence-Based Practices Resource Center 
(EBPRC), specifically regarding the possible introduction of three new 
domains for the EBPRC website (https://www.samhsa.gov/resource-search/ebp). In addition to addressing four general questions about the EBPRC 
overall, SAMHSA encourages members of the public to comment on several 
questions pertaining to each of the domains described. SAMHSA believes 
that public and expert input on the new domains will help make the 
EBPRC more responsive to the needs of the public and the behavioral 
health field.

DATES: Comments on this notice must be received by October 13th, 2023.

ADDRESSES: Please submit all responses via email to 
<a href="/cdn-cgi/l/email-protection#aaefe8faf8e9ead9cbc7c2d9cb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="aeebecfefcedeeddcfc3c6ddcf80c6c6dd80c9c1d8">[email protected]</span></a> as a Word document, Portable Document Format (PDF) 
file, or in the body of the email message. Please include ``Request for 
Information: Changes to SAMHSA's EBPRC'' in the subject line of the 
message.

FOR FURTHER INFORMATION CONTACT: Carter A Roeber, Telephone: 240-276-
1488, Email: <a href="/cdn-cgi/l/email-protection#3b785a494f5e491569545e595e497b485a5653485a15535348155c544d"><span class="__cf_email__" data-cfemail="ecaf8d9e98899ec2be83898e899eac9f8d81849f8dc284849fc28b839a">[email protected]</span></a>, or <a href="/cdn-cgi/l/email-protection#d0959280829390a3b1bdb8a3b1feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="e1a4a3b1b3a2a192808c899280cf898992cf868e97">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The EBPRC was established in 2018 to fulfill 
the statutory requirements of the 21st Century Cures Act (Pub. L. 144-
255). Specifically, section 7002 of the 21st Century Cures Act requires 
that, as appropriate, SAMHSA shall ``improve access to reliable and 
valid information on evidence-based programs and practices, including 
information on the strength of evidence associated with such programs 
and practices, related to mental and substance use disorders for 
States, local communities, nonprofit entities, and other stakeholders, 
by posting on the internet website of the Administration information on 
evidence-based programs and practices that have been reviewed by the 
Assistant Secretary in accordance with the requirements of this 
section.'' SAMHSA has designated the EBPRC, managed by the agency's 
National Mental Health and Substance Use Policy Laboratory (NMHSUPL), 
to fulfill this charge.
    With the directive to publish information on evidence-based 
programs and practices (EBPs), the EBPRC relies on SAMHSA's 
relationships with key behavioral health stakeholders, including 
researchers, clinical and public health service providers, program 
administrators, and people with lived experience to inform the content 
it distributes. Further, SAMHSA's repository of EBPRC materials is 
organized by topic area and made searchable to maximize navigability, 
utility, and relevancy of content to those poised to implement EBPs. In 
this way, the EBPRC aims to broaden the scale of EBP implementation and 
provide support to improve behavioral health outcomes nationwide.
    Recognizing the ever-changing nature of the evidence base, the 
EBPRC seeks to take a dynamic and responsive approach to its curation 
of resources. To date, however, the EBPRC has primarily posted 
federally developed materials on practices. The programs and practices 
mentioned in the posted materials are vetted through a review of the 
evidence. However, unlike Crimesolutions.gov or the What Works 
Clearinghouse (WWC), the EBPRC does not currently incorporate and 
publish a systematic process for identifying, evaluating and rating 
specific programs and practices across the behavioral health field and 
related subspecialty fields for inclusion, as envisioned by section 
7002, subsections (b), (c), or (d) of the 21st Century Cures Act. The 
inclusion of reviews and ratings of particular programs would allow 
users to search for and learn about specific programs that might meet 
their population's needs.
    To ensure that the EBPRC fulfills its roles in the analysis, 
synthesis, and dissemination of behavioral health evidence, SAMHSA 
requests that members of the public respond to the following questions, 
the answers to which will help frame the agency's efforts to improve 
the EBPRC's utility to the public.

Framing Questions

    <bullet> Question A: How can SAMHSA improve the EBPRC to better 
meet the needs of the behavioral health field?
    <bullet> Question B: What strategies should the EBPRC use to ensure 
its content is high-quality and supported by strong evidence?
    <bullet> Question C: How can SAMHSA expand the reach of the EBPRC?
    <bullet> Question D: How can SAMHSA solicit feedback on the use of 
its resources and information?
    In addition, SAMHSA requests that commenters consider the following 
three domains of the EBPRC, upon which it seeks specific feedback, as 
enumerated below.
    Domain 1. Adding a program review and rating component to the 
EBPRC.
    SAMHSA's EBPRC provides communities, clinicians, policymakers, and 
others with the information and tools needed to improve the quality of 
care, by incorporating EBPs into their communities or clinical 
settings. Evidence-based practices and programs (EBPs) are defined as 
interventions that are guided by the best research evidence with 
practice-based expertise, cultural competence, and the values of the 
persons receiving the services that promote individual or population-
level outcomes. The distinction between

[[Page 61609]]

programs and practice is important, however.
    A Program is a specific set of activities carried out according to 
guidelines to achieve a defined purpose. To determine whether 
individual programs are effective, we rely on studies using randomized 
experimental (i.e., controlled) evaluation designs and quasi-
experimental evaluation designs. Program profiles tell us whether a 
specific program was found to achieve its goals when it was carefully 
evaluated. The results apply to the exact set of activities and 
procedures used for the program as implemented at the time of 
evaluation. Thus, the program profile tells us that a program is likely 
to produce the observed result if it is implemented in exactly the same 
way. A program profile can answer: Did the ABC mentoring program in 
Anytown, USA, achieve its goals?
    A Practice is a general category of programs, strategies or 
procedures that share similar characteristics with regard to the issues 
they address and how they address them. We rely on meta-analyses 
instead of evaluations of individual programs. Practice profiles tell 
us about the average results from multiple evaluations of similar 
programs, strategies, or procedures. The programs, strategies or 
procedures within a practice are similar because they share certain 
defining characteristics that are described for each practice profile. 
Thus, practice profiles tell us about the average result across 
multiple evaluations. A practice profile can answer: Does mentoring 
usually achieve its goals?
    It is well established that individuals, for-profit and non-profit 
businesses, universities, and other groups develop and market 
proprietary or copywritten interventions/programs, both as a source of 
revenue, and as a means of improving the quality of behavioral health 
services. Similarly, the development of a new pharmaceutical product 
for a substance use or mental health condition is driven by both market 
forces and health care needs. In the fields of substance use 
prevention, mental health promotion, as well as treatment and recovery 
for behavioral health conditions, organizations may charge fees for the 
specific manualized program they developed or for additional consulting 
services. These programs (i.e., manualized interventions) may or may 
not be effective.
    In its current form, the EBPRC posts relevant materials developed 
by SAMHSA staff or on behalf of SAMHSA by contractors. These products 
cover a wide range of topics and are generally in the format of a 
comprehensive evidence-based guide, practical guide, or advisory. 
Evidence-based guides are developed for topics on which the evidence is 
well established, providing background information, a review of the 
evidence, guidance on implementation and process improvement, and case 
studies on specific evidence-based programs and practices. These guides 
are targeted to the general public and various behavioral health 
stakeholders across disciplines, including providers, researchers, and 
administrators. Practical guides are developed when a topic is urgent 
and for which there is an established evidence base, but uptake has 
been slow due to various barriers. Practical guides address those 
barriers through an environmental scan of up-to-date literature, 
curated through the lens of implementation, with the aim of informing 
end users. Using a similar methodology as practical guides, advisories 
provide brief guidance on a given topic for a broad audience, focusing 
on actionable steps to promote effective behavioral health practice and 
mitigate immediate behavioral health risks.
    SAMHSA also posts treatment improvement protocols, toolkits, fact 
sheets, and systematic evidence reviews. Organizations and providers 
can download these products at no cost. These products are one way of 
disseminating information about EBPs in summarized form. However, there 
may be other ways of disseminating information about EBPs.
    The EBPRC does not currently seek applications for inclusion in its 
website as envisioned by section 7002 (b) of the 21st Century Cures Act 
and similarly has not established a review and rating system as 
outlined in section 7002(c). Section 7002(b) suggests that the 
Assistant Secretary for Mental Health and Substance Use Services (AS) 
``may establish a period for the submission of applications for 
evidence-based programs and practices to be posted publicly. . ..'' and 
section 7002(c) states that the AS ``may establish minimum requirements 
for the applications related to submission of research and 
evaluation.'' In summary, the EBPRC may request that programs are 
submitted for review and rating, requiring that minimum criteria be met 
for inclusion on the EBPRC website. As such, this RFI seeks input on 
the best ways to solicit program submissions as well as to review and 
rate submitted programs.
    Evidence-based practice registries, like CrimeSolutions.gov or What 
Works in Education (https://ies.ed.gov/ncee/wwc/), provide ratings of 
individual programs. Similar to consumer group websites, these 
registries' ratings provide useful information about a single program's 
effectiveness, without going into detail about how the program should 
be implemented, how much it may cost, or whether it is appropriate for 
a particular organization or provider. This method has the advantage of 
sharing critical information quickly. However, it may not provide 
enough information to help an organization or provider make a final 
decision regarding which program to select.
    Relatedly, the impact of program selection on behavioral health 
outcomes raises the question of how the EBPRC should consider and 
select programs for review. The EBPRC has limited resources for 
conducting program reviews and rating each submission.
    Therefore, SAMHSA is interested in the following questions:
    <bullet> Question 1a: Please describe the extent to which a new 
EBPRC component that reviews the evidence for a manualized 
intervention/program and publicly posts the results would be of use to 
the behavioral health field.
    <bullet> Question 1b: If SAMHSA chooses to add the program review 
component, how should it decide which programs get reviewed and which 
do not?
    <bullet> Question 1c: Please describe the extent to which an 
evaluation of a program's dissemination materials, costs, and other 
issues associated with implementation would be of use to the behavioral 
health field.
    Domain 2. Including implementation science, process improvement, 
capacity building and program evaluation resources.
    Implementation science is defined as ``the scientific study of 
methods to promote the systematic uptake of clinical research findings 
and other evidence-based practices (EBPs) into routine practice and 
hence improve the quality and effectiveness of health care.'' \i\ The 
new field of study emerged with increased emphasis on EBPs and the 
barriers that organizations faced in adopting them.
---------------------------------------------------------------------------

    \i\ Wiltsey Stirman, S., Baumann, A. A., & Miller, C. J. (2019). 
The FRAME: an expanded framework for reporting adaptations and 
modifications to evidence-based interventions. Implementation 
Science, 14, 1-10, https://doi.org/10.1186/s13012-019-0898-y.
---------------------------------------------------------------------------

    Improvement science draws heavily on process improvement 
models.\ii\ Underlying most of these models is the Plan, Do, Study, Act 
(PDSA) cycle, which involves systematically gaining

[[Page 61610]]

learning and knowledge for the continual improvement of a product or 
process through an iterative process of planning, making small changes, 
and monitoring and responding to results.\iii\Like implementation 
science, improvement science aims to improve population outcomes and 
acknowledges the gap between current and ideal practice.\iv\
---------------------------------------------------------------------------

    \ii\ Pflager, D. (2022, August 2). Getting it right: Using 
implementation research to improve outcomes in early care and 
education. Foundation For Child Development. https://www.fcd-us.org/getting-it-right-using-implementation-research-to-improve-outcomes-in-early-care-and-education/.
    \iii\ Consumer assessment of healthcare providers and Systems 
(CAHPS). AHRQ. (n.d.). https://www.ahrq.gov/cahps/.
    \iv\ Nilsen, P., Thor, J., Bender, M., Leeman, J., Andersson-
G[auml]re, B., & Sevdalis, N. (2022). Bridging the silos: a 
comparative analysis of implementation science and improvement 
science. Frontiers in Health Services, 1, 18.
---------------------------------------------------------------------------

    For population outcomes to improve, the individuals, organizations, 
systems, and communities implementing these processes must have 
capacity to do so successfully. As such, in achieving population impact 
goals, capacity building can be described as ``the ways to the means,'' 
and ``the process through which individuals, groups of people, and 
organizations obtain, strengthen, and maintain the capabilities they 
need to set and advance goals.'' \v\
---------------------------------------------------------------------------

    \v\ Early childhood systems building resource guide. Why 
Capacity Building? <radical> Child Care Technical Assistance 
Network. (n.d.). https://childcareta.acf.hhs.gov/systemsbuilding/systems-guides/capacity-building-self-assessment-tool/why-capacity-building.
---------------------------------------------------------------------------

    Also, essential to improving population health is program 
evaluation,\vi\ which can be defined as ``an assessment using 
systematic data collection and analysis of one or more programs, 
policies, and organizations intended to assess their effectiveness and 
efficiency.'' \vii\
---------------------------------------------------------------------------

    \vi\ Edwards, B., Stickney, B., Milat, A., Campbell, D., & 
Thackway, S. (2016). Building research and evaluation capacity in 
population health: the NSW Health approach. Health promotion journal 
of Australia: official journal of Australian Association of Health 
Promotion Professionals, 27(3), 264-267. https://doi.org/10.1071/HE16045.
    \vii\ Gao-21-404SP, program evaluation: Key terms and concepts. 
Government Accountability Office. (2021, March). https://www.gao.gov/assets/gao-21-404sp.pdf.
---------------------------------------------------------------------------

    <bullet> Question 2a: What types of implementation science, process 
improvement, and capacity building resources should SAMHSA include in 
the EBPRC to facilitate the adoption of EBPs?
    <bullet> Question 2b: What additional resources on program 
evaluation would be helpful to provide through the EBPRC?
    Domain 3. Culturally informed and community-driven programs and 
practices.
    SAMHSA's mission covers the entire continuum of care, from 
substance use prevention and mental health promotion to treatment and 
services fostering recovery.\viii\ Furthermore, as a federal agency, 
SAMHSA serves all Americans, with a special emphasis on equity for 
under-resourced communities. For the purpose of this RFI, under-
resourced communities are defined as ``population groups that 
experience greater obstacles to health, based on characteristics such 
as, but not limited to, race, ethnicity, religion, income, geography, 
gender identity, sexual orientation, and disability.'' \ix\ Steps 
toward fulfilling that mission include listening to and collaborating 
with under-resourced communities to address the barriers that limit 
access to behavioral health services and to support community 
development through culturally informed interventions. SAMHSA has a 
long history of promoting and disseminating community-based and 
culturally based programs that are developed in collaboration with 
under-resourced populations. Yet, for several reasons, many community- 
and culturally-based programs are excluded from evidence-based 
registries or clearinghouses. The way these programs are developed and 
implemented means that they cannot ethically or logistically be 
evaluated using randomized controlled trial or quasi-experimental 
designs that registries require for consideration. The programs can 
also be small in scale and geographically specific, making it even more 
difficult to randomly select participants or develop matching control 
groups.
---------------------------------------------------------------------------

    \viii\ White House (2023, May 18). Biden-Harris Administration 
Announces New Actions to Tackle Nation's Mental Health Crisis [Fact 
sheet]. https://www.whitehouse.gov/briefing-room/statements-releases/2023/05/18/fact-sheet-biden-harris-administration-announces-new-actions-to-tackle-nations-mental-health-crisis/.
    \ix\ Substance Abuse and Mental Health Services Administration 
(SAMHSA): Adapting Evidence-Based Practices for Under-Resourced 
Populations. SAMHSA Publication No. PEP22-06-02-004. Rockville, MD: 
National Mental Health and Substance Use Policy Laboratory. 
Substance Abuse and Mental Health Services Administration, 2022.
---------------------------------------------------------------------------

    Taking these factors into account, please answer the following 
questions:
    <bullet> Question 3a: In what ways, if any, would an EBPRC 
component that assesses and shares findings from research on community-
based and/or culturally driven behavioral health programs be of use to 
the behavioral health field?
    <bullet> Question 3b: What methods should SAMHSA use to assess 
community- or culturally-based behavioral health programs and present 
them on the EBPRC?
    <bullet> Question 3c: If SAMHSA convenes a technical expert panel, 
what areas of expertise should be included?
    Responses from the public will inform SAMHSA's efforts to improve 
the EBPRC and better disseminate programs and practices to our partners 
and collaborators. Responses from the public are one of the best ways 
for SAMHSA to hear from people and organizations who are directly 
affected by SAMHSA's work. Thank you for your consideration.

How To Submit a Response

    Responses will be accepted through October 13th, 2023. Responses 
must be emailed to <a href="/cdn-cgi/l/email-protection#b5f0f7e5e7f6f5c6d4d8ddc6d49bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="c98c8b999b8a89baa8a4a1baa8e7a1a1bae7aea6bf">[email protected]</span></a>. Please include ``Request for 
Information: Changes to SAMHSA's EBPRC'' in the subject line.
    Responders are free to address any or all the questions listed 
above. Please identify the question or question(s) to which you are 
responding. Responses also may address concerns or issues not 
identified above.
    The submitted information will be reviewed by SAMHSA and HHS staff. 
However, individual comments may not be acknowledged by SAMHSA due to 
the volume of comments received.
    Responses to this RFI are entirely voluntary and may be submitted 
anonymously. Please do not include any personally identifiable 
information or any information that you do not wish to make public. 
Proprietary, classified, confidential, or sensitive information should 
not be included in your response.
    SAMHSA will use the information submitted in response to this RFI 
at its discretion. SAMHSA reserves the right to use any submitted 
information on public websites, in reports, in summaries of the state 
of the science, in any possible resultant solicitation(s), grant(s), 
contract(s) or cooperative agreement(s), or in the development of 
future funding opportunity announcements.
    This RFI is for informational and planning purposes only and is not 
a solicitation for applications or an obligation on the part of the 
Government to provide support for any ideas identified in response to 
it. Please note that the Government will not pay for the preparation of 
any information submitted or for use of that information.

    Dated: August 31, 2023.
Carlos Castillo,
Committee Management Officer.
[FR Doc. 2023-19272 Filed 9-6-23; 8:45 am]
BILLING CODE 4162-20-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>