[Federal Register Volume 76, Number 180 (Friday, September 16, 2011)]
[Notices]
[Pages 57742-57744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23757]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Registry of Evidence-Based Programs and Practices

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Notice Regarding Substance Abuse and Mental Health Services 
Administration's National Registry of Evidence-based Programs and 
Practices (NREPP): Open Submission Period for Fiscal Year 2012.

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SUMMARY: The mission of the Substance Abuse and Mental Health Services 
Administration (SAMHSA) is to reduce the impact of substance abuse and 
mental illness on America's communities. Established in 1992, the 
Agency was directed by Congress to target effective substance abuse and 
mental health services to the people most in need, and to translate 
research in these areas more effectively and more rapidly into the 
general health care system. The National Registry of Evidence-based 
Programs and Practices (NREPP) is a key public resource SAMHSA has 
developed to help meet this directive. This notice announces NREPP's 
open submission period for Fiscal Year 2012, during which developers of 
interventions may submit an application for a potential review. The 
notice explains how submissions will be screened and selected, and 
provides guidance on the submission process. Potential applicants 
should be aware that this notice includes updated information relating 
to the eligibility of interventions and the review process that 
supersedes guidance provided in earlier Federal Register notices.

FOR FURTHER INFORMATION CONTACT: Kevin D. Hennessy, Ph.D., Science to 
Service Coordinator, Center for Behavioral Health Statistics and 
Quality, SAMHSA, 1 Choke Cherry Road, Room 2-1017, Rockville, MD 20857, 
telephone 240-276-2234.

Rose Shannon,
Director, Division of Executive Correspondence.

Substance Abuse and Mental Health Services Administration's National 
Registry of Evidence-Based Programs and Practices (NREPP): Open 
Submission Period for Fiscal Year 2012

Background

    The Substance Abuse and Mental Health Services Administration's 
(SAMHSA) National Registry of Evidence-based Programs and Practices 
(NREPP) is a voluntary rating system designed to provide the public 
with reliable information about interventions that promote mental 
health or prevent or treat mental disorders, substance abuse, substance 
use disorders, and/or co-occurring disorders. Programs and practices 
that are accepted for inclusion in the registry undergo two independent 
review processes in which their (1) Quality of research and (2) 
readiness for dissemination are evaluated and rated. The results of 
these reviews are published on the NREPP Web site (http://nrepp.samhsa.gov).
    It should be noted that inclusion in NREPP does not constitute 
endorsement of an intervention by SAMHSA. Moreover, since NREPP has not 
reviewed all interventions, the use of NREPP as an exclusive or 
exhaustive list of interventions is not appropriate. Policymakers and 
funders in particular are discouraged from limiting contracted 
providers and/or potential grantees to selecting only among NREPP 
interventions.
    This notice announces the next open submission period during which 
SAMHSA will consider and accept new applications for review, describes 
the minimum requirements and other considerations that will be used in 
screening and selecting interventions, and provides guidance on the 
submission process.

Dates of Open Submission Period

    SAMHSA has established a 3-month period for receipt of NREPP 
submissions for Fiscal Year 2012 that will begin November 1, 2011, and 
end February 1, 2012. Interventions submitted after February 1, 2012, 
will not be considered during this submission cycle. Program 
developers, researchers, and others interested in submitting an 
intervention should read this notice for information about current 
minimum requirements, and examine the information provided on the NREPP 
Web site about the review process and criteria (http://nrepp.samhsa.gov/Reviews.aspx) and guidance for preparing an 
intervention for submission (http://nrepp.samhsa.gov/SubmissionCourse.aspx). The selection of interventions will take place 
after the closing of the open submission period, and applicants will be 
informed of their acceptance status at that time. The number of reviews 
conducted will depend on the availability of funds, with the final 
selection of interventions and the timing of reviews to be determined 
at the discretion of SAMHSA.
    In submitting an intervention, applicants understand that the 
results of NREPP reviews are considered public information and will be 
posted on the NREPP Web site. Once a review is completed, the applicant 
will be provided with a summary document (``intervention summary'') 
that presents ratings and descriptive information about the 
intervention. Anyone that consents to a review is expected to authorize 
publication of the intervention summary on the NREPP Web site. If a 
summary is completed and consent is not given to publish the summary, a 
statement to that effect will be posted on the NREPP Web site.
    Applicants are encouraged to view examples of NREPP intervention 
summaries on the NREPP Web site to become familiar with the end product 
of the review process.

[[Page 57743]]

Minimum Requirements

    To be considered for review, interventions must meet four minimum 
requirements:
    1. The intervention has produced one or more positive behavioral 
outcomes (p <= .05) in mental health, mental disorders, substance 
abuse, or substance use disorders among individuals, communities, or 
populations.
    2. Evidence of these outcomes has been demonstrated in at least one 
study using an experimental or quasi-experimental design. Experimental 
designs require random assignment, a control or comparison group, and 
pre- and postintervention assessments. Quasi-experimental designs do 
not require random assignment, but do require a comparison or control 
group and pre- and postintervention assessments; this category includes 
longitudinal/multiple time series designs with at least three 
preintervention or baseline measurements and at least three 
postintervention or follow-up measurements. Studies that are based on 
single group, pre-/posttest designs do not meet this requirement.
    3. The results of these studies have been published in a peer-
reviewed journal or other professional publication, or documented in a 
comprehensive evaluation report. Comprehensive evaluation reports must 
include a review of the literature, theoretical framework, purpose, 
methodology, findings/results with statistical analysis and p values 
for significant outcomes, discussion, and conclusions. Submissions must 
include information that can be rated according to the six Quality of 
Research criteria identified on the NREPP Web site.
    4. Implementation materials, training and support resources, and 
quality assurance procedures have been developed and are ready for use 
by the public.
    Applicants are required to provide documentation at the time of 
submission that demonstrates the intervention meets these minimum 
requirements. Table 1 lists examples of appropriate supporting 
documentation.

                  Table 1--Documentation for Demonstrating Compliance With Minimum Requirements
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                                              Minimum requirement                       Documentation
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Quality of Research................  1. Intervention has produced one or    A list of significant behavioral
                                      more positive behavioral outcomes (p   outcomes that includes supporting
                                      <= .05) in mental health, mental       citations (document/page number)
                                      disorders, substance abuse, or         for each outcome; and
                                      substance use disorders among
                                      individuals, communities, or
                                      populations.
                                     2. Evidence of these outcomes has      A full-text copy of each article/
                                      been demonstrated in at least one      report cited in the list of
                                      study using an experimental or quasi-  outcomes. Other research articles,
                                      experimental design.                   published or unpublished evaluation
                                                                             reports, grant final reports, and
                                                                             replication studies may be
                                                                             submitted as additional supporting
                                                                             documentation.
                                     3. Results of these studies have been  Note: Abstracts or URLs to partial
                                      published in a peer-reviewed journal   articles are regarded as incomplete
                                      or other publication or documented     and will not be considered.
                                      in a comprehensive evaluation report.
Readiness for Dissemination........  4. Implementation materials, training  A brief narrative description and
                                      and support resources, and quality     list of available materials,
                                      assurance procedures have been         resources, and systems to support
                                      developed and are ready for use by     implementation (e.g., treatment
                                      the public.                            manuals, information for
                                                                             administrators, tested training
                                                                             curricula, mechanisms for ongoing
                                                                             supervision and consultation,
                                                                             protocols for gathering process and
                                                                             outcome data, ongoing monitoring of
                                                                             intervention fidelity, processes
                                                                             for gathering feedback); and
                                                                            A brief description of the method
                                                                             through which new implementation
                                                                             sites acquire the above materials.
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    The following types of interventions are not eligible for review 
and should not be submitted to NREPP:
    1. Stand-alone pharmacologic treatments--The evidence base for 
pharmacologic treatments is reviewed and approved through the U.S. Food 
and Drug Administration (FDA). FDA-approved pharmacotherapy 
interventions (on-label use) are considered for NREPP review only when 
combined with one or more behavioral or psychosocial treatments.
    2. To remain consistent with SAMHSA's mission (``to reduce the 
impact of substance abuse and mental illness on American 
communities''), NREPP will not accept for review, or otherwise include 
on the NREPP Web site, any interventions that have been developed or 
evaluated with funds or other support--either partially or wholly--from 
organizations whose goals or activities are determined to be 
inconsistent with SAMHSA's mission.

Selection of Interventions for Review

    All submissions meeting the minimum requirements will be considered 
eligible for review. In selecting interventions for review, SAMHSA may 
choose to give special consideration to interventions that meet one or 
more of the following conditions:
     The original investigator(s) or an independent party has 
used the same protocol with an identical or similar target population, 
and/or has used a slightly modified protocol based on a slightly 
modified population, where results are consistent with positive 
findings from the original evaluation.
     Implementation materials (e.g., program manuals, training 
guides, measurement instruments, implementation fidelity guides) are 
available to the public at no cost.
     The intervention targets underserved populations (e.g., 
minority populations, elderly, young adults, individuals who are 
incarcerated).
     The intervention contributes to a content area where there 
are currently limited evidence-based interventions.
    Interventions that are not selected for review may be resubmitted 
by the applicant in a future open submission period.

[[Page 57744]]

Instructions for Submitting an Intervention

    To submit an intervention, individuals should send a written 
statement to NREPP expressing their interest along with documentation 
that demonstrates the intervention meets the minimum requirements as 
described above. All submissions must be made either by a principal 
investigator (PI) who has conducted research on the intervention, a 
project director (PD) who has worked with an evaluator of the 
intervention, or a formally authorized delegate of the PI or PD. For 
information on where to submit materials, please call 1-866-436-7377. 
Electronic submissions are preferred, but materials may be sent to 
NREPP in hard copy via postal mail or fax. To be eligible for 
consideration, submissions must be received no later than 11:59 p.m. 
E.S.T. on February 1, 2012; those received before November 1, 2011, 
will be disregarded.
    For each intervention that is accepted, the Principal (the 
individual, usually the PI, formally designated as the intervention's 
point of contact and decisionmaking authority during the review 
process) will be asked to submit additional documentation to be used in 
the review. This additional documentation includes full-text copies of 
all articles and reports that provide evidence of significant outcomes 
(p <= .05) as well as copies of selected dissemination materials in the 
format they are provided to the public (e.g., hard copies or electronic 
versions of manuals, training presentations, tools, quality assurance 
protocols; URLs for interactive Web-based resources).
    The Principal continues to work with NREPP staff throughout the 
review and is responsible for approval of the final intervention 
summary that is developed by NREPP staff once the review has been 
completed.

Contact Information

    Individuals who have questions about the information contained in 
this notice may write to NREPP staff at [email protected] or call 1-
866-436-7377.

[FR Doc. 2011-23757 Filed 9-15-11; 8:45 am]
BILLING CODE 4160-01-P