[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33853-33855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13223]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration (SAMHSA)


Announcement for the National Registry of Evidence-Based Programs 
and Practices (NREPP): Open Submission Period for Fiscal Year 2014

AGENCY: SAMHSA, Health and Human Services.

ACTION: Announcement.

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SUMMARY: The mission of SAMHSA is to reduce the impact of substance 
abuse

[[Page 33854]]

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. NREPP is a key public resource SAMHSA has 
developed to help meet this directive. As of June 2013, approximately 
290 interventions developed in the U.S. and abroad have been reviewed 
and added to the registry. This notice announces NREPP's open 
submission period for fiscal year 2014, during which program developers 
may submit a request to have their intervention reviewed. The notice 
provides information about the documentation that submissions must 
include to demonstrate that an intervention meets NREPP's minimum 
requirements; the responsibilities of the Principal during the review 
process; and the process for submitting materials for review during the 
open submission period.

FOR FURTHER INFORMATION CONTACT: Alyson Essex, Ph.D., MHS, Social 
Science Analyst, SAMHSA, 1 Choke Cherry Road, Room 2-1002, Rockville, 
MD 20857, telephone 240-276-0529.

Substance Abuse and Mental Health Services Administration's National 
Registry of Evidence-Based Programs and Practices (NREPP): Open 
Submission Period for Fiscal Year 2014

Background

    The Substance Abuse and Mental Health Services Administration's 
(SAMHSA) National Registry of Evidence-based Programs and Practices 
(NREPP) is a searchable online database of interventions that have been 
shown to produce significant behavioral outcomes in substance abuse 
prevention, mental health promotion, or the treatment of mental or 
substance abuse disorders and that are ready to be implemented by the 
public. Interventions that are accepted for review by NREPP undergo an 
independent review process in which (1) up to three studies are 
assessed and rated for Quality of Research and (2) the intervention's 
implementation, training, and quality assurance materials and processes 
are assessed and rated for Readiness for Dissemination. The results of 
these reviews are published on the NREPP Web site, http://nrepp.samhsa.gov. NREPP is designed as a decision-support tool for 
providers responsible for selecting and implementing interventions. The 
acceptance of interventions for review and the inclusion of 
interventions on the NREPP Web site are not intended to convey 
endorsement, recommendation, or approval of these interventions by 
SAMHSA. Policymakers and funders, in particular, are discouraged from 
requiring contracted providers or grantees to use specific 
interventions based on their inclusion in the registry.
    This notice announces the next open submission period during which 
SAMHSA will consider and accept requests for review, describes the 
requirements for submission, and provides information about the review 
process.

Open Submission Period

    SAMHSA has established a 2-month period for receipt of requests for 
NREPP reviews for fiscal year 2014 that will begin January 2, 2014, and 
end February 28, 2014. Submitters are encouraged to visit the NREPP Web 
site to learn more about the review process. The Reviews & Submissions 
page (http://nrepp.samhsa.gov/Reviews.aspx) provides an overview of the 
steps involved in reviews, the rating criteria used to assess Quality 
of Research and Readiness for Dissemination, and how reviewers are 
selected and trained. Examples of published intervention summaries, the 
end product of each review, can be viewed at http://nrepp.samhsa.gov/ViewAll.aspx.

Minimum Requirements

    For an intervention to be eligible for review, the submitter must 
provide written documentation that demonstrates the following minimum 
requirements have been met:
    1. The intervention has produced one or more positive behavioral 
outcomes (p<=.05) in mental health or substance abuse among 
individuals, communities, or populations. Significant differences 
between groups over time must be demonstrated for each outcome.
    2. Evidence of the positive behavioral outcome(s) has been 
demonstrated in at least one study using an experimental or quasi-
experimental design. Experimental designs include random assignment of 
participants, a control or comparison group in addition to the 
intervention group, and pre- and posttest assessments. Quasi-
experimental designs include a control or comparison group and pre-and 
posttest assessments but do not use random assignment. Studies with 
single-group, pretest/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 (e.g., a book 
volume) or documented in a comprehensive evaluation report. 
Comprehensive evaluation reports must include the following sections or 
their equivalent: a review of the literature, theoretical framework, 
purpose, methodology, findings/results (with statistical analysis and p 
values for significant outcomes), discussion, and conclusions. 
Information must be included to enable rating of the six Quality of 
Research criteria: (1) Reliability of measures, (2) validity of 
measures, (3) intervention fidelity, (4) missing data and attrition, 
(5) potential confounding variables, and (6) appropriateness of 
analysis.
    4. Implementation materials, training and support resources, and 
quality assurance procedures have been developed and are ready for use 
by the public.
    The documentation demonstrating these minimum requirements must be 
provided at the time of submission. Table 1 lists examples of 
appropriate supporting documentation.

    Table 1--Documentation for Demonstrating Satisfaction of 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
     more positive behavioral outcomes    behavioral outcomes that
     (p<=.05) in mental health or         includes supporting citations
     substance abuse among individuals,   (document/page number) for the
     communities, or populations.         location of each outcome
     Significant differences between      showing p values and
     groups over time must be
     demonstrated for each outcome.
    2. Evidence of these outcomes has    A full-text copy of each
     been demonstrated in at least one    article/report cited in the
     study using an experimental or       list of outcomes. Other
     quasi-experimental design.           research articles, published
                                          or unpublished evaluation
                                          reports, grant final reports,
                                          and replication studies may be
                                          submitted as additional
                                          supporting documentation.

[[Page 33855]]

 
    3. Results of these studies have     Documentation must be provided
     been published in a peer-reviewed    to enable the rating of the
     journal or other professional        six Quality of Research
     publication (e.g. book volume) or    criteria (i.e., reliability of
     documented in a comprehensive        measures, validity of
     evaluation report.                   measures, intervention
                                          fidelity, missing data and
                                          attrition, potential
                                          confounding variables, and
                                          appropriateness of analysis).
                                         NOTE: Abstracts or URLs to
                                          partial articles are regarded
                                          as incomplete documentation
                                          and will not be considered.
                                          Meta-analyses will not be
                                          considered for review.
Readiness for Dissemination:
    4. Implementation materials,         A brief narrative description
     training and support resources,      and list of available
     and quality assurance procedures     materials, resources, and
     have been developed and are ready    systems to support
     for use by the public.               implementation (e.g.,
                                          treatment 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.
------------------------------------------------------------------------

Ineligible Interventions

    The following types of interventions are not eligible for review:
    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. 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.

Acceptance of Interventions

    Submissions that meet the four minimum requirements (excluding 
ineligible interventions previously noted) will be considered for 
review. The number of interventions selected by SAMHSA for review and 
the timing of these reviews depend on the availability of funds and 
will be determined at SAMHSA's discretion. Interventions not selected 
for review during this fiscal year may be resubmitted during a future 
open submission period.

Role of the Principal

    Before an intervention can be formally accepted for review and 
added to the Accepted for Review list on the NREPP Web site, there must 
be agreement upon and designation by the submitting organization of a 
Principal to oversee the review. The designation of the Principal role 
must be agreed to by those who have had a major role in the development 
and/or evaluation of the intervention. The Principal is typically a 
principal investigator who has conducted research on the intervention, 
a program developer who has collaborated with an evaluator of the 
intervention, or an official of the organization requesting the review.
    The Principal is responsible for ensuring provision of all 
materials and documentation to be used in the review. This includes 
full-text copies of articles and reports that provide evidence of 
significant outcomes as well as copies of 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 is required to participate in a kickoff call at the 
commencement of review and may be asked to answer questions about the 
intervention, the articles, or the intervention materials for 
clarification at various points throughout the review process.
    At the end of the review, the Principal receives a draft 
intervention summary presenting the results of the review and is asked 
to provide corrections and comments. The results of NREPP reviews are 
considered public, and after having the opportunity to comment on the 
summary, the Principal is expected to authorize publication of the 
summary on the NREPP Web site. If the Principal does not provide that 
authorization, the intervention will be identified on the NREPP Web 
site as having undergone review, with a statement indicating the 
Principal did not authorize publication of the summary.

Instructions for Submitting an Intervention

    Submissions must include (1) a letter formally requesting a review 
and (2) documentation demonstrating that the minimum requirements 
described above have been met. NREPP prefers letters of interest and 
supporting materials to be submitted electronically using an online 
submission tool that will be made available during the open submission 
period. On January 2, 2014, NREPP will post a link to the online 
submission tool and instructions for how to obtain a username and 
password at http://www.nrepp.samhsa.gov/ReviewSubmission.aspx. Please 
call 1-866-436-7377 for technical assistance on the electronic 
submission process or to arrange for submission by hard copy or fax if 
electronic submission is not possible. To be eligible for 
consideration, a complete submission including both the letter of 
request and supporting documents must be received no later than 11:59 
p.m. E.S.T. on February 28, 2014; materials received before January 2, 
2014, will be disregarded.

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

Summer King,
Statistician.
[FR Doc. 2013-13223 Filed 6-4-13; 8:45 am]
BILLING CODE 4162-20-P