[Federal Register Volume 74, Number 119 (Tuesday, June 23, 2009)]
[Notices]
[Pages 29706-29708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


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 2010

AGENCY: Substance Abuse and Mental Health Services Administration.

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 2010.

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SUMMARY: The Substance Abuse and Mental Health Services Administration 
(SAMHSA) is committed to preventing the onset and reducing the 
progression of mental illness, substance abuse, and substance-related 
problems among all individuals. As part of this effort, SAMHSA has 
expanded and refined the agency's National Registry of Evidence-based 
Programs and Practices (NREPP). Two previous notices announcing these 
changes have been published in the Federal Register (70 FR 50381, Aug. 
26, 2005; 71 FR 13133, Mar. 14, 2006). Since 2006, SAMHSA has held two 
open submission periods during which interventions could be submitted 
for potential review and inclusion on the NREPP Web site (71 FR 37590, 
June 30, 2006; 72 FR 30814, June 4, 2007). This notice announces the 
open submission period for fiscal year 2010, explains

[[Page 29707]]

how submissions will be screened and selected, and provides guidance on 
the submission process for individuals and organizations seeking to 
have an intervention reviewed and listed on the NREPP Web site. 
Potential applicants should be aware that this notice includes new 
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/SAMHSA, 1 Choke Cherry Road, Room 8-1017, 
Rockville, MD 20857, (240) 276-2234.

    Dated: June 16, 2009.
Eric B. Broderick,
Acting Administrator, SAMHSA Assistant Surgeon General.

Substance Abuse and Mental Health Services Administration's National 
Registry of Evidence-based Programs and Practices (NREPP): Open 
Submission Period for Fiscal Year 2010

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 illness, substance use disorders, 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 4-month period for receipt of NREPP 
submissions for fiscal year 2010 that will begin October 1, 2009, and 
end February 1, 2010. Interventions submitted after February 1, 2010, 
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 review criteria (http://nrepp.sarnhsa.gov/review.asp). 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. 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.

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<=.O5) in mental health or substance use 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.
    3. The results of these studies have been published in a peer-
reviewed journal or other publication or documented in a comprehensive 
evaluation report. Comprehensive evaluation reports must include a 
review of the literature, theoretical framework, purpose, methodology, 
findings/results, discussion, and conclusions.
    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 that 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    A list of significant behavioral
                                         one or more positive            outcomes that includes supporting
                                         behavioral outcomes (p. <=      citations for each outcome; and
                                         .05) in mental health or
                                         substance use among
                                         individuals, communities, or
                                         populations.
                                        2. Evidence of these outcomes   A full-text copy of each article/report
                                         has been demonstrated in at     cited in the list of outcomes. Other
                                         least one study using an        research articles, published or
                                         experimental or                 unpublished evaluation reports, grant
                                         quasiexperimental design.       final reports, and replication studies
                                                                         may be submitted as additional
                                                                         supporting documentation.

[[Page 29708]]

 
                                        3. Results of these studies     Note: Abstracts or URLs to partial
                                         have been published in a peer-  articles are regarded as incomplete and
                                         reviewed journal or other       will not be considered.
                                         publication or documented in
                                         a comprehensive evaluation
                                         report.
Readiness for Dissemination...........  4. Implementation materials,    Brief narrative description and list of
                                         training and support            available materials, resources, and
                                         resources, and quality          systems to support implementation
                                         assurance procedures have       (e.g., treatment manuals, information
                                         been developed and are ready    for administrators, tested training
                                         for use by the public.          curricula, mechanisms for ongoing
                                                                         supervision and consultation, protocols
                                                                         for gathering process and outcome data,
                                                                         ongoing monitoring of intervention
                                                                         fidelity, processes for gathering
                                                                         feedback).
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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. Stand-alone smoking prevention and/or cessation interventions--
Interventions to prevent or reduce tobacco use are eligible for NREPP 
review only when conducted as part of a program that also addresses the 
prevention or treatment of alcohol or other drugs of abuse.

Selection of Interventions for Review

    All submissions meeting the minimum requirements will be considered 
eligible for review. The priority point system described in past 
Federal Register notices will no longer be used in the prioritization 
of submissions. 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, and 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.

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 that 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 pm EST 
on February 1, 2010; those received before October 1, 2009, will be 
disregarded.
    If an intervention is accepted, the PI will be contacted and 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<=.O5) as well 
as 8 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 PI is expected to serve as the main point of contact throughout 
the remainder of the review process, including 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. E9-14621 Filed 6-22-09; 8:45 am]
BILLING CODE 4160-01-M