[Federal Register Volume 75, Number 159 (Wednesday, August 18, 2010)]
[Notices]
[Pages 51075-51077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20016]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


National Registry of Evidence-Based Programs and Practices 
(NREPP): Open Submission Period for Fiscal Year 2011

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

ACTION: Notice.

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

SUMMARY: The Substance Abuse and Mental Health Services 
Administration's (SAMHSA's) mission is to reduce the impact of 
substance abuse and mental illness on America's communities. The Agency 
was established in 1992 and 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. 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, March 14, 2006). Since 2006, 
SAMHSA has held three 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 Federal 
Fiscal Year 2011, explains 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 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 7-1041, 
Rockville, MD 20857, telephone 240-276-2234.

    Dated: August 6, 2010.
Pamela S. Hyde,
Administrator, SAMHSA.

Substance Abuse and Mental Health Services Administration's National 
Registry of Evidence-Based Programs and Practices (NREPP): Open 
Submission Period for Fiscal Year 2011

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

[[Page 51076]]

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.
    Please note four changes from the previous submission period:
    1. Submissions will be accepted from November 1, 2010, through 
February 1, 2011.
    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.
    3. Due to a combination of limited resources and a large number of 
previously accepted mental health submissions, only a small number of 
mental health promotion or mental health treatment interventions will 
be accepted for review by NREPP in FY 2011.
    4. Because of limited resources for FY 2011, multiple submissions 
from the same developer--regardless of content area--will not be 
accepted.

Dates of Open Submission Period

    SAMHSA has established a 3-month period for receipt of NREPP 
submissions for fiscal year 2011 that will begin November 1, 2010, and 
end February 1, 2011. Interventions submitted after February 1, 2011, 
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.samhsa.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 NIREPP 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~05) 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 post intervention assessments. Quasi-experimental designs do 
not require random assignment but do require a comparison or control 
group and pre- and post-intervention 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 technical 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. Submissions 
must include information that can be rated according to the six (6) 
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
------------------------------------------------------------------------
          Minimum requirement                     Documentation
------------------------------------------------------------------------
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 use among individuals,     (document/page number) for
     communities, or populations.         each outcome and
    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
    3. Results of these studies have     Note: Abstracts or URLs to
     been published in a peer-reviewed    partial articles are regarded
     journal or other publication or      as incomplete and will not be
     documented in a comprehensive        considered.
     evaluation report.
Readiness for Dissemination:
    4. Implementation materials,         Brief narrative description and
     training and support resources,      list of available materials,
     and quality assurance procedures     resources, and systems to
     have been developed and are ready    support implementation (e.g.,
     for us by the public.                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).
------------------------------------------------------------------------


[[Page 51077]]

    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.
    3. 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.
    4. Due to a combination of limited resources and a large number of 
previously accepted mental health submissions, only a small number of 
mental health promotion or mental health treatment interventions will 
be accepted for review by NREPP in FY 2011.
    5. Because of limited resources for FY 2011, multiple submissions 
from the same developer-regardless of content area-will not be 
accepted.

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.

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 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. 
EST on February 1, 2011; those received before November 1, 2010, 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 ~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 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. 2010-20016 Filed 8-17-10; 8:45 am]
BILLING CODE 4160-01-M