E9-14621. 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.

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 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, [phone].

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

	Minimum requirement	Documentation
Quality of Research	1. Intervention has produced one or more positive behavioral outcomes (p. ≤ .05) in mental health or substance use among individuals, communities, or populations	A list of significant behavioral outcomes that includes supporting citations for each outcome; and
	2. Evidence of these outcomes has been demonstrated in at least one study using an experimental or quasiexperimental design	A full-text copy of each article/report cited in the list of outcomes. Other 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 been published in a peer-reviewed journal or other publication or documented in a comprehensive evaluation report	Note: Abstracts or URLs to partial articles are regarded as incomplete and will not be considered.
Readiness for Dissemination	4. Implementation materials, training and support resources, and quality assurance procedures have been developed and are ready for use by the public	Brief narrative description and list of available materials, resources, and systems to support 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).

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 [e-mail] or call 1-866-436-7377.