National Registry of Evidence-Based Programs and Practices (NREPP): Open Submission Period for Fiscal Year 2011, 51075-51077 [2010-20016]

Download as PDF Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Notices EZ Cruise, Inc. (NVO & OFF), 1209–11 167th Street, Baltimore, MD 21237. Officers: Omar Akbar, President, (Qualifying Individual), Etiq Shukran, Secretary/Treasurer, Application Type: New NVO & OFF License. Hawaii Intermodal Tank Transport, LLC (NVO & OFF), 2350 S. Dock Street, #D, Palmetto, FL 34221. Officer: Bahman Sadeghi, Managing Member, (Qualifying Individual), Application Type: New NVO & OFF License. Juan C. Fernandez dba Mind Over Business (NVO), 2301 East Edgar Road, Bldg. #4, Linden, NJ 07036. Officer: Juan C. Fernandez, Sole Proprietor, (Qualifying Individual), Application Type: New NVO License. Mercator Transport Houston Corporation (OFF), 10418 Sagerock Drive, Houston, TX 77089. Officers: Joseph Carrion, President, (Qualifying Individual), Denis Couroux, Director, Application Type: New OFF License. Springfield Marine Limited (NVO), Pasea Estate, P.O. Box 958, Road Town, Tortola, BVI, United Kingdom. Officers: Georges Kriemadis, Vice President, Marine Operations, (Qualifying Individual), Laurence L. MacGowan, Director, Application Type: New NVO License. Super Cargo International Services, Inc. (OFF), 5519 N.W. 72nd Avenue, Miami, FL 33166. Officers: Jorge L. Martinez, Director, (Qualifying Individual), Richardo E. Sanabria, President, Application Type: New OFF License. Dated: August 13, 2010. Karen V. Gregory, Secretary. [FR Doc. 2010–20484 Filed 8–17–10; 8:45 am] BILLING CODE P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Reissuance Notice is hereby given that the following Ocean Transportation Intermediary licenses have been reissued by the Federal Maritime Commission pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. Chapter 409) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, 46 CFR Part 515. License No. Name/address 008904N .................................................... Port Jersey Shipping International Inc., 268 Seaview Avenue, Jersey City, NJ 07305. Cargo Plus, Inc., 8333 Wessex Drive, Pennsauken, NJ 08109 ................................ C & L, USA, Inc. dba C&L Freight Srvs., 20 Broadhollow Road, Suite 1005, Melville, NY 11747. Gold Coast Shipping, LLC, 2964 Main Street, Hartford, CT 06120 .......................... Around The World Shipping, Inc., 6726 Reseda Blvd., Suite A–10, Reseda, CA 91335. 015941NF ................................................. 019408N .................................................... 020821NF ................................................. 021246N .................................................... Sandra L. Kusumoto, Director, Bureau of Certification and Licensing. [FR Doc. 2010–20483 Filed 8–17–10; 8:45 am] BILLING CODE P 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 Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. AGENCY: 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, sroberts on DSKD5P82C1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:40 Aug 17, 2010 Jkt 220001 SAMHSA has expanded and refined the agency’s National Registry of Evidencebased 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. PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 51075 Date reissued July 1, 2010. June 23, 2010. July 17, 2010. June 11, 2010. July 7, 2010. 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 E:\FR\FM\18AUN1.SGM 18AUN1 51076 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Notices 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 quasiexperimental design. Experimental designs require random assignment, a control or comparison group, and preand 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 sroberts on DSKD5P82C1PROD with NOTICES 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. 2. Evidence of these outcomes has been demonstrated in at least one study using an experimental or quasi-experimental design. 3. Results of these studies have been published in a peer-reviewed journal or other publication or documented in a comprehensive evaluation report. Readiness for Dissemination: 4. Implementation materials, training and support resources, and quality assurance procedures have been developed and are ready for us by the public. VerDate Mar<15>2010 18:40 Aug 17, 2010 Jkt 220001 PO 00000 Frm 00094 Fmt 4703 A list of significant behavioral outcomes that includes supporting citations (document/page number) for each outcome and 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 Note: Abstracts or URLs to partial articles are regarded as incomplete and will not be considered. 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). Sfmt 4703 E:\FR\FM\18AUN1.SGM 18AUN1 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Notices sroberts on DSKD5P82C1PROD with NOTICES 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). FDAapproved 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 whollyfrom 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 VerDate Mar<15>2010 18:40 Aug 17, 2010 Jkt 220001 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 nrepp@samhsa.hhs.gov or call 1–866– 436–7377. [FR Doc. 2010–20016 Filed 8–17–10; 8:45 am] BILLING CODE 4160–01–M PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 51077 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0422] Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Processors That Export to the European Community AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements in implementing the lists of U.S. firms/processors exporting shell eggs, dairy products, game meat, game meat products, animal casings, gelatin, and collagen to the European Community (the EC). DATES: Submit either electronic or written comments on the collection of information by October 18, 2010. ADDRESSES: Submit electronic comments on the collection of information to http://www. regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide SUMMARY: E:\FR\FM\18AUN1.SGM 18AUN1

Agencies

[Federal Register Volume 75, Number 159 (Wednesday, August 18, 2010)]
[Notices]
[Pages 51075-51077]
From the Federal Register Online via the Government Printing 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 nrepp@samhsa.hhs.gov or call 1-
866-436-7377.
[FR Doc. 2010-20016 Filed 8-17-10; 8:45 am]
BILLING CODE 4160-01-M