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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Veterans Affairs Department

NOTICE: Part II

DOCUMENT ACTION: Notice of final Service-to-Science Grants announcement.

SUBJECT CATEGORY: Notice of Final Standard Service-to-Science Grants Announcement

DATES: Use of the standard Service-to-Science Grants announcement will be effective November 21, 2003. The standard ServicetoScience Grants announcement must be used in conjunction with separate Notices of Funding Availability (NOFAs) that will provide application due dates and other key dates for specific SAMHSA grant funding opportunities.

DOCUMENT SUMMARY: On August 21, 2003, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced plans to change its approach to announcing and soliciting applications for its discretionary grant programs in Fiscal Year (FY) 2004.
[[Page 65808]]
These changes involved the publication of four standard grant announcements that would provide the basic program design and application instructions for four types of grantsServices Grants, Infrastructure Grants, Best Practices Planning and Implementation Grants, and ServicetoScience Grants. The four announcements were made available for public review and comment for 60 days. The comments received and changes made to the standard grant announcements are described in a separate Federal Register notice. This notice provides the final text for SAMHSA's standard ServicetoScience Grants announcement.

Authority: Sections 509, 516, and 520A of the Public Health Service Act.

SUMMARY: Health and Human Services Department, Substance Abuse and Mental Health Services Administration,

SUPPLEMENTAL INFORMATION

Starting in FY 2004, SAMHSA is changing its approach to announcing and soliciting applications for its discretionary grants. SAMHSA will publish four standard grant announcements that will describe the general program design and provide application instructions for four types of grantsServices Grants, Infrastructure Grants, Best Practices Planning and Implementation Grants, and ServicetoScience Grants. The text for the final standard ServicetoScience Grants announcement is provided below.

The standard ServicetoScience Grants announcement will be posted on SAMHSA's Web page (http://www.samhsa.gov) and will be available from SAMHSA's clearinghouses on an ongoing basis. The standard announcements will be used in conjunction with brief Notices of Funding Availability (NOFAs) that will announce the availability of funds for specific grant funding opportunities within each of the standard grant programs (e.g., Homeless Treatment grants, Statewide Family Network grants, HIV/AIDS and Substance Abuse Prevention Planning Grants, etc.).

ServicetoScience GrantsSTS 04 (Initial Announcement)

Catalogue of Federal Domestic Assistance (CFDA) No.: 93.243 (unless otherwise specified in a NOFA in the Federal Register and on http://www.grants.gov).

Authority: Sections 509, 516 and/or 520A of the Public Health Service Act, as amended and subject to the availability of funds (unless otherwise specified in a NOFA in the Federal Register and on http://www.grants.gov). Key Dates
Application Deadline.............. This Program Announcement provides instructions and guidelines for multiple funding opportunities. Application deadlines for specific funding opportunities will be published in Notices of Funding Availability (NOFAs) in the Federal Register and on http://www.grants.gov. Intergovernmental Review (E.O. Letters from State Single Point of 12372). Contact (SPOC) are due 60 days after application deadline Public Health System Impact Applicants must send the PHSIS to Statement (PHSIS)/Single State appropriate State and local health Agency Coordination. agencies by application deadline. Comments from Single State Agency are due 60 days after application deadline.
Table of Contents
I. Funding Opportunity Description

A. Introduction

B. Expectations
II. Award Information

A. Award Amount

B. Funding Mechanism
III. Eligibility Information

A. Eligible Applicants

B. CostSharing

C. Other
IV. Application and Submission Information

A. Address to Request Application Package

B. Content and Form of Application Submission

C. Submission Dates and Times

D. Intergovernmental Review (E.O. 12372) Requirements

E. Funding Limitations/Restrictions

F. Other Submission Requirements
V. Application Review Information

A. Evaluation Criteria

B. Review and Selection Process

C. Award Criteria
VI. Award Administration Information

A. Award Notices

B. Administrative and National Policy Requirements

C. Reporting Requirements
VII. Agency Contacts
VIII. Other Information

A. Human Subjects Protection

B. Intergovernmental Review (E.O. 12372) Instructions

C. Public Health System Impact Statement
Appendix A: Checklist for Application Formatting Requirements Appendix B: Glossary
Appendix C: Logic Model Resources
I. Funding Opportunity Description

A. Introduction

The Substance Abuse and Mental Health Services Administration (SAMHSA) announces its intent to solicit applications for Serviceto Science grants. These grants will document and evaluate innovative practices that address critical substance abuse and mental health service gaps but have not yet been formally evaluated. Applicants who seek to stabilize, document, and evaluate promising practices for mental health and/or substance abuse treatment, prevention, and support services should apply for awards under this announcement.

SAMHSA also funds grants under three other standard grant announcements:
[sbull] Services Grants provide funding to implement substance abuse and mental health services.
[sbull] Infrastructure Grants support identification and implementation of systems changes but are not designed to fund services.
[sbull] Best Practices Planning and Implementation Grants help communities and providers identify practices to effectively meet local needs, develop strategic plans for implementing/adapting those practices and pilottest practices prior to fullscale implementation.

This announcement describes the general program design and provides application instructions for all SAMHSA ServicetoScience Grants. [[Page 65809]]
The availability of funds for specific ServicetoScience Grants will be announced in supplementary Notices of Funding Availability (NOFAs) in the Federal Register and at http://www.grants.gov_the Federal grant announcement Web page.

Typically, funding for ServicetoScience Grants will be targeted to specific populations and/or issue areas, which will be specified in the NOFAs. The NOFAs will also:
[sbull] Specify total funding available for the first year of the grants and the expected size and number of awards;
[sbull] Provide the application deadline;
[sbull] Note any specific program requirements for each funding opportunity; and
[sbull] Include any limitations or exceptions to the general provisions in this announcement (e.g., eligibility, award size, allowable activities).

It is, therefore, critical that you consult the NOFA as well as this announcement in developing your grant application.

B. Expectations

While there is a wellestablished evidence base for many behavioral health practices, critical service gaps exist for which there is no formal evidence base. Stakeholders have developed many innovative practices to fill these gaps, but they may lack the expertise and/or resources to formally document and evaluate their practices. Consequently, it is not clear whether these innovative practices are effective, and they are not disseminated widely. SAMHSA seeks to encourage continued development of evidencebased practices to fill service gaps by documenting and evaluating promising stakeholder initiated practices. This program will help organizations that have identified promising new practices to evaluate and package those innovations for review and inclusion in the National Registry of Effective Programs (NREP) as well as for further research.

1. Program Design

SAMHSA will fund ServicetoScience grants in two phases. You may apply for Phase I and II combined or for Phase II alone. Applications for Phase I alone will not be accepted.

Phase I provides support for up to 2 years to stabilize and document an existing practice that fills an identified gap. During Phase I, you may:
[sbull] Further develop or refine the promising practice; [sbull] Develop training and practice manuals;
[sbull] Train persons who are implementing the practice; [sbull] More systematically implement the practice;
[sbull] Develop measurement instruments; and
[sbull] Ensure that the intended target population (see Glossary) is being reached by the practice.

The desired endpoint of Phase I is readiness to conduct a high quality, systematic evaluation.

Phase II provides support for 13 years to evaluate the success of the practice. The purpose of Phase II is to conduct a highquality, systematic evaluation to document shortterm outcomes and demonstrate that the practice is worthy of an experimental study. On the basis of the evaluation, you may need to further refine the practice and further refine the practice manual. The evaluation may use a prepost approach, an open trial model, other quasi or nonexperimental model, or an experimental model.

The desired endpoint for Phase II is readiness to submit the practice for inclusion in SAMHSA's NREP and/or to submit applications to various research institutions for additional research.

SAMHSA's ServicetoScience grants will provide support to stabilize practices so that they may be documented and evaluated. However, these grants are not intended to support development of entirely new practices. The practices must be in place and operational for at least one year prior to application, and you must have at least anecdotal evidence that the practice is effective.

You may apply for a combination of Phases I and II in a single grant application if you have identified a priority gap for which a fully developed and documented practice currently does not exist. [sbull] During Phase I, you will further develop and document the practice.
[sbull] During Phase II, you will evaluate the practice.

At the conclusion of Phase I, SAMHSA staff will review your progress to determine whether Phase II is warranted. This decision will be based on review of the documentation required by the end of Phase I, as described under the Performance Expectations section below. You must provide compelling evidence that the practice has been sufficiently developed and documented to be evaluated and has produced positive results.

For practices that are already fully developed, implemented, stabilized, and documented but that have not yet been formally evaluated, you may apply for Phase II only. Applications for Phase I alone will not be accepted.

Depending on your readiness, you may receive a combination of Phases I and II for a period of up to, but not more than, 5 years. You may apply for a shorter grant period than the maximum, and SAMHSA may award a grant for a shorter time period than you request.

2. Establishing Need

ServicetoScience grants are intended to develop solutions to widespread needs. This grant program is not intended to address a local community's need for funds to solve a local problem. Therefore, you must demonstrate that the broader substance abuse and/or mental health fieldnot just your local communityhas a need for the practice. You must also show that no welldocumented solution to the problem exists, and that your local community can support an evaluation that will increase the knowledge base of the field.

3. Allowable Activities

Phase I: Practice Development and Documentation. In Phase I, you will further develop and document the practice. The types of activities that may be needed and that are allowable include, but are not limited to, the following:
[sbull] Strategic planning.
[sbull] Convening stakeholder meetings.
[sbull] Training of practitioners.
[sbull] Efforts to overcome policy and funding barriers to practice stability.
[sbull] Development of an action plan for systematizing and stabilizing the practice.
[sbull] Development of a practice support system.
[sbull] Developing needed partnerships for ongoing implementation. [sbull] Logic model development.
[sbull] Documentation of core elements of the practice. [sbull] Practice manual development.
[sbull] Measurement instrument development/selection.
[sbull] Participant recruitment.
[sbull] Development of quality assurance and accountability mechanisms.
[sbull] Implementation and refinement of the practice.
[sbull] Implementation process evaluation.
[sbull] Management information system development.

[sbull] Collection of pilot outcome data.

Phase II: Practice Evaluation. During Phase II, SAMHSA will (if necessary) continue to fund implementation of the practice being evaluated. Other types of allowable activities include, but are not limited to, the following:
[sbull] Convening relevant stakeholder meetings.
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[sbull] Alignment of management information systems with data collection needs.
[sbull] Training evaluators.
[sbull] Measurement instrument development/selection.
[sbull] Data collection.
[sbull] Database management.
[sbull] Data and cost analysis.
[sbull] Dissemination of results.
[sbull] Refinement of logic model and practice manual based on evaluation results.

4. Performance Expectations

All grantees will be expected to meet the following performance requirements by the end of their grant projects.

Phase I. By the end of Phase I, documentation for the practice must include:
[sbull] A logic model depicting the principles and concepts underlying the practice.
[sbull] A manual describing the practice in detail that would allow others to replicate the practice.
[sbull] Documentation of how critical stakeholders were included in the development of the practice.
[sbull] A detailed description of the population that the practice is designed to serve, and demographic characteristics of the people served by the practice over the past year.
[sbull] Documentation that the number of people being served by the practice has been stabilized.
[sbull] Documentation of the number and percentage of staff trained in the practice, and a mechanism for ongoing training for any new staff.
[sbull] A process evaluation demonstrating that the practice is in full operation and that a routine service delivery process is in place. [sbull] Pilot outcome results. (Note: Collection of these data need not include an extensive set of outcomes systematically collected on all participants, but quantitative project data should provide some indication that key outcomes are being achieved.)

Phase II. By the end of Phase II, the evaluation of the practice must have demonstrated that:
[sbull] Key outcome measures have been clearly identified and defined.
[sbull] Participant data collection systems are in place that include:
[sbull] Demographic characteristics.
[sbull] Practice outcomes.
[sbull] Service utilization.
[sbull] Service delivery costs.
[sbull] Satisfaction with services.
[sbull] Demographic characteristics of participants, as well as the types of services that participants have received, are consistent with expectations based on the logic model for the practice.
[sbull] Service delivery patterns are stable.
[sbull] A fidelity scale has been developed for assessing the integrity of the practice, and the practice has been implemented with fidelity according to the scale.
[sbull] Systematically collected shortterm outcome measures indicate meaningful results.
[sbull] Consumers, family members, and other critical stakeholders are satisfied with the practice.

In addition, at the end of Phase II, grantees must: [sbull] Demonstrate how consumers, family members, and other critical stakeholders participated in the evaluation of the practice. [sbull] Demonstrate how the practice will be sustained over the 5 years following the end of the grant period.
[sbull] As appropriate, submit the practice to the SAMHSA National Registry of Effective Programs (NREP).
[sbull] Demonstrate the willingness of those who initiated the practice to participate in rigorous research over the next 5 years (e.g., through submission of grant applications to the National Institutes of Health, private foundations, or other research funding sources; through formal agreements between practice initiators and researchers; etc.)

5. Data and Performance Measurement

The Government Performance and Results Act of 1993 (Pub. L. 10362, or ``GPRA'') requires all Federal agencies to set program performance targets and report annually on the degree to which the previous year's targets were met.

Agencies are expected to evaluate their programs regularly and to use results of these evaluations to explain their successes and failures and justify requests for funding.

To meet the GPRA requirements, SAMHSA must collect performance data (i.e., ``GPRA data'') from grantees. Grantees are required to report these GPRA data to SAMHSA on a timely basis.

Specifically, grantees will be required to provide data on a set of required measures, as specified in the NOFA. The data collection tools to be used for reporting the required data will be provided in the application kits distributed by SAMHSA's clearinghouses and posted on SAMHSA's Web site along with each NOFA. In your application, you must demonstrate your ability to collect and report on these measures, and you may be required to provide some baseline data.

The terms and conditions of the grant award also will specify the data to be submitted and the schedule for submission. Grantees will be required to adhere to these terms and conditions of award.

Applicants should be aware that SAMHSA is working to develop a set of required core performance measures for each of SAMHSA's standard grants (i.e., Services Grants, Infrastructure Grants, Best Practices Planning and Implementation Grants, and ServicetoScience Grants). As this effort proceeds, some of the data collection and reporting requirements included in SAMHSA's NOFAs may change. All grantees will be expected to comply with any changes in data collection requirements that occur during the grantee's project period.

6. Grantee Meetings

You must plan to send a minimum of two people (including the Project Director) to at least one joint grantee meeting in each year of the grant, and you must include funding for this travel in your budget. At these meetings, grantees will present the results of their projects and Federal staff will provide technical assistance. Each meeting will be 3 days. These meetings will usually be held in the Washington, DC, area, and attendance is mandatory.
II. Award Information

A. Award Amount

The NOFA will specify the expected award amount for each funding opportunity. Regardless of the amount specified in the NOFA, the actual award amount will depend on the availability of funds.

You may apply for either a combined Phase I & II grant or for a Phase II only grant.
[sbull] Awards for Phase I of the combined grants are for up to $150,000 (direct and indirect costs) per year for up to 2 years. [sbull] Awards for Phase II are $300,000$500,000 (direct and indirect costs) per year for 13 years.
[sbull] Awards for combined Phase I and II grants may not exceed 5 years.

Phase II funding will be approved only if you provide compelling evidence that the practice has been sufficiently developed and documented to be evaluated and has produced positive results.

Applications with proposed budgets that exceed the allowable amount as specified in the NOFA in any year of the proposed project will be screened out and will not be reviewed. Annual continuation awards will depend on the availability of funds, grantee progress in meeting project goals and objectives, and timely submission of required data and reports.
[[Page 65811]]
Summary Table: Funding level Phase Activity focus Years of Application (direct and support requirement indirect costs) I............................... Practice Development and 02 Optional........... Up to $150,000 per Documentation. year II.............................. Practice Evaluation..... 13 Required........... $300,000$500,000 per year Total.......................... ........................ 15 B. Funding Mechanism

The NOFA will indicate whether awards for each funding opportunity will be made as grants or cooperative agreements (see the Glossary in Appendix B for further explanation of these funding mechanisms). For cooperative agreements, the NOFA will describe the nature of Federal involvement in project performance and specify roles and
responsibilities of grantees and Federal staff.
III. Eligibility Information

A. Eligible Applicants

Eligible applicants are domestic public and private nonprofit entities. For example, State, local or tribal governments; public or private universities and colleges; community and faithbased organizations; and tribal organizations may apply. The statutory authority for this program precludes grants to forprofit
organizations. The NOFA will indicate any limitations on eligibility.

Though not required, SAMHSA encourages communitybased providers and independent researchers to partner when applying for Serviceto Science grants. Such partnerships will use the expertise of each partner to ensure sound service delivery, highquality evaluation, independent results, and relevance of the evaluation design to service delivery outcomes.

B. CostSharing

Costsharing (see Glossary) is not required in this program, and applications will not be screened out on the basis of costsharing. However, you may include cash or inkind (see Glossary) contributions in your proposal as evidence of commitment to the proposed project. C. Other

SAMHSA applicants must comply with certain program requirements, including:
[sbull] Budgetary limitations as specified in Sections I, II, and IVE of this document; and
[sbull] Documentation of nonprofit status as required in the PHS 51611.

You also must comply with any additional program requirements specified in the NOFA, such as the required signature of certain officials on the face page of the application and/or required memoranda of understanding with certain signatories.

Applications that do not comply with the eligibility and specific program requirements for the funding opportunity for which the application is submitted will be screened out and will not be reviewed. IV. Application and Submission Information
(To ensure that you have met all submission requirements, a checklist is provided for your use in Appendix A of this document.) A. Address To Request Application Package

You may request a complete application kit by calling one of SAMHSA's national clearinghouses:
[sbull] For substance abuse prevention or treatment grants, call the National Clearinghouse for Alcohol and Drug Information (NCADI) at 18007296686.
[sbull] For mental health grants, call the National Mental Health Information Center at 1800789CMHS (2647).

You also may download the required documents from the SAMHSA Web site at http://www.samhsa.gov. Click on ``grant opportunities.''

Additional materials available on this Web site include: [sbull] A technical assistance manual for potential applicants; [sbull] Standard terms and conditions for SAMHSA grants; [sbull] Guidelines and policies that relate to SAMHSA grants (e.g., guidelines on cultural competence, consumer and family participation, and evaluation); and
[sbull] Enhanced instructions for completing the PHS 51611 application.
B. Content and Form of Application Submission

1. Required Documents

SAMHSA application kits include the following documents: [sbull] PHS 51611 (revised July 2000)Includes the face page, budget forms, assurances, certification, and checklist. You must use the PHS 51611 unless otherwise specified in the NOFA. Applications that are not submitted on the required application form will be screened out and will not be reviewed.
[sbull] Program Announcement (PA)Includes instructions for the grant application. This document is the PA.
[sbull] Notice of Funding Availability (NOFA)Provides specific information about availability of funds, as well as any exceptions or limitations to provisions in the PA.

The NOFAs will be published in the Federal Register as well as on the Federal grants Web site (http://www.grants.gov).

You must use all of the above documents in completing your application.

2. Required Application Components

To ensure equitable treatment of all applications, SAMHSA will accept only complete applications for review. In order for your application to be complete, it must include the required ten application components (Face Page, Abstract, Table of Contents, Budget Form, Project Narrative and Supporting Documentation, Appendices, Assurances, Certifications, Disclosure of Lobbying Activities, and Checklist). Applications that do not contain the required components will be screened out and will not be reviewed.
[sbull] Face PageUse Standard Form (SF) 424, which is part of the PHS 51611. [Note: Beginning October 1, 2003, applicants will need to provide a Dun and Bradstreet (DUNS) number to apply for a grant or cooperative agreement from the Federal Government. SAMHSA applicants will be required to provide their DUNS number on the face page of the application. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access the Dun and Bradstreet Web site at http://www.dunandbradstreet.com or call 18667055711. To expedite the process, let Dun and Bradstreet know that you are a public/private nonprofit
[[Page 65812]]
organization getting ready to submit a Federal grant application.] [sbull] AbstractYour total abstract should be no longer than 35 lines. In the first five lines or less of your abstract, write a summary of your project that can be used, if your project is funded, in publications, reporting to Congress, or press releases.
[sbull] Table of ContentsInclude page numbers for each of the major sections of your application and for each appendix.
[sbull] Budget FormUse SF 424A, which is part of the PHS 51611. Fill out Sections B, C, and E of the SF 424A.
[sbull] Project Narrative and Supporting DocumentationThe Project Narrative describes your project. It consists of Sections A through D. These sections in total may be no longer than 25 pages. More detailed instructions for completing each section of the Project Narrative are provided in ``Section VApplication Review Information'' of this document.

The Supporting Documentation provides additional information necessary for the review of your application. This supporting documentation should be provided immediately following your Project Narrative in Sections E through H. There are no page limits for these sections, except for Section G, the Biographical Sketches/Job Descriptions.
[sbull] Section ELiterature Citations. This section must contain complete citations, including titles and all authors, for any literature you cite in your application.
[sbull] Section FBudget Justification, Existing Resources, Other Support. You must provide a narrative justification of the items included in your proposed budget, as well as a description of existing resources and other support you expect to receive for the proposed project.
[sbull] Section GBiographical Sketches and Job Descriptions. [sbull] Include a biographical sketch for the Project Director and other key positions. Each sketch should be 2 pages or less. If the person has not been hired, include a letter of commitment from the individual with a current biographical sketch.
[sbull] Include job descriptions for key personnel. Job descriptions should be no longer than 1 page each.
[sbull] Sample sketches and job descriptions are listed on page 22, Item 6 in the Program Narrative section of the PHS 51611.
[sbull] Section HConfidentiality and SAMHSA Participant Protection/Human Subjects. VIIIA of this document describes requirements for the protection of the confidentiality, rights and safety of participants in SAMHSAfunded activities. This section also includes guidelines for completing this part of your application. [sbull] Appendices 1 through 5Use only the appendices listed below. Do not use more than 30 pages for Appendices 1, 4, and 5. There are no page limitations for Appendices 2 and 3. Do not use appendices to extend or replace any of the sections of the Project Narrative unless specifically required in the NOFA. Reviewers will not consider them if you do.
[sbull] Appendix 1: Letters of Support.
[sbull] Appendix 2: Documentation of the Practice (Phase II only applicants).
[sbull] Appendix 3: Data Collection Instruments/Interview Protocols.
[sbull] Appendix 4: Sample Consent Forms.
[sbull] Appendix 5: Letter to the SSA (if applicable; see Section VIIIC of this document).
[sbull] AssurancesNonConstruction Programs. Use Standard Form 424B found in PHS 51611. Some applicants will be required to complete the Assurance of Compliance with SAMHSA Charitable Choice Statutes and Regulations Form SMA 170. If this assurance applies to a specific funding opportunity, it will be posted on SAMHSA's Web site with the NOFA and provided in the application kits available at SAMHSA's clearinghouse (NCADI).
[sbull] CertificationsUse the ``Certifications'' forms found in PHS 51611.
[sbull] Disclosure of Lobbying ActivitiesUse form SF LLL found in the PHS 51611. Federal law prohibits the use of appropriated funds for publicity or propaganda purposes, or for the preparation, distribution, or use of the information designed to support or defeat legislation pending before the Congress or State legislatures. This includes ``grass roots'' lobbying, which consists of appeals to members of the public suggesting that they contact their elected representatives to indicate their support for or opposition to pending legislation or to urge those representatives to vote in a particular way.
[sbull] ChecklistUse the Checklist found in PHS 51611. The Checklist ensures that you have obtained the proper signatures, assurances and certifications and is the last page of your application.

3. Application Formatting Requirements

Applicants also must comply with the following basic application requirements. Applications that do not comply with these requirements will be screened out and will not be reviewed.
[sbull] Text must be legible.
[sbull] Paper must be white and 8.5'' by 11.0'' in size. [sbull] Pages must be typed singlespaced with one column per page. [sbull] Page margins must be at least one inch.
[sbull] Type size in the Project Narrative cannot exceed an average of 15 characters per inch when measured with a ruler. (Type size in charts, tables, graphs, and footnotes will not be considered in determining compliance.)
[sbull] Photo reduction or condensation of type cannot be closer than 15 characters per inch or 6 lines per inch.
[sbull] Pages cannot have printing on both sides.
[sbull] Page limitations specified for the Project Narrative and Appendices cannot be exceeded.
[sbull] Information provided must be sufficient for review.

To facilitate review of your application, follow these additional guidelines:
[sbull] Applications should be prepared using black ink. This improves the quality of the copies of applications that are provided to reviewers.
[sbull] Do not use heavy or lightweight paper or any material that cannot be photocopied using automatic photocopying machines. Oddsized and oversized attachments, such as posters, will not be copied or sent to reviewers. Do not send videotapes, audiotapes, or CDROMs. [sbull] Pages should be numbered consecutively from beginning to end so that information can be located easily during review of the application. For example, the cover page should be labeled ``page 1,'' the abstract page should be ``page 2,'' and the table of contents page should be ``page 3.'' Appendices should be labeled and separated from the Project Narrative and budget section, and the pages should be numbered to continue in the sequence.

C. Submission Dates and Times

Deadlines for submission of applications for specific funding opportunities will be published in the NOFAs in the Federal Register and posted on the Federal grants Web site (http://www.grants.gov).

Your application must be received by the application deadline. Applications received after this date must have a proofofmailing date from the carrier dated at least 1 week prior to the due date. Private metered postmarks are not acceptable as proof of timely mailing.

You will be notified by postal mail that your application has been received.

[[Page 65813]]

Applications not received by the application deadline or not postmarked by a week prior to the application deadline will be screened out and will not be reviewed.

D. Intergovernmental Review (E.O. 12372) Requirements

Executive Order 12372, as implemented through Department of Health and Human Services (DHHS) regulation at 45 CFR Part 100, sets up a system for State and local review of applications for Federal financial assistance. Instructions for this review are included in Section VIIIB of this document. Section VIIIC provides instructions for the Public Health System Impact Statement (PHSIS) and submission of comments from the Single State Agency (SSA).

E. Funding Limitations/Restrictions

Cost principles describing allowable and unallowable expenditures for Federal grantees, including SAMHSA grantees, are provided in the following documents:
[sbull] Institutions of Higher Education: OMB Circular A21 [sbull] State and Local Governments: OMB Circular A87
[sbull] Nonprofit Organizations: OMB Circular A122

[sbull] Appendix E Hospitals: 45 CFR part 74

In addition, SAMHSA ServicetoScience grant funds may not be used to:
[sbull] Pay for any lease beyond the project period.
[sbull] Provide services to incarcerated populations (defined as those persons in jail, prison, detention facilities, or in custody where they are not free to move about in the community).
[sbull] Pay for the purchase or construction of any building or structure to house any part of the program. (Applicants may request up to $75,000 for renovations and alterations of existing facilities, if necessary and appropriate to the project.)
[sbull] Provide residential or outpatient treatment services when the facility has not yet been acquired, sited, approved, and met all requirements for human habitation and services provision. (Expansion or enhancement of existing residential services is permissible.) [sbull] Pay for housing other than residential mental health and/or substance abuse treatment.
[sbull] Provide inpatient treatment or hospitalbased
detoxification services. Residential services are not considered to be inpatient or hospitalbased services.
[sbull] Pay for incentives to induce clients to enter treatment. However, a grantee or treatment provider may provide up to $20 or equivalent (coupons, bus tokens, gifts, childcare, and vouchers) to clients as incentives to participate in required data collection followup. This amount may be paid for participation in each required interview.
[sbull] Implement syringe exchange programs, such as the purchase and distribution of syringes and/or needles.
[sbull] Pay for pharmacologies for HIV antiretroviral therapy, sexually transmitted diseases (STDs)/sexually transmitted illnesses (STI), TB, and hepatitis B and C, or for psychotropic drugs. F. Other Submission Requirements

1. Where To Send Applications

Send applications to the following address: Substance Abuse and Mental Health Services Administration, Office of Program Services, Review Branch, 5600 Fishers Lane, Room 1789, Rockville, Maryland, 20857.

Be sure to include the funding announcement number from the NOFA in item number 10 on the face page of the application. If you require a phone number for delivery, you may use (301) 4434266.

2. How To Send Applications

Mail an original application and 2 copies (including appendices) to the mailing address provided above. The original and copies must not be bound. Do not use staples, paper clips, or fasteners. Nothing should be attached, stapled, folded, or pasted.

You must use a recognized commercial or governmental carrier. Hand carried applications will not be accepted. Faxed or emailed applications will not be accepted.
V. Application Review Information

A. Evaluation Criteria

Your application will be reviewed and scored according to the quality of your response to the requirements listed below for developing the Project Narrative (Sections AD). These sections describe what you intend to do with your project.
[sbull] In developing the Project Narrative section of your application, use these instructions, which have been tailored to this program. These are to be used instead of the ``Program Narrative'' instructions found in the PHS 51611.
[sbull] You must use the four sections/headings listed below in developing your Project Narrative. Be sure to place the required information in the correct section, or it will not be considered. Your application will be scored according to how well you address the requirements for each section.
[sbull] Reviewers will be looking for evidence of cultural competence in each section of the Project Narrative. Points will be assigned based on how well you address the cultural competence aspects of the evaluation criteria. SAMHSA's guidelines for cultural competence can be found on the SAMHSA Web site at http://www.samhsa.gov. Click on ``Grant Opportunities.''
[sbull] The Supporting Documentation you provide in Sections EH and Appendices 1 through 5 will be considered by reviewers in assessing your response, along with the material in the Project Narrative. [sbull] The number of points after each heading below is the maximum number of points a review committee may assign to that section of your Project Narrative. Bullet statements in each section do not have points assigned to them. They are provided to invite the attention of applicants and reviewers to important areas within each section. Section A: Statement of Need (15 points)
[sbull] Describe the problem the project will address. Describe the national significance of the problem. Documentation of need may come from a variety of qualitative and quantitative sources in the professional literature. The quantitative data could also come from national data available regarding mental health and substance use needs, gaps, and priorities. For example:
[sbull] Applications focusing on substance abuse might draw from SAMHSA's National Household Survey on Drug Use and Health (NHSDUH); Drug Abuse Warning Network (DAWN); and Drug and Alcohol Services Information System (DASIS), which includes the Treatment Episode Data Set (TEDS).
[sbull] Applications focusing on mental health might draw on data available from the National Association of State Mental Health Program Directors (NASMHPD), SAMHSA (http://www.samhsa.gov/cmhs/MentalHealthStatistics ), or other sources.

Qualitative sources may also include conclusions of conferences and events of national significance.
[sbull] Describe the target population for the practice, including demographic information. Discuss the target population's language, beliefs, norms and values, as well as socioeconomic factors that must be considered in delivering programs to this population
[sbull] Review the literature that demonstrates a need to develop or adapt an effective practice for the target
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population. Demonstrate through the literature review that current evidencebased approaches to the problem do not exist or have not been evaluated for the specific target populations, or that approaches of greater clinical or cost effectiveness are needed.
[sbull] Demonstrate that the need in the community in which the project will be carried out is of sufficient magnitude that an adequate evaluation of the practice can be conducted. To the extent possible, use locally generated data or State data such as that available through State needs assessments.
[sbull] Check the NOFA for any additional requirements. Section B: Proposed Approach (30 points)
[sbull] Describe the practice proposed for evaluation. Document that the practice has been in place and operational for at least one year prior to the application due date.
[sbull] Describe how the proposed practice will respond to the needs described in Section A of your Project Narrative.
[sbull] Discuss the potential effectiveness of the practice proposed for evaluation. Why has this practice been selected? Present the theoretical underpinnings, core principles, and major assumptions of the proposed practice. Outline the key operational elements of the practice and summarize any relevant literature.
[sbull] Identify any necessary collaborators on the project, including their roles and responsibilities. Demonstrate their commitment to the project. Include letters of support in Appendix 1: Letters of Support.
[sbull] Describe your experience with similar collaborative projects, and explain why you believe you will be able to sustain this collaboration throughout the project period.
[sbull] If applying for combined Phase I and II, describe the extent to which the practice has been previously developed, implemented, stabilized, and documented. Include a description of the extent to which the support system needed for full implementation of the proposed practice is in placee.g., community collaboration and consensus building; alignment of management information systems, policies, and funding mechanisms; documentation of core elements of the practice; reliable recruitment and intake procedures; quality assurance and accountability mechanisms; training and overall readiness of those implementing the practice; and involvement of families and consumers in the project.
[sbull] If applying for Phase II only, show that the practice is ready for systematic evaluation by providing documentation, in Appendix 2, that includes all of the following:
[sbull] A logic model depicting the principles and concepts underlying the practice.
[sbull] A copy of the Title Page and Table of Contents for a manual describing the practice in detail that would allow others to replicate the practice, and details on how the manual can be acquired. [sbull] Documentation of how critical stakeholders were included in the development of the practice.
[sbull] A detailed description of the population that the practice is designed to serve, and demographic characteristics of the people served by the practice over the past year.
[sbull] Demonstration of stability in the number of people being served by the practice.
[sbull] Documentation that staff are trained in the practice (via the number and percentage of staff trained), and a mechanism for ongoing training for any new staff.
[sbull] Evidence demonstrating that the practice is in full operation and that a routine service delivery process is in place. [sbull] Pilot outcome results. (Note: Collection of these data need not include an extensive set of outcomes systematically collected on all participants, but quantitative project data should provide some indication that key outcomes are being achieved.)
[sbull] Present the goals and measurable objectives of the project. Describe why the practice can better be evaluated for effectiveness following completion of the grant activities. For applications that include Phase I, include in your description how achievement of your goals will fulfill the Performance Expectations cited in Section IB of this document.
[sbull] Describe the action steps to accomplish the goals and objectives. Demonstrate that the action steps will lead to successful accomplishment of the goals and objectives.
[sbull] Describe the potential barriers to successful conduct of the proposed project and how you will overcome them.
[sbull] Describe how the proposed project will address issues of age, race/ethnicity, culture, language, sexual orientation, disability, literacy, and gender in the target population.
[sbull] Check the NOFA for any additional requirements. Section C: Evaluation Design and Analysis (40 points)
[sbull] Describe in detail your evaluation design for determining the effectiveness of the practice. For applications that include Phase I, describe your process evaluation to determine that the practice is in full operation, as well as how you will track the number and percentage of staff fully trained in the practice.
[sbull] Describe the process and outcome evaluation protocols you intend to use. Include in Appendix 3 evaluation instruments to be used. Describe any literature or pilot testing done to verify the validity and reliability of the instruments to be used or how you plan to develop the instruments during the grant period.
[sbull] Discuss the reliability and validity of evaluation methods and instrument(s) in terms of the gender/age/culture of the target population.
[sbull] Describe how you will develop and manage a database management system to record participant demographic characteristics, practice outcomes, service utilization, practice costs, and satisfaction of stakeholders with the practice.
[sbull] Describe how the integrity of the practice will be assessed using a fidelity (see Glossary) scale. If no fidelity scale currently exists for the practice, describe the process by which you will develop one during the grant period. Describe how you will document and assess changes to the model that occur throughout the project.
[sbull] Document your ability to collect and report on the required performance measures as specified in the NOFA, including data required by SAMHSA to meet GPRA requirements. Specify and justify any additional measures you plan to use for your grant project.
[sbull] Describe how you will analyze the data collected. Include any analyses that will be done to determine the effectiveness of the practice for diverse subgroups, as well as the satisfaction of various stakeholder groups with the practice.
[sbull] Describe how your process evaluation will document the role of critical stakeholders in the development and/or evaluation of the practice.
[sbull] Check the NOFA for any additional requirements. Section D: Management Plan and Staffing (15 points)
[sbull] Provide a realistic time line for the project (chart or graph) showing key activities, milestones, and responsible staff. [Note: The time line should be part of the Project Narrative. It should not be placed in an appendix.]
[sbull] Discuss the capability and experience of the applicant organization and other participating organizations with similar projects and populations, including experience in providing [[Page 65815]]
culturally appropriate/competent services.
[sbull] Provide a list of staff members who will conduct the project, showing the role of each and their level of effort and qualifications. Include the Project Director and other key personnel, such as evaluators and database management personnel.
[sbull] Describe the racial/ethnic characteristics of key staff and indicate if any are members of the target population/community. If the target population is multilinguistic, indicate if the staffing pattern includes bilingual and bicultural individuals.
[sbull] If you plan to include an advisory body in your project, describe its membership, roles and functions, and frequency of meetings.
[sbull] Describe the resources available for the proposed project (e.g., facilities, equipment), and provide evidence that resources are adequate for conducting a highquality evaluation of the identified practice.
[sbull] Check the NOFA for any additional requirements.

Note: Although the budget for the proposed project is not a review criterion, the review group will be asked to comment on the appropriateness of the budget after the merits of the application have been considered.

B. Review and Selection Process

SAMHSA applications are peerreviewed according to the review criteria listed above. For those programs where the individual award is over $100,000, applications must also be reviewed by the appropriate National Advisory Council.
C. Award Criteria

Decisions to fund a grant are based on:
[sbull] The strengths and weaknesses of the application as identified by the peer review committee and approved by the appropriate National Advisory Council; and
[sbull] Availability of funds.
VI. Award Administration Information

A. Award Notices

After your application has been reviewed, you will receive a letter from SAMHSA through postal mail that describes the general results of the review, including the score that your application received.

If you are approved for funding, you will receive an additional notice, the Notice of Grant Award, signed by SAMHSA's Grants Management Officer. The Notice of Grant Award is the sole obligating document that allows the grantee to receive Federal funding for work on the grant project. It is sent by postal mail and is addressed to the contact person listed on the face page of the application.

If you are not funded, you can reapply if there is another receipt date for the program.
B. Administrative and National Policy Requirements
[sbull] You must comply with terms and conditions of the grant award. Standard SAMHSA terms and conditions are available on SAMHSA's Web site (http://www.samhsa.gov). [sbull] Depending on the nature of the specific funding opportunity and/or the proposed project as identified during review, additional terms and conditions may be identified in the NOFA or negotiated with the grantee prior to grant award. These may include, for example: [sbull] Actions required to be in compliance with human subjects requirements;
[sbull] Requirements relating to additional data collection and reporting;
[sbull] Requirements relating to participation in a crosssite evaluation; or
[sbull] Requirements to address problems identified in review of the application.
[sbull] You will be held accountable for the information provided in the application relating to performance targets. SAMHSA program officials will consider your progress in meeting goals and objectives, as well as your failures and strategies for overcoming them, when making an annual recommendation to continue the grant and the amount of any continuation award. Failure to meet stated goals and objectives may result in suspension or termination of the grant award, or in reduction or withholding of continuation awards.
[sbull] In an effort to improve access to funding opportunities for applicants, SAMHSA is participating in the U.S. Department of Health and Human Services ``Survey on Ensuring Equal Opportunity for Applicants.'' This survey is included in the application kit for SAMHSA grants. Applicants are encouraged to complete the survey and return it, using the instructions provided on the survey form.
C. Reporting Requirements
1. Progress and Financial Reports
[sbull] Grantees must provide annual and final progress reports. The final progress report must summarize information from the annual reports, describe the accomplishments of the project, and describe next steps for implementing plans developed during the grant period. [sbull] Grantees must provide annual and final financial status reports. These reports may be included as separate sections of annual and final progress reports or can be separate documents. Because SAMHSA is extremely interested in ensuring that treatment or prevention service efforts are sustained, your financial reports should explain plans to ensure the sustainability (see Glossary) of efforts initiated under this grant. Initial plans for sustainability should be described in year 1 of the grant. In each subsequent year, you should describe the status of the project, successes achieved and obstacles encountered in that year.
[sbull] SAMHSA will provide guidelines and requirements for these reports to grantees at the time of award and at the initial grantee orientation meeting after award. SAMHSA staff will use the information contained in the reports to determine the grantee's progress toward meeting its goals.

2. Government Performance and Results Act (GPRA)

The Government Performance and Results Act (GPRA) mandates accountability and performancebased management by Federal agencies. To meet the GPRA requirements, SAMHSA must collect performance data (i.e., ``GPRA data'') from grantees. These requirements will be specified in the NOFA for each funding opportunity.

3. Publications

If you are funded under this grant program, you are required to notify the Government Project Officer (GPO) and SAMHSA's Publications Clearance Officer (3014438596) of any materials based on the SAMHSA funded project that are accepted for publication.

In addition, SAMHSA requests that grantees:
[sbull] Provide the GPO and SAMHSA Publications Clearance Officer with advance copies of publications.
[sbull] Include acknowledgment of the SAMHSA grant program as the source of funding for the project.
[sbull] Include a disclaimer stating that the views and opinions contained in the publication do not necessarily reflect those of SAMHSA or the U.S. Department of Health and Human Services, and should not be construed as such.

SAMHSA reserves the right to issue a press release about any publication deemed by SAMHSA to contain information of program or policy significance to the substance abuse
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treatment/substance abuse prevention/mental health services community. VII. Agency Contacts

The NOFAs provide contact information for questions about program issues.

For questions on grants management issues, contact: Stephen Hudak, Office of Program Services, Division of Grants Management, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockwall II 6th Floor, Rockville, MD 20857, (301) 4439666, shudak@samhsa.gov. VIII. Other Information

A. Human Subjects Protection

You must describe your procedures relating to Confidentiality and the Protection of Human Subjects Regulations in Section H of your application, using the guidelines provided below. Problems with confidentiality and protection of human subjects identified during peer review of your application may result in the delay of funding. Confidentiality and Participant Protection

All applicants must address each of the following elements relating to confidentiality and participant protection. You must describe how you will address these requirements.
1. Protect Clients and Staff From Potential Risks
[sbull] Identify and describe any foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects as a result of the project itself or any data collection activity. [sbull] Describe the procedures you will follow to minimize or protect participants against potential risks, including risks to confidentiality.
[sbull] Identify plans to provide guidance and assistance in the event there are adverse effects to participants.
[sbull] Where appropriate, describe alternative treatments and procedures that may be beneficial to the participants. If you choose not to use these other beneficial treatments, provide the reasons for not using them.
2. Fair Selection of Participants
[sbull] Describe the target population(s) for the proposed project. Include age, gender, and racial/ethnic background and note if the population includes homeless youth, foster children, children of substance abusers, pregnant women, or other targeted groups. [sbull] Explain the reasons for including groups of pregnant women, children, people with mental disabilities, people in institutions, prisoners, and individuals who are likely to be particularly vulnerable to HIV/AIDS.
[sbull] Explain the reasons for including or excluding participants.
[sbull] Explain how you will recruit and select participants. Identify who will select participants.
3. Absence of Coercion
[sbull] Explain if participation in the project is voluntary or required. Identify possible reasons why participation is required, for example, court orders requiring people to participate in a program. [sbull] If you plan to compensate participants, state how participants will be awarded incentives (e.g., money, gifts, etc.). [sbull] State how volunteer participants will be told that they may receive services intervention even if they do not participate in or complete the data collection component of the project.
4. Data Collection
[sbull] Identify from whom you will collect data (e.g., from participants themselves, family members, teachers, others). Describe the data collection procedures and specify the sources for obtaining data (e.g., school records, interviews, psychological assessments, questionnaires, observation, or other sources). Where data are to be collected through observational techniques, questionnaires, interviews, or other direct means, describe the data collection setting. [sbull] Identify what type of specimens (e.g., urine, blood) will be used, if any. State if the material will be used just for evaluation or if other use(s) will be made. Also, if needed, describe how the material will be monitored to ensure the safety of participants. [sbull] Provide in Appendix 3: Data Collection Instruments/ Interview Protocols, copies of all available data collection instruments and interview protocols that you plan to use.
5. Privacy and Confidentiality
[sbull] Explain how you will ensure privacy and confidentiality. Include who will collect data and how it will be collected. [sbull] Describe:
[sbull] How you will use data collection instruments.
[sbull] Where data will be stored.
[sbull] Who will or will not have access to information. [sbull] How the identity of participants will be kept private, for example, through the use of a coding system on data records, limiting access to records, or storing identifiers separately from data.

Note: If applicable, grantees must agree to maintain the confidentiality of alcohol and drug abuse client records according to the provisions of Title 42 of the Code of Federal Regulations, Part II.
6. Adequate Consent Procedures
[sbull] List what information will be given to people who participate in the project. Include the type and purpose of their participation. Identify the data that will be collected, how the data will be used, and how you will keep the data private.
[sbull] State:
[sbull] Whether or not their participation is voluntary. [sbull] Their right to leave the project at any time without problems.
[sbull] Possible risks from participation in the project. [sbull] Plans to protect clients from these risks.
[sbull] Explain how you will get consent for youth, the elderly, people with limited reading skills, and people who do not use English as their first language.

Note: If the project poses potential physical, medical, psychological, legal, social or other risks, you must obtain written informed consent.
[sbull] Indicate if you will obtain informed consent from participants or assent from minors along with consent from their parents or legal guardians. Describe how the consent will be documented. For example: Will you read the consent forms? Will you ask prospective participants questions to be sure they understand the forms? Will you give them copies of what they sign?
[sbull] Include, as appropriate, sample consent forms that provide for: (1) Informed consent for participation in service intervention; (2) informed consent for participation in the data collection component of the project; and (3) informed consent for the exchange (releasing or requesting) of confidential information. The sample forms must be included in Appendix 4, ``Sample Consent Forms'', of your application. If needed, give English translations.

Note: Never imply that the participant waives or appears to waive any legal rights, may not end involvement with the project, or releases your project or its agents from liability for negligence. [sbull] Describe if separate consents will be obtained for different stages or parts of the project. For example, will they be needed for both participant protection in treatment intervention and for the collection and use of data?
[sbull] Additionally, if other consents (e.g., consents to release information to others
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or gather information from others) will be used in your project, provide a description of the consents. Will individuals who do not consent to having individually identifiable data collected for evaluation purposes be allowed to participate in the project? 7. Risk/Benefit Discussion

Discuss why the risks are reasonable compared to expected benefits and importance of the knowledge from the project.

Protection of Human Subjects Regulations

All applicants for ServicetoScience grants must comply with the Protection of Human Subjects Regulations (45 CFR part 46).

Applicants must describe the process for obtaining Institutional Review Board (IRB) approval fully in their applications. While IRB approval is not required at the time of grant award, you will be required, as a condition of award, to provide the documentation that an Assurance of Compliance is on file with the Office for Human Research Protections (OHRP) and that IRB approval has been received prior to enrolling any participants in the proposed project.

Additional information about Protection of Human Subjects Regulations can be obtained on the Web at http://ohrp.osophs.dhhs.gov. You may also contact OHRP by email (ohrp@osophs.dhhs.gov) or by phone (3014967005).

B. Intergovernmental Review (E.O. 12372) Instructions

Executive Order 12372, as implemented through Department of Health and Human Services (DHHS) regulation at 45 CFR part 100, sets up a system for State and local review of applications for Federal financial assistance. A current listing of State Single Points of Contact (SPOCs) is included in the application kit and can be downloaded from the Office of Management and Budget (OMB) Web site at http://www.whitehouse.gov/omb/grants/spoc.html .
[sbull] Check the list to determine whether your State participates in this program. You do not need to do this if you are a federally recognized Indian tribal government.
[sbull] If your State participates, contact your SPOC as early as possible to alert him/her to the prospective application(s) and to receive any

FOR FURTHER INFORMATION CONTACT Cathy Friedman, M.A., Office of Policy, Planning and Budget, 5600 Fishers Lane, Room 12C26, Rockville, Maryland, 20857. Fax: (3015946159) Email: cfriedma@samhsa.gov. Phone: (301) 4431910.