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Notice

Proposed Changes in Announcement of SAMHSA Discretionary Grant Funding Opportunities

Document Details

Information about this document as published in the Federal Register.

Published Document

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

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AGENCY:

Substance Abuse and Mental Health Services Administration, HHS.

ACTION:

Notice of proposed standard best practices planning and implementation grant announcement.

SUMMARY:

Beginning in Fiscal Year (FY) 2004, the Substance Abuse and Mental Health Services Administration (SAMHSA) plans to change its approach to announcing and soliciting applications for its discretionary grant programs. The following announcement is a proposed standard announcement for SAMHSA's Best Practices Planning and Implementation (BPPI) Grants. It is not an actual grant solicitation.

When published in final, the standard SAMHSA BPPI Grant announcement will be used by applicants in conjunction with specific Notices of Funding Availability (NOFAs) to prepare applications for certain SAMHSA grants. SAMHSA is providing this draft announcement for public review and comment in order to ensure that the field is aware of the planned Start Printed Page 50617change and has an opportunity to identify areas where the announcement is unclear and needs improvement.

DATES:

Submit written comments on this proposal by October 20, 2003.

ADDRESSES:

Interested persons are invited to submit comments regarding SAMHSA's proposed standard BPPI Grant announcement to: Office of Policy, Planning and Budget, SAMHSA, Attn: Jennifer Fiedelholtz by fax (301-594-6159) or e-mail (samhsa_standard_grants@samhsa.gov). Please include a phone number in your e-mail, so that SAMHSA staff may contact you if there are questions about your comments.

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FOR FURTHER INFORMATION CONTACT:

Jennifer Fiedelholtz of the Office of Policy, Planning and Budget, SAMHSA, by fax (301-594-6159) or e-mail (samhsa_standard_grants@samhsa.gov). If you would like a SAMHSA staff person to call you about your questions, please state this in an e-mail or fax request and provide a telephone number where you can be reached between 8:30 and 5 p.m. Eastern Standard Time.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Starting in FY 2004, SAMHSA plans to change its approach to announcing and soliciting applications for its discretionary grants. SAMHSA plans to issue the following BPPI Grant announcement as one of four standard grant announcements that will describe the general program design and provide application instructions for four types of grants—Services Grants, Infrastructure Grants, Best Practices Planning and Implementation Grants, and Service-to-Science Grants. 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, or HIV/AIDS and Substance Abuse Prevention Planning Grants).

A complete description of the proposed process, the other three proposed standard announcements and a sample NOFA are contained in separate notices in this issue of the Federal Register.

SAMHSA welcomes public comment on all aspects of the following announcement. In particular, SAMHSA welcomes comment on the following issues:

1. Is the difference between the standard announcement and a NOFA clear?

2. Are the programmatic requirements for SAMHSA's BPPI Grants clear?

3. Are the goals/objectives for SAMHSA's BPPI Grants clear?

4. If you are a potential applicant for a SAMHSA BPPI Grant, do you believe you will be able to use the standard BPPI Grant announcement with the NOFA to prepare your application? Will the ability to anticipate programmatic requirements through reviewing the standard grant announcements ahead of time improve your ability to prepare a solid application? Is the additional benefit “worth” the “cost” of having to use two different documents to prepare your application?

Text of Proposed Standard Announcement

Department of Health and Human Services

Substance Abuse and Mental Health Services Administration

Best Practices Planning and Implementation Grants BPPI 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 DeadlineThis 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. 12372)Letters from State Single Point of Contact (SPOC) are due 60 days after application deadline.
Public Health System Impact Statement (PHSIS)/Single State Agency CoordinationApplicants must send the PHSIS to appropriate State and local health 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. Cost-Sharing

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 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. SAMHSA Confidentiality and Participant Protection Requirements and Protection of Human Subjects Regulations

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

C. Public Health System Impact Statement

Appendix A: SAMHSA Best Practices Planning & Implementation Indicators

Appendix B: Checklist for Application Formatting Requirements

Appendix C: Glossary

Appendix D: National Registry of Effective Prevention Programs

Appendix E: Center for Mental Health Services Evidence-Based Practices Toolkits

Appendix F: Effective Substance Abuse Treatment Practices

I. Funding Opportunity Description

A. Introduction

The Substance Abuse and Mental Health Services Administration (SAMHSA) announces its intent to solicit applications for Best Practices Planning and Implementation (BPPI) grants for substance abuse prevention, substance abuse treatment, and mental health services. These grants will help communities and providers identify substance abuse prevention, substance abuse treatment, and/or mental health practices, develop strategic plans for implementing/adapting those practices, and pilot-test the practices. The practices proposed by applicants for SAMHSA's BPPI grants must incorporate the best objective information available from recognized experts regarding effectiveness and acceptability. Often, these practices will have strong evidence of effectiveness. Start Printed Page 50618However, because the evidence base is limited in some areas, SAMHSA may fund some practices for which the evidence of effectiveness is based on formal consensus among recognized experts in the field and/or evaluation studies that have not been published in the peer reviewed literature.

SAMHSA also funds grants under three other standard grant announcements:

  • Services Grants provide funding to implement substance abuse and mental health services.
  • Infrastructure Grants support identification and implement systems changes but are not designed to fund services.
  • Service to Science Grants document and evaluate innovative practices that address critical substance abuse and mental health service gaps but that have not yet been formally evaluated.

This announcement describes the general program design and provides application instructions for all SAMHSA BPPI Grants. The availability of funds for specific BPPI 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 BPPI Grants will be targeted to specific populations and/or issue areas, which will be specified in the NOFAs. The NOFAs will also:

  • Specify total funding available for the first year of the grants and the expected size and number of awards;
  • Provide the application deadline;
  • Note any specific program requirements for each funding opportunity; and
  • 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

SAMHSA's BPPI program promotes the use of practices that incorporate the best objective information available from recognized experts regarding effectiveness and acceptability. SAMHSA refers to these as “best practices.” BPPI grants may address needs in the areas of substance abuse prevention, substance abuse treatment and/or mental health services. SAMHSA understands that the “best practices” proposed for BPPI grants may need to be adapted to certain populations. Therefore, SAMHSA's BPPI grants support adaptation and evaluation of best practices in addition to planning and implementation.

1. Documenting the Evidence-Base for Selected Practices

Applicants must show that their proposed practices meet the standard for effectiveness. The practices proposed by applicants for SAMHSA's BPPI grants must incorporate the best objective information available from recognized experts regarding effectiveness and acceptability. Often, these practices will have strong evidence of effectiveness. However, applicants may propose practices with a sound, but limited, evidence base.

Applicants proposing to implement practices included in the following sources meet the standard of effectiveness for SAMHSA's BPPI Grants, and will not be required to provide further documentation of the practice's effectiveness:

  • SAMHSA's National Registry of Effective Programs (NREP) (see Appendix D);
  • Center for Mental Health Services (CMHS) Evidence Based Practice Tool Kits (see Appendix E);
  • List of Evidence-Based Substance Abuse Treatment Practices (see Appendix F); and
  • Additional practices identified in the NOFA for a specific funding opportunity.

Applicants for Phase II awards that have already received Phase I awards also have met the standard for effectiveness.

Applicants proposing practices that have not been identified by SAMHSA as meeting the required effectiveness standard must show that their proposed practice incorporates the best objective information available from recognized experts regarding effectiveness and acceptability. Such applicants must provide a narrative justification that describes the evidence base for the practice and summarizes the evidence for effectiveness. The evidence may come from a variety of sources, including the published research literature, formal consensus among recognized experts, and other studies that have not been published in the peer-reviewed research literature.

2. Program Design

SAMHSA will fund BPPI grants in two phases. Phase I is a planning and consensus-building phase that supports grantees for up to 18 months. Phase II is a pilot, adaptation, implementation, and evaluation phase that supports grantees for up to 3 years.

Phase I: Planning and Consensus Building

The goal of Phase I is to achieve consensus among community stakeholders to adopt a best practice and engage in strategic planning for its implementation. Phase I grants may include, but are not limited to, the following types of activities:

  • Build and maintain a coalition of stakeholders to fund, oversee, use, and provide a sustainable best practice.
  • Train and educate key stakeholders about the best practice.
  • Consult experts about the practice.
  • Consult leaders from other communities about their experiences in implementing the practice.
  • Reimburse stakeholders for their transportation or child care costs.
  • Engage professionals to help build consensus and plan strategy.
  • Adapt the best practice to community needs without sacrificing its effectiveness.
  • Identify and obtain the commitment of permanent sources to fund the best practice.
  • Design the evaluation of the best practice.
  • Evaluate the process of consensus building among stakeholders (required).

Phase II: Pilot Test, Adaptation, Implementation, and Evaluation

The goals of Phase II grants are to pilot test and evaluate the best practices before full implementation, modify strategic/financial plans, and prepare for full-scale implementation. The following are examples of activities that can be funded during Phase II:

  • Pilot test the practice on a sample of service recipients and evaluate the pilot test.
  • Modify the best practice based on consultation with stakeholders and practice experts, other community experiences, and pilot test results.
  • Revise the manual or documentation that describes in detail how the best practice was modified.
  • Maintain the coalition of stakeholders to oversee Phase II activities.
  • Secure consultants to make changes required to implement and finance the best practice.
  • Make organizational changes (e.g., hiring staff) necessary to implement the best practice.
  • Provide necessary education, training, and technical assistance for staff.

Up to 25% of the Phase II grant award may be used to evaluate the pilot test of the best practice. During the course of a Phase II award, SAMHSA will provide Start Printed Page 50619funding for direct services as part of the pilot test.

3. Performance Requirements

All grantees will be required to meet the following evaluation and performance requirements. Applicants are not required to receive a Phase I award before applying for a Phase II award. However, all Phase II applicants must meet the Phase I performance requirements (i.e., documentation that consensus has been achieved and that a strategic plan is in place) before applying for a Phase II award.

Phase I: Planning and Consensus Building

By the end of Phase I, grantees will be required to provide documentation that consensus has been achieved for adopting a best practice. That documentation must include:

  • A report that summarizes the evaluation of the consensus building process.
  • A description of how key stakeholders were included in the consensus building.
  • Letters of support or other demonstration of stakeholders' commitment to adopt the practice.
  • A strategic plan for implementing the best practice that includes a financing plan, signed by the funding source(s) that will provide the resources necessary to address barriers and implement a sustainable best practice. [Note: If it is not possible for a grantee to complete a strategic plan, grantees will be required to provide an analysis of progress made and barriers to completing the strategic plan instead.]

Phase II: Pilot Test, Adaptation, Implementation, and Evaluation

By the end of Phase II, grantees must provide the following information:

  • Pilot test results.
  • A manual describing the modified practice in detail for replication of the practice.
  • Documentation that staff are trained in the practice and of a mechanism for training new staff.
  • Process evaluation results that describe how the practice was operationalized, including changes in the organizational infrastructure, permanent funding sources, and staff consultation and training activities.
  • Outcome evaluation results that describe:
  • Demographic characteristics of the clients served;
  • Service utilization
  • Practice outcomes
  • Client satisfaction
  • Fidelity of the modified practice with the best practice
  • Sustainability of the best practice.

4. Performance Measurement

The Government Performance and Results Act of 1993 (Pub. L. 103-62, or “GPRA”) requires all Federal agencies to:

  • Develop strategic plans that specify what they will accomplish over a 3 to 5-year period;
  • Set performance targets annually related to their strategic plan; and
  • Report annually on the degree to which the previous year's targets were met.

The law further requires agencies to link their performance to their budgets. Agencies are expected to evaluate their programs regularly and to use results of these evaluations to explain their successes and failures.

To meet these requirements, SAMHSA must collect performance data (i.e., “GPRA data”) from grantees. You are required to report these GPRA data to SAMHSA on a timely basis so that performance results are available to support budgetary decisions.

In particular, you will be required to provide data on a core set of required measures, depending on the SAMHSA Center that is funding the grant. In your application, you must demonstrate your ability to collect and report on these measures, and you must provide some baseline data.

Appendix A provides the performance indicators for SAMHSA's BPPI grantees. For complete information on the core measures relating to these indicators and the methodology for data collection and reporting, please consult the following web sites:

This information will be provided in the hard copy application kits distributed by SAMHSA's Clearinghouses, as well.

In some instances, grantees may be required to participate in cross-site evaluations and comply with additional data collection requirements. The NOFA will indicate whether participation in a cross-site evaluation is required and will identify any additional data collection requirements.

Applicants may propose to collect additional information (i.e., beyond the required performance data) regarding both the nature and success of their process and outcomes. If grant funding is requested to support the additional data collected, this must be clearly justified in the application. Prior to grant award, a final agreement regarding data collection will be reached. The terms and conditions of award 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.

5. 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, the actual award amount will depend on the availability of funds.

Awards for SAMHSA's BPPI grants will be made in two phases:

Phase I—Phase I awards are expected to range from $150,000-$200,000 in total costs (direct and indirect) for a project period of up to 18 months.

Phase II—Phase II awards will range from $300,000-$500,000 per year in total costs (direct and indirect) for a project period of up to 3 years.

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.

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 C 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. Start Printed Page 50620

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 faith-based organizations; and tribal organizations may apply. The statutory authority for this program precludes grants to for-profit organizations. The NOFA will indicate any limitations on eligibility.

B. Cost-Sharing

Cost-sharing is not required in this program, and applications will not be screened out on the basis of cost-sharing. However, you may include cash or in-kind contributions in your proposal as evidence of commitment to the proposed project. Reviewers may consider this information in evaluating the quality of the application.

C. Other

SAMHSA applicants must comply with certain program requirements, including:

  • Provisions relating to participant protection and the protection of human subjects specified in Section VIII-A of this document;
  • Budgetary limitations as specified in Sections I, II, and IV-E of this document; and
  • Documentation of nonprofit status as required in the PHS 5161-1.

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 B of this document.)

A. Address To Request Application Package

You may request a complete application kit by calling one of SAMHSA's national clearinghouses:

  • For substance abuse prevention or treatment grants, call the National Clearinghouse for Alcohol and Drug Information (NCADI) at 1-800-729-6686.
  • For mental health grants, call the National Mental Health Information Center at 1-800-789-CMHS (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:

  • A technical assistance manual for potential applicants;
  • Standard terms and conditions for SAMHSA grants;
  • Guidelines and policies that relate to SAMHSA grants (e.g., guidelines on cultural competence, consumer and family participation, and evaluation); and
  • Enhanced instructions for completing the PHS 5161-1 application.

B. Content and Form of Application Submission

1. Required Documents

SAMHSA application kits include the following documents:

  • PHS 5161-1 (revised July 2000)—Includes the face page, budget forms, assurances, certification, and checklist. Applicants must use the PHS 5161-1 for their application, unless otherwise specified in the NOFA. Applications that are not submitted on the required application form (i.e., the PHS 5161-1 in most situations) will be screened out and will not be reviewed.
  • Program Announcement (PA)—Includes instructions for the grant application. This document is the PA.
  • 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. Order of Sections

Applications must be complete and contain all information needed for review. In order for your application to be complete, it must include the following sections in the order listed. Applications that do not contain these sections will be screened out and will not be reviewed.

  • Face Page—Use Standard Form (SF) 424, which is part of the PHS 5161-1. [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 1-866-705-5711. To expedite the process, let Dun and Bradstreet know that you are a public/private nonprofit organization getting ready to submit a Federal grant application.]
  • Abstract—Your 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.
  • Table of Contents—Include page numbers for each of the major sections of your application and for each appendix.
  • Budget Form—Use SF 424A, which is part of the PHS 5161-1. Fill out Sections B, C, and E of the SF 424A.
  • Project Narrative and Supporting Documentation—The Project Narrative describes your project. It consists of Sections A through E. Section A may not be longer than 3 pages in length. Sections B-E together may not be longer than 25 pages. More detailed instructions for completing each section of the Project Narrative are provided in “Section V—Application 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 F through H. There are no page limits for these sections, except for Section G, the Biographical Sketches/Job Descriptions.

  • Section F—Budget 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. If you are applying for a Phase II award, show that no more than 25% of the total grant award will be used for evaluation of the pilot test of the best practice.
  • Section G—Biographical Sketches and Job Descriptions.
  • 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. Start Printed Page 50621
  • Include job descriptions for key personnel. Job descriptions should be no longer than 1 page each.
  • Sample sketches and job descriptions are listed on page 22, Item 6 in the Program Narrative section of the PHS 5161-1.
  • Section H—Confidentiality and SAMHSA Participant Protection/Human Subjects. Instructions for completing Section H of your application are provided below in Section VIII-A of this document.
  • Appendices 1 through 5—Use only the appendices listed below. Do not use more than 30 pages (excluding instruments) for the appendices. 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.
  • Appendix 1: Letters of Support.
  • Appendix 2: Data Collection Instruments/Interview Protocols.
  • Appendix 3: Sample Consent Forms.
  • Appendix 4: Letter to the SSA (if applicable; see Section VIII-C of this document).
  • Appendix 5: A copy of the State Strategic Plan, a State needs assessment, or a letter from the State indicating that the proposed project addresses a State-identified priority.
  • Appendix 6: Evidence of Intent to Adopt (Phase II only).
  • Assurances—Non-Construction Programs. Use Standard Form 424B found in PHS 5161-1.
  • Certifications—Use the “Certifications” forms found in PHS 5161-1.
  • Disclosure of Lobbying Activities—Use Standard Form LLL found in PHS 5161-1. Federal law prohibits the use of appropriated funds for publicity or propaganda purposes, or for the preparation, distribution, or use of 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.
  • Checklist—Use the Checklist found in PHS 5161-1. 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.

  • Text must be legible.
  • Paper must be white and 8.5″ by 11.0″ in size.
  • Pages must be typed single-spaced with one column per page.
  • Page margins must be at least one inch.
  • 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.)
  • Photo reduction or condensation of type cannot be closer than 15 characters per inch or 6 lines per inch.
  • The pages cannot have printing on both sides.
  • Page limitations specified for the Project Narrative and Appendices cannot be exceeded.
  • Information must be sufficient for review.

To facilitate review of your application, follow these additional guidelines:

  • Applications should be prepared using black ink. This improves the quality of the copies of applications that are provided to reviewers.
  • Use white paper only. Do not use colored, heavy, or light-weight paper or any material that cannot be photocopied using automatic photocopying machines. Odd-sized and oversized attachments, such as posters, will not be copied or sent to reviewers. Do not send videotapes, audiotapes, or CD-ROMs.
  • Pages should be numbered consecutively from beginning to end so that information can be easily located 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 NOFAs in the Federal Register and 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 proof-of-mailing 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.

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 VIII-B of this document. Section VIII-C 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:

  • Institutions of Higher Education: OMB Circular A-21.
  • State and Local Governments: OMB Circular A-87.
  • Nonprofit Organizations: OMB Circular A-122.
  • Appendix E Hospitals: 45 CFR part 74.

In addition, SAMHSA BPPI Grant recipients must comply with the following funding restrictions:

  • No more than 25% of Phase II funding may be used to evaluate the pilot test.

BPPI grant funds may not be used to:

  • Pay for any lease beyond the project period.
  • 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).
  • Pay for the purchase or construction of any building or structure to house any part of the program. (Applicants may request no more than $75,000 for renovations and alterations of existing facilities, if appropriate and necessary to the project.)
  • 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.)
  • Pay for housing other than residential mental health and/or substance abuse treatment.
  • Provide inpatient treatment or hospital-based detoxification services. Start Printed Page 50622
  • 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 follow-up. This amount may be paid for participation in each required interview.
  • Implement syringe exchange programs, such as the purchase and distribution of syringes and/or needles.
  • Pay for pharmacologies for HIV antiretroviral therapy, sexually transmitted diseases (STDs)/sexually transmitted illness (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 17-89, 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) 443-4266.

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 e-mailed applications will not be accepted.

V. Application Review Information

A. Evaluation Criteria

Your application will be reviewed and scored against the requirements listed below for developing the Project Narrative (Sections A-E). These sections describe what you intend to do with your project.

  • 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 5161-1.
  • Be sure to provide references for any literature cited in your application. The reference list will not be counted toward the page limit for these sections. The Project Narrative may be no longer than 28 pages (3 pages for Section A and 25 pages total for Sections B-E).
  • You must use the five 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 of the Project Narrative.
  • The Supporting Documentation you provide in Sections F-H, Appendices 1-5, and the References list will be considered by reviewers in assessing your response, along with the material in the Project Narrative.
  • The number of points after each heading 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 the criterion.

For both Phase I and Phase II of SAMHSA's BPPI Grants there will be two levels of review.

  • Level One Review will consider how well the applicant addresses the requirements in Section A—Evidence of Effectiveness. If the practice proposed in the application does not meet the required standard for effectiveness as described below, the application will not move on to Level Two review and will not be considered for funding.
  • Level Two Review will consider how well the applicant addresses the requirements in Section B (Statement of Need), Section C (Proposed Approach), Section D (Staff, Management and Relevant Experience), and Section E (Evaluation and Data). The applicant's score on Sections B-E combined will be used to determine the applicant's priority score.

1. Phase I Criteria

Level One Review

Section A: Evidence of Effectiveness

Put all information to be considered in Level One in Section A: Evidence of Effectiveness. Section A may not be longer than 3 pages. During Level One review, reviewers will decide whether the applicant's proposed practice meets the required standard for effectiveness. Reviewers will assess Level One review on a pass/fail basis. Applications that do not pass Level One review will not move on to Level Two review.

Applicants proposing to implement practices included in the following sources are considered by SAMHSA to have met the effectiveness standard for SAMHSA's BPPI Grants. Such applicants are not required to provide further documentation of effectiveness of the services/practices. Such applicants must name the practice and indicate which of the following is the source(s) for the proposed practice:

  • SAMHSA's National Registry of Effective Programs (NREP) (see Appendix D to this document).
  • Center for Mental Health Services (CMHS) Evidence Based Practice Tool Kits (see Appendix E to this document).
  • Effective Substance Abuse Treatment Practices (see Appendix F to this document).
  • The NOFA for a specific funding opportunity (provide the name and funding opportunity number from the NOFA).

Applicants who select practices that are not identified in any of the sources listed above must provide a narrative justification that shows that the proposed practice includes the best objective information available from recognized experts regarding effectiveness and acceptability. The narrative must address the following:

  • Describe the proposed practice.
  • Indicate whether the evidence base for the proposed practice includes scientific studies published in the peer-reviewed literature, other studies not published in the peer-reviewed literature, and/or from formal consensus processes involving recognized experts in the field.
  • If the evidence base includes scientific studies published in the peer-reviewed literature or other studies that have not been published, describe:

—The extent to which the practice has been evaluated and the quality of the studies (e.g., whether they are descriptive, quasi-experimental studies, or experimental studies)

—The extent to which evaluation of the practice has demonstrated positive outcomes, and the extent to which positive outcomes have been demonstrated for different populations

—The extent to which evaluation of the practice has been studied

—The extent to which evaluation of the practice has been replicated

—The extent to which the practice has been documented (e.g., through guidelines, tool kits, treatment protocols, and/or manuals)

—The extent to which fidelity measures have been developed (e.g., no measures developed, key components identified, or fidelity measures developed)

  • If the evidence includes formal consensus involving recognized experts, describe:
Start Printed Page 50623

—The experts involved in the consensus development on the proposed services/practice (e.g., members of an expert panel formally convened by NIH, the Institute of Medicine or other nationally recognized organization, or members of an informal group of experts, such as faculty at a leading research institution)

—The nature of the consensus and how it was reached the process used to reach consensus

—The extent to which the consensus has been documented (e.g., in a consensus panel report, meeting minutes, or an accepted standard practice in the field)

—Any empirical evidence, formally published or not, supporting the effectiveness of the proposed practice

—Rationale for concluding that further empirical evidence does not exist to support the effectiveness of the proposed practice, if appropriate

In assessing applicants' narratives for Section A/Level One review, reviewers will consider whether the evidence presented in support of the proposed practice is, in their expert and professional opinion, commensurate with the best information available regarding effectiveness and acceptability.

Applicants should be aware that passing Level One review does not ensure that the application will be approved for funding, even if the proposed project includes a service/practice that is considered by SAMHSA to have met the standard of effectiveness.

Level Two Review

All information to be considered in Level Two review must be placed in Sections B through E, as described below. Only applications that pass Level One review will undergo Level Two review.

Section B: Need (10 Points)

  • Describe the environment (organization, community, city, or State) where the project will be implemented.
  • Describe the target population.
  • Describe the problem the project will address. Documentation of the problem may come from local data or trend analyses, State data, and/or national data. For data sources that are not well known, provide sufficient information on how the data were collected so that its reliability and validity can be assessed.
  • Non-tribal applicants must show that identified needs are consistent with the priorities of the State. Include, in Appendix 5, a copy of the State Strategic Plan, a State needs assessment, or a letter from the State indicating that the proposed project addresses a State-identified priority. Tribal applicants must provide similar documentation relating to tribal priorities.
  • Describe the best practice selected and how it will impact the problem.

Section C: Proposed Approach (40 Points)

  • Describe the goals of the project, including consensus building and strategic planning.
  • Describe the strategies or models used to build consensus. Describe how key stakeholders will be educated about the best practice.
  • Describe the process for developing a strategic plan to implement the best practice.
  • Describe the key stakeholders and how they represent the community.
  • Describe the involvement of key stakeholders in the proposed project, including roles and responsibilities of each stakeholder. Clearly demonstrate each stakeholder's commitment to the consensus building and strategic planning processes. Attach letters of support and other documents showing stakeholder commitment in Appendix 1: Letters of Support. Identify any cash or in-kind contributions that will be made to the project.
  • Describe the involvement of representatives of the target population in the conceptualization and planning of the consensus building process.
  • Describe how the proposed project will address issues of age, race/ethnicity, culture, language, sexual orientation, disability, literacy, and gender in the target population.
  • Describe potential barriers to achieving consensus among stakeholders. What resources and plans will you use to overcome these barriers?
  • Identify potential funding source(s) that will help implement the best practice. Describe how the funder(s) will join in the consensus building and strategic planning.

Section D: Management Plan and Staffing (35 Points)

  • Provide a time line for the project (chart or graph) showing key activities, milestones, and responsible staff. [Note: The timeline should be part of the Project Narrative. It should not be placed in an appendix.]
  • Discuss the capability and experience of the applicant organization and other participating organizations with similar projects and populations, including experience in providing culturally competent services.
  • Provide a list of staff members who will conduct the project. Describe the role, effort and qualifications of each. Include the Project Director and other key personnel, including evaluators and database management personnel.
  • If you plan to have an advisory body, describe its composition, roles, and frequency of meetings.
  • Describe the resources available for the proposed project (e.g., facilities, equipment), and provide evidence that services will be provided in a location that is adequate, accessible, Americans with Disabilities Act (ADA) compliant, and amenable to the target population.

Section E: Evaluation Design and Analysis (15 Points)

  • Describe the design for evaluating the consensus building and strategic planning processes. Include a detailed discussion of how all variables (e.g., community representation and stakeholder support) will be defined and measured. Explain how the evaluation plan will ensure that the decision to adopt is an accurate reflection of the stakeholders' intent.
  • Document your ability to collect and report on the required performance measures for SAMHSA's BPPI Grants. Specify and justify any additional outcome measures you plan to use for your grant project. (See Appendix A for required indicators.)
  • Describe the process for providing regular feedback from evaluation activities to the Project Director and participants.
  • Describe plans for data collection, management, analysis, interpretation and reporting. Describe the current approach to collection of relevant data, along with any necessary modifications.
  • Be sure to include data collection instruments/interview protocols in Appendix 2.

2. Phase II Criteria

Level One Review

Phase II applicants who were not Phase I grantees will go through a Level One review to determine if the selected practice meets SAMHSA's criteria as a best practice before they are reviewed for technical merit. This review process is identical to the Level One Review described for Phase I applicants. You must provide all information for Level One Review in Section A of the Project Narrative.

Phase II applicants who were Phase I grantees will undergo Level Two review only. If so, you should state in Section A that you were a Phase I grantee and provide the grant number.

Level Two Review

All information to be considered in Level Two review must be placed in Start Printed Page 50624Sections B through E, as described below. Only applications that pass Level One review will undergo Level Two review.

Section B: Need and Readiness (30 Points)

  • Describe the target population and setting. If applicant was a Phase I grantee, describe and explain any changes in the target population or setting.
  • Provide baseline data as required in Appendix A of this document.
  • Describe briefly the best practice approved under Level One Review.
  • Provide evidence that the community of stakeholders achieved a “decision to adopt” the practice. Attach a copy of the Phase I process evaluation or other evidence including contracts, memoranda of agreement, administrative memos, or other documents signed by key stakeholders that show their firm commitment to support the practice. Attach these supporting documents in Appendix 6: Evidence of Intent to Adopt.
  • Provide and describe the financing plan. Include anticipated costs and sources of revenue that will maintain the practice. Attach the financing plan, signed by the funding source(s), stating their intent to fund in Appendix 6: Evidence of Intent to Adopt.

Section C: Proposed Approach (25 Points)

  • Provide a strategic plan (including key action steps and a timeline) that addresses each of the following elements, as appropriate: pilot testing the best practice, evaluating the pilot test, modifying the best practice based on the pilot test, developing training materials, hiring/training staff, and securing funding to sustain services beyond the project period.
  • Describe the involvement of key stakeholders in the proposed project, including roles and responsibilities of each stakeholder. Demonstrate each stakeholder's commitment to the proposed project. Attach letters of support and similar documents showing stakeholder commitment in Appendix 1: Letters of Support. Identify any cash or in-kind contributions that will be made to the project.
  • Describe how the proposed project will address issues of age, race/ethnicity, culture, language, sexual orientation, disability, literacy, and gender in the target population.
  • Describe potential barriers to the successful conduct of the proposed project. What resources and plans will you use to overcome these barriers?
  • Describe oversight or feedback mechanisms to ensure that the implemented practice is consistent with the best practice model.

Section D: Management Plan and Staffing (25 Points)

  • Provide a time line for the project (chart or graph) showing key activities, milestones, and responsible staff. [Note: The timeline should be part of the Project Narrative. It should not be placed in an appendix.]
  • Discuss the capability and experience of the applicant organization and other participating organizations with similar projects and populations, including experience in providing culturally appropriate/competent services.
  • 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, including evaluators and database managers.
  • Describe the resources available for the proposed project (e.g., facilities, equipment), and provide evidence that services will be provided in a location that is adequate, accessible, Americans with Disabilities Act (ADA) compliant, and is amenable to the target population.

Section E: Evaluation Design and Analysis (20 Points)

  • Document your ability to collect and report on the required performance measures for Phase II Local Best Practices Grants. Specify and justify any additional measures you plan to use for your grant project. (See Appendix A for required indicators.)
  • Provide a logic model for the evaluation of the pilot test of the best practice as well as other implementation activities (e.g., training, securing financing).
  • Provide a plan for evaluating the pilot test of the best practice and other implementation activities that includes both process and client outcome measures. Describe the recruitment plan and sample size for your project. Describe any literature or pilot testing done to verify the validity and reliability of the instruments to be used. Attach instrumentation in Appendix 2: Data Collection Instruments.
  • Describe how the adaptations of the best practice will be documented. Demonstrate its fidelity to the best practice model. If no fidelity scale exists for the practice, describe how you will develop one.
  • Describe the process for providing regular feedback from evaluation activities to the Project Director and participants.
  • Describe the database management system that will be developed.

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 peer-reviewed 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:

  • The strengths and weaknesses of the application as identified by the Peer Review Committee and, when appropriate, approved by the appropriate National Advisory Council;
  • Availability of funds; and
  • Equitable allocation of grants among the principal geographic regions of the United States. SAMHSA does not intend to award more than 2 grants per State for each funding opportunity.

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 re-apply if there is another receipt date for the program.

B. Administrative and National Policy Requirements

  • You must comply with all terms and conditions of the grant award. SAMHSA's standard terms and conditions are available on the SAMHSA Web site (http://www.samhsa.gov).
  • Depending on the nature of the specific funding opportunity and/or the proposed project as identified during Start Printed Page 50625review, additional terms and conditions may be identified in the NOFA or negotiated with the grantee prior to grant award. These may include, for example:
  • Actions required to be in compliance with human subjects requirements;
  • Requirements relating to additional data collection and reporting;
  • Requirements relating to participation in a cross-site evaluation; or
  • Requirements to address problems identified in review of the application.
  • 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.
  • 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

1. Progress and Financial Reports

  • 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.
  • 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 its best practices efforts can be sustained, your financial reports must explain plans to ensure the sustainability 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.
  • 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

The Government Performance and Results Act (GPRA) mandates accountability and performance-based management by Federal agencies. The performance requirements for SAMHSA's BPPI Grants are described in Section I-B under “Performance Measurement” and listed in Appendix A of this document.

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 (301-443-8596) of any materials based on the SAMHSA-funded project that are accepted for publication.

In addition, SAMHSA requests that grantees:

  • Provide the GPO and SAMHSA Publications Clearance Officer with advance copies of publications.
  • Include acknowledgment of the SAMHSA grant program as the source of funding for the project.
  • 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 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/OPS, 5600 Fishers Lane, Rockwall II 6th Floor, Rockville, MD 20857, (301) 443-9666, shudak@samhsa.gov.

VIII. Other Information

A. SAMHSA Confidentiality and Participant Protection Requirements and Protection of Human Subjects Regulations

You must describe your procedures relating to Confidentiality, Participant Protection and the Protection of Human Subjects Regulations in Section G of your application, using the guidelines provided below. Problems with confidentiality, participant protection, 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 document how you will address these requirements or why they do not apply.

1. Protect Clients and Staff From Potential Risks

  • Identify and describe any foreseeable physical, medical, psychological, social, legal, or other risks or adverse affects.
  • Discuss risks that are due either to participation in the project itself or to the evaluation activities.
  • Describe the procedures you will follow to minimize or protect participants against potential risks, including risks to confidentiality.
  • Identify plans to provide help if there are adverse effects to participants.
  • 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

  • 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 groups.
  • Explain the reasons for including groups of pregnant women, children, people with mental disabilities, people in institutions, prisoners, or others who are likely to be vulnerable to HIV/AIDS.
  • Explain the reasons for including or excluding participants.
  • Explain how you will recruit and select participants. Identify who will select participants.

3. Absence of Coercion

  • Explain if participation in the project is voluntary or required. Identify Start Printed Page 50626possible reasons why it is required, for example, court orders requiring people to participate in a program.
  • If you plan to pay participants, state how participants will be awarded money or gifts.
  • State how volunteer participants will be told that they may receive services even if they do not participate in the project.

4. Data Collection

  • 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.
  • 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.
  • Provide in Appendix 2, “Data Collection Instruments/Interview Protocols,” copies of all available data collection instruments and interview protocols that you plan to use.

5. Privacy and Confidentiality

  • Explain how you will ensure privacy and confidentiality. Include who will collect data and how it will be collected.
  • Describe:
  • How you will use data collection instruments.
  • Where data will be stored.
  • Who will or will not have access to information.
  • 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

  • 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.
  • State:
  • Whether or not their participation is voluntary.
  • Their right to leave the project at any time without problems.
  • Possible risks from participation in the project.
  • Plans to protect clients from these risks.
  • 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 get written informed consent.

  • Indicate if you will get informed consent from participants or 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?
  • Include sample consent forms in your Appendix 3, “Sample Consent Forms.” 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.

  • 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.
  • Additionally, if other consents (e.g., consents to release information to others 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 proposing a pilot test of the best practice as part of a Phase II project must comply with the Protection of Human Subjects Regulations (45 CFR part 46).

Even if you are not proposing a Phase II pilot test of the best practice, the Protection of Human Subjects Regulations could apply depending on the evaluation you propose.

If you are a Phase II applicant proposing a pilot test or your project otherwise falls under the Protection of Human Subjects Regulations, you must describe the process for obtaining Institutional Review Board (IRB) approval in your application. 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 the IRB approval has been received before enrolling clients 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 e-mail (ohrp@osophs.dhhs.gov) or by phone (301-496-7005).

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.

  • 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.
  • If your State participates, contact your SPOC as early as possible to alert him/her to the prospective application(s) and to receive any necessary instructions on the State's review process.
  • For proposed projects serving more than one State, you are advised to contact the SPOC of each affiliated State.
  • The SPOC should send any State review process recommendations to the following address within 60 days of the application deadline: Substance Abuse and Mental Health Services Administration Office of Program Services, Review Branch 5600 Fishers Lane, Room 17-89, Rockville, Maryland, 20857, ATTN: SPOC—Funding Announcement No. [fill in pertinent funding opportunity number from the NOFA].

C. Public Health System Impact Statement (PHSIS)

The Public Health System Impact Statement or PHSIS (Approved by OMB Start Printed Page 50627under control no. 0920-0428; see burden statement below) is intended to keep State and local health officials informed of proposed health services grant applications submitted by community-based, non-governmental organizations within their jurisdictions. State and local governments and Indian tribal government applicants are not subject to the following Public Health System Reporting Requirements.

Community-based, non-governmental service providers who are not transmitting their applications through the State must submit a PHSIS to the head(s) of the appropriate State and local health agencies in the area(s) to be affected no later than the pertinent receipt date for applications. This PHSIS consists of the following information:

  • A copy of the face page of the application (SF 424); and
  • A summary of the project, no longer than one page in length, that provides: (1) A description of the population to be served, (2) a summary of the services to be provided, and (3) a description of the coordination planned with appropriate State or local health agencies.

For SAMHSA grants, the appropriate State agencies are the Single State Agencies (SSAs) for substance abuse and mental health. A listing of the SSAs can be found on SAMHSA's Web site at http://www.samhsa.gov. If the proposed project falls within the jurisdiction of more than one State, you should notify all representative SSAs.

Applicants who are not the SSA must include a copy of a letter transmitting the PHSIS to the SSA in Appendix 4, “Letter to the SSA.” The letter must notify the State that, if it wishes to comment on the proposal, its comments should be sent not later than 60 days after the application deadline to: Substance Abuse and Mental Health Services Administration, Office of Program Services, Review Branch, 5600 Fishers Lane, Room 17-89, Rockville, Maryland, 20857, ATTN: SSA—Funding Announcement No. [fill in pertinent funding opportunity number from NOFA].

In addition:

  • Applicants may request that the SSA send them a copy of any State comments.
  • The applicant must notify the SSA within 30 days of receipt of an award.

[Public reporting burden for the Public Health System Reporting Requirement is estimated to average 10 minutes per response, including the time for copying the face page of SF 424 and the abstract and preparing the letter for mailing. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0920-0428. Send comments regarding this burden to CDC Clearance Officer, 1600 Clifton Road, MS D-24, Atlanta, GA 30333, ATTN: PRA (0920-0428).]

Appendix A—SAMHSA BPPI Indicators

The purpose of the Best Practices Planning and Implementation grant program is to help communities plan for, adapt, pilot test, and evaluate best practices. Domains to be measured are the quality of the process and outcome evaluation, and individual/systems outcomes pertinent to the service improvement. This list of indicators and related measures will be updated periodically. The Notice of Funding Availability (NOFA) will specify which indicators are required for a particular funding opportunity. Applicants must provide expected baseline data for *asterisked items in the grant application. Grantees must collect and report data at the interval (e.g., quarterly, annually) specified in the NOFA. Specific instructions for data collection will be provided on SAMHSA's Web site and in application kits. Some NOFAs may specify indicators and measures not on this list or may request grantees to identify measures appropriate to their specific project.

ACCOUNTABILITY

Percent of grantees reporting valid data. (Phase 1, 2)

CAPACITY

* Number of persons served (Includes screening and assessment) (Phase 1, 2)

CMHS and CSAT grantees: Percent of providers providing services within approved costs (Costs to be proposed in application; to be approved by SAMHSA prior to award. A cost measure for substance abuse prevention is under development.) (Phase 1, 2)

* Number, type, and capacity of services/product available (Phase 1, 2)

* Percent of persons needing services/product who receive them (Phase 1, 2)

EFFECTIVENESS

Participation of persons served and family members in planning, policy, and service delivery (Phase 2)

Number of service/systems improvements implemented; maintained post-funding (Phase 2)

* Percent of programs reporting positive individual and systems outcomes (Phase 2)

CSAP grantees: Difference between 30 day substance use of population served by program and comparable local and national rates. CSAT grantees: Number of people who show no past month substance use 6 months post treatment admission. (Phase 2)

Grantees also will be required to report on several outcomes from the following list, as specified in the NOFA:

Individual outcomes: Participants (adults or children) disapproving of substance use; perceiving personal health risks associated with substance abuse; increasing age of first use; reporting abstinence at discharge; decreasing substance abuse risk factors related to spread of HIV/AIDS, including risky sexual behavior and sharing needles; improving employment/school attendance; having no criminal justice involvement; having stable living situation; reporting (consumer/family) improvement in behavioral/emotional symptoms. (Phase 2)

System outcomes: Percent of referrals from juvenile/adult justice systems to systems of care; decreased days in inpatient/residential facilities; readmission rates; past 30 day utilization of inpatient, outpatient facilities; inpatient, outpatient, or emergency room treatment for physical complaint, mental or emotional difficulties, or alcohol or substance abuse; seclusion/restraint deaths or injuries; number of communities with defined systems/continuum of care; number of persons contacted through outreach who enroll in services; percent of providers, administrators trained who report adopting approved service methods; percent of participants in sponsored events who have used information to change their practices; number of science-based programs implemented. Completion and documentation of one or more of the following, depending upon the scope of the project: Needs assessment; revised financing plan for coordinating funding streams; organizational/structural change or quality improvements; coordination and network improvements; workforce improvements; data infrastructure/performance measurement improvements. (Phase 2)

Appendix B—Checklist for Application Formatting Requirements

Your application must adhere to these formatting requirements. Failure to do so will result in your application being screened out and returned to you without review. In addition to these formatting requirements, there may be programmatic requirements specified in the NOFA. Please check the NOFA before preparing your application.

  • Use the PHS 5161-1 application.
  • Include the 10 application components required for SAMHSA applications (i.e., Face Page, Abstract, Table of Contents, Budget Form, Project Narrative and Supporting Documentation, Appendices, Assurances, Certifications, Disclosure of Lobbying Activities, and Checklist.)
  • Provide legible text.
  • Use white paper, 8.5″ by 11.0″ in size.
  • Type single-spaced text with one column per page.
  • Use margins that are at least 1 inch.
  • Use type size in the Project Narrative that does not 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.
  • Do not use photo reduction or condensation of type closer than 15 characters per inch or 6 lines per inch.
  • Print only on one side of the paper only; do not print on both sides.
  • Do not exceed page limitations specified for the Project Narrative (3 pages for Section Start Printed Page 50628A and 25 pages total for Sections B-E) and Appendices (30 pages).
  • Provide sufficient information for review.
  • Applications must be received by the application deadline. Applications received after this date must have a proof of mailing 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. Applications not received by the application deadline or not postmarked by a week prior to the application deadline will not be reviewed.
  • Applications that do not comply with the following program requirements, any additional program requirements specified in the NOFA, or are otherwise unresponsive to PA guidelines will be screened out:
  • Provisions relating to participant protection and the protection of human subjects specified in Section VIII-A of this document;
  • Budgetary limitations as specified in Sections I, II and IV-E of this document;
  • Documentation of nonprofit status as required in the PHS 5161-1;

To facilitate review of your application, follow these additional guidelines. Failure to follow these guidelines will not result in your application being screened out. However, following these guidelines will help reviewers to consider your application.

  • Please use black ink and number pages consecutively from beginning to end so that information can be located easily during review of the application. The cover page should be 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 the sequence.
  • Send the original application and two copies to the mailing address in the PA. Please do not use staples, paper clips, and fasteners. Nothing should be attached, stapled, folded, or pasted. Do not use any material that cannot be copied using automatic copying machines. Odd-sized and oversized attachments such as posters will not be copied or sent to reviewers. Do not include videotapes, audiotapes, or CD-ROM.

Appendix C: Glossary

Best Practice: Best practices are practices that incorporate the best objective information currently available from recognized experts regarding effectiveness and acceptability.

Cooperative Agreement: A cooperative agreement is a form of Federal grant. Cooperative agreements are distinguished from other grants in that, under a cooperative agreement, substantial involvement is anticipated between the awarding office and the recipient during performance of the funded activity. This involvement may include collaboration, participation, or intervention in the activity. HHS awarding offices use grants or cooperative agreements (rather than contracts) when the principal purpose of the transaction is the transfer of money, property, services, or anything of value to accomplish a public purpose of support or stimulation authorized by Federal statute. The primary beneficiary under a grant or cooperative agreement is the public, as opposed to the Federal Government.

Cost-Sharing or Matching: Cost-sharing refers to the value of allowable non-Federal contributions toward the allowable costs of a Federal grant project or program. Such contributions may be cash or in-kind contributions. For SAMHSA grants, cost-sharing or matching is not required, and applications will not be screened out on the basis of cost-sharing. However, applicants often include cash or in-kind contributions in their proposals as evidence of commitment to the proposed project. This is allowed, and this information may be considered by reviewers in evaluating the quality of the application.

Grant: A grant is the funding mechanism used by the Federal Government when the principal purpose of the transaction is the transfer of money, property, services, or anything of value to accomplish a public purpose of support or stimulation authorized by Federal statute. The primary beneficiary under a grant or cooperative agreement is the public, as opposed to the Federal Government.

In-Kind Contribution: In-kind contributions toward a grant project are non-cash contributions (e.g., facilities, space, services) that are derived from non-Federal sources, such as State or sub-State non-Federal revenues, foundation grants, or contributions from other non-Federal public or private entities.

Practice: A practice is any activity, or collective set of activities, intended to improve outcomes for people with or at risk for substance abuse and/or mental illness. Such activities may include direct service provision, or they may be supportive activities, such as efforts to improve access to and retention in services, organizational efficiency or effectiveness, community readiness, collaboration among stakeholder groups, education, awareness, training, or any other activity that is designed to improve outcomes for people with or at risk for substance abuse or mental illness.

Practice Support System: This term refers to contextual factors that affect practice delivery and effectiveness in the pre-adoption phase, delivery phase, and post-delivery phase, such as (a) community collaboration and consensus building, (b) training and overall readiness of those implementing the practice, and (c) sufficient ongoing supervision for those implementing the practice.

Stakeholder: A stakeholder is an individual, organization, constituent group, or other entity that has an interest in and will be affected by a proposed grant project.

Target population catchment area: The target population catchment area is the geographic area from which the target population to be served by a program will be drawn.

Wraparound Service: Wraparound services are non-clinical supportive services—such as child care, vocational, educational, and transportation services—that are designed to improve the individual's access to and retention in the proposed project.

Appendix D: National Registry of Effective Programs

To help SAMHSA's constituents learn more about science-based programs, SAMHSA's Center for Substance Abuse Prevention (CSAP) created a National Registry of Effective Programs (NREP) to review and identify effective programs. NREP seeks candidates from the practice community and the scientific literature. While the initial focus of NREP was substance abuse prevention programming, NREP has expanded its scope and now includes prevention and treatment of substance abuse and of co-occurring substance abuse and mental disorders, and psychopharmacological programs and workplace programs.

NREP includes three categories of programs: Effective Programs, Promising Programs, and Model Programs. Programs defined as Effective have the option of becoming Model Programs if their developers choose to take part in SAMHSA dissemination efforts. The conditions for making that choice, together with definitions of the three major criteria, are as follows.

Promising Programs have been implemented and evaluated sufficiently and are scientifically defensible. They have positive outcomes in preventing substance abuse and related behaviors. However, they have not yet been shown to have sufficient rigor and/or consistently positive outcomes required for Effective Program status. Nonetheless, Promising Programs are eligible to be elevated to Effective/Model status after review of additional documentation regarding program effectiveness. Originated from a range of settings and spanning target populations, Promising Programs can guide prevention, treatment, and rehabilitation.

Effective Programs are well-implemented, well-evaluated programs that produce consistently positive pattern of results (across domains and/or replications). Developers of Effective Programs have yet themselves.

Model Programs are also well-implemented, well-evaluated programs, meaning they have been reviewed by NREP according to rigorous standards of research. Their developers have agreed with SAMHSA to provide materials, training, and technical assistance for nationwide implementation. That helps ensure the program is carefully implemented and likely to succeed.

Programs that have met the NREP standards for each category can be identified by accessing the NREP Model Programs Web site at http://www.modelprograms.samhsa.gov.

Appendix E: Center for Mental Health Services Evidence-Based Practice Toolkits

SAMHSA's Center for Mental Health Services and the Robert Wood Johnson Foundation initiated the Evidence-Based Practices Project to: (1) Help more consumers and families find effective services, (2) help providers of mental health services develop effective services, and (3) help administrators support and maintain these services. The project is now also funded and endorsed by numerous national, State, local, private and Start Printed Page 50629public organizations, including the Johnson & Johnson Charitable Trust, MacArthur Foundation, and the West Family Foundation.

The project has been developed through the cooperation of many Federal and State mental health organizations, advocacy groups, mental health providers, researchers, consumers and family members. A Web site (http://www.mentalhealthpractices.org) was created as part of Phase I of the project, which included the identification of the first cluster of evidence-based practices and the design of implementation resource kits to help people understand and use these practices successfully.

Basic information about the first six evidence-based practices is available on the Web site. The six practices are:

1. Illness Management and Recovery

2. Family Psychoeducation

3. Medication Management Approaches in Psychiatry

4. Assertive Community Treatment

5. Supported Employment

6. Integrated Dual Disorders Treatment

Each of the resource kit contains information and materials written by and for the following groups:

—Consumers

—Families and Other Supporters

—Practitioners and Clinical Supervisors

—Mental Health Program Leaders

—Public Mental Health Authorities

Material on the Web site can be printed or downloaded with Acrobat Reader, and references are provided where additional information can be obtained.

Once published, the full kits will be available from National Mental Health Information Center at http://www.health.org or 1-800-789-CMHS (2647).

Appendix F: Effective Substance Abuse Treatment Practices

To assist potential applicants, SAMHSA's Center for Substance Abuse Treatment (CSAT) has identified the following listing of current publications on effective treatment practices for use by treatment professionals in treating individuals with substance abuse disorders. These publications are available from the National Clearinghouse for Alcohol and Drug Information (NCADI); Tele: 1-800-729-6686 or http://www.health.org and http://www.samhsa.gov/​centers/​csat2002/​publications.html.

CSAT Treatment Improvement Protocols (TIPs) are consensus-based guidelines developed by clinical, research, and administrative experts in the field.

  • Integrating Substance Abuse Treatment and Vocational Services. TIP 38 (2000) NCADI #BKD381
  • Substance Abuse Treatment for Persons with Child Abuse and Neglect Issues. TIP 36 (2000) NCADI #BKD343
  • Substance Abuse Treatment for Persons with HIV/AIDS. TIP 37 (2000) NCADI # BKD359
  • Brief Interventions and Brief Therapies for Substance Abuse. TIP 34 (1999) NCADI # BKD341
  • Enhancing Motivation for Change in Substance Abuse Treatment. TIP 35 (1999) NCADI # BKD342
  • Screening and Assessing Adolescents for Substance Use Disorders. TIP 31 (1999) NCADI # BKD306
  • Treatment for Stimulant Use Disorders. TIP 33 (1999) NCADI # BKD289
  • Treatment of Adolescents with Substance Use Disorders. TIP 32 (1999) NCADI # BKD307
  • Comprehensive Case Management for Substance Abuse Treatment. TIP 27 (1998) NCADI # BKD251
  • Continuity of Offender Treatment for Substance Use Disorders From Institution to Community. TIP 30 (1998) NCADI # BKD304
  • Naltrexone and Alcoholism Treatment. TIP 28 (1998) NCADI # BKD268
  • Substance Abuse Among Older Adults. TIP 26 (1998) NCADI # BKD250
  • Substance Use Disorder Treatment for People With Physical and Cognitive Disabilities. TIP 29 (1998) NCADI # BKD288
  • A Guide to Substance Abuse Services for Primary Care Clinicians. TIP 24 (1997) NCADI # BKD234
  • Substance Abuse Treatment and Domestic Violence. TIP 25 (1997) NCADI # BKD239
  • Treatment Drug Courts: Integrating Substance Abuse Treatment With Legal Case Processing. TIP 23 (1996) NCADI # BKD205
  • Alcohol and Other Drug Screening of Hospitalized Trauma Patients. TIP 16 (1995) NCADI # BKD164
  • Combining Alcohol and Other Drug Abuse Treatment With Diversion for Juveniles in the Justice System. TIP 21 (1995) NCADI # BKD169
  • Detoxification From Alcohol and Other Drugs. TIP 19 (1995) NCADI # BKD172
  • LAAM in the Treatment of Opiate Addiction. TIP 22 (1995) NCADI # BKD170
  • Matching Treatment to Patient Needs in Opioid Substitution Therapy. TIP 20 (1995) NCADI # BKD168
  • Planning for Alcohol and Other Drug Abuse Treatment for Adults in the Criminal Justice System. TIP 17 (1995) NCADI # BKD165
  • Assessment and Treatment of Cocaine-Abusing Methadone-Maintained Patients. TIP 10 (1994) NCADI # BKD157
  • Assessment and Treatment of Patients With Coexisting Mental Illness and Alcohol and Other Drug Abuse. TIP 9 (1994) NCADI # BKD134
  • Intensive Outpatient Treatment for Alcohol and Other Drug Abuse. TIP 8 (1994) NCADI # BKD139

Other Effective Practice Publications

CSAT Publications—

  • Anger Management for Substance Abuse and Mental Health Clients: A Cognitive Behavioral Therapy Manual (2002) NCADI # BKD444
  • Anger Management for Substance Abuse and Mental Health Clients: Participant Workbook (2002) NCADI # BKD445
  • Multidimensional Family Therapy for Adolescent Cannabis Users. CYT Cannabis Youth Treatment Series Vol. 5 (2002) NCADI # BKD388
  • Navigating the Pathways: Lessons and Promising Practices in Linking Alcohol and Drug Services with Child Welfare. TAP 27 (2002) NCADI # BKD436
  • The Motivational Enhancement Therapy and Cognitive Behavioral Therapy Supplement: 7 Sessions of Cognitive Behavioral Therapy for Adolescent Cannabis Users. CYT Cannabis Youth Treatment Series Vol. 2 (2002) NCADI # BKD385
  • Family Support Network for Adolescent Cannabis Users. CYT Cannabis Youth Treatment Series Vol. 3 (2001) NCADI # BKD386
  • Identifying Substance Abuse Among TANF-Eligible Families. TAP 26 (2001) NCADI # BKD410
  • Motivational Enhancement Therapy and Cognitive Behavioral Therapy for Adolescent Cannabis Users: 5 Sessions. CYT Cannabis Youth Treatment Series Vol. 1 (2001) NCADI # BKD384
  • The Adolescent Community Reinforcement Approach for Adolescent Cannabis Users. CYT Cannabis Youth Treatment Series Vol. 4 (2001) NCADI # BKD387
  • Substance Abuse Treatment for Women Offenders: Guide to Promising Practices. TAP 23 (1999) NCADI # BKD310
  • Addiction Counseling Competencies: The Knowledge, Skills, and Attitudes of Professional Practice. TAP 21 (1998) NCADI # BKD246
  • Bringing Excellence to Substance Abuse Services in Rural and Frontier America. TAP 20 (1997) NCADI # BKD220
  • Counselor's Manual for Relapse Prevention with Chemically Dependent Criminal Offenders. TAP 19 (1996) NCADI # BKD723
  • Draft Buprenorphine Curriculum for Physicians (Note: the Curriculum is in DRAFT form and is currently being updated) http://www.buprenorphine.samhsa.gov
  • CSAT Guidelines for the Accreditation of Opioid Treatment Programs http://www.samhsa.gov/​centers/​csat/​content/​dpt/​accreditation.htm
  • Model Policy Guidelines for Opioid Addiction Treatment in the Medical Office http://www.samhsa.gov/​centers/​csat/​content/​dpt/​model_​policy.htm

NIDA Manuals—Available through NCADI

  • Brief Strategic Family Therapy. Manual 5 (2003) NCADI # BKD481
  • Drug Counseling for Cocaine Addiction: The Collaborative Cocaine Treatment Study Model. Manual 4 (2002) NCADI # BKD465
  • The NIDA Community-Based Outreach Model: A Manual to Reduce Risk HIV and Other Blood-Borne Infections in Drug Users. (2000) NCADI # BKD366
  • An Individual Counseling Approach to Treat Cocaine Addiction: The Collaborative Cocaine Treatment Study Model. Manual 3 (1999) NCADI # BKD337
  • Cognitive-Behavioral Approach: Treating Cocaine Addiction. Manual 1 (1998) NCADI # BKD254
  • Community Reinforcement Plus Vouchers Approach: Treating Cocaine Addiction. Manual 2 (1998) NCADI # BKD255

NIAAA Publications—* These publications are available in PDF format or can be ordered on-line at http://www.niaaa.nih.gov/​publications/​guides.htm. An order form for the Project MATCH series is available on-line at http://www.niaaa.nih.gov/​publications/​Start Printed Page 50630match.htm. All publications listed can be ordered through the NIAAA Publications Distribution Center, P.O. Box 10686, Rockville, MD 20849-0686.

  • * Alcohol Problems in Intimate Relationships: Identification and Intervention. A Guide for Marriage and Family Therapists (2003) NIH Pub. No. 03-5284
  • * Helping Patients with Alcohol Problems: A Health Practitioner's Guide. (2003) NIH Pub. No. 03-3769
  • Cognitive-Behavioral Coping Skills Therapy Manual. Project MATCH Series, Vol. 3 (1995) NIH Pub. No. 94-3724
  • Twelve Step Facilitation Therapy Manual. Project MATCH Series, Vol. 1 (1995) NIH Pub. No. 94-3722
  • Motivational Enhancement Therapy Manual. Project MATCH Series, Vol. 2 (1994) NIH Pub. No. 94-3723
Start Signature

Dated: August 13, 2003.

Anna Marsh,

Acting Executive Officer.

End Signature End Supplemental Information

[FR Doc. 03-21118 Filed 8-20-03; 8:45 am]

BILLING CODE 4162-20-P