[Federal Register Volume 68, Number 162 (Thursday, August 21, 2003)]
[Notices]
[Pages 50630-50641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21119]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Proposed Changes in Announcement of SAMHSA Discretionary Grant 
Funding Opportunities

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

ACTION: Notice of proposed standard service-to-science grant 
announcement.

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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 Service-to-Science Grants. It is not 
an actual grant solicitation.

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

    When published in final, the standard SAMHSA Service-to-Science 
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 change 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 Service-to-Science Grant announcement to: 
Office of Policy, Planning and Budget, SAMHSA, Attn: Jennifer 
Fiedelholtz by fax (301-594-6159) or e-mail ([email protected]). Please include a phone number in your e-mail, so 
that SAMHSA staff may contact you if there are questions about your 
comments.

FOR FURTHER INFORMATION CONTACT: Jennifer Fiedelholtz of the Office of 
Policy, Planning and Budget, SAMHSA, by fax (301-594-6159) or e-mail 
([email protected]). 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.

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 Service-to-
Science 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 Service-to-
Science Grants clear?
    3. Are the goals/objectives for SAMHSA's Service-to-Science Grants 
clear?
    4. If you are a potential applicant for a SAMHSA Service-to-Science 
Grant, do you believe you will be able to use the standard Service-to-
Science 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

Service-to-Science Grants--STS 04 (Initial Announcement)

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

    Authority: Sections 509, 516 and/or 520A of the Public Health 
Service Act, as amended and subject to the availability of funds 
(unless otherwise specified in a NOFA in the Federal Register and on 
http://www.grants.gov)


                                Key Dates
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Application Deadline..............  This Program Announcement provides
                                     instructions and guidelines for
                                     multiple funding opportunities.
                                     Application deadlines for specific
                                     funding opportunities will be
                                     published in Notices of Funding
                                     Availability (NOFAs) in the Federal
                                     Register and on http://www.grants.gov.
Intergovernmental Review (E.O.      Letters from State Single Point of
 12372).                             Contact (SPOC) are due 60 days
                                     after application deadline.

[[Page 50631]]

 
Public Health System Impact         Applicants must send the PHSIS to
 Statement (PHSIS)/ Single State     appropriate State and local health
 Agency Coordination.                agencies by application deadline.
                                     Comments from Single State Agency
                                     are due 60 days after application
                                     deadline.
------------------------------------------------------------------------


Table of Contents

I. Funding Opportunity Description
    A. Introduction
    B. Expectations
II. Award Information
    A. Award Amount
    B. Funding Mechanism
III. Eligibility Information
    A. Eligible Applicants
    B. 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 Limitations/Restrictions
    F. Other Submission Requirements
V. Application Review Information
    A. Evaluation Criteria
    B. Review and Selection Process
    C. Award Criteria
VI. Award Administration Information
    A. Award Notices
    B. Administrative and National Policy Requirements
    C. Reporting Requirements
VII. Agency Contacts
VIII. Other Information
    A. Human Subjects Protection
    B. Intergovernmental Review (E.O. 12372) Instructions
    C. Public Health System Impact Statement
Appendix A: SAMHSA Service-to-Science Indicators.
Appendix B: Checklist for Application Formatting Requirements.
Appendix C: Glossary.

I. Funding Opportunity Description

A. Introduction

    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) announces its intent to solicit applications for Service-to-
Science grants. These grants will document and evaluate innovative 
practices that address critical substance abuse and mental health 
service gaps but have not yet been formally evaluated. Applicants who 
seek to stabilize, document, and evaluate promising practices for 
mental health and/or substance abuse treatment, prevention, and support 
services should apply for awards under this announcement.
    SAMHSA also funds grants under three other standard grant 
announcements:
    [sbull] Services Grants provide funding to implement substance 
abuse and mental health services.
    [sbull] Infrastructure Grants identify and implement systems 
changes but are not designed to fund services.
    [sbull] Best Practices Planning and Implementation Grants help 
communities and providers identify practices to effectively meet local 
needs, develop strategic plans for implementing/adapting those 
practices and pilot-test practices prior to full-scale implementation.
    This announcement describes the general program design and provides 
application instructions for all SAMHSA Service-to-Science Grants. The 
availability of funds for specific Service-to-Science 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 Service-to-Science Grants will be targeted 
to specific populations and/or issue areas, which will be specified in 
the NOFAs. The NOFAs will also:
    [sbull] Specify total funding available for the first year of the 
grants and the expected size and number of awards;
    [sbull] Provide the application deadline;
    [sbull] Note any specific program requirements for each funding 
opportunity; and
    [sbull] Include any limitations or exceptions to the general 
provisions in this announcement (e.g., eligibility, award size, 
allowable activities).
    It is, therefore, critical that you consult the NOFA as well as 
this announcement in developing your grant application.

B. Expectations

    While there is a well-established evidence base for many behavioral 
health practices, critical service gaps exist for which there is no 
formal evidence base. Stakeholders have developed many innovative 
practices to fill these gaps, but they may lack the expertise and/or 
resources to formally document and evaluate their practices. 
Consequently, it is not clear whether these innovative practices are 
effective, and they are not disseminated widely. SAMHSA seeks to 
encourage continued development of evidence-based practices to fill 
service gaps by documenting and evaluating promising stakeholder-
initiated practices. This program will help organizations that have 
identified promising new practices to evaluate and package those 
innovations for review and inclusion in the National Registry of 
Effective Programs (NREP) as well as for further research.
1. Program Design
    SAMHSA will fund Service-to-Science grants in two phases. You may 
apply for Phase I and II combined or for Phase II alone. Applications 
for Phase I alone will not be accepted.
    Phase I provides support for up to 2 years to stabilize and 
document an existing practice that fills an identified gap. During 
Phase I, you may:
    [sbull] Further develop or refine the promising practice;
    [sbull] Develop training and practice manuals;
    [sbull] Train persons who are implementing the practice;
    [sbull] More systematically implement the practice;
    [sbull] Develop measurement instruments; and
    [sbull] Ensure that the intended target population is being reached 
by the practice.
    The desired endpoint of Phase I is readiness to conduct a high-
quality, systematic evaluation.
    Phase II provides support for 1-3 years to evaluate the success of 
the practice. The purpose of Phase II is to conduct a high-quality, 
systematic evaluation to document short-term outcomes and demonstrate 
that the practice is worthy of an experimental study. On the basis of 
the evaluation, you may need to further refine the practice and further 
refine the practice manual. The evaluation may use a pre-post approach, 
an open trial model, other quasi or non-experimental model, or an 
experimental model.
    The desired endpoint for Phase II is readiness to submit the 
practice for inclusion in SAMHSA's NREP and/or to submit applications 
to various research institutions for additional research.
    SAMHSA's Service-to-Science grants will provide support to 
stabilize practices so that they may be

[[Page 50632]]

documented and evaluated. However, these grants are not intended to 
support development of entirely new practices. The practices must be in 
place and operational prior to application, and you must have at least 
anecdotal evidence that the practice is effective.
    You may apply for a combination of Phases I and II in a single 
grant application if you have identified a priority gap for which a 
fully developed and documented practice currently does not exist.
    [sbull] During Phase I, you will further develop and document the 
practice.
    [sbull] During Phase II, you will evaluate the practice.
    At the conclusion of Phase I, SAMHSA staff will review your 
progress to determine whether Phase II is warranted. This decision will 
be based on review of the documentation required by the end of Phase I, 
as described under the Performance Expectations section below. You must 
provide compelling evidence that the practice has been sufficiently 
developed and documented to be evaluated and has produced positive 
results.
    For practices that are already fully developed, implemented, 
stabilized, and documented but that have not yet been formally 
evaluated, you may apply for Phase II only. Applications for Phase I 
alone will not be accepted.
    Depending on your readiness, you may receive a combination of 
Phases I and II for a period of up to, but not more than, 5 years. You 
may apply for a shorter grant period than the maximum, and SAMHSA may 
award a grant for a shorter time period than you request.
2. Establishing Need
    Service-to-Science grants are intended to develop solutions to 
widespread needs. This grant program is not intended to address a local 
community's need for funds to solve a local problem. Therefore, you 
must demonstrate that the broader substance abuse and/or mental health 
field--not just your local community--has a need for the practice. You 
must also show that no well-documented solution to the problem exists, 
and that your local community can support an evaluation that will 
increase the knowledge base of the field.
3. Allowable Activities
    Phase I: Practice Development and Documentation
    In Phase I, you will further develop and document the practice. The 
types of activities that may be needed and that are allowable include, 
but are not limited to, the following:

    [sbull] Strategic planning
    [sbull] Convening stakeholder meetings
    [sbull] Training of practitioners
    [sbull] Efforts to overcome policy and funding barriers to practice 
stability
    [sbull] Development of an action plan for systematizing and 
stabilizing the practice
    [sbull] Development of a practice support system
    [sbull] Developing needed partnerships for ongoing implementation
    [sbull] Logic model development
    [sbull] Documentation of core elements of the practice
    [sbull] Practice manual development
    [sbull] Measurement instrument development/selection
    [sbull] Participant recruitment
    [sbull] Development of quality assurance and accountability 
mechanisms
    [sbull] Implementation and refinement of the practice
    [sbull] Implementation process evaluation
    [sbull] Management information system development
    [sbull] Collection of pilot outcome data
    Phase II: Practice Evaluation
    During Phase II, SAMHSA will (if necessary) continue to fund 
implementation of the practice being evaluated. Other types of 
allowable activities include, but are not limited to, the following:
    [sbull] Convening relevant stakeholder meetings
    [sbull] Alignment of management information systems with data 
collection needs
    [sbull] Training evaluators
    [sbull] Measurement instrument development/selection
    [sbull] Data collection
    [sbull] Database management
    [sbull] Data and cost analysis
    [sbull] Dissemination of results
    [sbull] Refinement of logic model and practice manual based on 
evaluation results
4. Performance Expectations
    All grantees will be expected to meet the following performance 
requirements by the end of their grant projects.

Phase I

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

Phase II

    By the end of Phase II, the evaluation of the practice must have 
demonstrated that:

    [sbull] Key outcome measures have been clearly identified and 
defined.
    [sbull] Participant data collection systems are in place that 
include:

    [sbull] Demographic characteristics;
    [sbull] Practice outcomes;
    [sbull] Service utilization;
    [sbull] Service delivery costs; and
    [sbull] Satisfaction with services.

    [sbull] Demographic characteristics of participants, as well as the 
types of services that participants have received, are consistent with 
expectations based on the logic model for the practice.
    [sbull] Service delivery patterns are stable.
    [sbull] A fidelity scale has been developed for assessing the 
integrity of the practice, and the practice has been implemented with 
fidelity according to the scale.
    [sbull] Systematically collected short-term outcome measures 
indicate meaningful results.
    [sbull] Consumers, family members, and other critical stakeholders 
are satisfied with the practice.

    In addition, at the end of Phase II, grantees must:

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

[[Page 50633]]

through formal agreements between practice initiators and researchers; 
etc.)
5. Data and Performance Measurement
    The Government Performance and Results Act of 1993 (Pub. L.103-62, 
or ``GPRA'') requires all Federal agencies to:

    [sbull] Develop strategic plans that specify what they will 
accomplish over a 3 to 5-year period;
    [sbull] Set performance targets annually related to their strategic 
plan; and
    [sbull] 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 
Service-to-Science 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:

    [sbull] Center for Mental Health Services-funded grants: http://www.samhsa.gov/aps/CMHS/GPRA
    [sbull] Center for Substance Abuse Prevention-funded grants: http://www.samhsa.gov/aps/CSAP/GPRA
    [sbull] Center for Substance Abuse Treatment-funded grants: http://www.samhsa.gov/aps/CSAT/GPRA.
    This information will be provided in the hard copy application kits 
distributed by SAMHSA's Clearinghouses, as well.
    In some instances, you may be required to participate in cross-site 
evaluations and comply with additional data collection requirements; if 
so, this will be specified in the NOFA. Before grant award, a final 
agreement regarding data collection will be reached. The terms and 
conditions of the grant 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.
6. Grantee Meetings
    You must plan to send a minimum of two people (including the 
Project Director) to at least one joint grantee meeting in each year of 
the grant, and you must include funding for this travel in your budget. 
At these meetings, grantees will present the results of their projects 
and Federal staff will provide technical assistance. Each meeting will 
be 3 days. These meetings will usually be held in the Washington, DC, 
area, and attendance is mandatory.

II. Award Information

A. Award Amount

    The NOFA will specify the expected award amount for each funding 
opportunity. Regardless of the amount specified in the NOFA, the actual 
award amount will depend on the availability of funds.
    You may apply for either a combined Phase I & II grant or for a 
Phase II only grant.

    [sbull] Awards for Phase I of the combined grants are for up to 
$150,000 per year for up to 2 years.
    [sbull] Awards for Phase II are $300,000-$500,000 per year for 1-3 
years.
    [sbull] Awards for combined Phase I and II grants may not exceed 5 
years.

    Phase II funding will be approved only if you provide compelling 
evidence that the practice has been sufficiently developed and 
documented to be evaluated and has produced positive results.
    Applications with proposed budgets that exceed the allowable amount 
as specified in the NOFA in any year of the proposed project will be 
screened out and will not be reviewed. Annual continuation awards will 
depend on the availability of funds, grantee progress in meeting 
project goals and objectives, and timely submission of required data 
and reports.
    Summary Table:

----------------------------------------------------------------------------------------------------------------
                                                                               Application
             Phase                Activity focus       Years of support        requirement       Funding level
----------------------------------------------------------------------------------------------------------------
I.............................  Practice                             0-2   Optional..........  Up to $150,000
                                 Development and                                                per year.
                                 Documentation.
II............................  Practice                             1-3   Required..........  $300,000-500,000
                                 Evaluation.                                                    per year.
                                                   -----------------------
    Total.....................  ..................                   1-5   ..................  .................
----------------------------------------------------------------------------------------------------------------

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.

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.
    Though not required, SAMHSA encourages community-based providers 
and independent researchers to partner when applying for Service-to-
Science grants. Such partnerships will use the expertise of each 
partner to ensure sound service delivery, high-quality evaluation, 
independent results, and relevance of the evaluation design to service 
delivery outcomes.

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

[[Page 50634]]

consider this information in evaluating the quality of the application.

C. Other

    SAMHSA applicants must comply with certain program requirements, 
including:
    [sbull] Provisions relating to participant protection and the 
protection of human subjects specified in Section VIII-A of this 
document;
    [sbull] Budgetary limitations as specified in Sections I, II, and 
IV-E of this document; and
    [sbull] 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:

    [sbull] For substance abuse prevention or treatment grants, call 
the National Clearinghouse for Alcohol and Drug Information (NCADI) at 
1-800-729-6686.
    [sbull] 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:

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

B. Content and Form of Application Submission

1. Required Documents
    SAMHSA application kits include the following documents:

    [sbull] PHS 5161-1 (revised July 2000)--Includes the face page, 
budget forms, assurances, certification, and checklist. You must use 
the PHS 5161-1 unless otherwise specified in the NOFA. Applications 
that are not submitted on the required application form will be 
screened out and will not be reviewed.
    [sbull] Program Announcement (PA)--Includes instructions for the 
grant application. This document is the PA.
    [sbull] Notice of Funding Availability (NOFA)--Provides specific 
information about availability of funds, as well as any exceptions or 
limitations to provisions in the PA. The NOFAs will be published in the 
Federal Register as well as on the Federal grants Web site (http://www.grants.gov).
    You must use all of the above documents in completing your 
application.
2. 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.

    [sbull] 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.]
    [sbull] 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.
    [sbull] Table of Contents--Include page numbers for each of the 
major sections of your application and for each appendix.
    [sbull] Budget Form--Use SF 424A, which is part of the PHS 5161-1. 
Fill out Sections B, C, and E of the SF 424A.
    [sbull] Project Narrative and Supporting Documentation--The Project 
Narrative describes your project. It consists of Sections A through D. 
These sections in total may be no longer than 25 pages. More detailed 
instructions for completing each section of the Project Narrative are 
provided in ``Section 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 E through G. There are no page limits for these 
sections, except for Section F, the Biographical Sketches/Job 
Descriptions.

    [sbull] Section E--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.
    [sbull] Section F--Biographical Sketches and Job Descriptions.
    [sbull] Include a biographical sketch for the Project Director and 
other key positions. Each sketch should be 2 pages or less. If the 
person has not been hired, include a letter of commitment from the 
individual with a current biographical sketch.
    [sbull] Include job descriptions for key personnel. Job 
descriptions should be no longer than 1 page each.
    [sbull] Sample sketches and job descriptions are listed on page 22, 
Item 6 in the Program Narrative section of the PHS 5161-1.
    [sbull] Section G--Confidentiality and SAMHSA Participant 
Protection/Human Subjects. Instructions for completing Section G of 
your application are provided in Section VIII-A of this document.
    [sbull] Appendices 1 through 5--Use only the appendices listed 
below. Do not use more than 30 pages total for Appendices 1, 4, and 5. 
Do not use appendices to extend or replace any of the sections of the 
Project Narrative unless specifically required in the NOFA. Reviewers 
will not consider them if you do.
    [sbull] Appendix 1: Letters of Support
    [sbull] Appendix 2: Documentation of the Practice (Phase II only 
applicants)
    [sbull] Appendix 3: Data Collection Instruments/Interview Protocols
    [sbull] Appendix 4: Sample Consent Forms

[[Page 50635]]

    [sbull] Appendix 5: Letter to the SSA (if applicable; see Section 
VIII-C of this document)
    [sbull] Assurances--Non-Construction Programs. Use Standard Form 
424B found in PHS 5161-1.
    [sbull] Certifications--Use the ``Certifications'' forms found in 
PHS 5161-1.
    [sbull] Disclosure of Lobbying Activities--Use form SF LLL found in 
the PHS 5161-1. Federal law prohibits the use of appropriated funds for 
publicity or propaganda purposes, or for the preparation, distribution, 
or use of the information designed to support or defeat legislation 
pending before the Congress or State legislatures. This includes 
``grass roots'' lobbying, which consists of appeals to members of the 
public suggesting that they contact their elected representatives to 
indicate their support for or opposition to pending legislation or to 
urge those representatives to vote in a particular way.
    [sbull] 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.

    [sbull] Text must be legible.
    [sbull] Paper must be white and 8.5'' by 11.0'' in size.
    [sbull] Pages must be typed single-spaced with one column per page.
    [sbull] Page margins must be at least one inch.
    [sbull] Type size in the Project Narrative cannot exceed an average 
of 15 characters per inch when measured with a ruler. (Type size in 
charts, tables, graphs, and footnotes will not be considered in 
determining compliance.)
    [sbull] Photo reduction or condensation of type cannot be closer 
than 15 characters per inch or 6 lines per inch.
    [sbull] The pages cannot have printing on both sides.
    [sbull] Page limitations specified for the Project Narrative and 
Appendices cannot be exceeded.
    [sbull] Information must be sufficient for review.

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

    [sbull] Applications should be prepared using black ink. This 
improves the quality of the copies of applications that are provided to 
reviewers.
    [sbull] 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.
    [sbull] Pages should be numbered consecutively from beginning to 
end so that information can be located easily during review of the 
application. For example, the cover page should be labeled ``page 1,'' 
the abstract page should be ``page 2,'' and the table of contents page 
should be ``page 3.'' Appendices should be labeled and separated from 
the Project Narrative and budget section, and the pages should be 
numbered to continue in the sequence.

C. Submission Dates and Times

    Deadlines for submission of applications for specific funding 
opportunities will be published in 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:

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

    In addition, SAMHSA Service-to-Science grant funds may not be used 
to:

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

F. Other Submission Requirements

1. Where To Send Applications
    Send applications to the following address: Substance Abuse and 
Mental Health Services Administration, Office of Program Services, 
Review Branch, 5600 Fishers Lane, Room 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

[[Page 50636]]

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-D). These sections describe what you intend to do with your 
project.

    [sbull] In developing the Project Narrative section of your 
application, use these instructions, which have been tailored to this 
program. These are to be used instead of the ``Program Narrative'' 
instructions found in the PHS 5161-1.
    [sbull] Be sure to provide complete references for any literature 
cited in your Project Narrative. The reference list will not be counted 
toward the 25-page limit for these sections.
    [sbull] You must use the four sections/headings listed below in 
developing your Project Narrative. Be sure to place the required 
information in the correct section, or it will not be considered. Your 
application will be scored according to how well you address the 
requirements for each section.
    [sbull] The Supporting Documentation you provide in Sections E-G, 
Appendices 1 through 5, and the Reference list will be considered by 
reviewers in assessing your response, along with the material in the 
Project Narrative.
    [sbull] The number of points after each heading below is the 
maximum number of points a review committee may assign to that section 
of your Project Narrative. Bullet statements in each section do not 
have points assigned to them. They are provided to invite the attention 
of applicants and reviewers to important areas within each section.
Section A: Need (20 points)
    [sbull] Describe the problem the project will address. Describe the 
national significance of the problem. Documentation of need may come 
from a variety of qualitative and quantitative sources in the 
professional literature. The quantitative data could also come from 
national data available regarding mental health and substance use 
needs, gaps, and priorities. For example:
    [sbull] Applications focusing on substance abuse might draw from 
SAMHSA's National Household Survey on Drug Use and Health (NHSDUH); 
Drug Abuse Warning Network (DAWN); and Drug and Alcohol Services 
Information System (DASIS), which includes the Treatment Episode Data 
Set (TEDS).
    [sbull] Applications focusing on mental health might draw on data 
available from the National Association of State Mental Health Program 
Directors (NASMHPD), SAMHSA (http://www.samhsa.gov/cmhs/MentalHealthStatistics), or other sources.
    Qualitative sources may also include conclusions of conferences and 
events of national significance.
    [sbull] Describe the target population for the practice.
    [sbull] Review the literature that demonstrates a need to develop 
or adapt an effective practice for the target population. Demonstrate 
through the literature review that current evidence-based approaches to 
the problem do not exist or have not been evaluated for the specific 
target populations, or that approaches of greater clinical or cost 
effectiveness are needed.
    [sbull] Demonstrate that the need in the community in which the 
project will be carried out is of sufficient magnitude that an adequate 
evaluation of the practice can be conducted. To the extent possible, 
use locally generated data or State data such as that available through 
State needs assessments.
Section B: Proposed Approach (30 points)
    [sbull] Describe the practice proposed for evaluation.
    [sbull] Describe how the proposed practice will respond to the 
needs described in Section A of your Project Narrative.
    [sbull] Discuss the potential effectiveness of the practice 
proposed for evaluation. Why has this practice been selected? Present 
the theoretical underpinnings, core principles, and major assumptions 
of the proposed practice. Outline the key operational elements of the 
practice and summarize any relevant literature.
    [sbull] Identify any necessary collaborators on the project, 
including their roles and responsibilities. Demonstrate their 
commitment to the project. Include letters of support in Appendix 1: 
Letters of Support. Identify any cash or in-kind contributions to the 
project.
    [sbull] If applying for combined Phase I and II, describe the 
extent to which the practice has been previously developed, 
implemented, stabilized, and documented. Include a description of the 
support system needed for full implementation of the proposed 
practice--e.g., community collaboration and consensus building, 
training and overall readiness of those implementing the practice, and 
involvement of families and consumers in the project.
    [sbull] If applying for Phase II only, show that the practice is 
ready for systematic evaluation by providing, in Appendix 2, the 
documentation for the practice described in the Performance Measurement 
section of this PA for Phase I, including all of the following:

    [sbull] A logic model depicting the theory underlying the practice.
    [sbull] A manual describing the practice in detail that would allow 
others to replicate the practice.
    [sbull] Documentation of how critical stakeholders were included in 
the development of the practice.
    [sbull] A detailed description of the population that the practice 
is designed to serve, and demographic characteristics of the people 
served by the practice over the past year.
    [sbull] Demonstration of stability in the number of people being 
served by the practice.
    [sbull] Documentation that staff are trained in the practice (via 
the number and percentage of staff trained), and a mechanism for 
ongoing training for any new staff.
    [sbull] Evidence demonstrating that the practice is in full 
operation and that a routine service delivery process is in place.
    [sbull] Pilot outcome results. (Note: Collection of these data need 
not include an extensive set of outcomes systematically collected on 
all participants, but quantitative project data should provide some 
indication that key outcomes are being achieved.)
    [sbull] Present the goals and measurable objectives of the project. 
Describe why the practice can better be evaluated for effectiveness 
following completion of the grant activities. For applications that 
include Phase I, include in your description how achievement of your 
goals will fulfill the Performance Expectations cited above and in 
Section I-B of this document.
    [sbull] Describe the action steps to accomplish the goals and 
objectives. Demonstrate that the action steps will lead to successful 
accomplishment of the goals and objectives.
    [sbull] Describe the potential barriers to successful conduct of 
the proposed project and how you will overcome them.
    [sbull] Describe how the project will address issues of age, race/
ethnicity, culture, language, sexual orientation, disability, literacy, 
and gender in the target population.

[[Page 50637]]

Section C: Evaluation Design and Analysis (30 points)

    [sbull] Describe in detail your evaluation design for determining 
the effectiveness of the practice. For applications that include Phase 
I, describe your process evaluation to determine that the practice is 
in full operation, as well as how you will track the number and 
percentage of staff fully trained in the practice.
    [sbull] Describe the evaluation protocol you intend to use. Include 
in Appendix 3 evaluation instruments to be used. Describe any 
literature or pilot testing done to verify the validity and reliability 
of the instruments to be used or how you plan to develop the 
instruments during the grant period.
    [sbull] Describe how you will develop and manage a database 
management system to record participant demographic characteristics, 
practice outcomes, service utilization, practice costs, and 
satisfaction of stakeholders with the practice.
    [sbull] Describe how the integrity of the practice will be assessed 
using a fidelity scale. If no fidelity scale currently exists for the 
practice, describe the process by which you will develop one during the 
grant period.
    [sbull] Document your ability to collect and report on the required 
program measures for SAMHSA Service-to-Science Grants. Specify and 
justify the outcome measures you plan to use for your grant project. 
Identify any required program measures that you believe are 
inappropriate for your project and provide a rationale for excluding 
them. (See Appendix A for required program measures.)
    [sbull] Describe how you will analyze the data collected. Include 
any analyses that will be done to determine the effectiveness of the 
practice for diverse subgroups, as well as the satisfaction of various 
stakeholder groups with the practice.
    [sbull] Describe how you will document the role of critical 
stakeholders in the development and/or evaluation of the practice.
Section D: Management Plan and Staffing (20 points)
    [sbull] Provide a time line for the project (chart or graph) 
showing key activities, milestones, and responsible staff.
    [sbull] 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.
    [sbull] Provide a list of staff members who will conduct the 
project, showing the role of each and their level of effort and 
qualifications. The Project Director and other key personnel, including 
evaluators and database management personnel, must be included.
    [sbull] If you plan to include an advisory body in your project, 
describe the composition, roles/functions, and frequency of meetings of 
the proposed advisory body.
    [sbull] Describe the resources available for the proposed project 
(e.g., facilities, equipment), and provide evidence that resources are 
adequate for conducting a high-quality evaluation of the identified 
practice.

    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:
    [sbull] The strengths and weaknesses of the application as 
identified by the peer review committee and approved by the appropriate 
National Advisory Council; and
    [sbull] Availability of funds.

VI. Award Administration Information

A. Award Notices

    After your application has been reviewed, you will receive a letter 
from SAMHSA through postal mail that describes the general results of 
the review, including the score that your application received.
    If you are approved for funding, you will receive an additional 
notice, the Notice of Grant Award, signed by SAMHSA's Grants Management 
Officer. The Notice of Grant Award is the sole obligating document that 
allows the grantee to receive Federal funding for work on the grant 
project. It is sent by postal mail and is addressed to the contact 
person listed on the face page of the application.
    If you are not funded, you can re-apply if there is another receipt 
date for the program.

B. Administrative and National Policy Requirements

    [sbull] You must comply with terms and conditions of the grant 
award. Standard SAMHSA terms and conditions are available on SAMHSA's 
Web site (http://www.samhsa.gov).
    [sbull] Depending on the nature of the specific funding opportunity 
and/or the proposed project as identified during review, additional 
terms and conditions may be identified in the NOFA or negotiated with 
the grantee prior to grant award. These may include, for example:

    [sbull] Actions required to be in compliance with human subjects 
requirements;
    [sbull] Requirements relating to additional data collection and 
reporting;
    [sbull] Requirements relating to participation in a cross-site 
evaluation; or
    [sbull] Requirements to address problems identified in review of 
the application.

    [sbull] You will be held accountable for the information provided 
in the application relating to performance targets. SAMHSA program 
officials will consider your progress in meeting goals and objectives, 
as well as your failures and strategies for overcoming them, when 
making an annual recommendation to continue the grant and the amount of 
any continuation award. Failure to meet stated goals and objectives may 
result in suspension or termination of the grant award, or in reduction 
or withholding of continuation awards.
    [sbull] In an effort to improve access to funding opportunities for 
applicants, SAMHSA is participating in the U.S. Department of Health 
and Human Services ``Survey on Ensuring Equal Opportunity for 
Applicants.'' This survey is included in the application kit for SAMHSA 
grants. Applicants are encouraged to complete the survey and return it, 
using the instructions provided on the survey form.

C. Reporting

1. Progress and Financial Reports
    [sbull] Grantees must provide annual and final progress reports. 
The final progress report must summarize information from the annual 
reports, describe the accomplishments of the project, and describe next 
steps for implementing plans developed during the grant period.
    [sbull] Grantees must provide annual and final financial status 
reports. These reports may be included as separate sections of annual 
and final progress reports or can be separate documents. Because SAMHSA 
is extremely interested in ensuring that treatment or prevention 
service efforts are sustained, your financial reports should explain 
plans to ensure the sustainability of

[[Page 50638]]

efforts initiated under this grant. Initial plans for sustainability 
should be described in year 1 of the grant. In each subsequent year, 
you should describe the status of the project, successes achieved and 
obstacles encountered in that year.
    [sbull] SAMHSA will provide guidelines and requirements for these 
reports to grantees at the time of award and at the initial grantee 
orientation meeting after award. SAMHSA staff will use the information 
contained in the reports to determine the grantee's progress toward 
meeting its goals.
2. Government Performance and Results Act (GPRA)
    The Government Performance and Results Act (GPRA) mandates 
accountability and performance-based management by Federal agencies. 
The performance requirements for SAMHSA's Service-to-Science Grants are 
described in Section I-B under ``Data and 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:
    [sbull] Provide the GPO and SAMHSA Publications Clearance Officer 
with advance copies of publications.
    [sbull] Include acknowledgment of the SAMHSA grant program as the 
source of funding for the project.
    [sbull] Include a disclaimer stating that the views and opinions 
contained in the publication do not necessarily reflect those of SAMHSA 
or the U.S. Department of Health and Human Services, and should not be 
construed as such.
    SAMHSA reserves the right to issue a press release about any 
publication deemed by SAMHSA to contain information of program or 
policy significance to the substance abuse 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, 
[email protected].

VIII. Other Information

A. Human Subjects Protection

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

    Note: If applicable, grantees must agree to maintain the 
confidentiality of alcohol and drug abuse client records according 
to the provisions of Title 42 of the Code of Federal Regulations, 
Part II.

6. Adequate Consent Procedures
    [sbull] List what information will be given to people who 
participate in the project. Include the type and purpose of their 
participation. Identify the data that will be collected, how the data 
will be used, and how you will keep the data private.
    [sbull] State:

[[Page 50639]]

    [sbull] Whether or not their participation is voluntary.
    [sbull] Their right to leave the project at any time without 
problems.
    [sbull] Possible risks from participation in the project.
    [sbull] Plans to protect clients from these risks.
    [sbull] Explain how you will get consent for youth, the elderly, 
people with limited reading skills, and people who do not use English 
as their first language.

    Note: If the project poses potential physical, medical, 
psychological, legal, social or other risks, you must get written 
informed consent.

    [sbull] 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?
    [sbull] Include sample consent forms in your Appendix 4: Sample 
Consent Forms. If consent forms are in languages other than English, 
provide English translations.

    Note: Never imply that the participant waives or appears to 
waive any legal rights, may not end involvement with the project, or 
releases your project or its agents from liability for negligence.

    [sbull] Describe if separate consents will be obtained for 
different stages or parts of the project. For example, will they be 
needed for both participant protection in treatment intervention and 
for the collection and use of data?
    [sbull] Additionally, if other consents (e.g., consents to release 
information to others or gather information from others) will be used 
in your project, provide a description of the consents. Will 
individuals who do not consent to having individually identifiable data 
collected for evaluation purposes be allowed to participate in the 
project?
7. Risk/Benefit Discussion
    Discuss why the risks are reasonable compared to expected benefits 
and importance of the knowledge from the project.
Protection of Human Subjects Regulations
    All applicants for Service-to-Science grants must comply with the 
Protection of Human Subjects Regulations (45 CFR part 46).
    Applicants must describe the process for obtaining Institutional 
Review Board (IRB) approval fully in their applications. While IRB 
approval is not required at the time of grant award, you will be 
required, as a condition of award, to provide the documentation that an 
Assurance of Compliance is on file with the Office for Human Research 
Protections (OHRP) and that IRB approval has been received prior to 
enrolling any participants in the proposed project.
    Additional information about Protection of Human Subjects 
Regulations can be obtained on the web at http://ohrp.osophs.dhhs.gov. 
You may also contact OHRP by e-mail ([email protected]) 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.
    [sbull] Check the list to determine whether your State participates 
in this program. You do not need to do this if you are a federally 
recognized Indian tribal government.
    [sbull] If your State participates, contact your SPOC as early as 
possible to alert him/her to the prospective application(s) and to 
receive any necessary instructions on the State's review process.
    [sbull] For proposed projects serving more than one State, you are 
advised to contact the SPOC of each affiliated State.
    [sbull] 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 
under 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:
    [sbull] A copy of the face page of the application (SF 424); and
    [sbull] 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 5: 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--Announcement 
No. [fill in pertinent funding opportunity number from NOFA].
    In addition:
    [sbull] Applicants may request that the SSA send them a copy of any 
State comments.
    [sbull] 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

[[Page 50640]]

Officer, 1600 Clifton Road, MS D-24, Atlanta, GA 30333, ATTN: PRA 
(0920-0428)].

Appendix A--SAMHSA Service to Science Indicators

    The purpose of ``service to science'' grant program is to 
document and evaluate innovative practices with potential for broad 
application. The domain measured to determine success of these 
programs is the quality of the documentation and evaluation of the 
practice. This assessment is conducted by SAMHSA based upon 
information submitted by the grantee. Individual/systems outcomes 
pertinent to the service improvement are part of the grantee's 
outcome evaluation. 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.

CAPACITY

    * Number of persons served (Includes screening and assessment).
    Percent of providers providing services within expected costs.
    * Number, type, and capacity of services/product ready for 
designation as ``best practices''; number ready for further 
research.
    * Percent of persons needing services/product who receive them.

EFFECTIVENESS

    Participation of persons served and family members in planning, 
policy, and service delivery.
    * Percent of programs reporting positive individual and system 
outcomes.
    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.
    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.
    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. 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

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.
    [sbull] Use the PHS 5161-1 application.
    [sbull] 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.)
    [sbull] Provide legible text.
    [sbull] Use white paper, 8.5'' by 11.0'' in size.
    [sbull] Type single-spaced text with one column per page.
    [sbull] Use margins that are at least 1 inch.
    [sbull] 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.
    [sbull] Do not use photo reduction or condensation of type 
closer than 15 characters per inch or 6 lines per inch.
    [sbull] Do not exceed page limitations specified for the Project 
Narrative (25 pages) and Appendices (30 pages).
    [sbull] Provide sufficient information for review.
    [sbull] 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 postmarked a week prior to the application deadline will 
not be reviewed.
    [sbull] Applications that do not comply with the following 
requirements and any additional program requirements specified in 
the NOFA, or are otherwise unresponsive to PA guidelines will be 
screened out and returned to the applicant without review:
    [sbull] Compliance with the Human Subjects Regulations.
    [sbull] Budgetary limitations as specified in Section I, II, and 
IV-E of this document.
    [sbull] 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.
    [sbull] 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.
    [sbull] 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-ROMs.

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

[[Page 50641]]

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.

    Dated: August 13, 2003.
Anna Marsh,
Acting Executive Officer.

[FR Doc. 03-21119 Filed 8-20-03; 8:45 am]
BILLING CODE 4162-20-P