[Federal Register Volume 68, Number 225 (Friday, November 21, 2003)]
[Notices]
[Pages 65807-65818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28877]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Notice of Final Standard Service-to-Science Grants Announcement

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

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

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SUMMARY: On August 21, 2003, the Substance Abuse and Mental Health 
Services Administration (SAMHSA) announced plans to change its approach 
to announcing and soliciting applications for its discretionary grant 
programs in Fiscal Year (FY) 2004.

[[Page 65808]]

These changes involved the publication of four standard grant 
announcements that would provide the basic program design and 
application instructions for four types of grants--Services Grants, 
Infrastructure Grants, Best Practices Planning and Implementation 
Grants, and Service-to-Science Grants. The four announcements were made 
available for public review and comment for 60 days. The comments 
received and changes made to the standard grant announcements are 
described in a separate Federal Register notice. This notice provides 
the final text for SAMHSA's standard Service-to-Science Grants 
announcement.

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


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

ADDRESSES: Questions about SAMHSA's standard Service-to-Science Grants 
announcement may be directed to Cathy Friedman, M.A., Office of Policy, 
Planning and Budget, 5600 Fishers Lane, Room 12C-26, Rockville, 
Maryland, 20857. Fax: (301-594-6159) E-mail: [email protected].

FOR FURTHER INFORMATION CONTACT: Cathy Friedman, M.A., Office of 
Policy, Planning and Budget, 5600 Fishers Lane, Room 12C-26, Rockville, 
Maryland, 20857. Fax: (301-594-6159) E-mail: [email protected]. 
Phone: (301) 443-1910.

SUPPLEMENTARY INFORMATION: Starting in FY 2004, SAMHSA is changing its 
approach to announcing and soliciting applications for its 
discretionary grants. SAMHSA will publish four standard grant 
announcements that will describe the general program design and provide 
application instructions for four types of grants--Services Grants, 
Infrastructure Grants, Best Practices Planning and Implementation 
Grants, and Service-to-Science Grants. The text for the final standard 
Service-to-Science Grants announcement is provided below.
    The standard Service-to-Science Grants announcement will be posted 
on SAMHSA's Web page (www.samhsa.gov) and will be available from 
SAMHSA's clearinghouses on an ongoing basis. The standard announcements 
will be used in conjunction with brief Notices of Funding Availability 
(NOFAs) that will announce the availability of funds for specific grant 
funding opportunities within each of the standard grant programs (e.g., 
Homeless Treatment grants, Statewide Family Network grants, HIV/AIDS 
and Substance Abuse Prevention Planning Grants, etc.).

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 
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 
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 www.grants.gov.
Intergovernmental Review (E.O.      Letters from State Single Point of
 12372).                             Contact (SPOC) are due 60 days
                                     after application deadline
Public Health System Impact         Applicants must send the PHSIS to
 Statement (PHSIS)/Single State      appropriate State and local health
 Agency Coordination.                agencies by application deadline.
                                     Comments from Single State Agency
                                     are due 60 days after application
                                     deadline.
------------------------------------------------------------------------

Table of Contents

I. Funding Opportunity Description
    A. Introduction
    B. Expectations
II. Award Information
    A. Award Amount
    B. Funding Mechanism
III. Eligibility Information
    A. Eligible Applicants
    B. 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: Checklist for Application Formatting Requirements
Appendix B: Glossary
Appendix C: Logic Model Resources

I. Funding Opportunity Description

A. Introduction

    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) announces its intent to solicit applications for 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 support identification and 
implementation of systems changes but are not designed to fund 
services.
    [sbull] Best Practices Planning and Implementation Grants help 
communities and providers identify practices to effectively meet local 
needs, develop strategic plans for implementing/adapting those 
practices and 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.

[[Page 65809]]

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 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 (see Glossary) 
is being reached by the practice.
    The desired endpoint of Phase I is readiness to conduct a high-
quality, systematic evaluation.
    Phase II provides support for 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 documented and evaluated. 
However, these grants are not intended to support development of 
entirely new practices. The practices must be in place and operational 
for at least one year prior to application, and you must have at least 
anecdotal evidence that the practice is effective.
    You may apply for a combination of Phases I and II in a single 
grant application if you have identified a priority gap for which a 
fully developed and documented practice currently does not exist.
    [sbull] During Phase I, you will further develop and document the 
practice.
    [sbull] During Phase II, you will evaluate the practice.
    At the conclusion of Phase I, SAMHSA staff will review your 
progress to determine whether Phase II is warranted. This decision will 
be based on review of the documentation required by the end of Phase I, 
as described under the Performance Expectations section below. You must 
provide compelling evidence that the practice has been sufficiently 
developed and documented to be evaluated and has produced positive 
results.
    For practices that are already fully developed, implemented, 
stabilized, and documented but that have not yet been formally 
evaluated, you may apply for Phase II only. Applications for Phase I 
alone will not be accepted.
    Depending on your readiness, you may receive a combination of 
Phases I and II for a period of up to, but not more than, 5 years. You 
may apply for a shorter grant period than the maximum, and SAMHSA may 
award a grant for a shorter time period than you request.
2. Establishing Need
    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.

[[Page 65810]]

    [sbull] Alignment of management information systems with data 
collection needs.
    [sbull] Training evaluators.
    [sbull] Measurement instrument development/selection.
    [sbull] Data collection.
    [sbull] Database management.
    [sbull] Data and cost analysis.
    [sbull] Dissemination of results.
    [sbull] Refinement of logic model and practice manual based on 
evaluation results.
4. Performance Expectations
    All grantees will be expected to meet the following performance 
requirements by the end of their grant projects.
    Phase I. By the end of Phase I, documentation for the practice must 
include:
    [sbull] A logic model depicting the principles and concepts 
underlying the practice.
    [sbull] A manual describing the practice in detail that would allow 
others to replicate the practice.
    [sbull] Documentation of how critical stakeholders were included in 
the development of the practice.
    [sbull] A detailed description of the population that the practice 
is designed to serve, and demographic characteristics of the people 
served by the practice over the past year.
    [sbull] Documentation that the number of people being served by the 
practice has been stabilized.
    [sbull] Documentation of the number and percentage of staff trained 
in the practice, and a mechanism for ongoing training for any new 
staff.
    [sbull] A process evaluation demonstrating that the practice is in 
full operation and that a routine service delivery process is in place.
    [sbull] Pilot outcome results. (Note: Collection of these data need 
not include an extensive set of outcomes systematically collected on 
all participants, but quantitative project data should provide some 
indication that key outcomes are being achieved.)
    Phase II. By the end of Phase II, the evaluation of the practice 
must have demonstrated that:
    [sbull] Key outcome measures have been clearly identified and 
defined.
    [sbull] Participant data collection systems are in place that 
include:
    [sbull] Demographic characteristics.
    [sbull] Practice outcomes.
    [sbull] Service utilization.
    [sbull] Service delivery costs.
    [sbull] Satisfaction with services.
    [sbull] Demographic characteristics of participants, as well as the 
types of services that participants have received, are consistent with 
expectations based on the logic model for the practice.
    [sbull] Service delivery patterns are stable.
    [sbull] A fidelity scale has been developed for assessing the 
integrity of the practice, and the practice has been implemented with 
fidelity according to the scale.
    [sbull] Systematically collected 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; 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 set program performance 
targets and report annually on the degree to which the previous year's 
targets were met.
    Agencies are expected to evaluate their programs regularly and to 
use results of these evaluations to explain their successes and 
failures and justify requests for funding.
    To meet the GPRA requirements, SAMHSA must collect performance data 
(i.e., ``GPRA data'') from grantees. Grantees are required to report 
these GPRA data to SAMHSA on a timely basis.
    Specifically, grantees will be required to provide data on a set of 
required measures, as specified in the NOFA. The data collection tools 
to be used for reporting the required data will be provided in the 
application kits distributed by SAMHSA's clearinghouses and posted on 
SAMHSA's Web site along with each NOFA. In your application, you must 
demonstrate your ability to collect and report on these measures, and 
you may be required to provide some baseline data.
    The terms and conditions of the grant award also will specify the 
data to be submitted and the schedule for submission. Grantees will be 
required to adhere to these terms and conditions of award.
    Applicants should be aware that SAMHSA is working to develop a set 
of required core performance measures for each of SAMHSA's standard 
grants (i.e., Services Grants, Infrastructure Grants, Best Practices 
Planning and Implementation Grants, and Service-to-Science Grants). As 
this effort proceeds, some of the data collection and reporting 
requirements included in SAMHSA's NOFAs may change. All grantees will 
be expected to comply with any changes in data collection requirements 
that occur during the grantee's project period.
6. Grantee Meetings
    You must plan to send a minimum of two people (including the 
Project Director) to at least one joint grantee meeting in each year of 
the grant, and you must include funding for this travel in your budget. 
At these meetings, grantees will present the results of their projects 
and Federal staff will provide technical assistance. Each meeting will 
be 3 days. These meetings will usually be held in the Washington, DC, 
area, and attendance is mandatory.

II. Award Information

A. Award Amount

    The NOFA will specify the expected award amount for each funding 
opportunity. Regardless of the amount specified in the NOFA, the actual 
award amount will depend on the availability of funds.
    You may apply for either a combined Phase I & II grant or for a 
Phase II only grant.
    [sbull] Awards for Phase I of the combined grants are for up to 
$150,000 (direct and indirect costs) per year for up to 2 years.
    [sbull] Awards for Phase II are $300,000-$500,000 (direct and 
indirect costs) per year for 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.

[[Page 65811]]



                                                 Summary Table:
----------------------------------------------------------------------------------------------------------------
                                                                                                 Funding level
              Phase                    Activity focus         Years of       Application          (direct and
                                                              support        requirement        indirect costs)
----------------------------------------------------------------------------------------------------------------
I...............................  Practice Development and          0-2  Optional...........  Up to $150,000 per
                                   Documentation.                                              year
II..............................  Practice Evaluation.....          1-3  Required...........  $300,000-$500,000
                                                                                               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 B for further explanation of these funding mechanisms). For 
cooperative agreements, the NOFA will describe the nature of Federal 
involvement in project performance and specify roles and 
responsibilities of grantees and Federal staff.

III. Eligibility Information

A. Eligible Applicants

    Eligible applicants are domestic public and private nonprofit 
entities. For example, State, local or tribal governments; public or 
private universities and colleges; community- and 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 (see Glossary) 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 (see Glossary) contributions 
in your proposal as evidence of commitment to the proposed project.

C. Other

    SAMHSA applicants must comply with certain program requirements, 
including:
    [sbull] Budgetary limitations as specified in Sections I, II, and 
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 A of this document.)

A. Address To Request Application Package

    You may request a complete application kit by calling one of 
SAMHSA's national clearinghouses:
    [sbull] For substance abuse prevention or treatment grants, call 
the National Clearinghouse for Alcohol and Drug Information (NCADI) at 
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 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 (www.grants.gov).
    You must use all of the above documents in completing your 
application.
2. Required Application Components
    To ensure equitable treatment of all applications, SAMHSA will 
accept only complete applications for review. In order for your 
application to be complete, it must include the required ten 
application components (Face Page, Abstract, Table of Contents, Budget 
Form, Project Narrative and Supporting Documentation, Appendices, 
Assurances, Certifications, Disclosure of Lobbying Activities, and 
Checklist). Applications that do not contain the required components 
will be screened out and will not be reviewed.
    [sbull] Face 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 
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

[[Page 65812]]

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 H. There are no page limits for these 
sections, except for Section G, the Biographical Sketches/Job 
Descriptions.
    [sbull] Section E--Literature Citations. This section must contain 
complete citations, including titles and all authors, for any 
literature you cite in your application.
    [sbull] 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.
    [sbull] Section G--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 H--Confidentiality and SAMHSA Participant 
Protection/Human Subjects. VIII-A of this document describes 
requirements for the protection of the confidentiality, rights and 
safety of participants in SAMHSA-funded activities. This section also 
includes guidelines for completing this part of your application.
    [sbull] Appendices 1 through 5--Use only the appendices listed 
below. Do not use more than 30 pages for Appendices 1, 4, and 5. There 
are no page limitations for Appendices 2 and 3. Do not use appendices 
to extend or replace any of the sections of the Project Narrative 
unless specifically required in the NOFA. Reviewers will not consider 
them if you do.
    [sbull] Appendix 1: Letters of Support.
    [sbull] Appendix 2: Documentation of the Practice (Phase II only 
applicants).
    [sbull] Appendix 3: Data Collection Instruments/Interview 
Protocols.
    [sbull] Appendix 4: Sample Consent Forms.
    [sbull] Appendix 5: Letter to the SSA (if applicable; see Section 
VIII-C of this document).
    [sbull] Assurances--Non-Construction Programs. Use Standard Form 
424B found in PHS 5161-1. Some applicants will be required to complete 
the Assurance of Compliance with SAMHSA Charitable Choice Statutes and 
Regulations Form SMA 170. If this assurance applies to a specific 
funding opportunity, it will be posted on SAMHSA's Web site with the 
NOFA and provided in the application kits available at SAMHSA's 
clearinghouse (NCADI).
    [sbull] 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] Pages cannot have printing on both sides.
    [sbull] Page limitations specified for the Project Narrative and 
Appendices cannot be exceeded.
    [sbull] Information provided must be sufficient for review.
    To facilitate review of your application, follow these additional 
guidelines:
    [sbull] Applications should be prepared using black ink. This 
improves the quality of the copies of applications that are provided to 
reviewers.
    [sbull] Do not use heavy or 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 the NOFAs in the Federal Register 
and posted on the Federal grants Web site (http://www.grants.gov).
    Your application must be received by the application deadline. 
Applications received after this date must have a 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.

[[Page 65813]]

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

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

    Executive Order 12372, as implemented through Department of Health 
and Human Services (DHHS) regulation at 45 CFR Part 100, sets up a 
system for State and local review of applications for Federal financial 
assistance. Instructions for this review are included in Section 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. Residential services are not considered to be 
inpatient or hospital-based 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 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 according to the 
quality of your response to 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] You must use the four sections/headings listed below in 
developing your Project Narrative. Be sure to place the required 
information in the correct section, or it will not be considered. Your 
application will be scored according to how well you address the 
requirements for each section.
    [sbull] Reviewers will be looking for evidence of cultural 
competence in each section of the Project Narrative. Points will be 
assigned based on how well you address the cultural competence aspects 
of the evaluation criteria. SAMHSA's guidelines for cultural competence 
can be found on the SAMHSA Web site at http://www.samhsa.gov. Click on 
``Grant Opportunities.''
    [sbull] The Supporting Documentation you provide in Sections E-H 
and Appendices 1 through 5 will be considered by reviewers in assessing 
your response, along with the material in the Project Narrative.
    [sbull] The number of points after each heading below is the 
maximum number of points a review committee may assign to that section 
of your Project Narrative. Bullet statements in each section do not 
have points assigned to them. They are provided to invite the attention 
of applicants and reviewers to important areas within each section.
Section A: Statement of Need (15 points)
    [sbull] Describe the problem the project will address. Describe the 
national significance of the problem. Documentation of need may come 
from a variety of qualitative and quantitative sources in the 
professional literature. The quantitative data could also come from 
national data available regarding mental health and substance use 
needs, gaps, and priorities. For example:
    [sbull] Applications focusing on substance abuse might draw from 
SAMHSA's National Household Survey on Drug Use and Health (NHSDUH); 
Drug Abuse Warning Network (DAWN); and Drug and Alcohol Services 
Information System (DASIS), which includes the Treatment Episode Data 
Set (TEDS).
    [sbull] Applications focusing on mental health might draw on data 
available from the National Association of State Mental Health Program 
Directors (NASMHPD), SAMHSA (http://www.samhsa.gov/cmhs/MentalHealthStatistics), or other sources.
    Qualitative sources may also include conclusions of conferences and 
events of national significance.
    [sbull] Describe the target population for the practice, including 
demographic information. Discuss the target population's language, 
beliefs, norms and values, as well as socioeconomic factors that must 
be considered in delivering programs to this population
    [sbull] Review the literature that demonstrates a need to develop 
or adapt an effective practice for the target

[[Page 65814]]

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.
    [sbull] Check the NOFA for any additional requirements.
Section B: Proposed Approach (30 points)
    [sbull] Describe the practice proposed for evaluation. Document 
that the practice has been in place and operational for at least one 
year prior to the application due date.
    [sbull] Describe how the proposed practice will respond to the 
needs described in Section A of your Project Narrative.
    [sbull] Discuss the potential effectiveness of the practice 
proposed for evaluation. Why has this practice been selected? Present 
the theoretical underpinnings, core principles, and major assumptions 
of the proposed practice. Outline the key operational elements of the 
practice and summarize any relevant literature.
    [sbull] Identify any necessary collaborators on the project, 
including their roles and responsibilities. Demonstrate their 
commitment to the project. Include letters of support in Appendix 1: 
Letters of Support.
    [sbull] Describe your experience with similar collaborative 
projects, and explain why you believe you will be able to sustain this 
collaboration throughout the project period.
    [sbull] If applying for combined Phase I and II, describe the 
extent to which the practice has been previously developed, 
implemented, stabilized, and documented. Include a description of the 
extent to which the support system needed for full implementation of 
the proposed practice is in place--e.g., community collaboration and 
consensus building; alignment of management information systems, 
policies, and funding mechanisms; documentation of core elements of the 
practice; reliable recruitment and intake procedures; quality assurance 
and accountability mechanisms; training and overall readiness of those 
implementing the practice; and involvement of families and consumers in 
the project.
    [sbull] If applying for Phase II only, show that the practice is 
ready for systematic evaluation by providing documentation, in Appendix 
2, that includes all of the following:
    [sbull] A logic model depicting the principles and concepts 
underlying the practice.
    [sbull] A copy of the Title Page and Table of Contents for a manual 
describing the practice in detail that would allow others to replicate 
the practice, and details on how the manual can be acquired.
    [sbull] Documentation of how critical stakeholders were included in 
the development of the practice.
    [sbull] A detailed description of the population that the practice 
is designed to serve, and demographic characteristics of the people 
served by the practice over the past year.
    [sbull] Demonstration of stability in the number of people being 
served by the practice.
    [sbull] Documentation that staff are trained in the practice (via 
the number and percentage of staff trained), and a mechanism for 
ongoing training for any new staff.
    [sbull] Evidence demonstrating that the practice is in full 
operation and that a routine service delivery process is in place.
    [sbull] Pilot outcome results. (Note: Collection of these data need 
not include an extensive set of outcomes systematically collected on 
all participants, but quantitative project data should provide some 
indication that key outcomes are being achieved.)
    [sbull] Present the goals and measurable objectives of the project. 
Describe why the practice can better be evaluated for effectiveness 
following completion of the grant activities. For applications that 
include Phase I, include in your description how achievement of your 
goals will fulfill the Performance Expectations cited in Section 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 proposed project will address issues of 
age, race/ethnicity, culture, language, sexual orientation, disability, 
literacy, and gender in the target population.
    [sbull] Check the NOFA for any additional requirements.
Section C: Evaluation Design and Analysis (40 points)
    [sbull] Describe in detail your evaluation design for determining 
the effectiveness of the practice. For applications that include Phase 
I, describe your process evaluation to determine that the practice is 
in full operation, as well as how you will track the number and 
percentage of staff fully trained in the practice.
    [sbull] Describe the process and outcome evaluation protocols you 
intend to use. Include in Appendix 3 evaluation instruments to be used. 
Describe any literature or pilot testing done to verify the validity 
and reliability of the instruments to be used or how you plan to 
develop the instruments during the grant period.
    [sbull] Discuss the reliability and validity of evaluation methods 
and instrument(s) in terms of the gender/age/culture of the target 
population.
    [sbull] Describe how you will develop and manage a database 
management system to record participant demographic characteristics, 
practice outcomes, service utilization, practice costs, and 
satisfaction of stakeholders with the practice.
    [sbull] Describe how the integrity of the practice will be assessed 
using a fidelity (see Glossary) scale. If no fidelity scale currently 
exists for the practice, describe the process by which you will develop 
one during the grant period. Describe how you will document and assess 
changes to the model that occur throughout the project.
    [sbull] Document your ability to collect and report on the required 
performance measures as specified in the NOFA, including data required 
by SAMHSA to meet GPRA requirements. Specify and justify any additional 
measures you plan to use for your grant project.
    [sbull] Describe how you will analyze the data collected. Include 
any analyses that will be done to determine the effectiveness of the 
practice for diverse subgroups, as well as the satisfaction of various 
stakeholder groups with the practice.
    [sbull] Describe how your process evaluation will document the role 
of critical stakeholders in the development and/or evaluation of the 
practice.
    [sbull] Check the NOFA for any additional requirements.
Section D: Management Plan and Staffing (15 points)
    [sbull] Provide a realistic time line for the project (chart or 
graph) showing key activities, milestones, and responsible staff. 
[Note: The time line should be part of the Project Narrative. It should 
not be placed in an appendix.]
    [sbull] Discuss the capability and experience of the applicant 
organization and other participating organizations with similar 
projects and populations, including experience in providing

[[Page 65815]]

culturally appropriate/competent services.
    [sbull] Provide a list of staff members who will conduct the 
project, showing the role of each and their level of effort and 
qualifications. Include the Project Director and other key personnel, 
such as evaluators and database management personnel.
    [sbull] Describe the racial/ethnic characteristics of key staff and 
indicate if any are members of the target population/community. If the 
target population is multi-linguistic, indicate if the staffing pattern 
includes bilingual and bicultural individuals.
    [sbull] If you plan to include an advisory body in your project, 
describe its membership, roles and functions, and frequency of 
meetings.
    [sbull] Describe the resources available for the proposed project 
(e.g., facilities, equipment), and provide evidence that resources are 
adequate for conducting a high-quality evaluation of the identified 
practice.
    [sbull] Check the NOFA for any additional requirements.

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

B. Review and Selection Process

    SAMHSA applications are 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 (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 Requirements

1. Progress and Financial Reports
    [sbull] Grantees must provide annual and final progress reports. 
The final progress report must summarize information from the annual 
reports, describe the accomplishments of the project, and describe next 
steps for implementing plans developed during the grant period.
    [sbull] Grantees must provide annual and final financial status 
reports. These reports may be included as separate sections of annual 
and final progress reports or can be separate documents. Because SAMHSA 
is extremely interested in ensuring that treatment or prevention 
service efforts are sustained, your financial reports should explain 
plans to ensure the sustainability (see Glossary) of efforts initiated 
under this grant. Initial plans for sustainability should be described 
in year 1 of the grant. In each subsequent year, you should describe 
the status of the project, successes achieved and obstacles encountered 
in that year.
    [sbull] SAMHSA will provide guidelines and requirements for these 
reports to grantees at the time of award and at the initial grantee 
orientation meeting after award. SAMHSA staff will use the information 
contained in the reports to determine the grantee's progress toward 
meeting its goals.
2. Government Performance and Results Act (GPRA)
    The Government Performance and Results Act (GPRA) mandates 
accountability and performance-based management by Federal agencies. To 
meet the GPRA requirements, SAMHSA must collect performance data (i.e., 
``GPRA data'') from grantees. These requirements will be specified in 
the NOFA for each funding opportunity.
3. Publications
    If you are funded under this grant program, you are required to 
notify the Government Project Officer (GPO) and SAMHSA's Publications 
Clearance Officer (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

[[Page 65816]]

treatment/substance abuse prevention/mental health services community.

VII. Agency Contacts

    The NOFAs provide contact information for questions about program 
issues.
    For questions on grants management issues, contact: Stephen Hudak, 
Office of Program Services, Division of Grants Management, Substance 
Abuse and Mental Health Services Administration, 5600 Fishers Lane, 
Rockwall II 6th Floor, Rockville, MD 20857, (301) 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 H of your 
application, using the guidelines provided below. Problems with 
confidentiality and protection of human subjects identified during peer 
review of your application may result in the delay of funding.
Confidentiality and Participant Protection
    All applicants must address each of the following elements relating 
to confidentiality and participant protection. You must describe how 
you will address these requirements.

1. Protect Clients and Staff From Potential Risks

    [sbull] Identify and describe any foreseeable physical, medical, 
psychological, social, and legal risks or potential adverse effects as 
a result of the project itself or any data collection activity.
    [sbull] Describe the procedures you will follow to minimize or 
protect participants against potential risks, including risks to 
confidentiality.
    [sbull] Identify plans to provide guidance and assistance in the 
event there are adverse effects to participants.
    [sbull] Where appropriate, describe alternative treatments and 
procedures that may be beneficial to the participants. If you choose 
not to use these other beneficial treatments, provide the reasons for 
not using them.

2. Fair Selection of Participants

    [sbull] Describe the target population(s) for the proposed project. 
Include age, gender, and racial/ethnic background and note if the 
population includes homeless youth, foster children, children of 
substance abusers, pregnant women, or other targeted groups.
    [sbull] Explain the reasons for including groups of pregnant women, 
children, people with mental disabilities, people in institutions, 
prisoners, and individuals who are likely to be particularly vulnerable 
to HIV/AIDS.
    [sbull] Explain the reasons for including or excluding 
participants.
    [sbull] Explain how you will recruit and select participants. 
Identify who will select participants.

3. Absence of Coercion

    [sbull] Explain if participation in the project is voluntary or 
required. Identify possible reasons why participation is required, for 
example, court orders requiring people to participate in a program.
    [sbull] If you plan to compensate participants, state how 
participants will be awarded incentives (e.g., money, gifts, etc.).
    [sbull] State how volunteer participants will be told that they may 
receive services intervention even if they do not participate in or 
complete the data collection component of the project.

4. Data Collection

    [sbull] Identify from whom you will collect data (e.g., from 
participants themselves, family members, teachers, others). Describe 
the data collection procedures and specify the sources for obtaining 
data (e.g., school records, interviews, psychological assessments, 
questionnaires, observation, or other sources). Where data are to be 
collected through observational techniques, questionnaires, interviews, 
or other direct means, describe the data collection setting.
    [sbull] Identify what type of specimens (e.g., urine, blood) will 
be used, if any. State if the material will be used just for evaluation 
or if other use(s) will be made. Also, if needed, describe how the 
material will be monitored to ensure the safety of participants.
    [sbull] Provide in Appendix 3: Data Collection Instruments/
Interview Protocols, copies of all available data collection 
instruments and interview protocols that you plan to use.

5. Privacy and Confidentiality

    [sbull] Explain how you will ensure privacy and confidentiality. 
Include who will collect data and how it will be collected.
    [sbull] Describe:
    [sbull] How you will use data collection instruments.
    [sbull] Where data will be stored.
    [sbull] Who will or will not have access to information.
    [sbull] How the identity of participants will be kept private, for 
example, through the use of a coding system on data records, limiting 
access to records, or storing identifiers separately from data.

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

6. Adequate Consent Procedures

    [sbull] List what information will be given to people who 
participate in the project. Include the type and purpose of their 
participation. Identify the data that will be collected, how the data 
will be used, and how you will keep the data private.
    [sbull] State:
    [sbull] Whether or not their participation is voluntary.
    [sbull] Their right to leave the project at any time without 
problems.
    [sbull] Possible risks from participation in the project.
    [sbull] Plans to protect clients from these risks.
    [sbull] Explain how you will get consent for youth, the elderly, 
people with limited reading skills, and people who do not use English 
as their first language.

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

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

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

    [sbull] Describe if separate consents will be obtained for 
different stages or parts of the project. For example, will they be 
needed for both participant protection in treatment intervention and 
for the collection and use of data?
    [sbull] Additionally, if other consents (e.g., consents to release 
information to others

[[Page 65817]]

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

Appendix A--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] The 10 application components required for SAMHSA 
applications must be included (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] Text must be legible.
    [sbull] Paper must be white paper and 8.5'' by 11.0'' in size.
    [sbull] Pages must be single-spaced with one column per page.
    [sbull] 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] Page limitations specified for the Project Narrative (25 
pages) and Appendices (30 pages) cannot be exceeded.
    [sbull] Information provided must be sufficient 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

[[Page 65818]]

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] Provisions relating to confidentiality, participant 
protection and the protection of human subjects specified in Section 
VIII-A of this document.
    [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 B--Glossary

    Best Practice: Best practices are practices that incorporate the 
best objective information currently available regarding 
effectiveness and acceptability.
    Catchment Area: A catchment area is the geographic area from 
which the target population to be served by a program will be drawn.
    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.
    Fidelity: Fidelity is the degree to which a specific 
implementation of a program or practice resembles, adheres to, or is 
faithful to the evidence-based model on which it is based. Fidelity 
is formally assessed using rating scales of the major elements of 
the evidence-based model. A toolkit on how to develop and use 
fidelity instruments is available from the SAMHSA-funded Evaluation 
Technical Assistance Center at http://tecathsri.org or by calling 
(617) 876-0426.
    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.
    Logic Model: A logic model is a diagrammatic representation of a 
theoretical framework. A logic model describes the logical linkages 
among program resources, conditions, strategies, short-term 
outcomes, and long-term impact. More information on how to develop 
logics models and examples can be found through the resources listed 
in Appendix C.
    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.
    Sustainability: Sustainability is the ability to continue a 
program or practice after SAMHSA grant funding has ended.
    Target Population: The target population is the specific 
population of people whom a particular program or practice is 
designed to serve or reach.
    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 C--Logic Model Resources

    Chen, W.W., Cato, B.M., & Rainford, N. (1998-9). Using a logic 
model to plan and evaluate a community intervention program: A case 
study. International Quarterly of Community Health Education, 18(4), 
449-458.
    Edwards, E.D., Seaman, J.R., Drews, J., & Edwards, M.E. (1995). 
A community approach for Native American drug and alcohol prevention 
programs: A logic model framework. Alcoholism Treatment Quarterly, 
13(2), 43-62.
    Hernandez, M. & Hodges, S. (2003). Crafting Logic Models for 
Systems of Care: Ideas into Action. [Making children's mental health 
services successful series, volume 1]. Tampa, FL: University of 
South Florida, The Louis de la Parte Florida Mental Health 
Institute, Department of Child & Family Studies, http://www.cfs.fmhi.usf.edu or phone (813) 974-4651
    Hernandez, M. & Hodges, S. (2001). Theory-based accountability. 
In M. Hernandez & S. Hodges (Eds.), Developing Outcome Strategies in 
Children's Mental Health, pp. 21-40. Baltimore: Brookes.
    Julian, D.A. (1997). Utilization of the logic model as a system 
level planning and evaluation device. Evaluation and Planning, 
20(3), 251-257.
    Julian, D.A., Jones, A., & Deyo, D. (1995). Open systems 
evaluation and the logic model: Program planning and evaluation 
tools. Evaluation and Program Planning, 18(4), 333-341.
    Patton, M.Q. (1997). Utilization-Focused Evaluation (3rd Ed.), 
pp. 19, 22, 241. Thousand Oaks, CA: Sage.
    Wholey, J.S., Hatry, H.P., Newcome, K.E. (Eds.) (1994). Handbook 
of Practical Program Evaluation. San Francisco, CA: Jossey-Bass Inc.

    Dated: November 13, 2003.
Daryl Kade,
Director, Office of Policy, Planning and Budget, Substance Abuse and 
Mental Health Services Administration.

[FR Doc. 03-28877 Filed 11-20-03; 8:45 am]
BILLING CODE 4162-20-P