Department of Health and Human Services

Substance Abuse and Mental Health Services Administration

**Opioid Treatment Program Accreditation Grants**

**Short Title: Accreditation of OTPs**

**\
(Initial Announcement)**

**Request for Applications (RFA) No. TI-08-008**

**Catalogue of Federal Domestic Assistance (CFDA) No**.: 93.243

**Key Dates:**

  ----------------------- -----------------------------------------------
  **Application           **Applications are due by January 8, 2008**
  Deadline**              

  ----------------------- -----------------------------------------------

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

H. Westley Clark, M.D., J.D., M.P.H. Terry L. Cline, Ph.D.

Director Administrator

Center for Substance Abuse Treatment Substance Abuse and Mental Health

Substance Abuse and Mental Health Services Administration

Services Administration

**Table of Contents**

[I. FUNDING OPPORTUNITY DESCRIPTION 4](#funding-opportunity-description)

[1. INTRODUCTION 4](#introduction)

[2. EXPECTATIONS 4](#expectations)

[II. AWARD INFORMATION 7](#ii.-award-information)

[1. AWARD AMOUNT 7](#award-amount)

[2. FUNDING MECHANISM 8](#funding-mechanism)

[III. ELIGIBILITY INFORMATION 8](#eligibility-information)

[1. ELIGIBLE APPLICANTS 8](#eligible-applicants)

[2. COST SHARING and MATCH REQUIREMENTS
8](#cost-sharing-and-match-requirements)

[3. OTHER 8](#other)

[IV. APPLICATION AND SUBMISSION INFORMATION
9](#application-and-submission-information)

[1. ADDRESS TO REQUEST APPLICATION PACKAGE
9](#address-to-request-application-package)

[2. CONTENT AND FORM OF APPLICATION SUBMISSION
9](#content-and-form-of-application-submission)

[3. SUBMISSION DATES AND TIMES 11](#submission-dates-and-times)

[4. INTERGOVERNMENTAL REVIEW (E.O. 12372) REQUIREMENTS
12](#intergovernmental-review-e.o.-12372-requirements)

[5. FUNDING LIMITATIONS/RESTRICTIONS
12](#funding-limitationsrestrictions)

[6. OTHER SUBMISSION REQUIREMENTS 13](#other-submission-requirements)

[V. APPLICATION REVIEW INFORMATION 14](#application-review-information)

[1. EVALUATION CRITERIA 14](#evaluation-criteria)

[2. REVIEW AND SELECTION PROCESS 19](#review-and-selection-process)

[VI. ADMINISTRATION INFORMATION 19](#administration-information)

[1. AWARD NOTICES 19](#award-notices)

[2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS
19](#administrative-and-national-policy-requirements)

[3. REPORTING REQUIREMENTS 20](#reporting-requirements)

[VII. AGENCY CONTACTS 21](#agency-contacts)

[Appendix A -- Checklist for Formatting Requirements and Screenout
Criteria for SAMHSA Grant Applications
23](#appendix-a-checklist-for-formatting-requirements-and-screenout-criteria-for-samhsa-grant-applications)

[Appendix B -- Guidance for Electronic Submission of Applications
25](#appendix-b-guidance-for-electronic-submission-of-applications)

[Appendix C -- Confidentiality and Participant Protection
28](#appendix-c-confidentiality-and-participant-protection)

[Appendix D -- Funding Restrictions
32](#appendix-d-funding-restrictions)

[Appendix E -- Sample Budget and Justification
34](#appendix-e-sample-budget-and-justification)

**Executive Summary:**

# The Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment (CSAT) is accepting applications for fiscal year (FY) 2008 for Opioid Treatment Program (OTP) Accreditation grants. The purpose of this program is to reduce the costs of basic accreditation education and accreditation/reaccreditation surveys (site visits) for OTPs participating in the accreditation process pursuant to Title 42 of the Code of Federal Regulations Part 8 (42 CFR Part 8). A copy of 42 CFR Part 8 is available at [**http://www.dpt.samhsa.gov/pdf/regs.pdf**](http://www.dpt.samhsa.gov/pdf/regs.pdf). CSAT is announcing the OTP Accreditation Program for a final cycle of 3 years. {#the-substance-abuse-and-mental-health-services-administration-center-for-substance-abuse-treatment-csat-is-accepting-applications-for-fiscal-year-fy-2008-for-opioid-treatment-program-otp-accreditation-grants.-the-purpose-of-this-program-is-to-reduce-the-costs-of-basic-accreditation-education-and-accreditationreaccreditation-surveys-site-visits-for-otps-participating-in-the-accreditation-process-pursuant-to-title-42-of-the-code-of-federal-regulations-part-8-42-cfr-part-8.-a-copy-of-42-cfr-part-8-is-available-at-httpwww.dpt.samhsa.govpdfregs.pdf.-csat-is-announcing-the-otp-accreditation-program-for-a-final-cycle-of-3-years. .unnumbered}

#   {#section .unnumbered}

**Funding Opportunity Title:** OTP Accreditation Grants

**Funding Opportunity Number:** TI-08-008

**Due Date for Applications:** January 8, 2008

**Anticipated Total Available Funding:** \$1 million

**Estimated Number of Awards:** 6

**Estimated Award Amount:** \$7,500-\$500,000

**Length of Project Period:** Up to 3 years

**Eligible Applicants:** Eligibility is limited to SAMHSA-approved
accreditation bodies: CARF, the Rehabilitation Accreditation Commission;
the Council on Accreditation; the Joint Commission on Accreditation of
Healthcare Organizations; the Division of Alcohol and Substance Abuse,
Washington Department of Social and Health Services; the Division of
Alcohol and Drug Abuse, State of Missouri; and the National Commission
on Correctional Health Care.

# FUNDING OPPORTUNITY DESCRIPTION

## INTRODUCTION

The Substance Abuse and Mental Health Services Administration, Center
for Substance Abuse Treatment (CSAT) is accepting applications for
fiscal year (FY) 2008 for Opioid Treatment Program (OTP) Accreditation
grants. The purpose of this program is to reduce the costs of basic
accreditation education and accreditation/reaccreditation surveys (site
visits) for OTPs participating in the accreditation process pursuant to
Title 42 of the Code of Federal Regulations Part 8 (42 CFR Part 8). A
copy of 42 CFR Part 8 is available at
<http://www.dpt.samhsa.gov/pdf/regs.pdf>. CSAT is announcing the OTP
Accreditation Program for a final cycle of 3 years.

[]{.mark}

This grant program was introduced to assist OTPs in transitioning to the
new accreditation process. It was important for SAMHSA to assist in the
transition to accreditation to ensure continuity of OTP operations and
prevent instability in the provision of treatment services, to improve
the quality of treatment in opioid treatment programs and to ensure that
OTPs meet minimum standards of care. The current OTP Accreditation Grant
Program, which expires March 2008, has provided funding for six grantees
to conduct a second round of accreditation surveys for approximately
1167 OTPs.

The OTP Accreditation Grant Program was never intended to become
permanent. Now that the vast majority of the OTPs have been
reaccredited, CSAT believes it is time to phase out the program.

During this cycle, the support available to defray the costs of basic
accreditation education and accreditation surveys will be reduced by
about 50 percent from the level available under previous cycles of the
program. This final grant cycle will allow OTPs to prepare to assume the
full costs of accreditation after the program ends.

## 2. EXPECTATIONS {#expectations .unnumbered}

OTPs are required to attain accreditation as a part of the process of
SAMHSA certification. Certification is the process by which SAMHSA
determines that an OTP is qualified to provide opioid treatment under
the Federal opioid treatment standards established by the Secretary of
Health and Human Services. In order to maintain a full and current
certification from SAMHSA, an OTP must:

-   Meet Federal opioid treatment standards found in 42 CFR Part 8.12;

-   Have been awarded an initial accreditation and subsequent
    reaccreditations (at least every 3 years) by a SAMHSA-approved
    accreditation body; and

-   Comply with any other conditions for certification established by
    SAMHSA.

Grantees will be SAMHSA-approved accreditation bodies and will be
expected to:

-   Prepare OTPs for accreditation through education;

-   Conduct accreditation/reaccreditation surveys using a peer review
    process;

-   Report accreditation/reaccreditation survey findings to OTPs and to
    SAMHSA. Use these survey findings for constructive feedback to OTPs;

-   Follow-up to ensure corrective action has been taken to optimize
    program functioning and treatment processes and to improve patient
    outcomes for the targeted population, that is, persons addicted to
    opiates;

-   Conduct \"for cause\" surveys of OTPs at the request of SAMHSA. "For
    cause" surveys are required to follow up on allegations of
    regulatory noncompliance or a pattern of complaints about an OTP.

A copy of the updated CSAT Guidelines for the Accreditation of Opioid
Treatment Programs can be downloaded from
<http://dpt.samhsa.gov/pdf/OTPAccredGuidelines-2007.pdf>.

Goals for this program include maintaining accreditation in over 1100
OTPs nationwide. Accreditation provides OTPs with the opportunity to
establish or improve methods of continuous quality improvement and to
underscore best practices in the field of opioid treatment. In addition,
accreditation is focused on improving OTP administration and management,
which presently varies widely. Other goals include increasing staff
retention; providing significantly more opportunities for OTP staff
training; making comprehensive services more available; making emergency
services more available; increasing patient access to treatment, and
improving positive patient outcomes. Being approved by a nationally
recognized accreditation organization will give increased credibility to
programs, remove some of the stigma frequently associated with this
treatment modality, and make OTPs a part of the mainstream health care
system.

1.  **Data Collection and Performance Measurement**

All SAMHSA grantees are required to collect and report certain data so
that SAMHSA can meet its obligations under the Government Performance
and Results Act (GPRA).  This information will be gathered using the
data collection tool referenced below.

You must document your ability to collect and report the required data
in "Section D: Performance Assessment and Data" of your application.  
Grantees must collect and report data using the **CSAT Training Baseline
and Follow-up GPRA forms**, which can be found at
[www.samhsa-gpra.samhsa.gov](http://www.samhsa-gpra.samhsa.gov/), along
with instructions for completing it.  Hard copies are available by
calling the SAMHSA Information Line at 1-877-SAMHSA7 \[TDD:
1-800-487-4889\].

 

The following GPRA measures have been established for this program:

-   Number of OTPs that have submitted applications for surveys;

-   Number of OTPs receiving accreditation surveys/site visits with
    assistance from this grant;

-   Results of each OTP accreditation survey supported by this grant;
    and

-   Percentage of OTP sponsors or directors satisfied with the
    accreditation process.

(Note: This information on satisfaction with the accreditation process
will be collected from ongoing assessments developed and conducted
independently by grantee organizations as a usual and customary part of
the accreditation process.)

In addition to these measures, grantees will be expected to collect and
report GPRA baseline (end of event) data and 30-day follow-up to the
event (with a minimum 80% of all baseline participants followed up) on
all participants at training events. Data are to be collected using the
CSAT Training Baseline and Follow-up GPRA forms and submitted using the
Web-based CSAT GPRA data collection system (SAIS) within 7 days after
data is collected.

Training and technical assistance on data collecting, tracking and
follow-up as well as data entry, will be provided by CSAT.

GPRA data will be reported to the public, the Office of Management and
Budget (OMB) and Congress as part of SAMHSA's budget request.

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.

######## **2.2 Performance Assessment** {#performance-assessment .unnumbered}

Grantees must assess their projects, addressing the performance measures
described in Section I-2.1. The assessment should be designed to help
you determine whether you are achieving the goals, objectives and
outcomes you intend to achieve and whether adjustments need to be made
to your project. You will be required to report on your progress
achieved, barriers encountered, and efforts to overcome these barriers
in a performance assessment report to be submitted at least annually.

In addition to assessing progress against the performance measures
required for this program, your performance assessment must also
consider outcome and process questions, such as the following:

*Outcome Questions:*

-   What was the effect of intervention on participants?

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-   What program/contextual factors were associated with outcomes?

-   What individual factors were associated with outcomes?

-   How durable were the effects?

*Process Questions*:

-   How closely did implementation match the plan?

-   What types of deviation from the plan occurred?

-   What led to the deviations?

-   What effect did the deviations have on the planned intervention and
    performance assessment?

-   Who provided (program staff) what services (modality, type,
    intensity, duration), to whom (individual characteristics), in what
    context (system, community), and at what cost (facilities,
    personnel, dollars)?

**No more than 5% of the total grant award may be used for data
collection, performance measurement, and performance assessment, e.g.,
activities required in Sections I-2.1 and 2.2 above.**

######## **2.3 Grantee Meetings** {#grantee-meetings .unnumbered}

Your Project Director must plan to participate in two joint grantee
meetings per year, 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 up to two days, and attendance is mandatory. One meeting
will usually be held in the Washington, D.C., area. The second meeting
will be held in connection with another appropriate national meeting
such as the American Association for Treatment of Opioid Dependence
Conference.

# II. AWARD INFORMATION {#ii.-award-information .unnumbered}

## 1. AWARD AMOUNT  {#award-amount .unnumbered}

**Funding Mechanism:** Grant

**Anticipated Total Available Funding:** \$1,000,000

**Estimated Number of Awards:** Up to 6

**Estimated Award Amount:** \$7,500 to \$500,000 per year

**Length of Project Period:** Up to 3 years

The amount of an individual award is expected to range between \$7,500
and \$500,000 in total costs (direct and indirect) in any year of the
proposed project. The maximum allowable annual award is \$500,000 in
total costs. The amount of an award will be determined by an estimate of
the number of OTPs the grantee is expected to accredit/reaccredit. For
example, SAMHSA-approved accreditation bodies that are State
organizations will accredit only OTPs in their State. These currently
total less than 20 OTPs. Other accrediting body applicants will estimate
the number of OTPs already planned for or expected to apply for
accreditation or reaccreditation in their grant applications. During
each triennial accreditation cycle, OTPs are permitted to change
accreditation bodies in some circumstances. Award amounts will be
determined based on the information provided in the application and an
equitable distribution will be determined during the award
decision-making process.

When preparing your budget, you must adhere to the following
guidelines/limitations:

\- Basic OTP accreditation and reaccreditation education is limited to
\$500 or less per OTP.

\- The actual cost of conducting site visits for accreditation,
reaccreditation, monitoring purposes or \"for-cause\" visits is limited
to \$2,000 or less per site visit.

**Proposed budgets cannot exceed the allowable amount in any year of the
proposed project**.

Annual continuation awards will depend on the availability of funds,
grantee progress in meeting program goals and objectives, timely
submission of required data and reports, and compliance with all terms
and conditions of award.

**This program is being announced prior to the annual appropriation for
FY 2008 for SAMHSA\'s programs, with funding estimates based on the
President\'s budget request for FY 2008. Applications are invited based
on the assumption that sufficient funds will be appropriated for FY 2008
to permit funding of a reasonable number of applications hereby
solicited. All applicants are reminded, however, that we cannot
guarantee that sufficient funds will be appropriated to permit SAMHSA to
fund any applications.**

## 2. FUNDING MECHANISM {#funding-mechanism .unnumbered}

Awards for this funding opportunity will be made as grants.

# ELIGIBILITY INFORMATION

## ELIGIBLE APPLICANTS

Only SAMHSA approved accreditation bodies are eligible applicants. This
is because under Federal regulation, "The Final Rule on Opioid Drugs in
Maintenance and Detoxification Treatment of Opiate Addiction" (42 CFR
Part 8), private nonprofit organizations or State governmental agencies,
or political subdivisions thereof, must be approved by SAMHSA in order
to conduct accreditation processes and site visits with OTPs. Therefore,
grant applications from organizations that have not met the regulatory
requirements, i.e., have not been approved by SAMHSA as an accreditation
body, will not be considered for an award. At present, the only six
eligible applicants are the following SAMHSA-approved accreditation
bodies: CARF, The Rehabilitation Accreditation Commission; the Council
on Accreditation; the Joint Commission on Accreditation of Healthcare
Organizations; the Division of Alcohol and Substance Abuse, Washington
Department of Social and Health Services; the Division of Alcohol and
Drug Abuse, State of Missouri; and the National Commission on
Correctional Health Care.

## COST SHARING and MATCH REQUIREMENTS

Cost sharing/match are not required in this program. []{.mark}

## OTHER

**You must comply with the following requirements, or your application
will be screened out and will not be reviewed:** use of the PHS 5161-1
application form; application submission requirements in Section IV-3 of
this document; and formatting requirements provided in Appendix A of
this document.

# APPLICATION AND SUBMISSION INFORMATION 

## ADDRESS TO REQUEST APPLICATION PACKAGE 

You may request a complete application kit from the SAMHSA Information
Line at 1-877-SAMHSA7 \[TDD: 1-800-487-4889\].

You also may download the required documents from the SAMHSA Web site at
[www.samhsa.gov/grants/apply.aspx](http://www.samhsa.gov/grants/apply.aspx)

Additional materials available on this Web site include:

-   a grant writing technical assistance manual for potential
    applicants;

-   standard terms and conditions for SAMHSA grants;

-   guidelines and policies that relate to SAMHSA grants (e.g.,
    guidelines on cultural competence, consumer and family
    participation, and evaluation); and

-   a list of certifications and assurances referenced in item 21 of the
    SF 424 v2.

## CONTENT AND FORM OF APPLICATION SUBMISSION

1.  **Application Kit**

SAMHSA application kits include the following documents:

-   PHS 5161-1 (revised July 2000) -- Includes the face page (SF 424
    v2), budget forms, assurances, certification, and checklist. You
    must use the PHS 5161-1. **Applications that are not submitted on
    the required application form will be screened out and will not be
    reviewed.**

-   Request for Applications (RFA) -- Provides a description of the
    program, specific information about the availability of funds, and
    instructions for completing the grant application. This document is
    the RFA. The RFA will be available on the SAMHSA Web site
    ([[www.samhsa.gov/grants/index.aspx]{.underline}](../www.samhsa.gov/grants/index.aspx))
    and a synopsis of the RFA is available on the Federal grants Web
    site ([www.Grants.gov](http://www.Grants.gov/)).

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

1.  **Required Application Components**

Applications 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).

-   **Face Page --** SF 424 v2 is the face page. This form is part of
    the PHS 5161-1. \[Note: Applicants must provide a Dun and Bradstreet
    (DUNS) number to apply for a grant or cooperative agreement from the
    Federal Government. SAMHSA applicants are required to provide their
    DUNS number on the face page of the application. Obtaining a DUNS
    number is easy and there is no charge. To obtain a DUNS number,
    access the Dun and Bradstreet Web site at
    [www.dunandbradstreet.com](http://www.dunandbradstreet.com/) or call
    1-866-705-5711. To expedite the process, let Dun and Bradstreet know
    that you are a public/private nonprofit organization getting ready
    to submit a Federal grant application.\]

-   **Abstract** -- Your total abstract should not be longer than 35
    lines. It should include the project name, population to be served
    (demographics and clinical characteristics),
    strategies/interventions, project goals and measurable objectives,
    including the number of people to be served annually and throughout
    the lifetime of the project, etc. In the first five lines or less of
    your abstract, write a summary of your project that can be used, if
    your project is funded, in publications, reporting to Congress, or
    press releases.

-   **Table of Contents** -- Include page numbers for each of the major
    sections of your application and for each appendix.

-   **Budget Form** -- Use SF 424A, which is part of the PHS 5161-1.
    Fill out Sections B, C, and E of the SF 424A. A sample budget and
    justification is included in Appendix E of this document.

-   **Project Narrative and Supporting Documentation** -- The Project
    Narrative describes your project. It consists of Sections A
    through D. Sections A-D together may not be longer than 30 pages.
    (Remember that if your Project Narrative starts on page 5 and ends
    on page 35, it is 31 pages long, not 30 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 G, Biographical Sketches/Job
    Descriptions. Additional instructions for completing these sections
    are included in Section V under "Supporting Documentation."
    Supporting documentation should be submitted in black and white (no
    color).

####### Appendices 1 through 3 -- Use only the appendices listed below. If your application includes any appendices not required in this document, they will be disregarded. Do not use more than a total of 30 pages for Appendices 1 and 2 combined. There is no page limitation for Appendix 3. Do not use appendices to extend or replace any of the sections of the Project Narrative. Reviewers will not consider them if you do.

-   *Appendix 1*: Data Collection Instruments/Interview Protocols

-   *Appendix 2*: Sample Consent Forms

-   *Appendix 3*: Copy of your Accreditation Standards Manual, including
    OTP standards

> []{.mark}

-   **Assurances** -- Non-Construction Programs. You must read the list
    of assurances provided on the SAMHSA Web site or in the application
    kit before signing the face page (SF 424 v2) of the application.

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-   **Certifications** -- You must read the list of certifications
    provided on the SAMHSA Web site or in the application kit before
    signing the face page (SF 424 v2) of the application.

-   **Disclosure of Lobbying Activities** -- You must submit Standard
    Form 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. If no lobbying is to be disclosed, mark
    N/A on the form.

-   **Checklist** -- Use the Checklist found in PHS 5161-1. The
    Checklist ensures that you have obtained the proper signatures,
    assurances and certifications. If you are submitting a paper
    application, the Checklist should be the last page.

2.3 Application Formatting Requirements

**Please refer to Appendix A, *Checklist for Formatting Requirements and
Screenout Criteria for SAMHSA Grant Applications*, for SAMHSA's basic
application formatting requirements. Applications that do not comply
with these requirements will be screened out and will not be reviewed.**

## SUBMISSION DATES AND TIMES 

Applications are due by close of business on **January 8, 2008**. Hard
copy applications are due by 5:00 PM (EST). Electronic applications are
due by 12:00 midnight (EST). **Hand carried applications will not be
accepted. Applications may be shipped using only DHL, Federal Express
(FedEx), United Parcel Service (UPS), or the United States Postal
Service (USPS).**

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

**Your application must be received by the application deadline or it
will not be considered for review.** Please remember that mail sent to
Federal facilities undergoes a security screening prior to delivery. You
are responsible for ensuring that you submit your application so that it
will arrive by the application due date and time.

If an application is mailed to a location or office (including room
number) that is not designated for receipt of the application and, as a
result, the designated office does not receive your application by the
deadline, your application will be considered late and ineligible for
review.

SAMHSA will not accept or consider any applications sent by facsimile.

SAMHSA accepts electronic submission of applications through
[www.Grants.gov](http://www.Grants.gov/). Please refer to Appendix B for
"Guidance for Electronic Submission of Applications."

## INTERGOVERNMENTAL REVIEW (E.O. 12372) REQUIREMENTS

The purpose of the "Accreditation of OTPs" program is to partially
subsidize the cost of the accreditation of opioid treatment programs.
Grants are intended to reduce the costs of basic accreditation education
and accreditation/reaccreditation surveys (site visits) for OTPs
participating in the accreditation process pursuant to Title 42 of the
Code of Federal Regulations Part 8 (42 CFR Part 8). None of the six
eligible applicants (i.e., SAMHSA-approved

Accreditation bodies pursuant to 42 CRF Part 8) will be providing direct
substance abuse treatment services and four of the six will be
performing accreditation surveys at opioid treatment programs throughout
the U.S. Therefore, the Public Health System Impact Statement (PHSIS)
reporting requirements are not applicable. The Intergovernmental Review
(E.O. 12372) requirement for applicants serving more than one State to
contact the Single Point of Contact of each affiliated State would be an
overly burdensome reporting requirement for the four eligible entities
serving OTPs in multiple States, and is, therefore, not required for the
"Accreditation of OTPs" program.

## FUNDING LIMITATIONS/RESTRICTIONS

Cost principles describing allowable and unallowable expenditures for
Federal grantees, including SAMHSA grantees, are provided in the
following documents, which are available at
[www.samhsa.gov/grants/management.aspx](http://www.samhsa.gov/grants/management.aspx):

-   Institutions of Higher Education: OMB Circular A-21

-   State and Local Governments and Federally Recognized Indian Tribal
    Governments: OMB Circular A-87

-   Nonprofit Organizations: OMB Circular A-122

-   Hospitals: 45 CFR Part 74, Appendix E

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

-   Grant funds must not be used for any purposes except
    accreditation/reaccreditation education, the
    accreditation/reaccreditation surveys or "for cause" surveys at the
    request of SAMHSA.

-   Grant funds may not be used to subsidize the accreditation survey
    process for OTPs operated by the Department of Veterans Affairs or
    by other Federal agencies.

    []{.mark}

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-   No more than 5% of the grant award may be used for evaluation and
    data collection expenses.

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-   Grant funds may not be used to pay for the purchase or construction
    of any building or structure to house any part of the grant project.

**SAMHSA grantees must also comply with SAMHSA's standard funding
restrictions, which are included in** **Appendix D**.

## OTHER SUBMISSION REQUIREMENTS

You may submit your application in either electronic or paper format:

**[Submission of Electronic Applications]{.underline}**

SAMHSA accepts electronic submission of applications through
[www.Grants.gov](http://www.Grants.gov/). Electronic submission is
voluntary. No review points will be added or deducted, regardless of
whether you use the electronic or paper format.

To submit an application electronically, you must use the
[www.Grants.gov](http://www.Grants.gov/) apply site. You will be able to
download a copy of the application package from
[www.Grants.gov](http://www.Grants.gov/), complete it off-line, and then
upload and submit the application via the Grants.gov site. E-mail
submissions will not be accepted.

**Please refer to Appendix B for detailed instructions on submitting
your application electronically.**

**[Submission of Paper Applications]{.underline}**

You must submit an original application and 2 copies (including
appendices). The original and copies must not be bound. Do not use
staples, paper clips, or fasteners. Nothing should be attached, stapled,
folded, or pasted.

Send applications to the address below:

**For United States Postal Service:**

> Crystal Saunders, Director of Grant Review
>
> Office of Program Services
>
> Substance Abuse and Mental Health Services Administration
>
> Room 3-1044
>
> 1 Choke Cherry Road
>
> Rockville, MD **20857**

Change the zip code to **20850** if you are using another delivery
service.

Do not send applications to other agency contacts, as this could delay
receipt. Be sure to include "**Accreditation of** **OTPs -- TI-08-008**"
in item number 12 on the face page (SF 424 v2) of any paper
applications. If you require a phone number for delivery, you may use
(240) 276-1199.

**Hand carried applications will not be accepted. Applications may be
shipped using only DHL, Federal Express (FedEx), United Parcel Service
(UPS), or the United States Postal Service (USPS).**

**SAMHSA will not accept or consider any applications sent by
facsimile.**

# APPLICATION REVIEW INFORMATION

##  {#section-1 .unnumbered}

## EVALUATION CRITERIA

The Project Narrative describes what you intend to do with your project
and includes the Evaluation Criteria in Sections A-D below. Your
application will be reviewed and scored according to the
[quality]{.underline} of your response to the requirements in Sections
A-D.

-   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**.

-   The Project Narrative (Sections A-D) together may be no longer than
    30 pages.

-   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 of the Project Narrative.

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-   Reviewers will be looking for evidence of cultural competence in
    each section of the Project Narrative, and will consider how well
    you address the cultural competence aspects of the evaluation
    criteria when scoring your application. SAMHSA's guidelines for
    cultural competence can be found on the SAMHSA Web site at
    [www.samhsa.gov](http://www.samhsa.gov/). Click on "Grants/Applying
    for a New SAMHSA Grant/Guidelines for Assessing Cultural
    Competence."

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-   The Supporting Documentation you provide in Sections E-G and
    Appendices 1-3 will be considered by reviewers in assessing your
    response, along with the material in the Project Narrative.

-   The number of points after each heading is the maximum number of
    points a review committee may assign to that section of your Project
    Narrative. Although scoring weights are not assigned to individual
    bullets, applicants are encouraged to respond to each bulleted
    statement.

    **Section A: Project Description: (20 points)**

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-   List your project goals and objectives and describe how they relate
    to the purpose and goals of this RFA. In particular, describe your
    goals for the provision of accreditation/reaccreditation education
    and the accreditation/reaccreditation surveys. For example, to whom
    will you provide the accreditation/reaccreditation education and
    what will be the intended outcomes of that education? How will
    reaccredidation training differ from accreditation training? How
    many accreditation/reaccreditation surveys do you anticipate
    conducting during the 3-year project period? What is your time frame
    for initiating and completing the anticipated
    accreditation/reaccreditation surveys?

-   Discuss the functions and roles that your proposed project will
    require your organization to develop and your approach to the
    challenges and obstacles involved in these efforts.

-   Discuss your experience to date doing accreditation/reaccreditation
    surveys and education including problems and their resolutions as
    well as lessons learned.

-   Provide an estimate of the usual, average charges billed for an
    accreditation/reaccreditation survey of an OTP, and the incremental
    increase for accreditation as an OTP when part of a broader
    accreditation survey. Identify any cash and in-kind contributions
    that will be made to the project.

**Section B: Proposed Approach (35 points)**

-   Describe the processes, activities, methodologies, and approaches
    that will achieve project goals and objectives.

-   Describe the OTP educational activities to be conducted to prepare
    OTPs for accreditation and reaccreditation.

-   Describe how required activities and reporting requirements will be
    carried out.

-   Describe examples of problems that may occur and strategies for
    overcoming them. []{.mark}SAMHSA is particularly interested in
    learning about your organization's strategies for educating and
    preparing for accreditation those OTPs which have severe quality
    problems or which are particularly resistant to adhering to
    accreditation standards.

-   Describe how the accreditation body will use approaches that are
    culturally appropriate and competent in addressing age, culture,
    race/ethnicity, language, sexual orientation, gender, and disability
    issues.

**Section C: Staff, Management, and Relevant Experience (30 points)**

-   Describe the project director's experience and qualifications in the
    fields of opioid

treatment, continuous quality improvement, and accreditation.

-   Describe the specific expertise of key personnel in
    medication-assisted treatment and in the development of
    accreditation standards.

-   Describe the experience of key personnel in management,
    administration, accreditation technical assistance, meeting
    planning, and automated data processing, which make them qualified
    to carry out project tasks.

-   Justify proposed time commitments of key personnel.

-   Describe the feasibility of accomplishing the project in terms
    of (1) time frame, (2) availability of resources (e.g., facilities
    and ability to schedule, carry out accreditation/reaccreditation
    site visits, and analyze their results), and (3) management plan.

-   Discuss the capability and experience of the applicant organization
    with similar projects.

-   Describe the project management plan, with a time line for tasks and
    staffing pattern for staff.

-   Discuss your organization's capability to obtain and maintain a
    sufficient number of staff and surveyors to complete the project.

    -   Provide evidence that your organization's facilities include
        adequate office space, meeting rooms, and equipment (such as
        personal computers, automated data processing capability,
        photocopying equipment, and FAX machines) to accomplish project
        goals.

**Section D: Performance Assessment and Data (15 points)**

-   Document your ability to collect and report on the required
    performance measures as specified in Section I-2.1 of this RFA.
    Describe your plan for data collection, management, analysis and
    reporting. Specify and justify any additional measures or
    instruments you plan to use for your grant project.

    -   Describe how data will be used to manage the project and assure
        continuous quality

improvement.

-   Describe your plan for conducting the performance assessment as
    specified in

Section I**-**2.2 of this RFA and document your ability to conduct the
assessment.

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.

**SUPPORTING DOCUMENTATION**

**Section E:** Literature Citations. This section must contain complete
citations, including titles and all authors, for any literature you cite
in your application.

**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. Be sure to
show that no more than 5% of the total grant award will be used for data
collection and performance assessment. An illustration of a budget and
narrative justification is included in Appendix E of this document.

####### Section G: Biographical Sketches and Job Descriptions.  {#section-g-biographical-sketches-and-job-descriptions. .unnumbered}

####### 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 position description and/or a letter of commitment with a current biographical sketch from the individual.

####### Include job descriptions for key personnel. Job descriptions should be no longer than 1 page each.

-   Information on what should be included in biographical sketches and
    job descriptions can be found on page 22, Item 6, in the Program
    Narrative section of the PHS 5161-1 instruction page, available on
    the SAMHSA Web site.

    **Section I:** Confidentiality and SAMHSA Participant
    Protection/Human Subjects: You must describe procedures relating to
    Confidentiality, Participant Protection and the Protection of Human
    Subjects Regulations in Section I of your application, using the
    guidelines provided below.

    **[Confidentiality and Participant Protection]{.underline}:**

Because of the confidential nature of the work in which many SAMHSA
grantees are involved, it is important to have safeguards protecting
individuals from risks associated with their participation in SAMHSA
projects. All applicants must address the eight bullets below. Appendix
C of this RFA provides a more detailed discussion of issues applicants
should consider in addressing the seven bullets below. If some are not
applicable or relevant to the proposed project, simply state that they
are not applicable and indicate why. In addition to addressing these
seven bullets, read the section that follows entitled Protection of
Human Subjects Regulations to determine if the regulations may apply to
your project. If so, you are required to describe the process you will
follow for obtaining Institutional Review Board (IRB) approval. While we
encourage you to keep your responses brief, there are no page limits for
this section and no points will be assigned by the Review Committee.
Problems with confidentiality, participant protection, and the
protection of human subjects identified during peer review of the
application must be resolved prior to funding.

-   Identify foreseeable risks or adverse effects due to participation
    in the project and/or in the data collection (performance
    assessment) activities (including physical, medical, psychological,
    social, legal, and confidentiality) and provide your procedures for
    minimizing or protecting participants from these risks. Identify
    plans to provide guidance and assistance in the event there are
    adverse effects to participants.

-   Describe the target population and explain why you are including or
    excluding certain subgroups. Explain how and who will recruit and
    select participants.

-   State whether participation in the project is voluntary or required.
    If you plan to provide incentives/compensate participants, specify
    the type (e.g., money, gifts, coupons), and the value of any such
    incentives. Provide justification that the use of incentives is
    appropriate, judicious, and conservative and that incentives do not
    provide an "undue inducement" which removes the voluntary nature of
    participation. Incentives should be the minimum amount necessary to
    meet the programmatic and performance assessment goals of the grant.
    Applicants should determine the minimum amount that is proven to be
    effective by consulting with existing local programs and reviewing
    the relevant literature. In no case may the value of an incentive
    paid for with SAMHSA discretionary grant funds exceed \$20. (See
    Appendix C: Confidentiality and Participant Protection.)

-   Describe data collection procedures, including sources (e.g.,
    participants, school records) and the data collecting setting (e.g.,
    clinic, school). Provide copies of proposed data collection
    instruments and interview protocols in **Appendix 1** of your
    application, "Data Collection Instruments/Interview Protocols."
    State whether specimens such as urine and/or blood will be obtained
    and the purpose for collecting the specimens. If applicable,
    describe how the specimens and process will be monitored to ensure
    both the safety of participants and the integrity of the specimens.

-   Explain how you will ensure privacy and confidentiality of
    participants' records, data collected, interviews, and group
    discussions. Describe where the data will be stored, safeguards
    (e.g., locked, coding systems, storing identifiers separate from
    data), and who will have access to the information.

-   Describe the process for obtaining and documenting consent from
    adult participants and assent from minors along with consent from
    their parents or legal guardians. Provide copies of all consent
    forms in **Appendix 2** of your application, "Sample Consent Forms."
    If needed, give English translations.

-   Discuss why the risks are reasonable compared to expected benefits
    from the project.

    **[Protection of Human Subjects Regulations]{.underline}**

SAMHSA expects that most grantees funded under this announcement will
not have to comply with the Protection of Human Subjects Regulations (45
CFR 46), which requires Institutional Review Board (IRB) approval.
However, in some instances, the applicant's proposed performance
assessment design may meet the regulation's criteria of research
involving human subjects. For assistance in determining if your proposed
performance assessment meets the criteria in 45 CFR 46, Protection of
Human Subjects Regulations, refer to the SAMHSA decision tree on the
SAMHSA Web site, under "Applying for a New SAMHSA Grant,"
<http://www.samhsa.gov/grants/apply.aspx>.

Applicants whose projects must comply with the Human Subjects
Regulations must, in addition to the bullets above, fully describe the
process for obtaining IRB approval. While IRB approval is not required
at the time of grant award, these grantees will be required, as a
condition of award, to provide documentation that an Assurance of
Compliance is on file with the Office for Human Research Protections
(OHRP). IRB approval must be received in these cases prior to enrolling
clients in the project. General information about Human Subjects
Regulations can be obtained through OHRP at <http://www.hhs.gov/ohrp>,
or <ohrp@osophs.dhhs.gov>, or (240) 453-6900. SAMHSA--specific questions
should be directed to the program contact listed in Section VII of this
announcement.

## REVIEW AND SELECTION PROCESS

SAMHSA applications are peer-reviewed according to the evaluation
criteria listed above. For those programs where the individual award is
over \$100,000, applications also must be reviewed by the appropriate
National Advisory Council.

Decisions to fund a grant are based on:

-   the strengths and weaknesses of the application as identified by
    peer reviewers and, when applicable, approved by the Center for
    Substance Abuse Treatment's National Advisory Council; and

-   availability of funds.

# ADMINISTRATION INFORMATION

## AWARD NOTICES 

#######  {#section-2 .unnumbered}

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 through postal mail, the Notice of Grant Award, signed by
SAMHSA's Grants Management Officer. The Notice of Grant Award is the
sole obligating document that allows you to receive Federal funding for
work on the grant project.

## ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS 

-   If your application is funded, you must comply with all terms and
    conditions of the grant award. SAMHSA's standard terms and
    conditions are available on the SAMHSA Web site at
    http://[www.samhsa.gov/grants/management.asp](http://www.samhsa.gov/grants/management.aspx)x.

-   If your application is funded, you must also comply with the
    administrative requirements outlined in 45 CFR Part 74 or 45 CFR
    Part 92, as appropriate. For more information see the SAMHSA Web
    site
    (http://[www.samhsa.gov/grants/management.aspx](http://www.samhsa.gov/grants/management.aspx)).

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-   Depending on the nature of the specific funding opportunity and/or
    your proposed project as identified during review, SAMHSA may
    negotiate additional terms and conditions with you prior to grant
    award. These may include, for example:

    -   actions required to be in compliance with confidentiality and
        participant protection/human subjects requirements;

    -   requirements relating to additional data collection and
        reporting;

    -   requirements relating to participation in a cross-site
        evaluation; or

    -   requirements to address problems identified in review of the
        application.

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-   If your application is funded, 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.

-   Grant funds cannot be used to supplant current funding of existing
    activities. "Supplant" is defined as replacing funding of a
    recipient's existing program with funds from a Federal grant.

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-   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 and is posted on the SAMHSA Web site. You are
    encouraged to complete the survey and return it, using the
    instructions provided on the survey form.

## REPORTING REQUIREMENTS

In addition to the data reporting requirements listed in Section I-2.1,
you must comply with the following reporting requirements:

1.  **Progress and Financial Reports**

-   Grantees must provide quarterly, annual and final progress reports
    in electronic and hard copies. 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.

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-   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.

-   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.

    1.  **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. The performance requirements for SAMHSA's
OTP grant program are described in Section I-2.1 of this document under
"Data Collection and Performance Measurement."

2.  **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 (240-276-2130) of any materials based on the SAMHSA-funded grant
project that are accepted for publication.

In addition, SAMHSA requests that grantees:

-   Provide the GPO and SAMHSA Publications Clearance Officer with
    advance copies of publications.

-   Include acknowledgment of the SAMHSA grant program as the source of
    funding for the project.

-   Include a disclaimer stating that the views and opinions contained
    in the publication do not necessarily reflect those of SAMHSA or the
    U.S. Department of Health and Human Services, and should not be
    construed as such.

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

# AGENCY CONTACTS

For questions about program issues contact:

Alina Walizada

Center for Substance Abuse Treatment

Substance Abuse and Mental Health Services Administration

1 Choke Cherry Road

Room 2-1090

Rockville, MD 20857

\(240\) 276-2755

<alina.walizada@samhsa.hhs.gov>

For questions on grants management issues contact:

Kathleen Sample

Office of Program Services, Division of Grants Management

Substance Abuse and Mental Health Services Administration

1 Choke Cherry Road

Room 7-1089

Rockville, Maryland 20857

\(240\) 276-1407

<kathleen.sample@samhsa.hhs.gov>

### Appendix A -- Checklist for Formatting Requirements and Screenout Criteria for SAMHSA Grant Applications

*SAMHSA's goal is to review all applications submitted for grant
funding. However, this goal must be balanced against SAMHSA's obligation
to ensure equitable treatment of applications. For this reason, SAMHSA
has established certain formatting requirements for its applications.
**If you do not adhere to these requirements, your application will be
screened out and returned to you without review.***

-   Use the PHS 5161-1 application form.

-   Applications must be received by the application due date and time,
    as detailed in Section IV-3 of this grant announcement.

-   Information provided must be sufficient for review.

-   Text must be legible. Pages must be typed in black ink,
    single-spaced, using a font of Times New Roman 12, with all margins
    (left, right, top, bottom) at least one inch each. (For Project
    Narratives submitted electronically, see separate requirements in
    Section IV-6 of this announcement under "Submission of Electronic
    Applications.")

-   To ensure equity among applications, page limits for the Project
    Narrative cannot be exceeded.

-   Paper must be white paper and 8.5 inches by 11.0 inches in size.

*To facilitate review of your application, follow these additional
guidelines. Failure to adhere to the following guidelines will not, in
itself, result in your application being screened out and returned
without review. However, the information provided in your application
must be sufficient for review. Following these guidelines will help
ensure your application is complete, and will help reviewers to consider
your application.*

-   The 10 application components required for SAMHSA applications
    should be included and submitted in the following order:

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-   Face Page (Standard Form 424 v2, which is in PHS 5161-1)

-   Abstract

-   Table of Contents

-   Budget Form (Standard Form 424A, which is in PHS 5161-1)

-   Project Narrative and Supporting Documentation

-   Appendices

-   Assurances (Standard Form 424B, which is in PHS 5161-1)

-   Certifications

-   Disclosure of Lobbying Activities (Standard Form LLL, which is in
    PHS 5161-1)

-   Checklist (a form in PHS 5161-1)

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-   Applications should comply with the following requirements:

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-   Provisions relating to confidentiality and participant protection
    specified in Section V-1 of this announcement.

-   Budgetary limitations as specified in Sections I, II, and IV-5 of
    this announcement.

-   Documentation of nonprofit status as required in the PHS 5161-1.

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-   Pages should be typed single-spaced in black ink with one column per
    page. Pages should not have printing on both sides.

-   Pages should be numbered consecutively from beginning to end so that
    information can be located easily during review of the application.
    The abstract page should be page 1, the table of contents should be
    page 2, etc. The four pages of Standard form 424 v2 are not to be
    numbered. Appendices should be labeled and separated from the
    Project Narrative and budget section, and the pages should be
    numbered to continue the sequence.

-   The page limits for Appendices stated in Section IV-2.2 of this
    announcement should not be exceeded.

-   Send the original application and two copies to the mailing address
    in Section IV-6 of this document. Please do not use staples, paper
    clips, and fasteners. Nothing should be attached, stapled, folded,
    or pasted. Do not use heavy or lightweight paper or 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 -- Guidance for Electronic Submission of Applications

If you would like to submit your application electronically, you may
search [www.Grants.gov](http://www.Grants.gov/) for the downloadable
application package by the funding announcement number (called the
opportunity number) or by the Catalogue of Federal Domestic Assistance
(CFDA) number. You can find the CFDA number on the first page of the
funding announcement.

You must follow the instructions in the User Guide available at the
[www.Grants.gov](http://www.Grants.gov/) apply site, on the Help page.
In addition to the User Guide, you may wish to use the following sources
for help:

-   By e-mail: <support@Grants.gov>

-   By phone: 1-800-518-4726 (1-800-518-GRANTS). The Customer Support
    Center is open from 7:00 a.m. to 9:00 p.m. Eastern Time, Monday
    through Friday, excluding Federal holidays.

**If this is the first time you have submitted an application through
Grants.gov, you must complete four separate registration processes
before you can submit your application. Allow at least two weeks (10
business days) for these registration processes, prior to submitting
your application.** The processes are: 1) DUNS Number registration; 2)
Central Contractor Registry (CCR) registration; 3) Credential Provider
registration; and 4) Grants.gov registration.

**It is strongly recommended that you submit your grant application
using Microsoft Office products (e.g., Microsoft Word, Microsoft Excel,
etc.).** If you do not have access to Microsoft Office products, you may
submit PDF files. Directions for creating PDF files can be found on the
Grants.gov Web site. Use of file formats other than Microsoft Office or
PDF may result in your file being unreadable by our staff.

The Project Narrative must be a separate document in the electronic
submission. Formatting requirements for SAMHSA grant applications are
described in Appendix A of this announcement. These requirements also
apply to applications submitted electronically, with the following
exceptions only for Project Narratives submitted electronically in
Microsoft Word. These requirements help ensure the accurate transmission
and equitable treatment of applications.

-   *Text legibility*: Use a font of Times New Roman 12, line spacing of
    single space, and all margins (left, right, top, bottom) of at least
    one inch each. Adhering to these standards will help to ensure the
    accurate transmission of your document.

-   *Amount of space allowed for Project Narrative*: The Project
    Narrative for an electronic submission may not exceed **15,450**
    words. **If the Project Narrative for an electronic submission
    exceeds the word limit, the application will be screened out and
    will not be reviewed**. To determine the number of words in your
    Project Narrative document in Microsoft Word, select
    file/properties/statistics.

**Keep the Project Narrative as a separate document. Please consolidate
all other materials in your application to ensure the fewest possible
number of attachments. Be sure to label each file according to its
contents, e.g., "Appendices 1-3", "Appendices 4-5." **

Ensure all pages in your application are numbered consecutively, with
the exception of the standard forms in the PHS-5161 application package.
**Documents containing scanned images must also contain page numbers to
continue the sequence.** Failure to comply with these requirements may
affect the successful transmission and consideration of your
application.

Applicants are strongly encouraged to submit their applications to
Grants.gov early enough to resolve any unanticipated difficulties prior
to the deadline. You may also submit a back-up paper submission of your
application. Any such paper submission must be received in accordance
with the requirements for timely submission detailed in Section IV-3 of
this announcement. The paper submission must be clearly marked:
**"Back-up for electronic submission."** The paper submission must
conform with all requirements for non-electronic submissions. If both
electronic and back-up paper submissions are received by the deadline,
the electronic version will be considered the official submission.

After you electronically submit your application, you will receive an
automatic acknowledgement from Grants.gov that contains a Grants.gov
tracking number. It is important that you retain this number. **Include
the Grants.gov tracking number in the top right corner of the face page
(SF 424 v2) for any paper submission. Receipt of the tracking number is
the only indication that Grants.gov has successfully received and
validated your application. If you do not receive a Grants.gov tracking
number, you may want to contact the Grants.gov help desk for
assistance.**

The Grants.gov Web site does not accept electronic signatures at this
time. Therefore, you must submit a signed paper original of the face
page (SF 424 v2), the assurances (SF 424B), and hard copy of any other
required documentation that cannot be submitted electronically. **You
must include the Grants.gov tracking number for your application on
these documents with original signatures, on the top right corner of the
face page, and send the documents to the following address. The
documents must be received at the following address within 5 business
days after your electronic submission.** Delays in receipt of these
documents may impact the score your application receives or the ability
of your application to be funded.

**For United States Postal Service:**

Crystal Saunders, Director of Grant Review

Office of Program Services

Substance Abuse and Mental Health Services Administration

Room 3-1044

1 Choke Cherry Road

Rockville, MD **20857**

ATTN: Electronic Applications

**For other delivery services, change the zip code to 20850.**

If you require a phone number for delivery, you may use (240) 276-1199.

###  Appendix C -- Confidentiality and Participant Protection 

### 

1.  [Protect Clients and Staff from Potential Risks]{.underline}

-   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.

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-   Describe the procedures you will follow to minimize or protect
    participants against potential risks, **including risks to
    confidentiality**.

-   Identify plans to provide guidance and assistance in the event there
    are adverse effects to participants.

-   Where appropriate, describe alternative treatments and procedures
    that may be beneficial to the participants. If you choose not to use
    these other beneficial treatments, provide the reasons for not using
    them.

2.  [Fair Selection of Participants]{.underline}

-   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.

-   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.

-   Explain the reasons for [including or excluding]{.underline}
    participants.

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-   Explain how you will recruit and select participants. Identify who
    will select participants.

3.  [Absence of Coercion]{.underline}

-   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.

-   If you plan to compensate participants, state how participants will
    be awarded incentives (e.g., money, gifts, etc.). Provide
    justification that the use of incentives is appropriate, judicious,
    and conservative and that incentives do not provide an "undue
    inducement" which removes the voluntary nature of participation.
    Incentives should be the minimum amount necessary to meet the
    programmatic and performance assessment goals of the grant.
    Applicants should determine the minimum amount that is proven
    effective by consulting with existing local programs and reviewing
    the relevant literature. In no case may the value if an incentive
    paid for with SAMHSA discretionary grant funds exceed \$20.

-   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]{.underline}

-   Identify from whom you will collect data (e.g., from participants
    themselves, family members, teachers, others). Describe the data
    collection procedures and specify the sources for obtaining data
    (e.g., school records, interviews, psychological assessments,
    questionnaires, observation, or other sources). Where data are to be
    collected through observational techniques, questionnaires,
    interviews, or other direct means, describe the data collection
    setting.

-   Identify what type of specimens (e.g., urine, blood) will be used,
    if any. State if the material will be used just for evaluation or if
    other use(s) will be made. Also, if needed, describe how the
    material will be monitored to ensure the safety of participants.

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-   Provide in **Appendix 1, "Data Collection Instruments/Interview
    Protocols,"** copies of [all]{.underline} available data collection
    instruments and interview protocols that you plan to use.

5.  [Privacy and Confidentiality]{.underline}

-   Explain how you will ensure privacy and confidentiality. Include who
    will collect data and how it will be collected.

-   Describe:

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-   How you will use data collection instruments.

-   Where data will be stored.

-   Who will or will not have access to information.

-   How the identity of participants will be kept private, for example,
    through the use of a coding system on data records, limiting access
    to records, or storing identifiers separately from data.

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

6.  [Adequate Consent Procedures]{.underline}

-   List what information will be given to people who participate in the
    project. Include the type and purpose of their participation.
    Identify the data that will be collected, how the data will be used
    and how you will keep the data private.

-   State:

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-   Whether or not their participation is voluntary.

-   Their right to leave the project at any time without problems.

-   Possible risks from participation in the project.

-   Plans to protect clients from these risks.

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-   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]{.underline} informed consent.

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-   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?

-   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 2, "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.

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-   Describe if separate consents will be obtained for different stages
    or parts of the project. For example, will they be needed for both
    participant protection in treatment intervention and for the
    collection and use of data?

-   Additionally, if other consents (e.g., consents to release
    information to others or gather information from others) will be
    used in your project, provide a description of the consents. Will
    individuals who do not consent to having individually identifiable
    data collected for evaluation purposes be allowed to participate in
    the project?

7.  [Risk/Benefit Discussion]{.underline}

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

    **[Protection of Human Subjects Regulations]{.underline}**

Applicants may also have to comply with the Protection of Human Subjects
Regulations (45 CFR 46), depending on the evaluation and data collection
procedures proposed and the population to be served.

Applicants must be aware that even if the Protection of Human Subjects
Regulations do not apply to all projects funded, the specific
performance assessment design proposed by the applicant may require
compliance with these regulations. For assistance in determining if your
proposed performance assessment meets the criteria in 45 CFR 46,
Protection of Human Subjects Regulations, refer to the SAMHSA decision
tree on the SAMHSA Web site, under "Applying for a New SAMHSA Grant,"
<http://www.samhsa.gov/grants/apply.aspx>.

Applicants whose projects must comply with the Protection of Human
Subjects Regulations 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, these
applicants 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 clients in the proposed project.

General information about Protection of Human Subjects Regulations can
be obtained on the Web at <http://www.hhs.gov/ohrp>. You may also
contact OHRP by e-mail (<ohrp@osophs.dhhs.gov>[)]{.underline} or by
phone (240/453-6900). SAMHSA-specific questions related to Protection of
Human Subjects Regulations should be directed to the program contact
listed in Section VII of this RFA.

### 

###  

### Appendix D -- Funding Restrictions

SAMHSA grant funds must be used for purposes supported by the program
and may not be used to:

-   Pay for any lease beyond the project period.

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-   Provide services to incarcerated populations (defined as those
    persons in jail, prison, detention facilities, or in custody where
    they are not free to move about in the community).

-   Pay for the purchase or construction of any building or structure to
    house any part of the program. (Applicants may request up to
    \$75,000 for renovations and alterations of existing facilities, if
    necessary and appropriate to the project.)

-   Provide residential or outpatient treatment services when the
    facility has not yet been acquired, sited, approved, and met all
    requirements for human habitation and services provision. (Expansion
    or enhancement of existing residential services is permissible.)

-   Pay for housing other than residential mental health and/or
    substance abuse treatment.

-   Provide inpatient treatment or hospital-based detoxification
    services. Residential services are not considered to be inpatient or
    hospital-based services.

-   Make direct payments to individuals to induce them to enter
    prevention or treatment services. However, SAMHSA discretionary
    grant funds may be used for non-clinical support services (e.g., bus
    tokens, child care) designed to improve access to and retention in
    prevention and treatment programs.

-   Make direct payments to individuals to encourage attendance and/or
    attainment of prevention or treatment goals. However, SAMHSA
    discretionary grant funds may be used for non-cash incentives of up
    to \$20 to encourage attendance and/or attainment of prevention or
    treatment goals when the incentives are built into the program
    design and when the incentives are the minimum amount that is deemed
    necessary to meet program goals. SAMHSA policy allows an individual
    participant to receive more than one incentive over the course of
    the program. However, non-cash incentives should be limited to the
    minimum number of times deemed necessary to achieve program
    outcomes. A grantee or treatment or prevention provider may also
    provide up to \$20 cash or equivalent (coupons, bus tokens, gifts,
    child care, and vouchers) to individuals as incentives to
    participate in required data collection follow up. This amount may
    be paid for participation in each required interview.

-   Food is generally unallowable unless it's an integral part of a
    conference grant or program specific, e.g., children's program,
    residential.

-   Implement syringe exchange programs, such as the purchase and
    distribution of syringes and/or needles.

-   Pay for pharmacologies for HIV antiretroviral therapy, sexually
    transmitted diseases (STD)/sexually transmitted illnesses (STI), TB,
    and hepatitis B and C, or for psychotropic drugs.

SAMHSA will not accept a "research" indirect cost rate. The grantee must
use the "other sponsored program rate" or the lowest rate available.

### Appendix E -- Sample Budget and Justification

**ILLUSTRATION OF A SAMPLE DETAILED BUDGET AND**

**NARRATIVE JUSTIFICATION TO ACCOMPANY**

**SF 424A: SECTION B FOR 01 BUDGET PERIOD**

**[OBJECT CLASS CATEGORIES]{.underline}**

**[Personnel]{.underline}**

**Job Annual Level of SAMHSA Non-Federal TOTAL**

**Title** **Name Salary Effort Funded Sources**

Project

> Director J. Doe \$30,000 1.0 \$30,000 \$-0-
>
> Clinical
>
> Director J. Doe \$-0- In-Kind

Secretary Unnamed \$18,000 0.5 \$-0- \$ 9,000

Counselor R. Down \$25,000 1.0 \$25,000 \$-0-

**SUBTOTAL \$55,000 \$9,000**

**Enter Personnel subtotal on 424A, Section B, 6.a. \$64,000**

**[Fringe Benefits]{.underline}** (24%) \$15,360 \$-0-

**SUBTOTAL \$15,360 \$-0-**

**Enter Fringe Benefits subtotal on 424A, Section B, 6.b. \$15,360**

**[Travel]{.underline}**

2 trips for SAMHSA Meetings for 2 Attendees

(Airfare @ \$600 x 4 = \$2,400) + (per diem

@ \$120 x 4 x 6 days = \$2,880) \$5,280 \$-0-

Local Travel (500 miles x .24 per mile) \$-0- \$120

\[Note: Current Federal Government per diem rates are available at
[www.gsa.gov](http://www.gsa.gov/).\]

**SUBTOTAL \$5,280 \$120**

**Enter Travel subtotal on 424A, Section B, 6.c. \$ 5,400**

**[Equipment]{.underline}** (List Individually)

\"Equipment\" means an article of nonexpendable, tangible personal
property having a useful life of more than one year and an acquisition
cost which equals the lesser of (a) the capitalization level established
by the governmental unit or nongovernmental applicant for financial
statement purposes, or (b) \$5000.

**SUBTOTAL \$-0- \$-0-**

**Enter Equipment subtotal on 424A, Section B, 6.d. \$-0-**

ILLUSTRATION OF DETAILED BUDGET AND NARRATIVE JUSTIFICATION (cont'd.)

**[Supplies]{.underline}**

Office Supplies \$500 \$-0-

Computer Software -- Microsoft Word \$-0- 500

**Enter Supplies subtotal on 424A, Section B, 6.e. \$1,000**

**[CONTRACTUAL COSTS]{.underline}**

**[Evaluation]{.underline}**

**Job Annual Level of SAMHSA Non-Federal TOTAL**

**Title** **Name Salary Effort Funded Sources**

Evaluator J. Wilson \$48,000 .05 \$24,000 \$-0-

Other Staff \$18,000 1.0 \$18,000 \$-0-

Fringe Benefits (25%) \$10,500 \$-0-

**Travel**

2 trips x 1 Evaluator

(\$600 x 2) \$ 1,200 \$-0-

Per Diem @ \$120 x 6 720 \$-0-

Supplies (General Office) 500 \$-0-

Evaluation Contractual Direct Costs \$54,920 \$-0-

Evaluation Contractual Indirect Costs (19%) \$10,435 \$-0-

Evaluation Contract Subtotal **\$65,355**

**SUBTOTAL \$65,355** **\$-0- \$65,355**

**[Training]{.underline}**

**Job Annual Level of SAMHSA Non-Federal TOTAL**

**Title** **Name Salary Effort Funded Sources**

Coordinator M. Smith \$ 12,000 0.5 \$12,000 \$-0-

Admin. Asst. N. Jones 9,000 0.5 9,000 \$-0-

Fringe Benefits (25%) 5,250 \$-0-

**Travel**

2 Trips for Training

Airfare @ \$600 x 2 \$1,200 \$-0-

Per Diem \$120 x 2 x 2 days 480 \$-0-

Local (500 miles x .24/mile) 120 \$-0-

**Supplies**

Office Supplies \$500 \$-0-

Software (Microsoft Word) \$500 \$-0-

Training Contractual Direct Costs Subtotal \$40,025 \$-0- **\$40,025**

Training Contractual Indirect Costs Subtotal \$-0- \$-0- **\$-0-**

ILLUSTRATION OF DETAILED BUDGET AND NARRATIVE JUSTIFICATION (cont'd.)

**SUBTOTAL \$105,380 \$-0-** **\$105,380**

**Enter Contractual subtotal on 424A, Section B, 6.f. \$105,380**

**SAMHSA Non-Federal TOTAL**

**Funded Sources**

**[OTHER]{.underline}**

Rent (500 Sq. Ft. x \$9.95) \$ 4,975 \$-0-

Telephone \$ 500 \$-0-

Maintenance (e.g., van) \$-0- \$ 2,500

Audit \$-0- \$ 3,000

Consultants = Expert @ \$250/day X 6 day \$ 1,500 \$-0-

(If expert is known, should list by name)

**SUBTOTAL \$6,957 \$5,500**

**Enter Other subtotal on 424A, Section B, 6.h. \$12,475**

**[TOTAL DIRECT CHARGES]{.underline} (sum of 6.a-6.h)**

> **Enter Total Direct on 424A, Section B, 6.i. \$192,640**

**[INDIRECT CHARGES]{.underline}**

15% of Salary and Wages (copy of negotiated

Indirect Cost Rate Agreement attached) \[\$64,000 X 15% = \$9,600\]

> **Enter Indirect Costs subtotal of 424A, Section B, 6.j. \$9,600**
>
> **Enter TOTALS on 424A, Section B, 6.k. (sum of 6i and 6j) \$202,240**

**[JUSTIFICATION]{.underline}**

PERSONNEL - Describe the role and responsibilities of each position.

FRINGE BENEFITS - List all components of the fringe benefit rate.

EQUIPMENT - List equipment and describe the need and the purpose of the
equipment in relation to the proposed project.

SUPPLIES - Generally self-explanatory; however, if not, describe need.
Include explanation of how the cost has been estimated.

TRAVEL - Explain need for all travel other than that required by SAMHSA.

CONTRACTUAL COSTS - Explain the need for each contractual arrangement
and how these components relate to the overall project.

OTHER - Generally self-explanatory. If consultants are included in this
category, explain the need and how the consultant's rate has been
determined. If rent is requested, provide the name of the owner of the
building/facility. If anyone related to the project owns the building
which is a less than arms length arrangement, provide cost of
ownership/use allowance.

INDIRECT COST RATE - If your organization has no indirect cost rate,
please indicate whether your organization plans to: a) waive indirect
costs if an award is issued; or b) negotiate and establish an indirect
cost rate with DHHS within 90 days of award issuance.

OTHER SOURCES -- If other non-Federal sources of funding, including
match or cost sharing as a total operating budget is included, provide
the name of the source, e.g., in-kind, foundation, program income,
Medicaid, State funds, applicant organization, etc., and explain its
use.

[CALCULATION OF FUTURE BUDGET PERIODS]{.underline}

[(based on first 12-month budget period)]{.underline}

Review and verify the accuracy of future year budget estimates.
Increases or decreases in the future years must be explained and
justified. (NOTE: salary cap of \$186,600 is effective for all FY 2008
awards.)

First Second Third

12-month 12-month 12-month

Period Period Period

Personnel

Project Director 30,000 30,000 30,000

Secretary\* 9,000 18,000 18,000

Counselor 25,000 25,000 25,000

TOTAL PERSONNEL 64,000 73,000 73,000

\*Increased from 50% to 100% effort in 02 through 03 budget periods.

Fringe Benefits (24%) 15,360 17,520 17,520

Travel 5,400 5,400 5,400

Equipment -0- -0- -0-

Supplies\*\* 1,000 520 520

\*\*Increased amount in 01 year represents costs for software.

Contractual

Evaluation\*\*\* 65,355 67,969 70,688

Training 40,025 40,025 40,025

\*\*\*Increased amounts in 02 and 03 years reflect the increase in
client data collection.

Other 1,500 1,500 1,500

Total Direct Costs 192,640 205,934 208,653

Indirect Costs 9,600 9,600 9,600

(15% S&W)

TOTAL COSTS 202,240 216,884 219,603

The Federal dollars requested for all object class categories for the
first 12-month budget period are entered on Form 424A, Section B, Column
(1), lines 6a-6i. The [total]{.underline} Federal dollars requested for
the second through the fifth 12-month budget periods are entered on Form
424A, Section E, Columns (b) -- (e), line 20. The RFA will specify the
maximum number of years of support that may be requested.