Department of Health and Human Services

Substance Abuse and Mental Health Services Administration

**Cooperative Agreement for a Physician Clinical Support System for the
Appropriate Use of Methadone in the Treatment of Pain and Opioid
Addiction**

**(Short Title: PCSS- M)**

**(Initial Announcement)**

[]{.mark}

**Request for Application (RFA) No. TI-08-014**

[]{.mark}

[]{.mark}

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

**Key Dates:**

+----------------------+-----------------------------------------------+
| **Application        | **May 1, 2008.**                              |
| Deadline**           |                                               |
+----------------------+-----------------------------------------------+
| **Intergovernmental  | **Letters from State Single Point of Contact  |
| Review**             | (SPOC) are due no later than 60 days after    |
|                      | the application deadline.**                   |
| **(E.O. 12372)**     |                                               |
+----------------------+-----------------------------------------------+
| **Public Health      | **Applicants must send the PHSIS to           |
| System Impact        | appropriate State and local health agencies   |
| Statement            | by the application deadline. Comments from    |
| (PHSIS)/Single State | Single State Agency are due no later than 60  |
| Agency               | days after the application deadline.**        |
| Coordination**       |                                               |
+----------------------+-----------------------------------------------+

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

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
3](#i.-funding-opportunity-description)

[II. AWARD INFORMATION 5](#ii.-award-information)

[1. AWARD AMOUNT 8](#award-amount)

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

[III. ELIGIBILITY INFORMATION 9](#iii.-eligibility-information)

[1. ELIGIBLE APPLICANTS 9](#eligible-applicants)

[2. COST-SHARING 10](#cost-sharing)

[3. OTHER 10](#other)

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

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

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

[3. SUBMISSION DATES AND TIMES 13](#submission-dates-and-times)

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

[5. FUNDING RESTRICTIONS 15](#funding-restrictions)

[6. OTHER SUBMISSION REQUIREMENTS 16](#other-submission-requirements)

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

[1. EVALUATION CRITERIA 18](#evaluation-criteria)

[2. REVIEW AND SELECTION PROCESS 20](#review-and-selection-process)

[VI. AWARD ADMINISTRATION INFORMATION
20](#vi.-award-administration-information)

[1. AWARD NOTICES 20](#award-notices)

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

[3. REPORTING REQUIREMENTS 21](#reporting-requirements)

[VII. AGENCY CONTACTS 22](#vii.-agency-contacts)

[Appendix A -- Guidance for Electronic Submission of Applications
23](#appendix-a-guidance-for-electronic-submission-of-applications)

[Appendix B -- Sample Budget and Justification
26](#appendix-b-sample-budget-and-justification)

**Executive Summary:**

The Substance Abuse and Mental Health Services Administration, Center
for Substance Abuse Treatment is announcing the availability of FY 2008
funds for a single source award to the American Society of Addiction
Medicine (ASAM) for a Physician Clinical Support System for the
Appropriate Use of Methadone in the Treatment of Pain and Opioid
Addiction (PCSS-M) Cooperative Agreement. The purpose of this project is
to establish a national mentoring network offering support (clinical
updates, evidence-based outcomes and training) free of charge to
physicians and other medical professionals in the appropriate use of
methadone for the treatment of chronic pain and opioid addiction. SAMHSA
is responsible for certifying over 1,000 Opioid Treatment Programs
(OTPs) that use methadone and buprenorphine in the treatment of opioid
addiction. This initiative will help address the nation's rise in
methadone-associated deaths that has been spurred by misuse/abuse and
fatal drug interactions involving methadone.

**Funding Opportunity Title:** Cooperative Agreement for a Physician
Clinical Support System for the Appropriate Use of Methadone in the
Treatment of Pain and Opioid Addiction

**Funding Opportunity Number:** TI-08-014

**Due Date for Applications:** May 1, 2008

**Anticipated Total Available Funding:** \$500,000

**Estimated Number of Awards:** 1

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

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

**Eligible Applicant:** American Society of Addiction Medicine

###  {#section .unnumbered}

###  {#section-1 .unnumbered}

###   {#section-2 .unnumbered}

### I. FUNDING OPPORTUNITY DESCRIPTION {#i.-funding-opportunity-description .unnumbered}

The Substance Abuse and Mental Health Services Administration, Center
for Substance Abuse Treatment is announcing the availability of FY 2008
funds for a single source award to the American Society of Addiction
Medicine (ASAM) for the Physician Clinical Support System for the
Appropriate Use of Methadone in the Treatment of Pain and Opioid
Addiction (PCSS-M) Cooperative Agreement. The purpose of this project is
to establish a national mentoring network offering support (clinical
updates, evidence-based outcomes and training) free of charge to
physicians and other medical professionals in the appropriate use of
methadone for the treatment of chronic pain and opioid addiction. SAMHSA
is responsible for certifying over 1,000 Opioid Treatment Programs
(OTPs) that use methadone and buprenorphine in the treatment of opioid
addiction. This initiative will help address the nation's rise in
methadone-associated deaths that has been spurred by misuse/abuse and
fatal drug interactions involving methadone.

The mission of the American Society of Addiction Medicine (ASAM) is to
educate physicians/other medical professionals and promote the
appropriate role of the physician and other medical professionals in the
care of patients with addiction. ASAM has developed and disseminated
course materials addressing pain and addiction and presently provides
training on the use of methadone in SAMHSA certified OTPs throughout the
country. Thus, ASAM continues to provide critical support that is vital
to the safety of patients receiving methadone-based therapies involving
addiction and chronic pain.

SAMHSA presently collaborates with the CDC, DEA, NIDA, and FDA, as well
as with State agencies most directly affected by rising methadone
mortalities. The collaborative trainings of these agencies, coupled with
an increase in requests for consultation and assistance from State
authorities and practitioners in the field, has created a need for
SAMHSA to evaluate and address the causes of the increase in fatalities
and non-medical use of methadone. While the data strongly suggest that
most of the increase in methadone-associated deaths is related to the
rapid increase in the prescription of methadone for treatment of chronic
pain, there is a widespread public perception that diversion of
methadone from OTPs and OTP clients, and inappropriate client care in
some OTPs, are major reasons for the rise of methadone related
mortality. This perception not only damages attitudes toward methadone
maintenance treatment, which has been demonstrated scientifically in
numerous studies to be the most effective treatment for opioid
addiction, but also undermines public support for treatment generally.
Therefore, SAMHSA has a strong interest and responsibility to help
ensure that methadone, whether prescribed for pain management or
dispensed for the treatment of opioid dependence, is being used
appropriately by physicians who have been trained in the latest
evidence-based practices.

The target population for this initiative includes physicians and other
health professionals working in SAMHSA certified OTPs and physicians
prescribing methadone for pain. The training and clinical support
provided under this initiative will address the specific complexities
that are inherent to the medication itself and how those characteristics
affect appropriate care of individuals being treated for pain and opioid
dependence.

SAMHSA has convened two expert panels in response to the increase in
methadone-associated deaths (the reports are available at
[www.dpt.samhsa.gov](http://www.dpt.samhsa.gov/).) Panel results show
that medical education is critical and warranted to reduce
methadone-associated deaths.  Also, addictions and pain medicine
specialists will be encouraged to participate in the project to serve as
mentors for physicians and other medical professionals desiring to treat
patients for opioid dependency and chronic pain with methadone products.

The PCSS-M program is authorized under Section 509 of the Public Health
Service Act, as amended. This announcement addresses Healthy People 2010
focus area 26 (Substance Abuse).

**2. EXPECTATIONS**

**2.1 Background**

In view of the present healthcare crisis of rising methadone-related
mortalities, there is an immediate and major concern to ensure the
safety of all patients who utilize methadone-based therapies.

Methadone is an important medication for the treatment of opioid use
disorders and chronic pain. It is a well studied, safe and powerful
medication when prescribed and consumed properly. Methadone has been
used for more than 40 years in the treatment of drug addiction, and its
use for the treatment of pain has increased in the last 5 to 10
years.[^1]

Methadone is life saving, yet it presents special challenges. Some
pharmacologic and pharmacokinetic properties of methadone can lead to
harm if it is misused, abused or used for nonmedical purposes. The short
duration of analgesic effect with methadone and significantly longer
elimination half-life increase the risk for methadone toxicity.
Methadone can cause fatalities among individuals who have not developed
any tolerance to opiates. Deaths have occurred among children and adults
who have accidentally taken methadone. Fatal intoxications have also
been observed during the first weeks of treatment and adjustment of the
methadone dose.[^2]

The lack of a common nomenclature and uniform case definition that
distinguish between deaths caused by methadone and deaths in which
methadone is a contributing factor or merely present make it difficult
to determine the true number and nature of methadone-involved deaths
nationwide. Despite this, methadone-associated deaths have continued to
rise. In addition, deaths also have been escalating for other opioids
such as oxycodone and hydrocodone.[^3]

According to SAMHA's 2007 Methadone Mortality Report, distribution of
methadone has increased as has the number of prescriptions. However, the
causes of methadone-associated deaths remain unclear. Some data suggest
that the deaths are most likely the result of the accidental misuse of
the drug rather than intentional abuse.

The following risk factors for methadone-related mortality have been
identified:

-   Concomitant use of benzodiazepines, other opioids, and/or alcohol;

-   Unpredictability of cardio toxicity (Torsades de Pointes) in some
    patients;

-   Inadequate or erroneous induction dosing and monitoring by
    physicians, primarily when prescribing methadone for pain; and

-   Drug poisoning that occurs as a result of diversion of the drug and
    its non-medical use.

Data indicate that the greatest risk in the use of methadone occurs
during the induction phase of addiction treatment and with the wide
variety of pain management regimens.

Accordingly, health care professionals require better training in how to
manage opioid addiction and pain, which are medical disorders for which
health professionals have an ethical obligation to provide the best
available treatment. To do so, physicians and other health care
providers need credible, reliable information about the appropriate use
of methadone.

In addition, health care providers involved in opioid addiction and
chronic pain therapy need continuous up-to-date information on the
documented risks and benefits associated with the use of methadone, as
well as guidelines for assessing risk-benefit ratios specific to
individual patients. They also need to understand methadone's
pharmacology and "best practices" for its use, as well as specific
indications and cautions to consider when deciding whether to use
methadone in the treatment of addiction/chronic pain.

By enlisting the assistance of professional medical organizations and
groups, the grantee will offer physicians and other medical
professionals the information and consultation they need to provide safe
and effective pharmacologic treatment for opioid dependence and chronic
pain, thereby reducing methadone mortality.

**2.2 Required Activities**

At a minimum ASAM will use funds awarded to conduct the following
activities:

-   Establish and maintain a cadre of expert clinicians and educators to
    provide support for qualified healthcare providers preparing for, or
    engaging in, methadone use in treatment of opioid addiction and
    chronic pain.

-   Disseminate authoritative and standardized clinical materials and
    clinical tools.

-   Promote PCSS-M services to identified target populations.

-   Provide mentoring support, observation of practice, and consultative
    services by phone and E-mail that promote and support qualified
    healthcare providers in the use of methadone in the treatment of
    opioid addiction and chronic pain.

-   Educate prospective practitioners through Web site and published
    resources, such as Treatment Improvement Protocols (TIPS) containing
    science-based best practice guidelines for the treatment and
    maintenance of patients with opioid dependency and chronic pain.

In addition, ASAM may propose to conduct other activities with
cooperative agreement funds in its application.

**2.3 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 tools referenced
below. 

 

You must document your ability to collect and report the required data
in "Section D:

Performance Assessment and Data" of your application.  You must collect
and report

data using the CSAT Baseline Meeting Satisfaction Survey, the CSAT
Follow-up Meeting

Satisfaction Survey, the CSAT Baseline Training Satisfaction Survey, or
the CSAT Follow-

up Training Satisfaction Survey which can be found at
[www.samhsa-gpra.samhsa.gov](http://www.samhsa-gpra.samhsa.gov/), along

with instructions for completing these.  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 consultation events, educational events, technical
    assistance events or contacts;

-   Number of physicians participating in each event;

-   Percentage of physicians satisfied with educational and support
    services offered; and

-   Percentage of physicians who report that consultation or educational
    events resulted in appropriate practice change(s).

GPRA data must be collected at the end of each event and 30 days
following the event. Data

are to be submitted using the Web-based CSAT GPRA data collection system
(SAIS) within

7 days after data are collected. GPRA data will be reported to the
public, the Office of

Management and Budget (OMB) and Congress as part of SAMHSA's budget
request.

**2.4 Performance Assessment**

You must assess your project, addressing the performance measures
described above. 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 20% of the total grant award may be used for data
collection, performance**

**measurement, and performance assessment.**

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

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

A total of \$500,000 may be awarded each year for up to three years for
this project. This amount includes direct and indirect costs. Your
proposed budget cannot exceed \$500,000 in any year of the proposed
project. Annual continuation awards will depend on the availability of
funds, your progress in meeting project goals and objectives, and timely
submission of required data and reports.

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

# The award will be made as a cooperative agreement. Under this cooperative agreement, the roles and responsibilities of the grantee and SAMHSA staff are:  {#the-award-will-be-made-as-a-cooperative-agreement.-under-this-cooperative-agreement-the-roles-and-responsibilities-of-the-grantee-and-samhsa-staff-are .unnumbered}

#  {#section-3 .unnumbered}

# [Role of Grantee]{.underline}:  {#role-of-grantee .unnumbered}

-   Implement and assess the program in full cooperation with SAMHSA
    staff members and contractors;

-   Establish a steering committee to oversee the development of the
    PCSS-M for methadone-based treatment of opiate addiction and chronic
    pain and determine the direction of the project. The steering
    committee must be comprised of representatives from participating
    national professional medical organizations authorized by law to
    conduct trainings, other stakeholders, and the Government Project
    Officer;

-   Convene the steering committee, at a minimum, yearly and confer by
    conference call semiannually to develop strategies to further
    enhance the project;

-   Comply with all aspects of the terms and conditions of the
    cooperative agreement (to be issued with the award);

-   Participate in selecting a chairperson for the steering committee;

-   Provide required reports, including those related to the Government
    Performance and Results Act (GPRA); and

-   Respond to requests by the Government Project Officer for
    information or data related to the program.

**[Role of SAMHSA Staff:]{.underline}**

-   Participate in the selection of physician and non-physician members
    of a steering committee that will develop the PCSS-M. The Government
    Project Officer (GPO) will serve as a voting member of the steering
    committee, but will not chair the committee;

-   Ensure that consultation services are provided to the States and
    regions of the country with the greatest need;

-   Assist the grantee to plan for health care infrastructure
    development;

-   Help to establish measures of cost effectiveness;

-   Assist the grantee to meet quality improvement goals;

-   Provide advice and assistance in developing the performance
    assessment;

-   Foster learning, collaboration and coordination with other
    SAMHSA-funded activities; and

-   Provide some of the on-site educational activities, observation of
    practice, consultative services, peer monitoring, and other services
    envisioned under this program.

### III. ELIGIBILITY INFORMATION {#iii.-eligibility-information .unnumbered}

# 1. ELIGIBLE APPLICANTS {#eligible-applicants .unnumbered}

# Only an application from ASAM will be considered for funding under this announcement.  {#only-an-application-from-asam-will-be-considered-for-funding-under-this-announcement. .unnumbered}

#  {#section-4 .unnumbered}

# There is a public health crisis involving the misuse, non medical use and fatalities associated with the increased availability of methadone for the treatment of pain and opioid addiction.  {#there-is-a-public-health-crisis-involving-the-misuse-non-medical-use-and-fatalities-associated-with-the-increased-availability-of-methadone-for-the-treatment-of-pain-and-opioid-addiction. .unnumbered}

#  {#section-5 .unnumbered}

# According to the National Center for Health Statistics (NCHS), methadone poisoning deaths nationwide increased 390% from 786 deaths in 1999 to 3,849 deaths in 2004, and on going data indicate that the number of deaths in many states continued to increase in 2005 and 2006. Thus, prompt and direct implementation of this cooperative agreement is necessary to help ensure public health and safety. {#according-to-the-national-center-for-health-statistics-nchs-methadone-poisoning-deaths-nationwide-increased-390-from-786-deaths-in-1999-to-3849-deaths-in-2004-and-on-going-data-indicate-that-the-number-of-deaths-in-many-states-continued-to-increase-in-2005-and-2006.-thus-prompt-and-direct-implementation-of-this-cooperative-agreement-is-necessary-to-help-ensure-public-health-and-safety. .unnumbered}

To address this healthcare crisis in a timely manner, eligibility for
the cooperative agreement is limited to ASAM to establish a national
mentoring network and to carry out the dissemination of information and
education as it relates to methadone use in the treatment of opioid
addiction and chronic pain. ASAM presently provides a parallel service
under a SAMHSA cooperative agreement to operate a Physician Clinical
Support System (PCSS) to assist physicians with issues related to
office-based treatment of opioid dependence with buprenorphine. As a
result, ASAM is in the unique position to have the infrastructure and
capacity in place to expeditiously meet the specific and unique needs
outlined in this announcement. In addition, ASAM has demonstrated in the
past (through the PCSS project) the capability to implement and achieve
the goals of this program.

# 2. COST-SHARING  {#cost-sharing .unnumbered}

Cost-sharing is not required in this program.

# 3. OTHER {#other .unnumbered}

**Additional Eligibility Requirements**

You must use the PHS 5161-1.

### IV. APPLICATION AND SUBMISSION INFORMATION  {#iv.-application-and-submission-information .unnumbered}

# 1. ADDRESS TO REQUEST APPLICATION PACKAGE  {#address-to-request-application-package .unnumbered}

Required application forms and guidelines are included in this mailing.
You may download additional copies of the application forms from the
SAMHSA Web site at
[www.samhsa.gov/grants](http://www.samhsa.gov/grants).

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

-   enhanced instructions for completing the PHS 5161-1 application.

# 2. CONTENT AND FORM OF APPLICATION SUBMISSION {#content-and-form-of-application-submission .unnumbered}

**2.1 Application Kit**

The SAMHSA application kit includes the following documents:

-   PHS 5161-1 (revised July 2000) -- Includes the face page (SF 424
    v2), budget forms, assurances, certification, and checklist.

-   Cover Letter -- Invites submission of your application and includes
    instructions specific to your grant application.

-   Request for Application (RFA) -- Includes instructions for the grant
    application. This document is the RFA.

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

**2.2 Required Application Components**

The application should be complete and contain all information needed
for review. In order for your application to be complete, it must
include the following 10 sections.

-   **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 B of this document.

-   **Project Narrative and Supporting Documentation** -- The Project
    Narrative describes your project. It consists of Sections A
    through D. Sections A through D together may not exceed 25 pages.
    More detailed instructions for completing each section of the
    Project Narrative are provided in Section V of this document under
    "Evaluation Criteria."

> The Supporting Documentation provides additional information necessary
> for the review of your application. This supporting documentation
> should be provided immediately following your Project Narrative in
> Sections E through G. There are no page limits for these sections,
> except for Section F, 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 4 -- In your application, include the appendices listed below. Please label the appendices as: Appendix 1, Appendix 2, etc.

#######  {#section-6 .unnumbered}

-   *Appendix 1*: Letters of Support

-   *Appendix* *2*: Data Collection Instruments/Interview Protocols

-   *Appendix 3*: Roles and Responsibilities of Participating National
    Professional Medical Organizations

####### *Appendix 4*: Letter to the SSA 

#######  {#section-7 .unnumbered}

-   **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 the 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 Guidelines**

To facilitate review of your application, you are encouraged to follow
these guidelines:

-   Text must be legible and applications should be prepared using black
    ink. This improves the quality of the copies of applications that
    are provided to reviewers.

-   Use white paper only (8.5" by 11.0" in size). Do not use colored,
    heavy, or light-weight paper or any material that cannot be
    photocopied using automatic photocopying machines. Odd-sized and
    oversized attachments, such as posters, will not be reviewed. Do not
    send videotapes, audiotapes, or CD-ROMs.

-   Pages should be numbered consecutively from beginning to end so that
    information can be located easily during review of the application.
    For example, 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 1-4 should be labeled and
    separated from the Project Narrative and budget section, and the
    pages should be numbered to continue in the sequence.

# 3. SUBMISSION DATES AND TIMES  {#submission-dates-and-times .unnumbered}

Your application is due by close of business on **May 1, 2008**. A hard
copy application is due by 5:00 PM (EST). An electronic application is
due by 11:59 PM (EST). **A** **hand carried application will not be
accepted. Your application 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.

**Failure to meet the timely submission requirements above may affect
the ability of your application to be reviewed.** 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, it may affect the ability of your application to be reviewed.

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 A for
"Guidance for Electronic Submission of Applications."

#  {#section-8 .unnumbered}

# 4. INTERGOVERNMENTAL REVIEW (E.O. 12372) REQUIREMENTS {#intergovernmental-review-e.o.-12372-requirements .unnumbered}

This grant program is covered under Executive Order (EO) 12372, as
implemented through Department of Health and Human Services (DHHS)
regulation at 45 CFR Part 100. Under this Order, States may design their
own processes for reviewing and commenting on proposed Federal
assistance under covered programs. Certain jurisdictions have elected to
participate in the EO process and have established State Single Points
of Contact (SPOCs). A current listing of 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](http://www.whitehouse.gov/omb/grants/spoc.html).

-   Check the list to determine whether your State participates in this
    program. You **do not** need to do this if you are an American
    Indian/Alaska Native tribe or tribal organization.

    -   If your State participates, contact your SPOC as early as
        possible to alert him/her to the prospective application(s) and
        to receive any necessary instructions on the State's review
        process.

    -   For proposed projects serving more than one State, you are
        advised to contact the SPOC of each affiliated State.

    -   The SPOC should send any State review process recommendations to
        the following address within 60 days of the application
        deadline. **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: SPOC
        -- Funding Announcement No. **TI-08-014**. Change the zip code
        to **20850** if you are using another delivery service.

In addition, if you are a community-based, non-governmental service
provider and you are not transmitting your application through the
State, you must submit a Public Health System Impact Statement
(PHSIS)[^4] to the head(s) of appropriate State and local health
agencies in the area(s) to be affected no later than the application
deadline. The PHSIS 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. If you are a [State or local government or American
Indian/Alaska Native tribe or tribal organization, you are not subject
to these requirements]{.underline}.

The PHSIS consists of the following information:

-   a copy of the face page of the application (SF 424 v2); and

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

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

If applicable, you [must]{.underline} include a copy of a letter
transmitting the PHSIS to the SSA in **Appendix 4, "Letter to the
SSA**." The letter must notify the State that, if it wishes to comment
on the proposal, its comments should be sent not later than 60 days
after the application deadline to the following address. **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: SSA -- Funding Announcement No. **TI-08-014**. Change
the zip code to **20850** if you are using another delivery service.

In addition:

-   Applicants may request that the SSA send them a copy of any State
    comments.

-   The applicant must notify the SSA within 30 days of receipt of an
    award.

# 5. FUNDING RESTRICTIONS  {#funding-restrictions .unnumbered}

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

SAMHSA's PCSS-M Cooperative Agreement recipient must comply with the
following funding restrictions:

Cooperative agreement funds may not be used for:

-   Needs assessment;

-   Strategic planning;

-   Financing/coordination of funding streams;

-   Policy development to support needed service improvements (e.g.,
    rate-setting activities, establishment of standards of care,
    development/revision of credentialing, licensure, or accreditation
    requirements);

-   Performance measurement development;

-   Data infrastructure/MIS development;

In addition, you must comply with SAMHSA's funding restrictions:

Funds must be used for purposes supported by the program and may not be
used to:

-   Pay for any lease beyond the project period.

```{=html}
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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).

> []{.mark}

-   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.

# 6. OTHER SUBMISSION REQUIREMENTS {#other-submission-requirements .unnumbered}

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 A 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 "**PCSS-M, TI-08-014**" 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.**

### V. APPLICATION REVIEW INFORMATION {#v.-application-review-information .unnumbered}

# 1. EVALUATION CRITERIA {#evaluation-criteria .unnumbered}

Your application will be reviewed and scored against the requirements
listed below for developing the Project Narrative (Sections A-D).
**These are to be used instead of the "Program Narrative" instructions
found in the PHS 5161-1.** Independent reviewers will review and score
your application and report to SAMHSA on the quality of your response to
the requirements listed below, on issues that may impede the effective
implementation of your project, and on participant protection issues
that may need to be addressed. Deficiencies may delay or prevent grant
award or lead to special terms and conditions being placed on your
award. In Sections A-D of the Project Narrative, you must clearly
describe how you intend to use grant funds. Sections A-D of your
application may not exceed 25 pages.

**Section A:** **Statement of Need (10)**

-   Document the need for infrastructure to increase the capacity to
    implement and sustain the PCSS-M for the proposed target population.

-   Describe the gaps, barriers, and other problems related to the need
    for infrastructure development. Describe the stakeholders and
    resources in the target area that can help implement the needed
    infrastructure development.

**Section B:** **Proposed Approach (45)**

-   Clearly state the purpose of the proposed project, with goals and
    objectives. Describe how achievement of goals will increase system
    capacity to address the rise in methadone-associated deaths as a
    result of misuse/abuse.

-   Describe the proposed project, including how you will conduct the
    required activities outlined in Section I-2.2 of this RFA. Provide
    evidence that the proposed activities meet the infrastructure needs
    and show how your proposed infrastructure development strategy will
    meet the goals and objectives.

-   Describe the Project Steering Committee including its membership,
    roles and functions, and frequency of meetings.

-   Identify stakeholders and any other organizations that will
    participate and describe their roles and responsibilities.
    Demonstrate their commitment to the project. Include letters of
    commitment/coordination/support from these organizations in
    **Appendix 1** of your application.

-   Describe the potential barriers to successful conduct of the
    proposed project and how you will overcome them.

-   Describe how your activities will increase the appropriate use of
    methadone for the treatment of chronic pain and opioid addiction.

-   Describe your plan to continue the project after the funding period
    ends. Also describe how program continuity will be maintained when
    there is a change in the operational environment (e.g., staff
    turnover, change in project leadership) to ensure stability over
    time.

**Section C: Staff, Management and Relevant Experience (25)**

-   Provide a realistic time line for the entire project period (chart
    or graph) showing key activities, milestones, and responsible staff.
    \[Note: The time line should be part of the Project Narrative. It
    should not be placed in an appendix.\]

-   Discuss the capability and experience of the applicant organization
    and other participating organizations with similar projects and
    populations, including experience in providing culturally
    appropriate/competent services.

-   Provide a list of staff who will participate in the project, showing
    the role of each and their level of effort and qualifications.
    Include the Project Director and other key personnel, such as the
    evaluator and treatment/prevention personnel.

-   Describe the resources available for the proposed project (e.g.,
    facilities, equipment).

**Section D:** **Performance Assessment and Data (20)**

-   Document your ability to collect and report on the required
    performance measures as specified in Section I-2.3 of this document,
    including data required by SAMHSA to meet GPRA requirements. Specify
    and justify any additional measures 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-2.4 of this RFA and document your ability to
    conduct the assessment.

(Note: If there is other information about your proposed project that
you deem important to the application, discuss it in the appropriate
section above, while staying within the 25-page limit.)

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:** **Biographical Sketches and Job Descriptions:** Include a
biographical sketch for the Project Director and other key positions.
Each sketch should be 2 pages or less. If the person has not been hired,
include a 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 of the PHS 5161-1 instruction page, available on the
SAMHSA Web site.

**Section G:** **Budget Justification:** 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. Discuss plans to continue activities
after the period of grant funding. Use SF 424A, which is attached to
form PHS 5161-1. Fill out Sections B, C, and E. If you are requesting
funding for one year, complete Section B only. An illustration of a
detailed budget and narrative justification is included in Appendix B of
this document.

# 2. REVIEW AND SELECTION PROCESS {#review-and-selection-process .unnumbered}

SAMHSA applications are reviewed according to the evaluation criteria
listed in Section V. For those programs where the individual award is
over \$100,000, applications must also 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 the
    independent

> reviewers and, when applicable, approval by the appropriate National
> Advisory Council; and

-   availability of funds.

### VI. AWARD ADMINISTRATION INFORMATION {#vi.-award-administration-information .unnumbered}

# 1. AWARD NOTICES  {#award-notices .unnumbered}

If you are approved for funding, you will receive a notice through
postal mail, the Notice of Award (NoA), signed by SAMHSA's Grants
Management Officer. The Notice of Award is the sole obligating document
that allows you to receive Federal funding for work on your grant
project.

#######   {#section-9 .unnumbered}

# 2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS  {#administrative-and-national-policy-requirements .unnumbered}

-   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:

    -   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.

# 3. REPORTING REQUIREMENTS {#reporting-requirements .unnumbered}

**3.1 Progress and Financial Reports**

As a SAMHSA grantee, you will be required to submit annual and final
progress and financial reports. The format and requirements for
completing and submitting the reports will be provided to you by your
Government Project Officer (GPO).

**3.2 Publications**

As a SAMHSA grantee, you are required to notify the 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 as a grantee you:

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

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

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

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

### VII. AGENCY CONTACTS {#vii.-agency-contacts .unnumbered}

For questions about program issues contact:

Anthony Campbell

Project Officer

1 Choke Cherry Road

Room 2 -1067

Rockville, Maryland 20857

\(240\) 276-2702

<anthony.campbell@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 -- Guidance for Electronic Submission of Applications {#appendix-a-guidance-for-electronic-submission-of-applications .unnumbered}

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 2003 products (e.g., Microsoft Word 2003,
Microsoft Excel, etc.).** **The new Microsoft Vista operating system and
Microsoft Word 2007 products are not currently accepted by Grants.gov.**
The new Microsoft Vista operating system and Microsoft Word 2007
products are not currently accepted by Grants.gov. 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 your application are provided in
Section IV-2.2 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 **12,875**
    words. If the Project Narrative for an electronic submission exceeds
    the word limit, **then any part of the Project narrative in excess
    of these limits will not be submitted to review**. 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 B -- Sample Budget and Justification {#appendix-b-sample-budget-and-justification .unnumbered}

**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 \$191,300 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.

##  {#section-10 .unnumbered}

[^1]: 1, 2, 3 Summary Report of the Meeting: Methadone Mortality -- A
    Reassessment; July 20, 2007; SAMHSA/CSAT.

[^2]:

[^3]:

[^4]: Approved by OMB under control no. 0920-0428; 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 v2 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).