[Federal Register Volume 69, Number 146 (Friday, July 30, 2004)]
[Notices]
[Pages 45837-45845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Notice of Request for Applications for Grants for Opioid 
Treatment Program (OTP) Accreditation

    Authority: Section 501(d)(5) of the Public Health Service Act.
AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Notice of request for applications for grants for Opioid 
Treatment Program (OTP) accreditation.

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SUMMARY: The Substance Abuse and Mental Health Services Administration 
(SAMHSA), Center for Substance Abuse Treatment (CSAT) is accepting 
applications for Fiscal Year 2005 grants to partially subsidize the 
cost of accreditation of Opioid Treatment Programs (OTPs). The purpose 
of these grants 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).

DATES: Applications are due on September 30, 2004.

FOR FURTHER INFORMATION CONTACT: For questions on program issues 
contact: Jacqueline Hendrickson, MSW, SAMHSA/CSAT, Division of 
Pharmacologic Therapies, 5600 Fishers Lane, Rockwall II, Suite 618, 
Rockville, MD 20857, Phone: (301) 443-1109; E-Mail: 
[email protected].
    For questions on grants management issues contact: Kimberly 
Pendleton, SAMHSA/Division of Grants Management, 5600 Fishers Lane, 
Rockwall II, Suite 630, Rockville, MD 20857, Phone: (301) 443-6133; E-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

Grants for Opioid Treatment Program (OTP) Accreditation

    Short Title: Accreditation of OTPs (Initial announcement).

Request for Applications (RFA) No. TI 05-001

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

    Key Dates: Application Deadline, September 30, 2004.
    Date of Issuance: July 2004.

Table of Contents

I. Funding Opportunity Description
    1. Introduction
    2. Expectations
II. Award Information
    1. Award Amount
    2. Funding Mechanism
III. Eligibility Information
    1. Eligible Applicants
    2. Cost Sharing
    3. Other
IV. Application and Submission Information
    1. Address To Request Application Package
    2. Content and Form of Application Submission
    3. Submission Dates and Times
    4. Intergovernmental Review (E.O. 12372) Requirements
    5. Funding Limitations/Restrictions
    6. Other Submission Requirements
V. Application Review Information
    1. Evaluation Criteria
    2. Review and Selection Process
VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements
    3. Reporting Requirements
VII. Agency Contacts
Appendix A--Checklist for Formatting Requirements for SAMHSA Grant 
Applications

I. Funding Opportunity Description

1. Introduction

    As authorized by Section 501(d)(5) of the Public Health Services 
Act, the Substance Abuse and Mental Health Services Administration 
(SAMHSA), Center for Substance Abuse Treatment (CSAT), announces the 
availability of Fiscal Year (FY) 2005 grants to partially subsidize the 
cost of accreditation of Opioid Treatment Programs (OTPs). The purpose 
of these grants 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 can be downloaded from http://www.dpt.samhsa.gov/regulation.htm. 
This Request for Applications (RFA) is a reissuance (with 
modifications) of RFA number TI 02-003 issued in October 2001.
    The current CSAT accreditation grants program has provided funding 
for the first round of accreditation surveys for approximately 1100 
OTPs by four grantees. Since the first grants were

[[Page 45838]]

awarded, two additional organizations have developed OTP accreditation 
standards and have become approved by SAMHSA to accredit OTPs. 
Accreditation and reaccreditation is an ongoing, continuous quality 
improvement process. Some OTPs need to be resurveyed within one year of 
achieving their first accreditation and others will need to become 
reaccredited within three years. Continuing efforts are needed to 
finalize the accreditations of the OTPs that have not achieved full 
accreditation and reaccredit those who currently have full 
accreditation at a minimum of every three years. In addition there are 
approximately 100 new OTPs that open each year that will be seeking 
accreditation from SAMHSA-approved accreditation bodies.

2. Expectations

    The purpose of Opioid Treatment Program (OTP) Accreditation grants 
is to: (1) Reduce the costs of basic accreditation education and 
accreditation surveys and ongoing reaccreditation for OTPs; (2) ensure 
that new OTPs and OTPs that did not become fully accredited before the 
May, 19, 2004, regulatory target date become fully accredited under 42 
CFR Part 8; and (3) ensure that OTPs maintain their accreditation by 
undergoing the reaccreditation process at least every 3 years.
    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 CSAT Guidelines for the Accreditation of Opioid 
Treatment Programs can be downloaded from http://www.dpt.samhsa.gov/regulation.htm.
    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.
2.1 Data and Performance Measurement/Government Performance and Results 
Act
    The Government Performance and Results Act of 1993 (Pub. L. 103-62, 
or ``GPRA'') requires all Federal agencies to set program performance 
targets and report annually on the degree to which the previous year's 
targets were met. Agencies are expected to evaluate their programs 
regularly and to use results of these evaluations to explain their 
successes and failures and justify requests for funding. To meet the 
GPRA requirements, SAMHSA must collect performance data (i.e., ``GPRA 
data'') from grantees. Grantees are required to report these GPRA data 
to SAMHSA on a timely basis.
    In addition to providing data on the four measures listed below, 
you must collect 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 Knowledge Application training events. 
CSAT's GPRA Training (baseline and follow-up) Survey forms can be found 
at http://www.csat-gpra.samhsa.gov. Click on General Information for 
CSAT's GPRA Strategy, then click on Data Collection Tools/Instructions, 
click on Knowledge Application Program, then click on Data Collection 
Tools. GPRA data must be entered into CSAT's GPRA Data Entry and 
Reporting System at http://www.csat-gpra.samhsa.gov. Training and 
technical assistance on data collecting, tracking and follow-up as well 
as data entry, will be provided by CSAT.
    (1) Number of OTPs that have submitted applications for surveys;
    (2) Number of OTPs receiving accreditation surveys/site visits with 
assistance from this grant;
    (3) Results of each OTP accreditation survey supported by this 
grant; and
    (4) Percentage of OTP sponsors or directors satisfied with the 
accreditation process.

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

    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 Grantee Meetings

    Your Project Director must plan to participate in two joint grantee 
meetings each year of the grant, and you must include funding for this 
travel in your budget. At these meetings, grantees will present the 
results of their projects and Federal staff will provide technical 
assistance. Each meeting will be up to two days, and attendance is 
mandatory. One meeting will usually be held in the Washington, DC, 
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

1. Award Amount

    It is expected that up to $2,000,000 will be available to fund up 
to 6 awards in FY 2005. The amount of an individual award is expected 
to range between $15,000 and $1,000,000 in total costs (direct and 
indirect) per year for 3 years. The maximum allowable annual award is 
$1,000,000 in total costs. The

[[Page 45839]]

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 
only accredit 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 $1,000 or less per OTP.
    --The actual cost of conducting site visits for accreditation, 
reaccreditation, monitoring purposes or ``for-cause'' visits is limited 
to $4,000 or less per site visit.
    Proposed budgets cannot exceed the allowable amount in any year of 
the proposed project.
    This program is being announced prior to the annual appropriation 
for FY 2005 for SAMHSA's programs, with funding estimates based on the 
President's budget request for FY 2005.
    Applications are invited based on the assumption that sufficient 
funds will be appropriated for FY 2005 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.
    Annual continuations will depend on the availability of funds, 
grantee progress in meeting program goals and objectives, and timely 
submission of required data and reports.

2. Funding Mechanism

    Awards for this funding opportunity will be made as grants.

III. Eligibility Information

1. 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 opioid 
treatment programs (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. Current grantees whose OTP accreditation projects end on or 
before April 14, 2005, are eligible to apply under this program.

2. Cost Sharing

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

3. Other

    Applications must comply with the following requirements: Use of 
the PHS 5161-1 application; application submission requirements in 
Section IV-3 of this document; and formatting requirements provided in 
Section IV-2.3 of this document.

IV. Application and Submission Information

    (To ensure that you have met all submission requirements, a 
checklist is provided for your use in Appendix A of this document.)

1. Address To Request Application Package

    Required application forms and guidelines are being provided to all 
eligible applicants. You also may download the required documents from 
the SAMHSA Web site at http://www.samhsa.gov. Click on ``grant 
opportunities.''
    Additional materials available on this Web site include:
     A technical assistance manual for potential applicants;
     Standard terms and conditions for SAMHSA grants;
     Guidelines and policies that relate to SAMHSA grants 
(e.g., guidelines on cultural competence, consumer and family 
participation, and evaluation); and
     Enhanced instructions for completing the PHS 5161-1 
application.

2. Content and Form of Application Submission

2.1 Required Documents
    SAMHSA application kits include the following documents:
     PHS 5161-1 (revised July 2000)--Includes the face page, 
budget forms, assurances, certification, and checklist. You must use 
the PHS 5161-1.
     Request for Applications (RFA)--Includes instructions for 
the grant application. This document is the RFA.
    You must use the above documents in completing your application.
2.2 Required Application Components
    To ensure equitable treatment of all applications, applications 
must be complete. In order for your application to be complete, it must 
include the required ten application components (Face Page, Abstract, 
Table of Contents, Budget Form, Project Narrative and Supporting 
Documentation, Appendices, Assurances, Certifications, Disclosure of 
Lobbying Activities, and Checklist).
    [squ] Face Page--Use Standard Form (SF) 424, which is part of the 
PHS 5161-1. [Note: Beginning October 1, 2003, applicants will need to 
provide a Dun and Bradstreet (DUNS) number to apply for a grant or 
cooperative agreement from the Federal Government. SAMHSA applicants 
will be required to provide their DUNS number on the face page of the 
application. Obtaining a DUNS number is easy and there is no charge. To 
obtain a DUNS number, access the Dun and Bradstreet Web site at http://www.dunandbradstreet.com or call 1-866-705-5711. To expedite the 
process, let Dun and Bradstreet know that you are a public/private 
nonprofit organization getting ready to submit a Federal grant 
application.]
    [squ] Abstract--Your total abstract should not be longer than 35 
lines. In the first five lines or less of your abstract, write a 
summary of your project that can be used, if your project is funded, in 
publications, reporting to Congress, or press releases.
    [squ] Table of Contents--Include page numbers for each of the major 
sections of your application and for each appendix.

[[Page 45840]]

    [squ] Budget Form--Use SF 424A, which is part of the 5161-1. Fill 
out Sections B, C, and E of the SF 424A.
    [squ] Project Narrative and Supporting Documentation--The Project 
Narrative describes your project. It consists of Sections A through C. 
These sections in total may not be longer than 25 pages. More detailed 
instructions for completing each section of the Project Narrative are 
provided in ``Section V--Application Review Information'' of this 
document.
    The Supporting Documentation provides additional information 
necessary for the review of your application. This supporting 
documentation should be provided immediately following your Project 
Narrative in Sections D through G. There are no page limits for these 
sections, except for Section F, Biographical Sketches/Job Descriptions.
     Section D--Literature Citations. This section must contain 
complete citations, including titles and all authors, for any 
literature you cite in your application.
     Section E--Budget Justification, Existing Resources, Other 
Support. You must provide a narrative justification of the items 
included in your proposed budget, as well as a description of existing 
resources and other support you expect to receive for the proposed 
project.
     Section F--Biographical Sketches and Job Descriptions.
    [cir] 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.
    [cir] Include job descriptions for key personnel. Job descriptions 
should be no longer than 1 page each.
    [cir] Sample sketches and job descriptions are listed on page 22, 
Item 6 in the Program Narrative section of the PHS 5161-1.
     Section G--Confidentiality and SAMHSA Participant 
Protection/Human Subjects. Section IV-2.4 of this document describes 
requirements for the protection of the confidentiality, rights and 
safety of participants in SAMHSA-funded activities. This section also 
includes guidelines for completing this part of your application.
    [squ] Appendices 1 through 3--Use only the appendices listed below. 
Do not use more than 30 pages for Appendices 1 and 2. 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
    [squ] Assurances--Non-Construction Programs. Use Standard Form 424B 
found in PHS 5161-1.
    [squ] Certifications--Use the ``Certifications'' forms found in PHS 
5161-1.
    [squ] Disclosure of Lobbying Activities--Use 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.
    [squ] Checklist--Use the Checklist found in PHS 5161-1. The 
Checklist ensures that you have obtained the proper signatures, 
assurances and certifications and is the last page of your application.
2.3 Application Formatting Requirements
    Applicants also must comply with the following basic application 
requirements.
    [squ] Information provided must be sufficient for review.
    [squ] Text must be legible.
     Type size in the Project Narrative cannot exceed an 
average of 15 characters per inch, as measured on the physical page. 
(Type size in charts, tables, graphs, and footnotes will not be 
considered in determining compliance.)
     Text in the Project Narrative cannot exceed 6 lines per 
vertical inch.
    [ballot] Paper must be white paper and 8.5 inches by 11.0 inches in 
size.
    [ballot] To ensure equity among applications, the amount of space 
allowed for the Project Narrative cannot be exceeded.
     Applications would meet this requirement by using all 
margins (left, right, top, bottom) of at least one inch each, and 
adhering to the 25-page limit for the Project Narrative.
     Should an application not conform to these margin or page 
limits, SAMHSA will use the following method to determine compliance: 
The total area of the Project Narrative (excluding margins, but 
including charts, tables, graphs and footnotes) cannot exceed 58.5 
square inches multiplied by 25. This number represents the full page 
less margins, multiplied by the total number of allowed pages.
     Space will be measured on the physical page. Space left 
blank within the Project Narrative (excluding margins) is considered 
part of the Project Narrative, in determining compliance.
    [ballot] The page limitation for Appendices 1 and 2 cannot be 
exceeded.
    To facilitate review of your application, follow these additional 
guidelines. Following these guidelines will help reviewers to consider 
your application.
    [ballot] Pages should be typed single-spaced with one column per 
page.
    [ballot] Pages should not have printing on both sides.
    [ballot] Please use black ink and number pages consecutively from 
beginning to end so that information can be located easily during 
review of the application. The cover page should be page 1, the 
abstract page should be page 2, and the table of contents page should 
be page 3. Appendices should be labeled and separated from the Project 
Narrative and budget section, and the pages should be numbered to 
continue the sequence.
    [ballot] Send the original application and two copies to the 
mailing address in Section IV-6.1 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.
2.4 SAMHSA Confidentiality and Participant Protection Requirements and 
Protection of Human Subjects Regulations
    Applicants must describe procedures relating to Confidentiality, 
Participant Protection and the Protection of Human Subjects Regulations 
in Section G of the application, using the guidelines provided below. 
Problems with confidentiality, participant protection, and protection 
of human subjects identified during peer review of the application may 
result in the delay of funding. If one or all of the following seven 
areas are not relevant to your project, you must document the reasons.
Confidentiality and Participant Protection:
    All applicants must describe how they will address the requirements 
for

[[Page 45841]]

each of the following elements relating to confidentiality and 
participant protection.
1. Protect Clients and Staff From Potential Risks
     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.
     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
     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 
participants.
     Explain how you will recruit and select participants. 
Identify who will select participants.
3. Absence of Coercion
     Explain if participation in the project is voluntary or 
required. Identify 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.).
     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
     Identify from whom you will collect data (e.g., from 
participants themselves, family members, teachers, others). Describe 
the data collection procedures and specify the sources for obtaining 
data (e.g., school records, interviews, psychological assessments, 
questionnaires, observation, or other sources). Where data are to be 
collected through observational techniques, questionnaires, interviews, 
or other direct means, describe the data collection setting.
     Identify what type of specimens (e.g., urine, blood) will 
be used, if any. State if the material will be used just for evaluation 
or if other use(s) will be made. Also, if needed, describe how the 
material will be monitored to ensure the safety of participants.
     Provide in Appendix 1, ``Data Collection Instruments/
Interview Protocols,'' copies of all available data collection 
instruments and interview protocols that you plan to use.
5. Privacy and Confidentiality
     Explain how you will ensure privacy and confidentiality. 
Include who will collect data and how it will be collected.
     Describe:
    [cir] How you will use data collection instruments.
    [cir] Where data will be stored.
    [cir] Who will or will not have access to information.
    [cir] How the identity of participants will be kept private, for 
example, through the use of a coding system on data records, limiting 
access to records, or storing identifiers separately from data.

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

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

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

     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.

     Describe if separate consents will be obtained for 
different stages or parts of the project. For example, will they be 
needed for both participant protection in treatment intervention and 
for the collection and use of data?
     Additionally, if other consents (e.g., consents to release 
information to others or gather information from others) will be used 
in your project, provide a description of the consents. Will 
individuals who do not consent to having individually identifiable data 
collected for evaluation purposes be allowed to participate in the 
project?
7. Risk/Benefit Discussion
    Discuss why the risks are reasonable compared to expected benefits 
and importance of the knowledge from the project.
Protection of Human Subjects Regulations
    Applicants may have to comply with the Protection of Human Subjects 
Regulations (45 CFR 46), depending on the evaluation and data 
collection requirements of the particular funding opportunity for which 
the applicant is applying or the evaluation design proposed in the 
application.
    Applicants must be aware that even if the Protection of Human 
Subjects Regulations do not apply to all projects funded under a given 
funding opportunity, the specific evaluation design proposed by the 
applicant may require compliance with these regulations.
    Applicants whose projects must comply with the Protection of Human

[[Page 45842]]

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.
    Additional 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 ([email protected]) or by phone 
(301-496-7005).

3. Submission Dates and Times

    The deadline for submission of applications for specific funding 
opportunities is September 30, 2004. Your application must be received 
by the application deadline. Applications sent through postal mail and 
received after this date must have a proof-of-mailing date from the 
carrier dated at least 1 week prior to the due date. Private metered 
postmarks are not acceptable as proof of timely mailing.
    You will be notified by postal mail that your application has been 
received.
    Applications not received by the application deadline or not 
postmarked by a week prior to the application deadline will be screened 
out and will not be reviewed.

4. 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.

5. Funding Limitations/Restrictions

    Cost principles describing allowable and unallowable expenditures 
for Federal grantees, including SAMHSA grantees, are provided in the 
following documents:
     Institutions of Higher Education: OMB Circular A-21.
     State and Local Governments: OMB Circular A-87.
     Nonprofit Organizations: OMB Circular A-122.
     Appendix E Hospitals: 45 CFR Part 74.
    In addition, SAMHSA 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.
     No more than 5% of the grant award may be used for 
evaluation and data collection expenses.
     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.

6. Other Submission Requirements

6.1 Where to Send Applications
    Send applications to the following address.
    If using U.S. Postal Service Mail, use the following address: 
Office of Program Services, Review Branch, Substance Abuse and Mental 
Health Services Administration, Room 3-1046, 1 Choke Cherry Road, 
Rockville, MD 20857.
    If using UPS/DHL/FedEx, use the following address: Office of 
Program Services, Review Branch, Substance Abuse and Mental Health 
Services Administration, Room 3-1046, 1 Choke Cherry Road, Rockville, 
MD 20850.
    Be sure to include ``Accreditation of OTPs--TI 05-001'' in item 
number 10 on the face page of the application. If you require a phone 
number for delivery, you may use (301) 443-4266.
6.2 How to Send Applications
    Mail an original application and 2 copies (including appendices) to 
the mailing address provided above. The original and copies must not be 
bound. Do not use staples, paper clips, or fasteners. Nothing should be 
attached, stapled, folded, or pasted.
    You must use a recognized commercial or governmental carrier. Hand 
carried applications will not be accepted. Faxed or e-mailed 
applications will not be accepted.

V. Application Review Information

1. Evaluation Criteria

    Your application will be reviewed and scored according to the 
quality of your response to the requirements listed below for 
developing the Project Narrative (Sections A-C). These sections 
describe what you intend to do with your project.
     In developing the Project Narrative section of your 
application, use these instructions, which have been tailored to this 
program. These are to be used instead of the ``Program Narrative'' 
instructions found in the PHS 5161-1.
     You must use the three 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.
     Reviewers will be looking for evidence of cultural 
competence in each section of the Project Narrative. Points will be 
assigned based on how well you address the cultural competence aspects 
of the evaluation criteria. SAMHSA's guidelines for cultural competence 
can be found on the SAMHSA Web site at http://www.samhsa.gov. Click on 
``Grant Opportunities.''
     The Supporting Documentation you provide in Sections D-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 below is the 
maximum number of points a review committee may assign to that section 
of your Project Narrative. Bullet statements in each section do not 
have points assigned to them. They are provided to invite the attention 
of applicants and reviewers to important areas within each section.
Section A: Project Description: (25 Points)
     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

[[Page 45843]]

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 reaccreditation 
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 (40 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. 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.
     Discuss how you will comply with the GPRA and other data 
collection requirements (including a 30-day follow up with a minimum of 
80% of all baseline participants followed up).
Section C: Staff, Management, and Relevant Experience (35 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.
     Describe procedures for continuous quality improvement and 
evaluation of accreditation/reaccreditation activities.
     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.

    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.

2. Review and Selection Process

    SAMHSA applications are peer-reviewed according to the review 
criteria listed above. For those programs where the individual award is 
over $100,000, applications must also be reviewed by the appropriate 
National Advisory Council.
    Decisions to fund a grant are based on:
     The strengths and weaknesses of the application as 
identified by peer reviewers and, when appropriate, approved by the 
appropriate National Advisory Council; and
     Availability of funds.

VI. Award Administration Information

1. Award Notices

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

2. Administrative and National Policy Requirements

2.1 General Requirements
    [dec222] 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/2004/useful_info.asp.
    [dec222] Depending on the nature of the specific funding 
opportunity and/or the proposed project as identified during review, 
additional terms and conditions may be identified or negotiated with 
the grantee prior to grant award. These may include, for example:
    [ctrcir] Actions required to be in compliance with human subjects 
requirements;
    [ctrcir] Requirements relating to additional data collection and 
reporting;
    [ctrcir] Requirements relating to participation in a cross-site 
evaluation; or
    [ctrcir] Requirements to address problems identified in review of 
the application.
     You will be held accountable for the information provided 
in the application relating to performance targets. SAMHSA program 
officials will consider your progress in meeting goals and objectives, 
as well as your failures and strategies for overcoming them, when 
making an annual recommendation to continue the grant and the amount of 
any continuation award. Failure to meet stated goals and objectives may 
result in suspension or termination of the grant award, or in reduction 
or withholding of continuation awards.
     In an effort to improve access to funding opportunities 
for applicants,

[[Page 45844]]

SAMHSA is participating in the U.S. Department of Health and Human 
Services ``Survey on Ensuring Equal Opportunity for Applicants.'' This 
survey is included in the application kit for SAMHSA grants. Applicants 
are encouraged to complete the survey and return it, using the 
instructions provided on the survey form.

3. Reporting Requirements

3.1 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.
     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.
3.2 Government Performance and Results Act
    The Government Performance and Results Act (GPRA) mandates 
accountability and performance-based management by Federal agencies. To 
meet the GPRA requirements, SAMHSA must collect performance data (i.e., 
``GPRA data'') from grantees. These requirements are specified in 
Section I-2.1 of this announcement.
3.3 Publications
    If you are funded under this grant program, you are required to 
notify the Government Project Officer (GPO) and SAMHSA's Publications 
Clearance Officer (301-443-8596) of any materials based on the SAMHSA-
funded project that are accepted for publication.
    In addition, SAMHSA requests that grantees:
     Provide the GPO and SAMHSA Publications Clearance Officer 
with advance copies of publications.
     Include acknowledgment of the SAMHSA grant program as the 
source of funding for the project.
     Include a disclaimer stating that the views and opinions 
contained in the publication do not necessarily reflect those of SAMHSA 
or the U.S. Department of Health and Human Services, and should not be 
construed as such.
    SAMHSA reserves the right to issue a press release about any 
publication deemed by SAMHSA to contain information of program or 
policy significance to the substance abuse treatment/substance abuse 
prevention/mental health services community.

VII. Agency Contacts

    For questions concerning program issues, contact: Jacqueline 
Hendrickson, MSW, Division of Pharmacologic Therapies, SAMHSA/CSAT, 
5600 Fishers Lane, Rockwall II, Suite 618, Rockville, MD 20857, (301) 
443-1109, [email protected].
    For questions on grants management issues, contact: Kimberly 
Pendleton, Office of Program Services, Division of Grants Management, 
Substance Abuse and Mental Health Services Administration, 5600 Fishers 
Lane, Rockwall II, Suite 630, Rockville, MD 20857, (301) 443-6133, 
[email protected].

Appendix A--Checklist for Formatting Requirements 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. In addition to these formatting requirements, 
programmatic requirements (e.g., relating to eligibility) may be 
stated in the specific grant announcement. Please check the entire 
grant announcement before preparing your application.
    [ballot] Use the PHS 5161-1 application.
    [ballot] Applications must be received by the application 
deadline. Applications received after this date must have a proof of 
mailing date from the carrier dated at least 1 week prior to the due 
date. Private metered postmarks are not acceptable as proof of 
timely mailing. Applications not received by the application 
deadline or not postmarked at least 1 week prior to the application 
deadline will not be reviewed.
    [ballot] Information provided must be sufficient for review.
    [ballot] Text must be legible.
     Type size in the Project Narrative cannot exceed an 
average of 15 characters per inch, as measured on the physical page. 
(Type size in charts, tables, graphs, and footnotes will not be 
considered in determining compliance.)
     Text in the Project Narrative cannot exceed 6 lines per 
vertical inch.
    [ballot] Paper must be white paper and 8.5 inches by 11.0 inches 
in size.
    [ballot] To ensure equity among applications, the amount of 
space allowed for the Project Narrative cannot be exceeded.
     Applications would meet this requirement by using all 
margins (left, right, top, bottom) of at least one inch each, and 
adhering to the page limit for the Project Narrative stated in the 
specific funding announcement.
     Should an application not conform to these margin or 
page limits, SAMHSA will use the following method to determine 
compliance: The total area of the Project Narrative (excluding 
margins, but including charts, tables, graphs and footnotes) cannot 
exceed 58.5 square inches multiplied by the page limit. This number 
represents the full page less margins, multiplied by the total 
number of allowed pages.
     Space will be measured on the physical page. Space left 
blank within the Project Narrative (excluding margins) is considered 
part of the Project Narrative, in determining compliance.
    [ballot] The page limitation for Appendices stated in the 
funding announcement cannot be exceeded.
    [ballot] To facilitate review of your application, follow these 
additional guidelines. 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.
    [ballot] The 10 application components required for SAMHSA 
applications should be included. These are:
     Face Page (Standard Form 424, 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 (a form within PHS 5161-1)
     Disclosure of Lobbying Activities (Standard Form LLL, 
which is in PHS 5161-1)
     Checklist (a form in PHS 5161-1)
    [ballot] Applications should comply with the following 
requirements:
     Provisions relating to confidentiality, participant 
protection and the protection of human subjects specified in Section 
IV-2.4 in this funding announcement.
     Budgetary limitations as specified in Section I, II, 
and IV-5 of this funding announcement.
     Documentation of nonprofit status as required in the 
PHS 5161-1.
    [ballot] Pages should be typed single-spaced with one column per 
page.
    [ballot] Pages should not have printing on both sides.
    [ballot] Please use black ink and number pages consecutively 
from beginning to end so that information can be located easily 
during review of the application. The cover page should be page 1, 
the abstract page should be page 2, and the table of contents page 
should be page 3. Appendices should be labeled and separated from 
the Project Narrative and budget section, and the pages should be 
numbered to continue the sequence.
    [ballot] Send the original application and two copies to the 
mailing address in the funding

[[Page 45845]]

announcement. 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.

    Dated: July 26, 2004.
Daryl Kade,
Director, Office of Policy, Planning and Budget, Substance Abuse and 
Mental Health Services Administration.

[FR Doc. 04-17354 Filed 7-29-04; 8:45 am]
BILLING CODE 4162-20-P