Skip to Content

Notice

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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble Start Authority

Authority: Section 501(d)(5) of the Public Health Service Act.

End Authority

AGENCY:

Substance Abuse and Mental Health Services Administration, HHS.

ACTION:

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

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.

Start Further Info

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: jhendric@samhsa.gov.

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: kpendlet@samhsa.gov.

End Further Info End Preamble Start Supplemental Information

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 Start Printed Page 45838awarded, 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 Start Printed Page 45839amount 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).

□ 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.]

□ 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.

□ Table of Contents—Include page numbers for each of the major sections of your application and for each appendix. Start Printed Page 45840

□ Budget Form—Use SF 424A, which is part of the 5161-1. Fill out Sections B, C, and E of the SF 424A.

□ 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.

○ 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.

○ 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.

□ 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

□ Assurances—Non-Construction Programs. Use Standard Form 424B found in PHS 5161-1.

□ Certifications—Use the “Certifications” forms found in PHS 5161-1.

□ 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.

□ 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.

□ Information provided must be sufficient for review.

□ 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.

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

☐ 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.

☐ 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.

☐ Pages should be typed single-spaced with one column per page.

☐ Pages should not have printing on both sides.

☐ 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.

☐ 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 Start Printed Page 45841each 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:

○ How you will use data collection instruments.

○ Where data will be stored.

○ Who will or will not have access to information.

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

Note:

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

6. Adequate Consent Procedures

  • 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:

○ Whether or not their participation is voluntary.

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

○ Possible risks from participation in the project.

○ Plans to protect clients from these risks.

  • 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 Start Printed Page 45842Subjects 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 (ohrp@osophs.dhhs.gov) 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 Start Printed Page 45843accreditation/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

■ 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.

■ 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:

◦ Actions required to be in compliance with human subjects requirements;

◦ Requirements relating to additional data collection and reporting;

◦ Requirements relating to participation in a cross-site evaluation; or

◦ Requirements to address problems identified in review of the application.

  • 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, Start Printed Page 45844SAMHSA 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, jhendric@samhsa.gov.

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, kpendlet@samhsa.gov.

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.

☐ Use the PHS 5161-1 application.

☐ 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.

☐ Information provided must be sufficient for review.

☐ 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.

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

☐ 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.

☐ The page limitation for Appendices stated in the funding announcement cannot be exceeded.

☐ 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.

☐ 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)

☐ 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.

☐ Pages should be typed single-spaced with one column per page.

☐ Pages should not have printing on both sides.

☐ 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.

☐ Send the original application and two copies to the mailing address in the funding Start Printed Page 45845announcement. 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.

Start Signature

Dated: July 26, 2004.

Daryl Kade,

Director, Office of Policy, Planning and Budget, Substance Abuse and Mental Health Services Administration.

End Signature End Supplemental Information

[FR Doc. 04-17354 Filed 7-29-04; 8:45 am]

BILLING CODE 4162-20-P