Notice of Request for Applications for SAMHSA Dissertation Grants: Support for Analyses in Substance Abuse (PA 04-001)

AGENCY:

Substance Abuse and Mental Health Services Administration, HHS.

ACTION:

Notice of request for applications for SAMHSA Dissertation Grants: Support for Analyses in Substance Abuse (PA 04-001).

Authority: Section 501(d)(8) of the Public Health Service Act.

SUMMARY:

The Substance Abuse and Mental Health Services Administration (SAMHSA), Office of Applied Studies, is accepting applications for Fiscal Year 2004 grants to support dissertation research on involving data analysis on substance abuse services issues. The purpose of the program is to expand the number of researchers who conduct high-quality substance abuse services research, the study of how various factors (social, financial, organizational, and personal) affect the need for and access to substance abuse treatment, the quality and cost of substance abuse treatment, and, ultimately, health and well being. Students registered and in good standing at an accredited academic doctoral degree program (e.g., Ph.D., Sc.D., or Dr.P.H.), which requires a dissertation based on original research, may apply. Students in such fields as sociology, psychology, social work, biostatistics, epidemiology, economics, policy, management, medicine, nursing, public health or health services research are especially encouraged to apply. The student must apply through a public or private nonprofit U.S. institution that will administer the grant on his or her behalf.

DATES:

Applications are due on June 1, 2004.

FOR FURTHER INFORMATION CONTACT:

For questions on program issues, contact: Sara Q. Duffy, Ph.D., Senior Economist, SAMHSA/Office of Applied Studies, 5600 Fishers Lane, Room 16-105, Rockville, MD 20857, Phone: (301) 443-8565; e-mail: sduffy@samhsa.gov.

For questions on grants management issues, contact: Gwendolyn Simpson, SAMHSA/Division of Grants Management, 5600 Fishers Lane, Room 13-103, Rockville, MD 20857, Phone: (301) 443-4456; e-mail: gsimpson@samhsa.gov.

SUPPLEMENTARY INFORMATION:

Department of Health and Human Services

Substance Abuse and Mental Health Services Administration

SAMHSA Dissertation Grants: Support for Analyses in Substance Abuse (PA 04-001)

(Initial Announcement)

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

Key Dates

Application Deadline—Applications for FY2004 grants are due by June 1, 2004. The annual application receipt date for subsequent fiscal years will be May 1, or, if May 1 is a Saturday or Sunday, the following Monday.

Intergovernmental Review (E.O. 12372)—Letters from State Single Point of Contact (SPOC) are due no later than 60 days after application deadline.

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 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: Performance Measures for the SAMHSA Dissertation Grants Program

Appendix B: Checklist for Application Formatting Requirements

Appendix C: Glossary

I. Funding Opportunity Description

1. Introduction

The Substance Abuse and Mental Health Services Administration (SAMHSA), Office of Applied Studies, is accepting applications for Fiscal Year 2004 grants to support dissertation research on involving data analysis on substance abuse services issues. Students registered and in good standing at an accredited academic doctoral degree program (e.g., Ph.D., Sc.D., or Dr.P.H.), which requires a dissertation based on original research, may apply. Students in such fields as sociology, psychology, social work, biostatistics, epidemiology, economics, policy, management, medicine, nursing, public health or health services research are especially encouraged to apply. The student must apply through a public or private nonprofit U.S. institution that will administer the grant on his or her behalf.

SAMHSA Dissertation Grants are authorized under section 501(d)(8) of the Public Health Service Act.

2. Expectations

The purpose of the program is to expand the number of researchers who conduct high-quality substance abuse services research, the study of how various factors (social, financial, organizational, and personal) affect the need for and access to substance abuse treatment, the quality and cost of substance abuse treatment, and, ultimately, health and well being. The research domains are individuals, families, organizations, institutions, communities and populations. Funded projects may address topics including the organization, financing and delivery of substance abuse prevention and treatment services, and the need for such services, as well as methodological advances in health services research methods applicable to the study of substance abuse issues. In addition, attention to substance abuse issues in racial/ethnic minority populations, women, children and families, older adults, low income groups, the homeless, those in rural settings, and persons with mental illness is encouraged. Topics of special interest include the factors affecting the supply of services, the cost effectiveness of prevention and treatment services, barriers to access to care, and alternative sources of treatment such as the criminal justice system and faith-based organizations. Given the program's focus, submission of proposals involving secondary analyses of existing data sources is encouraged, while submission of clinical research proposals is discouraged. In addition to developing a cadre of researchers capable of producing high-quality substance abuse services research, one of the goals of the program is to promote secondary analyses of data collected by SAMHSA, although secondary analyses of other relevant data sets is acceptable.

2.1 Allowable Activities

• The Principal Investigator's salary.
• Direct project expenses such as travel, data purchasing, data processing, and supplies.
• Fees for maintaining matriculation or other fees imposed on those preparing dissertations, providing the fees are required of all students of similar standing, regardless of the source of funding.
• Consultant fees when use of consultants conforms to university policy.

2.2 Data and Performance Measurement

The Government Performance and Results Act of 1993 (P.L. 103-62, or “GPRA”) requires all Federal agencies to:

• Develop strategic plans that specify what they will accomplish over a 3 to 5-year period;
• set performance targets annually related to their strategic plan; and
• report annually on the degree to which the previous year's targets were met.

The law further requires agencies to link their performance to their budgets. Agencies are expected to evaluate their programs regularly and to use results of these evaluations to explain their successes and failures.

To meet these requirements, SAMHSA must collect performance data (i.e., “GPRA data”) from grantees. You are required to report these GPRA data to SAMHSA on a timely basis so that performance results are available to support budgetary decisions.

Appendix A provides the performance indicators for SAMHSA's Dissertation Grant Program. You can obtain more detailed information on these measures by contacting the Government Project Officer at sduffy@samhsa.gov.

The information used to compile GPRA measures for the Dissertation Grant Program comes from the annual reports and completed dissertations, which are required to be reported under the terms and conditions of the grant award. Therefore, no additional data reporting by grantees will be required.

II. Award Information

1. Award Amount

It is expected that up to $150,000 will be available to fund up to five awards in FY2004. Awards are expected to be $20,000 to $30,000 per year in total costs (direct and indirect). Applicants may request a project period of up to 2 years.

Proposed budgets cannot exceed $30,000 in any year of the proposed project. Annual continuation awards will depend on the availability of funds, grantee progress in meeting project goals and objectives, and timely submission of required data and reports.

2. Funding Mechanism

Awards will be made as grants.

III. Eligibility Information

1. Eligible Applicants

Eligible applicants are domestic public or private, nonprofit entities. The statutory authority for this program precludes grants to for-profit organizations and any non-domestic entity.

Students registered and in good standing at an accredited academic doctoral degree program (e.g., Ph.D., Sc.D., or Dr.P.H.), which requires a dissertation based on original research, may apply. The student must apply through an eligible institution that will administer the grant on his or her behalf. The dissertation must examine in a quantitative way a problem or issue in the area of substance abuse. Students in such fields as sociology, psychology, social work, biostatistics, epidemiology, economics, policy, management, medicine, nursing, public health or health services research are especially encouraged to apply.

The student is the Principal Investigator and the institution is the applicant/grantee. In accordance with the Appropriations Act Ban, the doctoral student must be a citizen or a non-citizen national of the United States or an individual who has been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application. To be eligible, given the goals of the program, the dissertation must be a major part of the training program and be in an area of interest to SAMHSA with demonstrated relevance to the issues pertaining to substance abuse services in the United States. Requirements for the doctoral degree, other than the dissertation and any other contemporaneous requirements, must be completed before the funds provided can be spent. Confirmation that all requirements other than the dissertation have been completed and notification that the dissertation proposal has been accepted must be made in writing by the chairperson of the committee and submitted before initiation of the grant. SAMHSA will make the final determination of eligibility for support. Restrictions on eligibility are based on the program's goals and the desire to assure a successful outcome for the student.

2. Cost-Sharing

Cost-sharing is not required in this program, and applications will not be screened out on the basis of cost-sharing.

3. Other

Applications must comply with the following requirements or they will be screened out and not reviewed:

• Documentation of nonprofit status: If an applicant has evidence of current nonprofit status on file with an agency of PHS, it will not be necessary to file similar papers again. Simply specify the place (Federal Agency) and date of filing. Otherwise, private, nonprofit organizations must include evidence of nonprofit status with the application. Any of the following is acceptable evidence.

—A reference to the organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; or

—A copy of a currently valid Internal Revenue Service Tax exemption certificate; or

—A statement from a State taxing body, State Attorney General, or other appropriate State official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; or

—A certified copy of the organization's certificate of incorporation or similar document if it clearly establishes the nonprofit status of the organization; or

—Any of the above proof for a State or national parent organization, and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.

• Use of the PHS 398 [revised May 2001—updated 9/10/2003].
• Application submission requirements in Section IV-3 of this document.
• 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 B of this document.)

1. Address to Request Application Package

You may request a complete application kit by:

• Calling or emailing Jane Feldmann, (301) 443-5628, jfeldman@samhsa.gov; or
• This Program Announcement, PHS 398 Instructions and Forms, List of Offices Negotiating Indirect Cost Rates, State Single Point of Contact (SPOC) List, and Survey on Ensuring Equal Opportunity for Applicants are also available on http://www.SAMHSA.gov. Click on “Grant Opportunities”.

Additional materials available on this Web site include:

• Standard terms and conditions for SAMHSA grants; and
• Guidelines and policies that relate to SAMHSA grants (e.g., guidelines on cultural competence, consumer and family participation, and evaluation).

2. Content and Form of Application Submission

2.1 Required Documents

The application kit for the Dissertation Grant program contains the following documents:

• PHS 398 (REVISED May 2001)—Updated: 09/09/2003. Required sections include the Instructions; Face Page; Description, Performance Sites and Key Personnel; Research Grant Table of Contents; Modular Budget Form; Biographical Sketch; Resources; Research Plan; Checklist Form Page; and Personal Data Form Page. The Appendix is optional, unless you plan to collect data (please see section IV-2.4, below). Applications that are not submitted on the specified version of the PHS 398 will be screened out and will not be reviewed.
• Program Announcement (PA)—Provides specific information about the availability of funds along with instructions for completing the grant application. This document is the PA. The PA will be available on the SAMHSA Web site ( http://www.samhsa.gov ) and on the Federal grants Web site ( http://www.grants.gov ). A Notice of Funding Availability summarizing the PA will be published in the Federal Register. Note: In case of conflict between the PHS 398 Instructions and the instructions in this PA, please follow the instructions in this PA. Please contact the Government Project Officer if you have any questions.

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

2.2 Order of Sections

Applications must be complete and contain all information needed for review. In order for your application to be complete, it must include the following sections in the order listed.

• Face Page—Use the PHS 398 Form Page 1, Face Page. Please see Section I.C. of the PHS 398 Instructions, for guidance. In signing the face page of the application, you are agreeing that the information is accurate and complete. [Note: Beginning October 1, 2003, applicants will need to provide a Dun and Bradstreet (DUNS) number to apply for a grant from the Federal Government. SAMHSA applicants are required to provide their DUNS number on the face page of the application. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access the Dun and Bradstreet Web site at 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.]
• Description, Performance Sites, and Key Personnel—Your description must fit in the space provided on Form Page 2 of the PHS 398. Please see Section C of the PHS 398 Instructions for guidance. In the first 5 lines or less of your description, write a summary of your project that can be used, if your project is funded, in publications, reporting to Congress, or press releases.
• Research Grant Table of Contents—Using Form Page 3, please include page numbers for each required item as indicated on the PHS 398.
• Modular Budget Form—Since these projects are to be funded at less than $250,000, please use the “Modular Budget Format Page” in the PHS 398 to report the budget. You do not need to submit PHS 398 Form 4 or 5.
• Biographical Sketch—Please follow the instructions on the “Biographical Sketch Format Page” and section “6. BIOGRAPHICAL SKETCH” of the PHS 398 Instructions. This section must contain the biographical sketch of the Principal Investigator.
• Resources—Please use the “Resources Format Page” and consult section “7. RESOURCES” of the PHS 398 Instructions for guidance.
• Research Plan—The Research Plan describes your proposed project. It consists of Sections a through i. Please consult “8. RESEARCH PLAN” in the PHS 398 Instructions. Sections a-d may not be longer than 25 pages combined. If a specific section does not apply, please include it in the application and state that it is not applicable. More detailed information about Sections a through i, including the recommended number of pages for each section is available in the PHS 398 Instructions. The required sections are:
• Section a—Specific Aims.
• Section b—Background and Significance.
• Section c—Preliminary Studies/Progress Report.
• Section d—Research Design and Methods.
• Section e—Human Subjects Research. The projects SAMHSA expects to fund under this grant program are secondary analyses of existing data sources. As such, applicants will check “No” on item 4 of the Face Page, claim exemption 4 from Human Subjects Regulation (please see page 21 of the PHS 398 Instructions), and will not have to discuss these issues in their applications.

Instead, applicants conducting secondary analysis of these types of data are expected to discuss in this section how they will keep secure data that may be confidential. Pursuant to section 501(n) of the Public Health Service Act (42 U.S.C. 290aa), information obtained in the course of any SAMHSA-sponsored study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the use and purposes of the data collection. Applicants using SAMHSA-collected data must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of information where disclosure of individuals who supplied the data or might be identified in the data are possible. The description of the procedures should include a discussion of where the data are to be stored, who will and who will not be permitted access to them, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be safeguarded. Applicants using data collected by other organizations are expected to describe and show how they will uphold the provisions of the data use agreements they have with the providers of those data. Applicants using data from organizations that do not require a data use agreement should discuss any confidentiality concerns of the data they are using and how they will address them.

Applicants proposing to collect data (which is not encouraged under this grant announcement) are expected to describe how they will implement SAMHSA's Confidentiality Requirements and Protection of Human Subjects Regulations. Please see Section IV-2.4 of this Program Announcement.

• Section f—Vertebrate Animals. This program is not intended to fund research using vertebrate animals. Applicants should state “not applicable” in this section.
• Section g—Literature Citations.
• Section h—Consortium/Contractual Arrangements. We expect that most applications will not involve consortia or contractual arrangements. However, if your application does, please consult page 29 of the PHS 398 Instructions.
• Section i—Consultants.
• Checklist Form Page—Please consult Section C.10 of the PHS 398 Instructions for guidance.
• Personal Data Form Page—Self-explanatory.
• Letter From Faculty Committee Or University Official—A letter, on University letterhead, from the faculty committee or the university official directly responsible for supervising the dissertation research must be submitted with the grant application. The letter must certify that:
• The grant application represents the dissertation proposal on which the proposed Principal Investigator is working;
• A collaborative process was established between the proposed Principal Investigator and advisors in the development, review, and editing of the research application;
• The proposed Principal Investigator has completed all requirements for the doctoral degree, except the dissertation proposal and any other contemporaneous requirements, prior to submission of the application;
• Prior to initiation of the grant, the dissertation committee will send a letter to OAS indicating that it has approved the dissertation proposal and all other requirements for the degree, except the dissertation, have been fulfilled satisfactorily.
• Statement of Data Availability—If you have the data you plan to use in your analysis in hand, a simple statement to that effect will suffice. If you do not yet have the data in hand, please describe how you will gain access to the data, including a description of the approval process required by the data provider for you to gain access to the data and use it for your intended research.
• Assurances And Certifications—The signature of the Official Signing for Applicant Organization on the Face Page of the application verifies a number of assurances and certifications, which are described in Section III.G of the PHS 398 Instructions. These assurances and certifications must be verified regardless of whether the application is exempt from Human Subjects Regulation. These assurances and certifications include:
• Human Subjects.
• Research on Transplantation of Human Fetal Tissue.
• Women and Minority Inclusion in Clinical Research Policy.
• Inclusion of Children Policy.
• Research Using Human Embryonic Stem Cells.
• Vertebrate Animals.
• Debarment and Suspension.
• Drug-Free Workplace.
• Lobbying.
• Nondelinquency on Federal Debt.
• Research Misconduct.
• Compliance (Civil Rights, Handicapped Individuals, Sex Discrimination, Age Discrimination).
• Financial Conflict of Interest.
• Documentation of Nonprofit Status—Please see Section III-3 of this PA, above.
• Appendix—The appendix is optional, unless you propose to collect data. In that case you must provide copies of all available data collection instruments, interview protocols, and consent forms that you plan to use (please see Section IV-2.4 of this PA, below). The appendix may be used for supplemental material such as publications, or survey questionnaires that may support the application. Please pay careful attention to Section C.9 of the PHS 398 Instructions. Do not use appendices to extend or replace any of the sections of this PA (reviewers will not consider them if you do).

2.3 Application Formatting Requirements.

Applicants also must comply with the following basic application requirements. Applications that do not comply with these requirements will be screened out and will not be reviewed. Where a conflict exists, the instructions in this Program Announcement supersede those in the PHS 398 Instructions.

• Information provided must be sufficient for review.
• Text must be legible.
• Type size in the Research Plan 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 Research Plan 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 Research plan cannot be exceeded.
• Applications would meet this requirement by using all margins (left, right, top, bottom) of at least 1/2 inch each, and adhering to the 25-page limit for the Research Plan.
• 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 Research Plan (excluding margins, but including charts, tables, graphs and footnotes) cannot exceed 75 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 Research Plan (excluding margins) is considered part of the Research Plan, in determining compliance.

To facilitate review of your application, follow these additional guidelines. Failure to adhere to the following guidelines will not, in itself, result in your application being screened out and returned without review. However, 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 Face Page should be page 1, the Description, Performance Sites, and Personnel page, should be page 2, the table of contents page should be page 3, etc. Appendices should be labeled and placed at the end of the application, 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

If you plan to collect data as part of your research or otherwise conduct human subjects research (neither of which are priorities under this program), you must describe your procedures relating to confidentiality, participant protection and the protection of human subjects regulations in Section e of your Research Plan, using the guidelines provided below. Problems with confidentiality, participant protection, and protection of human subjects identified during the review of your application may result in the delay of funding.

Confidentiality and Participant Protection:

All applicants not using existing data sources must address each of the following elements relating to confidentiality and participant protection. You must document how you will address these requirements or why they do not apply.

1. Protect Clients and Staff From Potential Risks

• Identify and describe any foreseeable physical, medical, psychological, social, legal, or other risks or adverse affects.
• Discuss risks that are due either to participation in the project itself or to the evaluation activities.
• Describe the procedures you will follow to minimize or protect participants against potential risks, including risks to confidentiality.
• Identify plans to provide help if 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 groups.
• Explain the reasons for including groups of pregnant women, children, people with mental disabilities, people in institutions, prisoners, or others who are likely to be 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 it is required, for example, court orders requiring people to participate in a program.
• If you plan to pay participants, state how participants will be awarded money or gifts (Note: Dissertation Grant funds may not be used to pay participants).
• State how volunteer participants will be told that they may receive services even if they do not participate in 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 an appendix, entitled “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 2.

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 get written informed consent.

• Indicate if you will get informed consent from participants or 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 sample consent forms in an appendix entitled, “Sample Consent Forms.” 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

Depending on your proposed research design, you may have to comply with the Protection of Human Subjects Regulations (45 CFR 46).

Applicants whose projects must comply with the Protection of Human Subjects Regulations must describe the process for obtaining Institutional Review Board (IRB) approval fully in their applications. While IRB approval is not required at the time of grant award, these applicants will be required, as a condition of award, to provide the documentation that an Assurance of Compliance is on file with the Office for Human Research Protections (OHRP) and that IRB approval has been received prior to enrolling any clients in the proposed project.

Additional information about Protection of Human Subjects Regulations can be obtained on the web at http://ohrp.osophs.dhhs.gov. You may also contact OHRP by e-mail (ohrp@osophs.dhhs.gov) or by phone (301-496-7005).

3. Submission Dates and Times

Applications for FY 2004 funding are due by close of business on June 1, 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.

The Annual application receipt date for subsequent fiscal years will be May 1, or, if May 1 is a Saturday or Sunday, the following Monday.

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

Executive Order 12372, as implemented through Department of Health and Human Services (DHHS) regulation at 45 CFR part 100, sets up a system for State and local review of applications for Federal financial assistance. A current listing of State Single Points of Contact (SPOCs) is included in the application kit and can be downloaded from the Office of Management and Budget (OMB) Web site at http://www.whitehouse.gov/omb/grants/spoc.html.

• Check the list to determine whether your State participates in this program. You do not need to do this if you are a federally recognized Indian tribal government.
• If your State participates, contact your SPOC as early as possible to alert him/her to the prospective application(s) and to receive any necessary instructions on the State's review process.
• For proposed projects serving more than one State, you are advised to contact the SPOC of each affiliated State.
• The SPOC should send any State review process recommendations to the following address within 60 days of the application deadline: Substance Abuse and Mental Health Services Administration, Office of Program Services, Review Branch, 5600 Fishers Lane, Room 17-89, Rockville, Maryland 20857, ATTN: SPOC—Funding Announcement No. PA 04-001.

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 Dissertation Grant recipients must comply with the following funding restrictions. Grant funds may not be used to:

• Provide salary support for the dissertation committee.
• Buy, build, alter or renovate a facility to house any part of the project.
• Provide services to incarcerated populations (defined as those persons in jail, prison, detention facilities or in custody where they are not free to move about in the community.)

Also, the indirect cost rate for this project will be either 8% or the applicant organization's cost rate, whichever is lower.

6. Other Submission Requirements

6.1 Where To Send Applications

Send applications to the following address: Substance Abuse and Mental Health Services Administration, Office of Program Services, Review Branch, 5600 Fishers Lane, Room 17-89, Rockville, Maryland 20857.

Be sure to include the program announcement title, “SAMHSA Dissertation Grants: Support for Analyses in Substance Abuse”, and number, “PA 04-001,” in item number 2 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

• A review committee will assign a single score for each scored application, based on the criteria listed below.
• In evaluating these criteria, strong emphasis is placed on the reviewers' assessment of the quality and relevance of the written proposal, and on the degree of guidance and support to be provided to the student by the dissertation committee.
• In determining the strengths and weaknesses of the application, reviewers will evaluate the merits of the following 8 components: Biographical Sketch, Resources, Research Plan, Checklist Form Page, Personal Data Form Page, Letter From Faculty Committee or University Official, Statement of Data Availability, Assurances and Certifications.

Reviewers will use the following criteria in assessing the applications:

1. Significance and originality from a scientific or technical viewpoint: Does this study address an important problem? If the aims of the application are achieved, how will the findings be of benefit? What will be the effects of these studies on the concepts or method that drive the substance abuse services research field?

2. Topic: Does the proposed project analyze data on the incidence and prevalence of substance abuse, the distribution and characteristics of substance abuse treatment facilities and services, the costs and outcomes of substance abuse treatment programs, or other issues of interest to SAMHSA?

3. Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Are adequate data available for the project or is there an adequate proposed plan to collect data required for the project? Does the applicant recognize potential problem areas and explain how they might be resolved?

4. Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Is there evidence of institutional support? Is there sufficient evidence that the confidentiality of any data used in the study will be adequately protected?

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

A committee will review the applications based on the above criteria and make recommendations to SAMHSA.

Decisions to fund a grant are based on:

• The strengths and weaknesses of the application as identified by the Review Committee.
• The overall merit of the application. Some preference will be given to proposals that make use of SAMHSA-collected databases, such as the National Survey on Drug Use and Health (NSDUH, formerly known as the National Household Survey on Drug Abuse), the Alcohol and Drug Services Study (ADSS), and the Drug and Alcohol Services Information System (DASIS).
• 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 contains your score and a summary statement, prepared by SAMHSA staff, of the Review Committee's comments.

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 may re-apply at subsequent application deadlines.

2. Administrative and National Policy 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.
• In an effort to improve access to funding opportunities for applicants, SAMHSA is participating in the U.S. Department of Health and Human Services “Survey on Ensuring Equal Opportunity for Applicants.” This survey is included in the application kit for SAMHSA grants. Applicants are encouraged to complete the survey and return it, using the instructions provided on the survey form.

3. Reporting Requirements

3.1 Progress and Financial Reports

• Grantees are required to submit an annual progress report, as part of the continuation process, and two copies of the completed dissertation in a form acceptable and approved by the academic institution. All submitted documents must be written in English.
• 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 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. The performance requirements for SAMHSA's Dissertation Grants are described in Section I-2.2 under “Data and Performance Measurement” and listed in Appendix A of this PA.

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 on program issues, contact: Sarah Q. Duffy, Ph.D., Senior Economist, Government Project Officer, SAMHSA Dissertation Grants, Office of Applied Studies, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane Rm. 16-105, Rockville, MD 20857, (301) 443-8565.

E-mail: sduffy@samhsa.gov.

For questions on grants management issues, contact: Gwendolyn Simpson, SAMHSA/Division of Grants Management, 5600 Fishers Lane, Room 13-103, Rockville, MD 20857, 301-443-4456, E-mail: gsimpson@samhsa.gov.

Appendix A—Performance Indicators for SAMHSA Dissertation Grants

SAMHSA Dissertation Grants: Support for Analyses in Substance Abuse GPRA Performance Measures and Targets

Performance Goals and Measures

The goal of this program is to encourage progress on and the completion of substance abuse services research dissertations, and, by doing so, increase the number of knowledge products available. The outcome is the number of documents, either annual progress reports or completed dissertations. Grantees are required to submit these documents under the terms and conditions of award.

SAMHSA's measures will be based on the cumulative number of documents received. We expect to receive at least 5 documents each year, pending availability of funding. This will vary over the years, depending on the number of new and continuation grants we fund. Our target will be 80% of the minimum number expected each year, plus 80% of the cumulative expected number from previous years. This leads to the following targets:

2004: 4.

2005: 8.

2006: 12.

2007: 16, etc.

In addition to this information, the performance measurement system will contain the following information, all either available in the application or required under the terms of the award:

(1). Grantee.

(2). Principal Investigator.

(3). Application Abstract.

(4). Certificate of Institutional Review Board (IRB) approval, if applicable.

Appendix B—Checklist for Formatting Requirements and Screenout Criteria for SAMHSA Grant Applications

SAMHSA's goal is to review all applications submitted for grant funding. However, this goal must be balanced against SAMHSA's obligation to ensure equitable treatment of applications. For this reason, SAMHSA has established certain formatting requirements for its applications. If you do not adhere to these requirements, your application will be screened out and returned to you without review. In addition to these formatting requirements, programmatic requirements (e.g., relating to eligibility) may be stated in the specific funding announcement. Please check the entire funding announcement before preparing your application.

• Use the PHS 398 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 Research Plan 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 Research Plan 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 Research Plan cannot be exceeded.
• Applications would meet this requirement by using all margins (left, right, top, bottom) of at least 1/2 inch each, and adhering to the page limit for the Research Plan 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 Research Plan (excluding margins, but including charts, tables, graphs and footnotes) cannot exceed 75 square inches multiplied by the total number of allowed pages. 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 Research Plan (excluding margins) is considered part of the Research Plan, in determining compliance.
• The page limit for Appendices stated in the specific funding announcement cannot be exceeded. (Note: There are no page limits for appendices in PA 04-001).

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

• The 12 application components required for PA 04-001 applications should be included.

These are:

• Face Page.
• Description, Performance Sites, and Key Personnel.
• Research Grant Table Of Contents.
• Modular Budget Form.
• Biographical Sketch.
• Resources.
• Research Plan, Sections a-i.
• Checklist Form Page.
• Personal Data Form Page.
• Letter From Faculty Committee Or University Official.
• Statement of Data Availability.
• Documentation of Nonprofit Status.
• 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 of the specific funding announcement.
• Budgetary limitations as specified in Sections I, II, and IV-5 of the specific funding announcement.
• Documentation of nonprofit status as required in the PHS 398.
• 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 Face Page should be page 1, the Description, Performance Sites and Key Personnel page should be page 2, the table of contents page should be page 3, etc. Appendices should be labeled and separated from the rest of the application, and the pages should be numbered to continue the sequence.
• Send the original application and two copies to the mailing address in the funding 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.

Appendix C—Glossary

Services Research: Examines how people get access to health care, how much care costs, and what happens to patients as a result of this care. The main goals of health services research are to identify the most effective ways to organize, manage, finance, and deliver high quality care; reduce medical errors; and improve patient safety. Examples include research on the organization, financing, and delivery of health services, outcomes and cost-effectiveness research.

Biomedical Research: Examines the biological underpinnings of disease etiology, prevention, and treatment. Examples include basic science and clinical trials.

Cost-Sharing or Matching: Cost-sharing refers to the value of allowable non-Federal contributions toward the allowable costs of a Federal grant project or program. Such contributions may be cash or in-kind contributions. For SAMHSA grants, cost-sharing or matching is not required, and applications will not be screened out on the basis of cost-sharing. However, applicants often include cash or in-kind contributions in their proposals as evidence of commitment to the proposed project. This is allowed, and the information may be considered by reviewers in evaluating the quality of the application.

Grant: A grant is the funding mechanism used by the Federal Government when the principal purpose of the transaction is the transfer of money, property, services, or anything of value to accomplish a public purpose of support or stimulation authorized by Federal statute. The primary beneficiary under a grant or cooperative agreement is the public, as opposed to the Federal Government.