This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Substance Abuse and Mental Health Services Administration (SAMHSA), (http://www.samhsa.gov)

Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute on Mental Health (NIMH), (http://www.nimh.nih.gov/)
Center for Substance Abuse Treatment (CSAT), (http://csat.samhsa.gov/)
Center for Substance Abuse Prevention (CSAP), (http://prevention.samhsa.gov/)

Title: Enhancing Practice Improvement in Community-Based Care for Prevention and Treatment of Drug Abuse or Co-occurring Drug Abuse and Mental Disorders

Announcement Type
New

Update: The following updates relating to this announcement have been issued:

Request For Applications (RFA) Number: RFA-DA-06-001

Catalog of Federal Domestic Assistance Number(s)
93.279, 93.242, 93.243

Key Dates
 Release Date: August 5, 2005
Letters of Intent Receipt Date(s): November 18, 2005
Application Receipt Dates(s): December 19, 2005
Peer Review Date(s): May 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: December 2006
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: December 20, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I. Overview Information

Part II. Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

Community-based providers of services to prevent or treat substance abuse and related problems or co-occurring substance abuse and mental disorders are well-situated to bridge the gaps between science-based innovations and everyday service practices. This initiative is designed to strengthen the capacity of community-based providers with sufficient numbers of participants, sufficient numbers of sites, and sufficient site size and diversity to study and ultimately support system-wide assessment of existing or newly adopted therapeutic and/or business policies and practices. The National Institute on Drug Abuse (NIDA), with support from the National Institute on Mental Health (NIMH) and the Substance Abuse and Mental Health Services Administration (SAMHSA), will provide grants to community-based providers to use rigorous research designs to conduct preliminary or pilot studies of (a) the adoption, implementation, and sustained use of science-based policies and practices, and (b) the effectiveness of existing promising but unproven policies and practices, with the ultimate goal of practice improvement. This initial research should serve as a foundation for more in-depth health services research to be conducted subsequently by the provider and its collaborators to enhance continuous improvement in the prevention/treatment of drug abuse or of co-occurring drug abuse and mental disorders and to foster implementation and sustained use of proven, innovative therapeutic and business policies and practices.

A community-based provider is required to be the applicant organization under this RFA. For the purposes of this RFA, an eligible community-based provider is an organization, an agency, or an association/coalition of organizations/agencies (can be at the National, State, or Regional level) that deliver(s) services to prevent or treat (a) substance abuse and related problems or (b) co-occurring substance abuse and mental disorders in a nonacademic setting. Applicant community-based providers must demonstrate in their application that they have sufficient numbers of participants, sufficient numbers of sites, and sufficient site size and diversity to conduct system-wide assessment of existing or newly adopted therapeutic and/or business policies and practices. Applicants without adequate research capacity are required to partner with researchers from organizations having adequate capacity, such as universities and research institutes. In either case, applications must propose research questions of relevance and value to the community-based provider regarding the development of ongoing capacity to assess and deliver effective services to prevent or treat (a) substance abuse and related problems or (b) co-occurring substance abuse and mental disorders.

Background

Since publication in 1998 of the Institute of Medicine report, entitled Bridging the Gap between Practice and Research, NIDA, NIMH, and SAMHSA have focused attention and resources on improving the process of transporting science-based practice into community-based services. Initial research-to-practice efforts focused on identification, manualization, and dissemination of science-based interventions; adoption by community-based programs; and service provider fidelity to manual guidelines. Despite these efforts to expand the delivery of efficacious practices, translation into practice has been variable and slow. Some community-based providers find it difficult to select, implement, and sustain new science-based practices that can increase the quality and cost of care. Other provider organizations consider their current practices to be satisfactory and see no reason to test or to change them. To date, research-to-practice efforts have not met expectations among providers, researchers, and policymakers.

Recently, researchers have turned their attention to the change processes that occur within organizations seeking to improve their prevention and treatment services. Focus has shifted from viewing the science-to-services process as a one-time linear transfer of innovation from researchers to providers, to viewing it as a complex multidirectional process of continuous practice improvement that involves the interaction of multiple individual- and systems-level factors. The process often involves providers planning to demonstrate the effectiveness of their current practices, or becoming aware of a shortcoming in current practice that they would like to remedy. Providers may then search for a solution by assessing available innovations, often in comparison with usual practice; adopt an innovation that appears promising for some clients; and then implement, reconsider, adapt, and, sustain use of the innovation over time. This newly emerging practice improvement model, although complex, acknowledges the multidirectional and iterative nature of innovation and progress in health care delivery. Too often, however, practice improvement occurs in the absence of systematic examination and documentation, so that identification of the optimal process for ongoing innovation remains an elusive goal.

In 2004, NIDA's Blue Ribbon Task Force on Health Services Research issued its final report of recommendations for increasing the relevance and use of drug abuse research in practice and policy (http://www.drugabuse.gov/about/organization/nacda/HSRReport.pdf). In its report, the Task Force exhorted NIDA to stimulate and support innovative research to determine the components (e.g., administrative and service delivery structures, organizational and management functions, personnel qualifications) necessary for adopting, adapting, delivering, and sustaining effective research-supported policies and practices. Such research would include both the analysis of current capacity, and the development of additional expertise in areas of weakness in order for providers to adequately and continuously examine and improve performance in their service delivery systems.

Providers with sufficient patient loads, sufficient numbers of sites, and sufficient site size and diversity to study system-wide assessment of therapeutic and business practices can examine the systems-level structures, policies, strategies, methods, and tools that facilitate practice improvement. Findings from such research will help to improve the nature and pace of innovation adoption so that science-based prevention and/or treatment services reach the large numbers of individuals who need them, are widely adopted in diverse community settings, are effectively implemented by a range of educators and health care and social services providers with varying levels of training and expertise, and produce replicable and sustainable effects at reasonable cost.

However, even comparatively large community-based providers often lack the resources to analyze service-delivery activities, identify areas of inefficiency/ineffectiveness, and initiate, develop, implement, and sustain a continuous science-based practice improvement process that improves quality and efficiency. For example, provider databases often lack the capacity to capture and/or integrate information about the nature and extent of community needs and the degree to which the provider's services adequately address those needs. Furthermore, provider organizations vary in their levels of readiness to institutionalize a practice improvement process that can refine data, clarify areas for improvement, and monitor the success of improvement efforts. Accordingly, this RFA encourages community-based providers to conduct research geared to their specific level and needs as they develop, implement, modify, expand, or sustain a process of continuous practice improvement. Providers will not be at a disadvantage either for being at an early stage of development or at a more advanced stage.

Research Areas

This RFA encourages research proposals from community-based providers with sufficient patient load, sufficient numbers of sites, and sufficient site size and diversity to conduct research that can increase capacity for continuous practice improvement for both their own organization(s) and other similarly configured providers. Such research may entail examination of therapeutic and business practices currently in use but lacking in scientific evidence of effectiveness, or it may entail examination of the adoption, implementation, and sustained use of science-based therapeutic and business innovations. In designing research, community-based providers should be fully aware of the progression of drug use initiation to abuse, dependence, and finally to a chronic relapsing disease. Applicants should also be aware of other important service delivery considerations, including developmental appropriateness of intervention services for clients of different ages; gender sensitivity; cultural relevance; health disparities; co-occurring mental, social, and medical conditions; and links between drug and/or alcohol abuse and sexually transmitted and other infectious diseases. Appropriate and fundable research under this initiative includes preliminary or pilot studies on (1) organizational readiness and capacity for practice improvement; (2) systems-level factors that facilitate or impede the development, implementation, modification, expansion, or maintenance of practice improvement efforts; and (3) cost or cost-effectiveness analysis of practice improvement efforts.

Readiness and Capacity for Practice Improvement. Substantial variation exists in community-based providers' current readiness and capacity for practice improvement. Some providers currently promote and disseminate practices with little scientific evidence. Others endorse science-based services with little knowledge about the factors that contribute to local adoption, implementation, and sustained use. Limited personal knowledge about the role of organizational leadership in fostering adoption of science-based practices precludes some providers from taking a systematic science-based approach to continuous practice improvement. This RFA encourages providers to assess their readiness and capacity to develop, implement, modify, expand, or sustain continuous practice improvement efforts across service delivery sites. The following research areas are illustrative of those that might be proposed:

Systems-level Factors that Facilitate/Impede Continuous Practice Improvement. Structural, organizational, management, staffing, and financial arrangements affect the accessibility, quality, cost, outcomes, and delivery of drug abuse services. For example, inconsistent management and high rates of staff turnover can impede implementation and have a negative impact on the continuity of practice improvement efforts. Similarly, innovations in financing policy and practice are a key component of the drive to improve services, given that practice is largely determined by complex reimbursement schemes involving state, local, and third party payers. Moreover, all of these systems include interrelated multi-level factors, suggesting that innovative changes may have direct as well as indirect effects on services. The following research and development areas are illustrative of those that might be proposed:

Costs and Cost-Effectiveness of Practice Improvement. A priority in understanding the public health relevance of drug abuse and co-occurring mental disorders is cost - both service costs and societal costs. Economic and accounting costs must be applied throughout management cost systems. Accordingly, provider applicants will need to consider the costs and cost-effectiveness of developing, implementing, modifying, expanding, or sustaining continuous practice improvement efforts. The following research areas are illustrative of those that might be proposed:

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism with the following modifications: An applicant may request a project period of up to 3 years, and direct costs may not exceed $150,000 per year. Preliminary studies are not required.

As an applicant community-based providers will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is December 2006.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).

2. Funds Available

The National Institute on Drug Abuse, with support from the National Institute on Mental Health and the Substance Abuse and Mental Health Services Administration , intends to commit approximately $1.9 million dollars in FY 2006 to fund 8-12 new grants in response to this RFA. An applicant may request a project period of up to 3 years and direct costs may not exceed $150,000 per year. NIDA may give funding priority within this RFA to new applicants with no prior history of NIH research funding, to attaining a balance among grantees of different types of community-based providers, and to applications to examine SAMHSA supported activities aimed at fostering adoption of science-based practices or to applications designed to contribute knowledge that can be applied directly through such SAMHSA funding opportunities. Grant awards will include additional funds to support two project members to attend one grantee meeting per year for the life of the project.

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

A community-based provider is required to be the applicant organization. For the purposes of this RFA, an eligible community-based provider is an organization, an agency, or an association of organizations/agencies (can be at the National, State, or Regional level) that deliver(s) services to prevent or treat (a) substance abuse disorders or (b) co-occurring substance abuse and mental disorders in a nonacademic setting. Applicant community-based providers must demonstrate in their application that they have sufficient patient load, sufficient numbers of sites, and sufficient site size and diversity to study system-wide assessment of existing or newly adopted therapeutic and/or business policies and practices.

You may submit (an) application(s) if your community-based organization has any of the following characteristics:

1.B. Eligible Individuals

Any community-based direct provider of treatment with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Community-based providers without adequate research capacity are required to partner with researchers from organizations having adequate capacity, such as universities and research institutes. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. Agencies that distribute funds for the provision of treatment are not eligible to apply, unless they are also direct providers of treatment.

2. Cost Sharing or Matching

No cost sharing is required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria
Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: November 18, 2005
Application Receipt Dates(s): December 19, 2005
Peer Review Date(s): May 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: December 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Director - DA-06-001
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Director - DA-06-001
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Institute on Drug Abuse. Incomplete and non-responsive applications will not be reviewed.

If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $150,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute on Drug Abuse in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge of intervention effectiveness and real world practice be advanced? What will be the effect of these studies on the provision and receipt of care in community settings? Does this study have sufficient numbers of participants, sufficient numbers of sites, and sufficient site size and diversity to study system-wide assessment of existing or newly adopted therapeutic and/or business policies and practices.

Approach: Is the approach appropriately conceived? Is the approach likely to successfully develop capacity and/or partnerships needed to carry out relevant future studies? Does the applicant exhibit knowledge of and appreciation for the challenges involved in building capacity and conducting research in practice settings? Thus, does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Does the applicant acknowledge the complexity of the real world settings, populations, and professions engaged in the study? Does the applicant employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies for both conducting research and establishing research capacity? Will the proposed work improve or advance current community practices and/or inform health policy? How well will the work address the identification and removal of barriers to improvements in community practice and/or health policy? How well are the issues of relapse, comorbidity, developmental stage, gender, culture/ethnicity, and other factors taken into account? How well are organizational, management, and cost factors taken into account? Does the proposed research contribute knowledge that can be applied directly to and by community-based providers?

Investigators: Is the investigator appropriately trained and well suited to carry out this work, or does the investigator propose a reasonable partnership with others who are appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the practice and scientific environment in which the work will be done contribute to the probability of success? Does the proposed study benefit from unique features of real world practice contexts (e.g., clients, providers, system. Does the proposed study employ useful collaborative arrangements? Is there evidence of institutional support and leadership from all partners?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. Program staff will be responsible for the administrative review of the plan for sharing research data.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Thomas Hilton, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse/NIH/DHHS
NSC , Room 5185
6001 Executive Boulevard
Bethesda, MD 20892
Telephone: (301) 443-6504
FAX: 301-443-6815
Email: [email protected]

Carmen Moten, Ph.D.
Acting Chief, Primary Care Research Program
Chief, Disparities in Mental Health Services Research Program
Division of Services and Intervention Research
National Institute on Mental Health
NSC, Room 7130
6001 Executive Boulevard
Bethesda, MD 20892-9631
Telephone: (301) 443-3364
Email: [email protected]

For Treatment Services contact:

Linda K. Fulton, Ph.D.
Practice Improvement Branch
Division of Services Improvement
Center for Substance Abuse Treatment
Substance Abuse and Mental Health Services Administration
1 Coke Cherry Road, Rm. 5-1136
Rockville, MD 20857
Telephone: (240) 276-1573
FAX: (240) 276-2970
Email: [email protected]

2. Peer Review Contacts:

Teresa Levitin, Ph.D.
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]

3. Financial or Grants Management Contacts:

Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse:
 Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:
 The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


NIH Office of Extramural Research Logo
   Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) 		  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®