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 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. Submission, 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
6. Other Submission Requirements

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA) invite grant applications for research that will ultimately lead to a reduction in the burden of mental illness and drug abuse in rural and frontier populations. The purpose of this Funding Opportunity Announcement (FOA) is to stimulate research on mental health and/or drug abuse problems in rural and frontier communities that will: (1) enhance understanding of structural (including community risk and resilience factors), cultural, and individual factors that may enhance the provision and utilization of prevention and treatment services in these communities; and (2) generate knowledge to improve the organization, financing, efficiency, effectiveness, quality, and outcomes of mental health and drug abuse services for diverse populations in rural and frontier populations.

Applications may focus exclusively on mental disorders, drug abuse disorders, or on the co-occurrence of these and related disorders. Comparisons of rural and urban populations and/or comparisons between rural populations is encouraged, whenever possible, but this is not a requirement.

Background

The impact of mental illness and drug abuse upon the lives of people and nations has been profoundly underestimated and under-appreciated. A 2003 report from the President’s New Freedom Commission on Mental Health (http://www.mentalhealthcommission.gov) and other reports such as, Mental Health: A Report of the Surgeon General, (1999) (http://www.nimh.nih.gov/research/sgreports.cfm), document the enormous public health burden of mental health and co-occurring disorders in the United States. Much of the personal and societal burden of mental and drug abuse disorders could be prevented or alleviated if people at-risk for experiencing these disorders sought and received appropriate prevention and treatment interventions. These reports note that barriers such as limited insurance coverage, scarce availability of services, and stigma must be overcome in order to achieve further progress in preventing and reducing the toll of mental health and drug abuse disorders. Other barriers such as lack of community resources and distance contribute to the lack of adequate prevention approaches in many rural areas. Much scientific progress has been made in understanding, treating, and preventing mental health and drug abuse disorders, and in understanding their emotional and financial costs to families and society. A variety of well-established prevention and treatment interventions are available for the range of mental, emotional, and drug-abuse problems that occur across all ages, racial and ethnic groups, and gender. However, these interventions are not reaching many who need them. See, for example, National Institute of Mental Health/ NIH Health Disparities Strategic Plan-Fiscal Years 2004-2008; also An Investment in America’s Future- Racial/Ethnic Diversity in Mental Health Careers, NIMH National Advisory Mental Health Research Careers, Washington, DC, 2001.

The President’s New Freedom Commission Report noted that the public health burden of mental illness and drug abuse is great. Approximately 5% to 7% of adults have a serious mental disorder in any given year, and about 5% to 9% of children have a serious emotional illness. This means that millions of individuals are afflicted each year. The annual economic cost of these illnesses is estimated at $79 billion. Approximately $63 billion of this reflects lost productivity; mortality costs are $12 billion due to premature death, and almost $4 billion are attributed to productivity losses due to incarceration and the provision of family care. In the last 15 years, mental health spending has not kept pace with general health care. In 1997, the United States spent more than $1 trillion on health care. This included $71 billion to treat mental illnesses.

The public health burden of drug abuse is also great, particularly in association with HIV-risk behavior, smoking, criminal activity, lost work productivity, interrupted educational careers, family violence, and other adverse health outcomes. The most recent findings from the National Survey on Drug Use and Health found that in 2003, more than 8.2% of Americans age 12 and older had used an illicit drug within the past month. Methamphetamine use is becoming a major problem in rural/frontier communities. Despite the fact that effective prevention and treatment interventions exist to combat the behaviors and effects of drug use and abuse, too few individuals are provided with effective interventions. For example, for many of those who do receive treatment, the care provided is often inadequate not intensive enough, not long enough, or lacking in important supportive health and social services.

Although inconclusive, research evidence suggests that the prevalence and incidence of mental illness and drug abuse for adults and children are similar for rural and urban populations. Suicide rates differ in these communities, however, with rural suicide rates exceeding urban rates. Much of the personal and societal burden of these disorders could be alleviated if people experiencing one or more of them sought and received appropriate treatment. However, research has shown that major barriers deter many individuals from entering treatment. For the United States as a whole, these barriers are primarily stigma, lack of parity placed on mental health and drug abuse insurance benefits in private health care, and a fragmented system of care. An estimated 45 million Americans are without any health care coverage. For those with insurance, mental illness and drug abuse visits carry a patient co-payment of about 50%, compared to 10% to 15% for other illnesses. Stigma remains a powerful barrier to people seeking help for mental illness and drug addiction, and stigma is also reflected in the public’s reluctance to pay for treatments, particularly through insurance premiums or taxes.

Nearly 60 million Americans living in rural and frontier communities face additional barriers to receiving effective prevention and treatment services for mental health and drug abuse problems. Access to and availability of mental health and drug abuse specialists, such as psychiatrists, psychologists, and social workers appear to be seriously lacking. Poverty, geographic isolation, and cultural differences further limit the amount and quality of mental health care and drug abuse prevention and treatment services available to individuals in rural and frontier areas. This means that rural residents often enter care later in the course of their illness than their urban peers, enter care with more serious symptoms, and require more intensive and expensive treatment. Moreover, the cost of services especially prescription medications- may be too high for many rural (as well as urban) Americans. The President’s 2003 report suggests, Affordable and accessible transportation services may be unavailable, especially to rural children, the disabled, and the elderly. And, rural residents have longer periods without insurance coverage than their urban peers, and they are less likely to seek services when they cannot pay. Questions also arise about whether available providers are adequately trained to deliver culturally sensitive care to different groups living in these communities. Primary care physicians are often the only providers of mental health and drug abuse services in rural communities, and many of them have not been trained and/or do not have the time to adequately treat these illnesses.

Recent changes in the health care system (including managed care) that emphasize cost containment could further imperil access to mental health and drug abuse prevention and treatment services for people in rural and frontier areas. There is concern that, in the effort to trim health care costs, rural services could suffer disproportionately. There is a continuing need for studies to assess and monitor the availability, accessibility, quality and outcomes of mental health and drug abuse services for individuals in rural and frontier areas.

Areas of Research Opportunities

The following list of potential research topics is illustrative, not exhaustive. Researchers responding to this funding opportunity announcement are invited to identify additional areas of inquiry that, when explored, will lead to the enhancement of the delivery of mental health and drug abuse prevention and treatment services to diverse rural and frontier populations. Moreover, given that many health care needs are developmentally-based, gender-based, and culturally/technically-based, and given the growing body of research indicating developmental, gender, and ethnic differences in the developmental trajectories of mental health and drug abuse problems, researchers are encouraged to take developmentally-based, gender-based, and culturally-based approaches (including evidence-based practices) in designing their research and proposing hypotheses. Researchers are also encouraged to explore community-based participatory research areas that involve community and academic partners as research collaborators. The 1999 National Advisory Mental Health Council (NAMHC) Report, Bridging Science and Services, highlights several recommendations focused on increasing academic-community partnerships in research

1) Methodology

Several methodological issues challenge researchers seeking to study the provision of health services in rural and frontier communities. Although rural typologies have been devised to guide researchers and policy makers, they often fail to capture the relationship between (rural/frontier) population characteristics that are relevant to mental health service and drug abuse treatment outcomes. Statistical definitions, for example, have been used for implementing public policy, but the term rural, operationalized by these definitions, is only a proxy variable for identifying differences in availability, access, need, and use of services. When current definitions are used to design and assess mental health and drug abuse services, it is impossible to differentiate why a particular intervention is effective in one rural community and not another. Rural and frontier studies also often encounter difficulty in obtaining a sufficient sample size and thus lack the power to allow community to be utilized as an explanatory variable. Investigators are encouraged to consider promising methodologies that would include: multi-level studies that would represent individuals within communities and communities within regions or geographic entities; multivariate analysis, including structural equations modeling; and state-of-the-art methods for analyzing small samples as well as longitudinal data. Investigators are encouraged to identify or develop and test:

2) Epidemiology

Analyses of rural and frontier populations are needed to enhance the knowledge base about the prevalence of mental/drug abuse disorders and access to mental health/drug abuse prevention and treatment services in children and older adults. Results from available studies suggest that there is no difference in the prevalence of psychiatric disorders between metropolitan and non-metropolitan adults; however these results may be outdated due to demographic changes in rural areas and how rural is defined and measured. Existing studies also shed little light on intra-rural differences in the prevalence of psychiatric and drug abuse disorders. Similarly, little is known about differences in these disorders among rural and urban children. Thus, investigators are encouraged to:

3) Demand and Need for Care

Research is needed to identify factors that predict why some individuals recognize and accept the need for mental health care and/or drug abuse treatment and enter appropriate treatment. Metropolitan and non-metropolitan persons with psychiatric and drug abuse disorders have been reported as having comparable entry rates into care, though both populations have relatively low rates of entry into care. Some investigators have reported that rural residents are less likely than urban individuals to enter care, but these findings are difficult to interpret because they do not control for need. There is evidence that individuals in rural communities are more likely than their urban counterparts to use primary care providers, particularly if they are poor, a member of racial and ethnic groups, women and children, the elderly, individuals with substance abuse problems, or the severely mentally ill. Investigators are encouraged to:

4) Socio-cultural Beliefs About Mental Illness, Drug Addiction, and Disparities in Use of Mental Health and Drug Treatment Services

Rural and frontier communities are no longer viewed as being homogeneous, as more individuals from various racial and ethnic groups migrate to rural communities. Addressing these demographic changes is crucial to the delivery of effective health care. Research evidence suggests that cultural beliefs and values may shape one’s definitions of mental illness and drug abuse and influence one’s decision to seek formal or informal care and complete care. For example, studies have found that depressed and suicidal farmers are often reluctant to seek help because of their strongly-held values of self-reliance and concerns about confidentiality. Other studies suggest that members of ethnic and racial groups often may not seek care for mental illness or drug abuse due to distrust of outsiders, discrimination, religion, or a sense of fatalism. Investigators are encouraged to:

Study community readiness to identify and address mental health, health risk, and drug abuse problems; and care needs; and to develop appropriate responses and deliver effective interventions.

5) Access to and Quality of Care

Investigators have raised questions about whether specific aspects of rural life contribute to differences in access to and quality of mental health care and substance abuse treatment among rural communities and between rural and urban communities. An alternative view is that larger societal and structural factors are responsible for differences in access to and quality of services in rural and frontier areas. This remains an open question, so investigators are encouraged to:

6) Suicide in Rural and Frontier Areas

7) Economics of Mental Health Care and Drug Abuse Service

It is important to determine the impact of different costs and financing models on service delivery in rural and frontier communities. The health care plans for mental health and drug abuse services and the service systems that provide care to rural populations differ from plans and service systems for urban populations. Rural and frontier populations are less likely to have managed care, and there is a lack of mental health and addiction specialists to provide these specialized services. Studies are sought on the economics of mental health and drug abuse services for treatment and prevention, especially for research on alternative payment systems, public and private financing systems, and the design of insurance. Investigators are encouraged to:

8) Use of Technological Innovations In the Diagnosis and Delivery of Care

Rural advocates suggest that the use of telecommunications technology may offer an opportunity to overcome many barriers to service delivery and to enhance the quality of care provided to underserved rural and frontier populations. However, until there is evidence that services can be effectively delivered via telemedicine, third party payers are unlikely to reimburse for such services. Investigators are encouraged to:

9) Primary Care and Mental Health/Drug Abuse Services

Up to 80% of the mental health care in rural communities is delivered by primary care physicians, social workers, and psychiatric nurses. Availability of and access to mental health and drug addiction specialists remains a serious problem in many places. Several questions have been raised about the effects of provider distribution on the quality and outcomes of care. Studies of primary care providers and mental health/drug abuse treatment are needed to understand several issues. Thus, investigators are encouraged to:

10) Juvenile and Adult Justice and Mental Health/Drug Abuse Care

Rural communities are often called upon to respond to mental health and substance needs of offenders identified through the criminal justice system. In addition to managing the mental health and substance abuse issues of offenders initially entering the juvenile and adult criminal justice systems, rural areas increasingly need to address the treatment and service needs of offenders returning to their communities following incarceration. Studies are needed to identify, develop, and test other more effective therapeutic strategies for responding to persons in the justice system with mental illness and drug addiction problems who live in these remote areas. Investigators are encouraged to:

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

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Research Project Grant (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an R01 application submitted in response to this FOA may not exceed 5 years.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. 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 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

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

1.B. Eligible Individuals

Any individual 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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

Cost sharing is not 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 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.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Receipt Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Application Receipt Date(s): Standard dates apply. See http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm.
Council Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five 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).

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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 (http://grants.nih.gov/grants/policy/policy.htm).

Pre-Award Costs are allowable. A grantee may, at his/her 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 $250,000 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.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year:

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

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.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may 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.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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 or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

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).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods? The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

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.

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. 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.

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), 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 PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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 signing official shown on the electronic application.

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 NoA. 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:

Anthony Pollitt, Ph.D.
Office of Rural Mental Health Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7161, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-4525
FAX: (301) 443-2847
Email: [email protected]

Carmen Moten, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7130, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-3364
FAX: (301) 443-4045
Email: [email protected]

David M. Stoff, Ph.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-4265
FAX: (301) 443-9719
Email: [email protected]

Dionne J. Jones, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5185, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 402-1984
FAX: (301) 443-6815
Email: [email protected]

2. Peer Review Contacts:

Not applicable.

3. Financial or Grants Management Contacts:

Joy R Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6131, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
FAX: (301) 443-6885
Email: [email protected]

Edith Davis
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Room 270, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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).

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.

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 SF424 (R&R); 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.

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://PublicAccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/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.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA 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.

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