Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

Funding Opportunity Title

Reducing the Duration of Untreated Psychosis in the United States (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-13-187

Companion Funding Opportunity

PAR-13-188, R34 Clinical Trial Planning Grant Program

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.242 

Funding Opportunity Purpose

Approximately 100,000 adolescents and young adults in the United States experience a first episode of psychosis (FEP) every year. The early phase of psychotic illness is widely viewed as a critical opportunity for indicated prevention, and a chance to alter the downward trajectory and poor outcomes associated with serious mental disorders such as schizophrenia. Multi-element FEP specialty care programs can produce a range of positive clinical and functional outcomes. The timing of treatment is critical; short and long-term outcomes are better when individuals begin treatment close to the onset of psychosis. Numerous studies find a substantial delay between the onset of psychotic symptoms and the initiation of treatment; in the U.S. treatment is typically delayed between one and three years, suggesting that many FEP persons are missing a critical opportunity to benefit from early intervention. Early identification, rapid referral to specialty FEP care, and engagement in phase-specific treatment are essential to shortening the duration of untreated psychosis (DUP) and pre-empting functional deterioration. The World Health Organization advocates reducing DUP to 3 months or less by addressing “bottlenecks” in the pathway from early psychosis identification to initiation of specialty care. Accordingly, this Funding Opportunity Announcement (FOA) with set-aside funds will support R01 grants that test reproducible strategies for substantially reducing DUP among persons with FEP by removing significant bottlenecks in the pathway to specialty FEP care.  

Key Dates
Posted Date

April 10, 2013

Open Date (Earliest Submission Date)

June 1, 2013

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

July 1, 2013 and Standard dates apply thereafter, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

May 8, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Background

Approximately 100,000 adolescents and young adults in the United States experience a first episode of psychosis (FEP) every year (calculated from McGrath, Saha, Chant, et al., 2008). The early phase of psychotic illness is widely viewed as a critical opportunity for indicated prevention, and a chance to alter the downward trajectory and poor outcomes associated with serious mental disorders such as schizophrenia. Compared to traditional treatment approaches, programs that integrate pharmacologic, psychological, and rehabilitation interventions for FEP are associated with a range of positive outcomes, including remission of psychotic symptoms, lower-rates of re-hospitalization, shorter hospital stays, improved quality of life and social functioning, and increased cognitive performance, and reductions in substance use (Penn, Waldheter, Perkins, et al., 2005). The timing of treatment is critical; short and long-term outcomes are better when individuals begin treatment close to the onset of psychosis (Marshall, Lewis, Lockwood, et al., 2005; Perkins, Gu, Boteva, et al., 2005).

International consensus statements from the World Health Organization recommend that specialty care for FEP start within 3 months of illness onset (Bertolote and McGorry, 2005). However, more than two dozen studies conducted worldwide have observed a substantial delay (on average 2 years) between the appearance of psychotic symptoms and the initiation of appropriate treatment (Marshall et al., 2005). Two influential meta-analyses have clearly established that the duration of untreated psychosis (DUP), the time between the onset of psychosis and initiation of appropriate treatment, is correlated with poor outcome (Marshall et al., 2005; Perkins et al., 2005). In the United States, DUP ranges between one and three years (e.g., Hass and Sweeney, 1992; Ho, Andreasen, Flaum, et al., 2000), suggesting that many persons with FEP are missing a critical opportunity to benefit from early intervention. 

Research suggests that DUP can be reduced within healthcare systems by enhancing early detection and treatment referral mechanisms (Melle, Larsen, Haahr, et al., 2004). Reducing DUP in the United States from current levels of 1-3 years to the international standard of no more than 3 months should be a major focus of applied research efforts. Research to improve FEP case identification and referral in the United States is a logical complement to other NIMH initiatives on improving outcomes for people with FEP, such as the Recovery After an Initial Schizophrenia Episode (RAISE) initiative.

Nature of the Funding Opportunity

This FOA aims to support research that will test feasible strategies for substantially reducing DUP among persons with FEP in community settings by removing significant "bottlenecks" in the pathway to specialty FEP care. For the purpose of this announcement, we define "bottlenecks" as individual, organizational, systemic, and other barriers to rapid FEP identification, assessment, and connection to specialty FEP care. The target population is not limited to first episode schizophrenia, but includes all persons experiencing a first episode of psychosis regardless of presenting DSM-IV diagnosis. Responsive applications will base research activities in settings that link to treatment systems with evidence-based specialty care programs for FEP. A variety of configurations are possible, but evidence-based treatment programs typically feature use of single antipsychotic medications, prescribed in low doses; family psychoeducation; and supported employment (Addington, McKenzie, Norman, et al., 2013), along with cognitive-behavioral therapy, assertive case management, and continuity of care across inpatient and outpatient treatment settings (Bertolote and McGorry, 2005). Coordination of these treatment elements is also an important feature of specialty care programs for FEP. 

Applications submitted to this FOA should propose projects that test approaches for producing one or more of the following:

The strategies proposed to reduce DUP should aim to close gaps as well as remove significant bottlenecks in the referral pathway to specialty FEP care, including barriers that impede the following:

Applications submitted to this FOA should consider “supply side” approaches (e.g., targeting clinical and community systems), such as the development and testing of strategies for training primary care physicians and nurses, school and college counselors, emergency department staff, police, and mental health “generalists” to recognize signs of early psychosis, and the improvement of referral networks to fast-track the “on ramp” to FEP care initiation. This FOA is also intended to encourage “demand side” approaches (e.g., engaging people with FEP and their family members, friends, caregivers, etc.) to improve help-seeking, access, and engagement in care for persons with FEP and/or youth at high clinical risk for psychosis, through education, decision-support systems, and other tools, such as social media. 

Research to reduce DUP requires expertise on the characteristics of service delivery systems and community settings in which DUP reduction strategies would be embedded, as well as expertise on the needs, life circumstances, and diversity of the population of young people with FEP and/or at high clinical risk of psychosis. Investigators should convey knowledge of DUP assessment strategies and factors that may contribute to treatment delays in the U.S. health care system (see Compton & Broussard, 2011). Multi-disciplinary research teams with complementary areas of expertise are encouraged. NIMH encourages applications that involve collaboration with stakeholders from multiple clinical or community practice settings, as well as consumers of services and their family members and social contacts. In addition, NIMH welcomes applications proposing to leverage existing practice research infrastructures such as the Mental Health Research Network (MHRN), the Clinical Translational Science Awards Program (CTSA) and other research and practice networks looking to conduct studies to reduce DUP. NIMH also welcomes coordination of DUP research with other public and private initiatives that specifically address early identification and treatment of young people at high risk for mental illness.

This R01 FOA, and the related R34 FOA, PAR-13-188, support experimental and quasi-experimental studies focused on designing, refining, and testing algorithms of practical and accurate case identification of persons with FEP and/or at high risk of psychosis within a myriad of possible clinical and community contexts, and strategies that promote rapid referral to the appropriate stage-specific specialty care. 

Research Topics

Applications to this FOA should focus on substantial DUP reduction for persons with FEP. The NIMH encourages applications in which referral to appropriate stage-specific care is feasible. This FOA supports studies on the research topics listed below, which are intended to be illustrative, not exhaustive:

It is expected that applications submitted to this FOA will identify other important, innovative and impactful research topics.  Investigators considering applying to this FOA are encouraged to contact the Scientific/Research Contact for this FOA for additional guidance prior to submitting an application.

A variety of rigorous methodological approaches are possible for testing the impact of the proposed approach to reducing DUP. These approaches include randomized controlled trials, quasi-experimental designs with non-randomized comparison groups, time series designs, and other designs of equivalent rigor and relevance. Considerations for selecting a research design for the proposed study include the scientific question that the study is designed to answer, practical constraints, ethical issues, and the tradeoff between maximizing internal and external validity. The applicant should explain how the selected research methods minimize confounds that may limit the ability to infer causality. Regardless of the proposed methods, the project should include assessment of DUP.

Investigators in this area whose work is at a developmental stage should consider applying to R34, PAR-13-188

References

Addington DE, McKenzie E, Norman R, Wang JL, Bond, GR. Essential evidence-based components of first-episode psychosis services, Psychiatric Services in Advance, February 1, 2013; doi: 10.1176/appi.ps.201200156).

Bertolote J, McGorry P. (2005). Early intervention and recovery for young people with early psychosis: Consensus statement.  British Journal of Psychiatry, 187 (suppl. 48):s116 – s119.

Brunet KB, Lester M, Thornhill HK. (2007). Delays in mental health services and duration of untreated psychosis. Psychiatric Bulletin;31:408-10.

Compton MT & Broussard B. (2011). Conceptualizing determinants of DUP. Current Psychiatry Reviews, 7(1):1-11.

Haas G, Sweeney JA. Premorbid and onset features of first-episode schizophrenia. Schizophrenia Bulletin. 1992;18:373-386.

Ho B, Andreasen NC, Flaum M, Nopoulos P, Miller D. Untreated initial psychosis: Its relation to quality of life and symptom remission in first-episode schizophrenia. American Journal of Psychiatry 2000;157:808-815.

Marshall M, Lewis S, Lockwood A, Drake R, Jones P, Croudace T.  (2005). Association between duration of untreated psychosis and outcome in cohorts of first-episode patients: A systematic review. Archives of General Psychiatry, 62:975-983.

McGrath J, Saha S, Chant D, Welham J. (2008). Schizophrenia: a concise overview of incidence, prevalence, and mortality. Epidemiologic Reviews, 30:67-76.

Melle I, Larsen TK, Haahr U, Friis S, Johannessen JO, Opjordsmoen S, Simonsen E, Rund BR, Vaglum P, McGlashan T.Melle I, Larsen TK, Haahr U, et al. (2004). Reducing the duration of untreated first-episode psychosis: effects on clinical presentation. Archives of General Psychiatry, 61:143–150.

Penn D, Waldheter E, Perkins D, Mueser K, Lieberman J.  (2005). Psychosocial treatment for first-episode psychosis:  A research update. American Journal of Psychiatry,162:2220–2232.

Perkins D, Gu H, Boteva K, Lieberman J. (2005). Relationship between duration of untreated psychosis and outcome in first-episode schizophrenia: A critical review and meta-analysis. American Journal of Psychiatry, 162:1785–1804.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIMH intends to commit approximately $2,000,000 in FY 2013 to fund between 3 and 4 grants submitted to this FOA and the companion R34, PAR-13-188 announcement.

Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are not limited but should reflect the actual needs of the proposed project.

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed 5 years. 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.   

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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 NIMH staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Susan T. Azrin, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7145, MSC 9631
Rockville, MD 20892-9631
Rockville, MD 20852 (for express/courier service)
Telephone: 301-443-3267
Email: susan.azrin@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Letter

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: As part of the research strategy, applications should present empirical data that support the feasibility and acceptability of the proposed strategy for reducing DUP. The empirical data presented for the selected setting should (1) quantify the overall DUP among persons with FEP at baseline using a scientifically acceptable operational definition of DUP and reliable measures of DUP, (2) map the various referral pathways that channel persons with FEP to specialty care programs, and (3) identify gaps and bottlenecks in these referral pathways that prolong DUP.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed approach have the potential to substantially reduce DUP in the target population of people with FEP?

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Do the qualifications of the PD/PI and other senior investigators include expertise in the identification and treatment of people with FEP and expertise in the service delivery systems or community settings in which the selected DUP reduction strategies would be embedded? 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are novel strategies proposed for reducing DUP among people with FEP and/or measuring DUP in community treatment settings in the U.S.? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Does the project include a scientifically acceptable operational definition of DUP? Are methods described for obtaining reliable estimates of DUP in community programs? Does the project include substantial DUP reduction for persons with FEP as a primary outcome? If clinical, community or public health settings are involved, are stakeholders sufficiently engaged in the research process, including project design?  

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.   

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Susan T. Azrin, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3267
Email: susan.azrin@nih.gov

Peer Review Contact(s)

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: armstrda@mail.nih.gov

Financial/Grants Management Contact(s)

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


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