Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Mental Health (NIMH)
Funding Opportunity Title	Discovery, Development, and Testing of Novel Interventions to Advance HIV Prevention and Care (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	February 28, 2014 - This PA has been expired and reissued as PA-14-127. 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. July 26, 2011 - See Issuance of PA-11-271 Advancing the Impact of Effective HIV/AIDS Prevention and Treatment Interventions (R01).
Funding Opportunity Announcement (FOA) Number	PA-11-275
Companion FOA	PA-11-276, R03 Small Grant Program PA-11-277, R21 Exploratory/Developmental Research Grant Award PAR-11-278, 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
FOA Purpose	The Division of AIDS Research (DAR) at the National Institute of Mental Health (NIMH) issues this Funding Opportunity Announcement (FOA) to outline priority areas for innovative intervention development research to advance HIV prevention and care. This FOA encourages research designed to (a) conduct tests of the efficacy of novel behavioral and/or integrated behavioral and biomedical interventions, (b) conduct basic behavioral and social science research that is needed to advance the development of innovative interventions, and (c) translate and operationalize the findings from these basic studies to develop interventions and assess their feasibility. This FOA is informed by priority areas from the National HIV/AIDS Strategy, the NIH Office of AIDS Research (OAR) Plan for HIV/AIDS Related Research, as well as the NIMH Strategic Plan http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml, particularly objectives 1, 2, and 3 as adapted to HIV research. This FOA does not focus on NeuroAIDS, which is described and addressed in PA-11-014 This FOA encourages novel, high impact research approaches that will contribute to the creation of empirically-based HIV-risk reduction approaches that could be used to pave the way for prevention, reduction of clinical impact, and cure. High impact can be achieved either by large effect size or very broad reach. To achieve these goals, this FOA outlines the need to: (1) advance combination behavioral-biomedical approaches to HIV-related interventions, (2) increase intervention potency and durability, (3) enhance targeting on high risk vulnerable populations, (4) identify new behavioral targets and intervention approaches within multiple intervention areas (e.g., to serve novel HIV prevention and treatment adherence interventions), and (5) incorporate context into intervention development and testing, thereby advancing the development and testing of interventions delivered beyond the individual level.

Posted Date	July 26, 2011
Open Date (Earliest Submission Date)	August 7, 2011
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates apply
Scientific Merit Review	Standard dates
Advisory Council Review	Standard dates
Earliest Start Date(s)	Standard dates apply
Expiration Date	(Now Expired March 1, 2014 per issuance of PA-14-127), Originally May 8, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

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

The Division of AIDS Research (DAR) at the National Institute of Mental Health (NIMH) issues this Funding Opportunity Announcement (FOA) to outline priority areas for innovative research for intervention development to advance HIV prevention and care. This FOA encourages research designed to (a) conduct tests of the efficacy of novel behavioral and/or integrated behavioral and biomedical interventions, (b) conduct basic behavioral and social science research that is needed to advance the development of innovative interventions, and (c) translate and operationalize the findings from these basic studies to develop interventions and assess their feasibility. This FOA is informed by priority areas from the National HIV/AIDS Strategy, the NIH Office of AIDS Research (OAR) Plan for HIV/AIDS Related Research, as well as the NIMH Strategic Plan http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml, particularly objectives 1, 2, and 3 as adapted to HIV research.

This FOA does not focus on NeuroAIDS, which is described and addressed in PA-11-014.

Through this FOA, NIMH seeks novel, high impact research approaches that will contribute to the creation of empirically-based HIV-risk reduction approaches that could be used to pave the way for prevention, reduction of clinical impact, and cure. High impact can be achieved either by large effect size or very broad reach. To achieve these goals, this FOA outlines the need to: (1) advance combination behavioral-biomedical approaches to HIV-related interventions, (2) increase intervention potency and durability, (3) enhance targeting on high risk vulnerable populations, (4) identify new behavioral targets and intervention approaches within multiple intervention areas (e.g., to serve novel HIV prevention and treatment adherence interventions), and (5) incorporate context into intervention development and testing, thereby advancing the development and testing of interventions delivered beyond the individual level.

In 2011 almost 1.5 million people are living with HIV in the U.S. and it is estimated that 56,000 adults and adolescents become infected annually. Globally, an estimated 33.4 million people were living with HIV in 2008, with a projection of 2.7 million new infections each year. Of those living with HIV, an estimated 21% are unaware of their diagnosis and account for a disproportionate share of new infections. The expanding epidemic worldwide continues to bring immense suffering, causes needless loss of life, and exacts an enormous economic burden.

Globally, HIV rates differ by age, race, ethnicity, geographic location and risk behavior category. Thus, novel approaches are needed to ensure interventions that address the myriad of needs that exist within different groups of individuals. Similarly, the needs of those individuals who are (or believe themselves to be) HIV negative may be unique from the needs of those individuals who are known to be HIV positive. For those individuals living with HIV, interventions are needed that ensure they continue practicing safer sexual behavior, remain adherent to their HIV medication, receive consistent HIV medical care, and maintain a high quality of life free of suffering from mental illness, substance abuse, stigma and discrimination.

There has been great progress in the development of efficacious HIV-related interventions, including male circumcision, HIV testing, HIV treatment adherence, and pre-exposure prophylaxis (PrEP). Interventions that target individual-level behavior change are available and have likely impacted the epidemic by curbing HIV incidence in the face of growing HIV prevalence. However, incident infections remain unacceptably high in many US and global populations, and persons living with HIV still need better access to HIV-testing, preventive interventions, optimal HIV care, and management of co-morbidities. Therefore, the development of innovative behavioral, social, and integrated behavioral/biomedical approaches remains critical in order to address the HIV pandemic.

Innovative research is encouraged that engages multidisciplinary teams, including researchers from the fields of public health, public policy, behavioral science, systems science, health disparities, organizational behavior, demography, choice architecture, epidemiology, and behavioral economics.

To meet these aims, research is needed to address the following goals. The listed research questions are considered high priority, but this is not an exclusive list of potential important research directions.

1. Studies to advance combination behavioral-biomedical intervention approaches:

• Studies to elucidate behavioral decision-making under conditions of uncertainty, partial efficacy, and preventive misconceptions about the efficacy of experimental products or the benefits of participation in clinical trials
• Studies to assess and mitigate risk compensation/behavioral disinhibition (i.e., the extent to which biomedical prevention strategies may alter the real or perceived risk of HIV transmission risk behaviors, and subsequent engagement in those risk behaviors)
• Studies to optimize the provision of brief, evidence-based counseling that results in durable adherence to product and risk reduction guidelines

2. Studies to increase intervention potency and durability:

• Studies to improve intervention efficacy and effectiveness
• Studies to identify modifiable factors that affect the durability of effective prevention interventions and develop strategies to enhance long term maintenance
• Studies to develop novel approaches for augmenting the impact of interventions to promote HIV treatment adherence and persistence

3. Studies to enhance prevention efforts targeting high risk vulnerable populations:

• Studies to better understand and increase adoption of and adherence to biomedical prevention methods among most at risk persons
• Studies to understand and improve the differential effects of biomedical HIV prevention strategies in different populations
• Studies to develop and evaluate innovative prevention interventions for men who have sex with men (MSM) from diverse backgrounds which address the elevated community risks for these populations, such as late diagnosis and elevated prevalence in partner populations
• Studies that consider an integrated approach to prevention and care for subjects with co-morbidities that may affect HIV risk and treatment, with a special emphasis on subjects with neuropsychiatric diagnoses, youth, and/or the aging population
• Studies to develop and evaluate prevention interventions which make use of new technologies to identify recent infection, assess community-level risk for transmission, or identify co-factors for HIV transmission
• Studies designed to develop and test interventions to reduce racial/ethnic, gender, and age-related disparities in HIV care utilization, adherence, and treatment outcomes

4. Studies to identify new behavioral targets and intervention approaches:

• Studies using new and expanding technological approaches to recruit, enroll, and retain high risk groups (e.g., young men and women, MSM) who are difficult to reach by other means for prevention efforts and linkage to care
• Studies identifying the societal, environmental, genetic, developmental, and personality factors associated with the risk of acquiring or transmitting HIV
• Studies that identify and integrate biological markers (biomarkers) and behavioral indicators associated with the acquisition or transmission of HIV
• Studies to understand and promote adherence to biomedical HIV prevention strategies for the purpose of maximizing their effectiveness and impact
• Studies that seek to improve HIV treatment outcomes through the development and testing of interventions that will rapidly link individuals diagnosed with HIV to primary medical care, enhance readiness for initiation of antiretroviral medications, improve and sustain adherence to medications, and/or improve patient retention in medical care
• Studies that further elucidate individual-level risk by using geospatial, neighborhood mapping or other techniques to determine and target community-level risk

5. Studies to incorporate context into the development and testing of interventions beyond the individual level:

• Studies to address social and structural determinants of HIV infection that may facilitate or impede the outcome of interventions
• Research to define specific mechanisms by which cultural experience impacts neurobehavioral and HIV acquisition risk trajectories, and identify time-points and circumstances that would optimally allow a change in the trajectory to a more positive outcome
• Studies to develop and test innovative community, clinic and provider level strategies and combination behavioral-biomedical HIV approaches that reduce the risk of infection in high prevalence communities, improve engagement in primary HIV medical care, and improve treatment adherence and retention
• Studies to examine the impact of policies on the social environment that serves as a facilitator or barrier to risk reduction

This FOA is not encouraging applications in the following areas:

• International research in high resource countries or regions in countries that do not have a high or increasing prevalence rate of HIV;
• Research to develop and test individual-level interventions and/or group-based interventions that have limited potential for widespread uptake or significant population-level reach;
• Research that proposes adaptations of existing efficacious interventions. Such applications may be acceptable under PA-11-271 - Advancing the Impact and Effectiveness of Proven HIV Interventions (R01).

NIMH has established clear decision rules for deciding whether to invest in adapting or extending an effective treatment or preventive intervention. These are outlined in the 2010 NIMH National Advisory Mental Health Council (NAMHC) Report, From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses . NIMH views research to adapt existing, effective treatments as a priority only when:

1. Through adaptation the treatment will be accessible to a subgroup (e.g., taking an adult treatment and making it developmentally appropriate for a young child).

2. The study tests the efficacy of an evidence-based treatment from one domain and adapts it for use in another (e.g., a successful prevention intervention is revised and tested to target treatment adherence, a smoking cessation intervention approach is adapted to a HIV-prevention intervention).

3. The study tests a revised intervention that is based on remediating documented mechanisms of non-response to the existing intervention. That is, there is theoretical and empirical support for the adaptation target (e.g., the adaptation changes a factor that has been associated with non-response, partial response, patient non-engagement, or relapse).

4. New research generates predictors of benefits or adverse events that require validation that cannot be accomplished using existing data.

5. Evidence to suggest that the adapted intervention will result in a substantial improvement in response rate, speed of response, an aspect of care, or uptake in community/practice settings when compared to the existing intervention.

6. Clear explication of the mechanism by which a moderator variable functions to disadvantage or advantage a subgroup (ideally, with behavioral and/ or biological data that support the mechanism hypothesis).

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period	Scope of the proposed project should determine the project period. The maximum period is 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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

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

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

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.

The forms package associated with this FOA includes all applicable components, mandatory 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.

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

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

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..

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.

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF 424 (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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

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 SF 424 (R&R) Application Guide.

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

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.

Reviewers will provide an overall impact/priority 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).

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?

Investigator(s)

Are the PD/PIs, 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?

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?

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?

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?

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/priority 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

For 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.

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/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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.

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. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually 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.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Pim Brouwers, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: (301) 433-6000
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2805
Email: [email protected]

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.

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.