Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Mental Health (NIMH) National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Advancing Community-level Approaches to Reduce HIV Infection in Highly Impacted Communities (R21)
Activity Code	R21 Exploratory/Developmental Grant
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-MH-13-091
Companion Funding Opportunity	RFA-MH-13-090, R01 Research Project Grant RFA-MH-13-092, R34 Clinical Trial Planning Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.242, 93.279
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) seeks research to advance our understanding of community-level HIV-prevention and care interventions within geographic locations and specific populations highly impacted by HIV. In targeting communities, this FOA invites applications to address the need for efficacious interventions that simultaneously impact a large number of individuals. These interventions can target communities highly impacted by HIV based on geographic, social, or demographic criteria. Structural interventions and systemic interventions are encouraged. The goal is to lower HIV infections and HIV viral load at a community-level by changing individual behaviors via cost-effective and sustainable means. Interventions proposed in response to this initiative should target communities as defined by geographic proximity, shared goals, and/or common characteristics, which may include but are not limited to race/ethnicity, sexual orientation, social economic status, education level, behavior, and identity. This includes both populations that are vulnerable to HIV infection and individuals living with HIV. Intervention approaches should take into consideration the existing agencies or organizations in the community that are capable of adopting the efficacious community-level interventions that are developed and tested.

Posted Date	July 5, 2012
Open Date (Earliest Submission Date)	December 11, 2012
Letter of Intent Due Date	December 11, 2012
Application Due Date(s)	Not Applicable.
AIDS Application Due Date(s)	January 11, 2013, by 5:00 PM local time of applicant organization.
Scientific Merit Review	March 2013
Advisory Council Review	May 2013
Earliest Start Date(s)	July 2013
Expiration Date	January 12, 2013
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

Purpose

This Funding Opportunity Announcement (FOA) seeks research to advance our understanding of community-level HIV-prevention and care interventions among geographic locations and specific populations highly impacted by HIV. In targeting communities, this FOA invites applications to address the need for efficacious interventions that simultaneously impact a large number of individuals. These interventions can target communities highly impacted by HIV based on spatial, social, or demographic criteria. Structural interventions and systemic interventions are encouraged. The goal is to lower HIV infections and HIV viral load at a community-level by changing individual behaviors via cost-effective and sustainable means. Interventions proposed in response to this initiative should target communities as defined by geographic proximity, shared goals, and/or common characteristics, which may include but are not limited to race/ethnicity, sexual orientation, social economic status, education level, behavior, and identity. This includes both populations that are vulnerable to HIV infection and individuals living with HIV. Intervention approaches should take into consideration the existing agencies or organizations in the community that are capable of adopting the efficacious community-level interventions that are developed and tested.

Research Objectives

Almost three decades of HIV prevention research has resulted in multiple scientifically proven successful behavioral interventions focused on helping individuals reduce HIV-risk behaviors to curb new infections. Many of these interventions have been selected for the Centers for Disease Control and Prevention Diffusion of Effective Behavioral Interventions (CDC DEBI) project. However, most of these interventions are delivered at the individual level and require intensive investment of staff time that is beyond the capability of some agencies and non-governmental organizations (NGOs). These interventions may have limited reach and may not address factors associated with risk at the community level.

Recent US surveillance reports note that people newly diagnosed with HIV are concentrated in specific populations and geographic areas. Men who have sex with men (MSM) are the predominant risk group in the US, comprising 61% of new infections in 2009. Young African American MSM are the only group to experience an increase in new infections between 2006 and 2009. African American and Latino men and women also continue to be disproportionately affected by HIV/AIDS. Additionally, stark geographic disparities in HIV incidence and prevalence exist within the US. These disparities exist at a state level as well as within specific metropolitan areas and support the need for targeted prevention interventions that impact interlocking social networks within communities.

The explanations for these differential infection rates range from background HIV prevalence, access to antiretroviral therapy, stigma associated with HIV testing and HIV disease, and rates of undiagnosed HIV infection within these communities or groups. Additional contributing factors may include policies which inhibit implementation of effective community based prevention measures, limited availability of drug, alcohol and mental health treatment, and factors which limit social stability, making it difficult to maintain contacts with prevention and care systems, as well as maintenance of health care entitlements. Systems of care that serve at-risk individuals (emergency departments, mental health and substance abuse treatment systems) also may have limited capacity to provide adequate HIV prevention and follow-up care despite efforts to integrate HIV prevention into the health care system. These data point to the need for interventions to be developed and tested in high-incidence populations and for interventions to be developed that address the community-level factors that are influencing these high rates of new infections. For example, greater integration, coordination, and linkage between service providers and/or service systems could reduce the numbers of individuals who fail to get tested for HIV or fail to link to care when they test positive. Additionally, community-level interventions reducing HIV stigma and discrimination may improve community rates of HIV testing and primary care entry among HIV infected individuals.

There is increasing recognition that there are factors beyond those at the individual level that play a role in an individual s vulnerability to HIV infection. Environmental influences can be important determinants of health (e.g., number of bars in a neighborhood, 24-hour availability of condoms). For this reason, community-level, structural-level and systems-level interventions have promise to reduce rates of HIV in communities that have been hard hit by the epidemic. Another strength of community approaches is that they can be implemented on a scale that enables measurement of incidence outcomes and meaningful population-based estimates of viral load.

Community-level interventions can seek to reduce HIV risk by modifying community norms, attitudes, and values which can sustain behavior change (Cohen & Scribner, 2000). Interventions can also target conditions outside the control of a single individual by changing the context of risk behaviors within a defined community, often referred to as structural interventions. A handful of interventions targeting specific groups vulnerable to HIV have been developed and evaluated and found to reduce behavior associated with HIV infection (Jones et al., 2008; Kelly, Murphy, Sikkema et al, 1997; Kegeles, Hayes, Pollack, 1999; Lauby et al., 2000). Additionally, approaches have been implemented and tested that result in reduced HIV prevalence. Targeted populations include female, brothel-based sex workers (Basa, Jana, et al 2004), injection drug users (Hurley, Jolley, & Kaldor, 1997), and young, school-aged women (Baird et al., 2010).

In July of 2010, the US National HIV/AIDS Strategy was released. The strategy has three primary goals: 1) reducing the number of people who become infected with HIV, 2) increasing access to care and optimizing health outcomes for people living with HIV, and 3) reducing HIV-related health disparities. In response to the new strategy, the US Government has been implementing various initiatives in order to address these goals, including the Enhanced Comprehensive HIV Prevention Planning and Implementation for Metropolitan Statistical Areas Most Affected by HIV/AIDS (ECHPP). ECHPP aims to provide targeted funding to specific metropolitan areas to reduce the HIV risk and incidence. ECHPP and other initiatives emphasize the comprehensive prevention approach that the US Government is attempting to implement.

In the past few years, a number of advancements have occurred with regards to the development of biomedical HIV prevention strategies [Pre-Exposure Prophylaxis (PrEP), microbicides, circumcision, etc.]. As a result of these findings, research is now needed to advance our understanding of dissemination and implementation issues around community-level prevention strategies that include combination behavioral-biomedical HIV prevention approaches.

Specific Areas of Research Interest

To achieve the goal of advancing our understanding of community level HIV-prevention and care, this initiative will encourage research including, but not limited to:

• Develop and test innovative community-level prevention strategies that include combination behavioral-biomedical HIV prevention approaches in high prevalence communities in ways that advance our understanding of dissemination and implementation.
• Develop and test novel community-level approaches that address the need to integrate/coordinate HIV prevention and care with more comprehensive responses to social service needs. Approaches that address service integration at the level of the provider or service delivery system are encouraged.
• Evaluate community, state, and federal policies in communities highly impacted by HIV that facilitate or hamper comprehensive strategies that include increased utilization of voluntary counseling and testing; increased enrollment in primary HIV medical care; improved treatment adherence and retention that reduces viral load; and prevention programs designed for HIV-positive individuals.
• Evaluate how novel strategies may improve the implementation of policies that are known to reduce HIV incidence.
• Develop and test community-level interventions to reduce HIV related stigma and discrimination, with the goal of improving community rates of HIV testing and primary care entry among HIV infected individuals.
• Advance and improve HIV screening, surveillance activities, and community viral load measurement to identify populations at greatest risk that need to be targeted for HIV prevention services and optimal means to reach them.
• Develop and test interventions that improve the linkage between community-based sites for testing and prevention counseling and organizations that provide HIV care or human services needed to facilitate risk reduction (e.g., drug treatment, housing, social services). Interventions should focus on coordination among agencies and/or funding streams rather than on patient-level (e.g., case management) interventions.

This initiative corresponds to the priorities of the National HIV/AIDS Strategy for the United States, which seeks to Adopt community-level approaches to reduce HIV infection in high-risk communities as one of the principal means for achieving the central priorities of Reducing HIV-related disparities and health inequities. These priorities are further represented within the NIH Office of AIDS Research (NIH OAR) Trans-NIH Plan for HIV Research. Applicants should include collaborations necessary for successful implementation and evaluation of the interventions (e.g., service settings, community organizations, representatives of targeted communities, jurisdictional health departments). Lastly, when possible, applicants should include clinical outcome measures in addition to behavioral outcome data.

References

Basu, I, Jana, S, Rotheram-Borus, MJ, Swendeman, D, Lee, SJ, Newman, P, & Weiss, R (2004). HIV prevention among sex workers in India. J Acquir Immune Defic Syndr, 36(3), 845-52.

CDC AIDS Community Demonstration Projects Research Group (1999). Community-level HIV intervention in 5 cities: final outcome data from the CDC AIDS Community Demonstration Projects. American Journal of Public Health, 89(3), 336-45.

Cohen, DA & Scribner, R (2000). An STD/HIV prevention intervention framework. AIDS Patient Care STDs, 14(1), 37-45.

Jones, KT, Gray, P, Whiteside, O, Wang, T, Bost, D, Dunbar, E, Foust, E, & Johnson, WD (2008). Evaluation of an HIV prevention intervention adapted for black men who have sex with men. American Journal of Public Health, 98(6), 1043-50.

Kelly, JA, Murphy, DA, Sikkema, KJ et al (1997). Randomized, controlled, community-level HIV-prevention intervention for sexual-risk behavior among homosexual men in US cities. Community HIV Prevention Research Collaborative. Lancet, 350(9090), 1500-5.

Kegeles, Hayes, Pollack, & Coates, TJ (1999). Mobilizing young gay and bisexual men for HIV prevention: a two-community study. AIDS, 13(13), 1753-62.

Lauby, JL, Smith, PJ, Stark, M, Person, B, & Adams, J (2000). A community-level HIV prevention intervention for inner-city women: results of the women and infants demonstration projects. American Journal of Public Health, 90(2), 216-22.

Prejean, J, Song, R, Hernandez, A, Ziebell, R, Green T, Walker, F, Lin, LS, An, Q, Mermin, J, Lansky, A, Hall HI, for the HIV Incidence Surveillance Group (2011). PLoS ONE, 6(8), e17502.

Funding Instrument	Grant
Application Types Allowed	New 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 participating Institutes intend to commit approximately $2,500,000 in FY 2013 to fund up to 6-8 awards in response to this FOA and the companion announcements.
Award Budget	Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Although treated as direct costs, consortium Facilities and Administrative costs do not apply toward the direct cost cap.
Award Project Period	The total project period for an application submitted in response to this FOA may not exceed two 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 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 not 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 Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 4-6 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(s)/Principal Investigator(s) (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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) 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.

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.

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

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

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Susannah Allison
Division of AIDS Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6116, MSC 9619
Bethesda, MD 20892
Telephone: 301-443-3952
Email: [email protected]

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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(s)/PI(s) 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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? Does the project hold the potential to inform or advance strategies that could reduce rates of new infections in communities or populations highly impacted by HIV?

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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are appropriate expertise and collaboration present from providers in the settings/communities where the research will be conducted?

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? Does the project propose novel approaches to advance community-level HIV-prevention and care interventions among geographic locations and specific populations highly impacted by HIV?

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? Is the proposed approach toward research participant recruitment and enrollment likely to be feasible and successful?  For intervention studies, does the project propose to develop or test an intervention approach which is likely to be feasible within existing HIV prevention, testing, care, and treatment settings?

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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Council and the National Advisory Council on Drug Abuse. 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.
• Compliance with resource sharing policies.

After the peer review of the application is completed, the PD(s)/PI(s) 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]

Susannah Allison, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3952
Email: [email protected]

Richard Jenkins, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-1923
Email: [email protected]

Robert Freund, Ph.D.
Center for Scientific Review
Telephone: 301-435-1050
Email: [email protected]

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

Maryellen Connell
National Institute on Drug Abuse (NIDA)
Telephone: 301-774-3803
Email: [email protected]

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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.