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.

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 purpose of the U.S.-Russia Bilateral Collaborative Research Partnerships (CRP) on the prevention and treatment of HIV/AIDS and its comorbidities is to support innovative basic and multidisciplinary research for the prevention and treatment of HIV infection that will advance the field of HIV/AIDS research through the collaborative efforts of U.S. and Russian investigators and their institutions.

The National Institutes of Health (NIH) supports international collaborative research and research training on HIV/AIDS and the exchange of scientific information by HIV/AIDS researchers around the world. Scientific cooperation between the U.S. and Russia has been strengthened through joint research to address the global HIV/AIDS pandemic. Further targeted cooperative research and capacity building focused on HIV/AIDS and its comorbidities would be of mutual benefit to both countries.

The focus of this effort is joint HIV/AIDS studies between American and Russian research scientists affiliated with universities, research institutes, and other organizations and centers engaged in fundamental biomedical research, integrated with socio-behavioral components. A Memorandum of Understanding (MOU) signed in 2011 between the NIH and the RFBR (and renewed in 2015) seeks to facilitate and support collaborative research partnerships (CRPs) among these researchers and institutions.

This FOA further supports the MOU and the CRPs among researchers and institutions in the U.S. and Russia. Applications may be derived from collaborations with an established history of interaction, or from new partnerships developed in response to this FOA. The CRP must be based on interactive relationships that maximize the expertise of the individual U.S. and Russian research teams and interactions between their parent institutions and granting agencies. It is expected that this unique opportunity available through the U.S.-Russia CRP will foster collaborative partnerships that will mature into joint programs to pursue and develop HIV/AIDS prevention strategies/interventions beyond the scope of the work proposed in the application.

U.S. investigators who submit applications to this FOA are required to have a Russian collaborator who submits a parallel application to RFBR in order to be responsive. The applications must have identical project titles and content to both NIH and RFBR. Joint research projects between U.S. and Russian scientists on fundamental and multidisciplinary research in the field of the prevention and treatment of HIV/AIDS and its comorbidities are the focus of this FOA. By fundamental research, NIH refers to science that is directed toward increasing knowledge and understanding in behavioral, social, and biomedical research topics that will eventually impact HIV/AIDS and HIV-associated co-infections, comorbidities, and complications. These efforts form the scientific basis for subsequent advances in interventions and large-scale clinical testing of interventions in the biomedical disciplines, which may include: research in basic microbiology, basic virology, basic immunology, and pathogenesis and these studies may eventually contribute to the development of a vaccine, microbicide, or therapeutic drug. In the behavioral and social sciences, this would include basic studies (e.g., formative research, mixed-methods studies) to better understand the factors that contribute to HIV-testing, linkage and retention in HIV care, treatment adherence, and HIV prevention behaviors. A better understanding of these processes may lead to the development of more effective behavioral interventions.

Fundamental and multidisciplinary research, including capacity building, is encouraged in accordance with the NIH Director s statement describing the new NIH overarching AIDS research priorities, at the following link: http://www.nih.gov/about/director/08122015_statement_aids_pandemic.htm, and the accompanying NOT accessible at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html. The following topic areas are of particular interest, as they relate to a variety of HIV-affected and vulnerable populations (e.g., men who have sex with men (MSM), alcohol and drug users, women):

• Research toward a cure for HIV/AIDS including studies on: HIV reservoirs, latency, and persistence; screening and testing of novel compounds; developing and testing novel approaches to combining virologic-, immunologic-, and cell-based therapies, as well as strategies to activate latent virus;
• HIV treatment research, including the utility of biomarkers to assess use, adherence to treatment, and other HIV outcomes;
• HIV prevention in high-risk groups, including assessment of the acceptability, use, and adherence to prevention technologies.
• Multidisciplinary biomedical and behavioral research to enhance HIV testing, entry and retention in care, and treatment adherence with a focus on viral suppression in vulnerable and high-risk populations ("care cascade/continuum");
• Basic research on inflammatory processes related to HIV infection;
• Molecular biology and immunology studies on HIV disease and HIV-related co-morbidities, including microbiome studies;
• Genomic studies to identify or characterize genomic factors that improve the understanding of HIV pathogenesis, and that may affect or predict the effectiveness of prevention and/or intervention strategies for HIV and HIV-associated comorbidities;
• Research on HIV-associated co-infections, comorbidities and other complications related to HIV and/or consequences of ARV therapy, including pathophysiology of single and multiple comorbidities and the bio-behavioral intersection of these multi-morbidities; and
• Integration of epidemiological, social, and psychological aspects of HIV/AIDS in Russia and the United States as they pertain to the above priorities.

Applicants are also encouraged to integrate these important domains - for example, a study to examine behavioral/adherence facilitators of microbicide use, or studies regarding the basic science or genomics of HIV in the context of viral reservoirs.

Examples of topic areas that may be supported include, but are not limited to:

1. HIV Prevention

• Studies designed to evaluate individual or community-based prevention outreach and interventions targeted to adult men or women at risk for HIV through high-risk sexual behaviors, drug or alcohol use, or pre-existing mental health disorders.
• Studies to expand the battery of reliable and valid assessment tools to inform biomedical HIV prevention-product acceptability (e.g., microbicides), measure risk taking, and assess adherence to study regimens and HIV prevention guidelines.

2. Improving HIV Treatment Outcomes and HIV/AIDS Care Continuum

• Research that addresses issues related to living with and treating HIV at different ages and/or over the lifespan/life course (e.g., frailty).
• Utility of biomarkers to assess use, adherence to treatment, and other HIV outcomes.
• Research to enhance uptake, adherence, and persistence of PrEP for populations at high risk for acquiring HIV infection, including:
• Approaches to identify potential candidates for PrEP.
• Development and validation of tools to help individuals and clinicians make informed decisions about initiation/discontinuation.
• Studies of the interaction of comorbidities and contextual factors and retention in PrEP care.
• Innovations to increase retention in HIV care, including:
• System and structural approaches to improve care quality.
• Approaches to predict and prevent disengagement from care, interventions to address comorbid mental health issues, and tests of innovative models for care to enhance retention in care.
• Studies of innovative strategies to facilitate linkage to medical care after HIV-testing, and to promote treatment initiation and adherence, retention in HIV care and transmission risk reduction in adult populations.
• Identify implementation barriers (behavioral, structural, other) to treat and prevent HIV and its comorbidities while addressing health disparities.

3. Research Toward a Cure for HIV/AIDS

• Develop and evaluate novel strategies (such as novel imaging techniques) to detect, measure, and eliminate HIV reservoirs in the central nervous system (CNS), including studies of viral persistence, latency, and reactivation.

4. Prevention and Treatment of HIV-associated Comorbidities, Co-infections, and Related Complications

A. Cancer

• Epidemiologic studies to assess spectrum, incidence, prevalence and burden of cancers in persons infected with HIV.
• Studies to understand unusual patterns in the epidemiology of HIV-associated cancers in Russia.
• Strategies for optimizing prevention, screening, diagnosis, and treatment of cancers occurring in persons infected with HIV.
• Studies on developing optimal therapy for HIV-associated cancers.
• Research to understand the pathogenesis of HIV-associated cancers and genomic and epigenomic differences between similar tumors in HIV negative patients.
• Studies aimed at elucidating modifiable host risk factors (e.g., smoking) that interact with HIV and impact the risks of HIV-associated malignancies (e.g., lung cancer).

B. HIV-Associated Neurological and Neurocognitive Disorders

• HIV-associated neurocognitive disorders (HAND) in the HAART era
• Investigate the molecular mechanisms of HIV neuropathogenesis
• Develop novel biomarkers for detecting HAND
• Develop therapeutic strategies
• Effects of chronic HIV infection and antiretroviral therapy on:
• Immune reconstitution syndrome
• Accelerated aging
• Stroke and microvascular disease
• Neurodegenerative disease such as Parkinson’s disease and motor neuron disease
• Co-infections: Hepatitis C, JCV-associated Progressive multifocal leukoencephalopathy (PML), toxoplasmosis, etc.

C. Mental Health

• Studies to understand which mental disorders, including symptom clusters, are most associated with specific HIV/AIDS treatment and health outcomes (e.g., linkage to care, treatment adherence, morbidity and mortality).
• Studies integrating HIV testing approaches and linkage into mental health services, and mental disorder screening and linkage into HIV prevention and treatment.

D. Co-Infections

• Understand the role of other HIV comorbidities in increasing the morbidity and mortality of individuals infected with Hepatitis B or C and to assess the impact of available treatments for patients with acute Hepatitis C.
• Studies evaluating HIV/TB drug interactions and toxicities among vulnerable groups and high-risk adults (e.g., drinkers).

E. Continuum of Alcohol Use, Alcohol Use Disorders

• Interventions:
• Developmental studies to better define and pilot interventions addressing the social and behavioral factors associated with a continuum of alcohol use which affect utilization of HIV testing, treatment, and alcohol/HIV risk reduction counseling.
• Studies of the effectiveness of HIV prevention interventions targeting specific high-risk alcohol use venues such as settings where adults or at-risk youth may congregate, as well as in medical and health care settings concerned with the treatment of alcohol and associated co-occurring disorders.
• Interventions to mitigate the impact of alcohol-exposed pregnancies for HIV+ mothers, neonates, and infants.
• Studies of the role of alcohol use treatment practices on the recruitment, retention, and integration of affected individuals into HIV treatment and prevention programs and its impact on the care continuum, aging/frailty.
• Understand the role of acute and chronic alcohol consumption on neurodegeneration and the impact of alcohol tolerance and withdrawal on HIV outcomes related to neuropathogenesis and stress associated with vascular disease and viral control.
• Testing and development of next generation HIV therapies with better safety and ease of use over the life span for people who drink, including those individuals who are unable to tolerate therapies due to current and/or past alcohol use patterns or individuals at risk for medication-related toxicities due to current and/or past alcohol use patterns.
• Co-Infections, Other Comorbidities:
• Understand the role of alcohol consumption in increasing the morbidity and mortality of individuals co-infected with Hepatitis B or C and to estimate the impact of available treatments for patients with acute Hepatitis C.
• Understand the role of alcohol use in the progression of cardiovascular, lung, blood and metabolic disorders among HIV+ patients, particularly in the context of hepatotoxicity and continued inflammatory response related to alcohol-related microbial translocation in the gut.
• Understand the role of acute and chronic alcohol consumption in mediating the acquisition and progression of cancers among HIV positive individuals, including cancers of the liver, throat, and genitals and to improve the assessment of alcohol-related cancer risk in the context of other comorbidities (e.g., smoking, Hepatitis C).
• Develop HIV/TB/alcohol-focused pharmacological and behavioral interventions to improve treatment outcomes and interrupt transmission of TB and MDR-TB in HIV+ individuals who are also acute and chronic alcohol users.

F. Injection and Non-Injection Drug Use

• Basic, biomedical, prevention, and treatment research to reduce and mitigate the impact of HIV and HIV-associated co-infections, comorbidities and complications in the context of injection and non-injection drug use disorders.
• Basic/Biomedical

  o Target HIV/HCV co-infection, cardiovascular, neuro/neuropsychiatric, hepatic, renal, metabolic and aging-related complications associated with HIV, ART and drug use disorders.

  o Pathophysiology of single and multiple comorbidities.

  o Bio-behavioral intersection of these multi-morbidities.

  o Basic research on HIV inflammatory processes, viral-drug interactions, and molecular mechanisms in the context of drug use; genomic, epi-genomic and systems biology approaches.

  o Basic science related to HIV viral persistence/latency in brain or peripheral systems in the context of drug use.

• HIV Prevention Models

  o Seek, Test, Treat, and Retain: targeted HIV testing outreach, linkage to prevention and treatment; screening and prevention for HIV co-infections and comorbidities associated with drug use disorders.

  o HIV Treatment as Prevention tailored to persons with drug use disorders: combination biomedical and behavioral approaches, such as PrEP and initiation of immediate treatment in HIV positives to reduce viral load.

• HIV Treatment/Care Continuum Models

  o Maintain long-term engagement and adherence in HIV care and prevention, optimize treatment approaches to achieve sustained viral suppression and reduce associated morbidities in persons with drug use disorders.

  o Inclusion of medication-assisted treatment (MAT) for drug use disorders as components of HIV treatment and care.

  o Use of novel HIV therapeutics such as long-acting formulations to improve adherence in persons with drug use disorders.

  o Optimize existing venues and approaches for HIV outreach and intervention delivery in persons with drug use disorders.

  o Adapt cost effective models to improve coverage and impact of prevention and care in persons with drug use disorders.

  o Develop single venue settings for multiple needs: prevention, treatment and care for HIV, drug use, and HIV comorbidities such as TB and HCV.

5. Basic Research and Cross-Cutting Areas

• Basic research on inflammatory processes related to HIV infection and associated comorbidities.
• Molecular biology and immunology studies on HIV disease and HIV-related comorbidities, including microbiome studies.
• Studies on oncogenic viruses (e.g., KSHV, HPV, EBV, or Hepatitis B and C viruses), in the context of HIV infection.
• Studies of the biology of HIV transmission, including horizontal transmission.
• Studies using genomic or proteomic technologies to identify or test surrogate efficacy and/or behavioral correlates to measure the impact of a HIV prevention strategy or alter its implementation.
• Studies to identify or characterize genomic factors and genetic variability of HIV and the host that are associated with protection from or risk of acquiring HIV infection and associated comorbidities.
• Basic behavioral and biological research, including research on health disparities, in key HIV-infected and vulnerable populations (e.g., MSM, newly infected, minorities, women), and cross-training for HIV researchers in the use of new tools/techniques or for capacity building.

Applications in the following areas will be considered non-responsive and will be not be reviewed:

• This U.S.-Russia CRP requires that U.S. investigators applying to this FOA must have a collaborative partnership with Russian investigators who need to apply to the Russian Foundation for Basic Research (RFBR). Russian investigators need to submit a parallel application to the RFBR to ensure eligibility of the U.S. applicant to NIH. NIH applications that lack a Russian parallel research activity will not be considered responsive to this FOA.
• Applications not responsive to the NIH Office of AIDS Research NOT-OD-15-137 will NOT be considered.
• Clinical studies requiring an Investigative New Drug (IND), including Phase 0 (Exploratory), Phase I, Phase II and Phase III clinical trials. Non-IND studies to assess behavioral, social and/or epidemiological parameters associated with HIV, co-infections, and HIV-associated comorbidities are responsive and will be accepted.
• Development and/or incremental modification of a microbicide-based prevention strategy derived primarily from a detergent, surfactant, non-specific membrane active agent; over-the-counter products (OTC); non-specific female/male vaginal and/or rectal health products as a single or combination prevention strategy.
• Random or bulk screening (high through-put screening) of compound libraries or collections for potential anti-microbials, including HIV, STIs associated with HIV acquisition and/or pathogens associated with HIV-associated comorbidities.
• Screening efforts to identify new therapeutics for the cancers or STIs-associated with HIV acquisition.
• Clinical delivery of treatment and/or evaluation of clinical delivery methods (i.e., drugs, formulations, health foods, vitamins, Ayurvedic medicines or formulations) to individuals or populations for HIV/AIDS, opportunistic infections (OIs), co-infections or comorbidities.

See Section VIII. Other Information for award authorities and regulations.

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:

0 Hispanic-serving Institutions

0 Historically Black Colleges and Universities (HBCUs)

0 Tribally Controlled Colleges and Universities (TCCUs)

0 Alaska Native and Native Hawaiian Serving Institutions

0 Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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 allowed.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

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.

The PD(s)/PI(s) must be from a U.S. institution

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants must obtain 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, including Supplemental Grant Application Instructions 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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Abraham Bautista, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-443-9737
Email: bautista@mail.nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed. The collaborating partners must submit separate applications with identical project titles.

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

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

All instructions in the SF424 (R&R) Application Guide must be followed. The application must name an investigator from a Russian institution as a collaborating partner.

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

Applicants should include only budget information for the activities for which they are requesting NIH support. Do not include budget support for the activities that will be requested by the corresponding RFBR application and funded by the RFBR.

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

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

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

Research Strategy: Applicants should demonstrate the interdisciplinary nature of the research teams as a whole and the engagement of early-career investigators, and how the application will improve dissemination and translation of collaborative research findings.

Letters of Support: Applicants should include a Letter of Collaboration co-written and co-signed by the PD(s)/PI(s) and the Russian collaborating partner and co-signed by the authorized institutional officials confirming the new collaboration and confirming that the U.S. collaborator will provide a PDF copy of the NIH submitted application to the RFBR through their Russian collaborating partner.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans 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.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

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.

All applications recommended for funding must be pre-approved for funding by the NIH Office of AIDS Research.

The NIH will make awards to the U.S. institution, while the RFBR will make awards to the Russian collaborator.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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? Have the investigators described the general strengths and weaknesses of the prior research cited in the application as crucial to support the research?

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?

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 the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Have the investigators considered the general strengths and weaknesses that could include attention to the rigor of the previous experimental designs?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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 score, but will not give separate scores for these items.

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

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 score.

US-Russia Review Consideration

Reviewers will comment on the interdisciplinary nature of the research teams and the engagement of early-career investigators, and how the application will improve dissemination and translation of collaborative research findings.

Not Applicable

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 Center for Scientific Review, 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:

• 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 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 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 submitted in response to this FOA. 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Geraldina Dominguez, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-496-3204
Email: domingug@mail.nih.gov

Kendall Bryant, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0332
Email: kbryant@willco.niaaa.nih.gov

Jag H. Khalsa, MS, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2159
Email: jkhalsa@nida.nih.gov

Christopher M. Gordon, Ph.D.
National Institute on Mental Health (NIMH)
Telephone: 240-627-3867
Email: cgordon1@mail.nih.gov

May Wong, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1431
Email: wongm@ninds.nih.gov

Robert Freund, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1050
Email: freundr@csr.nih.gov

Shane Woodward
National Cancer Institute (NCI)
Telephone: 301-496-8791
Email: woodwards@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Pamela Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-253-8729
Email: pfleming@nida.nih.gov

Rita Sisco
National Institute on Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov

Tijuanna DeCoster
National Institute on Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

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 Part 75.