Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA) National Cancer Institute (NCI) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Mental Health (NIMH)
Funding Opportunity Title	U.S.-Russia Bilateral Collaborative Research Partnerships (CRP) on the Prevention and Treatment of HIV/AIDS and Co-morbidities (R21)
Activity Code	R21 Exploratory/Developmental Research Grant Award
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-DA-14-001
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.242, 93.273, 93.279, 93.393, 93.394, 93.395, 93.396, 93.399, 93.855, 93.856, 93.865
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) solicits Exploratory/Developmental (R21) applications from United Stated U.S.-based institutions with a Russia-institution partner in collaboration with the Russian Foundation for Basic Research (RFBR) to establish Collaborative Research Partnerships (CRP) in the field of HIV/AIDS in science that is directed toward increasing knowledge and understanding in behavioral, social, and biomedical topics that will eventually impact HIV/AIDS and HIV-associated co-infections, co-morbidities, and complications. The U.S.-Russia Bilateral CRP Program is designed to develop collaborations between scientists and institutions in the U.S. and Russia to conduct high quality HIV/AIDS research of mutual interest and benefit to both countries while developing the basis for future institutional and individual scientific collaborations. This FOA will utilize the research capacities of the institutions and scientists in both countries to advance the field of HIV/AIDS research and to develop preliminary data that may support a more extensive future research proposal to test an HIV/AIDS prevention and treatment program. It is expected as part of the U.S.-Russia collaboration that awardees will foster collaborative efforts, including but not limited to joint publications, poster and/or oral presentations.

Posted Date	November 16, 2012
Open Date (Earliest Submission Date)	December 15, 2012
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	January 15, 2013, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	March 2013
Advisory Council Review	May 2013
Earliest Start Date	October 2013
Expiration Date	January 16, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

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

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 is to support innovative and basic research for the prevention and treatment of HIV infection and transmission that will advance the field of HIV/AIDS research through the collaborative efforts of United States 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 during the global HIV/AIDS pandemic has been strengthened between the U.S. and Russia. Further cooperative research and capacity-building focused on HIV/AIDS would be of mutual benefit to both countries. This effort is under the auspices of the U.S.-Russia Bilateral Presidential Commission and references the Memorandum of Understanding between the Department of Health and Human Services of the United States of America and the Ministry of Health and Social Development of the Russian Federation on Cooperation in the field of Public Health and Medical Science, signed on July 6, 2009. The focus of this effort is joint HIV prevention studies between American and Russian research scientists affiliated with universities, research institutes, and other organizations and centers engaged in fundamental biomedical and behavioral research. The studies may include but are not limited to the support of HIV genomics, HIV-associated co-infections, and HIV-associated co-morbidities. An agreement signed in 2011 between the NIH and the RFBR seeks to facilitate and support collaborative research partnerships (CRPs) among researchers and institutions in the U.S. and Russia.

A critical feature of this FOA is the establishment and support of Collaborative Research Partnerships (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 R21 application.

Joint research projects between U.S. and Russian scientists on fundamental and applied research in the field of HIV prevention and treatment 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 topics that will eventually impact HIV/AIDS and HIV-associated co-infections, co-morbidities, and complications. These efforts form the scientific basis for subsequent advances in interventions and large-scale clinical testing of interventions in the biomedical disciplines, this could include: research in basic microbiology, basic virology, basic immunology, and pathogenesis; 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. Development and small-scale testing of innovative interventions also would be considered as fundamental and social science research.

Fundamental and applied research including capacity building is encouraged in a variety of HIV-affected populations (for example, women, Men who have Sex with Men (MSM), substance users, and adolescents) in the following priority areas:

• 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 cellular-based therapies, as well as strategies to activate latent virus; and adherence to treatment regimens, as well as research at the individual, community, and population levels on developing and applying a cure for HIV/AIDS.
• HIV vaccines, vaccines in the context of HIV disease, and vaccines for co-infections in the context of HIV disease
• Microbicides
• Molecular biology and immunology studies on HIV disease and HIV-related co-morbidities including microbiome studies
• Behavioral and social science research
• 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 co-morbidities

• Tuberculosis research that is applicable to TB/HIV co-infection
• Co-morbidities of HIV, for example, HIV-associated cancers or liver disease, and studies on etiologies of such co-morbidities including, for example, EBV or Hepatitis B and C viruses in the context of HIV infection
• Behavioral and integrated biomedical and behavioral research to address the intersection of injection and non-injection drug use, alcohol abuse, and mental health problems for individuals at risk for or with HIV/AIDS.

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 vaccine development.

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

Basic Science of HIV

• Studies to develop and enhance a range of laboratory assays to evaluate vaccine-induced blood and mucosal human immune responses that may be protective
• Studies of the biology of HIV transmission, including horizontal and vertical (perinatal) transmission
• Identify the tissue and cellular reservoirs of latent HIV in vivo
• Develop tools to measure and quantify HIV in reservoirs such as novel imaging techniques
• Develop novel strategies to inhibit HIV integration into host DNA and prevent the establishment of latency and define the molecular mechanisms that lead to the initial establishment, subsequent maintenance, and reactivation of latently infected cells
• Develop and evaluate novel mechanisms to eliminate HIV reservoirs or prevent viral reactivation in latently infected cells

Microbicides

• Studies to understand the effects of adherence to product, including the implications for product efficacy, effects on the risk for resistance during and after efficacy trials of antiretroviral treatment (ARV)-based prevention strategies, differential effects by sex, population level impacts, etc.
• 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
• Preclinical developmental studies of microbicides and other pre-exposure prophylaxis (PrEP) modalities
• Studies focused on the safety, acceptability, pharmacokinetics, and pharmacogenomics of microbicides and other PrEP agents in adolescents and adults

Vaccines

• Studies of immunogenic reagents in phase I/II studies -- to address specific scientific questions, designing studies clearly outside the critical pathway of product development, but important in forwarding vaccine discovery
• Studies of the feasibility and acceptability of testing vaccines in specific populations at risk for HIV infection
• Studies to improve the range of laboratory assays to evaluate vaccine-induced blood and mucosal human immune responses that may be protective
• Studies to design a simple to use, rapid HIV point-of-care diagnostic device for use in resource-limited settings that can distinguish HIV-infected from seronegative vaccinated individuals, as well as identify acute infection
• Studies of the behavioral and social aspects of vaccine interventions in preventing HIV infection

Behavioral and Social Science

• The design, development, and testing of studies of individual and community based strategies to improve access, engagement and sustained participation of most at-risk populations in HIV research. Such populations include but are not limited to men who have sex with men, adolescents, female sex workers, and persons with mental health and substance abuse disorders
• Studies designed to evaluate individual or community-based prevention outreach and interventions targeted to adolescents, labor migrants or adult men or women at risk for HIV through high-risk sexual behaviors, drug or alcohol use, and/or pre-existing mental disorders
• 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 pediatric, adolescent and adult populations
• Studies to examine behavior change in health care providers in clinics and other health care providing agencies to make the facilities more accessible to individuals at risk of infection
• Culturally competent studies of behavioral decision-making under conditions of uncertainty, including but not limited to individuals understandings of partial efficacy, and possible preventive misconceptions about the efficacy of experimental products or the benefits of participation in clinical trials (for microbicides, PrEP, vaccines, other interventions)
• Studies addressing prevention of mother-to-child HIV transmission, increasing HIV testing in antenatal settings, and/or use of antiretroviral prophylaxis to prevent transmission

Co-Morbidities

• Tuberculosis (TB)
  • Studies of immunologic interaction between TB and HIV infection and immunologic differences between TB monoinfection and TB/HIV co-infection
  • Evaluation of immune-modulatory agents that can improve the treatment of TB in co-infected individuals
  • Delineation of pathophysiologic characteristics of TB disease and latent infection
  • Studies designed to identify or validate biomarkers of TB activation, risk and/or disease progression, treatment efficacy, disease relapse after treatment and correlates of immunity in HIV/TB co-infected individuals
  • Risk factor studies for the development of drug resistance in HIV/TB co-infected individuals
  • Studies of risk factors for TB transmission among HIV-infected individuals
  • Studies of treatment and clinical outcomes among HIV/TB co-infected pregnant woman and their infants
  • Studies to develop and test improved pediatric TB diagnostics, and diagnostic and management strategies
  • Studies evaluating anti-HIV and anti-TB drug interactions and toxicities among children, pregnant women, and adults
  • Elucidation of the mechanisms of resistance to TB drugs
  • Comparative microbial molecular epidemiology of TB and associated drug resistance in HIV co-infected and uninfected populations
• Cancer
  • Studies on the interactions between HIV and oncogenic viruses such as Human Papilloma Virus (HPV), Epstein-Barr Virus (EBV), Kaposi’s Sarcoma-associated Herpes Virus, and Hepatitis B and C Virus (HBV and HCV) and cancer development
  • Systematic studies to collect information on incidence/prevalence and outcomes of HIV-associated malignancies
  • Studies aimed at elucidating epidemiological factors that impact the risks, and region specific patterns of HIV-associated malignancies, including viral, host, behavioral and other host genetic factors
• Non-injection and Injection Drug Use, Alcohol Use and Abuse
  • Developmental studies to better define and pilot interventions addressing the social and behavioral factors associated with drug and alcohol use which affect utilization of HIV testing, treatment, and sexual and substance use risk reduction counseling
  • Studies of medical and behavioral treatment interventions for drug and/or alcohol abuse in combination with biomedical treatment for HIV and its associated co-morbidities such as HCV and TB
  • Studies of HIV prevention interventions targeting specific high-risk 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 /or drug use disorders
  • Studies of the role of drug abuse and alcoholism on the recruitment, retention, and adherence of affected individuals into treatment and prevention
  • Studies of viral transmission/resistance patterns in the context of drug/alcohol use

Genomics

• Studies using genomic or proteomic approaches to understand host-infectious agent interactions and implications in the pathogenesis of disease
• Studies using genetic, epigenetic and proteomic approaches to elucidate differences in histologically comparable malignancies in HIV-infected and HIV-uninfected individuals
• Studies using genomic or proteomic technologies to identify or test surrogate safety, efficacy and/or behavioral correlates to measure the impact of the prevention strategy or alter its implementation
• Studies using genomic, epigenomic or proteomic technologies to understand the impact of substance abuse on HIV transmission dynamics and pathogenesis
• Studies to identify or characterize genomic factors that are associated with protection from HIV acquisition or disease progression
• Studies of the genetic variability of HIV and of the host, at sites that are conducting or may conduct future HIV vaccine, microbicides, or treatment as prevention (pre-exposure prophylaxis) clinical trials

Applications in the following areas will NOT be considered responsive and will be returned without review:

• Clinical studies requiring an 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, STI co-infection and HIV-associated co-morbidities are responsive and will be accepted as long as there is no clinical intervention.
• 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 co-morbidities.
• Screening efforts to identify new therapeutics for the cancers or STIs-associated with HIV acquisition.
• Delivery of treatment (i.e., drugs, formulations, health foods, vitamins, Ayurvedic medicines or formulations) to individuals or populations for HIV/AIDS, opportunistic infections (OIs), co-infections or co-morbidities.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	It is anticipated that $3 million will be available in FY 2014 to fund 8 to 10 new awards. The Russian Foundation for Basic Research will issue a similar announcement to support the Russian collaborators. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
Award Budget	The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
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
• 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 must complete the following registrations as described in the SF424 (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.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (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 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(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.

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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

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

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

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

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following addition:

• The Collaborative Strategy, which is uploaded via "Other Attachments" should not exceed 3 pages.

The NIH modular budget concept is NOT to be used. Even though the budget for the R21 phase is limited, applications must present the detailed SF424 (R&R) Budget forms for all years. The budget justification must include information about where the funds will be utilized.

Other Attachments. Applicants are required to include a Collaborative Strategy as an "Other Attachment." The Collaborative Strategy must include a description of the following information:

• How the collaboration will be established;
• How the collaboration will be maintained by the U.S. and Russian partners;
• Well-defined and identifiable responsibilities for the U.S. PD/PI and Russian collaborator;
• The governance and organizational structure of the collaboration;
• The plans for communication;
• The process for making decisions on scientific direction, and procedures for resolving conflicts.
• The contingency plans for setbacks and delays; and
• Plans for contribution and coordination of resources including individual contributions of specific reagents, i.e., patient samples, compounds, and access to populations for epidemiological and behavioral studies.

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

Specific Aims

Within the page limit, indicate which partner of the collaboration (U.S., Russia, or jointly) will be responsible for accomplishment for each proposed specific aim.

Research Strategy

Applicants should propose a single Research Plan for the combined efforts of the two organizations (U.S. and Russian collaborators). The Research Strategy should provide a complete description of the research, demonstrating the integration of the two researchers efforts. Within the page limitation of the Research Strategy section, there needs to be a plan for how resources will be shared and detail how the coordination will benefit HIV/AIDS prevention and treatment science.

In preparing the R21 application, investigators should consider clarity and completeness of the application with regard to specific goals and the proposed interactions of the U.S. and Russian collaborators. A poorly developed collaboration strategy that is not sufficient for assessing the potential for a successful R21 research effort may reflect poorly on the scientific merit of the application.

The duration and resources of the R21 exploratory/developmental grant mechanism do not allow for the conclusive and powered testing of proposed single and combination prevention and treatment strategies. However, this mechanism does accommodate the performance of incremental studies or interventions that can either support progression to more comprehensive studies or provide evidence that the proposed intervention is not effective. CRP applications should incorporate activities that can test and pilot specific prevention and treatment interventions.

The proposed studies must take into account the time limit and budget imposed by this mechanism (See Section II: Award Information). Where possible, the proposed studies should interact with ongoing prevention and treatment efforts in the U.S. and Russia and/or propose to integrate with existing Russian government-supported prevention programs, including non-governmental organizations.

Letters of Support

Include letters of support from the Russian partner(s) participating in the research effort.

Resource Sharing Plan

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

Appendix

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before 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 before the deadline 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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

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

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 (SAM). 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.

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.

For this particular announcement, note the following:

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

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

Significance

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

Investigator(s)

Are the PD(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?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

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

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are plans for collaboration and communications between the U.S. and Russian partners well described and as described will they enhance the interactions and contributions of the participating groups?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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 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), 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 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.

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, SAM 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

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]

NIDA

Katherine Davenny, M.P.H.
AIDS Research Program
National Institute on Drug Abuse
Telephone: (301) 443-2146
FAX: (301) 443-9127
Email: [email protected]

NCI

Geraldina Dominguez, Ph.D.
Office of HIV and AIDS Malignancy
National Cancer Institute
Telephone: (301) 496-3204
FAX: (301) 480-4137
Email: [email protected]

NIAAA

Kendall Bryant, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Telephone: (301) 402-9389
FAX: (301) 443-8774
Email: [email protected]

NIAID

Peter Kim, M.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Telephone: (301) 451-2761
FAX: (301) 402-1505
Email: [email protected]

NICHD

Lynne M. Mofenson, M.D.
Chief, Pediatric, Adolescent and Maternal AIDS Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health
Telephone: 301-435-6870
FAX: 301-496-8678
Email: [email protected]
Second new email: [email protected]

NIMH

Christopher M. Gordon, Ph.D.
Chief, Secondary HIV Prevention & Treatment Adherence
Division of AIDS Research
National Institute of Mental Health
Telephone: (301) 443-6100
Email: [email protected]

CSR

Robert Freund, Ph.D.
AIDS & AIDS Related Research IRG
Center for Scientific Review
Telephone: (301) 435-1050
FAX: (301) 594-6363
Email: [email protected]

NIDA

Pamela Fleming
National Institute of Drug Abuse (NIDA)
Phone: (301) 253-8729
FAX: (301) 594-6849
Email: [email protected]

NIAAA

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
FAX: (301) 443-3891
Email: [email protected]

NIAID

Jennifer Schermerhorn
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (301) 451-2649
Email: [email protected]

NCI

Shane Woodward
National Cancer Institute (NCI)
Telephone: (301) 496-8791
FAX: (301) 496-8601
Email: [email protected]

NICHD

Bryan S. Clark, M.B.A.
Chief Grants Management Officer
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Phone: (301) 435-6975
Fax: (301) 451-5510
Email: [email protected]

NIMH

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2805
FAX: (301) 480-1596
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.