Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.  The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of AIDS Research (OAR)

Funding Opportunity Title

U.S.-Brazil Collaborative Biomedical Research Program (R01 Clinical Trial Optional)

Activity Code

R01 Research Project Grant    

Announcement Type

New 

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-18-054

Companion Funding Opportunity

None      

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

93.855; 93.113; 93.865; 93.242; 93.853

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to promote collaborative biomedical research between the United States (U.S.) and Brazil under the U.S.-Brazil Collaborative Biomedical Research Program. Research areas supported under this program include allergy, immunology, and infectious diseases, including HIV/AIDS and its co-morbidities; neurological disorders and stroke, and environmental health sciences.  This program represents an outstanding opportunity for U.S. and Brazil scientists to pursue collaborative research partnerships that address public health topics of mutual benefit to both nations.    

Key Dates

 

Posted Date

December 4, 2018

Open Date (Earliest Submission Date)

February 8, 2019

Letter of Intent Due Date(s)

February 8, 2019

Application Due Date(s)

March 8, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

AIDS Application Due Date(s)

March 8, 2019, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on this date.

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

Scientific Merit Review

June 2019

Advisory Council Review

October 2019  

Earliest Start Date

December 2019

Expiration Date

March 9, 2019  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description
    Purpose

    The purpose of this Funding Opportunity Announcement (FOA) is to promote collaborative biomedical research between the United States (U.S.) and Brazil under the U.S.-Brazil Collaborative Biomedical Research Program. Research areas supported under this program include allergy, immunology, and infectious diseases, including HIV/AIDS and its co-morbidities; neurological disorders and stroke; and environmental health sciences.  This program represents an outstanding opportunity for U.S. and Brazil scientists to pursue collaborative research partnerships that address public health topics of mutual benefit to both nations.

    Background

    The National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) supports international collaborative biomedical research to advance science and expand biomedical knowledge. Scientific cooperation between the U.S. and the Federative Republic of Brazil spans over 50 years. Recognizing that enhanced cooperative biomedical research would be of mutual benefit to the U.S. and Brazil, NIH, the Brazil Ministry of Health (MS), and the Brazil Ministry of Science, Technology, Innovation, and Communication (MCTIC) signed a Letter of Intent in 2014 to establish the jointly funded, collaborative research program, the U.S.-Brazil Collaborative Biomedical Research Program. This collaborative program was strengthened further when the HHS Secretary and Brazil Minister of Health signed a Memorandum of Understanding in 2015 to enhance and expand cooperative efforts in health and medical sciences. A working group made of members from NIH, MS, and MCTIC developed strategic plans for collaboration. The NIH, MS, and MCTIC have allocated resources to support joint activities under this program.

    Structure of the U.S.-Brazil Collaborative Biomedical Research Program

    The structure of the U.S.-Brazil research partnership relies on the submission of a single application prepared jointly by U.S. and Brazilian scientist(s).  This application will be submitted to NIH and peer reviewed using the well-established NIH process at the Center for Scientific Review, which will include a review panel that incorporates the expertise of non-conflicted U.S. and Brazilian scientists in the proposed topic areas.  Funding will be provided to the meritorious application (per NIH peer review) from the U.S. and Brazilian funding agencies.  For successful applicants, the U.S. scientist(s) will receive funds from the NIH and the Brazilian scientist(s) will receive funds from the Brazil MS (http://portalms.saude.gov.br/) through the National Council for Scientific and Technological Development (CNPq) (http://www.cnpq.br/) within the Brazilian Government's MCTIC (http://www.mctic.gov.br/portal). The research project(s) proposed in the application will be a full partnership between the U.S and Brazilian scientists involving a collaboration of joint and mutual benefit to address both U.S. and Brazilian biomedical research questions and/or public health issues.

    By sending an application to NIH, the expectation is that the applicants agree to allow NIH to provide a copy of the submitted application and summary statement to the government of Brazil. Information about the MS and MCTIC funding for the program is provided at http://www.cnpq.br/. The government of Brazil will concurrently advertise this funding partnership opportunity on their website and provide a link to the announcement on the NIH website.  Information regarding the funding process to the Brazilian scientists will be given by the Brazilian Government upon announcement of the final results. This may include the submission of a Portuguese version of the proposal to MS and CNPq. Given this sharing requirement, applicants concerned about confidentiality or proprietary information should take this into account before deciding what information to submit in the application to NIH.

    Funding decisions will be made considering the research priorities of the U.S.-Brazil program. Applications must be determined to be eligible and responsive to the U.S. and Brazilian research interest areas as described in this FOA to be considered for funding under the program. Final funding decisions will be made by the NIH following consideration by the U.S.-Brazil Joint Committee utilizing the NIH peer review results.

    Through this U.S.-Brazil collaboration, projects supported under this FOA will focus on novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research common to the biomedical research needs of the U.S. and Brazilian governments.  This scientific collaboration is expected to be a true partnership between the U.S. and Brazilian scientists, with each providing substantial, responsible leadership for their portion of the project. Inclusion of early career investigators is strongly encouraged. Preliminary data are not required under this FOA.

    Applicants and collaborating partners are expected to adhere to the NIH policies on the use of human subjects and animals in research.  NIH expects awards using animals in research to comply with the animal welfare policies (https://grants.nih.gov/grants/policy/air/NIH_Funded_Resources.htm). Clinical research (https://grants.nih.gov/grants/glossary.htm#ClinicalResearch), clinical trials (https://grants.nih.gov/grants/glossary.htm#ClinicalTrial), and human subjects research (https://humansubjects.nih.gov/) are allowed under this FOA. For this FOA, NIH-defined clinical trials may be proposed only if they meet the definition of “mechanistic study” (https://grants.nih.gov/grants/glossary.htm#MechanisticStudy). NIH-defined clinical trials designed to develop or test treatment approaches or to evaluate safety, efficacy, clinical management, or implementation of an intervention will not be supported under this FOA. For the NIH definition of clinical research versus clinical trials, please see https://grants.nih.gov/policy/clinical-trials/definition.htm. Applicants desiring to conduct such clinical trials should contact the relevant NIH IC prior to submission to review the scope of the proposed clinical trial with the program contact. 

    Scope of the Research Responsive to this FOA

    The research that is responsive to this FOA is listed below. Applicants can obtain more information on the research interests listed below by referencing the websites of the participating Institutes and Brazilian agencies or through the Scientific/Research contacts listed in this announcement. 

    HIV/AIDS and Co-Morbidities

    Reduce Incidence of HIV (Prevention)

    • Developing novel prevention interventions, including combination prevention strategies, that will reduce HIV transmission among key populations in Brazil, including men who have sex with men (MSM), transgender persons, sex workers, pregnant and breastfeeding women and adolescents; addressing ethical challenges of working with stigmatized and marginalized groups.
    • Defining novel HIV vaccine candidates, including but not limited to identification of candidate novel immunogens, and novel adjuvants.
    • Developing novel epidemiologic tools to identify and track clusters of HIV transmission among individuals, including use of viral phylodynamic analysis at the population level; assessing social impact and associated ethical issues of identifying clusters.
    • Research leading to the development and validation of modeling and simulation methods and related tools to examine HIV transmission dynamics, make epidemic projections, and estimate the impact of HIV treatment and prevention interventions.
    • Multipurpose prevention technologies (MPT) for women who desire contraception and HIV/STI prevention in a single product.
    • Mother-to-child transmission of HIV.
    • Improving means to objectively measure adherence to antiretrovirals used as prevention.

    Develop Next-Generation HIV Therapies (Treatment and Care Continuum)

    • Delineating the demographics of the care continuum for the Brazilian epidemic and comparing the social and structural barriers seen in the epidemics in Brazil and the United States, which slow and prevent the full-scale implementation of antiretroviral therapy (ART).
    • Analysis of the factors that interfere in the adherence to ART for the young population living with HIV.
    • Improving means to objectively measure adherence to antiretrovirals used as treatment.
    • Evaluation of strategies for improving sustained adherence to ART in the young population living with HIV/AIDS, including children and pregnant and breastfeeding women.

    Research Toward HIV Cure

    • Studies on HIV reservoirs, latency, and persistence with the aim of achieving long-term remission for HIV/AIDS.
    • Development and testing of novel strategies that may reduce or eradicate HIV in persistent reservoirs (including those targeting the brain) or control viral rebound in the absence of ART.
    • Screening and/or testing of molecules that are unique to South American compound libraries or research programs or defines how these molecules influence the basic mechanisms of latency and persistence.
    • Developing genetic editing mechanisms to achieve clearance of HIV.
    • Research at the individual, community, and population levels developing and implementing a cure for HIV/AIDS, including social and ethical impact of HIV cure research in the context of the ongoing epidemic.

    Address HIV-Associated Comorbidities, Coinfections, and Complications

    Coinfections

    • Exploring the epidemiologic and/or biologic interactions between HIV and tuberculosis (TB), in those with dual infections, including children and pregnant women.
    • Research to develop point-of-care TB diagnostics and biomarkers to predict disease outcomes in TB infection or disease for people living with HIV.
    • Exploring novel strategies to interrupt TB transmission in people living with HIV.
    • Pre-clinical development of novel immune based therapeutic and prevention modalities for TB infection and disease in people living with HIV.
    • Development and/or evaluation of strategies to prevent, treat and diagnose coinfection with Hepatitis C, histoplasmosis, cryptococcosis, leishmaniasis and other tropical diseases.
    • HIV-associated coinfections in pregnant women.

    Non-Infectious Comorbidities: Mental Health and Neurological and Neurocognitive Disorders

    • Impact of Brazilian treatment strategies on the outcomes of treated HIV disease, specifically focusing on differences in the incidence, prevalence and mechanisms governing the onset of noninfectious co-morbidities in treated HIV-disease.
    • Neurological and neurocognitive complications associated with the disease and long-term ART
    • Identification of mental health factors which can impede optimal access and use of effective HIV prevention and treatment.
    • Development and testing of methods and strategies to aid HIV-infected individuals and their families to cope with HIV infection; engage in HIV/AIDS care and other services to enhance quality of life and improve health outcomes; prevent complications and reduce the impact of co-morbidities (especially mental disorders); and avoid new sexually transmitted illnesses and the onward transmission of HIV.
    • Identification of the effects of HIV infection on the central nervous system (CNS).
    • Identification of the cellular and molecular mechanisms underlying HIV-induced CNS dysfunction.
    • Development and testing of potential therapeutics to prevent or treat HIV/CNS disease.
    • Analysis of the impact of social determinants, such as gender, race and sexual orientation, on HIV/mental health interface.
    • Suicide risk and psychosocial health among people living with HIV and affected by mental disorders.

    Other Infectious Diseases

    Arboviruses and emerging/re-emerging viral pathogens, including but not limited to:

    • Identification and analysis of factors associated with atypical and/or severe clinical presentations of dengue, chikungunya and zika.
    • Development and evaluation of dengue, chikungunya and Zika vaccines, including studies on the effects of co-administration with other vaccines.
    • Analysis of the dynamics of the transmission of dengue, chikungunya and Zika viruses.
    • Development and/or evaluation of tools for the early diagnosis of arboviruses.
    • Development and/or evaluation of predictive models of the risk of wild transmission of Yellow Fever and of re-urbanization of transmission of Yellow Fever virus (by Aedes aegypti) in Brazil.
    • Basic research to develop countermeasures related to dengue.
    • Influenza.

    Bacterial Infections

    • Tuberculosis
    • Development of new adherence strategies for tuberculosis (TB) treatment based on the characterization of populations most likely to develop active TB, such as pregnant women and children, to improve clinical outcomes.
    •  Assess the impact of implementation of new TB drug regimens for the treatment of latent tuberculosis and active tuberculosis (observational studies).
    • Assess the impact of the implementation of the Combined Fixed-Dose regimen for the treatment of drug sensitive TB in Brazil (observational studies).
    • Identification of biomarkers or biosignatures for the diagnosis of active TB versus latent tuberculosis (LTBI), predict progression of LTBI to active disease, response to treatment and correlates or protection from infection or disease.
    • Define TB transmission patterns and identify locations of high risk for transmission.
    • Evaluation of social protection strategies in access, diagnosis, and treatment of people with TB and how these strategies impact public health outcomes.
    • Epidemiology/risk factors and interactions between diabetes and TB.
    • Basic research to develop countermeasures related to leprosy (Hansen's disease).
    • Evaluation of new strategies to control and eliminate leprosy (Hansen’s disease) and trachoma as a public health problem in Brazil.
    • Leptospirosis.
    • Identification of new strategies for the prevention and monitoring of antimicrobial resistance.

    Parasitic Infections


    •          Malaria

    • Evaluation of the level of resistance to insecticides used in the control of vectors transmitting malaria in Brazil and validation of new resistance analysis technologies to prevent its spread.
    • Development and/or validation of technologies for diagnosis of malaria in remote areas, such as the ones with difficult access and without electricity.
    • Cost-effectiveness and impact evaluation related to the use of insecticides for vector control (malaria transmitters).
    • Vector biology, including vector-pathogen interactions, vector ecology, and development and evaluation of new tools for vector control and early identification of resistance to insecticides.
    • Evaluation of environmental and ecologic modification and its impact on malaria transmission and incidence.
    • Transmission dynamics and molecular epidemiology of malaria in different eco-epidemiologic settings.
    • Studies on the molecular epidemiology, pathogenesis, immunology, vaccinology, and transmission of Plasmodium vivax.
    • Basic research to develop countermeasures related to Chagas, leishmaniasis, schistosomiasis, soil-transmitted helminths.
    • Evaluation of new strategies to control and eliminate geohelminths and schistosomiasis.

    Vector Biology and Control

    • Vector biology, including vector-pathogen interactions, vector ecology, development and evaluation of new tools for vector control and early identification of resistance to insecticides.
    • Evaluation of innovative strategies and technologies for the control of vectors of importance in public health in Brazil.
    • Pesticide resistance in disease vectors.

    Detection and Surveillance of Infectious Diseases

    • Innovation in multiplex diagnosis of communicable diseases, with evaluation of possible cross reactions.
    • Elaboration and/or analysis of prediction models for zoonosis and water and food transmission diseases.
    • Development of surveillance strategies that integrate the health, environment and agriculture sectors: integrated surveillance for communicable diseases.

    Allergy, Immunology, and Transplantation

    • Basic human immunology.
    • Host immune response and/or regulation of the inflammatory response to microbial and/or viral infection.
    • Topics of interest relevant to immunity to infection and/or vaccination include, but are not limited to:
    • Activation of innate immune cells and signaling pathways.
    • Positive and negative regulation of inflammation.
    • Mechanisms by which the innate immune system directs subsequent adaptive immune responses.
    • Generation and maintenance of effector and memory antigen-specific T and B lymphocytes.
    • Regulation of antibody production and mechanisms of antibody-mediated protection.
    • Definition of biomarkers of protective immune responses.
    • Characterization of innate and adaptive mucosal immune responses.
    • Mechanisms of immune-mediated pathogenesis triggered by responses to microbial infection.
    • Effect of viral and microbial infections, and environmental pollutants on innate immunity and epithelial/mucosa functions and their contribution to the pathogenesis of asthma and allergic diseases.

    Child Health and Human Development

    • Improved prevention, diagnostics, and treatment of congenital infections.
    • Analysis of growth and development of changes, from pregnancy to early childhood, of children with congenital syndrome associated with Zika and Syphilis, Toxoplasmosis, Rubella, Cytomegalovirus and Herpes (STORCH).
    • Safety and efficacy of infectious disease treatments for mothers and infants, including but not limited to, cytomegalovirus, influenza, syphilis, tuberculosis, malaria, Chagas disease, and toxoplasmosis.

    Neurological Disorders and Stroke

    • Basic or clinical research across the spectrum of neurological, neuromuscular, neuroinfectious and neurovascular diseases and disorders within the mission of NINDS and of significance to Brazil (refer to NINDS Disorder Index).   BRAIN Initiative research focused on mapping and understanding brain circuits is also of interest. 

    Environmental Health Sciences

    • Basic and/or epidemiological research that addresses or seeks to understand how exposures to toxic environmental insults alter biologic processes, are linked to disease initiation, progression or morbidity, and activities that lead to the development of prevention and intervention strategies to reduce environmentally induced diseases.
    • Airway diseases, CVD and neurological disorders, children’s environmental health and the unique vulnerability of developing children to harmful environmental exposures including outcomes such as low birth weight or premature birth, climate change and human health, research exploring exposures during early life stages or critical windows of susceptibility that may directly or indirectly affect the risk of developing disease, research examining health consequences due to the interplay between environmental exposures and cofactors such as infectious agents, and research that examines social factors that contribute to environmental health disparities.
    • Examples of environmental exposures relevant to the mission of the NIEHS include but are not limited to industrial chemicals or manufacturing byproducts, e-waste, metals, pesticides, herbicides, and inhaled toxicants including indoor air pollutants from cooking and other sources.
    • Evaluation of the direct costs to the Brazilian public health system (the Sistema Único de Saúde, or SUS) of indirect costs (such as productivity, years of life lost) related to the exposure of individuals to pesticides and agrochemicals.

    The following applications will be considered non-responsive and will not be reviewed.

    Note: For further information on the U.S.-Brazil Program for Collaborative Biomedical Research please visit the following website for general information and answers to commonly asked questions: https://www.niaid.nih.gov/grants-contracts/questions-answers-rfa-ai-18-054

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

    Section II. Award Information

     

    Funding Instrument

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

    Application Types Allowed

    New   

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

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s) 

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    Issuing IC and partners intend to commit up to an estimated total of $2.75 million to fund 8-10 awards in FY 2020.    

    Award Budget

    Application budgets are limited to $175,000 direct costs per year for the scope of work of the U.S. and Brazilian scientists.  Budgets must reflect the actual needs of the proposed project. The U.S. portion of the budget may not exceed $100,000 in direct costs per year. The Brazilian portion of the budget may not exceed $75,000 per year.      

    Award Project Period

    The scope of the proposed project should determine the project duration.  The maximum project period is 4 years.    

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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

     

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are    allowed.

    Only foreign components from Brazilian locations are eligible.

    Required Registrations

    Applicant Organizations

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

    • 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)– 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 to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

    The PD(s)/PI(s) must be from a U.S. institution, and the application must name the Brazilian scientist as a full collaborating partner. If the multi-PD(s)/PI(s) option is chosen, the U.S. PD(s)/PI(s) must be the contact PD(s)/PI(s) on the application, while other PD(s)/PI(s) could be from Brazil. Inclusion of early career investigators is highly encouraged.  

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

    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).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) 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.

    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows 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:

      Tami Lu, MPH 
      National Institute of Allergy and Infectious Diseases
      Telephone:  301-761-6859
      Fax: 301-480-2954 
      Email:  tami.lu@nih.gov

    Page Limitations

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

    Instructions for Application Submission

    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.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

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

    In the budget forms, the U.S. PD(s)/PI(s) should include only budget information for the activities related to the U.S. portion of the project. Do not include budget support for the activities proposed by the Brazilian scientist in the budget forms. 

    In the budget justification section, under Other Direct Costs, include the budget for the research activities to be carried out by the Brazilian scientist using the cost categories of Supplies (i.e., consumables), Travel Expenses, Subcontracts, Capital Expenditure (i.e., equipment) and Personnel Expenses (i.e., scholarships).  Applicants are strongly encouraged to utilize the suggested categorical areas above. Within each category applicants should list the number of units per category, the unit price per category, and the total amount per category and the total amount across the categories in U.S. Dollars and separated by annum for each year of the project.

    Provide the person months effort of the U.S. and Brazilian scientists for the proposed research project.

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Specific Aims: Briefly describe the individual specific aims for the proposed research to achieve the overall goals of the program.  Designate which specific aims will be conducted by the U.S and Brazilian partners.

    Research Strategy: Applicants should propose a single Research Strategy for the combined efforts of the research from the U.S. and Brazil scientists. 

    • Describe the overall scope of the proposed project and indicate the extent to which the success of the project relies on the planned organizational structure and specific roles and responsibilities of U.S. PD(s)/PI(s) and Brazilian partners.
    • Provide a timeline for the implementation of the proposed research project by all research partners.
    • Describe the unique features of the collaboration that will enhance or improve the biomedical knowledge to be gained through the partnership.  For example, what are the unique populations, resources, or integrated hypotheses that benefit from the proposed collaboration.
    • Describe in detail the integration of the U.S. PD(s)/PI(s) and Brazilian collaboration efforts including communication plans, processes for making decisions on scientific direction, procedures for resolving conflicts, and contingency plans related to potential setbacks and delays.
    • Based on the needs of the project, describe what aspects of the research will be performed in the U.S. and what aspects will be performed in Brazil.
    • Describe the nature of the resource or data sharing that will benefit the collaboration and how these will be distributed to address specific proposed project needs.
    • Describe the plans to obtain approval for the shipping of biospecimens, if applicable, and address how the project will be modified in scope and procedure if shipping approval cannot be obtained.
    • Potential U.S. applicants concerned about confidentiality or proprietary information should take this requirement into account before deciding what information to submit in their application.

    Note: Although preliminary data are not required under this FOA, evidence supporting past productivity, success with proposed techniques or methods, and feasibility of the approach should be included. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or evidence of productive collaborative team work in an area of expertise.

    Letters of Support

    • Applicants should include a Letter of Support co-written and co-signed by the U.S. PD(s)/PI(s) and the Brazilian collaborating partner and co-signed by the authorizing institutional officials confirming the new or existing collaboration and confirming that the U.S. awardee organization agrees to allow NIH to provide a copy of the submitted application and summary statement to the government of Brazil.  

    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:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

    PHS Assignment Request Form

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

     
    3. Unique Entity Identifier and System for Award Management (SAM)

    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

    4. Submission Dates and Times

    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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

    The NIH will make awards to the U.S. institution, while the Brazil MS will make awards to the Brazilian collaborators through CNPq.  

    7. Other Submission Requirements and Information

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

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

    For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process.

    Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    In addition, for applications involving clinical trials:

    A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

     
    Overall Impact

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

    Scored Review Criteria

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

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?

    Specific to this FOA:   How well will the outcomes from the proposed project advance the fundamental knowledge on the specific topic addressed?  In terms of the expected outcomes, will the partnership between U.S. and Brazilian scientists address key biomedical research questions and/or public health issues that would not otherwise be explored?

    In addition, for applications involving clinical trials

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?  

    In addition, for applications involving clinical trials

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center  

    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?  

    In addition, for applications involving clinical trials

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?  

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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? 

    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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?  

    Specific to this FOA: Does the application clearly state which partner of the collaboration will be responsible for accomplishment of each proposed specific aim? Does the application provide appropriate plans for the collaborative research, demonstrating the integration of the U.S. and Brazilian collaborator efforts, including communication plans, process for making decision on scientific direction, and procedures for resolving conflicts?  Does the application provide appropriate contingency plans and/or solutions for addressing setbacks and delay, including those related to biospecimen transfer or shipping? Will the net effect on outcomes from the U.S. and Brazil scientific collaboration result in greater synergy and outcomes than if the projects were performed separately? 

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?  

    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? 

    In addition, for applications involving clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?   

    Additional Review Criteria

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

    Study Timeline

    Specific to applications involving clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?  

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the  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  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.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 
     

    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 individuals of all ages (including children and older adults) 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.

    Vertebrate Animals

    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.

    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

    Additional Review Considerations

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

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

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

    Resource Sharing Plans

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

    Authentication of Key Biological and/or Chemical Resources:

    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.

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.
    • Relevance to the collaboration between the U.S. and Brazil.
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 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.

    Section VI. Award Administration Information
    1. Award Notices

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

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

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to 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.

    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.  Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    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 RPPR, 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.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Tami Lu, MPH
    Office of Global Research (OGR)
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-761-6859
    Email: tami.lu@nih.gov    

    Melanie C. Bacon, RN, MPH
    Division of AIDS (DAIDS)
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-627-3215
    Email: mbacon@niaid.nih.gov     

    Conrad Mallia, Ph.D.
    Division of Allergy, Immunology, and Transplantation (DAIT)
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-627-3491
    Email: cmallia@niaid.nih.gov

    Stephanie Coomes, Ph.D.
    Division of Microbiology and Infectious Diseases (DMID)
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-761-6855
    Email: stephanie.coomes@nih.gov

    Nahida Chakhtoura, Ph.D.
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Telephone: 301-435-6842
    Email: nahida.chakhtoura@nih.gov 

    Michael Humble, MD, MsGH
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone:  984-287-3272
    Email: humble@niehs.nih.gov

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

    Claudia Scala Moy, Ph.D.
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-9135
    Email: moyc@ninds.nih.gov

    Natalie Tomitch, MPH, MBA
    Office of AIDS Research (OAR)
    Telephone: 301-451-0098
    Email: tomitch@mail.nih.gov

    Government of Brazil Contact(s)
    Department of Science and Technology (DECIT) / Ministry of Health (MoH)
    Telephone: +55 61 3315-7606
    Email: utop.decit@saude.gov.br

    National Council for Scientific and Technological Development (CNPq)
    Telephone: +55 61 3211-9761
    Email: cgsau@cnpq.br

    Peer Review Contact(s)

    Patrick Lai, Ph.D.
    Center of Scientific Review (CSR)
    Telephone: 301-435-1052
    Email: pl177v@nih.gov

    Financial/Grants Management Contact(s)

    Adam Graham
    National Institute of Allergy and Infectious Diseases (NIAID)
    Phone: 301-761-6260
    adam.graham@nih.gov

    Bryan Clark
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Telephone: 301-435-6975
    Email: Clarkb1@mail.nih.gov

    Ashley Singh
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3323
    Email: ashley.singh@nih.gov

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

    Tijuana Decoster
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-9231
    Email: decoster@mail.nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 .

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