Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
U01 Research Project Cooperative Agreements
This Funding Opportunity Announcement (FOA) will support a Brazil-US Regional Prospective Observational Research in Tuberculosis (RePORT) network that will leverage the robust clinical research infrastructure of Brazil to advance our current understanding of the community, host and microbial factors that impact outcomes of tuberculosis (TB) infection and TB disease, including drug-resistant TB. Study participants will include adults and children with a particular emphasis on persons with HIV (PWH). This initiative will facilitate development of knowledge and tools to improve prevention and treatment outcomes at the individual level and to inform strategies to curtail the TB epidemic at the public health level.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| Not Applicable | Not Applicable | December 08, 2021 | April 2022 | May 2022 | August 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
Not Applicable
It is critical that applicants follow the instructions in 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 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.
Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to support a Brazil-US Regional Prospective Observational Research in Tuberculosis (RePORT) network to advance TB and TB/HIV science. The RePORT Brazil network will leverage and build upon Brazilian cohorts currently following adult and pediatric populations with active TB disease and their contacts or other high TB-risk individuals to address key research questions of regional and global interest. Specific areas supported under this program include, but are not limited to, research and development projects in TB/HIV in the areas of molecular epidemiology, diagnostics, biomarkers, vaccine development, and the impact of co-morbidities such as HIV and diabetes. Research outcomes should be capable of advancing tools with public health impact or of influencing decision making in TB public health to inform stakeholders on the best practices for early prevention, diagnosis, and clinical management of TB and TB/HIV.
Background
International collaborative research is critical to fighting a global disease such as TB, especially in the context of HIV. The World Health Organization (WHO) reported that an estimated 10 million people fell ill with TB, and about 1.4 million died in 2019; 200,000 of those deaths were among PWH. These numbers make TB the most significant cause of mortality among PWH and places TB in the top 10 causes of death globally.
Brazil and the other BRICS countries (Russia, India, China, and South Africa) account for more than 40% of the global TB disease burden in incidence and deaths and 58% of the worldwide burden of drug-resistant TB. According to the WHO Global Tuberculosis Report (2020), the incidence rate of TB in Brazil was 46/100,000 with an HIV-positive incidence rate of 5.1/100,000, while the drug-resistant TB incidence was 1.2/100,000 persons. Despite progress in controlling TB incidence and providing better care for PWH, Brazil still ranks among the countries with the highest TB and TB/HIV burdens. Recent research findings reinforce the importance of strengthening TB control strategies in Brazil through integrated and multisectoral actions that enable access to prevention interventions, early diagnosis, and timely treatment, with emphasis on the groups and populations most vulnerable to the disease.
Currently, Brazil’s clinical research infrastructure supports prospective cohorts of people with active TB disease undergoing treatment as well as their household contacts with TB. These cohorts provide a rich clinical data set to better understand TB transmission and protection from progression of infection to disease, and to inform the development of improved diagnostics, therapeutics, and vaccines. Clinical samples and data from individuals treated at various stages of disease also may be leveraged to advance research towards a better understanding of mechanisms of treatment failure/relapse, emergence of drug-resistance, and the development of tools for improved treatment monitoring.
Bilateral Network Requirements
The successful Brazil-US Regional Prospective Observational Research in Tuberculosis (RePORT) network will leverage existing prospective observational cohorts in Brazil and will have access to both clinical specimens as well as concomitant data collected at pre-defined time points for 1) individuals being treated for active TB and 2) close contacts to individuals with TB disease.
In order to leverage these existing cohort(s), applicants are strongly encouraged to include a multidisciplinary research team that includes collaborations to the existing resources (e.g. clinical research sites and laboratories, data management center, and central specimen biorepository) and must be led by at least one investigator from Brazil and one investigator from the US. 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 public health issues of TB/PWH.
Additional samples and clinical data may be collected if needed for the research proposed. In this case the applicant will need to leverage current infrastructure as described above and have the capacity to implement the research protocol as per the RePORT International standards based on the framework of the RePORT Common Protocol.
The Brazil Ministry of Health (MoH) will concurrently advertise this funding opportunity announcement on their website and provide a link to the announcement on the NIH website.Applicants will submit a single application prepared jointly by U.S. and Brazilian scientists to the NIH that will be peer-reviewed using the well-established NIH process, which includes review by a panel of non-conflicted U.S. and Brazilian scientists with relevant expertise. By sending an application to the NIH, the expectation is that the applicant agrees to allow the NIH to provide a copy of the submitted application and the summary statement from the peer review to the government of Brazil. 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 the NIH.
Funding will be provided by both the U.S. and Brazilian funding agencies to the meritorious application based on the outcome of the NIH peer review. Funding decisions will also consider the research priorities for the U.S. and Brazil governments. 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.
Structure of the Network
Executive Committee: The network will establish an Executive Committee (EC) with the Program Directors/Principal Investigators (PDs/PIs), key personnel, a NIAID Project Scientist, and at least one Brazilian MoH staff to coordinate and facilitate research activities supported by the award; facilitate compliance with the data- and other resource-sharing policies to meet international guidelines and standards; and promote research efficiency. Equal numbers of Brazilian and U.S. investigators in the EC is not required.
The EC will convene annual meetings to discuss the progress of network research projects. The network PD(s)/PI(s) are expected to participate in the annual meeting and other EC-related activities and meetings throughout the award period. NIH or Brazilian MoH staff may appoint other subject matter experts as non-voting members of the EC to provide additional expertise and perspective. Note that these potential outside EC members should not be named in the application or contacted prior to application submission or award.
Establishment of Partnerships: As a member of the network, applicants are expected to establish and maintain a collaboration with the Caribbean, Central and South America network for HIV epidemiology (CCASAnet) in order to facilitate standardized collection and sharing of TB/HIV epidemiological and clinical data. In addition, investigators are strongly encouraged to use national TB data in close collaboration with the National TB Programme from the Ministry of Health of Brazil and the NIH/US Government, which include but are not limited to 1) the Brazilian Ministry of Health (MoH) and US National Institutes of Health (NIH) previously supported regional prospective observational cohort in Brazil which is a rich resource of clinical data and samples for individuals treated for TB disease and their close contacts; 2) The Notifiable Diseases Information System (SINAN-Net) which includes clinical data for active TB cases in all municipalities of Brazil; 3) TB Special Treatments Information System (SITE-TB) which includes clinical data for active drug resistant TB cases in all tertiary clinics of Brazil. Applicants must be aware of Brazilian National Laws for Data Protection (Lei 12.257/2011 and Lei 13.709/2018) which precisely describes both flows and rules for the access of personal data in the country.
The successful applicant for the RePORT Brazil network will participate in the international effort to advance TB research with a focus on research to improve the health of PWH and will be a component of RePORT International, a global consortium of networks of TB/HIV longitudinal cohorts in countries with the highest burden of TB/HIV disease. The Brazil network is expected to collaborate with the TB-RePORT International Coordinating Center (TB-RICC) and RePORT networks in other countries as needed and as appropriate to advance shared research goals, which might include sample and data sharing or generating new resources for current and future use. Applicants are encouraged to engage with investigators from RePORT networks to take advantage of the collection of standardized data from different countries as appropriate for the proposed research projects.
Progress Review Criteria: Applicants must propose Go/No Go criteria to be met by the end of the third year of the award. At the end of the third year, the progress of research towards the stated Go/No-Go criteria will be evaluated by NIH and Brazilian MoH staff identified to determine if the project may continue for an additional two years, for a total of five years of support. Applicants failing to meet the Go/No Go criteria will continue under a reduced budget.
Research Objectives and Scope
The primary objective of this initiative is to enable a network of Brazilian and U.S. scientists to advance current understanding of the community, host and microbial factors that impact outcomes of TB infection and TB disease, especially among PWH, including drug-resistant TB (DR-TB), to facilitate development of tools to improve treatment outcomes at the individual level and to inform strategies to curtail the TB epidemic at the public health level.
This bilateral initiative between the United States and Brazil will support a Brazil-US Regional Prospective Observational Research in Tuberculosis (RePORT) network that will leverage the strong clinical research infrastructure within Brazil to facilitate a robust research plan. Research proposed should address TB/HIV priorities of relevance to NIAID and the Brazilian National Plan to End Tuberculosis as a Public Health Problem (Plano Nacional Pelo Fim da Tuberculose como Problema de Sa de P blica) by providing evidence-based strategies towards ending the TB and HIV epidemics. The research outcomes from the projects conducted through the network are also expected to inform Brazil’s national TB control strategy.
The following TB and TB/HIV research areas will be supported:
Research projects that include the following are encouraged:
Applications Not Responsive to this FOA
Applications that propose to conduct research in the following areas will be considered non-responsive and will not be reviewed:
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
NIAID intends to commit $1.0 million in FY 2022 to fund 1 award.
Recommended budget for direct costs of up to $700,000 may be requested.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The application must include a minimum of one PD/PI from either the U.S. institution or the Brazilian institution. For this FOA, the U.S. and Brazilian scientists will work as equal collaborating partners to implement the proposed research. If the multi-PD/PI(s) option is chosen, the U.S. scientist and the Brazilian scientists may be part of a multi-PD/PI(s) team on the application. The inclusion of other PD/PI(s) is allowed, and the inclusion of early career investigators is highly encouraged.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
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:
The letter of intent should be sent to:
Cynthia de la Fuente, PhD
Telephone: 240-669-2740
Email: cynthia.delafuente@nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed,
with the following additional instructions:
The requested budget should be separated into a budget to be supported by the U.S. NIH and a budget to be supported by the Brazilian MoH. The Brazilian MoH budget and the U.S. NIH budget should be mutually exclusive (i.e. no overlap should exist). The applicant institution should request the primary budget and collaborating institutions should be considered as subcontractors.
The U.S. budget should be requested within the SF424 (R&R) Budget forms. The requested U.S. budget should account for the activities related to the U.S. portion of the project in support of the proposed research, including salary support for U.S. PI/PD(s), research carried out at U.S. institutions, and/or research conducted under the auspices of U.S. institutions. Additionally, the NIH budget may include research costs (supplies and equipment) to support research at both U.S. and Brazilian institutions, if appropriately justified. Include the person months effort of the U.S. scientist and U.S. personnel within the U.S. budget.
The Brazilian MoH budget should be outlined in a table to be included in the budget justification under Other Direct Costs and should account for the activities to be carried out by the Brazilian scientists. The Brazilian MoH will provide support for the Brazilian investigators, the in-country proposed research activities, and any associated infrastructure costs for Brazil. The budget should include the total amount across the categories for new activities proposed in the application (recommended budgets up to $100,000 U.S. dollars), as well as in-kind support from the Brazilian Government in U.S. Dollars, separated by annum for each year of the project. The Brazilian budget should not include costs for equipment already available in the laboratories proposing the research, or for expenses to build any infrastructure such as laboratory extensions or new laboratory construction. Provide the person months effort of the Brazilian scientist for the proposed research project within the appropriate budget category for the Brazilian budget.
It is expected that the combined U.S. NIH and Brazilian MoH budget will be weighted towards supporting research projects, with a lesser amount requested in support for infrastructure, or as appropriate, the enrollment of additional participants.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Describe the overall goal(s) of the proposed research and briefly describe the specific aims that will drive the research program. When applicable, designate which specific aims or aspects of the research will be conducted by the U.S and Brazilian investigators.
Research Strategy:
Letters of Support: Applicants should provide letters of support from relevant organizations and collaborators who are lending their expertise or resources to the projects. Specifically, applicants should include a Letter of Support signed by the business official from the applicant organization that agrees to allow the U.S. 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.
The following modifications also apply:
When involving human subjects research, clinical research, and/or NIH-defined 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.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
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.
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.
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.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is 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:
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?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators 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:
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?
Specific to this FOA:
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.
Go/No-Go Decision Criteria
Are the proposed Go/No-Go decision criteria well-defined with quantifiable and measurable outcomes appropriate for assessing the success of the first 3 years of the application? Are the Go/No-Go decision criteria sufficiently described to enable a clear decision about attainment?
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
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
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) 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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases (NIAID), 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 will receive a written critique.
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.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
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 recipient's business official.
Recipients 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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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, Recipients, 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
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.
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.
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.
The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipient is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipient for the project as a whole, although specific tasks and activities may be shared among the recipient and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
During performance of the award, a NIAID Project Scientist and two representatives from the Brazilian MoH will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below:
Areas of Joint Responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, recipients 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 recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, 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
Sudha Srinivasan, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-281-0303
Email: sudha.srinivasan@nih.gov
Government of Brazil Contact(s)
Samantha Lemos Turte-Cavadinha
Coordenadora-Geral
Analista T cnica de Pol ticas Sociais
Coordena o-Geral de Fomento Pesquisa em Sa de CGFPS
Departamento de Ci ncia e Tecnologia - DECIT
Secretaria de Ci ncia, Tecnologia, Inova o e Insumos Estrat gicos em Sa de - SCTIE
Minist rio da Sa de
Telephone: +55 (61) 3315-7895
Email: samantha.lemos@saude.gov.br
Fernanda Dockhorn Costa Johansen
Coordenadora Geral
Coordena o Geral de Vigil ncia das Doen as de Transmiss o Respirat ria de Condi es Cr nicas/DCCI/SVS/MS
Telephone: +55 (61) 3315-2787
Email: fernanda.dockhorn@saude.gov.br
Cynthia de la Fuente, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2740
Email: cynthia.delafuente@nih.gov
Sufiyan Saeed
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3761
Email: Sufiyan.Saeed@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 2 CFR Part 200, 42 CFR Part 52, and 45 CFR Part 75.
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