EXPIRED
National Institutes of Health (NIH)
Office of The Director, National Institutes of Health (OD)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
National Cancer Institute (NCI)
U01 Research Project Cooperative Agreements
The goals of this funding opportunity announcement (FOA) are to implement and rigorously evaluate SARS-CoV-2 rapid testing strategies in communities experiencing COVID-19 health disparities. These two-year Rapid Testing Research Projects will evaluate (1) rapid testing interventions to prevent and control COVID-19 transmission among underserved and vulnerable populations and (2) partnership-driven research to implement and evaluate rapid testing and reduce COVID-19 disparities. The funding for this program is provided from the American Rescue Plan Act of 2021, PL 117-2.
Not applicable
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
May 02, 2022 | Not Applicable | Not Applicable | July 2022 | Not Applicable | December 2022 |
All applications are due by 5:00 PM local time of applicant organization.
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.
The National Institutes of Health (NIH) is issuing this Funding Opportunity Announcement (FOA) in response to the declared public health emergency issued by the Secretary, HHS, for the Novel Coronavirus 2019 (COVID-19). This FOA provides an expedited funding mechanism to support Phase III of the Rapid Acceleration of Diagnostics Underserved Populations (RADx -UP) initiative. This FOA highlights the urgent need to leverage rapid SARS-CoV-2 testing, which is often self-administered or administered outside of healthcare settings, to understand and address COVID-19 morbidity and mortality disparities among underserved and vulnerable populations across the United States. These two-year, community-engaged Rapid Testing Research Projects will examine SARS-CoV-2 infection patterns and interventions to increase access to and uptake of diagnostic methods through the RADx -UP initiative. Successful applications will pose novel and adaptable scientific questions given new variants and the availability of SARS-CoV-2 vaccines.
The Office of the Director (OD) is issuing this FOA to address the objectives described below.
Key Definitions
This FOA is applicable to those populations who are underserved as well as populations that are COVID-19 vulnerable due to medical, geographic, and social factors, as defined below (referred to as underserved and vulnerable elsewhere in this FOA):
Underserved: NIH-designated populations with health disparities and/or other groups known to experience barriers to accessing needed health care services or have inadequate health care coverage. A full description can be found at https://www.nimhd.nih.gov/about/overview/.
COVID-19 medically and/or socially vulnerable populations: Residents of nursing homes and assisted living facilities; community-dwelling older adults; individuals with intellectual, developmental, sensory, or physical disabilities, cognitive impairment or dementia, or communication disorders; homeless populations; individuals involved with the criminal or juvenile justice systems (incarcerated or under community supervision); individuals with medical comorbidities known to increase risk of severe COVID-19, including heart failure and related cardiovascular conditions, diabetes mellitus, chronic lung disease, obesity, HIV/AIDS; pregnant and post-partum women; children and adolescents; individuals living in congregate housing such as shelters or residential treatment facilities; individuals in overcrowded housing; individuals with substance use disorders or serious mental illness; migrant and immigrant populations; residents of tribal lands or reservations; communities exposed to high rates of air pollution or other toxic exposures; and rural and remote communities.
Rapid SARS-CoV-2 Diagnostic Testing (also referred to as rapid testing or rapid diagnostic testing below): Rapid tests are molecular or antigen tests used to diagnose infection performed at or near the place where a specimen is collected, usually outside of a laboratory setting. In the context of COVID-19, these tests are diagnostic tests that provide results to patients within minutes. They might be used to diagnose SARS-CoV-2 infections in various settings, including at home, community health clinics, schools, the workplace, or other locations where the rapid determination of SARS-CoV-2 infection status could lead to the reduction of COVID-19 cases in the community.
For the purposes of this FOA it will be understood that the term "rapid SARS-CoV-2 diagnostic testing" (see above) refers to the use of FDA Emergency Use Authorized (EUA) or Approved or Cleared tests for the specific, on-label purpose for which they were developed and authorized/approved/cleared.
Point-of-Care Testing: Medical testing done at or near the point of care that involves performing a diagnostic test.
Background
The overarching goal of the RADx -UP initiative, as seen in the Phase I and II funded projects, is to understand and address COVID-19 morbidity and mortality disparities for those underserved and vulnerable populations that are disproportionately affected by, have the highest infection rates of, and/or are most at risk for adverse outcomes from the COVID-19 pandemic. Implementing effective strategies for testing, contact tracing, surveillance, and mitigation requires individuals and communities to avail themselves of testing when offered, adhere to isolation and quarantine restrictions if they test positive, and not lessen their adherence to mitigation strategies if they test negative. Public health officials, policymakers and communicators are hampered by limited evidence on individual, community, and population-level interventions to optimize testing and mitigation adherence. This is also of concern among groups (including persons with mental illness, autism, developmental disabilities) who have not been consistently identified as vulnerable in the pandemic and/or may have considerable barriers to testing and mitigation adherence (e.g., unable to miss work to self-isolate after a positive test or exposure to an individual who has tested positive). In school and childcare settings, better understanding of effective new testing models such as Test-to-Stay (i.e., close contacts who continue to test negative remain in the classroom instead of quarantining at home) and other testing implementation strategies are important for keeping children, household members, and school staff safe during in-person instruction. Precisely quantifying and addressing the benefits, risks, and efficacy of testing and mitigation strategies at multiple levels and rapidly evaluating individual, community, and population level interventions (e.g., via pragmatic trials) to optimize testing, vaccination, and mitigation adherence is a crucial component of any successful national strategy for testing, contact tracing, vaccination, surveillance, and mitigation implementation.
To properly address, mitigate, and navigate the ongoing effects of COVID-19, innovative and flexible research plans, procedures, and protocols are needed to expand the reach, scope, and effectiveness of rapid diagnostic tests for communities that are experiencing COVID-19 health disparities. Successful projects will accomplish this by developing scientific questions and methods that are forward-thinking and can be adapted as the trajectories of COVID-19 cases, variants, hospitalizations, and mortality change over time.
FOA Goals
The Office of the Director (OD) is requesting applications for cooperative agreements (U01s) addressing the objectives described below. Projects supported via this FOA will be part of the RADx -UP initiative. This Rapid Testing Research Projects opportunity will support new cooperative agreements that have established community-engaged research and collaborations or partnerships to support SARS-CoV-2 (i.e., COVID-19) rapid testing at the point of care and/or for self-administration among underserved and vulnerable populations.
The U.S. Food and Drug Administration (FDA)-emergency use authorized (EUA) or Approved or Cleared (EUA/approved/cleared) SARS-CoV-2 testing options have expanded from laboratory-based diagnostics to include rapid tests administered in multiple settings, including outside of healthcare contexts (e.g., within homes, schools, and workplaces). Thus, there is a need for evidence-based optimization strategies that are responsive to community needs and that improve utilization of subsequent mitigation behaviors based on test results.
The goals of this FOA are to implement and evaluate interventions for underserved and vulnerable populations to increase access to, uptake of, and effective use of rapid diagnostic SARS-CoV-2 tests. Effective use indicates tests must be used for the specific, on-label purpose for which they were developed and authorized/approved/cleared (e.g., including serial administration of tests if part of the recommended approach) by the FDA.
Research Objectives:
This research will implement and evaluate SARS-CoV-2 rapid diagnostic testing in communities experiencing health disparities. Research projects will develop rapid testing implementation strategies among both unvaccinated and vaccinated individuals that leverage community relationships and cultural knowledge, specifically with respect to community entry, trust building, and culturally appropriate ways of engaging and tapping community held knowledge about best practices to reduce rapid testing barriers at various points-of-care and make best uses of test kits and results.
Rapid Testing Research topics of interest focused on underserved and vulnerable populations include, but are not limited to, the following areas:
Using Rapid Diagnostic Testing to Prevent and Control COVID-19 Transmission
Rapid SARS-CoV-2 Diagnostic Testing in School and Childcare Settings
Partnership-Driven Research to Implement and Evaluate Rapid COVID-19 Diagnostic Testing
Of specific interest for these topics are projects conducted in partnership with public health departments, local/state/tribal stakeholders, various federal entities (Veterans Health Administration [VHA], Indian Health Service, military installations, and others), Federally Qualified Community Health Centers, and/or national organizations.
Key project considerations are listed below:
Projects are strongly encouraged to support early-stage investigators and diverse teams.
Design, Analysis, and Sample Size for Studies: RADx -UP Phase III projects must demonstrate relevance of the scientific questions to COVID-19 testing among underserved and vulnerable populations. Projects should utilize rigorous research designs (e.g., randomized controlled trials, stepped wedge designs, multiphase optimization strategy (MOST) designs, pragmatic clinical trials, interrupted time series, dynamic wait list design, hybrid effectiveness-implementation designs, sequential multiple assignment trial (SMART) designs, and adaptive designs). Group and individual randomization may not be feasible in nor acceptable to participants in some community-engaged interventions among populations who experience health disparities or express research distrust. Applicants should use methods that are appropriate given their plans for assignment of participants and delivery of interventions. Projects must describe research strategies that will reflect the availability of COVID-19 vaccines. Projects must also demonstrate the ability to recruit and retain an adequate number of participants within the specified target populations and include sample size and power calculations. Given the RADx -UP goal of population-level impact, projects should also delineate verified testing as the primary outcome (e.g., rapid COVID-19 test completion measured objectively versus self-report). Changes in testing access, effective use, vaccination uptake, and other psychosocial or behavioral variables would be acceptable as secondary outcomes. Additional information is available at https://researchmethodsresources.nih.gov/.
Additional Requirements
Testing:
Data Collection, Sharing, and Coordination:
Research Plan:
Applications nonresponsive to terms of this FOA will not be considered.The following types of projects would generally not be appropriate and may be deemed non-responsive:
Investigators planning to submit an application in response to this FOA are encouraged to contact and discuss their proposed research/aims with Program staff listed on this FOA well in advance of the application receipt date to better determine appropriateness and interest. Applications are invited from investigators representing a wide range of disciplines, including but not limited to ethics, health disparities research, demography, health policy, health communication and communication science, implementation science, clinical care, home and community-based services, infectious disease, community-based participatory research, policy studies, public health, epidemiology, bioinformatics and health information sciences, behavioral and social sciences (e.g., psychology, sociology, social work, anthropology, nursing, political science, economics, communication science).
NIBIB Statement of Interest
The NIBIB supports technology development and translation of new or redesigned medical technologies that can have a significant impact on healthcare access and health outcomes for health disparate populations.
NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications". NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.
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.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NIH intends to commit $24 Million over 2 years to fund approximately 12 awards.
Application budgets are limited to $700,000 in direct costs per year and must reflect the actual needs of the proposed project.
The maximum period is 2 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
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 Government
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations
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.
2. Cost Sharing
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, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
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 instructions in 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.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.
In the biosketches, please outline the experience of the key personnel in community-engaged research and with community partners, including expertise such as years of work in the index community and successful delivery of health programs to underserved communities.
R&R or Modular Budget
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, with the following additional instructions:
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Specific Aims
Concisely state the specific aims and include research to be conducted as well as actionable sources of disparities to be addressed.
Research Strategy
The Research Strategy should include details on methods, assumptions, research designs, data analysis plans, and any interdependencies of Aims, and justify major choices about populations, goals, outcomes, and methods. Please do not duplicate information already addressed in the Inclusion of Women and Minorities or Inclusion Across the Lifespan sections.
The potential of the proposed approach to yield important contributions applicable to a range of populations and settings, or to inform intervention and prevention strategies, should be addressed. Applications focusing on specific communities should describe how findings and products can be generalized or implemented across other underserved and vulnerable populations or to the same populations in other settings (rural/urban and regional differences). Briefly describe the generalizability of study approaches and findings to broader populations and include plans for the development and sharing of materials or toolkits to facilitate adaptation, dissemination, and implementation. Where vaccination uptake is included as a (secondary) topic, the study of vaccination must clearly add value to the application's aims regarding COVID-19 testing in underserved and minority populations. The proposed approach should be dynamic and able to be responsive to evolving changes in COVID-19 diagnostics, vaccination, and treatment. Where a network of subprojects are collaborating in a project, plans for each subproject should include agreement with the requirements to collect all NIH RADx-UP Tier 1 Common Data Elements, and adherence to sharing of all data where not prohibited by Tribal sovereignty in the required format and on the NIH-directed timetable.
Where applicable the Research Strategy should detail community- or stakeholder-engaged methods to assess barriers to rapid COVID-19 test and vaccination access, uptake and follow-up, and develop and evaluate strategies or interventions to address those barriers.
This FOA supports collection of multiple types of data including qualitative and quantitative methods, as well as reviews of documents and available data where appropriate. Where possible, primary or alternate methods that are robust or unaffected by shelter-in-place, and other restrictions on research environments, or by existing digital divides are encouraged, although evidence of availability and acceptability for communities and individuals should be provided, along with the capacity to maintain standards of ethical research conduct.
Applicants should address whether and how ongoing or potential future public health changes or restrictions (e.g., closures, physical distancing, ability to hold large meetings) might affect the research approach and, if so, include a plan to prevent or mitigate any effect on the proposed study.
While preliminary data are not explicitly required, the application should clearly outline a solid rationale and conceptual framework to demonstrate the feasibility of the approach and document through letters of support, joint publications, and other methods the length and strength of the research team’s engagement with the communities with whom the project intends to work.
A description of how the institutional environment will facilitate community or stakeholder engagement and facilitate implementation and dissemination of results to the community should be included where appropriate.
The Research Strategy section should include a project timeline.
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Applicants should describe in the Research Strategy their ideas for working with other SEBI and RADx -UP sites to accomplish project goals, and their willingness to adhere to policies and procedures determined in cooperation with the CDCC (RFA-OD-20-013).
Letters of Support
Letters of support from the community partners (e.g., Tribal leaders, or other key representatives with the authority to speak on behalf of the communities to be included in the study) that demonstrate established and robust collaborations of the investigators and the community partners as well as strong support for community involvement in the research project should be included with the application.
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.
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.
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.
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
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.
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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to this emergency FOA will be evaluated for scientific and technical merit by objective review that will be conducted by the Center for Scientific Review.
For this particular announcement, note the following:
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?
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?
Specific to this FOA:
Do the key personnel have appropriate expertise in community engaged research?
When considering experience of community engaged researchers and community partners, nontraditional indices of expertise such as years of work in the index community or successful delivery of health programs to underserved communities can be considered. This experience should be documented through letters of support from community stakeholders, Tribal leaders, or other key representatives of the community with the authority to speak to the collaboration and past accomplishments.
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:
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?
Resource Sharing Plan
Is the resource sharing plan
timely and feasible? Does the plan make instruments, products, results, and data findable and accessible to the research and public health community, where not limited by Tribal data sovereignty? In instances involving Tribal data sovereignty, is there documentation of Tribal agreement with adapted data sharing plans? If school data are included, are there considerations of protections such as those included in the Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. 1232g; 34 CFR Part 99)?
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
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) Sharing Model Organisms; and (2) 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 through an objective review process conducted by the Center for Scientific Review, using the stated review criteria.
As part of the objective review process, all applications:
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.
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 objective review, recommended applications will receive additional levels of review by the RADx-UP Governance Committee and the RADx Executive Committee, with final approval from the NIH Director or Acting NIH Director. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award Dates
After the objective 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 objective review, , and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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 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.
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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.
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, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, 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 (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 and 2 CFR Part 200.206 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 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, 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 recipients 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The Principal Investigator(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:
NIH will assign a Program Official (see below) and Project Scientist(s) to the award. The Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination.
The Project Scientists(s) will:
Additionally, the NIH program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
The Program Official will:
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 theRADx -UP consortium member 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 awardee. 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.
3. Reporting
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.
The NIH Office of the Director plans to make awards using funds provided in the emergency supplemental appropriations for COVID-19 and coronavirus research: American Rescue Plan Act of 2021, Public Law 117-2".
Funds awarded using appropriations provided by the American Rescue Plan Act of 2021, Public Law 117-2" will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.
Interim Reports
In addition to the annual RPPR, recipients are required to submit an interim progress report every six months outlining key milestones that have been met.
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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
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: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Elizabeth Walsh
NIH Office of the Director (OD)
Telephone: 301-480-8127
Email:
Kelly Anne King, Au.D., Ph.D.
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301-402-3458
E-mail: kingke@mail.nih.gov
Dipanwita Basu, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
dipanwita.basu@nih.gov
240- 627-3469
Tammara Jenkins, MSN, RN, PCNS-BC, FCCM
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6837
Email: tjenkins@mail.nih.gov
Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov
Ming Lei, PhD
National Institute of General Medical Sciences (NIGMS)
Email: leim@mail.nih.gov
Qi Duan
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-827-4674
E-mail: qi.duan@nih.gov
Hiroko Iida, DDS, MPH
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-7404
Email: hiroko.iida@nih.gov
Richard T. Benson, MD, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Richard.benson@nih.gov
301-827-9071
Laura Elizabeth Kwako
NIAAA - NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
Phone: 301-451-8507
E-mail: laura.kwako@nih.gov
Gregory Greenwood, PhD, MPH
National Institute of Mental Health (NIMH)
Telephone: 240-669-5532
Email: gregory.greenwood@nih.gov
April Oh, Ph.D, MPH
National Cancer Institute (NCI)
april.oh@nih.gov
240-276-6709
Yolanda Vallejo, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
yolanda.vallejo@nih.gov
301-451-1751
Ebony Madden
National Human Genome Research Institute (NHGRI)
ebony.madden@nih.gov
301-503-5620
Rina Das, PhD
National Institutes on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: dasr2@mail.nih.gov
Cheri Wiggs, Ph.D
National Eye Institute (NEI)
cheri.wiggs@nih.gov
301-402-0276
Martha Lundberg
National Heart, Lung, and Blood Institute (NHLBI)
martha.lundberg@nih.gov
301-435-0513
Louis Vuga
National Heart, Lung, and Blood Institute (NHLBI)
louis.vuga@nih.gov
301-435-0233
Asif Rizwan
National Heart, Lung, and Blood Institute (NHLBI)
asif.rizwan@nih.gov
301-435-0070
Maliha Ilias, Ph.D
National Heart, Lung, and Blood Institute (NHLBI)
maliha.ilias@nih.gov
301-451-9921
Lindsey Martin, PH.D.
National Institute of Environmental Health Sciences (NIEHS)
lindsey.martin@nih.gov
984-287-4036
Dionne Godette-Greer, PhD
National Institute of Nursing Research (NINR)
dionne.godette@nih.gov
301-827-0095
Jonathan W. King, PHD
National Institute on Aging (NIA)
kingjo@nia.nih.gov
301-496-3136
Wilson Compton, M.D, M.P.E,
National Institute on Drug Abuse (NIDA)
wilson.compton@nih.gov
301-443-6480
Stephanie M George, PhD, MPH, MA
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: none
E-mail: stephanie.george@nih.gov
Raquel Greer, M.D., MHS, FACP
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-402-0306
E-mail: raquel.greer@nih.gov
Jenna Norton, Ph.D, M.P.A.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-451-7314
E-mail: jenna.norton@nih.gov
Shavon Artis Dickerson, Dr.P.H., M.P.H.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-435-3055
E-mail: shavon.dickerson@nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Christopher Myers
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 435-0713
E-mail: myersc@nidcd.nih.gov
Sam Ashe
National Institute of Allergy and Infectious Diseases (NIAID)
301-435-4799
Samuel.Ashe@nih.gov
Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov
Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov
Christy Leake
National Institute of General Medical Sciences (NIGMS)
Email: christy.leake@nih.gov
Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-451-4791
Email: kellis@mail.nih.gov
Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov
Judy Fox
NIAAA - NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov
Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
240-276-6277
wolfreyc@mail.nih.gov
Matthew Zeback
National Center for Advancing Translational Sciences (NCATS)
301-451-8309
matthew.zeback@nih.gov
Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
301 -435 - 7858
deanna.ingersoll@mail.nih.gov
Priscilla Grant, JD
National Institutes on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov
Karen Robinson-Smith
National Eye Institute (NEI)
301-435-8178
karen.smith2@nih.gov
Tracee Foster
National Heart, Lung, and Blood Institute (NHLBI)
301-827-8030
tracee.foster@nih.gov
Jenny Greer
National Institute of Environmental Health Sciences (NIEHS)
984-287-3332
jenny.greer@nih.gov
Brian Albertini
National Institute of Nursing Research (NINR)
301-594-6869
albertib@mail.nih.gov
Ryan Blakeney
National Institute on Aging (NIA)
301-451-9802
blakeneyr@mail.nih.gov
Pamela Fleming
National Institute on Drug Abuse (NIDA)
301-480-1159
pfleming@nida.nih.gov
Erik Edgerton
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.