Frequently Asked Questions for RFA-AG-24-027

The frequently asked questions below are related to RFA-AG-24-027 - Building Neuroscience Research Infrastructure for Alzheimer’s Disease for Related Dementias in Africa (UG3/UH3 Clinical Trial Not Allowed) .

Q: What is the purpose of the Funding Opportunity Announcement?

A: The purpose of this notice of funding opportunity (NOFO) is to promote collaborative research programs to support the development/enhancement of infrastructure (e.g., tools, surveys, biospecimens, data) for Alzheimer's disease (AD) and AD-related dementias (AD/ADRD) neuroscience research in low- and middle-income countries (LMICs) in Africa. Specifically, NIA seeks to support Phase Innovation Awards Cooperative Agreement (UG3/UH3) projects to enable: (1) the formation of transformative collaborations between institutions/scientists in the US and LMICs in Africa; (2) the development, or enhancement of research infrastructure and resources for studies of AD/ADRD neuroscience relevant to Africa as well as to examine how social or behavioral factors influence AD/ADRD in Africa; (3) the initiation of pilot or exploratory studies that will inform future research for AD/ADRD neuroscience in Africa.

Q: How do I know the income category for LMICs in Africa?

A: NIH uses the income categories as defined by the World Bank. To confirm the income category for LMICs in Africa, please visit http://data.worldbank.org/about/country-classifications/country-and-lending-groups .

Q: What is the UG3/UH3 activity code?

A: The UG3/UH3 activity code is a phased cooperative agreement. Each phase is milestone-driven and only those projects attaining the UG3 milestones will progress to the UH3 phase. The UG3 Planning Phase should include activities related to methodology for data collection (e.g., blood, brain donation, PET-tau/amyloid, MRI, etc.), development or testing of new tools (e.g., surveys, questionnaires, technology tools) or engagement of relevant stakeholders (e.g., focus groups). During the UH3 Implementation Phase, investigators will be expected to implement pilot research projects for the collection of preliminary data in preparation for larger research projects. The quality of the planning, design, and documentation of products for the UH3 phase will be given key consideration when NIA program staff reviews progress of UG3 phase. The cooperative agreement will enable program’s substantial involvement in overseeing the design and progress of the awarded grants. The proposed project period for the UG3 phase can range from 2 to 3 years, and the total duration of the UG3/UH3 phases combined may not exceed 6 years. Please see additional information below:

The specific aims page should include the aims to be accomplished in both UH2 and UH3 phase.

Planning Phase (UG3)

Years 1-3
Team building, feasibility studies, focus groups, etc.
Budget cap is $400K direct costs/year.

Implementation phase (UH3)

Years 3 - 6 if UG3 phase was 2 years or Years 4 – 6 if UG3 phase was 3 years.
Adequately powered pilot projects to lay the foundation for future, larger scale projects.
Budget cap is $800K direct costs/year.

Milestones and Transition to UH3

Application must include proposed milestones for UG3 phase.
UG3 milestones will require NIA approval (prior to funding).
The PIs will submit a detailed transition request to proceed to UH3 phase.
UH3 transition requests will undergo administrative review by NIA staff.

Cooperative Agreement

Facilitates NIA’s program staff involvement as Project Scientists
Allows additional oversight of awarded grants (i.e., review of milestones)
Promotes collaborative work among the awardees:
- Awardees should plan and budget for travel to an annual meeting.
- The annual meeting will provide a forum for investigators from all funded projects to discuss research updates, identify opportunities for synergy and collaboration (e.g., data harmonization, protocol optimization), and identify pertinent research challenges and solutions.

Q: What are milestones?

A: Milestones should describe the goal of the work and not just a statement that the work will be completed. The milestone should indicate the desired outcome of a study and not simply that the study was conducted. The milestones must provide objective and quantitative outcomes by which to justify advancing the project, and should be objective measures, recognizable as appropriate endpoints by reviewers knowledgeable in the specific scientific area. Visit the NINDS website for an example of milestones .

Q: When are the applications due?

A: There is a single receipt date for this NOFO: February 14, 2024. No late applications will be accepted. In general, investigators should try to submit their applications a few days prior to the deadline so that you can make changes if needed.

Applicants and their institutions should familiarize themselves with the requirements of electronic submission through grants.gov, including registration of the applicant and the institution through NIH Commons. Remember, you must check for error messages after submission to Grants.gov AND subsequently when the application is transferred automatically to eRA Commons (check your eRA Commons account).

You must correct any Grants.gov and eRA-identified errors BEFORE the submission deadline or your application will NOT be accepted by NIH. Verify that your application is viewable in your eRA Commons account. If you cannot view the application in eRA Commons, NIH has not yet accepted it! Do not wait until the last day.

Check your application for common errors before you submit or see " Avoiding Common Errors ."

Q: What is the maximum budget and how many projects will be funded?

A: NIA intends to commit $3 million in fiscal year 2024 to fund four awards. Application budgets are limited to $400,000 in direct costs per year in the UG3 phase, and $800,000 in direct costs per year in the UH3 phase.

Q: What are some examples of research areas of interest?

A: Investigators should propose studies that will enable: (1) the formation of transformative collaborations between institutions/scientists in the US and LMICs in Africa; (2) the development, or enhancement of research infrastructure and resources for studies of AD/ADRD neuroscience relevant to Africa as well as to examine how social or behavioral factors influence AD/ADRD in Africa; (3) the initiation of pilot or exploratory studies that will inform future research for AD/ADRD neuroscience in Africa. Investigators are encouraged to submit a draft specific aims page and discuss with Dr. Martin, Dr. Ghaleh and/or Dr. Chatterji.

Research areas include, but are not limited to, the following:

Studies of novel genetic variants that may have a strong genetic contribution to AD biology.
Studies that examine the association of highly prevalent co-morbidities (e.g., cardiovascular risk factors, diabetes, dyslipidemia, peripheral arterial disease), cognitive impairment and AD/ADRD phenotypes.
Environmental exposures including environmental toxicants, air pollution, and diet.
The role of infectious agents, including COVID-19 in cognitive impairment and age-related dementia.
Etiology of age-related dementia subtypes.
Genetic and other -omics data: APOE status, genome-wide association study or whole sequencing, epigenetics, transcriptomics, metabolomics, and proteomics.
Neurobiological and Neuropathological: Neuroimaging endpoints, including, but not limited to, the use of novel positron emission tomography (PET) ligands; cerebrospinal fluid, or blood-based biomarkers such as beta-amyloid, tau, and neurofilament; and autopsy tissue when possible.
Physiology and other co-morbidities: Obesity, diabetes, hypertension, and other vascular contributions to cognitive impairment (VCID); stress measures (e.g., autonomic, cortisol); role of inflammation or immune systems; and mental health history.
Identification of underlying mechanisms of resilience (e.g., protective genotypes of cognitive reserve).
Social determinants of health and exposome: poverty, discrimination, early or mid-life adversity, neighborhood, occupation and education, cultural and familial contexts, pollution and toxicants, and healthcare access.
Psychological: personality, cognitive ability, emotional function (e.g., stress reactivity and resilience, self-regulation), social connection, and loneliness.
Behavioral and functional: health behaviors (e.g., physical activity, smoking, diet, sleep, etc.), financial decision-making, physical function, sensory function, and social relationships.
Data collection at regional or state-level, particularly in large, populous countries, or on a probability-based sample with the long-term goal is to conduct a nationally representative study.
Conducting a multi-disciplinary nationally representative study that is harmonized with the HRS International Family of Studies and Harmonized Cognitive Assessment Protocol.

Q: What are some examples of data types of interest?

A: Some examples of data types of interest are:

Genetic and other -omics data: APOE status, genome-wide association study or whole sequencing, epigenetics, transcriptomics, metabolomics, and proteomics.
Neurobiological, Physiological, and Neuropathological: Neuroimaging endpoints, including, but not limited to, the use of novel positron emission tomography (PET) ligands; autonomic measures; cerebrospinal fluid, or blood-based biomarkers such as beta-amyloid, tau, and neurofilament; and autopsy tissue when possible.
Co-morbidities: Obesity, diabetes, hypertension, and other vascular contributions to cognitive impairment (VCID); mental health history.
Demographic: Race, ethnicity, gender, sex, immigration status, socioeconomic status, education, and geography.
Social determinants of health and exposome: poverty, discrimination, early or mid-life adversity, neighborhood, occupation and education, cultural and familial contexts, pollution and toxicants, and healthcare access.
Psychological: personality, cognitive ability, emotional function (e.g., stress reactivity and resilience, self-regulation), social connection, and loneliness.
Behavioral and functional: health behaviors (e.g., physical activity, smoking, diet, sleep, etc.), financial decision-making, physical function, sensory function, and social relationships.

Q: Which applications are considered non-responsive to this Funding Opportunity Announcement (FOA)?

A: The following types of applications will be considered non-responsive and will be withdrawn prior to review:

Applications that include non-human animals
Applications that include populations not from Africa.
Applications from high-income countries within Africa (please visit the World Bank http://data.worldbank.org/about/country-classifications/country-and-lending-groups. webpage for information on Low- and Middle-income Countries (LMICs) in Africa).
Applications that do not include all of the following components:
- US-Africa collaborative MPI plan.
- A description of the scientific area to be addressed and a description of how the proposed infrastructure and resources will help address that scientific area.
- A plan for appropriate and meaningful community engagement.
- A description of milestones, performance metrics, and a timeline for completion of milestones.

Please note that non-responsive applications will be withdrawn prior to review.

Q: Can I include high-income country (HIC) investigators as partners on an application?

A: Non-U.S.-based high-income countries (HIC) investigators are NOT eligible as Program Director (PD)/Principal Investigator (PI)s but may be included as consultants, especially if they present special opportunities for furthering research programs, present special opportunities and/or unusual talent for furthering research programs or provide resources relevant to the proposed project that either are not readily available in the eligible LMIC or the U.S. institution or which augment existing resources.

Q: What are additional resources I can reference while developing my application?

A: Some relevant resources that you can reference are:

Q: Where can I find more information on how to apply to NIH?

A: Potential applicants can find instructions for how to apply in the SF424 Application Guide . Carefully follow the specific guidelines/requirements found in both the SF424 Application Guide and the instructions in the Notice of Funding Opportunity (NOFO). Be aware that the instructions in the NOFO supersede those found in the SF424 application guide.

Additionally, tips for NIH applicants are provided in a video Grant Writing for Success NIH [Video via CUGH TV/YouTube] in which reviewers and staff at the NIH offer their insights to scientists seeking to improve their chances of getting a grant from the National Institutes of Health.

See the Annotated Forms for tips on how to fill in the SF424 forms.

Q: How do I find a US investigator to collaborate with?

A: You can find information about all funded NIH awards through the public database NIH RePORTER , which may be helpful in locating experts in specific scientific or geographic regions. Additionally, potential applicants may want to use World RePORT as a resource. This is an open-access, interactive mapping database project highlighting biomedical research investments and partnerships across many large funding organizations.

Q: Are Multiple PD/PIs required?

A: Yes. Multiple PD/PIs are required, and a Leadership Plan must be included in the application. 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 .

Q: Is having and maintaining a System for Award Management (SAM) registration required for applications submitted to tis NOFO?

A: Yes, the submitting institution and all PDs/PIs are required to register in order to submit an application using the online systems. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations:

System for Award Management (SAM) – Applicants must complete and maintain an active entity registration (formerly CCR registration), which requires renewal at least annually. The renewal process may require as much time as the initial registration. Use the Sam.gov "Manage Entity" function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons - Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Find detailed instructions about this multiple step process .

Your organization must be registered in SAM and your SAM credentials must be active at time of grant submission and time of grant award. A yearly renewal process is required to keep your credentials active. SAM uses the term "entity" to refer to your organization.

Purpose of SAM

SAM is a system required by the federal government to collect information on organizations applying for grants and contracts.
Quick Start Guide for International Registrants [PDF]

Note that NIH requires electronic applications, and it is critical that applicants complete all required registrations well in advance of the application deadline as the registration process can take several weeks or longer.

Q: Do all PDs/PIs need to have an eRA Commons ID?

A: All PDs/PIs 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. For additional information, see the eRA Commons Registration FAQs .

Q: How do I find out more about NIH Cooperative Agreements?

A: The Cooperative Agreement (U Series) mechanism is a support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities. The Cooperative Agreement Terms and Conditions of Award in the FOAs describe the respective roles and responsibilities of PDs/PIs and U.S. Government staff, as well as areas of joint responsibility. U.S. Government Project Collaborators will be appointed at the time of award and will have substantial programmatic involvement by providing advisory input as described in the FOAs. The role of the U.S. Government Project Collaborators will be to facilitate and not to direct activities.

Q: Where can I find instructions for preparing my Biographical Sketch (Biosketch)?

A: Access Biosketch Format Pages, Instructions and Samples from the NIH Office of Extramural Research (OER).

Please also see the following NIH Guide notice for Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021 (NOT-OD-21-073) .

Grants-Funding