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.

BACKGROUND

The purpose of this funding opportunity announcement (FOA) is to support research to explore the impacts of extreme weather and disaster events on the basic biology of aging. Together with the companion FOA (PAR-19-250) that focuses on how extreme weather and disaster events impact older adults in the human population, these complementary FOAs will help to explicate the behavioral, biological, epigenetic, genetic, neurological and socioecological processes that affect aging process. Through integration of this and the companion population studies FOA, the ultimate goal is to improve the health and well-being of older adults via increased knowledge about extreme weather and disaster preparedness, response, and recovery.

Clinical and mechanistic studies demonstrate that aging is a major risk factor for chronic disease and degenerative conditions. In addition, the past decade has seen considerable advancement in understanding the biologic hallmarks of aging which includes genomic instability, telomere attrition, epigenetic alterations, loss of proteostasis, deregulated nutrient sensing, cellular senescence, stem cell exhaustion, altered intercellular communication, and mitochondrial dysfunction. However, there is little mechanistic understanding of how exposure to extreme environmental changes, e.g. heat and other climate and disaster related exposures, interact with the biology of aging in human populations, either alone or along with other stressors (e.g., the status of social networks, the timing and duration of exposure in relation to the life course, and the type and severity of chemical exposures in disaster events). Although many studies have focused on early-life exposures and the later life health effects (e.g., Developmental Origins of Disease), limited research has addressed the effects of environmental exposures in the setting of later life on how this may affect biological aging. Furthermore, although increasing research has explored the effects of disaster events in specific regions and among specific subpopulations, relatively fewer studies have focused on extreme weather and natural or manmade disaster events in aging populations.

The impetus behind this population-based FOA are four converging factors that have led to heightened interest in research to understand how extreme weather and disaster events impact older adults.

First, health improvements have driven increases in life expectancy. Adults aged 65 and older make up about 13% of the current U.S. population, but by 2040 that number is projected to increase to 20%. For the first time in American history, people aged 65 and older will outnumber people under the age of 18 by 2030.

Second, while the US population is getting older, several types of extreme weather and disaster events have increased in frequency and/or severity. These events appear to have differential effects by age with older individuals being particularly vulnerable during and following these events. Though it is not fully clear why, physical well-being, functional health, cognitive function, residential context (e.g. community-dwelling versus living in a nursing home or assisted living), and social connectedness represent potential pathways to disproportionate effects in older adults.

Third, health inequities among vulnerable populations amplify the effects of natural disasters such as hurricanes, tornadoes, earthquakes, wildfires and manmade disasters. Inequalities may be particularly prevalent among older adults, given that disparities by race, ethnicity, class, and gender may grow across the life course.

Finally, because experiences aggregate across the life course, examining the impacts of current extreme weather and disaster events on older people enables an investigation not only of present conditions but myriad past experiences both separately and together with current events.

There have been many advances in understanding the biology of aging using laboratory animals. However, there is limited mechanistic understanding of how stressors such as exposure to extreme environmental changes interact with the biology of aging in human populations or in laboratory animals. Moreover, little is known how stressors interact with the hallmarks of aging, either alone or along with other stressors (e.g., the status of social networks, the timing and duration of exposure in relation to the life course). To a large extent this is due to limited studies and limitations of studying biological changes in aging human populations. In contrast, laboratory organisms offer unique opportunities to examine and understand the biological underpinnings of susceptibility to the stressors associated with extreme environmental changes. This is due to their shorter lifespans, making study across a life course tractable. This is especially important considering the progress made in bringing the environment into the laboratory coupled with the ability to modify the biology of aging in laboratory animals.

Using these hallmarks of aging to guide experimental work on the potential causal relationships between extreme environmental events and health at older ages, basic biological studies could inform epidemiological research. Importantly, because events in early- and mid-life also impact health at older ages, many aspects of human health can be recapitulated in laboratory animals with significantly shorter lifespans. Combining this knowledge with the ability and capacity to respond to stressors can provide a better understanding of what factors underlie increased susceptibility to, or diminished resiliency from extreme environmental events. It is also important to consider many health span-extending interventions in the context of extreme environmental events, in comparison to their effects in highly regularized laboratory environments because these promising interventions have not been tested in the context of stressors, and especially those resulting from extreme environmental events.

Terminology

Environmental influences on Aging include Biological, Environmental, Epigenetic, and Socioecological factors. There are a variety of definitions that can be used to describe aging and environmental exposures. For the purposes of this FOA, we provide definitions relevant to this announcement:

1. Aging populations We conceptualize human aging as a continuous process across the life span. We understand aging populations to include those in midlife and older life stages, while recognizing that the boundaries between life stages are fluid and conditional on context (e.g., cultural, economic development, and so forth). A focus on individuals solely from childhood or young adulthood is strongly discouraged. Aged laboratory animals are considered to have reached at least one-half of their life expectancies.
2. Biological factors include chemical, molecular, structural, or infectious factors that impact senescence processes at the cellular, tissue, or organismal level.
3. Disasters - includ eextreme weather-related disasters (hurricanes, storm surge, floods, wildfires); weather extremes (prolonged or excessively high heat waves, severe unseasonal cold spells); manmade disasters (oil spills, chemical spills, terrorism); and different kinds of slow disasters
   • disaster regions where natural and manmade disasters occur on a regular basis such as low-lying coastal regions (e.g., the Gulf of Mexico, barrier islands)
   • neighborhood and household violence
4. Displacements (resulting from loss of customary living environment) may include loss of social networks, disruption of daily living, and in laboratory animals may include remixing of animals and multiple alterations of their housing (within allowances of standard animal care).
5. Dissemination and Implementation - research on how evidence-based practices, interventions, and policies are effectively translated to and used in real-world settings like hospitals, schools, and communities.
6. Environmental factors encompass exogenous chemical and metal exposures, climatic conditions, as well as financial, cultural, natural, and built social capitals that impact a person’s health. Specifically, environment includes non-chemical stressors (e.g., social isolation) and chemical stressors (e.g., polycyclic aromatic hydrocarbons, volatile organic compounds, metals, etc.) that can result from extreme environmental changes or disasters
7. Epigenetic factors - molecular or chemical factors that affect how cells express genes, without modifying the underlying DNA sequence
8. Socioecological factors - factors that impact an individual’s behavior by working at various levels of a person’s social interactions (e.g. interpersonal relationships, social networks, community structures, government services)
9. Mixtures The study of multiple factors that may work synergistically as well as additively to impact the health of an individual. Mixtures may be of the same type of factor (e.g. multiple environmental chemicals released during a flooding event) or may represent different types of factors (e.g. heat stress, exposure to flame retardant aerosols/smoke, and social stresses that may result from evacuating in a wildfire event). This type of study is also referred to as research on combined or cumulative exposures which may include chemical stressors and the potential cumulative effects of chemical and non-chemical stressors
10. Risk communication - refers to language, images, and other symbols that facilitate cognitive-, decision-making, and other human processes to understand health-related benefits and deficits

SCOPE OF THE RESEARCH

Studies for this FOA research should be informative about the basic biology in three broad areas of research on aging. These include:

1. Understanding Effects of Combined Exposures
   • Lifelong, cumulative environmental exposures
   • Environmental factors in context of social stressors, including displacement, disruptions, trauma and cultural considerations
2. Hallmarks of Aging
   • Cellular and Molecular Processes
   • Sensory and mental decline/deficits
3. Biomarkers of Resilience
   • Individual vs. community resilience in humans
   • Social hierarchies in animal models

RESEARCH APPROACHES

Multidisciplinary research projects that can potentially address the multifactorial nature of exposures affecting aging are welcomed. Studies submitted in response to this FOA are therefore encouraged that utilize the appropriate inclusion of various scientific disciplines, methodologies and theoretical frameworks.

1. This may include the participation of basic scientists, epidemiologists, social scientists and communications research experts, among others, to conduct research on mixtures (i.e., combined and cumulative exposures).
2. Social scientific, community-engaged and behavioral interventional research on socioeconomic, cultural and behavioral stressors on aging populations.
3. Communications research, Dissemination & Implementation studies, and development of culturally appropriate risk messages.
4. Fundamental research on mechanisms of aging

Research Topics of specific interest in this FOA on Effects of Extreme Weather and Disaster Events as may be illuminated by the basic biology of aging include but are not limited to:

• Mimicry of environmental disasters in laboratory animals at different stages in the life course, with determination of effects on the rate of aging and health span using any of the indices from the hallmarks or aging.
• Impacts on resilience including speed, amplitude and duration of response, return to baseline and refractory periods after an exposure. Consideration should also be given to longitudinal studies with laboratory animals to track longer-term functional health and impacts on the aging health trajectory.
• Reducing vulnerability using interventions and modalities that extend lifespan or healthspan in laboratory animals.
• Impacts on mitochondrial function, its altered signaling, and quality control
• Impacts on genomic stability including DNA repair deficiency/damage/mutation accumulation, telomere lengths and telomerase activity, epigenomes.
• Impacts on burden and functions of senescent cells and cross-interactions with senolytics.
• Impacts on wound healing and repair supported by stem cells and other mechanisms altered by aging.
• Impacts on immune function and immune senescence, including tissue-resident immune cells, inflammatory resolution, and immune cell subtype distributions.
• Impacts on circadian rhythm and molecular signatures that track with circadian rhythms, including sleep
• Sensory deficits (e.g., deafness, smell or vision deficits), including nutrient sensing
• Impacts on cognitive functions on development or extent of dementias, including laboratory models of dementias
• In laboratory animals that form social groups, or have identifiable social hierarchies, research to elucidate or distinguish between individual and community resilience, (e.g., resilience of networks).
• Impacts in the context of cumulative exposures (e.g., environmental disasters and non-chemical stressors)

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

• Eligible Agencies of the Federal Government

• U.S. Territory or Possession

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Applicant organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

3. Additional Information on Eligibility

Number of Applications

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Ronald A. Kohanski, Ph.D.

National Institute on Aging (NIA)

Telephone: 301.496.6402

Fax: 301-402-0010

Email: [email protected]

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

Joint Meetings: Each PI is expected to budget sufficient funds to attend up to three joint meetings of the Environmental Influences on Aging Populations and Aging Processes program. The three meetings are anticipated to occur in Years 1, 3 and 5 in venues to be determined in collaboration with the Principal Investigators, NIA and NIEHS.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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?

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?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

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?

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

• Will receive a written critique.

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

1. Award Notices

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

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.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

3. Reporting

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

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

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: [email protected] (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: [email protected]

Ronald A. Kohanski, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6402
Email: [email protected]

Michelle Heacock, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3267
Email:[email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Traci Lafferty
National Institute on Aging (NIA)
Telephone: 301-496-8987
Email: [email protected]