The purpose of this Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions is to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing biomedical research experiences primarily for undergraduate students and enhancing the research environment at applicant institutions.Eligible institutions must award baccalaureate science degrees and have received no more than $6 million dollars per year of NIH support (in both direct and F and A/indirect costs) in 4 of the last 7 fiscal years. For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all the non-health professional schools and colleges within the institution as a whole.This Notice of Funding Opportunity (NOFO) supports investigator-initiated mechanistic and/or minimal risk clinical trials addressing the mission and research interests of the participating NIH institutes. For the purpose of this NOFO, minimal risk clinical trials are defined as those that do not require FDA oversight, do not intend to formally establish efficacy, and have low risks to potentially cause physical or psychological harm.

Funding Opportunity Number: PAR-24-214. Assistance Listing: 93.173,93.233,93.242,93.273,93.279,93.361,93.393,93.394,93.395,93.396,93.399,93.837,93.838,93.839,93.840,93.853,93.865,93.866,93.867. Funding Instrument: G. Category: ED,HL,ISS. Award Amount: Up to $375K per award.

PAR-25-134: Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions (R15 Clinical Trial Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of General Medical Sciences ( NIGMS ) National Eye Institute ( NEI ) National Heart, Lung, and Blood Institute ( NHLBI ) National Human Genome Research Institute ( NHGRI ) 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 Mental Health ( NIMH ) National Institute of Neurological Disorders and National Institute of Nursing Research ( NINR ) National Library of Medicine ( NLM ) National Center for Complementary and Integrative Health ( NCCIH ) National Cancer Institute ( NCI ) Tribal Health Research Office ( THRO ) Funding Opportunity Title Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions (R15 Clinical Trial Not Allowed) R15 Academic Research Enhancement Award (AREA) Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity Research Enhancement Awards (REA) See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 859, 93.

846, 93. 172, 93. 867, 93.

173, 93. 847, 93. 879, 93.

865, 93. 837, 93. 233, 93.

838, 93. 839, 93. 840, 93.

286, 93. 855, 93. 310, 93.

853, 93. 113, 93. 393, 93.

394, 93. 395, 93. 396, 93.

399, 93. 361, 93. 121, 93.

273, 93. 242, 93. 279, 93.

213, 93. 866 Funding Opportunity Purpose The purpose of this Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions is to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing biomedical research experiences primarily for undergraduate students, and enhancing the research environment at applicant institutions.

Eligible institutions must award baccalaureate science degrees and have received no more than $6 million dollars per year of NIH support (in both direct and F&A/indirect costs) in 4 of the last 7 fiscal years. For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all the non-health professional schools and colleges within the institution as a whole.

Consult Part 2. Section III. 1 Eligible Organizations for more information.

AREA (Academic Research Enhancement Awards) Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description The National Institutes of Health (NIH) is continuing to make a special effort to stimulate research at educational institutions that graduate baccalaureate students who go on to become the Nation's research scientists, but that have not been major recipients of NIH support.

This Notice of Funding Opportunity (NOFO) aims to support biomedical research projects proposed by faculty members at undergraduate-focused institutions that do not receive substantial funding from the NIH.

The three objectives of this NOFO are to: Provide support for meritorious research at undergraduate-focused institutions or institutional components Strengthen the research environment at these institutions/components Give undergraduate students an opportunity to gain significant biomedical research experience through active involvement in the research For the purpose of this NOFO, an undergraduate-focused institution/component is one in which the undergraduate enrollment is greater than the graduate enrollment.

The AREA program will enable eligible organizations to receive support for small-scale research projects led by faculty members.

It is anticipated that investigators supported under the AREA program will benefit from the opportunity to conduct independent research; that the grantee institution will benefit from a research environment strengthened through AREA grants; and that students at recipient institutions will benefit from exposure to and participation in scientific research in the biomedical sciences to encourage them to consider careers in biomedical research.

This AREA NOFO emphasizes the engagement and inclusion of undergraduates in research. The research project must involve undergraduate students, and the research team must be composed primarily of undergraduate students.

Student involvement in research may include participation in the design of experiments and controls, collection and analysis of data, execution and troubleshooting of experiments, presenting at meetings, drafting journal articles, participation in lab meetings to discuss results and future experiments, etc. The AREA program is a research grant program, not a training or fellowship program, and, as such, applications should not include training plans such as didactic training or non-research activities relating to professional development.

This NOFO does not provide for support of research at Health Professional Schools as defined in Part 2. Section III. 1 Eligible Organizations regardless of student composition.

An AREA application submitted to this NOFO may include other investigators, such as technicians, collaborators, consultants, or other individuals such as high school students, post-baccalaureate participants, graduate students, or postdoctoral fellows. However, involvement of such individuals does not fulfill the goal of engaging undergraduate students at eligible institutions in research.

In all cases, the majority of students conducting research through the award must be undergraduates. Prior Consultation with IC staff Participating NIH Institutes and Centers are indicated in Part 1. Overview.

Components of Participating Organizations. For additional scientific program information and for pre-application guidance, applicants are encouraged to contact the Scientific/Research Contact(s) in Part 2. Section VII with research interests relevant to the applicant's proposed topic.

Consultation with relevant NIH staff prior to the application due date is strongly encouraged for new and resubmission applications. Institute/Center-Specific Interests NIGMS The mission of NIGMS is to support basic research that increases our understanding of biological processes and lays the foundation for future advances in disease diagnosis, treatment, and prevention.

NIGMS also supports research in specific clinical areas that affect multiple organ systems; anesthesiology and peri-operative pain; clinical pharmacology common to multiple drugs and treatments; and injury, critical illness, sepsis, and wound healing. NIGMS-funded scientists investigate how living systems work at a range of levels - from molecules and cells to tissues and organs - in research organisms, humans, and populations.

The Institute’s research mission is aimed at understanding the principles, mechanisms, and processes that underlie living organisms, often using research models. NIGMS also supports the development of fundamental methods and new technologies to achieve its mission. Supported research may utilize specific cells or organ systems if they serve as models for understanding general principles.

For additional scientific program information and for pre-application guidance, a potential applicant is encouraged to contact the NIGMS Scientific/Research Contact or the Program Director with portfolios with research interests relevant to the applicant's proposed topic .

NIAAA The mission of NIAAA is to generate and disseminate fundamental knowledge about the adverse effects of alcohol on health and well-being and apply that knowledge to improve diagnosis, prevention, and treatment of alcohol-related problems, including alcohol use disorder, across the lifespan.

NIAAA supports alcohol-related research in a wide range of scientific areas that span neuroscience and behavior, epidemiology and prevention, treatment and recovery, and metabolism and health effects as well as research to address health disparities. For more information about NIAAA research initiatives and priorities, please visit https://www. niaaa.

nih. gov/research . Potential applicants are encouraged to contact the NIAAA Scientific Contact associated with this NOFO or the relevant programmatic contact within NIAAA’s extramural research divisions .

NIAID supports basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases, with the goal of developing new therapies, vaccines, diagnostic tests, and other technologies. Research areas include microbiology and infectious diseases, HIV/AIDS and AIDS-related research, immunology, allergy, transplantation, emerging and re-emerging infectious diseases, and biodefense.

NLM supports innovative research and development in biomedical informatics and data science. The scope of NLM's interest in these research domains is broad, with emphasis on new methods and approaches to foster data driven discovery in the biomedical and clinical health sciences as well as domain-independent, reusable approaches to discovery, curation, analysis, organization and management of health-related digital tools.

Biomedical informatics and data science draw upon many fields, including mathematics, statistics, information science, computer science and engineering, and social/behavioral sciences. Application domains include, but are not limited to, health care delivery, basic biomedical research, clinical and translational research, precision medicine, public health, surveillance, health information management, and health for all.

NICHD supports biological, behavioral, and clinical research related to conception and pregnancy, normal and abnormal development in childhood, reproductive health, population dynamics across the lifespan, and rehabilitation medicine ( https://www. nichd. nih.

gov/about/org/der ) . Research projects considered for funding by NICHD must fall within the scientific missions of the twelve Scientific Branches of the NICHD Division of Extramural Research (DER) or the National Center for Medical Rehabilitation Research (NCMRR). Information about those scientific missions and program staff contacts may be found on the web pages for the DER scientific branches and the NCMRR .

Potential applicants are strongly encouraged to read these webpages for any updates in response to recent scientific advances or emerging public health topics. NICHD encourages applications that address its extramural program priorities and will consider how well research projects align with one or more of those priorities when making award decisions. A detailed list of NICHD high priority research areas may be found at https://www.

nichd. nih. gov/about/org/der NHLBI supports basic and clinical research pertaining to the structure, function, and diseases of the cardiovascular system, lungs, blood and blood vessels, and sleep disorders.

The NHLBI also supports research in stem cell biology and transplantation, transfusion medicine, and blood resources. The NHLBI carries out its mission through a number of research programs that provide support for projects ranging from studies at the molecular level to whole body studies in man and animals.

Examples of research areas supported by the NHLBI include atherosclerosis, hypertension, cerebrovascular disease (directed at the dependent variable of blood, heart, or blood vessel), coronary heart disease, peripheral vascular diseases, arrhythmias, heart failure, and shock, congenital and rheumatic heart diseases, cardiomyopathies and infections of the heart, circulatory assistance, lung cell and molecular biology, chronic obstructive lung diseases, pediatric pulmonary diseases, cystic fibrosis, sleep-disordered breathing, asthma, fibrotic and immunologic lung diseases, acute respiratory failure, pulmonary vascular diseases, HIV-associated lung disorders and bone marrow suppression, bleeding and clotting disorders, disorders of the red blood cell such as sickle cell disease and Cooley's anemia, bone marrow failure syndromes, and blood resources.

NCCIH has a mission to determine, through rigorous scientific investigation, the usefulness and safety of complementary health approaches, and their roles in improving health and healthcare. NCCIH will accept applications for research projects in areas within the Center’s mission that are well-aligned with our strategic priorities .

Studies may range from basic, through translational, epidemiological, health services, and other human subjects research. Investigators are strongly encouraged to discuss their concepts with NCCIH program staff prior to applying.

NHGRI supports the development of resources, approaches, and technologies that will accelerate genomic research on the structure of genomes, the biology of genomes, and the biology of disease; that will use genomics to advance the science of medicine; and that will incorporate genomics to improve the effectiveness of healthcare.

NHGRI also supports genomic research in several cross-cutting areas, including the ethical, legal and societal implications of genomics and genetics research, bioinformatics, technology development, and research training and career development. In general, NHGRI supports studies that provide generalizable methods and knowledge.

Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. NHGRI strongly encourages potential applicants to reach out to the listed scientific contact in the early stages of developing an application. NIDCR supports basic, translational, and clinical research in dental, oral, and craniofacial health and disease.

Program areas include oral microbiota and bacterial disease; oral opportunistic pathogens and viral disease; salivary biology and immunology; oral and salivary gland cancers; neuroscience of orofacial pain and temporomandibular disorders; mineralized tissue physiology; dental materials and biomaterials; tissue engineering and regenerative medicine; genetics/genomics; developmental biology; data science; epidemiology; HIV/AIDS and oral health; oral health disparities and inequities; and mechanisms in the science of behavior change.

Potential applicants are strongly encouraged to discuss their research plans with Program Staff in relevant areas. NIDCD supports applications that propose research projects in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. Applicants are strongly encouraged to learn more about NIDCD research areas .

NIA will accept applications for research projects in areas within the Institute's mission that includes genetic, biological, behavior, social, and economic research on aging. In addition, NIA encourages applications on Alzheimer’s Disease (AD) and AD Related Dementias (ADRD). The NIA website provides additional information about the Institute mission and areas of research interest.

For additional scientific program information and for pre-application guidance, a potential applicant is encouraged to contact the NIA Program Director whose portfolio covers the scientific topic of interest. NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care.

An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases.

However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the Scientific/Research Contact to determine if their research fits within the NIBIB mission .

NIAMS supports research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. NIAMS also conducts and supports basic research on the normal structure and function of bones, joints, muscles, and skin.

Basic research involves a wide variety of scientific disciplines, including immunology, genetics, molecular biology, structural biology, biochemistry, physiology, virology, and pharmacology. Clinical research includes rheumatology, orthopedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine.

NIDDK conducts and supports medical research and research training and disseminates science-based information on diabetes and other endocrine and metabolic diseases; digestive, hepatobiliary, exocrine pancreatic, nutritional disorders and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.

Research projects considered for funding by NIDDK must fall within the scientific research mission of the Institute. Potential applicants are encouraged to contact the NIDDK Extramural Research Program Staff whose portfolio covers the scientific topic of interest. Specific information about our Research Programs & Contacts is available at https://www.

niddk. nih. gov/research-funding/research-programs .

NINR supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline. NINR discovers solutions to health challenges through the lenses of health for all, social determinants of health, population and community health, prevention and health promotion, and systems and models of care.

Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community.

NCI considers meritorious R15 applications requesting support for cancer research-focused projects across the full spectrum of its mission, including projects focused on studies of cancer biology, etiology, prevention, detection, diagnosis, treatment, control, survivorship, and population sciences.

The NCI R15 Program Contact person (indicated below) can be contacted for more information and guidance about NCI’s mission, priorities, and interests as related to the R15 Program, this R15 notice of funding opportunity, and R15 applications. NINDS seeks fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.

NINDS supports basic, translational, and clinical research within specifically defined areas of neuroscience. Research projects considered for funding by NINDS must fall within the scientific research mission of the Institute.

A key component of research projects submitted to NINDS in response to this NOFO is to provide an outstanding research experience for undergraduate students, which will enable them to gain a solid understanding of rigorous scientific methodology, experimental design, statistical methodology, and quantitative literacy, within the particular field of study.

NINDS also expects the application to contain evidence that the PI fosters a safe and supportive environment where all voices and perspectives are equally encouraged, as well as a strong commitment to providing effective, supportive mentorship. For this NOFO, projects are limited to prospective basic science studies not involving human participants and/or clinical trials as described in NOT-OD-24-118 .

It is critical that applicants with research interests relevant to the NINDS mission contact the person listed under Agency Contacts (Section VII) to confirm that the proposed research fits the NINDS’ scientific research mission.

Tribal Health Research Office (THRO): The mission of the Tribal Health Research Office (THRO) is to improve Native health, enhance capacity for health research in Native communities, and promote opportunities for the next generation of American Indian and Alaska Native (AI/AN) researchers.

THRO supports basic and applied biomedical and behavioral research that addresses critical issues relevant to the health of Tribal and AI/AN populations. THRO does not have grant-making authority or administer grants, however THRO can co-fund grants deemed scientifically meritorious after review by one of the institutes or centers (ICs) participating in this announcement.

In addition, applicants are encouraged to consult the Frequently Asked Questions website and the NIH Research Enhancement Award R15 website for more information about this program. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the number of meritorious applications submitted. Applicants may request up to $375,000 in direct costs, excluding consortium F&A, for the entire project period of up to 3 years. The scope of the proposed project should determine the project period.

The maximum project period is 3 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education In addition, all organizations must meet the following criteria at the time of application submission: 1. The applicant institution must be an accredited public or non-profit private school that grants baccalaureate degrees in biomedical sciences.

This NOFO does not provide support for research from Health Professional Schools and Colleges and accredited institutions that provide education and training leading to a health professional degree, including but not limited to: BSN, MSN, DNP, MD, DDS, DO, PharmD, DVM, OD, DPT, DC, ND, DPM, MOT, OTD, MS-SLP, CScD, SLPD, AuD, MSPO, MSAT, and MPH.

Health Professional Schools and Colleges may include but are not limited to schools of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy and podiatry. The application must be submitted by the eligible undergraduate-focused organization with a Unique Entity Identifier (UEI) and a unique NIH eRA Institutional Profile File (IPF) number. 2.

At the time of application submission, all the non-health professional components of the institution combined must not have received support from the NIH totaling more than $6 million per year (in both direct and F&A/indirect costs) in 4 of the last 7 years. A year is defined as a federal fiscal year: from October 1 through September 30.

For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all the non-health professional schools and colleges within the institution as a whole. Note that all activity codes are included in this calculation except the following: C06, S10, and all activity codes starting with a G.

Help determining the Organization Funding Level can be found at https://grants. nih. gov/grants/funding/Determing-Organization-Funding-Levels-R15-Eligibility.

pdf . An academic component is any school/college that is not a Health Professional School or College. A qualifying academic component (i.e., school/college) within an institution (e.g., School of Arts and Sciences) has greater undergraduate student enrollment than graduate student enrollment.

All types of Health Professional Schools and Colleges are not eligible to apply, and are not considered in this calculation. 3. For institutions with multiple campuses, eligibility can be considered for each individual campus (e.g., main, satellite, etc.) only if separate UEIs and NIH IPF numbers are established for each campus.

For institutions that use one UEI or NIH IPF number for all campuses, eligibility is determined for all campuses (e.g., main, satellite, etc.) combined. Additional Eligibility Guidance A signed letter is required from the Provost or similar official with institution-wide responsibility verifying the eligibility of the applicant institution at the time of application submission, according to the eligibility criteria indicated above.

Check the application instructions for "Other Attachments" on the SF424(R&R) Other Project Information form in Section IV. 2 Instructions for Application Submission. Final eligibility will be validated by NIH prior to award.

To assist in determining eligibility, organizations are encouraged to use the NIH RePORT website under NIH Awards by Location & Organization and to consult the NIH Research Enhancement Award R15 website . An AREA grant is permitted to have a subcontract to a non-AREA-eligible institution.

However, applicants should keep the goals of the AREA program in mind when preparing the application, including strengthening the research environment of eligible institutions and engaging undergraduate students from eligible institutions in research. The majority of the research must be directed by the PD(s)/PI(s) at the grantee institution. Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Late Applications for additional information.

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. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; 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 SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for 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 How to Apply-Application Guide.

To be eligible for an AREA grant, the PD(s)/PI(s) must meet the following additional criteria: Each PD/PI must have a primary appointment at a non-health professional school or college within the applicant institution, as defined in “Eligible Institutions” above. If proposing multiple PDs/PIs, each PD/PI must be at an AREA-eligible institution.

Each PD/PI may not be the PD/PI of an active NIH research grant, including another R15 grant, at the time of award of an AREA grant, although they may be one of the Key Personnel for an active NIH grant held by another PD/PI. Each PD/PI may not be awarded more than one R15 grant at a time, although they may hold successive New or Renewal grants.

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms . 3.

Additional Information on Eligibility 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 NIH Grants Policy Statement Section 2. 3.

7. 4 Resubmission of an Unfunded Application . 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 NIH Grants Policy Statement 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). Section IV.

Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that