Funding Opportunity Title

Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 - Clinical Trial Required)

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

The National Institutes of Health (NIH) is continuing to make a special effort to stimulate research at educational institutions that provide baccalaureate and/oradvanced degrees for a significant number of the Nation's research scientists, but that have not been major recipients of NIH support. Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have included funds for this initiative, which NIH has implemented through the Academic Research Enhancement Award (AREA) program. NIH is issuing this funding opportunity announcement to support AREA grants to undergraduate-focused institutions that do not receive substantial funding from the NIH, rather than all institutions with less than $6 million of NIH support, in order to provide biomedical research experiences for undergraduate students and enhance the research environment at these institutions. NIH will not accept applications under the parent AREA FOA after the January 7, 2019 AIDS due date (NOT-OD-19-015). AREA funds are intended to support new and renewal biomedical research projects proposed by faculty members of eligible institutions (see Part 2. Section III.1).

The three objectives of this FOA are: (1) provide support for meritorious research at undergraduate-focused institutions or institutional components; (2) strengthen the research environment at these institutions/components; and (3) give undergraduate students an opportunity to gain significant biomedical research experience through active involvement in the research. For the purpose of this announcement, an undergraduate-focused institution/component is one in which the undergraduate enrollment is greater than the graduate enrollment.

The AREA program will enable qualified scientists to receive support for small-scale research projects. 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 so that they consider careers in biomedical research. This AREA FOA 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. Students involvement in research may include participation in the design of experiments and controls, collection and analysis of data, execution and troubleshooting of experiments, presentation at meetings, drafting journal articles, collaborative interactions, 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.

An AREA application submitted to this FOA may include other investigators, such as technicians, collaborators or 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 to expose undergraduate students in eligible environments to research. AREA projects are encouraged to include students from diverse backgrounds, including those from groups underrepresented in the biomedical research workforce (See NOT-OD-18-129). This FOA does not provide for support of research from Health Professional Schools as defined in Section III.1 regardless of student composition.

This FOA will only accept applications for research projects in areas within the mission of the Institutes/Centers that are listed in Components of Participating Organization. Each participating NIH institute website provides 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 Scientific/Research Contact or the Program Director with portfolios with research interests relevant to the applicant's proposed topic.

This FOA supports investigator-initiated clinical trials proposing mechanistic and/or minimal risk study, with the goal of producing clinical findings that have significant public health impact. The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html)

Proposed studies should be hypothesis-driven and produce research data/evidence that are necessary to inform core scientific, design, implementation and issues essential to advance scientific knowledge.

This FOA is intended for a low/minimal risk clinical trial that meet the following criteria:

• Does not require FDA oversight such as those requiring Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. For example, clinical trials involving utilization of a licensed product/device for an approved dose, population, and indication may not require an IND or IDE.
• Potential of the intervention to cause physical or psychological harm is low, for example, risks that are no greater than those encountered in routine medical care or procedures.
• Intends to gather scientific data/evidence to inform subsequent studies but not aimed or sufficiently powered to directly change health policy or standard of care and is not an NIH defined Phase III Clinical Trial (https://humansubjects.nih.gov/glossary).

A mechanistic clinical trial meets the definition of a clinical trial and is designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.

It is advisable that only one clinical trial be proposed in each R15 clinical trial application.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The 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/grants-funding/opportunities-mechanisms/areas-research/Pages/default.aspx.

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 at: http://www.nichd.nih.gov/about/org/der/branches/Pages/index.aspx and the NCMRR at: http://www.nichd.nih.gov/about/org/ncmrr/Pages/overview.aspx. 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/grants-funding/opportunities-mechanisms/areas-research/Pages/priorities.aspx

National Eye Institute (NEI)

The NEI supports a broad range of basic and clinical research, clinical trials, epidemiologic studies related to health and disease in the eye and visual system. Research proposed should address a significant aspect of the leading causes of blindness and impaired vision, mechanisms of visual function, preservation of sight, or the special health problems and requirements of the blind.

Under this FOA, the NEI will consider clinical trials that are mechanistic or minimal risk and that are consistent with the NEI's research goals. A mechanistic trial is defined as "A study designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. "Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Consultation with relevant NEI staff prior to the application due date is strongly encouraged, including new and resubmission applications (NEI Division of Extramural Science Programs Staff).

National Institute of Nursing Research (NINR)
The National Institute of Nursing Research (NINR) supports clinical, basic, and translational research to build the scientific foundation for clinical practice, prevent disease and disability, manage and eliminate symptoms caused by illness, and enhance palliative and end-of-life care. In doing so, NINR promotes and improves the health of individuals, families, and communities across the lifespan, in a variety of clinical settings and within diverse populations. NINR’s goal is to enhance nursing science and health care by integrating the biological and behavioral sciences, applying new technologies, promoting health equity, and developing scientists of the future.

Research projects considered for funding should be aligned with NINR s scientific programs in the area(s) of:

Symptom Science: Promoting Personalized Health Strategies

Wellness: Promoting Health and Preventing Disease

Self-Management: Improving Quality of Life for Individuals with Chronic Illness

End-of-Life and Palliative Care: The Science of Compassion

Applicants are encouraged to contact the NINR Scientific/Research contact prior to submission to discuss the proposed project risk level and alignment with NINR’s mission and strategic plan.

National Institute on Deafness and Other Communication Disorders (NIDCD)

The NIDCD supports biomedical and behavioral research related to the normal and disordered processes of hearing, balance, smell, taste, voice, speech and language. Basic and clinical studies are encouraged of genetic, molecular, cellular, physiological, biochemical, and behavioral aspects of function in health and disease. The NIDCD also supports research concerned with disease prevention, health promotion and the special biomedical and behavioral problems associated with communication impairments and disorders.

National Institute on Drug Abuse (NIDA)
The projects should address critical issues of neuroscience, genetics, behavior, prevention, treatment, epidemiology, etiology, health services, HIV/AIDS, and co-occurring opportunistic infections (e.g., viral hepatitis C, tuberculosis, sexually transmitted infections) associated consequences in substance abusing populations, medication development, or other research areas relevant to drug abuse. NIDA priorities are further described in the NIDA Strategic Plan (see https://www.drugabuse.gov/about-nida/2016-2020-nida-strategic-plan) and on the NIDA Topics of Interest webpage (see https://www.drugabuse.gov/funding/funding-priorities/nida-topics-specialcontinuing-interest-dat). Applicants are encouraged to contact a program official to discuss the proposed application.

The National Institute of Neurological Disorders and Stroke (NINDS)

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. For this FOA, projects are limited to prospective basic science studies involving human participants that fall within the broad NIH definition of a clinical trial and also meet the definition of basic research as described in NOT-OD-18-212. 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 clinical trial meets NINDS requirements for this funding opportunity.

National Heart, Lung, and Blood Institute (NHLBI)

The 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.

National Institute of Mental Health (NIMH)

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. Applications submitted for funding by the NIMH must fall within the areas of priority detailed in the NIMH Strategic Plan and the NIMH Strategic Research Priorities. Applicants are strongly encouraged to contact the person listed under Agency Contacts (Section VII) prior to submission. For clinical trials (CTs), NIMH encourages an experimental therapeutics approach to the development and testing of interventions, in which they serve not only as potential treatments, but as probes to generate information about the mechanisms underlying a disorder or the therapeutic effect of the intervention. More information may be found on the NIMH clinical trials website and in the NIMH CT funding opportunity announcements for pilot/exploratory research (i.e., R61/R33, R33 and R34). NIMH encourages mechanistic CTs. These studies are designed to provide information about physiological function, target engagement of novel therapeutics, and/or mechanisms of therapeutic responses, all examined in the context of a CT. Further examples of mechanistic clinical trial studies relevant to the NIMH mission are detailed in NOT-MH-19-006.

Participating NIH Institutes and Centers are listed on the first page of this announcement ("Components of Participating Organizations"). For additional scientific program information and for pre-application guidance, applicants are encouraged to contact the person listed for the participating NIH IC(s) with research interests relevant to the applicant's proposed topic. Consultation with relevant NIH staff prior to the application due date is strongly encouraged including new and resubmission applications. See Section VII for contact information.

NIAAA will accept applications for research projects in areas within the Institute's mission. The NIAAA website (https://www.niaaa.nih.gov/) provides information about the institute mission (https://www.niaaa.nih.gov/about-niaaa/our-work/mission-statement) and areas of research interest (https://www.niaaa.nih.gov/about-niaaa/our-work/strategic-plan). For additional scientific program information and for pre-application guidance, potential applicants are encouraged to contact the NIAAA Extramural Research Program Staff whose portfolio covers the scientific topic of interest (https://www.niaaa.nih.gov/research/extramural-research).

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions

• 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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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.

2. At the time of application submission, all the non-health professional components of the institution together have not received support from the NIH totaling more than $6 million per year (in both direct and F&A/indirect costs; i.e., the Total Federal Award Amount cited on a Notice of Award) in 4 of the last 7 years. A year is defined as a federal fiscal year: from October 1 through September 30. Note that all activity codes are included in this calculation except the following: C06, S10, and all activity codes starting with a G.

• For this FOA: An academic component is any school, college, center, or institute that is not a Health Professional School or College.
• For this FOA: A qualifying academic component (school, college, center, or institute) within an institution (e.g. School of Arts and Sciences) has greater undergraduate student enrollment than graduate student enrollment.
• For this FOA: All types of Health Professional Schools are not eligible to apply and are not considered in this calculation.
• Health Professional Schools and Colleges provide education and training leading to a health professional degree (including but not limited to: MD, DDS, DO, PharmD, BSN, DVM, OD, DPT, DC, ND, DPM).
• Health Professional Schools and Colleges may include schools of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy and podiatry.

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. Eligible institutions must award NIH-relevant baccalaureate degrees and have received less than 6 million dollars per year of NIH support (total costs) in 4 of the last 7 fiscal years. See the application instructions for the Letters of Support attachment on the PHS 398 Research Plan form in Section IV.2 Instructions for Application Submission.

To assist in determining eligibility, organizations are encouraged to use the NIH RePORT website under NIH Awards by Location & Organization (http://projectreporter.nih.gov/reporter.cfm).

For this FOA: The AREA Ineligibility List does not apply. The Provost letter will certify that the applicant institution satisfies the requirements outlined above.

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, which include strengthening the research environment of eligible institutions and exposing students from eligible institutions to research. The majority of the research must be directed by the PD(s)/PI(s) at the grantee institution.

Although foreign institutions are not eligible, applications may include a foreign collaboration, component, or consortium

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

• 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

To be eligible for a grant to this FOA, the PD(s)/PI(s) must meet the following additional criteria:

• The PD(s)/PI(s) must have a primary appointment at the applicant institution, as defined in Eligible Institutions, above.
• The PD(s)/PI(s) may not be the PD(s)/PI(s) of an active NIH research grant at the time of award of a grant to this FOA, although he or she may be one of the Key Personnel for an active NIH grant held by another PD/PI.
• The PD(s)/PI(s) may not be awarded more than one R15 grant at a time, although he or she may hold successive new or renewal grants.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

• 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).

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.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

Facilities & Other Resources: The following information should be included.

• A profile of the students of the applicant institution and any information or estimate of the number who have obtained a baccalaureate degree and gone on to obtain an academic or professional doctoral degree in the health-related sciences during the last five years.
• Description of plans to recruit well-qualified undergraduate students from diverse backgrounds to participate in the research project.
• A description of the special characteristics of the applicant institution that make it appropriate for an AREA grant awarded through this FOA, where the goals of this FOA are to: (1) provide support for meritorious research at undergraduate-focused institution or institutional components; (2) strengthen the research environment at these institutions/components; and (3) give undergraduate students an opportunity to gain significant biomedical research experience through active involvement in the research.
• Description of the likely impact of an AREA grant on the PD(s)/PI(s).
• Description of the likely impact of an AREA grant on the research environment of the applicant institution.
• Description of the likely impact of the AREA grant on the ability of undergraduate students at the institution to gain experience conducting biomedical research.
• Provide a description of the resources of the grantee institution available for the proposed research (e.g., equipment, supplies, laboratory space, release time, matching funds, etc.).
• Although the majority of the research must be directed by the PD(s)/PI(s) and conducted at the grantee institution, limited use of special facilities or equipment at another institution is permitted. For any proposed research sites other than the applicant institution, provide a brief description of the resources and access students will need and have to these resources.
• If relevant, a statement of institutional support for the proposed research project (e.g., equipment, supplies, laboratory space, release time, matching funds, etc.).

All instructions in the SF424 (R&R) Application Guide must be followed. with the following additional instructions:

Biographical Sketch: The PD(s)/PI(s) should include a summary of his or her previous and/or current experience supervising undergraduate and/or graduate students in research in the Personal Statement. The PD(s)/PI(s) should indicate which peer-reviewed publications or other research products involved undergraduate and/or graduate students under his or her supervision.

All instructions in the SF424 (R&R) Application Guide must be followed. , with the following additional instructions:

• The total budget for all years of the proposed project must be requested in Budget Period 1. Do not complete Budget Periods 2 or 3. They are not required and will not be accepted with the application.
• Applicants submitting an application with direct costs of $250,000 or less (total for all years, excluding consortium Facilities and Administrative [F&A] costs) must use the Modular Budget.
• Applicants submitting an application with direct costs of $250,001 - $300,000 (total for all years, excluding consortium Facilities and Administrative [F&A] costs) must use the R&R Budget.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Budget Period 1: Direct Costs

• Direct Costs less Consortium F&A: Select the appropriate dollar amount from the drop-down list. This number must not exceed $250,000.

Budget Justification:

• Personnel Justification: Since a primary objective of the AREA program is to expose students to meritorious research, the research team must include undergraduate students from the applicant institution/ component. Indicate aspects of the proposed research in which undergraduate students will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. If there are any Collaborators or Consultants for the project, provide their names, organizational affiliations, and the services they will perform.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Budget Period 1: Direct Costs

• Total Direct Costs less Consortium F&A: This number must not exceed $300,000.

Budget Justification:

Personnel Justification: Since a primary objective of the AREA program is to expose students to meritorious research, the research team must include undergraduate students from the applicant institution/component. Indicate aspects of the proposed research in which undergraduate students will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. If there are any Collaborators or Consultants for the project, provide their names, organizational affiliations, and the services they will perform.

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

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: Describe how the proposed plan can achieve the specific aims using a research team composed primarily of undergraduate students. Describe how undergraduate students will be exposed to and supervised in conducting hands-on, rigorous research. Describe how undergraduate students will participate in research activities such as planning, execution and/or analysis of research. Formal training plans (e.g., non-research activities, didactic training, seminars) should not be provided, although a brief description of activities related to enhancing students research capabilities and progress (e.g., the use of individual development plans, etc.) is permitted.

A sound rationale should be offered as to why the approach and the research team, including undergraduate students, are appropriate to accomplish the specific aims and to make an important scientific contribution.

Progress Report Publication List: For renewals, when listing publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project, note which of these products have included the work of students conducting research supported by the AREA grant.

Letters of Support: The Letters of Support attachment must include a signed letter from the Provost or similar official with institution-wide responsibility attesting to the fact that the eligible academic component(s) has more undergraduates than graduate students as of the date of submission. The letter must certify that all the non-health professional components of the institution together have not 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, as described in Section III, Eligible Organization . Finally, the letter must validate that the PD(s)/PI(s) has a primary appointment at the qualifying component. Applications that do not contain this signed letter will be withdrawn without review.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

For this particular announcement, note the following:

This FOA has three objectives: (1) provide support for meritorious research at undergraduate-focused institution or institutional components; (2) strengthen the research environment at these institutions/components; and (3) give undergraduate students an opportunity to gain significant biomedical research experience through active involvement in the research. Preliminary data are not required for an R15 application; however, they may be included if available. For the purpose of this announcement, an undergraduate institution/component is one in which the undergraduate enrollment is greater than the graduate enrollment.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to make useful scientific contributions to the research field(s) involved, to provide research opportunities to undergraduate students by engaging them in primary research activities, and to strengthen the research environment of the institution, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in relation to the AREA program objectives and give a separate score for each. An application does not need to be strong in all categories to be judged likely to meet the goals of the FOA. For example, a solid and interesting scientific research project that is not by its nature innovative or paradigm-shifting and includes a good plan to engage undergraduates in primary research may be considered a strong AREA application.

Does the project address an important problem or a 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, will the data be publishable and useful to the field? If funded, will the AREA grant have a substantial effect on the applicant institution in terms of strengthening the research environment and exposing undergraduate students to research?

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

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?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Does the application take advantage of, challenge or build on current research concepts and models or research techniques? Are innovative approaches to engaging undergraduate students in research proposed?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Is the project appropriate for for execution primarily byundergraduates? Have the investigators described appropriate plans for how undergraduates will be included as an integral part of the research project? Does the application provide sufficient evidence that the project will likely stimulate the interests of students so that they can consider a career in the biomedical sciences? Are appropriate plans in place to recruit a diverse and inclusive team of undergraduate researchers? 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 scientific 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?

Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Does the application demonstrate appropriate plans to recruit well-qualified undergraduate students from diverse backgrounds to participate in the research project? Does the application provide sufficient evidence that students at the applicant institution/academic component have in the past and/or are likely in the future to pursue careers in the biomedical and behavioral sciences? Does the PD/PI(s) have sufficient time and institutional support to conduct the proposed project (e.g., equipment, supplies, laboratory space, release time, matching funds, etc.)?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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.

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.

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.

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.

For Renewals, the committee will consider the progress made in the last funding period.

For this FOA: Does the application provide sufficient evidence that students in the past have been included in publications?

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.

Not applicable.

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).

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).

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• 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.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights 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.

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.html; and https://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.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report using the RPPR are posted at http://grants.nih.gov/grants/policy/myf.htm.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for 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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Mahua Mukhopadhyay, PhD

Telephone: 301-435-6886
Email: mukhopam@mail.nih.gov

National Cancer Institute (NCI)

Cristopher Hatch, PhD

Telephone: 301-594-1403

Email: ch29v@nih.gov

National Eye Institute (NEI)

Cheri Wiggs, PhD
Telephone: 301-451-2020
Email: Cheri.Wiggs@nih.gov

National Institute of Nursing Research (NINR)

Amanda Alise Price, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-827-8391
Email: amanda.price2@nih.gov

National Institute on Deafness and Other Communication Disorders (NIDCD)

Susan L. Sullivan, PhD
Telephone: 301-451-3841
Email: sullivas@nidcd.nih.gov

National Institute on Drug Abuse (NIDA)

Troy Zarcone, PhD
Telephone:(301) 443-4577
Email: troy.zarcone@nih.gov

The National Institute of Neurological Disorders and Stroke (NINDS)

Letitia Weigand, Ph.D.
Telephone: 301-596-4188
Email: letitia.weigand@nih.gov

National Heart, Lung, and Blood Institute (NHLBI)

Aaron Laposky, Ph.D.
Telephone: 301-827-7837
Email: LaposkyA@nhlbi.nih.gov

National Institute on Aging (NIA)

Rene Etcheberrigaray, MD
Telephone: 301-496-9322
Email: rene.etcheberrigaray@nih.gov

National Institute of Mental Health (NIMH)

Aileen Schulte, PhD
Telephone: 301-443-1225
Email: aileen.schulte@nih.gov

Li Lin, Ph.D.
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-827-7749
Email: linli@mail.nih.gov

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Bryan S. Clark, M.B.A
Chief Grants Management Officer
Telephone: 301-435-6975
Email:clarkb1@mail.nih

National Cancer Institute (NCI)

Crystal Wolfrey
Telephone: 301-496-8634
Email: wolfreyc@mail.nih.gov

National Eye Institute (NEI)

Karen Robinson-Smith
Telephone: 301-451-2020
Email: Karen.Robinson.Smith@nei.nih.gov

National Institute of Nursing Research (NINR)

Ronald Wertz
Telephone: 301-594-2807
Email: wertzr@mail.nih.gov

National Institute on Deafness and Other Communication Disorders (NIDCD)

Christopher Myers
Telephone: 301-402-0909
Email: myersc@mail.nih.gov

National Institute on Drug Abuse (NIDA)

Pam Fleming
Telephone: 301-480-1159
Email: pfleming@nida.nih.gov

The National Institute of Neurological Disorders and Stroke (NINDS)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

National Heart, Lung, and Blood Institute (NHLBI)

Anthony Agresti
Telephone: 301-435-0186
Email: agrestia@nhlbi.nih.gov

National Institute on Aging (NIA)

Traci Lafferty
Telephone: 301-496-8987
Email: laffertt@nia.nih.gov

National Institute of Mental Health (NIMH)

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.