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/or advanced 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. NIGMS 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. NIGMS will not accept applications under the parent AREA FOA. 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. Student 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. Inclusion and support of masters and doctoral candidates in these research projects are allowable, but should be carefully considered. In all cases, the majority of students conducting research through the award must be undergraduates. Since diversity strengthens the research environment, 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.

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.

NIGMS will accept applications for research projects in areas within the Institute's mission. The NIGMS website provides information about the institute mission and areas of research interest. If other NIH Institutes or Centers participate in this FOA, their particular mission areas will be described on their websites as well. 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 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).

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, AIDS and AIDS -related research, immunology, allergy, transplantation, and biodefense.

In addition, applicants are encouraged to consult the Frequently Asked Questions website for more information about this program and areas that NIGMS does and does not support.

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 indicated above. 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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• 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 an AREA grant, 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, including another AREA grant, at the time of award of an AREA grant, 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 AREA 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).

Buttons to access the online ASSIST system or to download application forms 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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.

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 be composed primarily of 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 be composed primarily of 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.

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

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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. 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 there a strong scientific premise for the project? 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 PD(s)/PI(s), collaborators, and other researchers well suited to the project? If investigators are in the early stages of independent careers, do they have appropriate scientific experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their scientific field(s)? Do the PD(s)/PI(s) have suitable experience in supervising and engaging undergraduate students in research? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project??

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Is the project appropriate for execution primarily by undergraduates? 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 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 children, justified in terms of the scientific goals and research strategy proposed?

Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Does the application demonstrate the likely availability of well-qualified students to participate in the research project? 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 sciences? Does the PD/PI(s) have sufficient time and institutional support to conduct the proposed project?

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.

For research that involves human subjects but does not involve one of the six 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 six 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.

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 children 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.

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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 http://www.hhs.gov/ocr/civilrights/understanding/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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Christopher L. Hatch, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6454
Email: ch29v@nih.gov

Cheri Wiggs, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: Cheri.Wiggs@nih.gov

Aaron Laposky, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-7837
Email: LaposkyA@nhlbi.nih.gov

Bettie J. Graham, Ph.D.
National Human Genome Research Institute (NHGRI)
Phone: 301-496 7531
Email: Bettie_graham@nih.gov

Rene Etcheberrigaray, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-451-9798
Email: re4f@nih.gov

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

Joan Greve, Ph.D.
National Institute of Biomedical Imaging and Bioengineering
Telephone: 301-451-6649
Email: joan.greve@nih.gov

Mahua Mukhopadhyay, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-435-6886
Email: mukhopam@mail.nih.gov

Lanay M. Mudd, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: lanay.mudd@nih.gov

Susan L. Sullivan, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: 301-451-3841
Email: sullivas@nidcd.nih.gov

Alicia Dombroski, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4805
Email: adombroski@mail.nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Karl F. Malik, Ph.D.
Phone: 301-594-8843
Email: karl.malik@nih.gov

Troy Zarcone, PhD
National Institute on Drug Abuse (NIDA)
Telephone: (301) 443-4577
Email: troy.zarcone@nih.gov

Astrid C. Haugen
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3266
Email: Haugen@niehs.nih.gov

Alexandra M. Ainsztein, PhD.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0943
Email: alexandra.ainsztein@nih.gov

Letitia Weigand, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-4188
Email: letitia.weigand@nih.gov

Hua-Chuan Sim, M.D.
National Library of Medicine (NLM)
Telephone: 301-594-4882
Email: simh@mail.nih.gov

NIAID AI Training Help Desk
AITrainingHelpDesk@niaid.nih.gov

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

Aileen Schulte, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-1225
Email: aschulte@mail.nih.gov

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

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

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Karen Robinson-Smith
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: Karen.Robinson.Smith@nei.nih.gov

Ryan Lombardi, MS
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8042
Email: lombardr@nhlbi.nih.gov

Deanna L. Ingersoll
National Human Genome Research Institute (NHGRI)
Phone: 301-435-7858
Email: Deanna.Ingersoll@nih.gov

Traci Lafferty
National Institute on Aging (NIA)
Telephone: 301-496-8987
Email: laffertt@mail.nih.gov

Judy Fox
tional Institute of Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-4704
Email: jfox@mail.nih.gov

David Madoo
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6446
Email: david.madoo@nih.gov

Monique Day, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4787
Email: monique.day@nih.gov

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Bryan S. Clark, M.B.A
Phone: 301-435-6975
Email: clarkb1@mail.nih.gov

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: carows@mail.nih.gov

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: 301-402-0909
Email: myersc@mail.nih.gov

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ms. Aretina Perry-Jones
Phone: 301-594-8862
Email: ap19s@nih.gov

National Institute on Drug Abuse (NIDA)
Pam Fleming
Phone: 301-480-1159
Email: pfleming@nida.nih.gov

Lisa Archer Edwards
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3258
Email: archer@niehs.nih.gov

Maricela Trujillo
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3927
Email: maricela.trujillo@nih.gov

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

Samantha Tempchin
National Library of Medicine (NLM)
Telephone: 301-496-4221
Email: tempchins@mail.nih.gov

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

Rebecca Claycamp, M.S., C.R.A.
National Institute of Mental Health (NIMH)
Phone: 301-443-2811
Email: rclaycam@mail.nih.gov

Ronald Wertz
National Institute of Nursing Research (NINR)
Telephone: (301) 594-2807
Email: wertzr@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.