NIAID and NIDDK Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). This funding opportunity encourages research project applications within the mission of either NIAID or NIDDK from New Investigators or 'At-Risk' investigators from diverse backgrounds, including those underrepresented in the health-related sciences.

Expired PAR-23-275: NIAID and NIDDK Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) Funding Opportunity Title NIAID and NIDDK Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional) R01 Research Project Grant December 31, 2024 - This PA has been reissued as PA-25-249 .

April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 July 8, 2024 - NIAID and NIDDK Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional). See Notice NOT-AI-24-063 .

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

See Notice NOT-OD-22-189 . Notice of Funding Opportunity (NOFO) Number Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this notice of funding opportunity (NOFO) is to encourage researchers from diverse backgrounds to work with their institutions to submit applications for research projects within the mission of either NIAID or NIDDK.

This NOFO seeks to support either (a) a New Investigator (NI), who has not previously competed successfully for substantial, independent funding from NIH, or (b) an 'At-Risk' investigator, who had prior support as a PD/PI on a substantial independent research award and unless successful in securing a substantial research grant award in the current fiscal year, will have no substantial research grant funding in the following fiscal year.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. New Date January 08, 2025 per issuance of PA-25-249 .

(Original Expiration Date: September 08, 2025) Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

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

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The National Institutes of Health (NIH) recognizes the need to diversify the scientific workforce by enhancing the participation of individuals from diverse backgrounds, including those from groups identified as underrepresented (see, e.g., https://grants. nih. gov/grants/guide/notice-files/NOT-OD-20-031.

html ) in the biomedical, clinical, behavioral and social sciences research workforce. Diversity at all levels — from the kinds of science to the regions in which it is conducted to the backgrounds of the people conducting it — contributes to excellence in research training environments and strengthens the research enterprise.

The mission of the National Institute of Allergy and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. In addition, NIAID has a unique mandate which requires the Institute to respond to emerging public health threats.

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.

Research shows that having a diverse scientific and public health workforce benefits research on issues such as COVID-19, HIV, asthma, diabetes, obesity, and kidney disease, which disproportionately impact minority health and NIH-designated populations that experience health disparities.

Scientists from diverse backgrounds have the potential to engage with populations experiencing health disparities more effectively, and the knowledge and perspectives they bring from their own communities may help ensure that the research agenda addresses the needs of all who are affected by these diseases, including those most impacted by these diseases https://ajph. aphapublications. org/doi/full/10.

2105/AJPH. 2008. 153536 ; https://www.

nejm. org/doi/10. 1056/NEJMe2114651 ; https://www.

ncbi. nlm. nih.

gov/pmc/articles/PMC8461584/ ; https://covid19community. nih. gov/news/diversity-in-research-for-covid19-therapies ; https://pubmed.

ncbi. nlm. nih.

gov/35918144/ ; https://pubmed. ncbi. nlm.

nih. gov/36907515/ Furthermore, the missions of both NIAID and NIDDK include educational activities that complement the training of future scientists in NIAID- and NIDDK-related research areas.

NIAID and NIDDK seek to promote diversity in all its training and research programs and to enhance the diversity of the investigator pool, including participation by investigators from underrepresented groups in order to develop a highly competent and diverse scientific workforce capable of conducting state-of-the-art research in NIAID and NIDDK mission areas.

NIH, NIAID and NIDDK recognize a unique and compelling need to promote diversity in the biomedical, behavioral, clinical, and social sciences workforce.

NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from racial and ethnic minority and other NIH-designated populations that experience health disparities into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

For more information, see Notice of NIH's Interest in Diversity. Notice of NIH's Interest in Diversity Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints.

NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams.

Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems.

There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

NIH encourages applicants to diversify their student and faculty populations through means consistent with applicable law to enhance the participation of individuals from underrepresented groups (see NOT-OD-20-031 , Notice of NIH’s Interest in Diversity and NOT-OD-22-019 , Reminder: Notice of NIH’s Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities).

Underrepresented Populations in the U.S. Biomedical, Clinical, Behavioral and Social Sciences Research Enterprise In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all.

NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences, such as: A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at https://www. nsf.

gov/statistics/showpub. cfm? TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering ( http://www.

nsf. gov/statistics/women/ )). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians, and other Pacific Islanders.

In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this opportunity.

For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity ( https://www. govinfo. gov/content/pkg/FR-1997-10-30/html/97-28653.

htm ) B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended . See NSF data at, https://www.

nsf. gov/statistics/2017/nsf17310/static/data/tab7-5. pdf C.

Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria: 1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche. ed.

gov/legislation/mckinney-vento/) ; 2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www. acf.

hhs. gov/cb/focus-areas/foster-care ); 3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.

fns. usda. gov/cn/income-eligibility-guidelines ); 4.

Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces. ed. gov/pubs2018/2018009.

pdf) ; 5. Were or currently are eligible for Federal Pell grants (Definition: https://www2. ed.

gov/programs/fpg/eligibility. html ); 6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.

fns. usda. gov/wic/wic-eligibility-requirements) ; 7.

Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer ( https://data. hrsa. gov/tools/rural-health ), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas ( https://www.

qhpcertification. cms. gov/s/LowIncomeandHPSAZipCodeListingPY2020.

xlsx? v=1 ) (qualifying zip codes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.

Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces. ed. gov/programs/coe/indicator_tva.

asp ), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces. ed.

gov/ ; https://nces. ed. gov/programs/coe/indicator_tva.

asp ; https://www2. ed. gov/rschstat/research/pubs/advancing-diversity-inclusion.

pdf . D. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields.

(See e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce ( https://www. ncbi. nlm.

nih. gov/pmc/articles/PMC5008902/ ).

Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines (See data from the National Science Foundation National Center for Science and Engineering Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at https://www.

nsf. gov/statistics/2017/nsf17310/, especially Table 9-23, describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank).

Upon review of NSF data, and scientific discipline or field related data, NIH encourages institutions to consider women for faculty-level, diversity-targeted programs to address faculty recruitment, appointment, retention, or advancement.

Specific Areas of Research Interest 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 emerging and re-emerging infectious diseases. For the purposes of this NOFO, NIAID encourages research within the scope of all areas of NIAID's scientific areas of focus.

Applicants are advised to contact the scientific contact for the NIAID Division most closely aligned with their research interest and planned proposal. Clinical trials are optional, based on NIAID's determination of level of risk (see NOT-AI-21-037 ). Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Consultation with NIAID staff prior to the application due date is strongly encouraged for submission of a clinical trial application (see NOT-AI-21-037 ). NIDDK encourages research within the scope of any and all areas of its mission: diabetes and other endocrine and metabolic diseases; gastrointestinal, liver and pancreatic diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases.

Applicants are strongly encouraged to speak with both the Scientific/Research Contact(s) for this program (listed below) and the scientific contact(s) for the NIDDK research program most closely aligned with their research interest and planned proposal prior to submitting an application under this NOFO. NIDDK has many research areas within its mission, but all research related to relevant diseases may not be appropriate for NIDDK.

NIAID and NIDDK will convene a workshop for PD/PIs funded under this NOFO to foster networking, collaboration, mentorship, and career development. The workshop will be held once every three years (beginning in FY2025) in the Bethesda, MD region to occur over two full days. NIAID and NIDDK encourage all funded PD/PIs to attend at least once during their award period.

For additional information about this NOFO, see Frequently Asked Questions here . Applications Not Responsive to this NOFO Applications that do not include the two required documents listed below will be deemed non-responsive and will not be reviewed: Document 1: Certification that the PD/PI(s) satisfies the eligibility criteria listed under Section III.

"Eligible Individuals (Program Director/Principal Investigator), and a statement explaining how participation of the identified PDs/PI(s) would further the goals of this NOFO consistent with NOT-OD-20-031 . Document 2: A statement describing the PD/PI’s commitment to promoting diversity, equity, inclusion, and accessibility (DEIA). See Section VIII.

Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II.

Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is five years.

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

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the 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 Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

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

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

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

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities , NOT-OD-22-019 .

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. For a multiple PDs/PIs application under this NOFO, all of the individuals serving as PDs/PIs must meet all of the same eligibility criteria as for a single PD/PIs application.

Eligible candidates will identify with one of the two categories below: For the purpose of this NOFO, an investigator is considered a New Investigator (NI; https://grants. nih. gov/policy/early-investigators/index.

htm ) if they have not competed successfully for substantial, NIH independent funding from NIH. A "substantial" research award is a research grant award excluding smaller grants that maintain Early Stage Investigator (ESI)/NI status (see full list of awards here: https://grants. nih.

gov/policy/early-investigators/list-smaller-grants. htm ). PD/PIs of NIH Training-Related and Mentored Career Awards are still considered New Investigators if the NIH awards are in any of the following categories: fellowships (F awards), individual or institutional career awards (K awards), and loan repayment contracts (L30, L32, L40, L50, L60).

Appointees who have received support from any NIH training grants (T32, T34, T35, T90, D43) are also considered New Investigators.

For the purpose of this NOFO, an investigator is considered an At-Risk Investigator if they have had prior support as a Principal Investigator on a substantial independent research award and, unless successful in securing a substantial research grant award in the current fiscal year, will have no substantial research grant funding in the following fiscal year.

A "substantial" research award is a research grant award excluding smaller grants that maintain ESI/NI status (see here ) This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement. 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2. 3. 7.

4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

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

All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed.

The additional instructions apply: Candidate information must be submitted by the applicant institution that addresses both of the following areas: Document 1: Applicant institutions must include a certification that the PD/PIs satisfies the eligibility criteria listed under Section III.

"Eligible Individuals (Program Director/Principal Investigator), and a statement explaining how participation of the identified PDs/PI(s) would further the goals of this NOFO consistent with NOT-OD-20-031 . Name this letter “EligibilityCertificationD1. pdf” Document 2: Applicant institutions must include a statement describing the PD/PI’s commitment to promoting diversity, equity, inclusion, and accessibility (DEIA).

Name this document “DEIAD2. pdf” Examples can include, but are not limited to statements about: How the PD/PI's demonstrated participation as a mentor in training or related programs has enhanced opportunities for students and trainees from groups underrepresented in the biomedical, clinical, behavioral, and social sciences.

How the PD/PI has demonstrated leadership in organizations that promote DEIA at various levels within the research workforce. How the PD/PI's area of research (e.g., research in topic areas such as basic, applied, clinical, and health disparities and/or social determinants of health) contributes to promoting diversity and inclusive excellence at the institution or in the research field.

These attachments will be evaluated consistent with applicable law during the application review. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

Include the following within the budget section and budget justification: Budget for costs associated with travel for the PD/PI or all PD/PIs if multi-PD/PI application to attend a two-day workshop to be held in the Bethesda, MD area once during the project period.

As applicable, budget for costs associated with changes or adjustments in the research setting that will make it possible for an individual with a disability to perform the essential functions associated with their role on the project. These changes or adjustments must be directly related to the performance of the proposed role on the research project and must be appropriate to the proposed end user.

Examples or changes or adjustments might include, for example, specialized equipment, assistive devices, and personnel such as readers, interpreters, or assistants. In all cases, the total funds for accommodations requested must be reasonable. Costs for reasonable accommodations is not included in the direct cost limits.

All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

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. Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined 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.

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. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

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

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement . 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application