Part 1. Overview Information

Key Dates

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.

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

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
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

Purpose

Through this notice of funding opportunity (NOFO), the National Cancer Institute (NCI) intends  to support the rigorous assessment of barriers to quality cancer treatment and follow-up care for sexual and gender minority (SGM) cancer survivors. This funding opportunity is intended to address a critical need for improved care delivery and outcomes for SGM cancer survivors. The goal is to address the disease burden in an underserved and understudied population that is at higher risk of poorer health outcomes. The NCI solicits proposals for observational and/or interventional studies of SGM survivors designed to understand barriers and/or improve care and outcomes for SGM people with cancer, using interoperable sexual orientation and gender identity (SOGI) data collection in cancer care settings, where appropriate.

Background

Disparities in cancer care and outcomes pose substantial inequities for cancer survivors from underserved and minoritized communities. Recent federal commitments to improve equity and address structural and systemic inequities that continue to prevail in science and in society call for efforts to understand and improve health outcomes for underserved communities. Cancer patients from sexual and gender minority (SGM) populations (particularly those from multiple minoritized groups) face unique barriers. Due to the lack of systematic data on SGM populations, cancer incidence and mortality is very difficult to estimate in the United States. However, importantly, the existing evidence indicates that members of SGM populations have higher rates of certain cancers, and they experience worse physical and mental health after any cancer diagnosis. These outcomes have been attributed in part to treatment and survivorship care that fail to address SGM-specific considerations. Such considerations include but are not limited to: stigma and discrimination in healthcare settings and by providers, health system mistrust, poor understanding of the effects of gender-affirming care on cancer treatment and follow-up care, limited provider knowledge about SGM needs,  and the lack of recognized caregivers when they are not biologically or legally defined family members. To address these gaps, we are calling for research applications  to support the rigorous assessment of barriers to quality cancer treatment and follow-up care. The intention is for studies to use interoperable sexual orientation and gender identity (SOGI) data collection, such as the measures included in the National Academies of Sciences, Engineering, and Medicine (NASEM) report on SOGI data collection, in cancer care settings for observational and interventional studies of SGM survivors and call for interventions designed to improve care and outcomes for SGM people with cancer. 

Key Terms for this NOFO:

• Sex: determined via biological factors (such as  genitalia and other sex organs or chromosomes) and often assigned at birth; can be non-binary (e.g., male, female, intersex)
• Gender: refers to socially constructed roles, behaviors, activities, and/or attributes that a given society associates with being a woman, man, girl, or boy, as well as relationships with each other; as a social construct, gender varies from society to society and can change over time
• Gender Identity: an individual’s innate and personal sense of gender and how they identify along the gender spectrum; gender identity can deviate from sex (e.g., transgender, cisgender, gender-nonconforming)
• Sexual Orientation: an individual’s emotional, romantic, and/or sexual attraction or behavior towards other people (e.g., heterosexual, gay, bisexual, asexual)
• LGBTQI+: commonly used acronym to collectively refer to lesbian, gay, bisexual, transgender, queer and/or questioning, intersex, and other communities
• Sexual and Gender Minority (SGM):  populations  that include,  but are not limited to, individuals who identify as lesbian, gay, bisexual, asexual, transgender, Two-Spirit, queer, and/or intersex. Individuals with same-sex or -gender attractions or behaviors and those with a difference in sex development are also included. These populations also encompass those who do not self-identify with one of these terms but whose sexual orientation, gender identity or expression, or reproductive development is characterized by non-binary constructs of sexual orientation, gender, and/or sex.

Current estimates indicate that SGM individuals make up 7.1% of the United States (US) population.  Incidence and prevalence of cancer among SGM individuals have historically been difficult to determine, due to the lack of SOGI data collected in population-based medical data sources such as the Surveillance, Epidemiology, and End Results (SEER) Program.

High-quality cancer epidemiologic data for SGM people in the US are sparse. However, national surveys have shown that sexual minority individuals are more likely to have a cancer diagnosis than sexual majority individuals, and SGM people have higher rates of certain cancers such as anal, breast, cervical, colorectal, endometrial, lung, prostate, and skin cancers. Further, national survey data suggest that transgender individuals have higher rates of cancer, poorer health behaviors, and more comorbidities than cisgender people, those whose gender identity corresponds with their sex assigned at birth. SGM cancer survivors are more likely to have poorer health outcomes, including higher levels of psychological symptoms, poorer health-related quality of life (HRQOL), greater anxiety, depression, post-traumatic stress disorder, greater fear of recurrence, challenges with accessing quality care, and higher cancer-specific mortality rates than their majority peers. Rates of cancer screening among SGM populations are low, and care providers report lack of knowledge related to screening specifically for transgender populations. Due to a paucity of data, it is unclear whether patterns of care utilization for appropriate follow-up surveillance differ among SGM cancer survivors compared with non-SGM survivors.

SGM cancer patients are also less likely than non-SGM individuals to seek cancer care. For example, sexual minority cancer survivors more often report avoiding medical care and report poorer HRQOL than heterosexuals with cancer. Hypothesized reasons primarily include cost barriers due to higher poverty rates, inadequate insurance coverage and other economic strains, fears of disclosing SGM status, and stigmatization and discrimination experienced within healthcare settings reported by SGM survivors and caregivers. Additionally, the layered experience of multiple minoritized identities among SGM cancer survivors (including race, ethnicity, class, gender, and sexual orientation) interact in the context of cancer risk, access to care, and treatment by healthcare providers, suggesting the critical need to address such intersectionality when implementing appropriate cancer-related care for SGM populations.

Several studies suggest that there is a knowledge gap among oncology providers with respect to SGM experiences and care needs, which can deter patients from entering the healthcare system and reduce adherence to primary treatment or follow-up care. National data show that oncology providers have limited knowledge about SGM health and cancer-care needs and recommendations for screening, which may deter patients from pursuing follow-up care. Despite the lack of knowledge reported by providers, many report interest in receiving education regarding SGM cancer care needs and how to appropriately address them, suggesting a readiness for interventions targeting oncology care providers.

This NOFO is intended to address a critical need for improved care delivery and outcomes for SGM cancer survivors. The goal is to address the disease burden in an underserved and understudied population that is at higher risk of poorer health outcomes. SGM individuals face substantial barriers to accessing and adhering to appropriate cancer care due to significant social and economic obstacles, discrimination, psychological distress, anti-SGM stigma and healthcare system distrust, and persistent health disparities relative to their majority peers. This funding opportunity is consistent with multiple calls to action to improve SGM health. These include the recent White House executive order on SGM equality, HealthyPeople 2030 objectives, National Academies of Sciences, Engineering, and Medicine (NASEM) report on SOGI data collection, the NIH Minority Health and Health Disparities Strategic Plan (2021-2025), and the NIH Sexual & Gender Minority Research Office (SGMRO) Strategic Plan. 

Purpose of this NOFO

This NOFO solicits proposals that call for observational and/or intervention research to understand and address predictors of disparities experienced by SGM cancer survivors, and to support the foundation, development, testing, and/or scaling of innovative, feasible and effective interventions to address barriers experienced by SGM populations in cancer care.  This funding opportunity is intended to support studies that address one or more of the following key scientific areas:

1. Understanding and/or addressing barriers to cancer treatment and follow-up care for SGM cancer survivors;
2. Characterizing and/or developing approaches to address factors that put SGM cancer survivors at higher risk for poorer mental and physical health outcomes;
3. Testing interventions to improve cancer care targeting cancer care providers, that may be focused exclusively on clinicians, on clinician-survivor dyads, or on clinicians, SGM survivors, and caregivers.

 Examples of research topics may include, but are not limited to the following:

• Studies that characterize challenges faced by SGM cancer survivors that affect cancer treatment and follow-up care adherence (e.g., fear of prejudice/discrimination, fear of SGM disclosure, financial hardships, inclusion of caregivers, distance from treatment facilities);
• Studies to investigate barriers to quality care delivery associated with the cancer sites/types most prevalent among SGM individuals and to understand and address disparities related to HIV-associated malignancies in SGM cancer survivors;
• Intervention studies to address barriers to care that lead SGM cancer survivors to avoid or delay seeking or maintaining care, such as medical system mistrust, fear of SGM disclosure, or managing unconscious bias of providers;
• Interventions that increase rates of surveillance follow-up and referrals to supportive care for SGM cancer survivors such as tracking referrals and appointments linked to SOGI data, testing outreach strategies to SGM survivors to ensure adherence, and developing interventions that include integration with community organizations;
• Interventions to improve symptom management such as identifying and treating symptoms that may be unique to transgender populations arising from gender affirming treatments concurrent with cancer treatments, and managing psychological symptoms such as anxiety and depression that may be a consequence of the intersection of cancer, its treatment, and medical mistrust related to SGM status;
• Research to understand oncology care providers’ knowledge gaps related to unique SGM care needs, as well as implementation and testing of training programs for clinicians and their professional organizations to increase sensitivity to those needs;
• Studies to address survivor/caregiver/provider communication, including development and implementation of shared care approaches, such as interventions that address unique survivor/caregiver configurations, implementing provider education strategies to support culturally sensitive care, and implementation of SOGI data collection across providers, to support care coordination for survivors;
• Evaluation of strategies for surveillance and management of physical and psychosocial effects of cancer and treatment among SGM survivors;
• Evaluation of health-related outcomes for SGM survivors diagnosed with different types of cancer or at different sites, e.g., capturing longitudinal SOGI data among SGM survivors with different types of cancer to identify those cancers with higher need;
• SGM-tailored interventions to address palliative and end-of-life care needs;
• Studies of transgender and gender-nonconforming individuals to understand interactions between gender-affirming care (i.e., surgery, hormonal therapy) and cancer treatment such as treatment safety and efficacy, and follow-up care, including surveillance needs for individuals who have had gender affirming surgery and/or hormonal therapy;
• Studies examining intersections of sexual orientation, gender and gender identity, race, ethnicity, class, and/or geography are strongly encouraged; and
• Studies that include community clinics in addition to academic medical centers to support geographically, demographically, and linguistically diverse populations are encouraged.

 Key requirements:

• Where appropriate, applications must describe an existing interoperable SOGI data collection process that is fully integrated into clinical workflows or include plans to create such a process as part of the proposed research.
• Where appropriate, SOGI data collection measures should be consistent with the recent NASEM report and appropriately adapted for clinical use.
• Stakeholder engagement is required. Submissions must include a plan for integrated participation of researchers and SGM community members, and where relevant to the proposed research, must integrate care providers and health system administrators.

Non-responsive Applications

Applications that propose any of the following will be deemed non-responsive and will not be reviewed, including those that: 

• Studies that do not include human subjects;
• Studies that are exclusively focused on reducing primary cancer risk;
• Studies that are exclusively focused on recruitment and retention of SGM participants in clinical trials; and
• Studies that do not include SGM community partners.  

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

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

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Non-domestic (non-U.S.) Entities (Foreign Organizations) are 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

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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.

Letter of Intent 

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

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

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

The letter of intent should be sent to:

David Dean Jr., Ph.D., M.S.

National Cancer Institute (NCI)
Telephone: 240-276-7803 
Email: [email protected] 

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Research Strategy: The entire Research Strategy must address the following specific aspects. (i.e., Significance, Investigator(s), and Approach):

• Significance: Describe how the proposed research addresses understanding of barriers to cancer treatment and follow-up care for SGM cancer survivors and/or how to address those barriers, particularly factors that put SGM cancer survivors at risk for poorer outcomes.
• Investigator(s): Describe how the investigative team has experience working with SGM communities and appropriate health disparities scientific expertise. Where relevant to the proposed research, describe how care providers and health system administrators will be integrated.
• Approach: Specify and provide a clear justification for the selection of the specific SGM patient population(s), cancer type(s), and care setting(s). Describe considerations related to which SGM patient populations experience poorer outcomes, and plans to oversample or exclusively sample individuals from that group. Provide a rationale for the use of selected SOGI measures and outline the strategy that will be used to collect them in a sensitive and respectful manner.  Explain how the methods are inclusive and account for the social and intersectional contexts of the SGM populations proposed, including how these contexts are considered and accounted for in the research design, methods, and analyses.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s): 

All instructions in the How to Apply-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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

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

See Part 2. 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. 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 How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply 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 (CSR) and responsiveness by  NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

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

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR) 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 will receive a written critique.

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.

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 submitted in response to this NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

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

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

David Dean Jr.,  Ph.D., M.S.
National Cancer Institute (NCI)
Telephone: 240-276-8703 
Email:[email protected] 

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

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

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: [email protected]

Section VIII. Other Information

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 2 CFR Part 200.