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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Over the past several years, cancer clinical trials have become more complex in trial design, have a greater number of regulatory issues to address. This requires significant effort from cancer clinical trial investigators who provide leadership, participation, and scientific support for the NCI clinical trials networks at their institutions and within those networks through the development of concepts and protocols for clinical trials, participation in scientific steering committees and network committees, and accrual to NCI-sponsored clinical trials, and through institutional activities that may include activities such as implementation of cancer clinical trials, participation in the review of safety data, monitoring the conduct and progress of open clinical trials, and serving on institutional review committees. These activities are necessary for the successful conduct of NCI-sponsored cancer clinical trials. These efforts are frequently not reimbursed and are neither funded in research project grants nor funded through the NCI clinical trials networks. Typical research activities include service on institutional clinical research committees (institutional review boards, protocol review and monitoring for scientific prioritization, data safety, and management, disease- or modality-based disease groups, etc.), oversight of multiple clinical trials within a clinical trials office, service on national clinical trials committees (National Clinical Trials Network steering committees, etc.), developing new cancer clinical trials by writing and revising new protocols, recruiting patients to new and existing trials, and satisfying annual training in human subjects protection and regulatory compliance. The need for individuals with the broad research expertise and clinical background required of clinician scientists is rapidly growing. Current sources of support for the research activities of clinician scientists are inadequate and compete against the growing demands of clinical duties and responsibilities.

Scope of this NOFO 

The Research Specialist (Clinician Scientist) Award is intended to provide salary support for a sustained period of time and encourage the development of a stable career for exceptional clinical scientists who have a record of productivity and research excellence in the implementation of NCI-funded clinical trials within their institution and provide excellent leadership in the scientific development and implementation of NCI-sponsored clinical trials which are conducted through the NCI clinical trials networks. The proposed new research support is intended to provide salaries and sufficient autonomy so that individuals are not solely dependent on NCI-funded grants held by others or other sources of support for cancer research career continuity. As the PD/PI, Research Specialists would have the option, with prior NCI approval, to move to other research programs or institutions while maintaining funding from this award.

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 - Includes all types

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

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

Foreign Organizations/Foreign Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not 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 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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

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

Additional Eligibility Requirements:

• Eligible Principal Investigators (the Research Specialist) will be clinician scientists who have a clinical degree (M.D., D.O., D.D.S., D.M.D., O.D., D.C., PharmD., N.D., D.V.M.), possess active licensure, and are actively practicing in an oncology clinical setting. Individuals with a Ph.D. or other doctoral degree that have direct contact with patients or healthy subjects in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology, or rehabilitation are also eligible.
• At the time of application, the Research Specialist cannot be a Principal Investigator on an independent NIH grant (e.g., R01, P01, U10, UG1), or other significant NIH funding (past funding does not affect eligibility). Support from smaller NIH grants (e.g., R03, R21, P50 Career Development awards, P30 funding other than as Principal Investigator), or national network funding will be allowed, as long as the total NCI support does not exceed 6 person-months. Future substantial independent NIH funding will require the awardee to forfeit the R50.
• The Research Specialist must have a record of involvement in NCI-funded cancer clinical trial-related activities and be engaged in the conduct of NCI-sponsored clinical trials, which are conducted through the NCI clinical trials networks at an academic medical center or NCORP community site.
• At the time of submission of a new (A0) or resubmission (A1) application, the Research Specialist must have been at the institution for at least the previous two years.
• The Research Specialist must have a full-time position at the institution and be more than six years from initial faculty appointment at the time of the application submission deadline (including appointments held at other institutions). The Research Specialist must commit 2.4 to 4.8 person-months to NCI-funded clinical activities described in the Research Plan of the R50 application during the life of the award. The Research Specialist may engage in other duties as part of the remaining 9.6 to 7.2 person-month effort not covered by this award. The maximum funded effort allowed on all NCI grants, including the R50, will be capped at 6 person-months. 
• The Research Specialist must have demonstrated professional accomplishments consonant with their career status and should have demonstrated cancer clinical research experience relevant to the NCI mission. 

2. Cost Sharing

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

Applications are limited to four per institution per receipt date including new (A0), resubmissions (A1) and renewal (T2); NCI-designated cancer center consortia are considered one institution. In order to maximize the distribution of R50 Clinician Scientist awards to meritorious applicants and projects, award recipients may only receive one renewal of their R50 grant. NCI seeks a broad representation of institutions for this award mechanism and may take this into account when making funding decisions.

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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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.

Include a table summarizing the clinical trials in which the applicant has played a significant role. Include specific funding source, National Clinical Trial ID, other protocol ID, applicant's role, open and close dates, status, phase of trial, official title, targeted accrual (for the entire trial, and for the institution), and actual accrual by applicant.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

1. salary support for the Research Specialist commensurate with their level of effort devoted to the institution's NCI funded clinical trials activities with a minimum of 2.4 and a maximum of 4.8 person-months effort supported by this award; and
2. travel costs to attend research meetings/conferences: not to exceed $2,500 per year

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:

Specific Aims: Do NOT use - Specific Aims are not allowed.

Research Strategy: Applicants must upload the Research Strategy as a single attachment and the Research Strategy must be organized into the subsections identified below. Start each subsection of the document with the appropriate subheading.

Subheading A. Research Program(s) engaging the Research Specialist's activity/effort:

Describe the scope of the clinical trials program with the level of effort in at least one of the NCI-sponsored clinical trials networks at the applicant's institution.

Subheading B. Role of the Research Specialist in Research Program(s):

Describe the particular activities of the Research Specialist (PD/PI) in NCI-sponsored clinical trials and the need for the Research Specialist to ensure the success of the clinical trials program(s). This section should explain how the Research Specialist's qualifications, experience, productivity, accomplishments, and training are critical to achieving the scientific leadership in NCI-sponsored clinical trials networks and the leadership and participation in the successful implementation of the clinical trials at the applicant's institution. Provide in this section the Research Specialist's history of contributing to NCI-sponsored clinical trials networks at the institution by including the following:

• service and leadership of institutional clinical studies infrastructures, such as the clinical trials' office, institutional review board, protocol review and monitoring board for scientific prioritization, and data safety and monitoring board(s), and how the Research Specialist assists the institution to effectively and efficiently address compliance with regulations for clinical trials conduct;
• leadership of the institution's disease- or modality-based groups;
• leadership in NCI clinical trial networks, such as National Clinical Trials Network disease/modality steering committees and other NCI-funded networks;
• serving as national or site PI of NCI-funded clinical trials;
• writing and revising of new clinical trials protocols;
• accruing patients to new or existing trials (as provided in the Other Attachment table);
• recruitment of a representative patient population to clinical trials;
• Research Specialist's plans for meeting the objectives of the NCI-funded clinical trials research program at the institution over the next 5 years, emphasizing how the Research Specialist contributes to the productivity of the institution's clinical trials program and participation in the NCI-sponsored clinical trials network research program(s):
• how the Research Specialist has prioritized contributions to NCI-funded clinical research activity in their career; and
• the career goals of the Research Specialist with regard to continued support of NCI-funded clinical trial networks.

Subheading C. Plans to Develop New Research Capabilities and/or Approaches:

Describe the plans of the Research Specialist (PD/PI) to develop new research capabilities and/or approaches that will allow progress in the institution's clinical trials program to improve efficiencies and address novel opportunities in the research programs, and to develop new internal processes and procedures that will address and improve the clinical trials infrastructure and enhance the applicant institution's ability to contribute to NCI-sponsored clinical trials. Plans to enhance representativeness of participants accrued to clinical trials are encouraged.

Letters of Support:

Two types of Letters of Support are required for this application (all Letters of Support should be combined into a single PDF and submitted as one attachment):

I. A letter of support from the institution, which must detail the following:

a) The institution must document a strong, well-established cancer clinical trials program related to the Research Specialist's area of expertise, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the Research Specialist.

b) Include a statement attesting to the Research Specialist's current level of effort in support of NCI-sponsored clinical trials, and a commitment to continue institutional support of effort should the R50 be awarded.

II. At least three letters of recommendation from PDs/PIs (defined as PD/PI of a grant/program relevant to the applicant, e.g. NCTN, NCORP, LAPs, etc., or other individuals, such as a NCTN institutional or program PI, disease committee chair, etc.) who can attest to the Research Specialist's qualifications and contributions to NCI-funded clinical trials research, and the Research Specialist's potential for continued success/productivity.

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.

The following modifications also apply:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Other Plan(s): 

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

• A Data Management and Sharing Plan is not applicable for this NOFO.

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.

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.

Funding Restrictions specific to the NCI Research Specialist (Clinician Scientist) Award will include the following:

• The requested salary support for the Research Specialist should be commensurate with the level of effort on the institution's NCI-funded clinical trials.
• The Research Specialist is required to spend at least 2.4 to a maximum of 4.8 person-months of his/her effort NCI's clinical trials with salary supported by this award. The Research Specialist may engage in other duties as part of the remaining 9.6 to 7.2 person-month effort not covered by this award. The maximum funded effort allowed on all NCI grants, including the R50, will be capped at 6 person-months.
• The award will allow for travel funds but will not cover research expenses. Research expenses must be covered from other sources awarded to the Institution.
• The Research Specialist will have the option, with prior NCI approval, to move to another research program or institution.
• The R50 must be relinquished if an independent NIH grant (e.g., R01, P01, U10, UG1) is subsequently obtained by the Research Specialist.
• Change of PD/PI (Research Specialist) will not be allowed on the R50.
• Attend an NCI-organized annual meeting for Research Specialist (Clinician Scientist) Award recipients (virtual meeting).

7. Other Submission Requirements and Information

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, NIH. Applications that are incomplete or non-compliant 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 grantdisclosures@oig.hhs.gov. 

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.

For this particular announcement, note the following:
The Research Specialist Award applications do not require preliminary data, specific aims, and/or a detailed research plan.

Accordingly, reviewers will emphasize the following:

• Personal accomplishments of the Research Specialist, both individually and within the context of supporting the nominating institution's clinical trials program(s).
• The contributions of the Research Specialist to the cancer clinical trials program(s) of the institution to date and the NCI-sponsored clinical trials networks.
• The scope of NCI funded clinical trials at the institution, which the Research Specialist will support.
• The letter of institutional support and commitment as well as letters of recommendation from other investigators.
• For Renewals, the committee will consider the previous project period's achievements, contributions, innovations, publications acknowledging the R50 grant, and other activities to support the cancer clinical trials program(s) of the institution and the NCI-sponsored clinical trials networks.

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 review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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.

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 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 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.

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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

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.

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.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

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:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• 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.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

Recipients of both Clinical Trial Required and Clinical Trial Optional awards subject to this term shall report standardized clinical trial activation and enrollment performance data for any interventional clinical trial supported under the award. These metrics are intended to assess trial startup efficiency, site activation, and post-activation performance and to support continuous quality improvement in clinical trial operations (see supplemental guidance). Recipients shall report required data annually at the time of Research Performance Progress Report (RPPR) submission on clinical trial activation and enrollment performance milestone dates as calendar dates; NIH will calculate standardized interval metrics from these dates.

Institutions are expected to maintain capabilities that support efficient clinical trial startup, participant enrollment, and performance monitoring, including streamlined workflows and systems for electronic tracking of milestones.  Recipients are encouraged to implement and evaluate approaches that improve trial efficiency and the participant experience. 

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

• Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
• Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
• NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

Not Applicable

3. Data Management and Sharing

A Data Management and Sharing Plan is not applicable for this NOFO.

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. When contacting the email addresses below please add the NOFO number to the subject line to assist routing.

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Deputy Director, Coordinating Center for Clinical Trials
National Cancer Institute (NCI)
Telephone: 240-276-6241
Email: NCIR50@mail.nih.gov  

Please write "Clinician Scientist R50" in the email subject. 

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

Office of Grants Administration
National Cancer Institute (NCI)
Email: NCIFinancialContact@nih.gov

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.