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 

Pancreatic Cancer: Pancreatic cancer is the third leading cause of cancer-related mortality in the United States and is projected to move up to the second position by 2030. The poor prognosis of pancreatic cancer is primarily due to the diagnosis of the disease at advanced stages as patients often present with locally advanced or metastatic disease where resection is not feasible. The lack of symptoms or presence of non-specific symptoms at early stages makes it challenging to detect this cancer early.

The majority of PDAC is sporadic, i.e., occurring without a family history or a genetic predisposition of the disease. It is estimated that it takes more than 10 years before an initiating mutation in a normal pancreas cell progresses to the non-metastatic parental founder cell of PDAC, and at least five more years may be required for the acquisition of metastatic ability. This window of time offers an opportunity for curative interventions if the disease could be diagnosed at an earlier stage.

Overview of Current PCDC: The PCDC consortium is developing clinically useful screening markers from liquid biopsies that will predict progression of pre-cancer lesions and/or detect early stage PDAC in high-risk populations. PCDC is also integrating imaging approaches with liquid biopsies for PDAC detection. 

The PCDC currently focuses on two main types of high-risk populations that are outlined below:

(1) Individuals at high risk of developing PDAC because of genetic factors, i.e., presence of germline variants in cancer susceptibility genes that include high-penetrance genes, hereditary pancreatitis, and other known variants. Individuals could also be at high risk of PDAC due to a family history of pancreatic cancer. Approximately 10% of PDAC occurs in families with a history of PDAC.

(2) Individuals at high risk of developing PDAC because of the presence of mucinous cyst lesions (e.g., intraductal papillary mucinous neoplasm [IPMN], mucinous cystic neoplasm [MCN]), and other suspected precursors such as pancreatic intraepithelial neoplasia-grade 3 (PanIN-3).

PCDC Resource Building Efforts: A major impediment to pancreatic cancer research is the limited access to well-characterized and well-annotated specimens from early stages and lethal precursors, which are critical for biomarker discovery and validation. PCDC has initiated the establishment of comprehensive, longitudinal registries and biorepositories, a necessary and foundational step toward advancing early detection strategies.

PCDC is building two integrated, longitudinal biorepositories. Samples that have already been collected under ongoing PCDC activities are being shipped to a Central Repository for long-term storage.

PCDC Prospective Cohorts: This is a unique, ongoing collection of prospective, longitudinal biospecimens including blood (serum, plasma), cyst fluid, and pancreatic juice from the types of high-risk populations previously described. These cohorts known as "PCDC Prospective Cohorts", are being developed through strong multi-institutional collaborations across all PCDC awardees. The collection of sufficient biospecimens that will enable the design of adequately powered, EDRN-defined Phase 3 validation studies will require continued commitment and strong collaborations among multiple institutions and participating Cancer Centers.

PCDC Reference Sets: The PCDC teams are also prospectively collecting blood samples from consented participants who have the following conditions:

1. PDAC;
2. Pancreatic cyst;
3. Pancreatitis;
4. Other pancreatic cancer;
5. Familial/genetic risk;
6. New onset diabetes (NOD);
7. Non-PDAC control.

These biospecimens are designated as reference sets for various larger validation projects, within PCDC or with other NCI-funded consortia.

Note: Please see companion NOFO, PAR-28-056 for more background on this program

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.

An investigator designated as a Contact PD/PI or MPI on an application under this NOFO must not be the designated Contact PD/PI or MPI on any application for the companion U01 PCDC NOFO, PAR-28-056, or funded RU.

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).

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.

SF424(R&R) Senior/Key Person Profile

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

In addition, it is preferred that the PCDC-MDCU includes expertise in data analytics and artificial intelligence/deep learning/machine learning language, but it is not required.

R&R Budget

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

• PD(s)/PI(s) Effort: The Contact PD/PI must commit a minimum of 1.8 person-month of his/her time per year and all other PDs/PIs (if multiple) must commit a minimum of 1.2 person-month of their time per year to the U24 award. This commitment cannot be reduced in later years of the award.
• Travel Funds: Applicants must budget for travel and per diem expenses for Steering Committee meetings. The Contact PD/PI together with at least one MPI or a senior investigator and an early-stage/junior investigator, will attend two Steering Committee meetings each year of the award; one in-person meeting and one virtual meeting. The virtual meetings will allow participation of the larger team members.
• Support for Early-stage/Junior Investigators: The budget should include funds to enhance professional development of early-stage/junior investigators. In addition to the travel to the Steering Committee meeting, the budget should include funds to cover their participation in research projects.
• Other Budget-Related Information: As the MDCU is the site of record for the sIRB, applicants should budget for coordination of sIRB-related activities. Budget for personnel services directly involved in the activities of the MDCU should be clearly identified.

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: The PCDC-MDCU applicant must describe how the specific aims will help PCDC achieve its overall goals. The applicant must state their willingness and describe the strategies to work collaboratively with the PCDC-RUs, the PCDC Steering Committee, the NCI, and the NCI at Frederick Central Repository.

Research Strategy: Applicants must organize the Research Strategy to include the sub-section elements identified below. Applicants may include other sub-sections as needed.

Sub-section A: Coordination, Data Management Support and Statistical Support

(i) Team Organization, Administrative, and Logistics Support

• Without repeating the information provided in the Senior/Key Person section earlier or in the biosketches, describe the team leadership structure, project management skills, and how the team members bring complementary expertise for consortium coordination and data management activities to achieve the overall goals of the MDCU;
• Describe MDCU's plans for communication, management and integration of the PCDC-MDCU activities, and who will oversee the day-to-day activities for the different types of activities, and oversight mechanisms for ensuring effective PCDC-MDCU operations;
• Describe plans for communication with the PCDC-RUs and the NCI and support overall PCDC integration;
• Describe how to provide logistical and administrative assistance in arranging monthly Steering Committee calls, bi-annual meetings and PCDC working group calls and workshops;
• Describe plans to support NIH sIRB policy to enhance and streamline the current sIRB process for multi-site research studies;
• Describe strategies for preparing/maintaining listserv; preparing, distributing and maintaining meeting minutes; working with NCI for developing, populating, updating and maintaining the NCI-hosted PCDC portal, both public facing and secure sites; and updating the PCDC Manual of Operations document.

(ii)  Coordination of the Development of the PCDC Biorepository

• Describe plans to support the development of high-risk PCDC cohorts (e.g., PCDC Prospective Cohorts, mentioned earlier), including plans to work with the PCDC-RUs to track/monitor/document enrollment;
• Describe plans to build and maintain virtual databases (e.g., virtual management of patient registry with clinical and demographic information and biospecimen record keeping);
• Describe plans to work with the PCDC-RUs for building case-control PCDC Reference Sets (described earlier) and assist in data collection and entry, sample tracking, calculation of populations and power analysis;
• Describe plans to coordinate the transfer of biospecimens to the NCI at Frederick Central Repository.

(iii) Coordination of and Statistical Support for PCDC Collaborative Studies

• Describe how the MDCU will support the study design, data standardization and harmonization, management, coordination, implementation, and conduct of Steering Committee-approved collaborative studies;
• Describe statistical support for protocol development, collaborative studies and data analysis;
• Describe the process for blinding and unblinding that may be necessary for trans-PCDC validation projects;

(iv) Corrdination of Data Storage, Security and Analysis

• Describe the infrastructure for data storage, data security and data analysis to adequately and appropriately support the PCDC collaborative activities.

Sub-section B: Relevant Accomplishments

Describe accomplishments relevant to data coordination and management for programs focused on early detection of cancers and/or pancreatic cancer. The description should address, but is not limited to, the following:

• Organization and coordination of consortium or multi-institutional activities (e.g., meetings);
• Development and implementation of a sIRB;
• Biorepository building and management;
• Statistical design and support.

Progress Report (Renewal Applicants Only): Include additional information in this section summarizing the current 5-year funding period and include the following items (a to c):

• a) List the specific aims from previously funded application. Describe the progress made relevant to these specific aims during the current funding period and highlight the key findings for the biomarkers investigated.
• b) Describe the development and implementation of the sIRB;
• c) Describe contribution towards the PCDC Prospective Cohorts and/or towards building the case-control Reference Sets.

Sub-section C: Annual Milestones

The following major benchmarks of progress must be addressed. Any application lacking milestones will be considered incomplete.

Applicants should provide a clear set of annual, quantitative benchmarks for each specific aim of the PCDC-MDCU associated with timelines. These milestones must be well described and quantitative. Discuss the milestones as a means for judging the success of the MDCU functions. Specific aims may not be regarded as milestones (unless they include quantitative endpoints). 

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:

• A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.

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.

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.

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 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. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory 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.

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. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, 46 CFR 75 (for indirect cost provisions), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PDs/PIs will have primary responsibility for:

• Overseeing the PCDC-MDCU activities to ensure that its areas of responsibility are fulfilled.
• Actively participating in the PCDC, including collaboration, meetings, and scientific workshops; attending two annual Steering Committee meetings (one in-person, one virtual).
• Serving on the PCDC Steering Committee and participating as a voting member of the Steering Committee.
• Overseeing and ensuring implementation of approved data and resource sharing plans.
• Sharing data, materials, and resources, and disseminating tools and outputs to the broader scientific community, including via the PCDC website.
• Abiding by the governance of the PCDC.
• Providing annual progress reports and additional updates as requested by NCI.
• Participating in NCI-led program evaluations, including required reports and a site visit during the project period.
• Coordinate the transfer of biospecimens to the NCI at Frederick Central Repository.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

PD(s)/PI(s) responsibilities for PCDC collaborative studies are:

• Collaborating with PCDC-RUs to advance promising early detection assays/tests towards validation studies.
• Implement Steering Committee–approved goals, priorities, protocols, and policies.
• Ensure review and approval of study protocols, consent documents, and amendments by the Steering Committee and NCI; communicate protocol status updates.
• Support collaborative study design, data handling, and sharing across participating organizations.
• Coordinate specimen collection activities (e.g., Signature Cohorts).
• Provide logistical and operational support for Steering Committee meetings, workshops, and network activities.
• Coordinate sIRB processes as the IRB of Record, 
• Coordinate network agreements (e.g., MTA, DTA, consortium agreements), as applicable.

NCI Program Officials have substantial programmatic involvement that is above and beyond the normal stewardship role awards, as described below:

A designated NCI Program Official serving as the Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may also become substantially involved as needed. An NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Additional Program Officials who are not responsible for the normal scientific and programmatic stewardship of the award may be designated as Project Scientists and assist in Network activities.

The specific roles of the substantially involved NCI Program Officer  include the following activities:

• Coordinating and facilitating various activities of the PCDC program.
• Participating in the activities of the PCDC Steering Committee as a voting and/or non-voting member.
• Serving as a liaison between the Steering Committee, the PCDC recipients, and the NIH.
• Ensure effective communication across the network.
• Support development of operating policies and coordinated actions.
• Facilitate multi-site collaborations and avoid duplication of efforts.
• Assist recipients in leveraging NIH/NCI resources, such as the NCI Frederick Central Repository, and disseminating outputs.
• Co-organize and participate in PCDC meetings.
• Monitor scientific progress and compliance with Steering Committee recommendations.
• Establish working groups and cross-PCDC projects as needed.
• Approve use of set-aside funds for Steering Committee–endorsed activities.
• Assist recipients in leveraging NIH/NCI resources and disseminating outputs.

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to those Consortium recipient institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

Areas of joint responsibility include:

Steering Committee: The Steering Committee will be the main governing body for the PCDC. The Steering Committee will be composed of the following voting members:

• Two PDs/PIs representing each PCDC U01/U24 award; in case of a single PD/PI award, an additional key personnel may also vote to keep the number of voters uniform across all awards.
• The NCI-designated Project Coordinator.

Each voting member will have one vote. The NCI Project Coordinator will have one vote on behalf of all NIH participants. 

NIH staff and other experts may participate as non-voting members, as needed.

The Steering Committee Chair (non-NIH) is selected by the Committee.

The Committee meets twice annually (one in-person, one virtual).

Working groups may be established, with participation from NCI staff as appropriate.

Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:

• Identify consortium-level scientific and policy issues and recommend actions to NCI.
• Update and refine policies for collaborative projects, protocols, and underperforming studies; recommend replacement projects within existing budgets.
• Review patient accrual, compliance, audits, and regulatory requirements; report findings to NCI.
• Oversee the PCDC Manual of Operations, biorepository efforts, and guidelines for specimen sets and Signature Cohorts.
• Set research priorities, identify emerging opportunities, and promote trans-PCDC initiatives.
• Track research progress and ensure timely publication of results.
• Review and prioritize collaborative projects, oversee data submission and access policies, and advise NCI on use of set-aside funds.
• Evaluate validation data to determine readiness or discontinuation of assays.
• Monitor overall consortium performance and promote use of NIH/NCI resources.
• Ensure compliance with resource sharing and intellectual property policies across all collaborators.
• Support outreach to the broader research community.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

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).

PCDC Program Officers
Cancer Biomarker Branch
National Cancer Institute (NCI)
Email: ncipcdc@nih.gov

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.