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

Purpose

This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding. The purpose of this limited competition NOFO is to solicit applications to support the continuation of the National Cancer Institute's (NCI)-supported biospecimen banking resources, including the NCTN Biobank and the EET Biobank. These resources support the National Clinical Trials Network (NCTN) and NCI Community Oncology Research Program (NCORP), the Early Phase and Experimental Therapeutics Clinical Trials (ETCTN) and other NCI-supported early and experimental trials. 

The objective is to support the collection, processing, storage, and distribution of clinically annotated human biospecimens from NCI-supported clinical trials to enable biomarker development, validation, and translational cancer research.

Key Terms for This NOFO

Biobank: A biospecimen bank (biobank) refers to an infrastructure designed and operated to receive, process, store human biospecimens (along with associated clinical data) collected during NCI-supported clinical trials and to distribute these biospecimens to investigators.  

NCTN Clinical Trial Group: One of five NCI-supported large clinical trial oncology networks forming NCTN. Each NCTN group is organized around a Network Group Operations Center and includes several Lead Academic Institutions (clinical trial sites) and other affiliated supporting infrastructures.

NCTN Legacy specimens: Specimens remaining in excess after clinical trial requirements have been met are made available to investigators for secondary correlative studies following a defined NCTN biospecimen access process and approval by NCTN Core Correlative Science Committee (NCTN-CCSC)

The Experimental Therapeutics Clinical Trials Network: Conducts early phase clinical trials of innovative cancer therapies using a coordinated team-based approach. ETCTN clinical trials are supported by integrated centralized clinical and administrative services sponsored by NCI. The coordination of the ETCTN efforts and oversight of this program is provided by the NCI Investigational Drug Branch (IDB), which is part of the Cancer Therapy Evaluation Program (CTEP).

Background

The NCTN Biobank supports later-phase clinical trials (phase 2/3 and phase 3) within the NCTN. The EET Biobank is a separate entity that supports early-phase (Phase 0, I, and 2) Experimental Therapeutics Clinical Trials Network (ETCTN) and other NCI-supported early trials.

NCTN Biobanks

Current Situation and Organization of Biobanking Support for NCTN

The NCTN is funded through the Cancer Therapy Evaluation Program (CTEP) U10, UG1 and U24 Cooperative Agreement grants. The NCTN comprises five U.S. NCTN Clinical Trial Groups and one Canadian Collaborating Group (one pediatric group and four adult groups):

• COG-Children's Oncology Group;
• Alliance for Clinical Trials in Oncology;
• NRG Oncology;
• ECOG-ACRIN Cancer Research Group; and
• SWOG-Cancer Research Network. 

Characteristics of Biobanking Support for NCTN

The NCTN Biobanks, associated with the NCTN Clinical Trial Groups, receive, process, store, and provide researchers with well-annotated human specimens from cancer patients enrolled in NCI-funded late phase, and other cancer treatment trials. These specimen collections are unique because they are collected using standardized operating procedures with consistent QA/QC practices and are linked to detailed treatment histories and long-term follow-up data, including cancer recurrence. Furthermore, NCI has established a centralized database and website where both NCTN Group and non-NCTN Group community investigators can request access to "legacy" biospecimens from completed NCTN trials (NCTN Biospecimen Navigator) using a clearly defined access process.

The NCI Biobanking Program supported under this NOFO is intended to maintain continuity of operation across existing NCTN Biobanks, while allowing for limited operational optimization to improve efficiency and coordination.

EET Biobank

Current Situation and Reorganization of Biobanking Support for ETCTN

The NCI supports early-phase clinical trials through the Experimental Therapeutics Clinical Trials Network (ETCTN), funded through UM1 cooperative agreements (RFA-CA-19-007 and RFA-CA-19-008) to facilitate the early stages of development and evaluation of anti-cancer therapeutic agents in partnership with industry and academia. The EET Biobank, supported under a U24 mechanism (RFA-CA-20-003), provides centralized biospecimen support for ETCTN and other early-phase and experimental trials.

The objectives of the ETCTN include:

• Conducting early phase experimental therapeutic clinical trials of DCTD/CTEP-IND agents and agent combinations in high priority areas of unmet medical needs;
• Enabling efficient and timely trial activation and execution;
• Integrating molecular characterization, pharmacology, and cancer biology;
• Supporting biomarker-driven clinical research 
• Promoting collaboration among ETCTN institutions and investigators across the network; and
• Promoting collaboration with the All of Us program and associated biobank partnerships. 

The EET Biobank evolved from the ETCTN Biorepository, which was established in 2015 under RFA-CA-14-501 as part of the SWOG Biospecimen Bank. Initially focused on developing processes for receiving, processing, banking, and distributing biospecimens for ETCTN trials, the ETCTN Biorepository created the foundational tracking systems, SOPs, and quality standards for early-phase cancer clinical trial biobanking. In 2020, with the issuance of RFA-CA-20-003, NCI awarded a dedicated U24 grant to the Biopathology Center at Nationwide Children's Hospital, establishing the independent Early-Phase and Experimental Clinical Trials Biospecimen Bank (EET Biobank). This expanded the scope beyond ETCTN to include other early-phase and experimental trials, with governance provided by the Early Phase and Experimental Clinical Trials Biobanking Working Group (EBWG).

Characteristics of Biobanking Support for NCI Early Phase Clinical Trials.

The EET Biobank supports the collection and management of biospecimens obtained at multiple time points using protocol-defined procedures. These biospecimens are linked with detailed clinical and treatment data, including pharmacologic and outcome measures.

These biospecimens support:

• Biomarker development and validation;
• Assessment of drug target engagement and mechanisms of action or resistance;
• Pharmacokinetic and pharmacodynamic analyses; and
• Advancement of translational research to support the development of novel cancer therapies.

Program Evaluation

As ensuring the efficiency and impact of the supported activities is a priority for NCI, all Biobank recipients will be expected to participate in an external evaluation process coordinated by NCI program staff (see Section VI: Terms and Conditions of Cooperative Agreement).

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

Eligibility is limited to an institution/entity that is the recipient of an existing NCTN biobank of human biospecimens from NCI clinical trials funded under RFA-CA-20-002 or an existing EET Biobank of human specimens under RFA-CA-20-003.

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. 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.

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

In addition, any individual who is designated as a PD(s)/PI(s) on an application submitted in response to this NOFO must meet the following requirements:

• Individuals designated as contact PD(s)/PI(s) on an NCTN Biobank application may not serve as contact PD/PI on an EET Biobank application, and vice versa;
• Must not be listed as a PD/PI on the Network Group Operations Centers award (funded through RFA-CA-24-030)
• For NCTN Biobank applications: The PD(s)/PI(s) must be endorsed by the leadership of the NCTN Group with which the applicant's Biobank is affiliated (as documented by a Letter of Support).

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).

Number of Applications

Although only one application per institution (normally identified by having a unique UEI number or NIH IPF number) is allowed, an exception will be made for institutions/entities that currently host more than one biobank. Such institutions may submit a separate application for each Biobank they host.

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.

Other Attachments:

Applicants must provide the following additional materials in support of their application. Each attachment must be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks).

Attachment 1: Current Scale of Operation (use filename "Scale of Operation"). Provide summary table(s) containing data on the number of specimens acquired, processed, and distributed. Include specimen breakdown by tumor type and distribution data by investigator category (e.g., NCTN Group investigators, ETCTN investigators, or other qualified investigators, as applicable).

Attachment 2: Accomplishments (use filename "Accomplishments"). Summarize the major Biobank accomplishments. For example, include the number of publications and/or patents resulting from the use of bank specimens. List selected key publications and/or patents that contributed to changes in clinical practice and/or the development of diagnostic biomarkers and therapeutics.

Attachment 3: Standard Operating Procedures (use filename "SOPs").

Provide a list (with brief descriptions) of:

• Selected Local Standard Operating Procedures (SOPs) or the Biobank Manual of Operation;
• Relevant network or program procedures adopted and implemented by the Biobank (e.g., procedures harmonized across NCTN Biobanks or procedures supporting ETCTN or other early-phase trial biobanking operations);
• Key procedures related to data management, specimen processing, and informatics capabilities.

Specific names provided for Other Attachments must be no more than 50 characters including spaces.

SF424(R&R) Senior/Key Person Profile

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

For the individual designated as the contact PD/PI, the biosketch must demonstrate that the individual (a pathologist with an M.D. degree or a laboratory scientist with an M.D. and/or Ph.D. degree) is actively involved in the operation of a pathology laboratory that has demonstrated access to human cancer tissues from clinical trials.

R&R Budget

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

PD(s)/PI(s) Effort: All PD(s)/PI(s) are expected to contribute substantially to the activities of the proposed Biobank throughout the entire project period. A minimum effort of 2 person-months is required for the contact PD(s)/PI(s) and 1 person-month for each additional PD(s)/PI(s), if proposed. These commitments may not be reduced in later years of the award.

Budget Justification:

Applicants must describe the roles of all key personnel (which must align with their proposed level of effort) and planned mutual interactions within the Biobank and with relevant clinical trial network partners and data management centers, as applicable.

The budget request may include costs associated with:

• Materials and supplies needed for biospecimen collection/processing/storage/distribution;
• Local information technology (IT) systems supporting biospecimen tracking and data management;
• Quality assurance and quality control (QA/QC) activities;
• Integration with and data submission/uploads to NCI-supported informatics systems (e.g., NCTN Biospecimen Navigator)
• Retrieval, processing, QA/QC, and feasibility assessment of requested banked specimens;
• Management, scanning, storage, and quality control of whole slide images (digital pathology images, DPI) for defined specimen sets;
• Specialized processing, handling, storage, and distribution of specimens required for biomarker or immunotherapy studies, and other specific clinical trial programs and initiatives (e.g., CIMACs-CIDC and other initiatives);
• Applications should include appropriate budget support for activities related to NCORP and PEP-CTN biospecimen operations, as applicable, within the appropriate budget categories.

Travel Funds:

Applicants must include funds for appropriate biobank personnel to attend relevant network or program meetings (e.g., biobank governance or coordination meetings) as applicable.

Capital Equipment. In general, capital equipment (i.e., equipment with unit cost of $5,000 or more) is not allowed. However, in exceptional situations, capital equipment may be requested if supported by a clear and compelling justification (e.g., replacement of outdated or malfunctioning equipment essential for biobank operation). Each such request will be considered on a case-by-case basis.

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: Outline Specific Aims for the proposed Bank. Ensure that these Aims properly and comprehensively address the key responsibilities defined in Section I of the NOFO regarding: specimen collection/processing, QA/QC, storage and distribution of biospecimens.

Research Strategy: Instead of the standard sub-sections, Research Strategy must consist of the following sub-sections:

Sub-section A. Biobank Overview;

Sub-section B. Leadership Structure and Interactions;

Sub-section C. Biobank Operations; and

Sub-section D. Data Management and Informatics

Specific guidelines and requirements for these sub-sections are described below.

Sub-section A. Biobank Overview:

• Provide a brief background for the proposed biobank.
• Characterize the capabilities of your biobank in terms of the current and possible future scale of operation.
• Provide a progress report summarizing productivity and major contributions of the biobank during the last 5 years.
• Highlight the main accomplishments and scientific impact that resulted from specimen use.
• Describe organizational structure proposed of the proposed Biobank, including an organizational chart that defines lines of authority and individual responsibilities.
• Describe interactions between the Biobank leadership and the relevant clinical trial networks and collaborating entities, including NCTN Groups, NCORP, ETCTN investigators, affiliated institutions, and statistical or data management centers, as applicable, and explain how these interactions will support and enhance biobanking operations.

Note: supporting documentation for this sub-section is requested under "Other Attachments" (Attachment 1-3).

Sub-section B. Biobank Leadership:

Describe the responsibilities of the Biobank leadership and key personnel, including their interactions with the relevant clinical trial network(s) with which the Biobank is affiliated and with other biobanking resources when applicable. 

Describe the accomplishments of the proposed PD(s)/PI(s) and the extent of their hands-on leadership experience in clinical trial biobanking. 

This description should address:

The strengths that the applicant's team would bring to collaborative network activities such as:

• Updating Biobank policies and priorities;
• Improving the quality of shared network services;
• Promoting awareness and appropriate use of biospecimen resources by investigators;
• Improving information systems used to manage biobank resources;
• Monitoring operational progress;
• Developing new strategies, as needed to ensure that the resource remains responsive to researchers' needs;
• The applicant's vision for improving biobank operations; and
• How the proposed biobank will collaborate with and harmonize operations across relevant clinical trial networks and associated biobanking activities, as applicable.

Sub-section C. Biobank Operations:

This subsection should address all essential aspects of biobank operations, including QA/QC and human biospecimen-related legal and ethical issues. Specific items to be covered include but are not limited to:

• Receipt of biospecimens from the collection sites at the biobank (biospecimens include but are not limited to FFPE blocks, histological slides and frozen tissue from diagnostic biopsies and surgical resections, serum, plasma, whole blood, white blood cells, bone marrow, urine, skin, stool and sputum/buccal samples per trial protocol);
• Processing and storage of biospecimens at the biobank (including conducting pathology reviews and providing histology services, preparing nucleic acid extracts and ctDNA from specimens, and managing digital pathology images [e.g., whole slide images] for QA/QC and research use);
• Conducting QA/QC of the biospecimens prior to distribution to investigators;
• Processing and distribution of specimens to designated research laboratories or centers, including specialized distribution to CIMACs–CIDC for immunotherapy trials when applicable;;
• Distribution of biospecimens to qualified investigators and/or laboratories;
• Procedures for addressing legal,  ethical, and regulatory considerations related to human biospecimens;
• Description of the services provided by the biobank to investigators and researchers, and how those services will address the needs of the scientific community and current clinical trial investigators.

(Note on Innovative Aspects: In respective parts of this subsection, highlight any proposed improved practices for specimen processing and QA/QC, specimen tracking, optimized fee for service schemes, and/or other creative ways to increase the utilization of the resource.

Sub-section D. Data Management and Informatics:

This sub-section should address not only the local information technology (IT) infrastructure supporting the Biobank as well as integration with relevant NCI clinical trials informatics systems supporting NCTN, NCORP, ETCTN, and other NCI-supported early and experimental clinical trials. Specific items to be covered include but are not limited to:

• The biobank's current local IT system that tracks bank specimens, associated data, and investigator requests;
• Plans for integration or interoperability with NCI-supported informatics systems, including the NCTN Navigator system, ETCTN Specimen Tracking System, and other relevant NCI clinical trial informatics platforms;
• A plan to facilitate data exchange between clinical trial data systems (e.g., Medidata Rave) and biobank informatics systems;
• Cataloging, tracking, and retrieval of biospecimens and associated specimen-level data, including legacy specimens, (applies to NCTN Biobanks);
• Biobank assessment of the investigator requests for feasibility of using banked specimens for research including coordination with statistical and data management centers as applicable;
• Use of harmonized  Informatics and specimen tracking systems to support a common data environment connecting biobanks, statistical centers, and clinical trial data systems, enabling retrieval of de-identified specimen-associated data, and efficient access to biospecimens by the research community);
• Operational interactions between biobank informatics personnel and NCI-supported clinical trial data management systems and staff to ensure timely access to annotated biospecimens and associated data for approved research.

Letters of Support: In addition to following standard instructions, applicants must provide a letter of support from the leadership of the clinical trials network or program with which the Biobank is affiliated as applicable. The letter should be addressed to the proposed contact PD(s)/PI(s) and should confirm that the proposed Biobank is affiliated with the relevant clinical trials network or program, and that the designated contact PD/PI is endorsed by the leadership of that network or program.

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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. 

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

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at 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 NOFO, note the following:

The emphasis of this NOFO is to support an integrated biobanking resource that will serve NCTN, NCORP, ETCTN, and other NCI-supported early and experimental clinical trials. Therefore, each proposed NCTN Biobank must be able to collaborate with affiliated NCTN Groups as well as with other Biobanks. The Biobanks are also expected to ensure that biospecimens from patients participating in the NCI-supported cancer clinical trials are annotated, processed and distributed using harmonized standard operating procedures (SOPs). In addition, the NCTN Biobanks are expected to make "legacy" biospecimens available to qualified members of the cancer research community to facilitate innovative, clinically relevant secondary correlative studies. Biobank responsibilities also include maintaining an up-to-date specimen inventory.

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 policies and practices, 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.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the 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, 45 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 PD(s)/PI(s) will have the primary responsibility for:

• Providing comprehensive biobanking support for NCTN, ETCTN, and other NCI-supported clinical trial programs, including receipt, processing, storage, tracking, and distribution of biospecimens using standardized protocols and harmonized operating procedures;
• Receiving, processing, storing, and distributing a broad range of biospecimens (e.g., FFPE, fresh/frozen tissues, blood and derivatives, digital pathology imaging (DPI), and other protocol-defined samples) from adult and pediatric clinical trials, including early-phase, immunotherapy, biomarker-driven, cancer control and prevention, and other NCI-supported studies;
• Overseeing the operations of the Biobanks and associated informatics systems, including interactions with the NCTN Biospecimen Navigator System, ETCTN Specimen Tracking System, and other biospecimen tracking and data management platforms;
• Overseeing interactions between Biobank personnel, biospecimen collection sites, recipient laboratories, and informatics support personnel, including NCTN Biospecimen Navigator FDS personnel, as applicable;
• As applicable, collaborating and coordinating with NCTN Groups, ETCTN Lead Academic Organizations (LAOs), Lead Protocol Organizations (LPOs), Statistical and Data Management Centers, investigators, NCI, and other stakeholders to support integrated biobanking operations;
• Implementing robust quality assurance and quality control (QA/QC) programs and maintaining secure, reliable informatics systems for biospecimen tracking, inventory management, data interoperability, investigator access, and monitoring of utilization and scientific output;
• Ensuring appropriate physical and data security, including backup systems, disaster recovery plans, and compliance with applicable federal and institutional requirements;
• As applicable, participating in the NCTN Group Banking Steering Committee, EET Biobank Working Group (EBWG), and other relevant governance or advisory groups, directly or through designated representatives;
• Implementing, to the extent consistent with applicable grant regulations, policies and recommendations developed by the NCTN Group Banking Steering Committee, EBWG, and NCI, including regulatory procedures, best practices, operating policies, education and outreach, access procedures, fiscal arrangements, and quality assurance measures;
• Harmonizing Biobank operations to be consistent with the NCI Best Practices for Biospecimen Resources, applicable Biobank Manuals of Operations and Laboratory Manuals, and other documents prepared and/or approved by the relevant steering committees or working groups;
• Ensuring that designated biospecimens and associated clinical data remain available and accessible to authorized investigators and laboratories in accordance with applicable access policies and governance procedures;
• Providing specimen collection kits and supporting standardized biospecimen collection and handling procedures across participating clinical sites;
• Following applicable network and program policies to enable appropriate access to patient demographic, clinical, outcome, and treatment data for authorized users;
• Providing biospecimen inventory and associated data to relevant NCI biospecimen informatics platforms, including the NCTN Biospecimen IT Navigator and, as applicable, the NCI Specimen Resource Locator, to facilitate investigator access to available biospecimens;
• Establishing and implementing appropriate data governance and sharing policies in collaboration with statisticians, investigators, network groups, and NCI program staff;
• Addressing evolving legal, ethical, privacy, and human subjects considerations related to the use of human biospecimens for research purposes in accordance with NCI Best Practices, applicable federal guidance, Office for Human Research Protections (OHRP) guidance, and other relevant requirements;
• Complying with applicable Federal Human Subjects Regulations under 45 CFR 46 (the Common Rule) and other applicable federal regulations and guidance;
• Supporting specialized processing and distribution of biospecimens for immunotherapy and other biomarker-driven studies, including coordination with Cancer Immune Monitoring and Analysis Centers (CIMACs), the Cancer Immunologic Data Commons (CIDC), and related initiatives, as applicable; and
• Ensuring transparent, efficient, and standardized access to biospecimens and associated data through coordinated informatics infrastructure, harmonized operational practices, and responsive support for the research community.

In addition:

• Recipients will be expected to address evolving legal, ethical, and human subjects considerations related to biospecimens use in accordance with NCI Best Practices for Biospecimen Resources Guidelines, the Office for Human Research Protections (OHRP) website (http://www.hhs.gov/ohrp/) and applicable federal guidance;
• Recipients must comply with all applicable requirements of the Federal Human Subjects Regulations 45 CFR 46 (i.e., the Common Rule, for guidance, see http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf).
• Recipients will establish and implement appropriate data policies in collaboration with investigators and relevant data systems;
• The EET Biobank must ensure appropriate and efficient access to biospecimens and associated data through established NCI/CTEP-approved processes. The Biobank must maintain an informatics infrastructure capable of tracking biospecimens and integrating with ETCTN systems (e.g., ETCTN Specimen Tracking System, NCI Medidata Rave, and the Oncology Automated Reporting System (OARS).

Recipients will retain custody 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.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The substantially involved NCI program staff member(s), acting as Project Scientist(s), will coordinate recipient activities in a centralized manner.

Specific responsibilities of substantially involved NCI staff members will include:

• Serving as a liaison between the recipients and the NCI; 
• Facilitating interactions among recipients, NCI units (e.g., CTEP, CDP, and other relevant programs), collaborating research groups, and associated clinical trial, informatics, and data management systems, as applicable; 
• Interacting with and participating in relevant steering committees, working groups, and subcommittees to support coordination, harmonization, and overall program success; 
• Providing technical assistance, advice, and coordination for biobanking activities, including quality control/quality assurance (QC/QA), policy development, and standard operating procedures (SOPs); 
• Monitoring QC/QA activities, program performance, operational efficiency, responsiveness to specimen requests, and progress toward milestones and adherence to established timelines; 
• Working closely with committee or working group leadership to develop agendas, coordinate activities between meetings, and monitor progress toward program goals and policy development; 
• Providing technical advice and assisting with the development of best practices for biospecimen collection, processing, storage, retrieval, distribution, and informatics integration;  
• Providing consultation and advice regarding processes to ensure appropriate access to banked biospecimens and addressing legal and ethical considerations, including implementation of the DHHS Health Information Portability and Accountability Act (HIPAA) Privacy Rule, the Common Rule (45 CFR 46), and Institutional Review Board (IRB) requirements; 
• Supporting integration and interoperability of biobank informatics systems with relevant NCI systems and platforms, as applicable; 
• Participating in steering committee and working group meetings and conference calls to discuss program goals, operational needs, and coordination activities; 
• Providing periodic reports to NCI leadership, advisory boards, or other oversight bodies regarding biospecimen access activities and program performance, as appropriate; 
• Evaluating the performance of participating biobanks based on operational effectiveness, adherence to milestones, and efficiency and responsiveness in biospecimen distribution to investigators;
• Guiding coordination between the Biobank and the NCI Clinical Trial Management System to support efficient operational workflows. 

Additionally, an NCI program staff member 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.

The NCI will have access to all data collected and/or generated under this cooperative agreement and may periodically review the data. The NCI may also review all records related to recipients' performance to ensure appropriate collection, processing, and distribution of biospecimens.

The NCI reserves the right to reduce the budget or withhold an award in the event of substantial recipient under performance or substantial failure to comply with the terms of the award.

Areas of Joint Responsibility include:

Biobank Governance and Joint Responsibilities

The NCI will organize a governing and coordinating body to oversee and harmonize activities across the NCTN and EET Biobanks. For the NCTN Biobanks, this body will be referred to as the NCTN Group Banking Steering Committee, and for the EET Biobank, activities will be coordinated through the EET Biobanking Working Group (EBWG). These groups will facilitate collaboration, coordination, and policy development for biobanking activities supporting NCI-sponsored clinical trials.

The NCTN Group Banking Steering Committee will be a voting body with the following members:

• One or more NCTN Biobank PD(s)/PI(s) who will collectively have one vote for their Biobank; and
• Up to three additional non-voting representatives from NCTN Group, Statistical Center or IT personnel support each Biobank.
• Three NCI Project Scientists, who will collectively have one vote for NCI.
• Other NCI staff members may participate as non-voting members or attendees, if their expertise is needed.
• Non-NCI experts may be invited to attend Group Banking Steering Committee meetings as non-voting members or attendees, as appropriate.

The NCTN Group Banking Steering Committee will select one of the voting members, who represent Biobank recipients, as its chairperson (NCI staff members may not serve in this role).

The Group Banking Steering Committee may establish subcommittees as deemed appropriate. The NCI Project Scientists and other NCI staff members may participate in any subcommittee as appropriate.

The EET Biobanking Working Group (EBWG) will consist of the EET Biobank PD(s)/PI(s), NCI Cancer Diagnosis Program Project Scientist(s), a Cancer Therapy Evaluation Program/Investigational Drug Branch representative, and, as needed, additional experts or representatives from organizations involved in the EET biobanking, including the EET Biobank, ETCTN, CIMACs, and relevant NCI-supported clinical trial, informatics, and data management systems. Other NCI and non-NCI experts may be invited to participate in EBWG meetings or conference calls, as needed.

Responsibilities

The Steering Committee/Working Group will meet regularly (e.g., via teleconference and periodically in person, as appropriate) and will be responsible for coordinating and harmonizing biobanking activities across participating organizations. Responsibilities may include:

• Facilitating and monitoring collaboration among participating organizations and NCI units; 
• Coordinating biobanking operations and activities; 
• Developing and refining policies, procedures, and recommendations to support harmonized biobanking practices; 
• Establishing and promoting best practices for biospecimen collection, processing, storage, annotation, distribution, and operational workflows; 
• Developing standardized data structures, informatics integration approaches, and reporting practices; 
• Evaluating and adopting emerging technologies to support biobank operations; 
• Establishing appropriate timetables and milestones for implementation of policies and operational improvements; 
• Periodically updating relevant manuals of operations and guidance documents; 
• Establishing standardized reporting formats for biobanking activities, including annual progress reporting; 
• Addressing operational priorities, challenges, and other issues relevant to NCTN and EET biobanking activities.

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, or recipient (as applicable); 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).

NCI DCTD CDP PIRB NOFO
National Cancer Institute (NCI)
Email: NCICDPNOFO@mail.nih.gov

Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov

Office of Grants Administration
National Cancer Institute (NCI)
Telephone: 240-276-6291
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.