RFA-CA-28-004-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title

Limited Competition: Biospecimen Banks to support NCI National Clinical Trials Network Biospecimen Banks (NCTN Biobanks) and the NCI Early-Phase and Experimental Clinical Trials Biospecimen Bank (EET Biobank) (U24 Clinical Trial Not Allowed)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of

RFA-CA-20-002

Reissue of

RFA-CA-20-003

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-CA-28-004

Companion Funding Opportunity

None

Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.394

Funding Opportunity 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. Through this limited competition Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications to support continuation of two biospecimen banking resources.

The National Clinical Trials Network (NCTN) Biospecimen Banks (NCTN Biobanks) support the NCI-funded NCTN and the Community Oncology Research Program (NCORP), and The Early-Phase and Experimental Clinical Trials Biospecimen Bank (EET Biobank) supports the Experimental Therapeutics Clinical Trials Network (ETCTN) and other NCI-supported early phase and experimental clinical trials.

The objective is to maintain these national resources for the collection, processing, storage, and distribution of high-quality, clinically annotated human biospecimens. The goal of these resources is to ensure the availability of biospecimens from participants in NCI-funded clinical trials focused on treatment, prevention, and cancer control studies to enable translational cancer research.

The NCTN Biobanks support biomarker development and validation, secondary correlative studies, and broader scientific discovery using biospecimens collected through harmonized protocols and linked to clinical outcome data from large multi-site clinical trials.

The EET Biobank supports biospecimen banking for ETCTN and other early-phase and experimental therapeutic clinical trials involving investigational agents. Biospecimens collected through these studies support biomarker assay development, pharmacokinetic and pharmacodynamic analyses, investigation of drug response and resistance mechanisms, patient stratification, and translational research supporting development of novel cancer therapies. 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.

Funding Opportunity Goal(s)

To improve screening and early detection strategies and to develop accurate diagnostic techniques and methods for predicting the course of disease in cancer patients. Screening and Early Detection research includes development of strategies to decrease cancer mortality by finding tumors early when they are more amenable to treatment. Diagnosis research focuses on methods to determine the presence of a specific type of cancer; to predict its course and response to therapy, both a particular therapy or a class of agents; and to monitor the effect of the therapy and the appearance of disease recurrence. These methods include diagnostic imaging and direct analyses of specimens from tumor or other tissues. Support is also provided for establishing and maintaining resources of human tissue to facilitate research.

Key Dates

Posted Date

October 15, 2026

Open Date (Earliest Submission Date)

January 11, 2027

Not Applicable

February 11, 2027

Not Applicable

December 2027

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.

Expiration Date

February 12, 2027

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Conformance to all requirements (both in the 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.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose 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):

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:

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:

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

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

Renewal

The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

To support the NCTN Biobanks and EET Biobank, NCI intends to fund an estimate of six awards, corresponding to a total of $19 million (total costs) for fiscal year 2027.

Award Budget

Application budgets must reflect the actual needs and scale of the proposed activities. Budget requests must not exceed $3.0 million in direct costs per year.

However, the high budget level would be expected only for a large, comprehensive banking operation and significantly lower budget requests are expected for smaller banking operations.

Award Project Period

Applications should request a project period of 6 years

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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.

Required Registrations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

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

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:

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:

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.

Instructions for Application Submission

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

SF424(R&R) Other Project Information

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:

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

SF424(R&R) Senior/Key Person Profile

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

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:

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

PHS 398 Cover Page Supplement

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:

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:

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:

(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:

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

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

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.

Mandatory Disclosure

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.

Overall Impact

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).

Scored Review Criteria

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.

Significance

Does the proposed Biobank address the needs of the research resource that it will coordinate? Is the scope of activities proposed for the Biobank appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Biobank? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing biobanking research? Do the investigators demonstrate significant experience with coordinating collaborative biobanking research? If the Biobank is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Biobank? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research resource the Biobank will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Biobank will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

2. Data Management and Informatics:

Environment

Will the…