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)

Funding Opportunity Title

Limited Competition: Biospecimen Banks to Support NCI-National Clinical Trials Network (NCTN)(U24 Clinical Trials Not Allowed)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-CA-14-501

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-CA-20-002

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.394

Funding Opportunity Purpose

 This Funding Opportunity Announcement (FOA) solicits renewal applications for biobanks that will support the following NCI clinical trial programs:

The NCTN Biospecimen Banks (also referred to as NCTN Biobanks) will be responsible for collecting, processing, storing, and distributing well-annotated human specimens from patients with cancer who are participating in NCI-funded NCTN Phase II-III and other clinical treatment trials. 

The main goal is to support the NCTN with the state-of the-art banking infrastructure and operations including maintenance of up-to-date specimen inventory. The NCTN Biobanks will store trial biospecimens linked to high-quality clinical trial outcome data and distribute them to qualified investigators for approved studies for development and validation of biomarkers for cancer diagnosis, prognosis and prediction of responses to therapy.

The NCTN Biobanks work in collaboration with NCTN Groups and Group Statistical and Data Management Centers as well as other affiliated institutions to ensure effective operations. Each Biobank needs to maintain association with one specific NCTN Group and needs to be endorsed in that role by the group leaders.

Key Dates
Posted Date

October 24, 2019

Open Date (Earliest Submission Date)

November 17, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

December 17, 2019 

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s)

No late applications will be accepted for this Funding Opportunity Announcement.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March-April 2020

Advisory Council Review

May 2020

Earliest Start Date

July 2020

Expiration Date

December 18, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. 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. Funding Opportunity Description
    Purpose

    The purpose for this limited competition Funding Opportunity Announcement (FOA) is to support the biobanking infrastructure and operations for the National Cancer Institute Clinical Trials (NCI-Clinical Trials Network (NCTN) ; and NCI Community Oncology Research Program (NCORP).

    The goals of this FOA are:

    • To ensure the collection, processing, storage and distribution of well-annotated human biospecimens procured from cancer patients participating in NCTN Phase II-III and other clinical trials.
    • The objective of this FOA is to ensure that biospecimens collected in the course of the NCTN cancer clinical trials are available for distribution to interested, qualified members of the scientific community.
    • To provide support for collection and storage of biospecimens from patients participating in NCORP cancer prevention and control clinical trials.
    • To provide support for collection and storage of biospecimens from the Pediatric Early Phase Clinical Trial Network (PEP-CTN).

    Key Terms for This FOA

    Biobank: a biospecimen bank (biobank) infrastructure designed and operated to store human biospecimens (along with associated clinical data) collected during NCI-supported clinical trials and to distribute these biospecimens to investigators. Each Biobank serving NCTN Clinical Trial Groups (see definition below) is associated with one specific group.

    Biobank-hosting institution: an institution responsible for hosting a given biobank. Currently some, but not all, NCTN Biobank-hosting institutions are directly supported by U24 awards under RFA-CA-14-501.

    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)

    Background:

    The NCI supports a standing clinical trials infrastructure, the NCI National Clinical Trials Network (NCTN) which is funded through the Cancer Therapy Evaluation Program (CTEP) U10 Cooperative Agreement grants. The NCTN comprises five U.S. NCTN Clinical Trial Groups (one pediatric group and four adult groups):

    The NCTN Biobanks, associated with the NCTN Clinical Trial Groups, were established to collect, store, and provide researchers with well-annotated human specimens from cancer patients, who participate in NCI-funded Phase III and Phase II, and other cancer treatment trials. Specimen collections from such patients offer several advantages such as: (a) uniform information on medical history and treatment details; (b) consistency in standard operating procedures (SOPs) and biospecimen quality assurance/quality control (QA/QC); and (c) reasonable costs compared to other sources. These specimen collections are unique because they have detailed treatment histories and cancer recurrence data based on careful follow-ups of patients over long periods. Furthermore, NCI had established a national NCTN inventory of samples (NCTN Biospecimen Navigator) held in NCTN Biobanks with a clearly defined process for access by researchers. 

    The specimens to be collected are used for:

    The NCI Biobanking Program to be supported under this Limited Competition FOA is designed to ensure the continuity of operation of the five NCTN-supporting Biobanks that already exist and operate under individual awards. Whereas the existing Biobanks are expected to continue their operation, the FOA allows for some administrative rearrangements that applicant teams may need to optimize their operation.  

    Overall Goals and the Main Requirements of this FOA

    The goal of this FOA is to continue support for NCTN-serving biobanks via independent awards to biobank-hosting institutions/entities. The following Biobanks are subject of this FOA:

    • Four “adult" NCTN Biobanks that serve four Adult Oncology NCTN Groups; and
    • One "pediatric" NCTN Biobank that serves the Pediatric Oncology NCTN Group. 

    General Expectations:

    • The biobanks to be supported under this FOA should provide consistent, integrated and well-coordinated Biobanking Resource for specimens from the NCI-supported major clinical trials organizations.  Accordingly, all five NCTN Biobanks will be expected to form an integrated network and work closely with each other towards harmonizing biobanking operating procedures.
    • Each NCTN Biobank will be expected to have a scientific leadership with extensive hands-on expertise in Network Group clinical trial biobanking operations.

    Main Responsibility (towards an Affiliated NCTN Group)

    Each NCTN Biobank proposed must continue serving one specific NCTN Group that the applicant team has been assisting in the current funding period with specific responsibilities defined below.

    Responsibilities of each NCTN Biobank:

    • Maintaining affiliation with one of the five NCTN Groups that has current NCI funding for conducting NCI Phase II-III cancer clinical trials;
    • Collecting, processing, storing and distributing specimens from NCTN clinical trials;
    • Collaborating on the aspects relevant to the biobanking operation with affiliated NCTN Group Statistics and Data Management Centers, Operations Centers, other NCTN units and the NCI;
    • Distributing banked "legacy" specimens for the secondary correlative studies to the NCI-approved investigators outside of NCTN Groups by following a transparent NCTN Access Process; and

    Specific additional responsibility of Pediatric Biobank:

    • Receiving and storing specimens from Pediatric Early Phase Clinical Trial Network (PEP-CTN)".

    Additional Responsibility (towards NCORP Clinical Trials)

    All five NCTN Biobanks will be required to support collection and storage of biospecimens from NCORP cancer control and prevention clinical trials. Biospecimens from these clinical trials will be collected by NCORP Research Bases according to the trial protocols and adhering to the NCTN SOPs and sent to NCTN Biobanks.

    In this context, each NCTN Biobank will have the following specific obligations:

    • Receiving specimens from patients participating in approved longitudinal NCORP Phase II and III trials for cancer control and prevention;
    • Storing formalin-fixed paraffin-embedded (FFPE) tissue blocks and histological slides from diagnostic biopsies and surgical resections;
    • Storing frozen tissue specimens and nucleic acid derivatives;
    • Storing other human specimens including but not limited to serum, plasma, whole blood, white blood cells, bone marrow, urine, skin, and sputum/buccal samples (per trial protocol). 

    Required Capacities for Specimen Collections

    The specimens from NCTN Group collection sites will be sent to the designated NCTN Biobank of the lead NCTN group conducting the trial or to the biobank designated in a specific protocol. The clinical diagnostic data as well as treatment and outcome data linked to the biospecimens will be stored in Statistical Data Centers of the NCTN groups.

    All proposed NCTN Biobanks must be:

    • Capable of receiving, processing, storing and distributing NCTN clinical trial specimens for validation of predictive, prognostic and response-to-therapy (integral and integrated) markers from clinical trials conducted by NCTN Trial Groups (as defined in the trial protocol). The specimens will encompass adult and pediatric solid malignant tumors (e.g., tumors of the brain, breast, gastrointestinal tract, genitourinary tract, gynecologic/reproductive system, head and neck, melanoma-skin, central and peripheral nervous system, liver, lung/thoracic, soft tissue, and thyroid gland) and hematologic malignancies (leukemia, lymphoma, and multiple myeloma).
    • Able to work with formalin-fixed paraffin-embedded (FFPE) blocks and histological slides from diagnostic biopsies and surgical resections from patients with cancer, fresh and frozen specimens, serum, plasma, whole blood, white blood cells, circulating tumor DNA (ctDNA), bone marrow, biomolecules (such as nucleic acids), urine, skin, stool and sputum/buccal and other samples as defined in the trial protocol.
    • Able to develop and follow harmonized SOPs for use by the entire biobanking resource network.
    • Capable of building special collection kits as defined in the trial protocol and providing/shipping them to the NCTN Group clinical trial/patient specimen collection sites.
    • Able to perform a feasibility assessment on availability of banked specimens for research.
    • Be in a good working relationship with the Group Statistical and Data Center that will perform feasibility assessment on availability of statistical data on banked specimen for research.
    • Able to scan and store digital images of whole sections/slides of human tissues.
    • Capable of implementing specialized processing procedures for specimens from the NCTN Cancer Immunotherapy trials and distributing such specimens to Cancer Immune Monitoring and Analysis Centers (CIMACs; supported under RFA-CA-17-005).

    Requirements Regarding Access to NCTN Biospecimens and Specimen Distribution: 

    • NCTN biobanks are responsible for ensuring that the biospecimen needs of the NCTN clinical trial investigators studying "integral" and "integrated" markers are met.
    • NCTN Biobanks must follow transparent and harmonized procedures for ensuring centralized access to NCTN “legacy” specimens. These specimens should be available to investigators for secondary correlative studies following a defined NCTN biospecimen access process and approval by NCTN Core Correlative Science Committee (NCTN CCSC)
    • ·       Each NCTN Biobank is expected to have a local biospecimen access coordinator(s) to facilitate interested investigator access to available biospecimens, and to communicate with the central Front Door Service (FDS) coordinator(s). The NCI operates the Common NCTN Biospecimen Navigator IT System and a centralized "NCTN FDS assisting investigators to access “legacy” biospecimens at NCTN Banks or refers them to other suitable specimen resources (https://navigator.ctsu.org/navigator/login). FDS personnel manages and monitors each stage of the investigator request submitted through the NCTN Biospecimen Navigator, provides support to requestors, and maintains communication with appropriate NCTN Biobank staff.
    • Each Biobank must have an established local Informatics system that will connect the Biobank with: other NCTN Biobanks, the NCTN Biospecimen Navigator, NCTN Group Statistical and Data Centers and NCI Medidata Rave system.
    • Each NCTN Biobank is expected to use NCTN Navigator for the following aspects:
    • Providing a consolidated inventory of biospecimens across the NCTN Group clinical trials;
    • Connecting biospecimen inventory data with associated trial data and selected clinical data to allow assessment of biospecimen availability based on trial design and clinical data end points;
    • Providing tools and standard definitions to facilitate automated data loading from multiple systems;
    • Providing a secure, role-based, functional user interface for performing data queries and reporting as needed by stakeholders including the staff members of NCI, NCTN Trial Groups and Biobanks, as well as non-Group researchers;
    • Providing a user interface and data model for tracking requests, utilization/distribution of biospecimens, and monitoring scientific productivity; and
    • Connecting to Medidata Rave, a cloud clinical data management system that is used by the NCI-supported Cancer Trials Support Unit (CTSU, https://www.ctsu.org/Public/Default.aspx) to manage clinical trial data.  

    NCTN Biobanking Governance:

    The entire NCTN Biobanking Resource will be governed by an NCTN Group Banking Steering Committee.  The Group Banking Steering Committee will coordinate the biobanking activities across the entire biobanking resource. Awardees will be required to work with the NCTN Group Banking Steering Committee to develop policies and milestones for implementation of NCTN Biobanking resource activities. For details, see Section VI.2. Cooperative Agreement Terms and Conditions.

    Program Evaluation

    As the efficiency of the funded research is an important priority for NCI, all Biobank awardees 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 support 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 FOA.

    Application Types Allowed

    Renewal

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NCI intends to fund an estimate of five awards, corresponding to a total of $17.23 million (total costs) for fiscal year 2020.

    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

      Applicants 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 FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Eligibility is limited to an institution/entity that is an awardee of an existing NCTN biobank of human biospecimens from NCI clinical trials funded under RFA-CA-14-501, with the following provision:

    • The partnering institutions forming the current awardee team (including NCTN Biobank-hosting institutions/entities) may configure themselves at their discretion in terms of:
    • location of the biobanking infrastructure, (maintaining current or moving to a new location); and/or
    • the selection of the institution/entity submitting the application, which may be, for example, a biobank hosting institution even if the current awardee institution/entity is different and biobank-hosting institution participates via a sub-contractual arrangements.
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

     An individual designated as contact PD/PI can be either a pathologist (with an M.D. degree) or a laboratory scientist (with M.D and/or Ph.D. degree) and must have an expertise relevant to biospecimen science and a leadership experience in biospecimen banking for cancer clinical trials.

    In addition, any individual who is designated as a PD/PI on the application for the Biobanks to support NCTN must meet the following requirements:

    • Must be endorsed by the leadership of the NCTN Group with which the applicants' Biobank is affiliated (as indicated by a Letter of Support);
    • Must not be designated as a contact PD/PI on the Early Trials Biobank application under companion RFA-CA-20-003; and
    • Must NOT be listed as a PD/PI on the Network Group Operations Centers award (funded through RFA-CA-17-056).
    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed, except for institutions/entities that currently host more than one NCTN biobank. Such institutions should submit a separate application for each NCTN Biobank hosted.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).
    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 FOA. 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 Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

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

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

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

    The letter of intent should be sent or preferably emailed to:

    Irina A. Lubensky, MD
    Pathology Investigation & Resources Branch
    Cancer Diagnosis Program
    Division of Cancer Treatment and Diagnosis,
    National Cancer Institute (NCI)
    9609 Medical Center Drive, Room 4W452
    Rockville, MD 20850
    Telephone: 240-276-5902
    Fax: 301-276-7889
    Email: lubenskyI@mail.nih.gov

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with following modification:

    The page limit for this FOA is 30 pages.

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Project/Performance Site Locations

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Other Project Information

    All instructions in the SF424 (R&R) Application Guide must be followed. Additional instructions are provided below:

    Other Attachments:

    Applicants must provide the following additional materials in support of their application. Each attachment should 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 breakup by tumor type and distribution data by NCTN Group investigators versus non-NCTN investigators.

    Attachment 2: Accomplishments (use filename "Accomplishments"). Summarize the main Biobank accomplishments. For example, include such data as the number of publications/patents resulting from the use of bank specimens. List the most relevant publications/patents that led to changes in clinical practice and/or patents related to diagnostic markers and therapeutics.

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

    List (with synopses):

    • Selected Local SOPs or Manual of Operation of your Biobank;
    • Central Manual of Operations (Table of Contents only)
    • Harmonized documents and procedures as adopted and implemented by your Biobank as part of the NCTN Biobanking network;
    • Key procedures related to data processing and informatics capabilities.
    SF424(R&R) Senior/Key Person Profile

    All instructions in the SF424 (R&R) Application Guide must be followed.  Additional guidance applies:

    Biosketches: For the individual designated as the contact PD/PI, document that such individual (who must be either a pathologist with Medical Doctor degree or a Laboratory Scientist with 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.

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

    R&R Budget

    All instructions in the SF424 (R&R) Application Guide must be followed. The following additional guidance applies:

    PDs/PIs Effort: All PDs/PIs are expected to contribute substantially to the activities on NCTN bank awards throughout the entire project period. Effort level of at least 2 person-months is required for the contact PD/PI and 1 person-month for other PDs/PIs, if proposed. These commitments cannot be reduced in later years of the award.

    Budget Justification:

    Roles of all key personnel (must appropriately match their effort commitment) and planned mutual interactions within the Biobank, among the Biobanks and with the Group Coordinating and Statistical Centers.

    The budget request may include costs associated with:

    • Materials and supplies needed for biospecimen collection/processing/storage/distribution;
    • Local information technology (IT) system;
    • NCTN Biospecimen IT Navigator connection and uploads, & FDS curation & interactions;
    • NCTN “Legacy” specimens retrieval, processing and QA/QC;
    • NCTN biobank feasibility analysis of the requested NCTN bank specimens (minimal specimen-associated data will be provided by the NCTN Group Statistical and Data Center);
    • Scanning and storage of whole slide tissue digital images for defined specimen sets and for biobank QA/QC purposes;
    • Specialized processing/handling/distribution of NCTN immunotherapy trial specimens to CIMACs.

    All Applicants: NCORP Restricted Fund

    Under "Other Expenses" category, enter the amount of up to $258,000/year (direct costs) as "NCORP Restricted Fund". These funds can only be used only for specimens from NCORP cancer prevention and control clinical trials.

    Applicants for Pediatric NCTN Biobank only: PEP-CTN Restricted Fund

    Under "Other Expenses" category, enter the amount of up to $172,500/year (direct costs) as "PEP-CTN Restricted Fund". These funds can only be used only for specimens from PEP-CTN clinical trials.

    Travel Funds:

    Applicants must budget funds for up to three NCTN Biobank members to attend the NCTN Group Banking Committee face-to-face meetings twice each year. Applicants should assume that hosting of the meetings will alternate among the various participants’ banking sites.

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

    R&R Subaward Budget

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS 398 Cover Page Supplement

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    PHS 398 Research Plan

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

    Specific Aims: Outline Specific Aims for the proposed NCTN Bank. Ensure that these Aims properly and comprehensively address the key responsibilities defined in Section I of the FOA 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 your biobank.
    • Characterize the capabilities of your biobank in terms of the current and possible future scale of operation.  
    • Progress Report:

    --Summarize the productivity and specific contributions of the biobank in the last 5 years.

           --In addition, describe a contribution of your Biobank to the NCTN Banks Network (harmonized)

    • Highlight the main accomplishments and scientific impact that resulted from specimen use.
    • Describe organizational structure proposed for the NCTN Biobank and its relationship to the NCTN group structure (include organizational chart, define lines of authority and individual responsibilities); interactions between NCTN Biobanks and affiliated NCTN Group, Group leadership and Group Statistical Center in enhancing banking operation.

    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 NCTN Biobank leadership and key personnel interactions with the NCTN Group (with which the Biobank is affiliated) and with other Biobanks. This description should address:

    • The strengths that the applicant's team would bring to collaborative network activities such as:
    • updating NCTN Biobank policies and priorities;
    • improving quality of shared network services;
    • marketing the resource to increase the number of NCTN biospecimen users;
    • improving information systems to manage the resource;
    • monitoring progress; and/or
    • developing new strategies, as needed to ensure that the resource remains responsive to researcher’s needs.
    • Your vision on how your biobank operation might be improved and how the activities of your biobank(s) will harmonize with the other NCTN Biobanks.

    Sub-section C. Biobank Operations

    This sub-section should address all essential aspects of biobank operations, including QA/QA 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 (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 storing biospecimens at the biobank (including conducting pathology reviews and providing histology services, preparing nucleic acid extracts and ctDNA from specimens);
    • Conducting QA/QC of the biospecimens before distributing them to investigators;
    • Processing and sending specimens to CIMACs from cancer patients treated on NCTN immunotherapy trials;
    • Distributing biospecimens to investigators and/or laboratories;
    • The ways of handling legal and ethical aspects related to human biospecimens.
    • The services that your biobank intends to provide to investigators/researchers and how those services will address the needs of the scientific community and current investigators.

          (Note on Innovative Aspects: In respective parts of this sub-section, 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 IT solutions but also plans for integration with other NCTN Services. 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;
    • An integration/enhancement of the biobank IT system with the Shared NCTN IT Navigator system;  
    • A plan to facilitate data exchange, particularly between RAVE (clinical data) and NCTN Biobank systems;
    • Cataloguing and retrieval of “legacy specimens” and specimen-associated data;
    • Biobank assessment of the investigators' specimen requests for feasibility to use banked "legacy" specimens for research in coordination with Statistical Center;
    • Use of harmonized NCTN Navigator and Informatics tracking systems to support a common database to connect multiple NCTN Biobanks, STAT centers, and NCTN (to annotate biospecimens and retrieve de-identified specimen-associated data, and to permit easy access to biospecimens for the research community);
    • Interactions between the NCTN Biobank local biospecimen access coordinators with NCTN Navigator FDS staff to ensure optimal access to annotated “legacy” clinical trial specimens by the research community.

    Letters of Support: In addition to following standard instructions, provide a letter from the leadership of the NCTN Group that the given Biobank is affiliated with. The letter should be addressed to the proposed contact PD(s)/PI(s) and should confirm that the proposed NCTN Biobank is affiliated with a specific NCTN Group and that the designated contact PD/PI is endorsed by that NCTN Group.

    The letter is expected to be, for example, from the contact PD/PI of the NCTN Group Operation Center or from another member of NCTN Group leadership authorized by that Group.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    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 SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

    PHS Assignment Request Form

    All instructions in the SF424 (R&R) Application Guide must be followed. 

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

    See Part 1. 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. Overview Information 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 Policy on Late Application Submission.

    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 SF424 (R&R) 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.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) 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 the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions 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 announcement, note the following:

    The emphasis of this FOA is on building an integrated Biobanking Resource that will serve NCTN and NCORP Groups. Therefore, each proposed NCTN Biobank must be able to collaborate with affiliated NCTN Groups as well as with other Biobanks. The NCTN 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 approaches and procedures. In addition, the NCTN Biobanks are expected to make "legacy" specimens available to qualified members of the cancer research community to facilitate innovative, clinically relevant secondary correlative studies.

    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 project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

    Specific to this FOA: 

    • How significant has been the contribution of the applicants' Biobank to cancer research? How strong is the evidence from published studies that specimens from this biobank facilitated scientific progress?
    • Based on the scale, past productivity, and accomplishments, what is the likelihood that the     proposed banking operation and the use of biospecimens from this operation will contribute significantly to clinically relevant cancer research and/or influence clinical practices?
    • How well does the proposed Biobank address the needs of the scientific community (access to "legacy" specimens from NCTN Biobanks)?
    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

    Specific to this FOA: 

    • How strong are the background and expertise of the involved personnel in pathology and laboratory science, and hands-on leadership experience in biospecimen banking operation of the PD(s/PI(s)?
    • Are the Biobank leader(s) and key personnel well qualified and well suited to lead and operate a large-scale biospecimen banking operation, ensuring a high level of quality for specimens and records as well as providing efficient and equitable access to biospecimens? Based on accomplishments in the last 5 years, how competent is the PD/PI (or PDs/PIs) in overseeing/directing biospecimen banking operation for large-scale clinical trials?
    • How committed is the leadership to optimizing the NCTN Biobank functioning, including strong leadership interactions and oversight of NCTN biobanking operations, monitoring progress, developing new strategies, and ensuring that the resource remains responsive to researchers' needs?
    • Based on endorsement letters by the leadership of the NCTN Group, what is the likelihood that the Biobank leadership and NCTN Group leadership will have efficient collaborative arrangements?
    • Are the interactive structures and lines of communications between the PDs/PIs of the Biobank and the NCTN Group clearly defined and appropriate?
    • How strong is the vision of the Biobank leadership to improve and harmonize banking operations with the other NCTN Biobanks?
    Innovation

    Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? 

    Specific to this FOA: 

    • How has the applicant team introduced and/or proposed any innovative, improved specimen- related practices (e.g., with regard to specimen processing, QA/QC, specimen tracking, optimized fee for service schemes) and/or other creative ways to operate and increase the utilization of the resource?  
    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address

    1) the protection of human subjects from research risks, and

    2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?  

    Specific to this FOA: 

    • Biobank Operations: 
    • How capable and efficient is the biobanking operation in processing, storing, and distributing different types of biospecimens including FFPE blocks, histological slides, fresh-frozen tissues, others? Are the QA/QC efforts appropriate to ensure sufficiently high quality of biospecimens and their annotated data?
    • Are all the necessary QA/QC steps properly completed before the distribution of biospecimens and annotated data to the laboratories and investigators?
    • How well thought out are the applicant's plans to address the needs of the scientific community (access to "legacy" specimens from NCTN Biobanks)?
    • Are the legal and ethical issues related to human biospecimens receiving sufficient attention? Are these issues handled competently and adequately?
    • Data Management and Informatics:
    • How advanced is the integration of a local biobank IT system with the Shared NCTN Navigator system? Has the integration been achieved, in terms of functioning of all the NCTN Biobanks as an integrated resource?
    • How adequate is the proposed plan for feasibility assessment of the investigators’ specimen requests for use of "legacy" specimens for research?
    • How comprehensive is the plan for Biobank and Statistical Center assessment and response to provide annotated "legacy" specimen access to investigators (NCTN and non-NCTN)?
    • How efficient are the interactions between the Biobank and centralized NCTN Biospecimen FDS staff as well as the investigator to ensure timely response to researcher’s needs?
    Environment

    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?    

    Additional Review Criteria

    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.

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    Not Applicable

    Renewals

    For Renewals, the committee will consider the progress made in the last funding period.

    Revisions

    Not Applicable

    Additional Review Considerations

    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.

    Applications from Foreign Organizations

    Not applicable

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

    • Will receive a written critique.

    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

    Applications will be assigned s to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board (NCAB). 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.
    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 VI. Award Administration Information
    1. Award Notices

    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.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    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 (DHHS) grant administration regulations at 45 CFR Part 75, 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 awardees 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 award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

    The PD(s)/PI(s) will have the primary responsibility for:

    • Overseeing the operations of the NCTN Biobanks, Biobank Informatics and their interactions with NCTN Biospecimen Navigator System;
    • Overseeing Biobank personnel interactions with NCTN Biospecimen FDS personnel;
    • Coordinating with the NCTN Group Statistical and Data Management Center;
    • Participating in the work of NCTN Group Banking Steering Committee (both directly and through designated representatives);
    • Implementing (to the extent consistent with applicable grant regulations) policies and recommendations developed by the NCTN Group Banking Steering Committee (in areas such as defining regulatory procedures, best practices or operating policies, marketing the NCTN Biobanks, education of research community, access procedures, fiscal arrangements such as setting charges for the use of biobank specimens, and quality assurance measures for all aspects of the operation of the NCTN Biobanks).
    • Harmonizing the operations of the biobank to be consistent with the NCI Best Practices for Biospecimen Resources, NCTN Biobanks Central Manual of Operations, and other common documents prepared and/or approved by the NCTN Group Banking Steering Committee; and
    • Assuring that designated banked tissues remain available and that the relevant clinical data are obtainable in accordance with the policies developed by the NCTN Group Banking Steering Committee.

    Additional Requirements for All Biobank Awardees:

    • Biobank Awardees will have to follow the NCTN Groups' policies to make appropriate patient demographic, clinical, outcome and treatment data available to users of the NCTN Biobanks.
    • Biobank Awardees must agree to provide information about their biospecimen (inventory) and data collections to the NCTN Biospecimen IT Navigator (https://navigator.ctsu.org/navigator) and via URL link to the NCI Specimen Resource Locator (https://specimens.cancer.gov) after receipt of this award to allow interested researchers to locate biospecimens they may need.
    • Awardees will establish appropriate data policies (generally in collaboration with network group statisticians and other investigators involved in the clinical trial(s) in which the specimens were collected).
    • Awardees are expected to continuously address the evolving legal, ethical, and human subjects policy issues related to the use of human biospecimens for research purposes following the guidelines on these  issues in the NCI Best Practices for Biospecimen Resources Guidelines https://biospecimens.cancer.gov/bestpractices/index.asp and the Office for Human Research Protections (OHRP)  website (http://www.hhs.gov/ohrp/).
    • Each NCTN Biobank awardee must meet all the applicable requirements of the Federal Human Subjects Regulations 45CFR46 (i.e., the Common Rule, for guidance, see http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf).

    Awardees 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, as described below:

    An NCI Program staff member(s) acting as a Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may be designated to have substantial involvement (e.g., in the role of Project Coordinators).

    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 main responsibilities of substantially involved NCI staff members include but are not limited to the following:

    • Serving as a liaison between the NCTN awardees and the NCI;
    • Interacting with the members of the NCTN Group Banking Steering Committee to facilitate success of the program and to ensure smooth interactions among the cooperating organizations;
    • Serving as a voting member of the NCTN Group Banking Steering Committee and on any subcommittee as deemed appropriate;
    • Providing technical assistance, advice, and coordination of NCTN biobanking activities;
    • Coordinating activities of the NCTN Group Banking Steering Committee between meetings;
    • Working closely with the Chair of the NCTN Group Banking Committee to develop agendas and monitor progress toward developing policies and milestones and adhering to the time-lines set by the Committee;
    • Providing technical advice regarding the development of best practices for collection, processing, storage, retrieval, and shipping of specimens;
    • Providing consultation and advice regarding the development of appropriate processes for assuring access to the banked specimens, legal and ethical issues such as implementation of the DHHS Health Information Portability and Accountability Act (HIPAA) Privacy Rule, the ‘common rule’ (45 CFR 46) and Institutional Review Board (IRB) interactions, as well as other issues for which the NCTN Group Banking Steering Committee will develop policies;
    • Attending NCTN Group Banking Steering Committee meetings/conference calls;
    • Monitoring progress and performance of the key components of the NCTN Biobanks Program including the NCTN Navigator system;
    • Providing the NCI Board of Scientific Advisors (BSA) special review committee with an annual report on NCTN biospecimen access activity;
    • Evaluating the performance of individual NCTN Biobanks based on handling specimen requests and specimen distribution to investigators.

    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 awardees’ performance under the award for appropriate collection, review, and distribution of biospecimens collected in association with NCTN trials.

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

    Areas of Joint Responsibility include:

    NCTN Group Banking Steering Committee will serve as the governing and coordinating body for the NCTN Biobanks supported under this FOA. The Group Banking Steering Committee will consist of the following members:

    For each Biobank:

    • One or more NCTN Biobank PD(s)/PI(s) who will collectively have one vote for their Biobank; and
    • Three additional representatives from NCTN Group, Statistical Center or IT personnel supporting each Biobank.

    For NCI:

    • 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.

    Other non-NCI experts may be asked to attend Group Banking Steering Committee meetings as non-voting members or attendees, if their expertise is needed.

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

    The Group Banking Steering Committee may establish sub-committees as deemed appropriate. The NCI Project Scientists and other NCI staff members may participant on any subcommittee as deemed appropriate.

    The main responsibilities of the Group Banking Steering Committee will include the following:

    • Developing policies and recommendations to coordinate and harmonize the efforts of the individual participating NCTN Biobanks. These policies are expected to include (but will not be limited to) the following areas:
    • Coordination of NCTN biobanking activities;
    • Best practices for collection and storage of specimens;
    • Common data structures for biobanking; and specimen annotation;
    • Adapting emerging technologies for the needs of the NCTN Biobanks.
    • Establishing appropriate timetables and/or milestones for the implementation of these policies.
    • Periodically updating the NCTN Biobanks Central Manual of Operations;
    • Establishing a uniform format to be used by all the NCTN Biobanks for reporting their activities (including the format of the annual progress report).
    • Meeting monthly via teleconference calls and twice a year in a face-to-face meeting at biobanking sites.
    • The Chair of the Group Banking Steering Committee will be responsible for developing agendas, ensuring progress, facilitating cooperation among participants, and chairing meetings.

    Dispute Resolution:

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

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    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.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

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

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    General Programmatic Information 
    Irina A. Lubensky, MD
    National Cancer Institute (NCI)
    Telephone: 240-276-5902
    Email: lubenskyi@mail.nih.gov    

    Scientific Program and Grant-related Administrative Information
    Hala R. Makhlouf, MD, Ph.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-7782
    Email: hala.makhlouf@nih.gov

    Peer Review Contact(s)

    Referral Officer
    National Cancer Institute (NCI)
    Telephone: 240-276-6390
    Email: ncirefof@dea.nci.nih.gov

    Financial/Grants Management Contact(s)

    Shane Woodward 
    National Cancer Institute (NCI)
    Telephone: 240-276-6303
    Email: Woodwars@mail.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.

    Authority and Regulations

    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 45 CFR Part 75.

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