Required Application Instructions

It is critical that applicants follow the 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.

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

The purpose for this limited competition Funding Opportunity Announcement (FOA) is to support the infrastructure and banking operations for the NCI National Clinical Trials Network (NCTN; https://research.usc.edu/nci-national-clinical-trials-network-nctn-program/). The goal is to ensure the collection, storage, and distribution of well-annotated human biospecimens, procured from cancer patients participating in NCI-funded NCTN Phase III and large Phase II clinical treatment trials.

The advent of powerful molecular technologies and targeted therapeutics has allowed for development of more effective and, in some cases, individualized treatment of cancer patients. Access to specimens with associated high quality clinical, treatment, recurrence, and outcome data is critical to developing and validating the tests needed for diagnosis, target identification, and prediction of response to therapy. High quality banks of uniformly collected specimens and validated clinical data from patients treated in prospective randomized clinical trials are crucial for supporting cancer research. NCTN Groups organizing and carrying out NCI Phase II-III clinical trials are uniquely positioned to collect and bank biospecimens from clinical trials. The objective of this FOA is to ensure that biospecimens collected in the course of the NCI-supported cancer clinical trials are available for distribution to interested, qualified members of the scientific community.

For many years, the NCI has been supporting a standing clinical trials infrastructure, the NCI National Clinical Trials Cooperative Group Program. Each of the nine Cooperative Groups supported under this program was associated with one of the nine Cooperative Group Banks (CGBs; http://cgb.cancer.gov/). The Cooperative Group Banks were established to collect, store, and provide to researchers well-annotated human specimens from cancer patients, who participate in NCI-funded Phase III and Phase II 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 control; 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.

In 2009, NCI asked the Institute of Medicine (IOM) to review the entire NCI-sponsored clinical trials system. The IOM report (http://iom.edu/Reports/2010/A-National-Cancer-Clinical-Trials-System-for-the-21st-Century-Reinvigorating-the-NCI-Cooperative.aspx) recommended that the existing Clinical Trials Cooperative Groups be consolidated into a smaller number of Groups, each with greater capabilities and appropriate incentives to promote better overall system integration. Consolidation promotes efficiency by encouraging a structural makeover of clinical trial group operation centers and statistics and data management centers. Based on the IOM review recommendations, the NCI Cancer Therapy Evaluation Program (CTEP) has transformed the NCI-sponsored Clinical Trials Cooperative Group Program into a new consolidated Program referred to as the NCI National Clinical Trials Network (NCTN; http://ctep.cancer.gov/initiativesPrograms/nctn.htm). The NCTN comprises five U.S. Network Groups (1 pediatric group and 4 adult groups): COG, ALLIANCE, NRG, ECOG-ACRIN, and SWOG.

Furthermore, the IOM report underscored the importance of submission of annotated biospecimens collected from patients in the course of clinical trials to high-quality, standardized central biorepositories. The report recommended that NCI establish a national inventory of samples held in central repositories with a clearly defined process for access by researchers. Accordingly, the NCI leadership asked the Cancer Diagnosis Program (CDP; http://www.cancerdiagnosis.nci.nih.gov/) of the Division of Cancer Treatment and Diagnosis (DCTD; http://dctd.cancer.gov/) to re-assess the organization and operation of the CGBs to align the banking operation with the consolidated structure of 5 NCTN Groups.

This limited competition FOA reflects a comprehensive effort by the NCI to transform the current nine CGBs into five NCTN biospecimen banks aligned with the five NCI-funded NCTN Groups.

The overall goal is to support a new integrated and well-coordinated NCTN Biospecimen Banking Resource. This resource will store well-annotated, quality specimens for research and validation of predictive, prognostic and response to therapy markers from the NCI clinical trial initiatives.

The NCTN Banks must ensure the uninterrupted operation (collection, storage, distribution, etc.) in regard to specimens from Cooperative Group clinical trials as well as specimens from the ongoing NCTN clinical trials.

Furthermore, legacy specimens (specimens that remain in excess after clinical trial requirements have been met) will be annotated, catalogued and made available to qualified investigators from the research community for appropriately peer-reviewed scientific studies. Transparent access to legacy specimens and associated data is critical.

It is expected that by operating effectively, NCTN banks will have capabilities to accommodate additional tissue collections from other NCI clinical trials, such as, the NCI Experimental Therapeutics Clinical Trials Network (ETCTN).

The new structure of the NCTN Biospecimen Banking Resource will comprise up to 5 NCTN Banks serving 1 pediatric and up to 4 adult NCTN Groups. The NCTN Banks will form an integrated network and will collaborate with each other and with affiliated NCTN Group Statistics and Data Management Centers, Operations Centers, other NCTN units, NCI-sponsored programs and investigators, and the NCI.

Each NCTN Bank will be supported by a separate award, and will be expected to have an integrated organizational structure that relies on scientific leadership with extensive hands-on expertise in Network Group clinical trial biospecimen banking operations.

At the time of application submission, a biospecimen banking operation proposed to serve as an NCTN Bank should be affiliated with one of the 5 NCTN Groups that has current NCI funding for conducting NCI Phase II-III cancer clinical trials.

Specimen Collection and Distribution: The NCTN Banks will receive, store and distribute tissue specimens as well as blood and other biological fluids from patients participating in NCTN clinical trials. 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, skin, liver, lung, soft tissue, and thyroid gland) and hematologic malignancies (leukemia, lymphoma, and multiple myeloma).

The NCTN banks should demonstrate ability to receive and store formalin-fixed, paraffin-embedded (FFPE) blocks and histological slides from diagnostic biopsies and surgical resections from patients with cancer. It is expected that the applicant bank would receive and store fresh frozen specimens collected in at least some of the clinical trials. Other specimen types expected to be collected and stored include but are not limited to: serum, plasma, whole blood, white blood cells, bone marrow, urine, skin, and sputum/buccal samples as defined in the trial protocol. The NCTN Bank should have a capacity to prepare relevant biomolecules (such as nucleic acids) from the collected biospecimens.

The NCTN banks will receive biospecimens collected by NCTN Group member hospitals, and affiliated member institutions, including NCI Community Oncology Research Program (NCORP) hospitals, using special collection kits and standard operating procedures (SOPs) provided by the banks. The specimens will be sent to the designated NCTN Bank of the lead group conducting the trial or to the bank 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.

In addition to serving NCTN Groups, one NCTN Bank with appropriate capability will have expanded scope of activities to receive, process, store, and distribute biospecimens from cancer patients treated on ETCTN early phase trials. These ETCTN-related activities will be supported by restricted funds allocated to the NCTN Banking award.

Access to NCTN Biospecimens: The proposed bank infrastructure must allow for transparent access to the banked biospecimens and associated data for investigators. NCTN Banks will be responsible for ensuring that the biospecimen needs of the NCTN integral and integrated clinical studies are met. Any remaining biospecimens (after the needs of NCTN studies are met) have to be made available to qualified investigators in the research community, including those outside of the NCTN system. The remaining biospecimens, annotated with accompanying clinical data, are also referred to as "legacy specimens".

NCTN will have transparent harmonized procedures for a centralized access for investigators to request and obtain biospecimens. Access to the NCTN biospecimens requires a scientific merit review that is currently conducted by the NCI Correlative Science Committees and CTEP.

NCI-supported central "front door" service for investigators' access to biospecimens. The NCI's Cancer Diagnosis Program will establish and operate a centralized service assisting investigators to access biospecimens at all NCTN Banks. This centralized "front door" service will coordinate the entire biospecimen access process to facilitate access by investigators to the NCTN bank specimens or to other suitable specimen resources. Each NCTN Bank will be expected to have a local biospecimen access coordinator to interact with the interested investigators and facilitate their access to available biospecimens, and to communicate with the NCI central "front door" service coordinator.

Common Biospecimen IT System: Implementation of common informatics (IT) infrastructure to support biospecimen banking and integration of data management, statistical and banking operation systems is essential. Each bank will have an established local Informatics system that will connect the bank with the Group Statistical and Data Center, NCI enterprise and other NCTN banks. In addition, each NCTN Bank will be expected to use a common biospecimen inventory IT system and search engine that has the following functionalities:

• Provide a consolidated inventory of biospecimens across the NCTN Group clinical trials;
• Connect 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;
• Provide tools and standard definitions to facilitate automated data loading from multiple systems;
• Provide a secure, role-based, functional user interface for performing data queries and reporting as needed by stakeholders including the staff members of NCI, NCTN Group and Group Banks, as well as external researchers; and
• Provide a user interface and data model for tracking requests, utilization/distribution of biospecimens, and monitoring scientific productivity.

NCTN Bank awardees will not need to develop a common Biospecimen IT system; a system with all the required attributes is already being developed. The NCTN Bank awardees will be expected to implement this system.

The applicant team must be able to maintain and improve the functioning of their biospecimen banks in cooperation with the affiliated NCTN Clinical Trial Group and as a part of the integrated NCTN Banking resource.

All applicants must be able to meet specific requirements for the key capabilities and essential attributes listed below.

All applicants must have the following capabilities in place (by the time of award start):

• Availability of suitable NCI Phase II and III clinical trial biospecimens for research.
• Leadership experience in biospecimen banking for NCTN cancer clinical trials.
• Adequate established banking infrastructure to collect, store, quality control and distribute cancer trial specimens, including both frozen and FFPE tumor tissue, fluids and bio-molecules.
• Expertise and technical capabilities to provide additional processing of biospecimens (e.g., DNA/RNA preparations, tissue microarrays, or microdissections) that may be of importance to investigators seeking to use the resource.
• Adequate local Informatics system to support local and central banking operations and to ensure appropriate specimen annotation with trial data and selected clinical data (clinical annotation of the specimens will reside in the bank).
• IT connection to the Group Statistical, Data and Operations Centers and common Biospecimen IT Navigator system.
• Connect biospecimen inventory to allow assessment of biospecimen availability based on trial design and clinical data endpoints.
• Working relationship with the Group Statistical and Data Center which will perform feasibility assessment on availability of statistical data on banked specimen for research.
• Bank's ability to perform a feasibility assessment on availability of banked specimens for research.

Group Banking Governance:

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

The NCTN Banking program will be subject to external evaluation near the end of the funding period (to be coordinated by the NCI Program Staff). The general evaluation criteria for the NCTN Biospecimen Banking program include quality, value, scientific impact and publications, evidence of scientific leadership, demonstration of operational efficiency, effort on collaborative management and integration of biospecimen bank activities across the network and interactions with other relevant NCI-sponsored organizations and programs, stream-lined access to banked biospecimens by the researchers within and outside the NCTN network, and implementation of a fee for biospecimen/service to cover some of the costs of providing specimens.

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

Eligibility is limited to an institution/entity that is operating the physical infrastructure of one or more existing Group Banks of human specimens from Phase II and III cancer clinical treatment trials funded under RFA-CA-09-504 (irrespective of whether the actual award under RFA-CA-09-504 was made to this institution/entity or to another institution/entity under the former NCI-sponsored Clinical Trials Cooperative Group Program structure). The eligible institutions may configure themselves at their discretion in terms of location of the biospecimen banking infrastructure (maintaining current or moving to a new location) and/or the selection of the institution/entity submitting the application (which can also be a foundation if it is a recipient of the NCTN Operations Center award under RFA-CA-12-010) for one of the NCTN Groups, as long as a group of institutions applying together is affiliated for biospecimen banking with one and only one NCTN Group funded under RFA-CA-12-010.

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.

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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

With further restrictions specified below, 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.

This FOA requires that any individual designated as contact PD/PI must be a pathologist with medical doctoral degree. These individuals must also have hands on 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 Biospecimen Banks to support NCTN must meet the following two requirements:

• Must be endorsed by the leadership of the NCTN Group with which the applicants' Bank is affiliated (as indicated by a Letter of Support); and
• Must NOT be listed as a PD/PI on the Network Group Operations Centers award (funded through RFA-CA-12-010).

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

NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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 PI
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Irina A. Lubensky, MD
Pathology Investigation & Resources Branch
Cancer Diagnosis Program
Division of Cancer Treatment and Diagnosis, NCI, NIH
Shady Grove Campus
9609 Medical Center Drive, Rm 4W452
Rockville, MD 20850
Phone: 240-276-5902
FAX: 240-276-7889
Email: lubenskyi@mail.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements.

Research Strategy must not exceed 30 pages.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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.

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

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

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

Other Attachments: Applicants may provide additional materials supportive of their application.

The following information should be uploaded as distinct pdf attachments. The filename provided for each attachment will be the name used for the bookmark in the application image.

1) Documentation relevant to the actual and possible biobanking scale of operation (use filename "Scale"). For example, you should provide summary table(s) containing such data as the number of specimens acquired, processed, and distributed. Provide specimen breakup by tumor type and distribution data by internal investigators (i.e., from Cooperative Groups or NCTN) versus external investigators.

2) Documentation relevant to the biobanking accomplishments in the last 5 years (use filename "Accomplishments"). For example, you should list 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.

3) Sample SOPs relevant to the proposed banking operation system (use filename "SOPs", and provide a Table of Content). For example, you should provide:

• Selected Local Standard Operating Procedures or Manual of Operation of your Bank
• Central Manual of Operation developed by the Group Banking Committee
• Any other common or harmonized documents developed by the Group Banking Committee (e.g., Materials Transfer Agreement template, etc.)

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

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

The following additional guidance applies to all applicants:

Application budgets must reflect the actual needs and scale of the proposed activities. Budget requests must not exceed $3.1M in total costs per year. However, this level would be expected only for a large, comprehensive banking operation that would also compete for the restricted funds for ETCTN banking operation (see below). Significantly lower budget requests are expected for smaller banking operations, and those not competing for the restricted finds for ETCTN banking.

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.

A Budget for early stage feasibility analysis of the requested specimens and of the minimal specimen-associated data by the NCTN Group Statistical and Data Center statistician could be proposed.

A Budget for local bank IT system and for IT connection to the NCTN Biospecimen IT Navigator could be requested.

In addition, applicants must budget funds for at least 3 NCTN Bank members (but no more than 4) from their group to attend the NCTN Group Banking Committee face-to-face meetings twice each year. Applicants should assume that the meetings will alternate among the various participants banking sites. Travel budget for attending such face-to-face meetings should not exceed $16K/year per banking award.

Special guidance for applicants competing for the restricted funds for ETCTN operation.

Applicants competing for the restricted funds for ETCTN operation must include under Other Expenses category a line item: ETCTN Restricted Funds in the amount of $500,000/year direct cost.

In Budget Justification, these applicants should outline their anticipated (modest) infrastructure costs for the ETCTN banking with the breakdown of the main budget categories. As guidance, the sum of the reasonable infrastructure expenses is estimated to be approximately $70,000/year (in direct costs). In Budget Justification, applicants competing for ETCTN Restricted Funds should also provide estimated unit costs for different specimen types listed in sub-section E. Costs planned for ETCTN banking may include expenses related to: receiving, processing, and storing biospecimens and biomolecules (DNA, RNA) from cancer patients treated on ETCTN Phase I-II trials; and to distribute such specimens to participating investigators of the NCI ETCTN.

Applicants competing for the restricted funds for ETCTN banking operation must plan, however, that the actual dollar amounts to be released each year (on the top of modest infrastructure costs) will depend on the number of biospecimens received by the bank from the ETCTN. The restricted funds will be released in full (i.e., the entire $500,000/year direct cost) only when ETCTN becomes fully operational (which is expected to happen no sooner than in year 2 of the Project Period for NCTN Bank award).

Funds for ETCTN banking may be planned for: receiving, processing and storing biospecimens and biomolecules (DNA, RNA) from cancer patients treated on ETCTN Phase I-II trials; and to distribute such specimens to participating members of the NCI ETCTN.

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

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 aspects of the FOA: collection/processing, storage and distribution of biospecimens; biospecimen bank harmonization; access to specimens by researchers through implementation of Biospecimen IT Navigator and NCTN Biospecimen "front door" services; and banking for ETCTN.

Research Strategy: Research Strategy must have the following sub-sections:

A. Bank Overview;

B. Leadership Structure and Interactions;

C. Bank Operations;

D. Data Management and Informatics; and

E: Biospecimen Banking for ETCTN Clinical Trials.

Specific guidelines and requirements for these Sub-sections to be included in Research Plan are described below.

A: Bank Overview

• Provide a brief background for your bank.
• Characterize the capabilities of your bank in terms of the current and possible future scale of operation.
• Summarize the productivity and specific contributions of the bank in the last five years.
• Highlight the main accomplishments and scientific impact that resulted from specimen use.
• Describe organizational structure proposed for the NCTN bank and its relationship to the NCTN group structure (include organizational chart, define lines of authority and individual responsibilities); interactions between NCTN Banks 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".

B: Leadership Structure and Interactions

Describe the responsibilities of the Bank leadership and personnel interactions with the NCTN Group (with which the Bank is affiliated) and with other Banks. This description should address:

• The accomplishments of the proposed PD(s)/PI(s) and the extent of their hands-on leadership experience in clinical trial banking.
• Roles of all key personnel (must appropriately match their effort commitment) and planned mutual interactions within the Bank, among the Banks and with the Group Coordinating and Statistical Centers.
• The strengths that the applicant's team would bring to collaborative network activities such as updating NCTN bank 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, developing new strategies, as needed to ensure that the resource remains responsive to researcher’s needs.
• Your vision on how your bank operation might be improved and how the activities of your bank(s) will harmonize with the other NCTN Banks.

C: Bank Operations

This sub-section should address all essential aspects of bank operations, including Quality Control 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 NCTN Banks (biospecimens include but are not limited to FFPE blocks, histological slides from diagnostic biopsies and surgical resections, fresh frozen specimens, serum, plasma, whole blood, white blood cells, bone marrow, urine, skin, and sputum/buccal samples per trial protocol);
• Processing and storing biospecimens at the NCTN bank (including conducting pathology reviews and providing histology services, preparing nucleic acid extracts from specimens);
• Conducting quality assurance/quality control (QA/QC) of the biospecimens before distributing them to investigators;
• Distributing biospecimens to investigators;
• The services that your bank intends to provide and how those services will address the needs of the scientific community and current investigator access to your bank's human specimens for cancer research, including the number and types of specimens with associated histopathologic, demographic and clinical data that could be made available; and
• The ways of handling legal and ethical aspects related human biospecimens.

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.

D: Data Management and Informatics

This sub-section should address not only the local IT solutions but also plans for integration with NCTN Banks Shared Services. Specific items to be covered include but are not limited to:

• The bank’s current local IT system that tracks bank specimens, associated data, and investigator requests;
• A plan to integrate the bank IT system with the Shared NCTN IT Navigator system;
• Bank assessment of the investigators specimen requests for feasibility to use banked legacy specimens for research;
• Statistical Center assessment of the investigators specimen requests for feasibility to use banked legacy specimens for research;
• Assessment of the investigators specimen requests for feasibility to use banked legacy specimens for research;
• Use of harmonized NCTN Biospecimen IT-Navigator and Informatics tracking systems to support a common database to connect multiple NCTN banks, 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);
• Plans to catalogue and retrieve legacy specimens and specimen-associated data; and
• Plans for interactions between the NCTN Bank local biospecimen access coordinator with the centralized NCTN Biospecimen "front door" staff to ensure optimal access to annotated legacy clinical trial specimens by the research community.

E: Biospecimen Banking for ETCTN Clinical Trials

In addition to the NCTN banking operation, applicants with appropriate capabilities should propose to establish banking activities for the NCI ETCTN. The plans for this operation must address two main aspects:

• Receiving, processing and storing fresh frozen biospecimens and biomolecules (DNA, RNA) from cancer patients participating in ETCTN clinical trials; and
• Distributing such specimens to the NCI ETCTN investigators.

Note for applicants, who feel that their Bank has insufficient capabilities to fulfill the additional ETCTN Banking requirements and needs: Even if you believe that your Bank may not be able to take up additional responsibilities of ETCTN banking, please use this section to summarize briefly the areas in which your capabilities might be sufficient as well as the areas they might be inadequate for the ETCTN banking operation.

Applicant plans must ensure that this operation will be functional at the beginning of the first year of the project period. At the full operation, the ETCTN clinical trials are expected to have approximately 2000 patients per year, with multiple types of specimens collected from each patient. Note, however, that ETCTN clinical trials will reach this scale no sooner than in year 2 of the Project Period for NCTN Bank award. The initial scale of banking for the ETCTN and the number of biospecimens to be handled are expected to be considerably smaller.

Applicants should plan for the following banking parameters and requirements for ETCTN specimens (and indicate if any of these requirements cannot be met):

• Types of specimen to be collected: biopsy tissue, blood, plasma, serum, circulating DNA, CT-DNA (circulating tumor), CG-DNA (circulating germline), micro RNA, exosomal RNA, CTCs, buccal swabs, buffy coat;
• Specimen processing capability required: DNA, RNA, tumor sections/slides for path review or FISH, IHC, etc.;
• Follow standard frozen specimen preparation (SOPs will be provided by CDP & CTEP);
• Multiple specimen samplings: for example, up to three consecutive biopsies per patient need to be anticipated;
• Specimens to be received: throughout the year, concurrent with early clinical trial operations
• Specimens will be collected at grant and contract sites in NCI s ETCTN;
• Specimen storage requirements: as per CDP guidelines (e.g. liquid nitrogen, -80 C, -20 C freezers);
• Specimen QA/QC: currently planned to be done at the ETCTN specimen collection sites (not by the bank);
• Requests for specimens will come to the CTEP ECTN Program Director and be reviewed by the NCI Biomarker Review Committee (not by the bank);
• Specimen tracking requirements: will be determined pending evaluation of NCTN Biospecimen IT Navigator;
• Distribution requirements: to be sent to reference labs for CTEP/NCI approved biomarker/assays;
• Need for billing by the bank, if any, will be determined later.

Note: Plans for banking ETCTN specimens must be based on understanding that these specimens will be restricted to participating members of the NCI ETCTN and would not be used or distributed without written consent and agreement of the Program Directors of the ETCTN and its constituencies.

Letters of Support: In addition to standard instructions, the leadership of each NCTN Group should provide a letter to the proposed contact PD(s)/PI(s) confirming that the proposed NCTN Bank is affiliated with a specific 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

This initiative is not subject to intergovernmental review.

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.

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 Applying Electronically.

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 by the Center for Scientific Review and responsiveness by the NCI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The emphasis of this FOA is on building an integrated NCTN Biospecimen Banking Resource that will serve NCTN Groups. Therefore, the proposed NCTN Banks must be able to collaborate with each other and with affiliated NCTN Groups. The individual NCTN Banks and the entire Resource are expected to ensure that biospecimens from patients participating in the NCI-supported cancer clinical trials are made available to interested, qualified members of the scientific community to facilitate innovative, clinically relevant cancer research, consistent with achieving the goals of the program.

Although all applicants are encouraged to compete for the restricted funds for ETCTN banking, the priority is on the NCTN banking operation. Accordingly, applicants without the capabilities needed for the ETCTN operation will not be penalized.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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' Bank to cancer research? How strong is the evidence from published studies that specimens from this bank 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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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 in pathology and hands-on leadership experience in biospecimen banking operation of the PD(s/PI(s)?

Are the qualifications of the Bank leader(s) and key personnel well suited to lead and operate a large-scale biobanking 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 five years, how competent is the PD/PI (or PDs/PIs) in overseeing/directing biospecimen banking operation for large-scale clinical trials?

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: 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 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? 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?

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 children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Bank Overview: How capable are the bank and the applicant team to support without interruption the transition from Cooperative Group structure to NCTN structure for clinical trials? How appropriate are the plans for realigning with the reorganized system of NCI-supported clinical trials? How well can the Bank and its organizational structure support the banking needs of the affiliated NCTN Group?

Leadership Structure and Interactions: How committed is the leadership to optimizing the Bank functioning, including strong leadership interactions and oversight of NCTN banking operation, monitoring progress, developing new strategies, and ensuring that the resource remains responsive to researcher s needs? Based on endorsement letters by the leadership of the NCTN Group, what is the likelihood that the Bank leadership and NCTN Group leadership will have efficient collaborative arrangements? Are the interactive structures and lines of communications between the PD/PI (or PDs/PIs) of the Bank and the NCTN Group clearly defined and appropriate? How strong is the vision of the Bank leadership to improve and harmonize banking operation with the other NCTN Banks?

Bank Operations: How capable and efficient is the banking operation in procuring, storing, and distributing different types of biospecimens including FFPE blocks, histological slides, fresh-frozen tissues? 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? How well thought out are the applicant's plans to address the needs of the scientific community and facilitate investigators' access to biospecimens and related clinical data (including specimen annotation)? 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 are the plans to integrate the bank IT system with the Shared NCTN IT Navigator system? Are these plans reasonable, in terms of functioning of all the NCTN Banks 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 Statistical Center assessment and response to provide legacy specimen access to investigators (NCTN and non-NCTN)? Are there appropriate plans for interactions between the centralized NCI NCTN Biospecimen "front door" staff and the investigator to ensure access to annotated legacy trial specimens by the research community?

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?

Banking for ETCTN

(Relevant only to applicants competing for restricted funds for ETCTN banking operation): Does the Bank have sufficient capabilities (beyond the needs of NCTN banking) to additionally establish banking operations for the ETCTN early clinical trials? Is the bank fully capable of, and prepared to, receive, process, and store the full range of expected biospecimen types (fresh frozen biospecimens and biomolecules such as DNA and RNA) from cancer patients participating in ETCTN clinical trials? How comprehensive are the Bank's plans to cover all the specimen types to be collected from ETCTN?

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 six 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 six 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 Children

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 children 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

Not Applicable

Revisions

Not Applicable

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) Genome Wide Association Studies (GWAS)

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.

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 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.

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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.

Throughout these Terms and Conditions of Award, the term NCTN Banks refers to all individual NCTN bank awardees participating together in the NCTN Banking Resource. The individual NCTN Bank (each individual NCTN bank awardee) comprises the organizational structure which is composed of the awardees institution/foundation(s), PDs/PIs and other key personnel, all of whom agree to collaborate on research goals of the NCTN Banking Resource.

The NCTN Banks must meet the requirements of the Federal Human Subjects Regulations 45CFR46 (i.e., the Common Rule; http://grants.nih.gov/grants/oprr/humansubjects/45cfr46.htm). Federal requirements to protect human subjects apply to a much broader range of research than many investigators realize, including research that uses biospecimens (e.g., cells, blood, urine, and saliva), residual diagnostic biospecimens, and medical information. Information on Office for Human Research Protections (OHRP) Policy on Coded Specimens and Data can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf.

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

Awardees will be required to work separately and jointly towards the overall NCTN Banking Resource goals.

The NCTN Bank PDs/PIs and Bank awardees will have the following main responsibilities:

• Overseeing the operations of the NCTN Banks, Informatics and NCTN Biospecimen IT-Navigator Systems, NCTN Biospecimen front door service activities, and coordination with the 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 grant regulations) policies and recommendations developed by the NCTN Group Banking Steering Committee (in areas such as defining best practices or operating policies, marketing the NCTN banks, education of research community, access procedures, fiscal arrangements such as setting charges for the use of bank specimens, and quality assurance measures for all aspects of the operation of the NCTN banks). The PDs/PIs must also assure 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.
• 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.
• Bank 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 Banks.
• Awardees will be expected to establish a common public network bank portal (website) that will provide information on NCTN biospecimens with minimal clinical data annotation to research community is required.
• Bank Awardees must agree to provide information about their biospecimen (inventory) and data collections to the NCTN Biospecimen IT 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 and the Office for Human Research Protections (OHRP) website (http://www.hhs.gov/ohrp/)

All the NCTN Banks will be expected to comply, as much as possible, with the NCI Best Practices for Biospecimen Resources Guidelines (http://biospecimens.cancer.gov/practices/.

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 Coordinator(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).

NCI staff members who are substantially involved in the program activities will not attend peer review meetings of renewal and/or supplemental applications. If such participation is essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

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. Some Program Officials may also have substantial programmatic involvement (as Project Scientists/Coordinators). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver as stated above.

Substantially involved NCI staff members will prepare and provide to the NCI Board of Scientific Advisors (BSA) special review committee an annual report on NCTN biospecimen access activity.

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

• Serving as a liaison between the NCTN Bank awardees and the NCI;
• Interacting with the members of the NCTN Group Banking 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 Banking 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 Group Banking Committee will develop policies.
• Attending NCTN GBC meetings.
• Monitoring progress and performance of the key components of the NCTN Banks Program including the NCTN Biospecimen IT-Navigator system.
• Evaluating the performance of individual NCTN Banks based on handling specimen requests and specimen distribution to investigators.

The NCI will also establish and operate a centralized "front door" service that will coordinate the entire biospecimen access process to facilitate access by investigators to the NCTN bank specimens or to other suitable specimen resources. The coordinator for this service will log and track biospecimen requests; communicate with NCTN banks and Statistical Centers on feasibility of each request, and keep a record of time for each step of the access process; and send completed applications to the NCI correlative science review/CTEP committee. The NCI substantially involved staff members with monitor the performance of this central "front-door" biospecimen access service.

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 adjust funding, withhold support, suspend, terminate, or curtail an individual NCTN biospecimen banking award in the event of unacceptable performance or a failure to comply with the Terms and Conditions of Award.

Areas of Joint Responsibility include:

NCTN Group Banking Steering Committee will serve as the governing and coordinating body for the NCTN Banking Resource. The Steering Committee will consist of the following voting members:

• One PD/PI from each NCTN Bank;
• Three representatives from each NCTN Group, all of whom will collectively have one vote as a group; and
• Three NCI representatives, all of whom will collectively have one vote as a group.

NCTN Group Banking Committee will select one of the awardee representatives as its chairperson (NCI staff members cannot serve in this role).

The NCI representatives will include the NCI Project Coordinator and other NCI Program staff members as needed. Each participating organization has one vote on the NCTN Group Banking Committee.

Subcommittees may be established by the NCTN Group Banking Steering Committee as deemed appropriate and the NCI participants may serve on any subcommittee.

Other NCI staff members may be asked to attend the Committee meetings as non-voting members or attendees, if their expertise is needed.

The Chair of the NCTN Group Banking Committee (who cannot be NCI staff) will be responsible for developing agendas, ensuring progress, facilitating cooperation among participants, and chairing meetings.

As the NCTN Banking governing board, NCTN Group Banking Steering Committee will be primarily responsible for developing policies and recommendations to coordinate and harmonize the efforts of the individual participating NCTN Banks. The Steering Committee will also establish appropriate timetables and/or milestones for the implementation of these policies. These policies are expected to include (but will not be limited to) the following areas:

• Coordination of NCTN banking activities;
• Best practices for collection and storage of specimens;
• Common data structures for banking; and specimen annotation
• Adapting emerging technologies for the needs of the NCTN Banks.

The NCTN Group Banking Steering Committee will also establish a uniform format to be used by all the NCTN Banks for reporting their activities (including the format of the annual progress report).

The NCTN Group Banking Steering Committee will have monthly teleconference calls and meet twice a year in a face-to-face meeting at banking sites.

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 arbitration. A Dispute Resolution Panel will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's rights in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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
Aniruddha Ganguly, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5905
Email: gangulya@mail.nih.gov

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

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6300
Email: Woodwars@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.