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

Cooperative Human Tissue Network (CHTN) (UM1 Clinical Trial Not Allowed)

Activity Code

UM1 Research Project with Complex Structure Cooperative Agreement

Announcement Type

Reissue of RFA-CA-13-007

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-CA-18-025

Companion Funding Opportunity

None

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. Section III. 3. Additional Information on Eligibility.

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

 93.393, 99.394, 93.396

Funding Opportunity Purpose

 The purpose of this Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), is to support the Cooperative Human Tissue Network (CHTN). The goal for CHTN is to collect and distribute to investigators high quality human tissue specimens to facilitate basic and early translational cancer research. For example, such specimens may be needed for scientific discovery and the development of various molecular diagnostic tests, prognostic or predictive assays. The CHTN is designed as a unique biospecimen resource in that it is based on prospective collection and distribution of samples upon specific investigators' requests. Samples to be collected from patients include pre-cancerous, cancerous, and benign neoplastic tissues, as well as specimens corresponding to non-neoplastic diseases and uninvolved tissues.

This FOA solicits applications for CHTN awards from institutions/teams capable of contributing to the mission of CHTN by: (1) providing prospective investigator-defined procurement of high-quality malignant, benign, diseased, and uninvolved (normal adjacent) tissues and fluids from patients throughout North America and elsewhere; (2) assisting individual investigators with regard to specific specimen needs of their research; (3) assisting in developing and disseminating knowledge on high quality practices for successfully operating a biospecimen repository; and (4) educating the community about the importance of the availability of high quality human tissue specimens for medical research. Depending on their intentions and capabilities, applicants must indicate whether they propose to function as the CHTN adult biospecimen division or the pediatric specimen division. Nonetheless, it will be acceptable for an adult biospecimen division, if capable, to contribute pediatric samples for networked requests.

Key Dates

 

Posted Date

June 22, 2018

Open Date (Earliest Submission Date)

July 28, 2018

Letter of Intent Due Date(s)

July 28, 2018

Application Due Date(s)

August 28, 2018, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this FOA.

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

October-November 2018

Advisory Council Review

January 2019

Earliest Start Date

April 1, 2019

Expiration Date

August 29, 2018

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 of this Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), is to support the Cooperative Human Tissue Network (CHTN, https://www.chtn.org/). The CHTN is designed as a unique biospecimen resource in that it is based on prospective collection and distribution of samples upon specific investigators' requests. Samples to be collected from patients include pre-cancerous, cancerous, and benign neoplastic tissues, as well as specimens corresponding to non-neoplastic diseases and uninvolved tissues.

    All individual CHTN awardees (referred to as "CHTN Divisions") collectively will form the CHTN as a national resource network.

    The purpose of the CHTN as a resource is to collect and distribute high quality benign, pre-cancerous, and cancerous, as well as normal human tissue specimens, for basic and early translational studies (as well as assay development) in order to accelerate the advancement of discoveries in cancer diagnosis and treatment. In addition, research on basic biological mechanisms and on other types of human diseases has been supported. The Network was established to facilitate research by providing human tissue specimens to the scientific community. The objective of this Funding Opportunity Announcement (FOA) is to continue the support for CHTN to ensure that biospecimens critical to progress in cancer research are available to the scientific community.

    Presently, the organizational structure of the Network comprises six "Divisions" (i.e., six individual CHTN awardees), that include five adult biospecimen Divisions and one pediatric biospecimen Division. The continuation of CHTN will maintain these two types of Divisions.

    Applicants are expected and encouraged to apply for that type of CHTN Division that matches their capabilities. However, applicants proposing to predominantly procure adult specimens can also contribute pediatric samples for networked requests.

    Note: It is expected that some institutions that have already been part of the CHTN program will apply again for CHTN membership. However, prior association with this program is NOT required. All institutions with appropriate capabilities are encouraged to apply for these awards. Irrespective of prior participation in the program, all applications submitted in response to this FOA will be considered "new" applications.

    Key Terms for this FOA:

    Primary Institution: Institution application-submitting institution with which the Program Director/Principal Investigator (PD/PI) or multiple PDs/PIs (if that option is used) is/are affiliated.

    Remote/Satellite Sites: Other Institutions subcontracted by the Primary Institution to increase the procurement capability of the Division.

    Division: The Primary Institution together with its subcontracted remote sites.

    Biospecimen: Any individual portion or aliquot of tissue or biofluid distributed is considered a specimen, and include among others, fragments of fresh or fixed tissues, blocks, slides, recuts, etc.

    Geographical area: Group of states that are assigned to each adult Division. Investigators from a given area must first contact the corresponding Division for sample requests.

    BACKGROUND

    The CHTN was established to address the increasing demand by the scientific community for access to high quality human tissue specimens (biospecimens) for cancer research. Often, researchers are unable to establish the necessary clinical collaborations for access to the biospecimens they need. This network of tissue collection laboratories was established to make high quality human specimens available to the general scientific community for basic and early translational cancer research, as well as assay development.

    The CHTN currently consists of a network of six institutions, each of which is referred to as a CHTN "Division." The Network provides prospective investigator-defined procurement of pre-cancerous, cancerous, benign neoplastic, non-neoplastic samples, as well as uninvolved tissues and fluids to researchers throughout North America and elsewhere. Samples are de-identified but annotated with patient basic demographics including gender, age, and race. The pathology report is included. The Divisional PDs/PIs should be actively involved in the practice of anatomic pathology, provide quality control assessments of each sample, and be responsible for proper histopathological characterization.

    The CHTN provides tissues for investigators using several methods of specimen preparation including snap frozen, fresh, formalin-fixed paraffin embedded (FFPE) and/or stained and unstained slides. The CHTN also produces tissue microarrays (TMAs) representing multiple tissue types. The CHTN also provides macro-dissection and nucleic acid isolation services. The CHTN does not generally serve as a tissue bank, but it does store limited numbers of specialized tumor types, such as rare pediatric and adult tumors (gliomas, sarcomas, etc.), to ensure their availability in the future.

    Currently, five Divisions of the CHTN provide specimens from adults and each is assigned a geographic area of the United States (U.S.) from which researchers' requests are received. A sixth Division, the Pediatric Division, receives requests for pediatric specimens from across the U.S. In order to serve investigators as rapidly as possible, biospecimen requests that cannot be filled within a few weeks by the assigned division are "networked" to all Divisions.

    Systems have been developed to facilitate efficient communication among Divisions and to share investigators' requests and determine biospecimen availability. The CHTN Informatics System (IT) has two components:

    • The Donor IT system, which is used mainly for the specimen procurement workflow, includes the data about the biospecimens that are collected at each individual Division. This information is protected by the Health Insurance Portability and Accountability Act (HIPAA) and is stored locally by the individual Divisions. Each Division uses their own individual Donor System.
    • The Investigators' IT system is used for data about the investigator and his/her tissue requests. The data is not confidential and is stored in a centralized database system for this purpose. This component is shared by all CHTN Divisions.

    Since 1987, the CHTN has become a vital resource for the research community. The CHTN continues to have a significant scientific impact at several levels: more than 40,000 specimens are provided per year. Since its inception, the CHTN has distributed over 1,180,000 specimens. Currently, the CHTN serves over 400 individual researchers per year, supporting multiple requests and projects for many of them. The majority of CHTN users are grantees from academic institutions, with government funded grant, most of them R01 grants. About 20% of CHTN users are scientists affiliated with the biomedical industry.

    The continuation of the Network is expected to facilitate basic cancer research discovery, early translation, as well as the development and application of new technologies to clinical specimens.

    OBJECTIVES and SCOPE

    This FOA requests applications for cooperative agreements for the CHTN either for "Adult Biospecimen Division" or "Pediatric Biospecimen Division." Regardless of which type of Division is proposed, all applicants responding to this FOA must have appropriate capabilities to serve the CHTN objectives outlined below.

    The major focus of the entire Network is to collect and distribute high quality human biospecimens for basic "discovery" research, early translation research and molecular assay development.

    The NCI anticipates that CHTN will comprise up to six CHTN Divisions, each supported by a separate UM1 award. CHTN awardees will be part of a network to prospectively collect and distribute high quality tissue specimens to investigators throughout North America and elsewhere. The Network will be expected to provide sufficiently large numbers of tumor specimens from a wide variety of cancers. The CHTN network should also have access to biospecimens of rare tumor types and provide researchers with such specimens as needed. Pre-cancerous, cancerous, benign neoplastic, non-neoplastic diseases as well as uninvolved tissues will be collected and prepared to meet researcher requests. Tissues and fluids will be procured. Biopecimens will be excess materials collected during the course of routine medical care or at autopsy.

    Even though applicants proposing an Adult Biospecimen Division must be predominantly focused on procuring adult specimens, they may also contribute pediatric samples for networked requests, if they have (or expect having) access to such biospecimens

    Main Required Capabilities/Attributes

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

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

    • The leadership [including the designated Program Director/Principal Investigator (PD/PI)] with appropriate qualifications and current expertise in biospecimen collection, as needed to ensure meeting the goals of the CHTN.
    • Appropriate arrangements with partnering institutions to ensure the availability of suitable biospecimens for patient diagnosis and quality control of research specimens. Each Division is expected to collect samples from their affiliated local Institution(s). However, applicant's affiliated Institutions are expected to engage collection of specimens from geographically wide areas beyond the state of the primary Institution. In addition of samples obtained at the primary Institution, applicants must foresee sub-contractual arrangements with remote site hospitals, at least some outside the primary institution's state, for sample procurement. These arrangements with appropriate satellite sites (hospitals) should contribute to the procurement of a wide range of samples (including the types indicated above) and help to achieve a representation of the entire US population in the sample collection.
    • Adequate infrastructure to collect and distribute specimens, including both frozen and FFPE. Given the current state of operations of the CHTN (over 40,000 samples distributed per year), it is expected that each Division will provide its fair share of the total (at least 6,000 samples/year/Division or more.)
    • Ability to collect matched blood/tumor or other matched normal tissue/tumor specimens.
    • Ability to procure a wide range of samples, including: a) various tumor types, such as common cancers (lung, breast, ovary, colon, prostate, etc.); b) less frequent tumors (central nervous system, soft tissue sarcomas, head and neck tumors, endocrine tumors, etc.); c) normal, pre-malignant, malignant or matched uninvolved tissue samples; d) matched blood/normal or tumor samples; e) fluids such as plasma, serum, sputum, urine, etc.; f) nucleic acid extractions; g) specific samples that are difficult to procure for research purposes, such as bone marrow (normal, diseased), melanoma, others.
    • The ability to fulfill highly customized requests such as: a) fresh tissues prepared in requestor-specified media, including standard and customized media, requestor-defined use (or no use) of antibiotics etc.; b) touch preparations (slides); c) fluids processed at -20 °C, -80 °C, ambient temperature, ice pack, liquid Nitrogen/Vapor Phase, etc.
    • Appropriate informatics technology (IT) systems. Each applicant institution has to have an operating IT system that handles and tracks the following local data: availability of biospecimens, donor consent, HIPAA authorization, donor code, site where biospecimen was collected, donor demographics, biospecimen diagnosis (organ, diagnosis, modifiers of diagnosis), other biospecimen information such as amount, processing (e.g. paraffin block, frozen, etc), pathology report information, biospecimen quality control information, collection and processing times, storage sites for each biospecimen; investigators' information such as affiliation (academic institution, industry, government, other), funding mechanism (grant, other), etc.
    • Reliable Quality Management System for collecting, processing, storing, and shipping tissue and fluid biospecimens. All collection sites/Laboratories should be College of American Pathology (CAP) accredited. CAP accreditation for the biorepository/biobank is not mandatory.
    • Knowledge of and procedures regarding human subjects policy issues, in general, and in the applicant Institution related to the use of human biospecimens for research purposes, including assurances of appropriate informed consent as necessary.
    • Although the Network is not intended generally to function as a tumor bank, each proposed Division should have an ability to store biospecimens pending the completion of shipments. Likewise, it may need to bank rare tumors that would not otherwise be available (e.g., gliomas, sarcomas, pediatric tumors, etc.). Biospecimens corresponding to pre-malignant lesions, when available, can also be stored for future distribution. Most data routinely provided with the biospecimens is limited to histopathologic and demographic information, such as that related to diagnosis, sex, age, race, and pathology report.

    Individual CHTN Division awardees must be able to meet the requirements of the Federal Human Subjects Regulations 45CFR46 (i.e., the Common Rule; http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html ). Federal requirements to protect human subjects apply to a broader range of research, including research that uses biospecimens, residual diagnostic biospecimens, and medical information (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/biological-materials-and-data/index.html).

    In addition to the required aspects, the following (optional but encouraged) capabilities may be viewed as advantageous in terms of programmatic priorities:

    • It is expected that most biospecimens will be accompanied by basic annotations such as those included in the Pathology Report (age, gender, histological diagnosis). However, applicants are encouraged to develop capabilities for the collection of expanded sets of clinical data and do such collection, whenever feasible. An established broad Consent for all patients at the Institution for research to be conducted in remnant specimens facilitates this process.
    • The availability (at the applicants' institution) of collections of retrospective material, both FFPE and frozen, that can supplement/complement requests in the future, and therefore, expedite them, especially for rare or difficult to obtain samples (examples: gliomas, sarcomas, pediatric tumors, bone marrow, etc.); and
    • Expertise and technical capabilities to provide additional processing of biospecimens (e.g., DNA/RNA preparations, tissue microarrays, or macrodissections) that may be of importance to investigators seeking to use the resource.

    Trans-Network Interactions

    Given the diverse and variable needs of basic discovery and early translational research, it is expected that the proportion of highly customized and/or non-standard requests for biospecimen collection will increase. To meet these needs, it is essential to maximize the efficiency and capabilities of the entire CHTN operating as a network.

    Although separate awards will be made for each CHTN Division, awardees will be required to work collaboratively with other CHTN Divisions. Requests for biospecimens will be networked by Divisions so that they can be fulfilled more rapidly.

    Members of the Network (i.e., CHTN Divisions) will be expected to collaboratively establish and implement appropriate procedures to collect, process, and handle biospecimens to assure that they are of high quality and suitable for a wide variety of studies and technologies.

    Individual Divisions will be expected to provide some additional services matching their unique capabilities (for example, special types of biospecimen processing, which may include DNA/RNA preparations, tissue microarrays, or macrodissections).

    IT Coordinator. Although each Division may have their own Informatics module system for biospecimen collection, all Divisions need to use a common Informatics system for tracking the CHTN applications, requests, and distribution of specimens, as well as reports to NCI. Therefore, the CHTN program will support a dedicated, trans-network IT Coordinator. This IT Coordinator will be based at one of the CHTN Divisions but will be responsible for trans-network IT needs and priorities as determined by CHTN Coordinating Committee.

    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

    New
    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    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

     NIH intends to fund up to six awards, corresponding to a total of $5.8 million in total costs for fiscal year 2019. Future year amounts will depend on annual appropriations.

    Award Budget

     Budget requests must not exceed $800,000 in direct costs per year. However, all application budgets must reflect the actual needs of the proposed Division. It is expected that maximal allowable budget will be requested only when justified by particularly broad scope of activities whereas other applications will have smaller budget requests.

    Award Project Period

     All applicants must request a project period of 5 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

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • U.S. Territory or Possession
    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) (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.

    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.

     Any individual designated as the PD/PI for the proposed CHTN Division must be a board-certified anatomical and/or surgical pathologist, who is actively involved in the operation of a pathology laboratory that has demonstrated access to human cancer tissues.

    Applicants are encouraged to consider designating a single PD/PI located at the application-submitting institution (i.e., Primary Institution). If multiple PDs/PIs are designated, all of them must be affiliated with the application-submitting institution.

    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

    Applicant organization (normally identified by having a unique DUNS number or NIH IPF number) may submit only one application.

    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

    Buttons to access the online ASSIST system or to download application forms 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.

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

    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 to:

    Rodrigo F. Chuaqui, MD

    Telephone: 240-276-5910

    Fax: 240-276-7889

    Email: chuaquir@mail.nih.gov

    Page Limitations

    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 for the Research Strategy subsections listed below:

    A. Overview of the Proposed CHTN Division (12 pages)

    B. Leadership and Administration (6 pages)

    C. CHTN Operations and Quality Management (12 pages)

    D. Data Management and Informatics (6 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. Face Page

    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.

    Facilities and Other Resources:

    In addition to Application Guide instructions, document the team capabilities as well as the facilities /resources available for sample procurement, processing, storing and distribution, including associated data handling. To address these aspects, provide:

    • Appropriate detailed summary tables, lists, and other relevant specific information documenting team capabilities and accomplishments in biospecimen collection; and
    • Data documenting informatics capabilities;

    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). These additional materials must not exceed 20 pages.

    Attachment 1: Specimen-related Data [use filename "Specimens"].

    Provide numerical data summarizing information related to specimens over the last 5 years:

    • Samples that are collected and/or distributed in the biorepository;
    • Samples by disease (normal, benign, malignant, normal matched with tumor);
    • Samples by preparation (frozen tissue vs. FFPE);
    • Samples by organ, tumor types the repository has access to; and
    • Types of samples (tissue, fluids, other), etc.

    Attachment 2: Patient-related Data [use filename "Patients"].

    At a minimum, include the following data related to patients from which specimens were collected over the last 5 years:

    • Number of patients from whom samples are collected;
    • Patients by gender;
    • Patients by age; and
    • Patients by race/ethnicity.

    Attachment 3: Relevant SOPs [use filename "SOPs"].

    List all SOPs in place for tissue acquisition, various processing/preservation methods and storage. Attach full SOPs for the critical aspects of:

    • Sample collection;
    • Sample processing;
    • Sample distribution, etc.

    Attachment 4: IRB and Informed Consent Documents [use filename "Human Subjects"].

    Include current documents such as:

    • Documents related to local IRB rules; and
    • Blank/Sample Informed Consent forms.

    Attachment 5: Data on research projects aided by specimens distributed [use filename "Projects Served"].

    Provide summary documentation (tables and/or graphs) characterizing the research projects for which specimens were collected and distributed. Include, if possible, data on:

    • Sources of funding for these projects (e.g., NIH, NCI, DOD, other);
    • Institutions served by category (academic/for-profit/other);
    • Other relevant information (e.g., data obtained using distributed specimens contributing to successful grant application).
    SF424(R&R) Senior/Key Person Profile

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

    For any individual designated as the PD/PI for the proposed CHTN Division, document that such individual is a board-certified anatomical and/or surgical pathologist, who is actively involved in the operation of a pathology laboratory that has demonstrated access to human cancer tissues.

    OPTIONAL IT COORDINATOR FUNCTION: Applicants, who are interested in providing the trans-network function of CHTN IT Coordinator and have an appropriately qualified candidate for this position, should include such an individual as a Senior/Key person (see additional information under Budget section). Such individuals should describe their expertise including:

    • Substantial experience with Java web and Program development as well as expertise with other key technologies, such as JasperServer / JasperReports;
    • Relevant experience in cloud computing and interactions with providers of cloud-based services; and
    • System administration skills (installing patches, setting up backups, monitoring security, upgrading middleware).
    R&R Budget

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

    PD/PI Effort. An individual designated as PD/PI must commit a minimum of 1.8 person-months effort per year to the UM1 award. The commitment cannot be reduced in later years of the award.

    Personnel Costs. Include appropriate levels of effort for personnel dedicated to Division functional units:

    • Leadership and Administration;
    • CHTN Operations and Quality Management; and
    • Data Management and Informatics.

    Supplies and Capital Equipment. Budget requests may include costs of supplies and other expenses needed for the activities of the proposed Division and its functional units. Such costs may include (but are not limited to) laboratory supplies and consumables, computer hardware, software, development, quality management systems, etc., as needed for sample collection/processing/distribution, data management/informatics and quality management.

    Funds for capital equipment (i.e., equipment with unit cost of $5,000 or more) may also be requested. However, each such request must be supported by a clear and strong justification (e.g., to replace an outdated or malfunctioning equipment that is essential for the Division operation.) Each such request will be considered on a case-by-case basis.

    Travel Funds:

    Funds for travel of two people (e.g., a PD/PI and the Division coordinator) to attend each of the two Coordinating Committee meetings per year should be included as a budget line item. Travel to national meetings to take part in exhibits to publicize the CHTN should be included in Network Shared Expenses. Travel for other purposes may be proposed with appropriate justification. Justified situations include, but are not limited to, travel for Coordinating Committee subcommittee meetings and/or other appropriate meeting travel.

    Network Shared Expenses Fund. All applicants must include in the budget request restricted funds in the amount of 4% of direct cost requested (for each year) for expenses to be shared by all network awardees. Enter these funds in "Other Direct Costs" category under the heading "Network Shared Expense Fund".

    The final decision on the types of activities to be covered by this Shared Expenses Fund will be made by the CHTN Coordinating Committee after the awards are made. Nonetheless, it is expected that this fund will be used to support the key function of the Central Coordinator of the Network. This Central Coordinator will be mainly responsible for:

    • Coordinating teleconferences for all committees and sub-committees of the network, face-to-face meetings, etc.;
    • Various activities related to publicizing the Resource, such as the coordination of CHTN attendance to scientific meetings, social media for educating the scientific community about the CHTN, updates of the CHTN website, etc.; and
    • Other Network-related administrative/coordinating activities as appropriate.

    Other activities to be potentially supported by the Network Shared Expenses Fund may include (but are not limited to):

    • Database development/maintenance;
    • Publication and impact analysis; and
    • Publicizing the Resource activities, such as organization of workshops or presentations by PDs/PIs/Division Coordinators at biobanking meetings to educate the community on the CHTN.

    Note: Applicants may use Budget Justification attachment to list specific types of activities for potential post-award consideration as Shared Expenses by the CHTN Coordinating Committee.

    Budget Justification:

    In addition to standard justifications, provide a breakdown of the requested budget for the specific functional units of the proposed Division:

    • Leadership and Administration;
    • CHTN Operations and Quality Management; and
    • Data Management and Informatics.

    CHTN IT Coordinator Function (Optional). The CHTN will have a central, trans-network dedicated IT expert, serving as CHTN IT Coordinator. That position will be supported by extra funds (on the top of budget requested for the proposed Division. Applicants interested in providing this function, who have an appropriately qualified candidate for this position, should indicate so under Budget Justification. Respective entry under Budget Justification should:

    • State the applicants' willingness to house a CHTN IT Coordinator;
    • Name a specific qualified individual, who should also be included under Senior/Key Persons (see Senior/Key Persons section for the list of expected qualifications for such individual);
    • Estimate additional funds that would be needed (in direct costs) to cover 12 person-months of effort for such person.

    Note: If the proposed Division is selected for CHTN award and the individual named is selected for the function of CHTN IT Coordinator, the Applicant's award will be supplemented by the additional funds for this function.

    Therefore, do NOT include the funds for CHTN IT Coordinator in the budget forms (only mention the anticipated costs under Budget Justification). In addition, note that these funds do NOT count towards the budget cap stated in Section II.

    Consortium Justification:

    Use Consortium Justification attachment to explain the anticipated sub-contractual arrangements, including particularly those with all the partnering healthcare sites that will be involved in biospecimen collection.

    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 the Specific Aims that will illustrate how the proposed Division intends to contribute to the goals of the Network. The Aims should be clearly relevant to securing access to high quality samples (human tissues and fluids) that can be prospectively collected; publicizing the resource to outside investigators and assessing their biospecimen needs; handling the requests for specimens from investigators, collecting these specimens and distributing them to the investigators, etc.

    Research Strategy

    Research Strategy must consist of Sub-Sections A-D as defined below.

    Sub-Section A. Overview of the Proposed CHTN Division.

    In this sub-section, address the following aspects:

    Type of Division. Identify the type of CHTN Division proposed (i.e., Adult Biospecimen Division or Pediatric Biospecimen Division).

    Main Capabilities. Summarize the capabilities and collective experience of the team related to biospecimen procurement in the division type chosen.

    • Applicants representing current awardees of the CHTN: include in this narrative specifically your role and accomplishments under the current award.
    • Applicants previously unaffiliated with the CHTN: describe background, team experience, previous accomplishments regarding tissue procurement and collection. Specifically, the applicants should discuss the experience of the Institution and the participating investigators in activities relevant to biospecimens and biobanking. These include, but are not limited to: procurement, processing, storage, and distribution of biospecimens; Implementation of Quality Control/Quality Assurance Programs; IT and Tracking systems; previous tissue recipients from the institution, efforts to assist/advise investigators, remote sites collaborating in the procurement of samples.
    • All Applicants: Highlight the salient characteristics of tumor and biospecimen types, as well as processing methods that the applicant Institution can provide. (Note that detailed supporting data for this aspect are requested under Other Attachments in Attachment 1).

    Organizational Structure and Effort Integration. Address at a minimum the following elements:

    • Formal organizational structure for your proposed CHTN Division
    • Your vision of how the activities of the proposed Division will integrate with those of other Divisions of the CHTN.
    • Present your assessment of the needs of scientific community and explain how the proposed Division can address such needs

    Sub-Section B. Leadership and Administration

    Avoiding repetition with the Biosketches, describe succinctly the collective expertise and responsibilities of the leadership of the proposed CHTN Division. This description should emphasize:

    • The qualifications and scientific and administrative experience of the PD/PI and other key personnel in the collection, processing, quality control, and distribution of specimens for research.
    • Lines of authority and responsibility, with particular attention to how the organizational structure may relate to the Network's major objectives.
    • Planned mutual interactions of the participating investigators as well as integration of their efforts within the entire Network. Include the strengths that the applicant's group would bring to collaborative network activities such as updating CHTN policies and priorities, improving quality of shared network services, Publicizing the Resource the resource to increase the number of CHTN users, improving informatics systems to manage the resource, monitoring progress, developing new strategies, as needed to ensure that the resource remains responsive to researcher's needs. During the project period, individual CHTN Divisions will have opportunities to contribute to network activities by proposing to the CHTN Coordinating Committee pilot projects addressing relevant issues. The application may outline general directions that might be considered (but do not include any specific pilot projects).

    Sub-Section C. CHTN Operations and Quality Management

    Applicants should outline their strategy for collection of biospecimens, including the proportion of prospective collection vs samples to be stored for future research such as rare samples; etc.

    Describe the procedures for collecting, processing, and distributing specimens (provide an overview, not entire SOPs). Include the efforts to ensure the adherence to the NCI Best Practices for Biospecimen Resources (http://biospecimens.cancer.gov/bestpractices/2011-NCIBestPractices.pdf). At a minimum, all of the following aspects are required and must be addressed:

    • Propose a system to prioritize access to specimens;
    • Describe how requests for specimens will be received and shared with other Network Divisions;
    • Describe procedures to establish and implement individually and Network-wide QMS with adherence to the NCI Best Practices for Biospecimen Resources; and
    • Describe quality control (QC) and quality assurance (QA) approaches/measures that are in place to ensure the quality of the biospecimens. Specifically, explain QC approaches implemented in sample collecting sites that are specific to histological evaluation (confirming diagnosis, assessing the proportion of tumor cells in the specimen, and other relevant aspects.
    • Plans to obtain consent for future research use of specimens collected. Applications submitted in response to this FOA must include plans to obtain consent for future research use of specimens collected during the proposed project period or to sever any link between the specimen to be distributed to the researcher and the identity of the patient.
    • Describe the involvement of patient advocates with the applicant CHTN Division. Explain how their activities will contribute to increasing the public's awareness and understanding of the importance of biospecimens for cancer research as well as of the CHTN itself.

    Note: additional specific documentation relevant to this sub-section is requested in Other Attachments (Attachment 3)

    Sub-Section D. Data Management and Informatics

    Describe your institution's operating IT system that will be used by the proposed Division. Address in particular how the system will handle local data reflecting such aspects as:

    • Availability of biospecimens;
    • Donor consent / HIPAA authorization, donor code;
    • Site where biospecimen was collected;
    • Donor demographics;
    • Biospecimen diagnosis (organ, diagnosis, modifiers of diagnosis);
    • Other relevant biospecimen information for each biospecimen such as

    o  Sample amounts and storage sites;

    o  Pathology report information;

    o  Processing (e.g., FFPE, frozen, etc.);

    o  Collection and processing times;

    o  Biospecimen quality control information;

    Propose potential IT system for the Network. The CHTN Coordinating Committee will choose an IT system for the Network-wide data. Nonetheless, each CHTN applicant should propose the setup and attributes of such system based on their experiences. The description of the aspects listed above must accommodate the rule that Adoption of a common IT system and/or changes to a common system is a prerogative of the CHTN Coordinating Committee.

    Describe your IT system that you propose to be used to handle networked data regarding information about investigators and their requests. Address the ability of the system to track the information (for at least 1 year, within the last 5 years) and provide reports on:

    • Investigators served (including tracking information such as investigator affiliation: academic institution, industry, other), etc.
    • Applications status (fulfilled, being fulfilled, rejected);
    • Samples collected;
    • Samples distributed: the nature of project for which a given specimen will be used, its funding type (grant/contract/other), funding source, etc.
    • Projects/grants that were supported;
    • Clinical cases (patients from whom samples were collected);
    • Sample types categorized by disease status (normal, benign, malignant, normal matched to tumor), by organ, diagnosis, and by other aspects as appropriate;
    • Chart reviews in that period (as part of the initial request, or later after fulfillment of the request).

    NOTE: If appropriate to illustrate the capabilities of the IT system, refer to data in Other Attachments.

    In addition, indicate whether the informatics system can provide updates on the status of fulfillment for active requests, as well as the time to fulfill each request.

    Describe how the system can be potentially used as a common informatics system to manage the resource, monitor the progress, and develop the strategies to ensure that the resource remains responsive to researchers' needs. Highlight any innovation that your system may have regarding collection and tracking of biospecimen data. Describe a plan to integrate the institutions' informatics system into a Network IT system.

    The informatics system should follow conventions that would allow it to be integrated with local (e.g. hospital Electronic Medical Records) and national (e.g., National Cancer Database) systems for the purposes of providing electronic annotation.

    The Informatics system should also use a minimal set of standard data elements with controlled vocabularies. The approach should be based on and extended from existing biospecimen data models registered in the NCI Data Standards Repository (caDSR).

    Letters of Support

    Letters of supports documenting commitment to CHTN must be provided from all partnering healthcare sites that will be involved in biospecimen collection.

    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:

    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 NIH-defined human subjects research, clinical research, and/or 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

    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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 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. 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 optimizing prospective collection and distribution of human cancer and other relevant biospecimens in response to specific investigators' requests. For the optimal functioning of CHTN as a unique resource, it is essential that each proposed CHTN Division must have access to sufficiently large numbers of diverse tumor and normal samples. Also essential is the ability to meet highly individualized and changing requests from cancer researchers. Moreover, the proposed Divisions must have capabilities to ensure rigorous approaches to sample procurement, processing, handling, and documenting

    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 there a strong scientific premise for the project? 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 for this FOA:

    How will the CHTN Division, as proposed, help fulfill the needs of the cancer research community? What is the likelihood that the proposed CHTN Division will significantly facilitate/inspire cancer research by collecting and providing biospecimens that are needed by cancer research community? What is the potential of the proposed CHTN Division to contribute significantly to the goals of the CHTN as a national resource in cancer research?

    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 for this FOA:

    How strong are the credentials and experience of the PD/PI and the applicant group regarding sample procurement and preparation of specimens?

    Are the qualifications, experience, and proposed responsibilities of the PD/PI and other key personnel well suited to organize and maintain the CHTN Division, maintain quality control and equitable access, and manage record keeping?

    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 for this FOA:

    Are any innovative roles anticipated for both the institution's operating IT system to handle CHTN Division data, as well as for the proposed Network-wide data?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed?

    Specific for this FOA:

    How strong are the capabilities of the proposed CHTN Division in terms of collecting biospecimens of major tumor types, as well as matched blood and tumor specimens? Will the proposed Division have collections of retrospective material, both FFPE and frozen that could supplement/complement requests in the future, especially for more difficult-to-obtain samples?

    How sufficient are the proposed administrative infrastructure and approaches to ensure: (i) proper oversight of all operations and management; and (ii) integration with the other participating groups/Divisions?

    How meritorious are the proposed plans for the collection and distribution of specimens? Are these plans realistic and properly addressing the overall goals of the Network? What is the likelihood that the proposed Division will able to contribute a proportional share of samples to maintain or increase the current number specimens distributed by the CHTN yearly as a network?

    How strong are the plans to assure the collection of high quality specimens with associated demographic and histopathologic data?

    How adequate are the plans to assure collection of rare specimens (e.g., gliomas, sarcomas, pediatric tumors, etc.) which might otherwise not be available?

    How well are the plans developed for quality control of specimens and/or services?

    Are the proposed procedures for the protection of human subjects and patient confidentiality appropriate?

    How reasonable and equitable are the proposed procedures for the evaluation of requests for specimens and other services?

    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?  

    Specific for this FOA:

    How advantageous is the applicants' environment in terms of arrangements (consortia) with partnering healthcare sites to facilitate the procurement of a wide range of samples, including tumor, matched uninvolved tissue, and normal samples?

    How adequate are the facilities and equipment in the proposed Division for prospective tissue procurement, as well as retrospective collections of FFPE and frozen material and fluids?

    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 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 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

    Not applicable

    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:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities. The following programmatic factors may be considered in deciding on funding priority:
    • Geographical distribution of awardee institutions across the entire U.S.
    • The applicants' capabilities for the collection of samples with expanded sets of clinical data, including the ability and plans to establish broad Consent for all patients at the awardee Institution for research to be conducted on remnant specimens.
    • The applicants' ability to obtain material from minimally invasive procedures such as liquid biopsy material, including intact circulating tumor cells (CTCs); cell-free circulating tumor DNA (cfDNA; also referred to as circulating tumor DNA, or ctDNA), and tumor-derived exosomes.
    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.

    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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 http://www.hhs.gov/ocr/civilrights/understanding/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 performance of all activities supported by CHTN Division award, including, but not limited to, maintaining access to appropriate cancerous and normal human tissue and fluid specimens and to making such biospecimens available to the research community according to the policies established by the CHTN Coordinating Committee.
    • Committing and maintaining throughout the life of the CHTN Division award a minimum of at 1.8 person-months annual effort.
    • In case the PD/PI of CHTN Division cannot continue serving, the designated replacement PD/PI must also be an experienced anatomic and/or surgical pathologist with access to human tissue specimens.
    • Performing the histological quality assessment of specimens (for diagnosis confirmation, proportion of tumor tissue, etc).
    • Overseeing and resolving the legal, ethical, and human subjects policy issues related to the use of human biospecimens for research purposes in ways consistent with the applicable regulations and the NCI Best Practice Guidelines for Biospecimen Resources (https://biospecimens.cancer.gov/bestpractices/index.asp) and the OHRP website (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/biological-materials-and-data/index.html).
    • CHTN awardees will be expected to provide appropriate guidance to investigators applying to the CHTN regarding the collection and processing of samples they are requesting.
    • Adhering to and implementing the decisions/recommendations of the Coordinating Committee to the extent compatible with applicable grant regulations.
    • Serving as voting members on the CHTN Coordinating Committee;
    • Submitting reports summarizing the individual activities of a given CHTN Division to the Coordinating Committee, according to the formats, frequencies, and time frames to be established by the Committee.

    Awardees retain custody and primary rights to data developed under these awards, subject to government (e.g., NCI, NIH, or PHS) rights of access, consistent with current NIH, PHS, and HHS policies.

    Awardees must agree to provide biospecimens to the scientific community without requiring any collaborative arrangements. The costs of processing and handling, shipping and other appropriate costs may be charged to researchers, in accordance with policies established by the Coordinating Committee and consistent with NIH regulations.

    Individual awardees (and the entire CHTN Network) will be expected to use an Informatics system that maximizes consistency and compatibility with other NCI IT activities and initiatives that follow CBIIT hardware and security requirements (hardware, hosting, IT security, IT compliance and disaster recovery.)

    Awardees must be willing to collaborate with the other CHTN awardees as outlined in this FOA. Such collaborations will include, for example, a network-wide system of requests for samples, i.e., specimens requested from one Division may be referred (networked) to all Division(s) for collection and processing.

    NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:


    The NCI will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

    A designated NCI Program staff member will serve as a Project Scientist. Additionally, an NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  A Program Official may also have substantial programmatic involvement (as a Project Scientist).

    Specific activities of substantially involved NCI staff members will include:

    • Monitoring the operation of the Network and participate in the decisions of the Network by serving as a voting member on the Coordinating Committee;
    • Coordinating and facilitating the complex interactions and information sharing among multiple participating institutions;
    • Assisting the Coordinating Committee in developing operating policies and procedures and assure that those policies are acceptable to the NCI and consistent with NIH policies and federal regulations;
    • Assisting ongoing CHTN harmonization and standardization efforts to adhere to NCI "Best Practices for Biospecimen Resources;"
    • Coordinating the development of a centralized database and the informatics system which can best meet the needs of the individual Network institutions as well as the needs of the CHTN to be consistent with NCI "Best Practices for Biospecimen Resources;"
    • Providing close communication with the NCI Tissue Expediter (https://specimens.cancer.gov/contact/) to ensure referral of requests to the most appropriate resource and identify needs which are not currently being met;
    • Recommending to the Steering Committee ways/steps to improve Network functioning, e.g., in terms of serving new research needs of the scientific community or improving the system of quality control/quality assurance; and
    • Reviewing the operations of individual laboratories for compliance with quality control standards and with operating policies developed by the Coordinating Committee.

    Areas of Joint Responsibility include:

    CHTN Coordinating Committee. To oversee and coordinate the operations of the Network, awardees and involved NCI staff members will jointly establish the CHTN Coordinating Committee. The Coordinating Committee will act as the governing body of the CHTN. General operating policies for the Network will be established by the Coordinating Committee.

    Coordinating Committee Membership. The Coordinating Committee will consist of the following voting members:

    • Two representatives from each CHTN Division (one of whom must be the PD/PI), who will jointly have one vote;
    • One or more NCI Project Scientists (who will have collectively one vote).
    • The chairperson (who must be one of CHTN Division PDs/PIs) will be elected by voting members to serve for one calendar year."

    Additional members (without voting rights) may be added to the committee as needed.

    Coordinating Committee Responsibilities.

    The Coordinating Committee shall:

    • Develop Network operating policies for the implementation by the PDs/PIs at each Division of the Network;
    • Review the operating procedures of the CHTN Divisions to ensure that these procedures are compatible with the overall goals and policies of the Network, the NCI and the NIH; including uniform methods of histopathological diagnosis and appropriate control protocols of tissue quality;
    • Establish uniform standards, policies, and procedures for specimen acquisition, processing, distribution, tracking, and storage;
    • Define equitable policies for distributing specimens
    • Set specimen processing and handling fees which is uniform across the network
    • Establish strategies to publicize the resource;
    • Establish policies to address the legal, ethical, and human subjects issues related to the use of human specimens for research according to the NCI guidelines (https://biospecimens.cancer.gov/bestpractices/2016-NCIBestPractices.pdf) and recommendations by International Society for Biological and Environmental Repositories (ISBER, http://www.isber.org/?page=BPR) .
    • Develop guidelines and standards for informatics and data management required for operation of the Network;
    • Establish procedures for effective communications among awardees;
    • Establish subcommittees as necessary; and
    • Review and recommend for implementation pilot/collaborative studies to be proposed by the Division's PDs/PIs.
    • Assign each Adult Biospecimen CHTN Division to a specific geographic area of the U.S. as an area from which a given Division will handle researchers' requests for biospecimens. (These geographical areas assigned to adult biospecimen divisions should be equitable in terms of expected number of requests).
    • The Coordinating Committee will establish mechanisms to assess the changing specimen needs of the scientific community and make operational changes or modifications of CHTN services as needed to rapidly respond to those needs.

    The Coordinating Committee will meet initially to plan for integration of the awarded CHTN Divisions and to review and accept or modify currently established operating procedures and policies. The Coordinating Committee will meet at least twice a year.

    Subcommittees. The Coordinating Committee may establish subcommittees for specific purposes. The NCI Project Scientist(s) may serve on such subcommittees, as they deem appropriate. It is expected that one such sub-committee will deal with the optimal ways to publicize the Resource (including the use of appropriate tools for resource publicizing that the NCI may contribute). The responsibilities of this subcommittee may involve, among others:

    • Designation of one individual from each division to meet at regularly scheduled Publicizing the Resource committee either by phone or face to face
    • Participation in social media (includes: Twitter, Facebook, LinkedIn, Blogs) for advertising CHTN services to the scientific community.
    • Maintenance of a current website that is updated regularly with an administrator.
    • Development of a metric plan to capture success and for reporting on Publicizing the Resource efforts

    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 Coordinating 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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

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

    Scientific/Research Contact(s)

    Rodrigo F. Chuaqui, MD
    National Cancer Institute (NCI)
    Telephone: 240-276-5910
    Email: chuaquir@mail.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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