Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The purpose of this Notice of Funding Opportunity (NOFO), issued by the National Cancer Institute (NCI), is to invite competing continuation applications for cooperative agreement awards from current recipients of the NCI-supported Cooperative Human Tissue Network (CHTN). All individual CHTN recipients (Divisions) collectively form the CHTN national resource. Presently, the organizational structure of the Network comprises six Divisions. The goal of the CHTN is to collect and distribute to investigators high-quality human tissue specimens to facilitate basic and translational cancer research. Such specimens may be needed for scientific discovery and the development of various molecular diagnostic tests, and prognostic or predictive assays. The CHTN is designed as a unique biospecimen resource in that it is based on the prospective collection and distribution of samples upon specific investigators’ requests. Samples to be collected from patients include pre-cancerous, malignant, and benign neoplastic tissues, as well as tissues with non-neoplastic diseases and normal tissues. Since its establishment by the NCI in 1987, the CHTN has provided more than 1,350,000 malignant, benign, diseased, and uninvolved (normal adjacent) high-quality human tissue specimens from a wide variety of organ sites to over four thousand investigators.

Key Terms for this NOFO

Primary Institution: Application-submitting institution with which the Principal Investigator (PD/PI) or multiple 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 includes, 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 for 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 makes high-quality human specimens available to the general scientific community for basic and translational cancer research, as well as assay development.

The CHTN 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, and 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 are actively involved in the practice of anatomic pathology, provide quality control assessments of each sample, and are 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.

Five Divisions of the CHTN provide specimens from adults and each Division 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.

Informatics systems have been developed to facilitate efficient communication among Divisions, share investigators' requests and determine biospecimen availability. The CHTN informatics system 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 CHTN specialized system (Tissue Quest II) 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 allowing communication between each division and network investigator requests between the 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: about 40,000 specimens are provided per year. Since its inception, the CHTN has distributed over 1,350,000 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 awards, 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, translational science, assay validation as well as the development and application of new technologies to clinical specimens.

Research Objectives and Requirements

This limited competition NOFO requests applications for cooperative agreements from the six existing institutions participating in the CHTN.  The major focus of this cooperative biospecimen collection and distribution network will be to continue and improve access to high-quality human tumor tissue with associated histopathologic and demographic data. The NCI will fund the six institutions to work together as a network to prospectively collect and distribute high-quality tissue specimens to investigators throughout North America and elsewhere.  The Network will provide tumor specimens from a wide variety of cancers, and it will also provide researchers with access to biospecimens of rare tumor types. Normal, malignant, and benign human tissue specimens will be collected as well to meet researcher requests.  Biospecimens will be excess materials collected during routine medical care or at autopsy.  The Network does not generally function as a tumor bank, but it may store biospecimens pending the completion of shipments and may bank rare tumors that would not otherwise be available.  Pre-malignant lesions, when available, can also be stored for future distribution to facilitate early detection research.  The Network is intended to provide biospecimens for basic and developmental studies.  Therefore, data routinely provided with the biospecimens will generally be limited to histopathologic and demographic information, such as that related to diagnosis, sex, age, and race.

Members of the Network are expected to collaboratively establish and implement appropriate standard operation procedures to collect, process, and handle biospecimens to assure that they are of the highest quality and suitable for a wide variety of studies and technologies.  In order to ensure the availability of suitable research biospecimens with correct patient diagnosis and adequate quality control, the Principal Investigator (PI) of each participating group must be an experienced surgical or anatomical pathologist, actively involved in the operation of a pathology laboratory that has demonstrated access to human cancer tissues.  Applicant institutions with the necessary expertise will provide additional services such as RNA/DNA preparation, tissue microarrays, macrodissection, and/or laser capture microdissection; these services should be carefully described and justified.  Although separate awards will be made to several institutions, recipients will be required to work collaboratively with other Network members. Requests for biospecimens will be shared by network participants so that requests can be filled more rapidly.  The recipients will use a common informatics system to share requests for biospecimens.

General operating policies for the Network are established by a Coordinating Committee that consists of the Principal Investigators (PIs), representatives from each participating institution (the coordinator(s) and the representative(s) from the NCI (i.e., the Program Official serving as Project Scientist).  The Coordinating Committee establishes standards for quality control and operation, defines equitable policies for distributing specimens, sets processing and handling fees, develops biohazard procedures, and establishes policies to address the legal, ethical, and human subjects’ issues related to the use of human specimens for research.

Recipients must agree to provide biospecimens to the scientific community without any requirement for collaboration.  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.

The recipients will work, as much as possible, to adopt the recommendations by NCI Best Practices for Biospecimens Resources (https://biospecimens.cancer.gov/bestpractices/2016-NCIBestPractices.pdf)

The Network is expected to remain responsive to changes in science.  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 Network must meet the requirements of the Federal Human Subjects Regulations 45CFR46 (i.e., the Common Rule; https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html).  Federal requirements to protect human subjects apply to a much broader range of research than many investigators realize, including research that uses biospecimens (e.g., cells, blood, urine, and saliva), residual diagnostic biospecimens, and medical information.  Information on Office for Human Research Protections (OHRP) Policies and Regulations can be found at https://www.hhs.gov/ohrp/regulations-and-policy/index.html.

The Network is expected to address the evolving legal, ethical, and human subjects’ policy issues related to the use of human biospecimens for research purposes.  These issues are addressed in the NCI Best Practices for Biospecimen Resources and the OHRP website (http://www.hhs.gov/ohrp/).

Informed consent beyond that provided in the surgical consent form is desirable for research use of identifiable specimens collected during routine medical care. Applications submitted in response to this NOFO must include plans to obtain consent for future research use of specimens collected during this project or to sever any link between the specimen to be distributed to the researcher and the identity of the patient.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Trans-Network Interactions

Given the diverse and variable needs of basic discovery and 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 operation.

Although separate awards will be made for each CHTN Division, recipients will be required to work collaboratively with other CHTN Divisions. Requests for biospecimens will be networked among the 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, macrodissections, and preparation of fluid samples such as blood).

IT Coordinator. Although each Division may have its 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.

All the applicants must ensure to maintain the following capabilities in place:

• 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 primary Institution(s). However, applicants are encouraged to engage collection of specimens from geographically wide areas beyond the state of the primary Institution. Applicants must foresee sub-contractual arrangements with remote site hospitals, if possible, 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 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, and matched uninvolved tissue samples; d) matched blood/tumor or normal/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.
• Ability to collect matched blood (and blood derivative) samples. Therefore, applicants must have personnel or access to personnel (at least part-time) for this function, including: a) personnel for consenting patients (such as a clinical coordinator); b) personnel for drawing blood (such as a phlebotomist or nurse)
• 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 are limited to histopathologic and demographic information, such as that related to diagnosis, sex, age, race/ethnicity, and pathology report should be collected.

In addition to these required aspects, the following capabilities are encouraged:

• It is expected that most biospecimens will be accompanied by basic annotations such as those included in the Pathology Report (age, gender, histological diagnosis) and each proposed Division should make every effort to collect race/ethnicity information. 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.
• The ability to provide special blood preparations such as required for liquid biopsies including CTC, ctDNA, exosomes, etc.

The ability to provide produce digital images of tissue sections from samples distributed by the Division, archive them, and potentially made them available if the program offers digital images as a service to investigators.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• 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)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

This is a limited competition NOFO. Only current recipients of the NCI-supported Cooperative Human Tissue Network (CHTN) are eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Rodrigo Chuaqui, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-5910
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The Research Strategy must consist of the following sections with the indicated page limits:

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)
 

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

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

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

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

Facilities and Other Resources:

In addition to the 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 file name "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 file name "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 file name "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 file name "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 file name "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). 

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

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 the 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.

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 the 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. Applicants must include in the budget request restricted funds in the amount of 4% of the direct cost requested (for each year) for expenses to be shared by all network recipients. Enter these funds in the "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 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 the 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 the 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 a person.

Note: If the proposed Division is selected for the 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 the 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.

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

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

Specific Aims

Outline 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:

• Include in this narrative specifically your role and accomplishments under the current award.
• 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 the 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 the quality of shared network services, publicizing 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 does not include any specific pilot projects).

Sub-Section C. CHTN Operations and Quality Management

Applicants should outline their strategy for the 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 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 the 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 NOFO 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;
• Sites where biospecimen were collected;
• Donor demographics;
• Biospecimen diagnosis (organ, diagnosis, modifiers of diagnosis);
• Other relevant biospecimen information for each biospecimen such as
  • Sample amounts and storage sites;
  • Pathology report information;
  • Processing (e.g., FFPE, frozen, etc.);
  • Collection and processing times;
  • Biospecimen quality control information.

Ensure the capability of the institution to continue work with the CHTN Network IT system in order to communicate with other divisions, network investigator requests between the divisions, as well as track information such as:

• 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 the 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 are categorized by disease status (normal, benign, malignant, normal matched to the 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).

Letters of Support: Letters of support 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. 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• In addition, Data Management and Sharing Plans are expected to be consistent with the following provisions: 
  • CHTN recipients retain custody and primary rights to data developed under these awards, subject to government (e.g., NCI, NIH, U.S. Public Health Service [PHS], and U.S. Department of Health and Human Services [HHS]) rights of access, consistent with current NIH, PHS, and HHS policies.
  • Rights of users of the CHTN resources: investigators using biospecimens obtained from CHTN retain custody of the resulting data and full rights to the intellectual property generated with such biospecimens.
  • Published data using the Network resources must include a citation(s) for the source(s) of the biospecimens.

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

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

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.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: The emphasis of this NOFO is on optimizing the 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 the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this NOFO: 

How well will the CHTN Division 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 the cancer research community? What is the potential of the 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 NOFO:

How strong are the credentials and experience of the PD/PI and the applicant group regarding sample procurement and preparation of specimens? How well suited are the qualifications, experience, and proposed responsibilities of the PD/PI and other key personnel to organize and maintain the CHTN Division, maintain quality control and equitable access, and manage record keeping? How sufficient are the proposed efforts of the PI and key personnel to ensure (i) proper overseeing of all operations and management; (ii) integration with the other participating groups; and (iii) high quality of biospecimens?   
 

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 NOFO:

How well do the applicants propose creative or improved methods, such as more efficient and effective means of collecting high-quality specimens, new approaches for obtaining informed consent from human subjects and maintaining confidentiality, more efficient and effective methods of sharing specimen requests, improved information systems to support resources or more effective marketing techniques or strategies to utilize the resource? How innovative are the roles of both the institution's operating IT system to handle CHTN Division data, as well as for the 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 included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific for this NOFO:

How strong are the capabilities of the CHTN Division in terms of collecting biospecimens of major tumor types, as well as matched blood and tumor specimens? How extensive and varied are the collections of retrospective material by the Division, both FFPE and frozen, that could supplement/complement requests in the future, especially for more difficult-to-obtain samples? How sufficient is the administrative infrastructure to ensure: (i) proper oversight of all operations and management; and (ii) integration with the other participating groups/Divisions? How meritorious are the plans for the collection and distribution of specimens? How likely is it that the Division will be able to contribute a proportional share of samples to maintain or increase the current number of 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 the 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? How appropriate are the proposed procedures for the protection of human subjects and patient confidentiality? 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 NOFO:

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 tumors, 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 collection 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

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 Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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 recipient's business official.

Recipients 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

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, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the following primary responsibilities:

• 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 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 1.8 person-months annual effort.
• In case the PD/PI of the 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, the 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 recipients 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.
• Participate in the Strategic Planning Subcommittee (SPS), whose goal is to evaluate emerging and future needs of the CHTN investigators and the CHTN and develop appropriate responses to those needs.       
• 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.

Recipients 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.

Recipients 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 recipients (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.)

Recipients must be willing to collaborate with the other CHTN recipients as outlined in this NOFO. 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 will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  Designated Program Director(s) from NCI and other NIH Institutes supporting this initiative will have substantial involvement as Project Scientists. Activities of substantially involved staff members from NCI involved will include, but will not be limited to:

• 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;”
• Participate in the Strategic Planning Subcommittee (SPS), whose goal is to evaluate emerging and future needs of the CHTN investigators and the CHTN and develop appropriate responses to those needs.       
• 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.

Additionally, a 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. 

Areas of Joint Responsibility include:

CHTN Coordinating Committee. To oversee and coordinate the operations of the Network, recipients 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) will collectively have one vote.
• NCI Project Scientists will collectively have one vote.

The chairperson (who must be one of the 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 in 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 are required for the operation of the Network.
• Establish procedures for effective communications among recipients;
• Establish subcommittees as necessary; and
• Review and recommend the implementation of 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 the 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 the 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 subcommittee  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 a regularly scheduled publicizing resource committee either by phone or face to face.
• Participation in social media (including Twitter, Facebook, LinkedIn, and blogs) for advertising CHTN services to the scientific community.
• Maintenance of a current website that is updated regularly by an administrator.
• Development of a metric plan to capture success and for reporting on publicizing 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 Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

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

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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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.

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Rodrigo F. Chuaqui, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-5910
Email: [email protected]
 

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Shane Woodward 
National Cancer Institute (NCI) 
Telephone: 240-276-6303 
Email: [email protected]
 

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.