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 How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the 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

Through this single source Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits an application to fund a single award to George Washington University for the continuation of the AIDS and Cancer Specimen Resource (ACSR). If awarded, the applicant institution will be expected to maintain the cooperative group structure and the activities of the ACSR.

The primary objective of the ACSR will be to acquire, store, and equitably distribute tumor tissues, biological fluids, and associated demographic data from patients with human immunodeficiency virus (HIV)-associated malignancies. In addition to serving acquired immunodeficiency syndrome (AIDS) and cancer researchers at large, the ACSR will specifically provide biorepository functions for another NCI supported initiative, the AIDS Malignancy Consortium (AMC). The AMC performs clinical trials research in the treatment and prevention of HIV-associated malignancies in the United States (U.S.), Sub-Saharan Africa (SSA), and Latin America (LATAM). It is expected that the ACSR, will strategically enrich the existing inventory of rare and difficult to obtain specimens through a series of specimen sparing and optimizing initiatives.

Rationale for Single Source

Extensive funds and resources have been expended by the Office of HIV and AIDS Malignancy (OHAM) of the NCI, in its long-term effort to establish and expand the unique activities of the ACSR, led by George Washington University (GWU), as a cohesive efficient infrastructure for serving the general HIV-associated malignancy and HIV research community, and specifically serving as the cooperative group bank for the AIDS Malignancy Consortium’s (AMC) clinical trials activities throughout the world. Regardless of costs, it would be virtually impossible to recreate the ACSR specimen archive that spans over 30 years of the HIV-epidemic with its changing patterns, and patients who have had a range of HIV therapies. Given the long, substantial investment and the uniqueness of the resource, it is imperative to maintain the continuity of the collections and their availability to the research community at large.

The ongoing activities with the AMC include integration with the AMC’s extensive clinical trials operations. The AMC is the only NCI sponsored clinical trials group that performs clinical trials in international settings (specifically in Sub-Saharan Africa [SSA] and Latin America [LATAM]). Therefore, the ACSR is the only NCI sponsored cooperative group bank that services clinical trials internationally (again, in SSA and LATAM). The extensive integration of these two groups led to the ACSR serving 29 domestic sites biorepository needs, along with the biorepository needs of six sites in SSA and four in LATAM. The ACSR biorespository function for the AMC’s clinical trials involves complex international arrangements and multifaceted coordination across many clinical sites. All these activities require dedicated skills and specialized infrastructure. Maintaining the ACSR continuity is crucial for the AMC mission. Disruption of this ACSR function would have global catastrophic effect on research on cancers in people with HIV as well as on patients worldwide, who belong to this population.

While the NCI recognizes and endorses the need for full and open competition, and by preference uses open competition in the vast majority of its initiatives, we believe that the investments made by the NIH and the proven, unique and outstanding performance of the ACSR warrants an exception. The ACSR has an extensive infrastructure to support the general HIV-associated malignancy and HIV research community, along with the AMC. The ACSR has engaged in capacity building efforts to stand-up world class, clinical trial biorepositories in South Africa and Brazil. Both international sites have the capacity to perform as central pathology laboratories in-country eliminating the need to ship specimens to the USA for central pathology lab confirmation of cancer diagnosis. No other group of institutions/investigators has the expertise and capability to carry out the complex mission of the ACSR.

Key Terms for the NOFO

Low- and Middle-Income Countries (LMICs): LMICs are defined using the World Bank classification system according to Gross National Income (GNI) per capita as "low-income," "lower-middle-income," and "upper-middle-income" (http://data.worldbank.org/about/country-classifications/country-and-lending-groups).

HIV-associated, AIDS-defining and non-AIDS-defining cancers (ADCs and NADCs, respectively): People living with human immunodeficiency virus (HIV) are at substantially higher risk of developing cancer. The general term for these cancers is HIV-associated cancers. Three of these cancers are known as "acquired immunodeficiency syndrome (AIDS)-defining cancers," including Kaposi sarcoma, aggressive B-cell non-Hodgkin lymphoma, and cervical cancer. A diagnosis of any of these cancers in a person with HIV confirms a diagnosis of AIDS. People with HIV are at risk of several other types of cancer, collectively called "non-AIDS-defining cancers." These malignancies among others include anus, liver, oral cavity/pharynx, lung cancers, and Hodgkin lymphoma.

Regional Biospecimen Repositories (RBRs): The RBRs are localized biospecimen hubs for the ACSR that are supported by sub-contracts to appropriate institution(s) in a given region. Each RBR coordinates the biospecimen procurement/distribution activities and data management of that regional group.

AIDS Malignancy Consortium (AMC): The AIDS Malignancy Consortium (AMC) is a comprehensive NCI-supported clinical trials group focused on cancer prevention and treatment for people with HIV (PWH). AMC Biorepositories correspond to an ACSR unit that serves the biorepository needs for the AMC.

Background

There are approximately 38.4 million people with HIV (PWH) worldwide. Advances made throughout the forty years of HIV research have brought the identification of HIV as the causative agent of AIDS, and development of combination antiretroviral therapy (cART), changing HIV/AIDS from an almost certain cause of death to a manageable disease. However, malignancies that occur in the context of HIV infection continue to be one of the most common causes of morbidity and mortality in PWH. Early in the epidemic, rare malignancies such as Kaposi sarcoma (KS) and AIDS-related lymphomas (ARL) heralded the onset of AIDS. Successful treatment with cART led to a decrease in KS and ARL, (referred to as AIDS-defining cancers). This decrease, however, was associated with a concomitant increase in incidence of non-AIDS defining cancers (NADCs), such as anal cancer, hepatocellular carcinoma, and lung cancer. Most PWH reside in low- and middle-income countries (LMICs), with 70% living in Sub-Saharan Africa (SSA). There is a high incidence of HIV-associated malignancies in the people of SSA because of the high prevalence of oncoviruses that cause many HIV-associated malignancies, such as Kaposi sarcoma-associated herpesvirus (KSHV), Epstein-Barr virus (EBV), and human papillomavirus (HPV).

In 1993, a lack of high quality biospecimens from people with HIV-associated malignancies was identified as an impediment to research on HIV malignancies. The AIDS and Cancer Specimen Resource (ACSR) was created to respond to this need with the belief that the availability of such specimens would facilitate research directed toward identifying potential genetic, viral, and environmental cofactors contributing to the development of malignancies in people with HIV/AIDS.

From 1994 to 2013, the ACSR was supported by the NCI through independent cooperative agreement awards to support individual regional repositories and a separate coordinating center. For better efficiency, in the 2013 issuance of the initiative (RFA-CA-13-005), the ACSR was reorganized into a single, consolidated UM1 Cooperative Group structure. The consolidated ACSR serves primarily as a global repository of human biospecimens that reflects changes in people and populations in the HIV/AIDS epidemic, domestically and internationally, over time. In 2010, the ACSR also assumed the biorepository responsibilities of the AMC's US-based program; in 2013, the AMC's Sub-Saharan African program; in 2014, the AMC's Anal Cancer HSIL (high-grade squamous intraepithelial lesion) Outcomes Research (ANCHOR) Trial; and in 2022 the AMC’s Latin American program. The ACSR will be expected to continue the forementioned support of AMC activities.

In the past two issuances, the ACSR has endeavored to more strategically enhance the inventory of rare and difficult to obtain HIV-associated malignancy specimens through a series of specimen sparing and optimizing initiatives. The Tissue Microarray (TMA) production program permits the frugal and equitable distribution of highly precious tissues. The Biospecimen Science Program (BSP) develops, optimizes, and standardizes protocols to make high-quality molecular derivatives available from various biomaterials archived in the ACSR and therefore promotes the use of archived specimens previously thought to be inappropriate for genomic, proteomic, and transcriptomic analyses.

The current structure of the ACSR consists of five RBRs, four AMC Biorepositories and a technical core, supported by a data management and statistics core. All are governed and coordinated by an Executive Committee and supported by a single UM1 award.

Objectives and Scope of this NOFO

This NOFO is designed to maintain the ACSR and its structural/functional units under a single UM1 award and serve the following goals:

• The primary goal is to continue to meet the biospecimen needs of clinician and basic researchers in HIV-associated malignancies by acquiring, storing, and equitably distributing tumor tissues and biological fluids from patients with HIV-associated malignancies (both AIDS-defining and non-AIDS-defining).
• The secondary goal is to provide the biorepository functionality for the AMC clinical trials conducted in the U.S., SSA, and Latin America.
• A third goal is to continue to support the strategic enrichment of the existing inventory of rare and difficult to obtain specimens through a program of specimen sparing and optimizing initiatives.
• The ACSR may also establish collaborations and agreements with other NCI- or NIH-funded initiatives/investigators in HIV/AIDS and/or cancer-related research to improve the research community's access to biospecimens. It is expected that the ACSR awardees will consult with the NCI and seek its approval for such additional collaborations.

The applicant responding to this NOFO must be capable of scientifically appropriate and rigorous approaches to accruing, curating, and storing the requisite biospecimens and data. These approaches and activities must address all the specific key elements defining the scope of ACSR that are identified below but are also expected to reflect the creativity and distinct capabilities of the applicant team. These approaches must conform to best practices in biospecimen sciences (as defined by the NCI and/or the International Society for Biological and Environmental Repositories [ISBER]) and the laws of the countries from which biospecimens are procured.

Priorities for Biospecimen Collection

Applicants responding to this NOFO are expected to address the following priorities:

1) Collection of tumor tissue specimens from people with HIV should be prioritized over blood and bodily fluids from people with HIV, and HIV-uninfected control biospecimens of all types. One exception would be prioritized collection of Kaposi sarcoma biospecimens from HIV-uninfected people.

2) Collection of biospecimens with associated clinical, pathological, diagnostic, and demographic data, if available.

3) Collection of fresh frozen biospecimens with matching non-tumor germline samples suitable for comprehensive molecular and genomic analysis.

4) Collection of biospecimens representing non-AIDS-defining cancers (NADCs).

5) International collection of biospecimens, primarily from persons living in Sub-Saharan Africa, Latin America, and other areas of high disease burden.

Whereas this list defines priority collections, biospecimen collections for the ACSR should be broad in scope and need not be limited to these priority areas, as long as the procurement is scientifically well justified.

General Requirements and Capabilities

The proposed ACSR must be able to address the following specific challenges, requirements, and capabilities:

• Evolving Nature of the HIV Epidemic. It is essential that the ACSR collection reflects the evolution of the HIV epidemic and the ACSR is poised to accommodate future changes rapidly and efficiently. Applicants should have a strong understanding of the historic and current epidemiology of HIV-associated malignancies and be informed about proposed epidemiologic trends of the future.
• State of the Science of Biospecimen Research. Cancer "standard-of-care" is moving toward less invasive approaches, ultimately leading to decreased availability of patient specimens for research purposes. The applicant is expected to have a deep understanding of the ACSR's existing collections and an appreciation of how the collections can be used most efficiently by a broader community of investigators.
• Need to Curate Collections. The ACSR must maintain collections representing a wide variety of rare tumor types and biospecimen processing types. Collections should also include appropriate and justified control specimens.
• Value of Biospecimen Sets to the Community. As the ACSR continues to acquire specimens of unique value to the HIV-associated malignancy research community, there is potential for acquisition of biospecimens and associated data sets. It is expected that the applicants have (or will) established strong, informed, standard processes for acquisition of special collections and incorporation of large collections of biospecimens and data into the ACSR. It is important that the ACSR leadership give special consideration as to the extent these collection sets provide additional value to the ACSR and the broader research community over the existing collection.
• Applicants' Expertise and Background. Applicants are expected to be current in their knowledge and implementation of the most recent best practices in biospecimen science and have appropriate, up-to-date, expertise in technological advancements in clinical and basic research.
• Global Nature of the Collection. The proposed ACSR must be able to meet the challenge of the global nature of the HIV epidemic in humans. Applicants must have appropriate knowledge, experience, and capabilities to develop a collection that accurately reflects a global HIV epidemic and respects the cultures and laws of many different nations.
• Equitable Biospecimen Distribution. The ACSR team is expected to demonstrate commitment to equitable distribution of biospecimens to funded investigators engaged in research on HIV/AIDS and its associated malignancies.
• Marketing and Outreach Efforts. The proposed ACSR should have an efficient and effective marketing approach and outreach program that informs investigators about the ACSR and encourages them to use the ACSR's biospecimens in their research. Applicants should be aware of and actively pursue opportunities to coordinate with other NCI initiatives to improve and increase the use of the ACSR.
• Informatics Development and Maintenance. The proposed ACSR should have appropriate expertise and capabilities for maintenance and/or improvement of current informatics tools used by the ACSR; annotating and auditing the ACSR collections; monitoring and tracking inventory use; and serving the science being supported by the ACSR.

General Required Attributes of ACSR Organization and Structure

For optimal functioning, the proposed ACSR must include structural/functional units with the following characteristics:

1. Administrative Office of the ACSR Chairperson(s)

2. Working Groups for Scientific Programs and Strategic Planning

3. Regional Biospecimen Repositories (RBRs)/Technical Core(s) (TC)

4. AMC Biorepositories

5. Data Management and Statistics Support (DMSS)

Specific requirements and expectations for these characteristics are outlined below.

Administrative Office of the ACSR Chairperson(s)

The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) will provide centralized oversight of the ACSR's major structural/functional units as they carry out their respective responsibilities. The ACSR Chairperson (expected to be the PD/PI from the awardee institution) will be responsible for the scientific integrity, productivity, governance, and fiscal accountability of the group. The Administrative Office of the Chair(s) is expected to support the activities of the group as well as provide centralized administrative coordination, communications, logistical support, and generating conference call and meeting reports. If multi-PD/PI structure is proposed, clearly define the roles and responsibilities of each PD/PI.

Working Groups for Scientific Programs and Strategic Planning

The ACSR will establish Working Groups (WGs) to assist the Governing Committee with strategic planning related to scientific aspects of the ACSR. Working Groups will also be expected to contribute to the ongoing refinement and optimization of technical aspects of ACSR activities as well as its organization/administration. WGs are expected to be topic/task-oriented and include ACSR investigators of appropriate profile (e.g., scientists from the RBRs, DMSS unit, and/or statistical/epidemiological experts, as needed for a given WG). The number of WGs and the scope of work for each WG are up to the discretion of the applicant. However, these WGs are expected to cover, at a minimum, the following required activities:

a) Scientific and technological strategic planning; assessment of trends in the HIV epidemic, research or technology; promotion of new techniques; and identification of new scientific and/or technical opportunities that could be valuable for the ACSR;

b) ACSR data management, maintenance of the ACSR Website, and approaches of data harmonization/sharing with the AMC.

c) Tracking metrics of ACSR use;

d) Addressing quality management issues of ACSR biospecimens, data and controls; and

e) Marketing, outreach, and promotion of the ACSR to both the research and patient communities.

Regional Biospecimen Repositories (RBRs)/Technical Core(s)(TC)

The RBR/Cores are expected to provide the infrastructure to acquire, store, and distribute biospecimens and data for the ACSR enterprise and/or provide technological capabilities that enhance the overall function of the ACSR. Each RBR/Core is expected to be supported by separate sub-contractual/consortium arrangements with the ACSR awardee institution.

AMC Biorepositories

The ACSR awardee should have an AMC Biorepositories Unit. Through appropriate sub-contractual/ consortium arrangements, this unit is expected to continue performing biorepository support activities for the clinical trials of the AIDS Malignancy Consortium, both domestically and internationally.

Data Management and Statistics Support (DMSS)

ACSR should have a structural/functional unit(s) to support continued data management of the ACSR and to provide information technology-based solutions for operational activities of the ACSR. The proposed unit(s) should include robust epidemiology, biostatistics, data analysis, and information technology expertise to ensure the development of sound approaches for the operational activities of the ACSR as needed. This should include, but not be limited to: generating ACSR activity reports; tracking of letters of intent (LOIs) and tissue distributions; ACSR biorepository research efforts; community statistical research support; maintenance of the ACSR Website; and marketing and outreach efforts.

ACSR Governance

Governing Committee: This committee is led by the ACSR Chairperson and is the self-governing body of the ACSR.

An External Advisory Board: This board is to be composed of experts in fields pertinent to the ACSR (eg. HIV, HIV-associated malignancies, biorepository sciences, etc.) that are not affiliated with the ACSR. The EAB will meet annually to assess progress, problem solve, provide insights and advice, assist in developing strategic priorities and scientific initiatives, and critically evaluate partnerships and proposed areas of exploration/expansion of the ACSR.

Review and Evaluation Decision Panel (REDP): All research proposing to use biospecimens and data from the ACSR will be subject to evaluation by a panel of external experts, the Review and Evaluation Decision Panel (REDP). The REDP's decisions will be made independently from the ACSR or its Governing Committee. The NCI will coordinate the logistics for the REDP.

For details on the composition and functions of the Governing Committee, External Advisory Board, and Review and Evaluation Decision Panel, see Section VI.2A Cooperative Agreement Terms and Conditions of Award.

Program Evaluation

The program under which the ACSR is funded will be subject to external evaluation near the end of the third year of the funding period (to be coordinated by the NCI Program Staff). Such evaluation is part of NIH efforts to optimize the efficiency of the funded research. The evaluation process will involve monitoring and assessing the progress of the ACSR toward achieving its goals. This aspect includes evaluating the quality, value, and scientific impact of the biorepository activities conducted by the Consortium.

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

Only the following applicant may apply for this single source funding: George Washington University.

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • 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.

Only the PI/PDs associated with the award issued under RFA-CA-18-012 to George Washington University is eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

• 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

• Only a single award will be issued to George Washington University under this single source funding opportunity. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. 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.

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

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:

• Sub-section A. ACSR Overview: 12 pages
• Sub-section B. Working Groups for Scientific Programs and Strategic Planning: 6 pages
• Sub-section C. ACSR Chairperson's Administrative Office: 6 pages
• Sub-section D. ACSR Regional Biospecimen Repositories (RBRs) and Technical Core(s) (TC): 12 pages
• Sub-section E. Data Management and Statistics Support Unit (DMSS): 6 pages
• Sub-section F. AMC Biorepositories Unit: 12 pages

The following section supplements the instructions found in the How to Apply Application Guide and should be used for preparing an application to this NOFO.

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 & Other Resources: In addition to standard items, include the following:

• For each Regional Biospecimen Repository (RBR)/Technical Core (TC) provide documentation of the collective team scientific expertise and capacity to acquire, store, and distribute biospecimens and data for the ACSR enterprise and/or any technological capabilities that are relevant to the overall function of the ACSR.
• For each AMC Biorepository, document their capabilities to perform the required AMC Biorepository activities in a manner that adheres to established Standard Operating Procedures, protocols, and collaborative agreements between the ACSR and the AMC.
• For each RBR, AMC Biorepository and TC provide information on: infrastructure for specimen curation such as anatomical/clinical pathology, laboratory, specimen storage space, major equipment, instrumentation; infrastructure for document and data storage; facilities and equipment for administrative support; informatics support; intellectual and collaborative resources; and institutional support for the conduct of clinical research under U.S., HHS, and NIH regulations and policies regarding human subjects.
• Make note of those RBRs and/or AMC Biorepositories who have obtained the College of American Pathologists (CAP) Biorepository Accreditation.

Other Attachments: Applicants must provide the following additional materials specified below in support of their application. Each attachment should be uploaded as separate PDF files. The filename provided for each attachment will be the name used for the bookmark in the application image.

Attachment 1: Organizational Data (use filename "Organizational Data"):

• Table of contents of the attachment;
• Flow chart with the organizational structure, leadership, management/administration, Working Groups and committees, etc.;
• Summary Table for Working Groups. In the table, list members. Include members affiliations and fields of expertise. Other critical characteristics may also be listed, if appropriate; and
• Summary Table of RBRs and TC. For each RBR/institution and TC /institution (if the TC is a separate entity) include the most relevant site characteristics. If the site also serves as an AMC Biorepository, please note. Include a separate notation of any AMC Biorepositories that are not RBRs. Make note of CAP Biorepository Accreditation, if applicable.

Attachment 2: Accomplishment Data (use filename "Accomplishments"):

• Table of contents for the attachment;
• Summary tables by year (2018-2023) for inquiries and letters of intent (denote standard, short, feasibility, products of derivatives), approved letters of intent and samples shipped;
• Summary tables listing main reasons inquiries do not produce LOIs, LOIs are not approved, approved LOIs do not result in signed Material Transfer Agreements/sample provision. Provide average time between each step;
• Summary tables for specimen distributions (2018-2023) that include information such as: number of specimens, sample type, cancer type, date requested, date specimens shipped, RBRs responsible for providing specimens, Institution receiving specimens*;
• Summary tables for distributions of the "Special Collections" (2018-2023) that include information such as: number of specimens, sample type, cancer type, date requested, date specimens shipped, RBRs responsible for providing specimens, Institution receiving specimens*;
• Summary tables for Tissue Microarray (TMA) distributions (2018-2023) that include information such as: TMA description, RBRs contributing samples for the TMA, number of cores, number of cuts, Institution receiving specimens*; and
• Summary tables for other distribution types, such as: products of derivatives (PODs), data, and digital images, Institution receiving specimens*.

*NOTE: For transparency, make a notation if specimen recipient is an ACSR-associated investigator (PD/PI or another senior/key person).

Attachment 3: ACSR Collection Data (use filename "Collections"):

• Table of contents for the attachment;
• Concise information regarding the ACSR collection, including (but not limited to):
  • Specimens by cancer type;
  • Specimens by sample type;
  • Era of the epidemic/year specimen collected;
  • Geographic location of patient;
  • Associated demographic information;
  • Special Collections;
  • AMC donations;
  • Multisite Autopsy Collection;
  • TMA production/distribution; and
  • Summary tables for individual RBR acquisitions (2018-2023) that include information such as: number of specimens, cancer type, era of the epidemic/year specimen collected, geographic location of patient, and any associated clinical/demographic information that conveys strength of the acquisition.

Attachment 4: AMC Biorepository Support Activities (use filename "AMC Biorepository"):

• Table of contents for the attachment;
• AMC Domestic Biorepository
  • Summary table of trial numbers and titles (completed, active and in development) with a brief description of trial and biorepository activities associated with the trial; and
  • Summary tables for completed, active and in development clinical trials. For completed and active trials, tables should include number of cases, sample processes and other information that demonstrates biorepository activity associated with the trial.
• AMC Sub-Saharan Africa Biorepository
  • List of trial numbers and titles with a brief description of trial and biorepository activities associated with the trial; and
  • Summary tables for completed, active and in development clinical trials. For Completed and active trials, tables should include number of cases, sample processes and other information that demonstrates biorepository activity associated with the trial.
• AMC Latin America Biorepository
  • Summary tables/timelines for onboarding of the Latin American Biorepository. Include capacity building activities, renovation activities, training and other preparatory work to prepare the site for protocol activation. If there has been participation of the site in any Protocol Development activities, please include these activities in the table.
• AMC ANCHOR Biorepository
  • Summary table(s) demonstrating the biorepository activity associated with the trial.

Attachment 5: Data Management and Statistics Support. Provide the following information as a PDF file with the name "Data Management and Statistics Support".

• Table of contents for the attachment;
• Organizational flow chart;
• ACSR Data Management, Standardization and Integration plans;
• Description of software platforms used for ACSR operations:
• ACSR/AMC Data Harmonization and Sharing Plans; and
• AMC/ACSR Collaborative System Architecture Diagram.

Attachment 6: ACSR Operational/Policy Documents. Provide the following information as a PDF file with the name "Operational/Policy Documents".

• Table of contents for the attachment;
• Provide a Table of Contents for the Manual of Operations (MOO). Do NOT provide the MOO document, itself. A brief description of the purpose of the MOO may be provided. Brief descriptions of sub-sections may be provided, if clarification is necessary;
• Provide a Table of Contents for the Quality Management Plan (QMP) and the Quality Management Plan supportive documents. Do NOT provide the QMP, itself. A brief description of the purpose of the QMP may be provided. Brief descriptions of sub-sections may be provided, if clarification is necessary;
• Provide the ACSR’s Disaster Plan; and
• Provide a list of Standard Operating Procedure (SOP) Names within each set of SOPs listed below. Do NOT provide the SOP document, itself. A brief description of the purpose of the SOP may be provided, if clarification is necessary.
  • ACSR SOPs
  • AMC Biorepository SOPs
  • ANCHOR Biorepository SOPs

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

Name the individual who is designated to be the "Chairperson" of the ACSR. This individual is expected to be the PD/PI from the application submitting institution. If multiple PDs/PIs option is used, an additional PD/PI from a different institution may be designated as Co-Chairperson.

Name the individuals who will serve as leads of ACSR Working Groups, AMC Biorepositories, Directors of each RBR, and leads for Data Management and Statistics Support (DMSS) Units.

Biographical Sketches: In addition to standard content, as appropriate for individual researchers, include in the Biographical sketch under "Personal Statement" the ACSR leadership roles assigned and the major strengths, critical experience, and scientific contributions that make that individual uniquely qualified for those assigned leadership roles.

For the individual(s) designated as the Chairperson (or Co-Chairperson, if applicable), the biosketch should document appropriate leadership skills, expertise and experience (documented by their scientific contributions) to ensure their abilities to perform centralized oversight of the ACSR's major structural/functional units, and be responsible for the scientific integrity, productivity, governance, and fiscal accountability of the group based upon the roles and responsibilities outlined in the leadership plan.

For the individuals designated as the Directors of each RBR, the biosketches should document their appropriate leadership skills, expertise, and experience (scientific contributions) to ensure their abilities to design, prioritize and conduct required technical and research activities of the RBR and to fulfill assigned leadership roles on Committees and Working Groups.

For individual(s) designated to lead the Data Management and Statistics Support Unit, the biosketch should document appropriate leadership skills, expertise and experience (documented by their scientific contributions) to ensure their abilities to design, prioritize and conduct required technical and research activities of the informatics and epidemiology/statistics programs of the ACSR and to fulfill assigned leadership roles on Committees and Working Groups as outlined by the applicant in the Research Plan.

R&R Budget

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

The entire Budget requested must be within the caps defined in Section II. Award Information. The following information is meant to serve as guidance and suggestions for individual structural/functional units and special funds but are NOT mandatory caps, unless specifically noted.

ACSR Chairperson's Administrative Office: up to approximately 15% of total budget for years 1-5 may be allocated to this office (but no more than one-half of the allocated amount should be for the personnel costs of PDs/PIs and other personnel of this Unit).

• The individual designated as contact PD/PI is expected to commit (and maintain throughout the project period) effort level of at least 1.8 person-months. Any other individual designated as a PD/PI is expected to commit (and maintain throughout the project period) an effort level of at least 1.2 person-months.
• Other allowable costs that may be budgeted for this unit include (but are not limited to):
  • Support for administrative staff positions essential for this office; and
  • Costs associated with administrative activities, face-to-face meetings, telecommunications, marketing materials and attending meetings/conferences for marketing purposes.

SPECIAL FUNDS (related to activities of ACSR Chairperson's Administrative Office). It is recommended that applicants budget for two special funds, indicated below (the use of these funds will be subject to the authorization by the Governing Committee, with NCI concurrence):

• Independent Biospecimen Procurement Fund ($125,000 in direct costs suggested): Allowable costs for this fund may include procurement of biospecimens from independent sites or investigators that will not receive infrastructure funds. Allowable costs may include services such as collaborative projects, international collections, and/or to bring special collections to the ACSR. These costs should be entered as "Biospecimen Procurement Fund" in the "Other Expenses" category of the budget.
• Discretionary Fund ($50,000 in direct costs suggested): This fund is intended for piloting emerging scientific opportunities. These funds may be used for "beta-testing" new technologies, equipment, and/or other opportunities that become available for biospecimen repositories. These costs should be entered as "Discretionary Fund" under the "Other Expenses" category in the budget.

Basic Regional Biospecimen Repositories Unit : budget the same dollar amount for years 1-5, amounting to approximately 35% of total budget request for years 1-5. This amount should support three domestic RBRs and the Sub-Saharan Africa and Latin American RBRs through appropriate sub-contractual arrangements. The sub-budgets for individual RBRs are expected to range from approximately $300,000 to $750,000 per site. The allocation of funds to individual RBR sites should be commensurate with the scope of activities of a given site, its holdings, and other metrics of sustained productivity. CAP accreditation is required of all domestic RBRs. CAP accreditation or its regional equivalent is required of all international RBRs. The allowable costs for RBRs may include (but are not limited to):

• Personnel costs as needed for a given RBR;
• Equipment (including maintenance contracts), specimen storage costs (e.g., liquid nitrogen);
• Pathology/laboratory reagents and supplies, costs of biospecimen shipping;
• Travel of senior RBR staff to in-person Governing Committee meetings; and
• Costs associated with CAP accreditation for all domestic RBRs and CAP accreditation or its regional equivalent for the international RBRs.

Data Management and Statistics Support (DMSS) Unit: The budget for this unit should be adequate for its required functions and may include (but is not limited to):

• Personnel costs as needed for the leadership and staff members of the unit;
• Maintenance of the database, ACSR website, equipment, maintenance contracts; and
• Travel of senior staff to in-person Governing Committee meetings.

AMC Biorepository Unit: the budget for this Unit should amount to approximately 15% of total budget requested for year 1. In years two through five, the budget for this Unit should be expanded to include the fiduciary responsibility of the ANCHOR Biorepository. This would include an amount to approximately 30% of the total budget.

• The year one budget for this Unit should be adequate to support (via sub-contractual sub-budgets as appropriate) AMC Biorepositories. Years two through five will include the forementioned AMC Biorepositories and the ANCHOR Biorepository.
• Costs under this unit may include the laboratory costs for biospecimen processing, storage, protocol specific distribution of biospecimens to central laboratories, and data management system development specifically for AMC biospecimens. In addition, costs may include maintenance of biospecimen inventories for future correlative science and personnel costs for biorepository leadership and technical staff.

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

Succinctly describe the strategic objectives of the ACSR and the plan to achieve these goals.

Research Strategy

Standard sub-sections of the Research Strategy of the SF424 (R&R) Research Plan are replaced by the new sub-sections A-F detailed below.

Sub-section A. ACSR Overview/Progress Report

Outline the overall vision and proposed goals for the ACSR renewal. Address the salient features of the ACSR organizational and governing structures. Define lines of authority and key decision-making processes. Describe how the ACSR structural and functional units will interact to address key administrative, policy, scientific and technical aspects of the ACSR. Without repeating information in individual biosketches, summarize major collective strengths, critical experiences, and accomplishments of the team relevant to the ACSR structure. Also summarize other special features that reflect unique strengths of the structural/functional units and participants in the ACSR.

In this sub-section, summarize ACSR progress in the current funding period. Where appropriate, provide specific information about the AMC Biorepository, RBRs, Data Management and Statistics Support. Address the following elements:

• ACSR Biorepository activities and, if appropriate, AMC Biorepository activities and RBR activities
  • acquisitions/curations/distributions
  • requests vetted/approved
  • administrative
  • technical
  • CAP accreditation or its regional equivalent (international RBRs)
  • Name the Working Groups and their leaderships
  • Describe major initiatives and accomplishments of each Working Group
  • Describe key collaborative efforts between Working Groups or other functional units of the ACSR
  • Describe lessons learned, restructures, and changes in scope of any of the Working Groups.
• Other accomplishments
• ACSR collection overview
• Major adjustments to the organization
• Working Groups

Note: Supplementary documentation for the sub-section is requested under "Facilities and Resources" and "Other Attachments" (Attachments 1, 2, and 3).

Sub-section B. Working Groups for Scientific Programs and Strategic Planning:

Propose appropriate Working Groups that will support the research, scientific, and technological objectives of the ACSR. Explain how the specific structure and functions of the Working Groups are optimized to address the needs of the ACSR. Following the requirements defined in Section I under Objectives and Scope of this NOFO, address the following elements for each Working Group:

• Name the Working Groups and their leadership;
• Describe the intended activities, membership, and future goals and objectives;
• Without repeating information in individual biosketches, summarize strengths, critical experiences, and accomplishments of the leadership and membership of the Working Group that make them uniquely qualified to contribute to the Working Group;
• Outline how these Working Groups will contribute to the ongoing refinement and revision of the ACSR goals, objectives, and research agenda; and
• Briefly address changes, if any, to the number, leadership/membership and intended activities of the proposed Working Groups as compared to the Working Groups in the current funding period.

Note: Supplementary documentation for the sub-section is requested under "Facilities and Resources."

Sub-section C. ACSR Chairperson's Administrative Office:

In this sub-section, describe the infrastructure that supports the required administrative activities of the Administrative Office of the ACSR Chairperson (and Co-Chairperson, if applicable).

• Describe evaluation processes for RBRs and major structural/functional units of the ACSR;
• Outline the processes by which evaluation and assessment information is assessed, reported and used to make adjustments to the ACSR organization and budget;
• Describe the processes for development and prioritization of ACSR initiatives, special projects, new programs and collaborations;
• Outline the processes by which ACSR initiatives, special projects, new programs and collaborations are assessed, reported and how decisions are made for initiation, continuation or discontinuation of these activities;
• Describe the structure and roles of the governance and performance-evaluation bodies. Provide general desirable characteristics for the members of such bodies;
• Describe the plan for independent external advisory evaluation. Describe the structure of the External Advisory Board (EAB). Do NOT provide EAB candidate/member names; and
• Describe the infrastructure to support the required administrative activities of the ACSR Chairperson’s Administrative office, including, but not limited to, logistics and organization of meetings, and preparation of required reports.

Note: Supplementary documentation for the sub-section is requested under "Facilities and Resources" and "Other Attachments" (Attachment 6).

Sub-section D. ACSR Regional Biospecimen Repositories (RBRs) and Technical Core (TC):

List all the RBRs that are proposed be part of ACSR. It is anticipated that the five existing RBRs will be maintained in the ACSR structure along with the Technical Core (TC). If there is a proposed addition and/or elimination of an RBR/TC there should be an accompanying explanation for this proposed change.

For each RBR/TC, address the following elements:

• Describe the overall structure of the RBR/TC. This structure may be formed in a way that best suits the needs of the RBR/TC but should include administrative and informatics elements along with strong infrastructure to acquire, store and distribute biospecimens and data for the ACSR (or in the case of the TC, strong infrastructure to enhance the ACSR’s existing cancer tissue collections through the Biospecimen Science Program and the TMA Production Program).
• Define roles and responsibilities of key personnel. Without repeating information in individual biosketches, summarize major collective strengths, critical experiences, and accomplishments of the team relevant to the RBR structure.
• Outline the vision and proposed goals for the RBR during the upcoming issuance of the ACSR and describe how the RBR uniquely adds value to the ACSR's overall program.
• Outline internal processes for evaluation and assessment of the RBR, including, but not limited to, Quality Management/Assessment and productivity.

Note: Supplementary documentation for the sub-section is requested under "Facilities and Resources" and "Other Attachments" (Attachments 1, 2, and 3).

Sub-section E. Data Management and Statistics Support (DMSS) Unit

Explain how this unit will address ACSR data management needs, including development of appropriate solutions for data management and their maintenance. In addition, describe the unit that provides statistics research support for both ACSR customers requesting specimens and for the ACSR. Following the NCI guidance in Section I. Funding Opportunity Description, address the following elements for the unit(s):

• Describe the overall structure(s) of the unit(s) (diagrams are preferred).
• Describe the roles and responsibilities of the proposed leadership. Without repeating information in individual biosketches, summarize strengths, critical experiences, and accomplishments of the leadership relevant to the unit structure.
• Define the objectives of the entity/entities.
• Describe lines of authority, decision-making processes, management, and communications; and
• Describe plans for maintenance, revision, updates, and continued compliance to best practices for the data management systems of the ACSR.

Note: Supplementary documentation for the sub-section is requested under "Facilities and Resources" and "Other Attachments" (Attachments 1, 2, 3, and 5).

Sub-section F. AMC Biorepositories Unit:

Describe the plans for ACSR to continue serving the AMC Biorepository needs. Specifically address how the ACSR intends to maintain four existing entities:

• AMC Domestic Biorepository -- George Washington University;
• AMC Sub-Saharan Africa Biorepository-- Stellenbosch University;
• AMC Latin America Biorepository University of Sao Paulo; and
• ANCHOR Biorepository -- University of Arizona, Tucson.

Any proposed changes must be accompanied by a plan to facilitate these changes in a seamless manner for the AMC.

Following the requirements defined in Section I under Objectives and Scope of this NOFO, address the following elements for each entity proposed as AMC Biorepository:

• Describe the institutional location, leadership, and structure of each of the AMC Biorepositories;
• Describe plans for maintenance, revision, updates, and continued compliance to best practices for the informatics systems of the AMC Biorepositories;
• Discuss the processes of the ANCHOR Biorepository integration within the ACSR leadership and infrastructure; and
• Discuss CAP Accreditation (or its regional equivalent) obtained for the AMC Biorepositories and plan for attainment, if applicable.

Note: Supplementary documentation for the sub-section is requested under "Facilities and Resources" and "Other Attachments" (Attachments 1, 2, 3, and 4).

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.

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

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

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 and/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 the ability of the proposed Consortium to acquire, store, and equitably distribute biospecimens and associated data from patients with HIV-associated malignancies to researchers scientifically focused on HIV/AIDS and/or HIV-associated malignancies.

The Consortium must also organize and support biorepository banking activities for the AIDS Malignancy Consortium (AMC).

Finally, the Consortium must endeavor to more strategically enhance the inventory of rare and difficult to obtain HIV-associated malignancy specimens through a series of specimen sparing and optimizing initiatives.

For all roles, the reviewers will assess how the Consortium can adapt their activities to the evolving state of the cancer burden in people living with HIV/AIDS (both domestically and internationally) and how well the proposed approaches and technologies reflect the state-of-the-art in biospecimen science.

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?

Investigator(s)

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

Specific to this NOFO: How adequate are the qualifications and expertise of the proposed ACSR Leaders, RBR Leaders, other investigators, collaborators, and participants adequate to meet the unique goals and objectives of the ACSR? How well do the investigators represent the expertise that would be required for clinical, scientific and technical advancement of the ACSR? Have investigators demonstrated their ability to effectively contribute to the ACSR's scientific efforts in the past?

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?

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:

Proposed Overall ACSR Structure:

• How well does the plan ensure sufficiently centralized, effective leadership, administration, and oversight of the ACSR activities?
• How well does the proposed structure address issues regarding the efficiency, productivity, and communication for all the ACSR structural/functional units?
• How well does the overall plans for the organization and functioning of the resource clearly delineate roles and responsibilities, levels of oversight, and address the primary goals of acquiring, storing, and distributing specimens to the HIV research community?
• How sufficiently detailed and optimally structured are the proposed governance elements, including evaluation panels/committees?
• How well does the plan describe adequate centralized administrative support for the Chairperson(s) and ACSR enterprise?

ACSR Functioning: RBRs, AMC Biorepository, Technical Core:

• How adequate and appropriate are the plans for the collection, storage, and distribution of quality biospecimens and associated clinical data?
• How sufficient and realistic are the proposed accrual of new, rare, or difficult to obtain biospecimens (and associated data)?
• Specifically, what is the likelihood that the applicant(s) will be able to increase biospecimen donations to the ACSR in a manner that would properly reflect the identified priorities and changing patterns of the cancer burden among HIV-infected individuals?
• To what degree can the ACSR, as proposed, fulfill the goal of providing unique resources and/or services otherwise not available to the HIV/AIDS malignancy research community?
• How adequate are plans for equitable biospecimen distribution?
• How adequate, and appropriate are the plans and prioritization for specimen sparing and optimizing initiatives?
• How sufficient are the proposed efforts for continuous adjustments to resource functioning to meet the changing needs of external HIV/AIDS researchers?
• How adequate are the proposed systems for quality management?
• How appropriate and adequate are the proposed setup and procedures for serving the AIDS Malignancy Consortium (AMC) biobanking activities? Have the existing AMC Biorepositories demonstrated that they would adhere to established Standard Operating Procedures, protocols and collaborative agreements between the ACSR and the AMC?
• Are the ACSR plans in that regard optimal and sufficient for both domestic and international settings?

Working Groups and Strategic Planning:

• Are the structure and number of Working Groups appropriate and well selected?
• Will these Working Groups efficiently contribute to the ongoing refinement of the ACSR's biorepository efforts?
• Are the proposed plans for scientific and technical advancement of the ACSR progressive and timely?
• Are they likely to result in advancements that will benefit users of the ACSR and/or researchers in the field of HIV-associated malignancy/biorepository science?
• Do the plans describe a strong and revitalized marketing and outreach approach?

Data Management and Statistics Support (DMSS):

• How well does the plan for this unit(s) address the ongoing needs of the ACSR regarding data management and/or statistics support?
• How sufficient are the plans for data management and maintenance for the ACSR? How well do data management and maintenance plans address both internal and outward facing aspects of the information technology support needed for the ACSR enterprise?
• How adequate are the plans for statistics support? How well does the statistical support plan address both internal and outward facing aspects of the ACSR enterprise? How adequate are the plans focused on support for the ACSR "customer"?
• If the project involves human subjects and/or NIH-defined clinical research, how well does the plan(s) 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?

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: What is the likelihood that all the proposed ACSR structural/functional units and participating institutions will integrate into a cohesive environment? How sufficient is the evidence of commitment of the individual participating institutions in the activities of the ACSR?

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. 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 National Cancer Institute, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. 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 2.4.4 Disposition of Applications.

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.6. 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 Standard Terms and Conditions for Research Grants
• 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH 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.

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 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 (HHS) grant administration regulations at 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 purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 NIH as defined below.

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

• The PD/PI (or multiple PDs/PIs, if applicable) will have the primary responsibility for defining objectives and approaches for acquiring, storing, and equitably distributing tumor tissues and biological fluids from patients with HIV-associated malignancies;
• The PD/PI representing the application-submitting institution is expected to serve as the Chairperson of the ACSR;
• The PD(s)/PI(s) will assume primary responsibility for the ACSR serving as the AIDS Malignancy Consortium's (AMC) biorepository;
• The PD(s)/PI(s) will strategically develop and prioritize specimen sparing and optimizing initiatives to better use and enhance distribution of the extensive specimen archives of the ACSR;
• The Chairperson will oversee the update and maintenance of the Quality Management Plan, SOPs, Manual of Operations, and other policies and procedures that cover all aspects of ACSR activities;
• The ACSR Chairperson and other PDs/PIs (if applicable) will ensure that all RBRs and ACSR Collaborators receiving award funds for the acquisition, storage or distribution of biospecimens and data will continue to work towards compliance with the ACSR Quality Management Plan that reflects pertinent aspects of NCI's Best Practices for Biospecimen Resources (https://biospecimens.cancer.gov/bestpractices/2016-NCIBestPractices.pdf) and the International Society for Biological and Environmental Repositories Best Practices (http://www.isber.org/bp/);
• The ACSR Chairperson will ensure that all ACSR structural/functional units will undergo periodic evaluations that are commensurate with their roles in the ACSR;
• The ACSR Chairperson is expected to serve as the Chairperson of the Governing Committee (see below);
• The ACSR Chairperson is responsible for convening appropriate ACSR Working Groups and overseeing their activities (see below);
• The ACSR Chairperson is responsible for establishing and convening the External Advisory Board (EAB);
• The ACSR Chairperson will share the annual report of the EAB with the NCI Project Scientist if requested;
• The ACSR Chairperson will be responsible for providing the NCI Project Scientist a twice-yearly progress report indicating site/initiative/program-specific contributions to tissue acquisitions and tissue distribution in response to approved Letters of Intent. In addition, the progress report should include data regarding the utility of their specimens to the research community, including: Institutions requesting and receiving specimens, specimen types requested and distributed (both in number and as a percentage if the total collection), research published using samples from the ACSR, and major advances made using ACSR samples;
• The ACSR Chairperson will oversee the compliance of the ACSR with all the applicable regulations related to the protection of human subjects;
• The ACSR Chairperson, other PDs/PIs, and other senior representatives of the participating institutions will be expected to cooperate with the NCI in facilitating the conduct of the external evaluation of the ACSR program (to be coordinated by the NCI); and
• The recipient will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Responsibilities of the ACSR Chairperson's Administrative Office:

• The Administrative Office will perform the administrative coordinating activities of the ACSR's structural and functional units. They will provide logistical support for the conduct of meetings, telecommunications, the development of marketing materials and support for attendance at meetings/conferences for marketing purposes, travel, progress reports, ACSR programmatic tracking activities and other activities of the ACSR;
• The Administrative Office will provide support for the ACSR Chairperson in the preparation and maintenance of the Quality Management Plan, SOPs, MOO and other policies and procedures documents that cover all aspects of ACSR activities; and
• The Administrative Office will provide central support and coordination for the proposed performance evaluation processes of the RBRs and major functional/structural units and preparation of required reports associated with these activities.

Responsibilities of Regional Biorepositories (RBRs)/Technical Core (TC)

• Each RBR is expected to provide the infrastructure to acquire, store and distribute biospecimens and data for the ACSR enterprise. It is intended and expected that the RBRs will solely handle the storage/distribution of ACSR biospecimens and communication of associated data to the ACSR unit responsible for handling informatics;
• Each RBR must maintain both clinical laboratory and pathology units, and must include a pathologist as part of the key personnel;
• Each RBR must also include administrative and informatics elements that will perform RBR administrative duties and to manage clinical data and tissue and biological fluids related repository data;
• Personnel responsible for informatics elements of the RBR will supply biospecimen data update information to the ACSR's central informatics systems;
• Personnel responsible for administrative elements of the RBR will perform the RBR's self-auditing and reporting processes, and other administrative activities of the RBR. Administrative staff of the RBR will facilitate communication between the RBR and the Chairperson's Administrative Office;
• RBRs are expected to undergo yearly self-evaluations, and periodic site visits and internal evaluations to assure that their site is compliant with ACSR policies;
• RBRs must agree to provide access to biospecimens and associated data to investigators based on the prioritization of research proposals set by the REDP and final approval by the Governing Committee. RBRs must agree to abide by the decisions of the Governing Committee based on recommendations from the REDP;
• Each TC is expected to provide technical support for the ACSR’s specimen sparing and optimization initiatives; and
• TC(s) must maintain similar elements as the RBRs, such as clinical laboratory and pathology units, administrative and informatics elements, as appropriate for their role. TCs must agree to provide access to biospecimens and/or products of derivatives with associated data to investigators as is outlined above for the RBRs.

Responsibilities of Data Management and Statistics Support Unit (DMSS):

• The DMSS Unit will coordinate the activities of fielding inquiries, accepting requests for access to biospecimens and associated data, management of Letters of Intent (LOIs) and the coordination and communications regarding the distribution of biospecimens. This unit will be responsible for communications with the Executive Secretary of the REDP and the Governing Committee regarding LOI reviews and prioritization;
• The DMSS Unit will maintain the database of available biospecimens and clinical data;
• The DMSS Unit will be responsible for developing and instituting training programs for implementation and use of the ACSR's software tools as needed to fulfill the objectives and functions of the ACSR;
• The DMSS Unit will be responsible for collecting site-specific tissue acquisition and distribution information, and tracking information such as inquiries, LOI, acquisition and distribution information; and
• The DMSS must provide access to biospecimens and associated data to investigators based on the prioritization of research proposals set by the REDP and final approval by the Governing Committee. The DMSS must abide by the decisions of the Governing Committee based on recommendations from the REDP.

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

A staff member from the NCI Office of HIV and AIDS Malignancy Program will serve as the NCI Project Scientist for the ACSR. The NCI Project Scientist will have substantial scientific-programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Additionally, another NCI Program staff member acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The main responsibilities of substantially involved NCI staff members include the following:

• The NCI Project Scientist will serve as a voting member on the ACSR Governing Committee (GC);
• The NCI staff members will coordinate the logistics of the Review and Evaluation Decision Panel (REDP, see details below);
• The NCI Staff member will serve as the ex officio (non-voting) member and Executive Secretary of the REDP. In his/her role as Executive Secretary, NCI Staff will advise the ad hoc REDP members on the procedures for reviewing the proposals requesting biological biospecimens and clinical data. The REDP's decisions will be made independently from the ACSR or its Governing Committee;
• The NCI Project Scientist will provide technical assistance, advice, and coordination commensurate with his/her role, to assure that the Governing Committee, Advisory Committee(s), and REDP follow the NIH Guidelines on conflict-of-interest issues and play a critical role in promoting the availability and use of ACSR resources. The role of the NCI Project Scientist is to assist and facilitate, but not to direct activities of the ACSR;
• The NCI Project Scientist will act as a liaison between the ACSR and other Divisions, Offices and Centers of the NCI, specifically: NCI's Biorepositories and Biospecimen Research Branch (BBRB) as the ACSR works toward compliance with NCI's Best Practices; The Center for Global Health (CGH) as the ACSR continues to focus on collections from Sub-Saharan Africa and Latin America; and the NCI's Center for Biomedical Informatics and Information Technology (CBIIT). The Project Scientist will act as a liaison between the ACSR and other NCI/NIH-supported groups: The AIDS Malignancy Consortium (AMC); The NCI's National Clinical Trials Networks (NCTNs); and other NCI/NIH supported groups or individuals that could contribute to, or benefit from, the ACSR's mission;
• The NCI Project Scientist will act as an observer in internal evaluations; and
• The NCI staff members will coordinate external evaluations of the ACSR program.

Review and Evaluation Decision Panel (REDP): All research proposing to use biospecimens and data from the ACSR will be subject to evaluation by a panel of external experts, the Review and Evaluation Decision Panel (REDP). The REDP's decisions will be made independently from the ACSR or its Governing Committee. The NCI will coordinate the logistics for the REDP.

The NCI will have access to all data collected and/or generated under this Cooperative Agreement and may periodically review the data. The NCI may also review all records related to recipient's performance under the award.

The National Cancer Institute reserves the right to reduce the budget, to withhold support, and to suspend, phase out, or curtail a study or an award in the event of substantial shortfall in biospecimen accrual, data reporting, inadequate quality control in biospecimens or clinical data collection, non-adherence to biohazard precautions, refusal to carry out the recommendations of the REDP or the Governing Committee, or other substantial failure to comply with the terms of award. This right extends to the termination of specific sub-contractual arrangements in case of an underperforming structural/functional unit.

Areas of Joint Responsibility include:

A Governing Committee (GC) will serve as the governing body of the ACSR. GC will consist of the following voting members:

• ACSR PD(s)/PI(s) (ACSR Chairperson and co-Chair, if applicable) will collectively have one vote;
• One Representative of each ACSR functional unit (i.e., RBRs, AMC Repositories, and epidemiology/statistical leadership) will have one collective vote for the functional unit; and
• NCI Project Scientist(s) (if more than one Project Scientist is designated, they will collectively have one vote).

It is expected that the ACSR Chairperson will be the Chairperson of the GC.

The NCI Program Official will be a non-voting member of the GC.

Additional non-voting members may be added to the committee as needed.

Key responsibilities of the Governing Committee include:

• Administrative oversight for the ACSR enterprise;
• Final approval for LOIs;
• Recommendations regarding support for RBRs and initiatives based upon the results of evaluation procedures adopted by the ACSR;
• Develop evaluation criteria and processes for RBRs, the AMC Biorepository, the Data Management and Statistics Support unit(s) and other ACSR programs and initiatives;
• Make final decisions regarding changes to enhance the performance of the ACSR or address problems of performance, including modifications or cancellations of any sub-contractual arrangements under the ACSR award;
• Establish and maintain a Quality Management Plan that assures uniform collection methods and policies, and quality control of biospecimens and data;
• Develop an efficient, equitable and effective process to field inquiries, accept requests for access to biospecimens and associated data, review Letters of Intent (LOIs) and distribute biospecimens;
• Develop an efficient and effective process to identify emerging scientific and technical opportunities to improve the ACSR, evaluate these opportunities, and select the most promising opportunities for implementation;
• Evaluate Working Groups and adjust goals, objectives, leadership, membership, and other activities as needed; and
• Rulings on exceptions for sole RBR handling of the storage/distribution of ACSR biospecimens and communication of associated data to the ACSR data base.

The GC may form sub-committees as needed. Both the NCI Project Scientist and the Program Official may be members of such sub-committees as they deem appropriate (but will not chair those sub-committees).

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. The three members will be chosen as follows: a designee of the Governing 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 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

Consistent with the 2023 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 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 2 CFR Part 200 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]

Rebecca Liddell Huppi, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3324
Email: [email protected]

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

Dawn M. Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
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 2 CFR Part 200.