Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Limited Competition: AIDS and Cancer Specimen Resource (ACSR) (UM1 Clinical Trials Not Allowed)

Activity Code

UM1 Research Project with Complex Structure Cooperative Agreement

Announcement Type

Reissue of RFA-CA-13-005

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-CA-18-012

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

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

93.393, 93.394, 93.395, 93.396, 93.399 

Funding Opportunity Purpose

 Through this limited competition Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) solicits a single application for the continuation of the AIDS and Cancer Specimen Resource (ACSR). If awarded, the eligible applicant institutions (which are the two current NCI-supported ACSR lead institutions) 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 and Sub-Saharan Africa. As the AMC is currently expanding its agenda to include Latin America, it is expected that the ACSR will collaborate with the AMC to develop regional biorepository support for AMC activities in Latin American countries. The continuing ACSR must have appropriate strategies and capabilities to address several high priority areas of specimen acquisition including specific types of cancer (AIDS-defining as well as non-AIDS defining), types of biospecimens and accompanying clinical data, and biospecimens from geographic areas of interest.

Key Dates

 

Posted Date

August 9, 2018

Open Date (Earliest Submission Date)

 October 15, 2018  

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

November 15, 2018, by 5:00 PM local time of applicant organization. All  applications allowed for this funding opportunity announcement are due on this date.

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

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

AIDS Application Due Date(s)

November 15, 2018, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review

February-March 2019

Advisory Council Review

May 2019

Earliest Start Date

July 2019

Expiration Date

November 16, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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

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

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

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

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Through this limited competition Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) solicits a single application for the continuation of the AIDS and Cancer Specimen Resource (ACSR). If awarded, the eligible applicant institutions (which are the two current, NCI-funded ACSR lead institutions) 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 HIV-associated malignancies. In addition to serving 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.) and Sub-Saharan Africa (SSA). As the AMC is currently expanding its agenda to include Latin America, it is expected that the ACSR will collaborate with the AMC to develop regional biorepository support for AMC activities in Latin America.

    The continued ACSR must have appropriate strategies and capabilities to address several high priority areas of specimen acquisition including specific types of cancer (AIDS-defining as well as non-AIDS defining), types of biospecimens and accompanying clinical data, and biospecimens from geographic areas of interest.

    Key Terms for the FOA

    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 someone infected with HIV confirms a diagnosis of AIDS. People infected with HIV are at risk of several other types of cancer, collectively called "non-AIDS-defining cancers." These malignancies include anus, liver, oral cavity/pharynx, and 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 HIV-positive patients. AMC Biorepositories correspond to an ACSR unit that serves the biorepository needs for the AMC.

    Background

    There are approximately 36.7 million people living with HIV/AIDS (PLWHA) worldwide.  Advances made throughout the thirty-plus 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 PLWHA. 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 PLWHA 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 papilloma virus (HPV).

    In 1993, a lack of high quality biospecimens from patients with HIV 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 towards identifying potential genetic, viral, and environmental cofactors contributing to the development of malignancies in people living 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 activities of the AMC's US-based program; in 2013, the AMC's sub-Saharan African program; and in 2014, the AMC's Anal Cancer HSIL (high-grade squamous intraepithelial lesion) Outcomes Research (ANCHOR) Trial. The ACSR will be expected to continue the aforementioned AMC activities and grow its supportive biorepository role to accommodate the AMC's expansion into Latin America.

    The current structure of the ACSR consists of five RBRs and a Central Operations and Data Coordinating Center that are governed and coordinated by an Executive Committee, all supported by a single UM1 award.

    Objectives and Scope of this FOA

    This FOA 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. and SSA, as well as their current expansion into Latin America.
    • As development of the AMC biorepository in Latin America matures, the ACSR will work with the site to expand its capabilities as a Regional Biospecimen Repository (RBR) of the ACSR in Latin America, with the goal of fully integrating the RBR into the ACSR in the third year of the award.
    • 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.

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

    1) Collection of tumor tissue specimens from HIV-infected people should be prioritized over blood and bodily fluids from HIV-infected people, 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 rapidly and efficiently accommodate future changes. 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 towards less invasive approaches, ultimately leading to decreased availability of patient specimens for research purposes. The applicant(s) are 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 Diverse Collections. The ACSR must maintain diverse 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. ACSR Chairpersons' Administrative Office

    2. Working Groups for Scientific Programs and Strategic Planning

    3. Regional Biospecimen Repositories

    4. AMC Biorepositories

    5. Informatics and Epidemiology/Statistics Support

    Specific requirements and expectations for these characteristics are outlined below.

    ACSR Chairpersons' Administrative Office

    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 ACSR Chairpersons' Administrative Office 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, define clearly 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, information technology 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) Information technology strategic planning regarding internal aspects of the database platform and the database platform's outward interface, including website development, etc.;

    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)

    The five existing 'core' repositories 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 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. One of the expanded expectations of the ACSR awardee is collaboration with the AMC in the development of a Latin American AMC Biorepository. As development of the AMC biorepository in Latin America matures, the ACSR will work with the site to expand its capabilities as a Regional Biospecimen Repository (RBR) of the ACSR in Latin America, with the goal of fully integrating the Latin American RBR into the ACSR in the third year of the award.

    Informatics and Epidemiology/Statistics Support

    ACSR should have a structural/functional unit(s) to support continued maintenance of the ACSR database platform, 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; 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.

    A Steering Committee: This committee acts as a strategic 'think tank' for the ACSR. The Steering Committee should include experts from outside the ACSR to provide input/advice regarding issues brought to them by the Governing Committee.

    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, Steering Committee 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
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    Renewal

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

    Clinical Trial?

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NCI intends to fund one award for $4.1 million in fiscal year 2019. The financial plans of the NCI provide support for this initiative through 5 years.

    Award Budget

    Application budgets should reflect the actual needs of the proposed project.

    Proposed budgets for years 1 and 2 must not exceed $4,100,000, in total costs each year.

    Proposed budgets for years 3, 4, and 5 must not exceed $4,600,000, in total costs each year.

    Award Project Period

    Applicants must request a project period of up to 5 years.  

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Only two lead institutions that are currently supported by the ACSR award under RFA-CA-13-005 (whose PDs/PIs serve as the ACSR senior leaders, i.e., Cooperative Group Chair and Vice-Chair), are eligible to serve as applicant organizations for this limited competition FOA. Either of these two institutions may submit the application. 

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

    Required Registrations

    Applicant Organizations

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

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    If only one individual is designated as the PD/PI, this individual should have primary affiliation at the application-submitting institution and would be expected to serve as the "Chairperson" of the ACSR.

    Applicants are encouraged to designate an additional PD/PI affiliated with the second ACSR lead institution (who could serve as ACSR Co-Chairperson). 

    If the multiple PDs/PIs option is used, the PD/PI from the application-submitting institution should serve as contact PD/PI.    

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit only one application. scientifically distinct.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

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

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

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    Rebecca Liddell Huppi, Ph.D.
    Telephone: 240-781-3324
    Fax: 240-541-4520
    Email: liddellr@exchange.nih.gov

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following exceptions or additional requirements for the Research Strategy subsections listed below:

    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): 12 pages

    Sub-section E. Informatics and Epidemiology/Statistics Support Unit: 6 pages

    Sub-section F. AMC Biorepositories Unit: 6 pages

    Instructions for Application Submission

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

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

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

    • ·    For each Regional Biospecimen Repository provide documentation of the collective team scientific expertise and capacity to acquire, store, and distribute biospecimens and data for the ACSR enterprise. List also 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, as well as AMC Biorepository 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.

    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 member's affiliations and fields of expertise. Other critical characteristics may also be listed, if appropriate; and
    • Summary Table of RBRs. For each RBR/institution 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.

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

    • Table of contents for the attachment;
    • Summary tables by year (2013-2018) 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 (2013-2018) 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" (2013-2018) 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 (2013-2018) that include information such as: TMA description, RBRs contributing samples for the TMA, number of cores, number of cuts*; and
    • Summary tables for other distribution types, such as: products of derivatives (PODs), data, and Aperio ImageScope digital images*.

    *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 (2013-2018) 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 International 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 ANCHOR Biorepository

    • ·    Summary table(s) demonstrating the biorepository activity associated with the trial.

    Attachment 5: Informatics and Epidemiology/Statistics. Provide the following information as a PDF file with the name "Informatics and Epidemiology/Statistics".

    • Table of contents for the attachment;
    • Organizational flow chart;
    • Software Architecture Diagram;
    • Entity Relationship Diagram; and
    • Software Development Life Cycle.

    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; 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
    • ·    Informatics development and maintenance SOPs
    SF424(R&R) Senior/Key Person Profile

    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 Informatics and Epidemiology/Statistics Support Units.

    Name a senior investigator with primary affiliation at a U.S. institution, who will serve as a liaison for the Latin American AMC Biorepository site.

    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 biosketches 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 Informatics and Epidemiology/Statistics Support Unit, the biosketches 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 10% 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;
    • ·    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 ($150,000 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 unforeseen events and piloting emerging scientific opportunities. These funds may be used to immediately respond if a natural disaster threatens existing resources. 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 (excluding Latin America RBR): budget the same dollar amount for years 1-5, amounting to approximately 60% of total budget request for years 1-2. This amount should support five RBRs through appropriate sub-contractual arrangements. The sub-budgets for individual RBRs are expected to range from approximately of $150,000 to $500,000 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. 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; and
    • Travel of senior RBR staff to in-person Governing Committee and/or Steering Committee meetings.

    Latin America RBR Unit: budget of approximately $350,000 in direct costs (for years 3-5 only) is recommended for this Unit. The budgeted amounts should be adequate to support the continued development and maintenance of the Latin America RBR.

    • As appropriate, the budget for Latin America RBR may cover personnel costs and other costs/expenses mentioned for other RBRs.
    • Additional items specific to Latin America RBR include:
    • ·    Costs associated with oversight and coordination of the RBR by the ACSR Administrative Office; and
    • ·    Appropriate personnel costs for the effort of the individual designated as a U.S. Liaison and travel funds for that individual to the Latin American site.

    Informatics and Epidemiology/Statistics Unit: The budget for this unit should be adequate for its required functions and may include (but is not limited to):

    • Personnel costs (for senior IT and Statistical/Epidemiology leadership and statistical and IT staff members;
    • Maintenance of the cloud-based database, ACSR website, equipment, maintenance contracts; and
    • Travel of senior informatics and Epidemiology/Statistics staff to in-person Governing Committee and/or Steering Committee meetings.

    AMC Biorepository Unit: the budget for this Unit should amount to approximately 12% of total budget requested for years 1-2 (and should remain at the same dollar level for years 3-5).

    • The budget for this Unit should be adequate to support (via sub-contractual sub-budgets) the AMC Biorepositories at GWU and the sub-Saharan Africa AMC Biorepositories.
    • Costs under this unit may include the laboratory costs for biospecimen processing, storage, protocol specific distribution of biospecimens to central laboratories, and informatics 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.
    • Do NOT include any infrastructure costs for the ANCHOR Biorepository (as such costs will be covered by the AMC award through a sub-budget to the ANCHOR biorepository site). However, costs for the ANCHOR Biorepository's informatics system development and its harmonization with the other AMC Biorepositories may be supported through this unit.

    NOTE: Do NOT include costs pertaining to the first 2 years of the Latin America AMC biorepository site selection and development; these activities will be supported by the NCI directly beyond this FOA (via an Administrative Supplement to the AMC).

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Specific Aims

    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, RBR, Informatics, and Epidemiology/Statistics. Address the following elements:

    •  ACSR Biorepository activities and, if appropriate, AMC Biorepository activities and RBR activities
    • ·    acquisitions/curations/distributions
    • ·    requests vetted/approved
    • Other accomplishments
    • ·    administrative
    • ·    technical
    • ACSR collection overview
    • Major adjustments to the organization
    • Working Groups
    • ·    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.

    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 FOA, 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, steering, and performance-evaluation bodies. Provide general desirable characteristics for the members of such bodies (no specific candidate names are needed); and
    • Describe the infrastructure to support the required administrative activities of the ACSR Chairperson, including, but not limited to, logistics and organization of meetings, and preparation of required reports associated with performance evaluation.

    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):

    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. If there is a proposed addition and/or elimination of an RBR there should be an accompanying explanation for this proposed change.

    For each RBR, address the following elements:

    • Describe the overall structure of the RBR. This structure may be formed in a way that best suits the needs of the RBR, but should include administrative and informatics elements along with strong infrastructure to acquire, store and distribute biospecimens and data for the ACSR.
    • 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. Informatics and Epidemiology/Statistics Support Unit(s):

    Explain how this unit will address ACSR informatics needs, including development of appropriate database solutions for data management and their maintenance. In addition, describe the unit that provides epidemiology/statistics research support for both ACSR customers requesting specimens and for the ACSR, itself. 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 informatics 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 three existing entities:

    • ·    AMC Domestic Biorepository -- George Washington University;
    • ·    AMC Sub-Saharan Africa Biorepository-- Stellenbosch University; 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 FOA, 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; and
    • Discuss limitations and restrictions of the AMC informatics systems and ongoing efforts to serve the informatics needs of the biorepositories while also accommodating the informatics tools of the AMC.

    For development of a Latin American AMC Biorepository (years 1 and 2) and integration into the ACSR of the Latin American RBR (years 3-5), address the following elements:

    • Explain how the designated ACSR liaison will assist the Latin American site to adhere to established Standard Operating Procedures, protocols and collaborative agreements between the ACSR and the AMC;
    • Describe the process for site identification and development of a new Latin American Biorepository that will be developed in association with the AMC;
    • Provide information on the processes already undertaken for site identification;
    • Outline plans to fully and efficiently expand the Latin American AMC Biorepository to also serve as an ACSR Latin American RBR (beginning the third year of the project period); and
    • Provide plans for involving foreign investigators in ACSR activities, especially in continued training and capacity building activities that may serve to improve the Latin America site.

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

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

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    PHS Assignment Request Form

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

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

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

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

    For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NCI, NIH. Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed.

    Post Submission Materials

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

    Section V. Application Review Information
    1. Criteria

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

    For this announcement, note the following:

    The emphasis of this FOA 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).

    For both 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 there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

    Investigator(s)

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

    Specific to this FOA: 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 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? 

    Specific for this FOA:

    Proposed Overall ACSR Structure:

    • 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?
    • Do 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?
    • Are the proposed governance elements, including steering and evaluation panels/committees structured optimally and described in sufficient detail?
    • Does the plan describe adequate centralized administrative support for the Chairperson(s) and ACSR enterprise?

    ACSR Functioning: RBRs, AMC Biorepository:

    • Are the plans for the collection, storage, and distribution of quality biospecimens and associated clinical data adequate and appropriate?
    • Is the proposed accrual of new, rare, or difficult to obtain biospecimens (and associated data) sufficient and realistic?
    • 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 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?
    • Are the proposed setup and procedures for serving the AIDS Malignancy Consortium (AMC) biobanking activities appropriate and adequate? Have the existing AMC Biorepositories demonstrated that they will 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?
    • Based on the plans described, what is the likelihood that the Latin American RBR will be efficiently and optimally incorporated into the ACSR?

    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?

    Informatics and Epidemiology/Statistics Support:

    • How well does the plan for this unit(s) address the ongoing needs of the ACSR regarding Informatics and/or Statistics support?
    • Are the plans for informatics and database management, development, and maintenance sufficient for the ACSR? Do they address both internal and outward facing aspects of the information technology support needed for the ACSR enterprise? 
    • Are the plans for Epidemiology/Statistics support adequate? Do they address both internal and outward facing aspects of the ACSR enterprise? Do the plans adequately focus on support for the ACSR "customer"?
    • If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  
    Environment

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

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

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

    Inclusion of Women, Minorities, and Children 

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

    Not Applicable

    Renewals

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

    Revisions

    Not Applicable

    Additional Review Considerations

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

    Applications from Foreign Organizations

    Not Applicable.

    Select Agent Research

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

    Resource Sharing Plans

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

    Authentication of Key Biological and/or Chemical Resources:

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

    Budget and Period of Support

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

    2. Review and Selection Process

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

    As part of the scientific peer review, all applications:

    • Will receive a written critique.

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

    Applications will be assigned to the appropriate NIH Institute or Center. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

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

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

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

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

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Part 75and other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

    • 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 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 (http://biospecimens.cancer.gov/practices/2011bp.asp) 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 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 awardee 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)

    • 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; and
    • 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.

    Responsibilities of Informatics and Epidemiology/Statistics Support:

    • The Epidemiology/Statistics Support 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 Informatics Unit will maintain the database of available biospecimens and clinical data;
    • The Informatics Unit will be responsible for developing and instituting training programs for implementation and use of the ACSR's software tools;
    • The Informatics Unit and/or the Epidemiology/Statistics Support 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 Informatics Unit and/or the Epidemiology/Statistics Support 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. The Informatics Unit and/or the Epidemiology/Statistics Support must agree to 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. This designated Program Official may also have substantial involvement as a Project Scientist).

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

    • The NCI Project Scientist will serve as a voting member on 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, Steering Committee, 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 towards 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 developing a new AMC Biorepository in 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 awardees' 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);
    • Representatives of each ACSR functional unit (i.e., RBRs, AMC Repositories, and epidemiology/statistical leadership); 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 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 Informatics and Epidemiology/Statistics 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). One expected sub-committee to be formed is an Steering Committee (see below).

    • Steering Committee: This sub-committee of the GC is expected to function as a scientific 'think tank' for the ACSR. The Steering Committee may include representatives from RBRs, the informatics and statistical unit(s), Working Groups, and other aspects of the ACSR. It is suggested that the Steering Committee includes one or two external research scientist(s) with expertise in the field of HIV-associated malignancy research. It is expected that this sub-committee will have an AMC representative. The Steering Committee should be comprised of members that have a broad level of expertise, including expertise in HIV, HIV and cancer, epidemiology, anatomic/clinical pathology and biospecimen/biorepository sciences. The Steering Committee should meet at least one time per year.

    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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    3. Reporting

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

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

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

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

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

    Scientific/Research Contact(s)

    Rebecca Liddell Huppi, Ph.D.
    National Cancer Institute (NCI)
    Telephone: 240-781-3324
    Email: liddellr@exchange.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

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

    Section VIII. Other Information

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

    Authority and Regulations

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

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.