Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Center for Complementary and Integrative Health (NCCIH)

Funding Opportunity Title
Data Management and Coordinating Center (DMCC) for the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Collaborative Research Centers (CRC) (U24 Basic Experimental Studies with Humans Required)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
Reissue of RFA-NS-17-022
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-NS-22-020
Companion Funding Opportunity
RFA-NS-22-019 , U54 Specialized Center (Cooperative Agreements)
Assistance Listing Number(s)
93.853, 93.838, 93.837, 93.839, 93.840, 93.233, 93.855, 93.273, 93.213
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite new or renewal cooperative agreement applications for the Data Management and Coordinating Center (DMCC), which supports the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Collaborative Research Centers (CRC). This FOA will support the DMCC (U24) cooperative agreement that will focus on providing the infrastructure and support to the individual ME/CFS CRCs in their activities. Clinical data management for efficient data collection as well as data mining and data sharing will be addressed in the data management and coordinating center (DMCC). The ME/CFS CRCs will establish a network to facilitate research through: 1) collaborative basic and/or clinical research on ME/CFS; 2) provide and maintain tools for data and biospecimen sharing; 3) access to information related to ME/CFS for basic and clinical researchers, academic and practicing physicians, healthcare professionals, patients, and the lay public; and 4) facilitation of community outreach and engagement in the research activities.

Key Dates

Posted Date
February 16, 2022
Open Date (Earliest Submission Date)
April 24, 2022
Letter of Intent Due Date(s)

30 Days prior to application due date.

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
May 24, 2022 May 24, 2022 Not Applicable November 2022 January 2023 April 2023

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

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

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

Expiration Date
May 25, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

New or renewal applications (U24) are invited for the ME/CFS CRC Data Management and Coordinating Center (DMCC). In a companion FOA, the Trans-NIH Working Group also invites new or renewal applications (U54) for ME/CFS CRCs. The purpose of the DMCC is to facilitate and support basic and clinical research in the ME/CFS CRCs through1) data management for data mining, sharing and analysis across the ME/CFS CRCs; 2) management of biospecimen sharing in partnership with other NIH supported biospecimen repository resources; and 3) coordination of activities across the ME/CFS CRCs and in the outreach and partnership activities planned by the CRCs.

The ME/CFS CRCs working with the DMCC will perform research on ME/CFS within each CRC and in collaboration with other CRCs and investigators in the community. The ME/CFS CRCs and DMCC will utilize data standards and Common Data Elements to foster data sharing with the community. The DMCC will also coordinate tools for data sharing and for access to biospecimens in biospecimen repositories supported by NIH.

Background

The ME/CFS CRCs will partner with a single Data Management and Coordinating Center (DMCC). This initiative will support a collaborative and coordinated network comprised of investigators at multiple institutions/sites and patient advocacy groups committed to investigation of ME/CFS working in partnership to enhance communication and sharing of resources in a multidisciplinary approach. The DMCC together with the ME/CFS CRCs supports a comprehensive and integrated approach to data collection, storage, and management, and the integration of clinical data with other unique data, including, but not limited to genetic, imaging, pathologic, and laboratory data. This DMCC will serve the needs of the ME/CFS CRCs while striving to incorporate new approaches and technologies to increase efficiencies while lowering costs.

The ME/CFS CRCs (established under RFA-NS-22-019) will each consist of a group of multidisciplinary basic and clinical investigators, multiple institutions, and relevant organizations, including patient advocacy groups and will focus on areas of ME/CFS that are relevant to the interests of the participating NIH Institutes and Centers (ICs). The DMCC will serve as a resource, working with and providing expertise for the ME/CFS CRCs. It will provide a scalable coordinated clinical data integration of developed and publicly available datasets for data mining in the ME/CFS CRCs, tools for identification and access to biospecimens, and a user-friendly resource site for the public. In addition, the DMCC, in conjunction with the NIH, will provide logistical and administrative assistance for ME/CFS CRC activities; monitor compliance while addressing privacy and confidentiality issues related to database management, and multi-level data and biospecimen sharing. The ME/CFS CRCs will be expected to collaborate with the DMCC throughout the course of the studies in order to assure compatibility and standardization of data management approaches.

Organization of the ME/CFS CRCs and DMCC

The ME/CFS CRCs and DMCC will form a cooperative group composed of the ME/CFS CRC investigators and patient advocates and a single DMCC to facilitate research in ME/CFS carried out by the ME/CFS CRCs. A Steering Committee, composed at a minimum of the PD/PI (Director) of each ME/CFS CRC, the PD/PI (Director) of the DMCC, representatives of the patient advocacy groups, and the Administrator for each ME/CFS CRC will establish the procedures for the function of the ME/CFS CRCs, as outlined in section "Steering Committee."

The ME/CFS CRCs and DMCC will require cooperation among the Administrators for each ME/CFS CRC, the Director of each ME/CFS CRC and their collaborators, the Director of the DMCC, and the participating NIH IC Project Scientists to maximize their effectiveness.

The DMCC will develop and make available a secure, customizable coordinated clinical data management system for collection, storage, and analysis of diverse data types from multiple areas of ME/CFS research and from geographically disparate locations. The DMCC should develop and provide (as needed) a user-friendly system for web-based recruitment and referral, tools for data mining, and a portal for access and integration of publicly available data and biospecimen resources. The DMCC should have computational sophistication for scaling the systems and tools to allow incorporation into a distributed, national clinical information network. The DMCC must consider privacy and confidentiality issues related to database management and distributed computing and allow multiple levels of data sharing. The DMCC must also be able to work with consortia that have preexisting infrastructure (registries, patient databases, etc.), as well as those that are starting de novo. The Steering Committee will provide scientific and technical assistance and guidelines with respect to quality control, uniformity of data collection, management of the ME/CFS CRC database, and data analysis.

The DMCC will work collaboratively with the ME/CFS CRC to develop and maintain an overall website for the ME/CFS research network. The actual design and implementation of the website will be a collaborative activity of the DMCC and all of the ME/CFS CRCs through the Steering Committee (see below). The ME/CFS CRCs and the DMCC must work cooperatively to develop the web site resource and provide content related to ME/CFS. After receiving funding, the ME/CFS CRCs will work cooperatively with the DMCC to develop the web site resource and provide content related to ME/CFS. The DMCC will support the website for communicating ME/CFS information. The DMCC will provide information and tools on the website regarding available data and biospecimens either within the ME/CFS CRCs and DMCC or in other data and biospecimen repositories supported by NIH.

The DMCC will provide coordination, administration, data management, statistical support, and regulatory support (as needed) that are necessary to successfully support the ME/CFS CRCs and fulfill the following goals:

1) Provide medical and scientific leadership to enhance the overall effectiveness of the ME/CFS CRCs.

2) Provide assistance and/or management of scientific activities around study and protocol development, data analysis and results dissemination (as needed).

3) Provide all administrative activities for the ME/CFS CRCs working closely with the Administrators at each of the ME/CFS CRCs.

4) Provide all logistical and other support services for the ME/CFS CRCs.

Specifically, the DMCC will be responsible for the following research support activities:

1) Provide a secure, customizable, scalable coordinated clinical data management system for the integration of clinical data with other unique data, including genetic, imaging, pathologic, and laboratory. This support should include developing and/or adapting new technologies and technological advances to facilitate data collection, storage, and management from clinical researchers working on many different areas of ME/CFS research and from geographically disparate locations;

2) Provide a portal and tools for integration of developed and publicly available datasets for data mining at the ME/CFS CRCs;

3) Provide a user-friendly resource website for the public, research scientists, and clinicians for the overall project;

4) Incorporate new approaches to distributed computing and federated databases;

5) Incorporate new approaches to database support and clinical study management to reduce the burden of rising costs of software as well as reducing the time and financial burdens of clinical site audits;

6) Address privacy and confidentiality issues related to database management and distributed computing and allow multiple levels of data sharing;

7) Provide logistical and administrative assistance in arranging meetings of the Steering Committee and provide other operational support for the ME/CFS CRCs (e.g., communications, subcommittee meetings). The DMCC will prepare, distribute, and maintain minutes of the meetings;

8) Provide logistical and administrative assistance in arranging the annual ME/CFS CRC Director's meeting working together with the Steering Committee and NIH IC Project Scientists to plan this meeting;

9) Produce and maintain all ME/CFS research network documents, including Operating Policy and Procedures manuals;

10) Develop and maintain a "listserv" interactive email system for communication within the Consortium;

11) Provide scalable infrastructure. The ME/CFS CRCs and DMCC size and scope may expand in the future. A successful applicant must have the ability and resources to expand its operations to meet such future needs.

Organization and Governance

Data Management Coordinating Center (DMCC)

The DMCC is responsible for the coordination and administration of the ME/CFS research network; preparing minutes and reports for Network committees/ subcommittees, and the participating NIH ICs; statistical support, study design, and data analyses (as needed); preparing data reports; coordinating manuscript and presentation development; and coordinating meetings and activities of the ME/CFS CRC Steering Committee and other ME/CFS committees and subcommittees.

ME/CFS CRCs

The ME/CFS CRCs are supported by a separate award, described in detail in RFA-NS-22-019. The ME/CFS CRCs are responsible for conducting clinical study protocols consistent with the mission of the ME/CFS CRC program. ME/CFS CRC investigators are responsible for identifying, recruiting and retaining study subjects; entering data promptly and accurately into a web-based data collection system provided by the DMCC; and contributing to manuscripts and otherwise disseminating research findings in a timely manner. Study protocols will be submitted as part of applications to RFA-NS-22-019. In conjunction with the DMCC and Steering Committee (SC), the ME/CFS CRC Steering Committee will be responsible for developing common definitions and standardization across protocols. The ME/CFS CRCs will also participate intellectually in all aspects of the Network governance, including developing Network procedures and subcommittees. The PD/PI is directly responsible for ensuring that all aspects of ME/CFS CRC Network protocols conducted at each site are being followed. The PD/PI will be expected to propose and conduct sub-studies and participate fully in Network committees. The PD/PI will be expected to develop regular communication with investigators and administrators at each of the ME/CFS CRCs to identify and address enrollment, screening, adherence to protocols, and other Network issues.

The ME/CFS CRCs will also be responsible for the planning and collection of high-quality biospecimens that will permit the longitudinal molecular analysis of disease pathogenesis and recovery, as well as disease stratification and mechanistic studies. These samples will be available to the wider scientific community for mechanistic work conducted under other funding mechanisms through NIH-supported biorepositories.

NIH Program staff are responsible for organizing and providing overall support for the ME/CFS CRCs and for the overall management of the grants for the Network. In addition to regular grant stewardship, Project Scientists will be involved substantially with the awardees as a partner, consistent with the Cooperative Agreement mechanism.

Steering Committee (SC)

The SC will provide overall scientific governance for the ME/CFS CRCs and DMCC and will be comprised of each ME/CFS CRC PD/PI and Administrator, the PD/PI of the DMCC, and NIH Project Scientists. The SC will nominate a Chair, but NIH Project Scientists reserve the right to approve the nomination and may otherwise appoint a Chair for the SC. The Chair rotates every year. The SC formulates and implements all policy decisions related to the work of the ME/CFS CRC Network and establishes its scientific agenda.

The SC meets in-person at least one time annually and by teleconference monthly between the in-person meeting(s) to monitor the progress of the Network and consider special issues that arise. Administrative support for the SC will be provided by the DMCC.

IRB Approval

. All NIH funded studies being conducted at more than one U.S. site involving non-exempt human subjects research may be subject to the NIH Single IRB policy and/or the revised Common Rule cooperative research provision ( §46.114). It is expected that applicants will utilize a single IRB for multi-site clinical studies where the same protocol will be utilized. The intent of this policy is to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed as expeditiously as possible without compromising ethical principles and protections for human research participants. IRB application and review will be coordinated through the DMCC for all multi-center clinical studies when possible. IRB approval for clinical studies being carried out in individual Centers will be the responsibility of each ME/CFS CRC.

Coordination with and access to the NIH (Clinical and Translational Science Award) CTSA Program Consortium is encouraged. As appropriate, applicants are encouraged to employ the NCATS SMART IRB platform (https://ncats.nih.gov/expertise/clinical/smartirb) and Accelerated Research Agreements (https://www.ara4us.org/) for performance of clinical studies. Applicants are encouraged to consider potential collaborations on clinical studies with the CTSA Trial Innovation Network.

Administrative & Technical Committees

The ME/CFS CRCs and DMCC scientific and administrative work is assisted by a variety of committees whose membership is drawn from the ME/CFS CRCs, the DMCC, appropriate Project Scientists from NIH Institutes, and additional experts as needed. Committees may include protocol development committees, a publications committee, a finance committee, a biospecimen and a core lab committee. Other committees may be needed to support the research and outreach and partnership activities, and members will be drawn from the DMCC or from the ME/CFS CRCs and outside consultants, as needed.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Required:Basic Experimental Studies with Humans: Only accepting applications that propose clinical trial(s) that also meet the definition of basic research.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

Issuing IC and partner components intend to commit an estimated total of $500,000 direct costs to fund {1} award.

Award Budget

Application budgets are limited to direct costs of $500,000 per year.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
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.

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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.

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 more than one application, provided that each application is scientifically distinct.

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this 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 instructions in 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.

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:

Vicky Whittemore, PhD
Telephone: 301-496-1917
Fax: 301-402-1501
Email: vicky.whittemore@nih.gov

Page Limitations

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

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.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

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:Describe the overall aims of the proposed ME/CFS DMCC.

Research Strategy:Describe the proposed program for the DMCC. This description must include a detailed plan for addressing the DMCC responsibilities outlined below. The ability to carry out the proposed program must also be addressed. Describe the proposed data management and coordination program for the ME/CFS CRCs, indicating the experience in serving as a data management center for a large multi-institution research network. Describe the nature of the multidisciplinary team necessary to provide the internet, technical, and statistical resources required to maintain the DMCC, without duplicating information submitted on Biosketches.Applicants should describe the group expertise and experience of the PD(s)/PI(s) and other personnel as a whole and how they are suited to their roles in the DMCC without duplicating information submitted on Biosketches. Describe the leadership approach for governing the DMCC and coordinating and management of the ME/CFS CRCs, including plans for conflict resolution, and the organizational structure of the DMCC. Include plans and approaches for interacting with a consortium of basic and clinical investigators, institutions, and relevant organizations, including patient support organizations, focused on research on ME/CFS. To accomplish the program goals of the ME/CFS CRCs, the DMCC must serve as a core resource to the ME/CFS CRCs and be able to provide a number of services and activities. Describe novel organizational concepts and management strategies that will be utilized in the DMCC and in working with the ME/CFS CRCs. Include a description of methods that will be utilized for recruitment and outreach to individuals with ME/CFS.

Describe how the ME/CFS DMCC will be used by the ME/CFS Research Centers to store clinical data collected for ME/CFS CRC projects and cores. Describe how the ME/CFS DMCC will provide an essential data coordination tool for the entire ME/CFS research community through the development of a web-based data management system that provides tools to NIH-supported projects for both the collection and quality assurance of data in a standardized format. Describe how the ME/CFS DMCC will also coordinate the assembly of de-identified data into a common database thus enabling the query and distribution of aggregate data for the acceleration of ME/CFS research. For ME/CFS CRC projects, patient consent must allow broad sharing of de-identified data and biospecimen resources through the ME/CFS DMCC and the appropriate, approved biorepository, respectively, as appropriate.

Describe plans for the ME/CFS DMCC to conduct activities that are the sole purview of the DMCC including: 1) development of standardized electronic data forms, data formats and software for use across multiple cohorts and projects; 2) development of software to support study participant scheduling, site tracking, and facilitation and coordination of de- identified clinical and biospecimen data collection across multiple new cohorts and projects through an easy to use web-based entry system for submitters; 3) quality assurance checks of data entry and collections; 4) development of a user-friendly query system for users to evaluate availability of data and biospecimens within and across ME/CFS CRCs; 5) development of aggregate data report formats that are user-friendly and supported by well documented data dictionaries; 6) user training for both data submitters and data users; and 7) coordination of data and biospecimen summary reports and postings in collaboration with the approved biorepository. Describe plans for the development of all electronic data entry forms and quality assurance checks of de-identified data. Provide a proposed plan for work-flow and a proposed timeline for meeting the aims of the project, including strategies to ensure a robust and unbiased scientific approach to managing, integrating and coordinating the activities across the projects and resources required by the ME/CFS CRCs. Describe the ability for the DMCC to expand in future years to accommodate the possible growth and expansion of the ME/CFS CRCs.

Leveraging Existing Research Resources

Applicants are strongly encouraged to leverage existing NINDS research resources for their studies whenever possible. Such resources may include biospecimens from NINDS BioSEND repository or other cell and tissue repositories, such as the NINDS Human Cell and Data Repository (NHCDR) and the NIH NeuroBioBank, all of which bank biospecimens, cells and tissue.. Leveraging the resources and support from advocacy groups, private research foundations, academic institutions, other government agencies and the NIH Intramural program are also encouraged. Studies are also encouraged that leverage the resources of ongoing clinical trials supported through other Federal or private funds.

Clinical biospecimen collection

Applications proposing to collect biospecimens are strongly recommended to use the NINDS BioSpecimen Exchange for Neurological Disorders (BioSEND) repository including protocols and procedures, and all specimens collected and banked with BioSEND must come from individuals who have consented to banking and sharing broadly with academia and industry and must be consistent withNINDS BioSEND recommended consent language.

IMPORTANT: costs for biospecimen collection are not included as a component of the NINDS BioSEND repository award. Therefore, most costs for the biospecimen banking are borne by the grantees utilizing this resource (see NOT-NS-15-046). Applicants planning projects in which biospecimens will be collected are strongly advised to consult with NINDS Biomarkers Repository staff to obtain a quote for biospecimen banking costs (email: biosend@iu.edu).

Letters of Support:Each DMCC applicant must provide a statement that addresses how the institutional commitment will be established and sustained, and how the DMCC efforts will be given a high priority within the institution. The institutional commitment may be in the form of support for recruitment of scientific talent, provision of discretionary resources to the DMCC Director, assignment of space, sharing of resources, and/or other ways proposed by the applicant institution. Letters from a high-level institution official(s) (e.g., Dean of the School of Medicine, President, and Vice President for Research) should be attached confirming this commitment.

Consortium/Contractual Arrangements:Clearly describe the institutional commitment of the participating organization(s) (in the ways outlined above) to the DMCC Program.

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.

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data and Biospecimen 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 human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided 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 components of participating organizations, 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.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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 proposed Center address the needs of the research network that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing multidisciplinary, cross-institutional research? Do the investigators demonstrate significant experience with coordinating collaborative basic and/or clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure] appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application propose novel organizational concepts and/or management strategies in coordinating the research network the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts and/or management strategies proposed?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline


Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

s.For networks 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 Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

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

  • Recipients 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 DHHS, PHS, and NIH policies.
  • Coordinating the meetings of the Steering Committee that will be composed of the PDs/PIs of the DMCC and the Collaborative Centers.

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

The NINDS Project Coordinator will have substantial programmatic involvement that is above and beyond the typical stewardship role in other awards. The Project Coordinator, with no role in stewardship of the award, will provide technical assistance, advice, coordination, and other program actions to support the recipients of the cooperative agreement during the conduct of an activity. In addition to the Project Coordinator, a Program Officer (PO) will be responsible for normal program stewardship of awards and will sign off on the grant documents and be responsible for the stewardship of the award, including monitoring implementation of the data and research resource sharing plans. The PO is named in the award notice.

Other officials who can be advisory to the PO are:

  • The Project Team (PT), which is a group of NIH staff including subject matter experts (SMEs), that reviews and advises the PO on progress towards milestones and timeline but does not collaborate scientifically with the PI and does not have signing authority. The members are not listed on the Notice of Award.
  • An established oversight committee that will review proposed milestones and milestone progress reports from all the teams and provide feedback to the NIH. The Program Official will determine whether members of this committee have any connections to the projects that might constitute a COI. Members will be required to recuse themselves from reviews of any project for which they have a real or perceived COI.
  • The Program Official will approve final project milestone language based on feedback from the oversight committee and other NIH staff as is needed and appropriate.

Areas of Joint Responsibility include:

  • None; all responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

Finding Help Online: 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 instructions, 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)

Vicky Whittemore, PhD

National Institute of Neurological Disorders and Stroke
Telephone: 301-496-1917
Email: vicky.whittemore@nih.gov

Cheryl Mcdonald
National Heart, Lung, And Blood Institute (NHLBI)
Phone: 301-435-0545
E-mail: cm377e@nih.gov

Inna Belfer, MD, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-435-1573
Email: inna.belfer@nih.gov

M. Kathy Jung. Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
301-443-8744
Email: jungma@mail.nih.gov

Joseph J. Breen, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4123
E-mail: jbreen@niaid.nih.gov

Peer Review Contact(s)

Center for Scientific Review
Email: FOAReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS))
Email: ChiefGrantsManagementOfficer@ninds.nih.gov  

Leslye Fulwider
National Heart, Lung, And Blood Institute (NHLBI)
Phone: 301-480-9544
E-mail: leslye.fulwider@nih.gov

Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: shelley.headley@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Sufiyan Saeed
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3761
E-mail: sufiyan.saeed@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 2 CFR Part 200, 42 CFR Part 52, and 45 CFR Part 75.

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