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 Human Genome Research Institute (NHGRI)

Funding Opportunity Title
Limited Competition for the Continuation of Clinical Sites for the Undiagnosed Diseases Network (U01 Clinical Trial Not Allowed)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type
New
Related Notices

RFA-RM-17-019 - Clinical Sites for the Undiagnosed Diseases Network (UDN) Phase II (U01)

RFA-NS-22-051 - Data Management Coordinating Center for Diagnostic Centers of Excellence (U2C Clinical Trial Not Allowed)

Funding Opportunity Announcement (FOA) Number
RFA-NS-23-004
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.853, 93.172
Funding Opportunity Purpose

The purpose of this Limited Competition Funding Opportunity Announcement is to allow Undiagnosed Diseases Network (UDN) Clinical Sites that received an NIH award under RFA-RM-17-019 an opportunity to compete for one additional year of NIH funding to: continue their participation in the UDN; establish collaborations and efficient processes with the next phase Data Management and Coordinating Center (DMCC; see: RFA-NS-22-051); enroll and evaluate new participants; and further develop their sustainability plans.

Key Dates

Posted Date
July 22, 2022
Open Date (Earliest Submission Date)
August 02, 2022
Letter of Intent Due Date(s)

August 2, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable September 02, 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
September 03, 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.

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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The participating NIH Institutes and Centers invite applications to continue Undiagnosed Diseases Network (UDN) Clinical Site awards issued previously in response to RFA-RM-17-019. This Funding Opportunity Announcement (FOA) is limited to those organizations and associated Program Directors/Principal Investigators (PD/PI) of UDN Clinical Sites who received an NIH award under the NIH Common Fund UDN program through RFA-RM-17-019. The purpose of this Limited Competition FOA is to allow these UDN Clinical Sites an opportunity to compete for one additional year of NIH funding to: continue their participation in the UDN; establish collaborations and efficient processes with the next phase Data Management and Coordinating Center (DMCC; see: RFA-NS-22-051); enroll and evaluate new participants; and further develop their sustainability plans as the network transitions to a sustainable national resource.

The overarching goals of the UDN are to:

  1. Facilitate research into the etiology of undiagnosed diseases by collecting and sharing standardized, high-quality clinical and laboratory data including genotyping, phenotyping, and documentation of environmental exposures.
  2. Demonstrate means to improve the clinical evaluation of difficult-to-diagnose patients using a collaborative team approach and investigating and validating promising new diagnostic technologies.
  3. Promote an integrated and collaborative community across multiple Clinical Sites and among laboratory and clinical investigators prepared to investigate the pathophysiology, cell biologic, and molecular mechanisms underpinning these difficult-to-diagnose conditions.

Objectives of this Research Program

The research goals and objectives of this FOA are the same as those described in RFA-RM-17-019, with the following modifications:

  1. Enrollment projections are commensurate with prior experience and success of the Clinical Site, and should be reflected in the budget. However, at a minimum, applicants must recruit, select, evaluate, and follow at least 15 participants in this project period, and participant evaluations must be completed by the project end date of the grant.
  2. Clinical Sites are still encouraged to recruit, select, evaluate, and follow participants with disorders in any clinical specialty. However, in the transition of the UDN to a larger network that serves diverse undiagnosed patient populations in the US (see: RFA-NS-22-051), applicants have the option to specialize in one or more areas of clinical practice including but not limited to pediatrics, neurology, cardiology, gastroenterology, immunology, metabolism, environmentally-linked or infectious diseases, etc.
  3. Applicants may propose streamlined and more efficient, cost-effective diagnostic approaches (e.g., remote visits, tiered evaluation strategies, use of innovative tools or strategies for record review, etc.), while still providing a comprehensive and expeditious clinical evaluation of participants.
  4. The funds provided under this Limited Competition FOA are intended to augment the sustainability plans established by Clinical Sites in Phase II of the UDN (see: RFA-RM-17-019). Applicants should implement the sustainability plans developed at their site and, when possible, seek reimbursement from non-NIH sources for all or part of the clinical evaluation and sequencing costs (e.g., by billing insurance, utilizing support from outside partnerships).
  5. UDN Clinical Sites are encouraged to recruit and enroll participants from health disparity populations, including those from racially/ethnically minority populations, from urban and rural areas who are economically disadvantaged, medically underserved, and/or those with limited English proficiency. In this application, Clinical Sites should prioritize patient costs for under/uninsured UDN participants and other costs that cannot be reimbursed through billing insurance or supported by outside partnerships.
  6. Costs associated with research-grade testing or sequencing and other research activities (e.g., RNA sequencing, gene function studies in model organisms, metabolomics, immunologic profiling etc.), specifically those that are deemed “investigational” and not reimbursed by insurance or outside partnerships, will be supported through subawards issued by the DMCC (RFA-NS-22-051) to be awarded in FY2023. Applicants have the option to budget some of the costs associated with the evaluation (e.g., whole genome sequencing) in this application, if non-reimbursable and justified.
  7. Develop further UDN sustainability plans as the network transitions to a sustainable national resource.

The awards funded under this FOA will be cooperative agreements (see Section VI.2.A. Cooperative Agreement Terms and Conditions of Award). Close interactions among the awardees and NIH will be required to maintain this complex network. Shortly after the awards, representatives of all UDN sites and NIH program staff will meet to plan approaches, identify barriers, and propose strategies for maintaining the network after the awards end.

UDN program governance is the same as described in RFA-RM-17-019, and will include a Steering Committee that, in collaboration with NIH Program Official(s)/Projects Scientist(s) and with advice from external Program Consultants, will be responsible for the scientific direction of the UDN. The voting members of the Steering Committee are described in RFA-NS-22-051 and include:

  • The contact PD/PI of all Clinical Sites and the PI of the NIH Undiagnosed Diseases Program (UDP).
  • The contact PD/PI of the DMCC (or the current UDN Coordinating Center if warranted).
  • A representative from the participating undiagnosed diseases patient advocacy group(s). The patient advocacy groups will have one collective vote.
  • NIH Program Official(s)/Projects Scientist(s) from participating Institutes. The NIH will have one collective vote.
  • Other key stakeholders including outside funding or resource partners.

Data Sharing under this Initiative

Data from the UDN are expected to be managed to increase the value of the significant public investment in the creation and operation of the Network. Consistent with achieving the goals of the program, NIH expects that the project datasets (phenotypic, genomic, environmental, covariates, and other relevant data and metadata) will be widely shared with the scientific community for research, while carefully observing standards of patient privacy, confidentiality, and management of health information in compliance with local, international, and federal regulations. Awardees must comply with the NIH Genomic Data Sharing Policy (https://gds.nih.gov/). Information is expected to be deposited in database repositories, such as dbGaP, and published in the scientific literature with plans for outreach beyond database repositories. Plans for data sharing are also expected to be sustainable and maintained after the award ends. The UDN Steering Committee will additionally develop and implement network-wide guidelines for data deposition.

Resource Sharing under this Initiative

Resources generated by the Clinical Sites are also expected to be widely shared within the UDN and with the broader scientific community for research as appropriate considering patient confidentiality. The UDN Steering Committee will develop and implement network-wide approaches for resource deposition and use including submission to national repositories as appropriate.

Interim and Final Reports

Applicants are expected to participate with the DMCC in preparing interim or a final report for the NIH, Program Consultants, and other key stakeholders, 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
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?

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

Funds Available and Anticipated Number of Awards

Issuing IC and co-funding ICs intend to commit an estimated total of $6,500,000 total costs to fund up to 11 awards, contingent upon available funds and submission of meritorious applications.

Award Budget

Application budgets are limited to $400,000 direct costs and need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 1 year.

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

This is a Limited Competition. The PD(s)/PI(s) must have received an NIH award through RFA-RM-17-019.

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. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their 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)

The PD(s)/PI(s) and applicant organization must have received an NIH award through RFA-RM-17-019. Applicants are limited to one application.

The PD(s)/PI(s) and applicant institutions must have received an NIH award through RFA-RM-17-019.

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

 In this Limited Competition FOA, only 1 Competing Renewal (Type 2) application per applicant is allowed.

Only one application per applicant organization is allowed. The PD(s)/PI(s) and their respective applicant organizations must have received an NIH award through RFA-RM-17-019.

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:

Argenia Doss
Telephone: 301-827-1373
Email: argenia.doss@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.

Facilities and Other Resources:

Applicants should describe the relevant institutional environments which would facilitate the effective implementation of the proposed program including but not limited to: bioinformatics infrastructure, capabilities, and computational resources; consultative and statistical resources; and geographic distribution of space and personnel. Applicants should also describe existing or planned resources that would be available to the Clinical Site, such as clinical and laboratory facilities, private funding or other resource partnerships (e.g., established during Phase II of the UDN as part of the site's sustainability plans), and participating and affiliated institutions and units.

Non compliant applications will not move forward in review.

SF424(R&R) Senior/Key Person Profile

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

The PD(s)/PI(s) must have received an NIH award through RFA-RM-17-019, and at least one must devote a minimum of 2.4 person months (20% of full-time professional effort) to this Program.

R&R or Modular Budget

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

Clinical services and sequencing costs for UDN participants should be billed to insurance when allowed. However, Clinical Sites must also plan for participants who are uninsured or under-insured and should include these costs in their budgets if justified and not reimbursable by billing insurance or through outside partnerships. Applicants may also budget other costs associated with the clinical evaluation (e.g., whole genome sequencing) if not reimbursable or supported by other sources of funds.

Include costs to support the travel, room and board for economically disadvantaged UDN participants, if needed and not covered by outside partnerships.

Do not include costs associated with research-grade testing or sequencing (e.g., RNA sequencing, metabolomics, immunologic profiling, etc.) and other research activities (e.g., gene function studies in model organisms) that can be supported through subawards issued by a Data Management Coordinating Center (RFA-NS-22-051) to be awarded in FY2023.

In the budget justification, include an estimate of the number participants your site expects to enroll who are insured vs. under/uninsured, and the per-patient costs to conduct the clinical evaluation and sequencing (if indicated) in each case.

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

List each aim for the Clinical Site and how it supports the Objectives of this Research Program as described in Section I. Funding Opportunity Description.

Research Strategy

Describe how the following responsibilities for the continuation of this Clinical Site will be accomplished:

  • Clinical Sites are still encouraged to recruit, select, evaluate, and follow participants with disorders in any clinical specialty. However, in the transition of the UDN to a larger network that serves diverse undiagnosed patient populations in the US (see: RFA-NS-22-051), applicants have the option to specialize in one or more areas of clinical practice (e.g., pediatrics, neurology, cardiology, gastroenterology, immunology, metabolism, environmentally-linked or infectious diseases, etc.). Applicants should describe unique strengths such as systems- or disease-specific clinical expertise available at their site; the specific area(s) of clinical practice that the site intends to pursue; and their willingness and approach for making such expertise available network-wide.
  • Clinical Sites are expected to utilize the sustainability plans that they established in Phase II of the UDN, when possible, and continue to develop outside funding and resource partnerships in this project year as the UDN transitions to a sustainable national resource. Applicants should prioritize patient costs for under/uninsured UDN participants and other non-reimbursable costs. Describe the site’s current sustainability options (and those being developed) including plans for billing insurance or obtaining support from outside partnerships to cover clinical services and other associated costs (e.g., genome sequencing) in the evaluation of participants. Describe and justify which costs are not reimbursable through insurance or outside partnerships at your site and thus require NIH funds. Do not include costs associated with specialized testing or sequencing, and other research activities that can be supported through subawards issued by a Data Management Coordinating Center (RFA-NS-22-051) to be awarded in FY2023.
  • Describe plans to recruit and enroll participants from health disparity populations, including those from racially/ethnically minority populations, from urban and rural areas who are economically disadvantaged and medically underserved and/or those with limited English proficiency. The costs for clinical services of under/uninsured UDN participants should be prioritized in application. Include plans to support the travel, room and board for economically disadvantaged UDN participants, either through outside partnerships or using NIH funds.

Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project, including:

  • Prior experience and success of your site in: participating in Phase II of the UDN; recruiting, enrolling and completing the evaluation of UDN participants in Phase II and whether enrollment milestones were met.
  • The proposed approaches, and potential alternatives to performing the various Clinical Site tasks as summarized below. Additional tasks not detailed here but, in the applicant’s view, essential to UDN operations should be noted and potential approaches described. Applicants should articulate their plans for all aspects of participant recruitment, selection, consent, and counseling; clinical evaluation and data collection; investigation of family members, where appropriate; final diagnosis and, if feasible, recommendations for medical management and treatment of participant; return of information to affected participants, their families, and their referring physicians; transfer of care to referring clinicians; participant follow-up for psychosocial, health, and other relevant outcomes; data analysis and re-analysis when appropriate; data sharing and publication(s); and complementary laboratory and gene function studies, as appropriate to make a diagnosis.
  • Novel approaches that increase the efficiency, yield, and cost-effectiveness of the diagnosis (e.g., remote visits, tiered evaluation strategies, use of innovative tools or strategies for record review, etc.), while still providing a comprehensive and expeditious clinical evaluation of participants.  Describe the evaluation of those cases (and under what conditions) that require assessment by a complete array of medical professionals and consultants including an in-patient stay and/or well–coordinated multidisciplinary outpatient evaluations.
  • The willingness of applicants to adhere to network-wide policies and procedures for the key UDN Clinical Site functions described above as well as network-defined timelines for recruitment, data collection, and accurate submission of process and tracking data and scientific variables such as phenotype, genotype, and environmental exposures data. Describe plans for, and willingness to abide by Memoranda of Understanding (MOU) or other sharing agreements potentially needed for data and sample sharing within the UDN.
  • Plans to continue collaborating in the central collection and distribution of inquiries across sites, sharing of chart review, potential use of special participant evaluations at specific Clinical Sites to take advantage of local expertise, and transfer of participants among Clinical Sites based upon expertise, interest and geographic proximity to the participant.
  • Plans to collect data on genotype, phenotype, and environmental exposures including plans to work with the Data Management and Coordinating Center (DMCC) to optimize data collection (such as use of standard collection tools or ontologies) and analysis strategies, and facilitate public access to the UDN data through the DMCC and organizations such as the National Center for Biotechnology Information (NCBI), which maintains NIH databases such as dbGaP, to optimize data analysis and public access to the data.
  • Providing a timeline to recruit, enroll and complete the clinical evaluation of at least 15 affected UDN participants within the project year. Plans to meet these recruitment goals should be described, as should plans for analyzing exome or genome, metabolomics, and gene function studies in model organisms in the project period.

Integration and collaboration are essential tasks for UDN Clinical Sites. Applicants should describe the following:

  • Plans to collaborate with the DMCC, other UDN Clinical Sites, UDN research cores and laboratories, and NIH Program Officials and Project Scientists to design and implement UDN operations and implement protocols. This includes reviewing and modifying draft protocols and operating guidelines developed for handling participant inquiries, reviewing prior diagnostic efforts, accepting participants for and conducting detailed evaluation, collecting and submitting data, discussing results with affected participants, their families, and their clinicians, and conducting follow-up and program assessment.
  • Plans for identifying and solving operational problems involving recruitment, data collection, quality assurance and refinement of protocols and the UDN Manual of Operations. Applicants should suggest plans that will assist in developing collaborations between clinical and laboratory scientists both within and outside the UDN.
  • Applicants should indicate their willingness to participate in a network that uses a single IRB. The UDN will use a single IRB at the NIH to accelerate IRB approval of network-wide protocols.

Bioinformatics Plan

Propose a plan for bioinformatics analysis to include:

  • Plans for how bioinformatics infrastructure, capabilities, and computational resources in place (or readily obtainable) as described in Facilities and Other Resources will be leveraged.
  • Bioinformatics approaches and innovation to provide the best utilization of the data produced by the UDN including innovative approaches capable of identifying rare and novel diagnoses.
  • Plans to collaborate with the DMCC and other UDN sites to develop and disseminate bioinformatics tools and resources within the UDN and to the scientific community to improve the UDN model.

Assessment, Dissemination, Outreach, and Training

Propose a plan for assessment, dissemination, outreach, and training to include:

  • Collaborating with the DMCC and other Clinical Sites to assess and disseminate data, protocols, consent materials, and methods developed for or derived from the UDN within and outside the Network.
  • Assisting the DMCC to develop and implement appropriate educational and outreach materials for participants, clinicians, and other researchers.
  • Continuing training activities to expose students, fellows, staff, and faculty to the UDN model.

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.

The following modifications also apply:

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

Letters of Support: Institutional and other external commitments to providing a comprehensive and expeditious clinical evaluation, evaluating uninsured participants, and sustaining the program beyond this grant award support are encouraged.

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 provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review 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.

For this particular Limited Competition announcement, note the following: all applicants have received a UDN Common Fund award under RFA-RM-17-019. Reviewers may consider prior progress and productivity from this award, and whether recruitment milestones were met by the Clinical Site in Phase II of the UDN.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

Will this project make a significant contribution to the overall goals and objectives of the UDN and assist in the diagnosis of participants who suffer from rare or difficult-to-diagnose diseases?

Will the Clinical Site’s conceptual design and overall operating plan provide the required strategy and resources to advance the diagnoses of rare or difficult-to-diagnose diseases?

Does the applicant effectively leverage their sustainability plans developed in Phase II of the UDN (see RFA-RM-17-019) and is the proposal likely to contribute to the transition of the UDN to a sustainable national resource?

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:

Have the PD(s)/PI(s) and research team demonstrated from their Phase II UDN award (RFA-RM-17-019) that they have:

  • the required experience and expertise in evaluating and managing difficult-to-diagnose participants and are they recognized within and outside their institutions as expert diagnosticians?
  • a track record of meeting enrollment milestones?
  • a track record of working collaboratively and disseminating findings?
  • the appropriate experience in managing complex, projects involving teams of scientists?
  • a track record of collecting, analyzing, and publishing phenotypic and genomic data?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

Have the applicants proposed creative new strategies that have the potential to increase the efficiency, yield, and cost-effectiveness of the diagnosis, while still providing a comprehensive and expeditious clinical evaluation of participants?

As new technologies become available, is the research team poised to recognize when they are sufficiently developed and validated to be added to the UDN protocols?

Are the bioinformatics approaches described state-of-the-art and likely to provide the best utilization of the data produced for the UDN?

Will this research advance the use of genomics, related technologies and the use standard protocols in clinical management of patients with rare or difficult-to-diagnose diseases?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

Specific to this FOA:

Do the project plan and bioinformatics plan propose cutting edge, innovative approaches capable of identifying rare and novel diagnoses?

Will the Clinical Site’s conceptual design and overall operating plan effectively investigate the underlying pathogenicity of the UDN’s rare and yet to-be-described diseases?

Will the Clinical Site’s design and operating plan provide ample opportunity for collaboration, integration, and interaction within the UDN in order to diagnose participants and investigate UDN disease phenotypes?

Are the applicants effectively using their sustainability plans developed in Phase II of the UDN to support the clinical evaluation and other costs when indicated?

Does the applicant have an effective plan for recruiting and enrolling participants from health disparity populations, including those from racially/ethnically minority populations, from urban and rural areas who are economically disadvantaged and medically underserved, and/or with limited English proficiency?

Are NIH resources being appropriately used to support the clinical services of under/uninsured UDN participants when necessary?

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 to this FOA:

Are the resources, equipment, and infrastructure available and in place (or readily obtainable) to support the clinical evaluation of participants at the Clinical Site?

Are the bioinformatics infrastructure and capabilities and computational resources in place (or readily obtainable) and adequate to support the project?

Are institutional resources and infrastructure being committed or leveraged?

Are adequate plans in place for the evaluation and referral for care of uninsured or under-insured participants including those from health disparity populations?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

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

2. Administrative and National Policy Requirements

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

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

The administrative and funding instrument used for the UDN will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipient is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by working jointly with the award recipients in a partnership role. The NIH will not have primary responsibility for the execution of the award. The prime responsibility resides with the recipient of, although specific tasks and activities may be shared among the recipient and the NIH as defined below. 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. The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

  • Determining research approaches, designing protocols, setting project milestones, and conducting research.
  • Participating in group activities, including a network-wide Steering Committee and working groups as needed.
  • Refining and implementing the resulting consensus framework at their UDN site and network-wide, in collaboration with the Data Management Coordinating Center (DMCC) and NIH UDP.
  • Providing protocols, reports, and data in a timely fashion as agreed upon by the Steering Committee.
  • Submitting all data from UDN participants as soon as they are collected to the DMCC for quality control and compilation in a network-wide dataset to be made available to all Clinical Sites (including the NIH UDP), as agreed upon by the UDN Steering Committee, and deposited in database repositories such as dbGaP.
  • Preparing abstracts, presentations, and publications and collaborating network-wide in making the public and professionals aware of the program.
  • Assessing and disseminating data, protocols, consent materials, and methods developed for or derived from the UDN within and outside the Network.
  • Developing and implementing appropriate educational materials for participants, clinicians, and other researchers.
  • Adhering to policies regarding data access, publication, and intellectual property established by the NIH and the UDN Steering Committee.
  • Abiding by common definitions, protocols, and procedures, as chosen by a majority vote of the UDN Steering Committee.
  • Accepting and complying with study policies established by NIH and with additional non-conflicting policies approved by the UDN Steering Committee.
  • Submitting periodic progress reports in a standard format, as agreed upon by the Steering Committee and Trans-NIH UDN Working Group.
  • Attending and participating in UDN Steering Committee meetings and accepting and implementing decisions by the Trans-NIH UDN Working Group, as appropriate.

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

The Project Scientist(s) will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. However, the role of NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the UDN and that NIH staff will be given the opportunity to offer input to this process. The Project Scientist(s) will participate as members of the Steering Committee and will have one vote. The Project Scientist(s) will have the following substantial involvement:

  • Participating with the other UDN Steering Committee members in addressing issues that arise with UDN planning, operation, assessment, and data analysis. The Project Scientist(s) will assist and facilitate the group process and not direct it.
  • Serving as a liaison, helping to coordinate activities, including acting as a liaison to other NIH Institutes/Centers, and as an information resource for the recipients. The Project Scientist(s) will also help coordinate the efforts of the UDN with other groups conducting similar efforts.
  • Attending all Steering Committee meetings as a voting member and all Working Group meetings, assisting in developing operating guidelines, quality control procedures, and consistent policies for dealing with situations that require coordinated action. The Project Scientist(s) will be responsible for working with the grantee as needed to manage the logistic aspects of the UDN.
  • Reporting periodically on UDN progress to the Trans-NIH UDN Working Group and through it to the NIH National Advisory Neurological Disorders and Stroke Council.
  • Serving on subcommittees of the Steering Committee and Working Groups as appropriate.
  • Assisting recipients in the development, if needed, of policies for dealing with situations that require coordinated action.
  • Providing advice on the management and technical performance of the award.
  • Assisting in promoting the availability of the data and related resources developed in the course of this program to the scientific community at large.
  • Participating in data analyses and interpretations where warranted.
  • Other Trans-NIH UDN Working Group staff may assist the recipient as designated by the Program Official.

Additionally, an agency Program Official (PO) or IC Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

Close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to manage, assess, and disseminate the UDN model. The recipients and the Project Scientist(s) and PO will meet in person or virtually with the program Steering Committee on a quarterly schedule or as needed to share information on data resources, methodologies, analytical tools, as well as data and preliminary results. PDs/PIs, key co-investigators, and preand post-doctoral trainees, especially those who are members of underrepresented minority groups or those from different but related disciplines, are eligible to attend these meetings.

The Steering Committee will serve as the main scientific body of the program. The Steering Committee will be responsible for coordinating the activities being conducted by the program. The Steering Committee membership is defined in Part 2. Section 1. Funding Opportunity Description. The Steering Committee may add additional members, and other government staff may attend the Steering Committee meetings as desired. The Steering Committee may establish working groups as needed to address particular issues, which will include representatives from the program and the NIH and possibly other experts. The UDN Steering Committee will have the overall responsibility of assessing and prioritizing the progress of the various working groups and other needed subcommittees.

The Clinical Site recipient agrees to work collaboratively to:

  • Assist in refining a common approach for participants with Undiagnosed Diseases.
  • Participate in network-wide processes for participant selection and assignment to specific Clinical Site for evaluation.
  • Provide secure, accurate, and timely data submission.
  • Participate in presenting and publishing new processes and substantive findings
  • Assess and disseminate the UDN model.
  • Participate in the governance of the UDN as a member of the Steering Committee.
  • Interact with other relevant NINDS and participating NIH Institute activities, as needed, to promote synergy and consistency among similar projects.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the 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, 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)

Argenia Doss
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-1373
Email: argenia.doss@nih.gov

Jyoti Dayal
National Human Genome Research Institute (NHGRI)
Phone: 301.480.2307
E-mail: jyotig@nhgri.nih.gov

Peer Review Contact(s)

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: nindsreview.nih.gov@mail.nih.gov

Financial/Grants Management Contact(s)

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