Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Advancing Translational Sciences (NCATS)

Funding Opportunity Title
Multi-disciplinary Machine-assisted, Genomic Analysis and Clinical Approaches to Shortening the Rare Diseases Diagnostic Odyssey (UG3/UH3 Clinical Trial Not Allowed)
Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type


Related Notices

  • January 25, 2021 - Notice of Termination of RFA-TR-20-030. See Notice NOT-TR-21-018.
  • January 15, 2021 - This RFA has been reissued as RFA-TR-21-008.
  • September 18, 2020 - Pre-Application Webinar for RFA-TR-20-030. See Notice NOT-TR-20-037.

Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity


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


Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites researchers to submit applications for multidisciplinary diagnostic strategies for rare diseases that combine machine-assistance, genomic analysis, and clinical consultation. Of particular importance, these strategies must be able to be adopted and performed at the primary or secondary care levels by front-line healthcare providers and be readily integrated into their clinical care workflow.

Key Dates

Posted Date
August 28, 2020
Open Date (Earliest Submission Date)
October 12, 2020
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

November 12, 2020

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

January 2021

Advisory Council Review

May 2021

Earliest Start Date

July 2021

Expiration Date
November 13, 2020
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


Most rare disease patients experience years-long delays and often need to consult with multiple physicians and specialists before obtaining a correct diagnosis. This diagnostic delay is so pervasive in rare diseases that it is termed the diagnostic odyssey. Delays in obtaining a correct diagnosis lead to several problems for rare disease patients, such as undergoing redundant testing and procedures, misdiagnosis which may lead to inappropriate treatment, and importantly, substantial delays in obtaining disease-appropriate management and treatment, and when available, disease-modifying therapies. For many diseases, such as neurodegenerative disorders, delays in diagnosis can result in irreversible disease progression, and in some cases, the time window for intervention can be passed leading to unrelenting progression of the disease.

This FOA invites researchers to submit applications for support of clinical projects that address the critical need for timely identification and accurate diagnosis of rare disease patients. The Office of Rare Diseases Research (ORDR) within the National Center for Advancing Translational Sciences (NCATS) [along with the Institutes and Centers (ICs) listed in Part 1 at the National Institutes of Health (NIH)] intends to facilitate rare diseases research by enabling more rapid identification and diagnosis of patients, who may then be eligible for targeted interventions, research protocols (including clinical trials, natural history studies and registries, and epidemiologic studies), or disease-appropriate care and evaluation of their disease. Applications are being sought that propose diagnostic strategies that incorporate clinical consultation, machine-assistance and genomic analyses that could provide more rapid identification, escalation, and accurate diagnosis of hard-to-diagnose patients, and that could be readily integrated into front-line clinical care.


There are an estimated 7,000 different rare diseases, most of which (~85%) are monogenic disorders, many of which are very low prevalence disorders (<3,500, or fewer, patients in the US), and most have considerable within-disease phenotypic heterogeneity. Given the low prevalence, most front-line clinicians may have no prior experience with the individual diseases, which contributes to the difficulty in diagnosis, and often requires specialist, sub-specialist or multi-disciplinary referral to accurately diagnose the patient.

Current diagnostic approaches for hard-to-diagnose patients, many of which have rare diseases, are typically made through idiosyncratic specialist and sub-specialist referrals, often located at tertiary care and/or academic institutions. Specialists and sub-specialists are a scarce resource that may result in substantial time delays in obtaining appointments, and for some patients, may require travel of long distances for evaluation. Because rare disease and hard-to-diagnose patients often require multiple specialist referrals, and typically multiple tests and procedures, there can be substantial time delays in obtaining a diagnosis.

Genomic analyses are not routinely performed in clinical practice. In recent years, genomic testing has become more available, and for more commonly encountered conditions, a diagnosis may be readily made in the appropriate context. However, interpretation of genomic analyses for rare monogenic diseases is difficult, and often requires subspecialty evaluation and genetic counseling referral. These are also scare resources contributing to diagnostic delays.

Additionally, knowledge accumulation in rare genetic diseases is rapidly advancing; clinicians need access to accurate and up-to-date information that is readily available, and able to be integrated into clinical practice to facilitate rare disease recognition. The volume of this information is nearly impossible for clinicians to manage and machine-assistance to facilitate decision support has been recommended as an area of interest and development; however, currently most decision support is focused on common disease approaches, such as cardiovascular disease algorithms, and safety warnings for drug prescribing and interactions. Rare disease tools are being developed, but most are stand-alone programs that require clinician awareness, often require substantial data entry or training to use, and are not integrated into usual care. Similarly, voluminous information is available in healthcare system databases and electronic medical records (EMR), but the management of this information to facilitate diagnosis is challenging.

Thus, developing better diagnostic strategies that could incorporate clinical, machine-assisted and genomic analyses that could be readily integrated into front-line clinical care is likely to provide more rapid identification, escalation, and accurate diagnosis of hard-to-diagnose patients.

Clinical approaches for these projects may include multidisciplinary expert diagnostic teams, comprised of, for example, clinical specialists, informatics experts, geneticists, and other subject matter experts, who would work collaboratively to diagnose patients referred by primary care physicians, or the development of frameworks through which primary care providers can escalate a suspected rare disease patient to a multidisciplinary diagnostic team.

Artificial intelligence, including machine learning or other information technology (IT) (collectively referred to as machine-assistance ), components of the project may include the development of algorithms that computationally make predictions based on data. Machine assistance strategies may be applied to the EMR or other healthcare system databases, genomic data, imaging data, and other biological domains. Methods may include knowledge extraction, such as natural language processing; or machine capture and interpretation, such as facial recognition. The goal would be to develop and apply algorithms that could identify potential rare disease patients on the basis of, for example: medical utilization patterns such as high-utilizers, young age; sentinel characteristics or other features (e.g., abnormal gait, facial features, delayed development);imprecise diagnosis (e.g., neurologic disorder not otherwise specified, failure to thrive) or based on clusters of diseases that are related in some way, such as generalized seizures or motor impairment.

Research Objectives and Scope

The objective of this FOA is to promote the planning and development of multi-disciplinary rare disease diagnostic strategies that will rapidly identify and escalate hard-to-diagnose or undiagnosed patients, and that must be applicable to a broad array of rare diseases. Diagnostic strategies must integrate machine-assistance strategies, rapid genomic analysis or interpretation of a laboratory testing panel, and clinical consultation within the project. Importantly, these strategies must be able to be adopted and performed at the primary or secondary care levels by front-line healthcare providers, and must be readily integrated into their clinical care workflow.

Examples of approaches that could be incorporated into a diagnostic strategy supported through this FOA include, but are not limited to, those listed below. The overall approach must include one strategy each for clinical, genomic analyses and machine-assistance.

  • Clinical strategies:
    • Creation of a multidisciplinary expert diagnostic team
    • Creation of a framework through which primary care providers can rapidly escalate hard-to-diagnose patients
  • Machine-assistance
    • Development of disease-agnostic algorithms to identify hard-to-diagnose patients through the EMR or other healthcare system databases
    • Use of facial recognition or augmented reality software in the diagnostic process
    • Development of a strategy to seamlessly integrate machine-assistance into the diagnostic process, such as through machine-alerts to clinicians
  • Genomic analysis
    • Creation of a framework through which rapid genomic analysis will be obtained and interpreted
    • Identification of clusters of related disorders that could be escalated to laboratory/genetic panel-testing

The following approaches will be considered non-responsive to this FOA and will result in the application being withdrawn prior to review:

  • Strategies focused on the identification of a single disease or a narrow subgroup of rare diseases.
  • Strategies focused on diseases already identified by Newborn Screening.

This FOA will use the UG3/UH3 Cooperative Agreement mechanism. This funding mechanism involves two Phases. During the UG3 Phase (3 years), support will be provided to develop an innovative diagnostic strategy and pilot test the strategy at a single primary care setting. If successful, the UH3 period (2 years) will support the feasibility of disseminating the diagnostic strategy into at least one other clinical setting.

The UG3 Phase:

The primary focus of the UG3 phase should be on planning and developing a diagnostic process for rare diseases, and pilot testing of critical experimental parameters in a single primary care setting. The evaluation of this pilot testing should include quantifiable outcome measures.

Transition to the UH3 Phase:

Delineation of milestones is a key characteristic of this FOA. The application is expected to propose a well-defined set of milestones for the UG3 phase as well as the UH3 phase. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to enhance the likelihood that the project will be completed on-time and on-budget. It is understood that the proposed milestones for the UH3 phase may be revised as activities in the UG3 phase progress. In the event of an award, the PD/PI and NCATS staff will negotiate the final list of milestones for each year of support. Satisfactory completion of UG3 milestones will be assessed administratively to determine eligibility to transition to the UH3 implementation phase. The quality of the planning, design, and documentation products for the UH3 phase will be given key consideration when the NCATS considers the transition to the UH3 implementation phase. If at any time the project fails to make progress toward meeting milestones (e.g., developing a final protocol and/or manual of procedures including a detailed description of study procedures and process details, etc.), the NCATS may consider ending support and negotiating an orderly close-out of the award.Applicants and recipients of UG3 funding should note that the UG3 award does not guarantee subsequent UH3 funding. An administrative review of the extent to which peer-reviewed milestones are met in the UG3 phase will determine whether the UH3 phase award will be issued, subject to NCATS funding availability.

The criteria to determine whether a UG3 project will be continued into the UH3 Phase will be negotiated between the NIH and applicant prior to funding. The UG3 phase must include milestone-driven work to determine if the planning period is justified. Projects should have clear, testable components for each of the 3 required areas (clinical, genomic analysis, machine-assistance) and the research plan should use quantifiable measures for making a go/no-go decision to progress to clinical testing. Funding of the UH3 award will be determined by successful completion of UG3 scientific milestones as determined by the NIH.

The UH3 Phase:

The major goals of the UH3 phase are to disseminate the diagnostic strategy into at least one other clinical care setting and identify and overcome challenges to doing so. Ideally, this would include clinical care settings which reflect health disparities, and which differ with regard to demographic, geographic (e.g., rural versus urban), and socioeconomic factors.

Prior Consultation:

Applicants are strongly encouraged to consult with NCATS Scientific and Program Staff early on during the planning for an application. This early contact will provide an opportunity to discuss and clarify NIH policies and guidelines, including the scope of project relative to the intent of this FOA.

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

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCATS intends to commit $1,000,000 per year FY2021-2026 to fund up to 4 awards.

Award Budget

Direct cost funding support may not exceed $125,000 per year for the UG3 phase of awards and $250,000 per year for the UH3 phase awards.

Award Project Period

The scope of the proposed project should determine the project period.

The project period may not exceed 3 years for the UG3 phase.

The project period may not exceed 2 years for the UH3 phase.

The maximum project period for the entire UG3/UH3 award 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 Governments

  • U.S. Territory or Possession


  • 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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or registration, but 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.
  • Applicants must have an active DUNS number and SAM registration in order to complete the 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.

In view of the goals of this FOA, applicants should assemble a multi-disciplinary team with expertise in medical informatics, genetic analysis, rare diseases, and primary care when preparing the application.

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. This means that the NIH will not accept:

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Workspace or an institutional system-to-system solution. Links to apply using ASSIST or 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:

Carol Lambert, PhD

National Center for Advancing Translational Sciences (NCATS)

Telephone: 301-435-0814


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:Provide the overall goals or hypotheses for the entire project period and identify separate Specific Aims to be accomplished in the UG3 phase and in the UH3 phase.

Research Strategy:

  • Must provide separate sections that describe both the UG3 and UH3 phases
  • Must provide a description of the hypothesis to be tested in the UH3 phase of the study
  • Must include diagnostic strategies applicable to a broad array of rare diseases that integrate machine assistance, genomic analysis or laboratory panel testing and clinical consultation within the project that can be adopted and performed by front-line healthcare providers

Transition Milestones for transition from the UG3 Phase to the UH3 Phase

  • Must include clearly identified milestones for completion of the UG3 phase at the end of Year 3 and transition to the UH3 phase for 2 years of additional funding.
  • A timeline (Gannt chart) including milestones required for all components of the diagnostic strategy. Quantitative milestones are required in order to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review, but also in consideration of the awarded project for funding of non-competing award years.

The milestones and timeline for each stage must be provided in a separate heading at the end of the approach section for the UG3 and the UH3 component and include the following:

  • Provide detailed quantitative criteria by which milestone achievement will be assessed
  • Provide a detailed timeline for the anticipated attainment of each milestone and the overall goal

Identify any impediments that could require an addendum to the research plan, milestones, or timeline with a discussion of alternative approaches.

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.

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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 announcement, note the following: The UG3/UH3 cooperative agreement provides support for a bi-phasic approach to funding innovative exploratory and developmental research. It provides support for the first phase of the award. Only UG3 projects that meet the scientific milestones and feasibility requirements may transition to the UH3 phase.

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.


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:

To what extent will the outcomes of the proposed diagnostic strategy represent a substantial advance over available approaches for hard-to-diagnosis patients? How will successful completion of the aims change the methods for adoption of coordinated diagnostic strategies into clinical practice for suspected rare disease patients across the rare disease field?


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:

How strong is the rare disease, genomics, informatics and primary care research expertise of the PD(s)/PI(s) and Key Personnel involved in the multi-disciplinary diagnostic approach? Is there strong evidence that the PD/PI has experience leading a multi-disciplinary team and managing administrative functions? Is the Multi-PI leadership plan, if applicable, well-described, including plans for dispute resolution? Have project leadership and other key personnel demonstrated a record of directing research activities related to creating and validating the individual components of the diagnostic strategy within their areas of expertise?


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:

How strong is the justification/rationale provided that the diagnostic strategy is applicable to a broad array of rare diseases? How strong is the justification/rationale provided that the diagnostic strategy seeks to shift current research or clinical practice paradigms by utilizing multi-disciplinary and coordinated approaches to rare disease diagnosis, including machine-assistance, genomics/laboratory panel analyses and clinical consultation?


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?

Specific to this FOA:

How strong is the justification/rationale that the plan to develop and integrate a machine-learning tool into the diagnostic strategy will result in an improvement in rare disease diagnosis? To what extent will genomic/laboratory panel analyses contribute to an improvement in rare disease diagnosis? How strong is the justification/rationale that the plan to integrate the proposed diagnostic strategy into clinical practice is clear and feasible? To what extent will the measurement tools for assessing healthcare provider uptake and acceptance into clinical care provide interpretable information? For the UH3 phase, how strong is the justification/rationale that the plan for initiating the proposed diagnostic strategy at more than one clinical site is clear and feasible?

Milestones: Are appropriate, clearly-defined quantitative milestones provided for the UG3 and UH3 phases of the overall project? Are the UG3 and UH3 milestones feasible, well developed and quantitative with regard to the specific aims within each phase? Is the overall timeline feasible for the UG3 and UH3 phases? Are adequate criteria provided in the UG3 phase to assess milestone completion in order to make a decision to advance studies to the UH3 phase?

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?


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:

To what extent does the UG3 phase of the application provide for integration of the diagnostic strategy into a primary care setting? To what extent does the application propose sites to be chosen for the UH3 phase representing diverse primary care settings?

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.


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.


Not Applicable.


Not Applicable.


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 NCATS, 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 NCATS Advisory 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 grantee’s business official.

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

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see and

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 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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

  • Defining the details and goals of the project as a whole within the guidelines of this FOA.
  • Determining experimental approaches, designing protocols, setting project milestones and conducting experiments
  • Adhering to the NIH policies regarding intellectual property, data release and other policies that might be established during the course of this activity
  • Organizing and participating in monthly webinars with NIH program staff
  • Attending workshops organized by the NIH
  • Managing all data acquired in a coherent database that will be available to government and private partners.
  • Coordinating, cooperating, and participating with NIH staff in the scientific, technical, and administrative management.
  • Identifying and maintaining infrastructure and collaborations needed to support the development of the proposed diagnostic strategy.
  • Working with NIH Program Officials and industry partners to establish context of use, standardizing and validating approaches.
  • Performing established standardization and validation milestones.
  • Ensuring that all affiliated staff will maintain the confidentiality of the information developed by the investigations, including, without limitation, informatics tools, protocols, data analysis, conclusions, etc. as well as any confidential information received by third party collaborators.
  • Analyzing, publishing and/or publicly releasing and disseminating results, data and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and goals of the FOA.
  • Participating in a cooperative and interactive manner with NIH staff.
  • Sharing data, materials, informatics tools, methods, information and unique resources that are generated by the project as appropriate and in accordance with NIH policies in order to facilitate progress and consistent with achieving the goals of the FOA.
  • Ensuring that for activities that involve academic and/or industry collaborations within and outside the project there are appropriate research collaboration agreements (e.g. CRA, CDA, MTA etc.) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement terms of award as well as any additional applicable NIH policies and procedures.
  • Upon completion or termination of the project, ensuring all study materials, tools, databases and procedures developed from the project are broadly available (e.g., putting into the public domain) or made accessible to the research community according to the NIH-approved plan submitted for each project, for making data and materials available to the scientific community and the NIH for the conduct of research. The data sharing plan should include a plan to accomplish this within 90 days of the end of the study.

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

  • Coordinate and facilitate the activities of the program, attend and participate in all meetings for the project
  • Review the scientific progress and administrative accomplishments of the awardee, and review the project for compliance with operating policies and procedures, including meeting milestones. Based on this review, the Program Officer may recommend to the NIH to continue funding, or to withhold or restrict support for lack of progress or failure to adhere to NIH policies. Review of progress may include regular communications between the Principal Investigator and NIH staff, periodic site visits for discussions with research teams, fiscal review, and other relevant matters. The NIH retains the option of organizing periodic external review of progress.
  • Prepare up-to-date summaries of program accomplishments based on manuscripts provided by the awardee within two weeks of acceptance for publication
  • Participate in the process of setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols, project milestones or approaches as warranted.
  • Coordinate the efforts of the awardee with others engaged in diagnostic strategy research, including other awardees under this FOA and those awardees involved in related NIH programs;
  • Monitor milestone progress and help identify recourses if needed
  • Ensure that the awarded project(s) adhere to cooperative agreement data-sharing and other resource-sharing policies.
  • Facilitate collaborations with and access to other NIH-supported research resources and services.
  • Provide advice on project management and technical performance.
  • The NIH reserves the right to curtail or phase out the award in the event of (1) a substantial shortfall in accomplishing the management goals and responsibilities as stated in the reviewed application, (2) failure to meet procedures and milestones, and/or (3) substantive changes in the management of award(s) that are not in keeping with the objectives of the FOA.


The Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by project investigators and supported in whole or in part under this Cooperative Agreement. The Principal Investigator and Project Leaders are requested to submit manuscripts to the NIH Project Scientist within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the Principal Investigator and appropriate Project Leaders and will require appropriate acknowledgement of NIH support. Timely publication of major findings is encouraged.

Areas of Joint Responsibility include:

  • Collectively awardee(s) and the Project Scientist will determine criteria and processes for quality control of information and data to be posted for the research community, consistent with NIH policies and achieving the goals of the program as described in this Funding Opportunity Announcement.
  • Participate in recurring monthly meetings to discuss progress, obstacles and any other related issues and/or activities.

Intellectual Property

The successful development of diagnostic strategies and the integration of these strategies into clinical practice may require either substantial investment and support by private sector industries, and/or may involve collaborations with other organizations such as academic, other government agencies, and/or non-profit research institutions not directly involved in NIH programs. NIH recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees shall understand and acknowledge the following:

  • The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the applicant to perform the project.
  • Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.
  • The awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).


Awardees will retain custody of and have primary rights to the data and resources developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

3. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at 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: (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: (preferred method of contact)
Telephone: 301-945-7573 Customer Support (Questions regarding registration and Workspace)
Contact Center Telephone: 800-518-4726

Scientific/Research Contact(s)

Alice Chen Grady, MD
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-2015

Peer Review Contact(s)

Carol Lambert, PhD
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0814

Financial/Grants Management Contact(s)

Neena Gohil
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-451-8313

Section VIII. Other Information

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

Authority and Regulations

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

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