Part 1. Overview Information

Key Dates

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

NIH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This emergency funding opportunity announcement (FOA) from the National Institutes of Health (NIH) provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Radical (RADx-rad) Initiative.

Specifically, this FOA seeks to fund a single cooperative agreement for a RADx-rad Data Coordination Center (DCC) to serve as a communication center and data hub for RADx-rad awardees.

The funding for this award is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.

Background

SARS-CoV-2 is a novel coronavirus that has recently been identified as the causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe viral pneumonia, Acute Respiratory Distress Syndrome (ARDS), Multisystem Inflammatory Syndrome in Children (MIS-C), acute kidney injury, thrombotic disorders, and serious cardiac, cerebrovascular and vascular complications. On March 11, the SARS-CoV-2 outbreak was classified as a pandemic by the WHO. Research is an important component of the public health emergency response before, during and after the emergency. The United States Food and Drug Administration (FDA)-authorized COVID-19 diagnostic testing is critical for slowing the spread of the virus and preventing future outbreaks. Given this, there is an urgent public health need for the National Institutes of Health (NIH) to support the development of a variety of approaches to testing.

Expanding the capacity, throughput, and regional placement of existing technologies and accelerating the development of new technologies will contribute significantly to the current national efforts to curb the COVID-19 pandemic. To help meet this need, NIH launched the Rapid Acceleration of Diagnostics (RADx) program to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. The RADx program is a national call for scientists and organizations to bring their innovative ideas for new COVID-19 testing approaches and strategies.

As a part of this program, the NIH developed the RADx Radical (RADx-rad) initiative. RADx-rad will support new, or non-traditional applications of existing approaches, to enhance their usability, accessibility, and/or accuracy. RADx-rad will be centrally aligned and coordinated to harmonize the data collection, storage, and management, providing an opportunity to further explore and identify additional approaches to understand this novel virus. Beyond the current crisis, it is anticipated that the technologies advanced through RADx-rad may also be applicable to other, yet unknown, infectious agents.

The RADx-rad Data Coordination Center (DCC) will provide overarching support and guidance to RADx-rad awardees in the following three areas: (1) Administrative Operations and Logistics, (2) Data Collection, Integration and Sharing, and (3) Data Management and Use.

The DCC will be the hub in a hub-and-spoke organizational framework within RADx-rad, and the spokes, in this framework, will be the funded RADx-rad projects. Further, the DCC will also serve as a spoke in the larger NIH initiatives by providing deidentified individual data to an NIH-based data center. The DCC, will provide management, direction, and overall coordination of the RADx-rad awardees as it relates to data management and common data elements. The DCC will also serve as a liaison between the RADx-rad awardees and other NIH-supported RADx initiatives.

• The RADx-rad DCC will provide support and guidance to RADx-rad awardees in the following three areas: (1) Administrative Operations and Logistics, (2) Data Collection, Integration and Sharing, and (3) Data Management and Use. The DCC will develop (and revise as necessary) a framework for standards, metadata and common data elements that apply to all types of data gathered by RADx-rad awardees in order to maximize potential for longitudinal research, integration with other RADx data, and for evaluation of RADx-rad program impact. The DCC will provide access to data that result from the RADx-rad projects, coordinate quality control, data curation, and analyses, and provide tools to monitor progress, performance, and use of the curated data. The DCC will create a mechanism to support harmonizing RADx-rad data with data from other large-scale COVID-19 research efforts and will participate in trans-NIH efforts to support scientific collaboration and data-sharing, evaluation of progress towards sustainable infrastructure, partnership and rapid dissemination of RADx findings. RADx-rad awardees are expected to work with the RADx-rad Data Coordinating Center (DCC) to submit common evaluation metrics on COVID-19 testing-related outcomes and implementation to the DCC.

Specific Research Objectives

1. Administration and Coordination
   The administrative functions include facilitating the work of the RADx-rad research awardees and NIH scientific staff in the overall program management of the initiative. Activities should include, but are not limited to:

• Leadership and project management for the administrative and data coordinating functions
• Establish and manage committees and communication mechanisms that bring together the RADx-rad PIs and NIH Program and Science officers; establish a DCC Steering Committee to develop policies governing matters such as (e.g., authorship, communications, data sharing, etc.); establish a RADx-rad Governance Committee); establish a Data Safety Monitoring Board, and provide logistics and management support, such as organizing meetings, and maintaining documentation
• Develop an organizational and administrative structure to promote communication, provide technical assistance, and facilitate interaction across the RADx-rad awardees, including maintaining a RADx-rad directory and a web-portal to assist with information sharing
• Establish and implement an evaluation plan for the RADx-rad program, including a logic model, evaluation data collection, processes to specify, track, and assess testing milestones, and metrics of success
• Prepare and distribute regular reports to RADx-rad awardees, NIH and regulatory agencies, including progress and data summaries; participant demographics, enrollment and COVID-19 testing data; Data Safety and Monitoring Board reports, interim findings, and scientific outputs such as publications and presentations
• Implement a DCC data management model (i.e., RADx-rad hub) that serves as a repository for data from the RADx-rad awardees (i.e., RADx-rad spokes), and that will also provide appropriately deidentified data for inclusion in larger NIH data integration model.
• Bring awardees together to reach consensus around appropriate data standard, CDEs and data sharing methods for management of diverse data sets (e.g., qualitative, quantitative, EHR, geospatial, healthcare systems and settings, implementation data types), such that preparation of de-identified data for public use is supported

2. Data Collection, Integration and Sharing
   The DCC will manage data collection, integration, and sharing for the RADx-rad awardees. It will apply appropriate biomedical informatics and data science approaches for managing a broad range of data types, including identifying approaches for harmonizing and merging data where feasible, working with latent variable structures, and other strategies to create a data ecosystem for the RADx-rad consortia . The DCC should also have expertise in the design and analytic methods appropriate for studies that test and evaluate technologies for human use. Activities must include at least the following:

• Build a DCC data management capability (i.e., RADx-rad hub) that serves as a repository for data from awardee projects (i.e., RADx-rad spokes), and that will also link to the NIH data hub in the larger NIH data integration framework.
• Facilitate data standardization, harmonization, integration, and analysis across RADx-rad projects
• Provide expertise and assistance on data sharing, IRB and other human subject issues, including cross-consortium human subjects consent and assent procedures
• Document and recommend standards for describing data sources, common data elements, vocabularies, storage and integration methods that support FAIR data use
• Provide consultation on use of standards, common data elements, common data models taking into account existing standards and resources including:
  • Data Harmonization for Social Determinants of Health via the PhenX Toolkit: (www.phenxtoolkit.org)
  • NIH Common Data Elements (CDE) Repository https://cde.nlm.nih.gov/
  • Use of trans-NIH COVID-19 survey items via the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/]
  • Use of OMOP models (https://www.ohdsi.org/data-standardization/the-common-data-model/)[B[1] when applicable
  • Implementation of the schemas proposed under the ABOUT ML effort ( Annotation and benchmarking on understanding and transparency for machine learning lifecycles ; available at https://www.partnershiponai.org/about-ml/
• Develop agreements about the structure and content to enable sharing and aggregation required by multiple projects. The use of standard vocabularies, CDEs and data dictionaries will support joint analyses and sharing.
• Maintain up-to-date knowledge and expertise on new COVID-19 related diagnostics and provide frequent communication to the RADx-rad awardees about new testing approaches, FDA-authorization or approval status, testing supply availability, and considerations for the implementation of emerging testing protocols
• Communicate and provide technical assistance, as needed to encourage adherence to federal health data standards including FHIR (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-122.html) and USCDI (https://www.healthit.gov/isa/sites/isa/files/2020-03/USCDI-Version1-2020-Final-Standard.pdf), where applicable and within scope.
• Provide support for adherence to federal health data standards including FHIR (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-122.html) and USCDI (https://www.healthit.gov/isa/sites/isa/files/2020-03/USCDI-Version1-2020-Final-Standard.pdf)- which includes three NLM supported vocabulary standard for codes (and names) for drugs, tests diagnoses, symptoms, some social determinants of health, some psychologic scores and all of the Medicare/Medicaid assessments.

3. Data Management and Use
   The RADx-rad DCC will provide expertise and disseminate information on emerging and new innovations on COVID-19 diagnostics and test modalities.

• Establish a secured, centralized, user-friendly data warehouse for RADx-rad that can accept individual participant data including unique participant IDs but does not contain personal identifiers. The data resource should be designed to promote and leverage standardization of data collection by identifying common data elements (CDEs) of COVID-19 and social determinants of health (SDOH) to be collected across the RADx-rad projects; prepare and release data sets in consultation with the DCC Steering Committee in accordance with determined timelines and milestones
• Provide access to tools and resources that support needs of RADx-rad members to make their data FAIR
• Develop model requirements or characteristics of successful tests, including the availability of automatic data capture as well as use of standard LOINC outputs, identity management, device identifiers, etc.
• Provide access to useful and practical administrative data systems that may assist research sites in identifying high-risk populations and subpopulations where increasing testing may be most useful. A centralized data warehouse with integrated data across the RADx-rad projects and related administrative data should be available for secondary data analysis to the RADx-rad awardees and the broader research and practice community.

Resources and Infrastructure
The DCC must have ready access to appropriate infrastructure to accomplish DCC activities and processes, including relevant administrative and support services, data storage and management capacity, and expertise to meet the objectives of the DCC.
Large datasets procured under this program (e.g., claims or EHR data) should have provisions of re-use, including in data use agreements and Informed Consent for NIH funded COVID or other NIH funded studies (intramural and extramural).

Data and Resource Sharing
The RADx-rad program requires sharing of resources, with broad availability of policies, practices, materials, protocols, tools and testing technologies to facilitate collaboration across multiple programs as well as reuse and replication by a range of researchers and private entities when applicable. Developing creative approaches that foster the development of artificial-intelligence ready data sets (AI-Ready data sets) is highly desired. Applicants are required to provide an overarching data and resource sharing plan. The NIH expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals, with full understanding Data and Resource sharing may not be applicable for all research sites or projects. The final Resources and Data Sharing Plan is expected to be developed in conjunction with RADx-rad awardees post award.

The DCC must address how it will preserve utility of resources for the future. Resources produced, coordinated, and shared through the DCC should be transferable, such that other individuals or teams can continue if the original investigators are unwilling or unable to do so.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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

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

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 not allowed.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. 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. In the case of Emergency awards, if the applicant is unable to comply with the requirement to complete and maintain SAM registration at the time of application submission, contact the agency immediately.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov 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.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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)

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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

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:

Valerie Bartlett
Telephone: 301-594-5400
Email: [email protected]

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

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.

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

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

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

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.

The central functions of (1) Administration, (2) Data Collection, Integration and Sharing and (3) Data Management and Use are within this application. A single unified budget is expected.

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

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

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

The application should explain how the following central functions will be done: (1) Administrative, (2) Data Collection, Integration and Sharing, and (3) Data Management and Use. A single research plan narrative covers all the activities of the various central functions.

Describe how the proposed Center will work with awardees to develop consensus on metadata standards, common data elements, terminologies, data sharing approaches and other data strategies to advance understanding of testing for and preventing the disparate effects of SARS-CoV-2 and/or COVID-19.

Applicants must provide evidence that the infrastructure, resources, and institutional support needed to achieve the goals are available. Applications should include a plan that demonstrates they have ready access to infrastructure and personnel (e.g., coordinating and contracting outside the institution) to accomplish DCC activities and processes, including relevant support services, data management and analytic support, and real-time analytic capacity. The plan should include provisions for reuse related to large datasets procured under this program (e.g., claims or EHR data), including in data use agreements and Informed Consent for NIH funded COVID or other NIH funded studies (intramural and extramural). Plans must include how the DCC will preserve utility of resources for the future. Resources produced, coordinated, and shared through the DCC are to be transferable, such that another individuals or teams can continue development if the original investigators are unwilling or unable to do so.

Research Strategy

Significance

• Describe the specific objectives of the proposed DCC and how they will help accomplish the goals of the RADx-rad initiative.
• Describe the specific strategies that will be implemented to support data collection, standardization, integration and sharing, curation, management and use
• Identify the specific problems or limitations funded projects might encounter that will be addressed by the proposed DCC.
  

Approach

• Describe an overall strategy for addressing the aims of the DCC. Describe how the proposed DCC will interact with the RADx-rad awardees to accomplish the goals of the DCC. Describe metrics that will be used to assess progress toward specific DCC goals. Provide timelines and an organizational chart.
• Describe the organizational structure of the DCC, including a leadership body that will have primary responsibility for overseeing the DCC. This leadership body is in addition to the Steering Committee and External Advisory Board. Describe plans for day-to-day operations overseen by the leadership body.
• Describe how the DCC shall support various scientific and administrative meetings
• Describe the existing infrastructure at the applicant’s institution(s), current capacity, research activities, data platforms, and how it will support needs of administering and developing the data hub
• For each DCC function, describe specific activities that will meet the goals of RADx-rad, how the various domains and activities will interact/intersect, and how they will foster interaction among RADx-rad awardees
• Describe briefly the applicant’s team and level of experience in coordinating a research data hub and the applicant’s experience coordinating a group of research and development projects related to testing for human health conditions or public health outbreaks
• Describe plans for monitoring progress of the RADx-rad program, and DCC functions. Briefly describe how the DCC will adapt or eliminate processes based on the needs of RADx-rad awardees and the larger RADx initiative.
• Describe how the proposed RADx-rad DCC will provide dynamic guidance to RADx-rad funded investigators as current testing landscape changes

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 must provide a Data Sharing Plan that addresses public access to data from the RADx-rad awardees and coordination with the NIH Data Hub.

Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

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.

Pre-award costs may be incurred from January 20, 2020 during the public health emergency period and prior to the date of the federal award.

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.

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 Funding Opportunity Announcement, note the following:

The DCC, by its nature, is not innovative but may be essential to advance the work of RADx. The overall DCC structure must have administrative, biomedical, informatics and data science expertise and collaboratively work with awardees to make an overall impact on testing and eventual health outcomes related to COVID-19 and SARS-CoV-2.

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).

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

Significance

Does the proposed DCC address the needs of RADx-rad as described in the FOA? Will successful completion of the aims strengthen the RADx-rad initiatives? If fully successful, is the DCC likely to provide national leadership in advancing policies and practices that enhance FAIR access to biomedical research findings from RADx-rad?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the DCC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing complex research data coordination efforts? Do the project team members have relevant expertise in administration of complex biomedical data sets, and appropriate types of scientific expertise to manage all activities of the DCC? If the DCC is multi-PD/PI, do the investigators have complementary and integrated expertise and skills? Is their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the DCC?

Specific to this FOA:

Does the application describe how the investigative team will remain up to date on the changing landscape of COVID-19 testing in various communities and in health care systems and settings and research participant protection regulations?

Will the proposed activities in this application bring together experienced administrators with testing expertise, human subjects expertise, data management expertise and analytic expertise, to manage all activities of the DCC?

Innovation

Will the DCC have a positive effect on current COVID testing data strategies? Does the application include mechanisms for leveraging communication strategies to coordinate timely COVID data access and sharing? Is the proposed approach dynamic and responsive to evolving changes in COVID-19 diagnostics in the United States? Does the design/research plan include innovative elements, as appropriate, that enhance its potential for sharing information or potential to advance COVID-19 testing and outcomes knowledge?

Approach

Are the overall strategies, methodologies, structures and systems proposed well-reasoned and appropriate to accomplish the specific aims of the DCC? ?Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the RADx-rad program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented?

Specific to this FOA:

Will the proposed approach allow for rapid deployment of administration, technology infrastructure and data coordination for RADx-rad awardees? Is the plan for administrative support across the DCC well designed? How feasible and appropriate are the plans to coordinate data submission, data collection, curation and sharing?

Does the application demonstrate sufficient knowledge of approaches to create AI-Ready data sets, including acquisition, collection and curation, in a manner that could lead to effective guidance statements for use by all projects?

Is the management plan well-described and commensurate with the level of complexity required for the DCC? Are the proposed approaches likely to yield important contributions?

Does the DCC provide adequate processes for coordinating with the broader NIH data hub and other RADx initiatives?

Are the plans to standardize, assure quality of, and monitor adherence to data collection or distribution guidelines appropriate? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are the procedures for data deposit, management, access and quality control of data adequate? Have the methods for standardizing data formats and labelling been addressed? Is there a plan to monitor and evaluate progress on RADx-rad studies and outcomes within the proposed period for RADx-rad funded studies?

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?

Environment

Specific to this FOA:

Will the proposed activities facilitate flexible, modular, and scalable policies, practices, algorithms, protocols, and tools to enable FAIR access to data generated by RADx-rad awardees? Will the proposed approach allow efficient management upkeep of a public website? Does the proposed approach explain how DCC will coordinate meetings when in-person meetings may not be viable?

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

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with the stated review criteria.

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.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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.
• Applications that include plans to rapidly make data available to the research community, when not limited by Tribal data sharing policy.

3. Anticipated Announcement and Award Dates

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

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.

NIH is requiring data sharing for all COVID-19 projects, where it is not prohibited (i.e., Tribal data sovereignty). The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products, and procedures to improve human health. Grantees are expected to work with the RADx-rad DCC to submit common evaluation metrics on COVID-19 testing-related outcomes and implementation to the DCC. Grantees should identify a dedicated unit responsible for these data reporting activities. NIH expects that all projects funded under this FOA will actively coordinate, collaborate, and share data with the RADx-rad DCC, as allowed, and with considerations under tribal IRB processes, as appropriate. Researchers applying to this funding opportunity are strongly encouraged to review the DCC funding opportunity. To the extent possible, data acquisition, collection, and curation strategies should be coordinated with the DCC guidance for annotation and benchmarking of data, including obtaining appropriate consent for data sharing and implementation of the schemas proposed under the ABOUT ML effort ( Annotation and benchmarking on understanding and transparency for machine learning lifecycles ; available at https://www.partnershiponai.org/about-ml/). Grantees are expected to participate in DCC-organized activities, including regular (e.g., monthly) progress meetings with individual or subsets of awardees, and twice annual meetings with all RADx-rad awardees.

The DDC will develop the final Resources and Data Sharing Plan in conjunction with RADx-rad awardees post award.

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 https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (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, 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:

• Supporting the Key Component Activities, including determining approaches, designing, and setting project milestones and implementing the project plan for the RADx-rad DCC;
• Coordination of development, adoption and implementation of the agreed-upon policies, procedures, best practices, or other measures;
• Coordination of sharing issues related to data quality, data management, data biases and errors, query quality and sampling challenges, and pitfalls in utilization of testing and health care data for research;
• Organizing and participating in group activities, including program-wide meetings and Steering Committee meetings at RADx-rad level or the NIH level, as needed;
• Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, and facilitating work group meetings, committee meetings, and conference calls, preparing concise minutes or summaries of meetings for distribution;
• Cooperating with RADx-rad awardees in the publication and dissemination of program results and the eventual release to the scientific and healthcare communities of methods, tools, results, and other resources;
• Providing high-quality documentation as needed for storage requirements, standards, common data elements and other features of the data hub feature
• Providing expertise and leadership in addressing issues of broad applicability, such as informed consent, data sharing standards, analysis methodology, and dissemination;
• Planning and hosting virtual and face to face meetings of the Work Groups, Steering Committee, and any subcommittees, one of which is an annual face to face meeting, conditions permitting, in Bethesda, MD;
• Retaining custody and having primary rights to the data generated by RADx-rad awardees, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies and goals of this program, when not limited by Tribal data sharing policy. It is expected the DCC will have a Data Sharing plan which will protect human subjects and account for tribal sovereignty, and resources generated are expected to have broad availability through a public-access entity (e.g., Figshare, Github) in order to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the program
• Providing information to the NIH Program Officer(s) and Project Scientist(s) concerning progress;

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NLM will assign a Program Official, one or more Project Scientist(s), and a Grants Management Specialist to the DCC.
NIH Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. NIH Project Scientists(s) will:

• Assist in coordinating activities with other ongoing studies supported through statewide, regional, or national programs to avoid duplication of efforts and encourage sharing and collaboration in the development of new clinically useful resources and methodologies;
• Review and comment on reports, progress reports and evaluation studies of Radx-rad activities;
• Assist in coordinating access to other resources available through statewide, regional, or national specialized technology projects, or through other RADx projects
• Attend and participate in meetings/workshops to address emerging areas of high priority among RADx-rad awardees
• Link the approaches developed from DCC to other RADx or NIH-supported networks to ensure that information is shared and utilized on the widest basis possible.

The NLM Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The program official(s) will:

• Assist in enforcing general statutory, regulatory or administrative assistance policy requirements;
• Evaluate progress by reviews of technical or fiscal reports or by site visits to determine that performance is consistent with objectives, terms and conditions of the award;
• Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other peer reviewed funding mechanisms;
• Review and approve all major transitional changes of DCC activities prior to implementation to ensure consistency with the goals of the FOA;
• Monitor institutional commitments and resources to ensure that DCC receives the maximum chance of stabilization and success;
• Assist the Grants Management Official with financial oversight of the Program as needed.

The NLM Program Official, in conjunction with the Project Scientist(s), may recommend the termination or curtailment of an activity in the event the proposed activities fail to evolve within the intent and purpose of this initiative.

Areas of Joint Responsibility include:
Awardees agree to governance, through voting and decision making, of the DCC through a Steering Committee. Steering Committee voting membership shall consist of the Principal Investigator(s), NLM Program Official and NIH Project Scientist(s). Quarterly meetings of the Steering Committee will be held in the first year of the award. One of these meetings must be an in-person meeting if possible, travel conditions permitting, in Bethesda, MD. Each member of the Steering Committee will have one vote. The DCC leadership will be required to accept and implement policies approved by the Steering Committee.

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 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

Funds awarded using appropriations provided by the Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139 will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.

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

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

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

Section VII. Agency Contacts

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

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: [email protected] (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: [email protected]

Valerie Florance, PhD
National Library of Medicine (NLM)
Telephone: 301-496-4621
Email: [email protected]

Vinod Charles, Ph.D.
Center for Scientific Review
Telephone: 301-496-2236
Email: [email protected]

Samantha Tempchin
National Library of Medicine (NLM)
Telephone: 301-496-4221
Email: [email protected]

Section VIII. Other Information

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

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