Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title
IDeA Clinical Research Resource Center (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-22-150
Companion Funding Opportunity
None
Number of Applications

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

Assistance Listing Number(s)
93.859
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support an IDeA Clinical Research Resource Center (I-CRRC) that addresses two specific needs for increasing capacity to conducting clinical trials and complex observational studies in IDeA states. I-CRRC will 1) strengthen communication and develop collaborations between health research institutions in IDeA-eligible states and clinical trial sponsors, and 2) develop clinical trial and observational study coordinators with the knowledge and skills to manage clinical studies.

Key Dates

Posted Date
April 12, 2022
Open Date (Earliest Submission Date)
August 26, 2022
Letter of Intent Due Date(s)

August 26, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
September 26, 2022 Not Applicable Not Applicable March 2023 May 2023 July 2023

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

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

Expiration Date
September 27, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Clinical trials and complex observational studies are essential for understanding health conditions and translating biomedical research advances into better patient care. The National Institutes of Health (NIH) supported more than 8000 clinical trials and observational studies in fiscal year 2021 (NIH RePORTER). However, fewer than 10% of these were conducted in the 23 Institutional Development Award (IDeA)-eligible states and Puerto Rico, which have large rural and socioeconomically disadvantaged populations. Lack of access to clinical studies in IDeA states leads to the underrepresentation of their populations in clinical trials and complex observational cohort studies. Significantly increasing the number of clinical trials and complex observational studies in IDeA states is a pressing need and a monumental challenge that requires continued efforts to strengthen clinical research capacity and employ innovative approaches that maximize the use of existing resources in IDeA states. The purpose of this Funding Opportunity Announcement (FOA) is to support an IDeA Clinical Research Resource Center (I-CRRC) that addresses two specific needs for increasing clinical research capacity in IDeA states. I-CRRC will 1) strengthen communication and develop collaborations between health research institutions in IDeA-eligible states, hereafter called IDeA institutions, and clinical trial sponsors; and 2) develop clinical research coordinators with the knowledge and skills to manage clinical trials and complex observational studies.

Applications submitted to this FOA must propose plans to support a Clinical Trial Service Core and a Clinical Research Coordinator Development Program.

Clinical Trial Service Core

The goal of this Core is to strengthen communication and develop collaborations between clinical trial sponsors and IDeA institutions. The Core is expected to develop and maintain an updated inventory of solicitations of upcoming and ongoing clinical trials sponsored by federal agencies, pharmaceutical companies, medical device companies, and other sources. The Core is also expected to develop and maintain a database of areas of clinical trial expertise, capacities, patient care catchment regions, and patient population characteristics of IDeA institutions including IDeA Networks for Clinical and Translational Research program (IDeA-CTR)-affiliated Practice Based Research Network sites. The Core will develop practical mechanisms to disseminate the information it collects to sponsors, Contract Research Organizations (CROs), and IDeA-state clinical research leaders so that trial sponsors become better versed in the clinical expertise and patient populations that IDeA institutions may bring to their trials, and IDeA institutions are well-informed about national trial opportunities. Furthermore, the Core is expected to develop mechanisms to screen the trial inventory described above and ongoing trials on clinicaltrials.gov for those suitable for IDeA-state populations, match the sponsors/CROs with the appropriate IDeA institutions, and facilitate collaborations among them.

Clinical Research Coordinator Development Program

The goal of this Program is to develop clinical research coordinators with the knowledge and skills needed to manage clinical trials and complex observational studies in IDeA states. The Program is expected to establish learning objectives and develop a curriculum that provides the key competencies required of clinical research coordinators. The curriculum should include both didactic and immersive experiences. The didactic component will build participants’ knowledge base on trial and complex observational study management topics such as regulatory policies, billing, trial site qualification, participant enrollment and retention, adverse event monitoring, health records management as well as data collection and management, and data sharing policies. Virtual learning should be used as much as possible for the didactic component. The immersive component will provide participants with opportunities to work under the guidance of experienced clinical research coordinators and clinical investigators of ongoing clinical trials or complex observational studies at IDeA institutions, through which they will gain hands-on experience in clinical research management and apply the knowledge obtained through the didactic component. The curriculum may be up to two years and organized with progressively more advanced didactic modules interspersed with immersive experiences. The curriculum should allow different entry points to accommodate participants with more extensive experience. The Program should encourage participation by nurses with experience in research and/or in clinical care, however, other non-physician health professionals with experience in clinical research or in the administration of clinical research are also eligible to participate. Participants will take at least one module of the didactic component and one module of the immersive component. Upon completing the full curriculum, or portions of the curriculum that include both didactic and immersive components, I-CRRC should issue one or more Clinical Research Coordinator Certificate(s) to the participants.

I-CRRC will advertise the Coordinator Development Program and work with IDeA institutions and IDeA-CTRs to recruit participants. Commitment of participants’ home institutions/employers to support their enrollment in the Program must be secured. Participants are expected to commit up to 75% of their professional effort to the Program, for which the I-CRRC award may provide commensurate salary. The Program will also vet and recruit IDeA institutions with robust ongoing clinical trials and/or complex observational studies to host the immersive components, with funding support from the Program. The Program is expected to assign participants to appropriate host institutions that are within commuting distance and develop guidelines to ensure the immersive component provides hands-on experience in the key competencies.

Qualifications of Applicant Institutions and Program Director(s)/Principal Investigator(s) (PD/PI(s))

The applicant institution should have a track record in conducting clinical trials and/or complex observational studies, and in providing educational activities related to clinical research. It should also have existing infrastructure including experienced clinical researchers, clinical research coordinators, and clinical research educators, as well as resources, such as trial software and patient database platforms, to support required activities of I-CRRC. The PD/PI(s) should be established clinical investigator(s) with extensive experience in leading clinical trials and/or complex observational studies who understand the needs and challenges faced by IDeA institutions and investigators in conducting clinical research. Additionally, the PD/PI(s) should have in-depth knowledge of clinical trial sponsors nationwide and NIH-funded programs, such as the IDeA-CTR program, that support clinical research, clinical trials and complex observational studies in IDeA states. The PD/PI(s) should have prior experience in leading programs involving multiple stakeholders.

Governance

A Steering Committee (SC) will provide oversight of the Center. The PD/PI, or Contact PD/PI if a multiple-PD/PI (MPI) application is submitted, serves as the Chairperson of the SC. The SC should be diverse and inclusive in its representation. The SC membership, its roles and responsibilities are described in Section VI.2 under Cooperative Agreement Terms and Conditions of Award.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. NIGMS intends to fund one IDeA Clinical Research Resource Center award.

Award Budget

Application budgets are expected to be approximately $1,800,000 per year in annual direct costs, excluding facilities and administrative (F&A) costs on consortium arrangements, and must reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

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

Eligible institutions must be located in an IDeA-eligible state, commonwealth, or jurisdiction which are: Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming.

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 not allowed. 

Required Registrations

Applicant organizations

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

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

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

All PD/PI(s) must have an eRA Commons account.  PD/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//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, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

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

Only one application per institution, normally identified by having a unique entity identifier such as DUNS or IPF, 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

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/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:

Lumy Sawaki-Adams, M.D., Ph.D.
Email: lumy.sawaki-adams@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments: Applicants are encouraged to include an attachment titled “Proposed Clinical Research Coordinator Syllabus” that describes the didactic component of the curriculum. If the material is to be delivered through more than one didactic module, the syllabus should specify the number, duration, and learning objectives of each module. The syllabus should also outline the didactic and immersive modules required to earn one or more Clinical Research Coordinator Certificate of the I-CRRC Program.

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.

The I-CRRC budget is expected to be approximately $1,800,000 in annual direct costs, excluding facilities and administrative (F&A) costs on consortium arrangements, and must reflect the actual needs of the proposed project. Additional guidelines for budget development are as follows:

A budget of approximately $300,000 annual direct costs for the overall administration of I-CRRC should include:

  • Salary support and levels of professional effort for the PD/PI(s), a Program Coordinator (PC, optional) who provides operational assistance to the PD/PI(s) in assigned area(s) of responsibilities, and other personnel
  • Costs for the I-CRRC website development and upkeep, online communication and conferencing licenses, and other types of IT support
  • Travel expenses (in Year 1 only) for non-NIH members of the Steering Committee to attend one in-person meeting

A budget of approximately $300,000 annual direct costs for the Clinical Trial Service Core should include:

  • Salary support and levels of professional effort for personnel who manage the Core
  • Costs to develop and maintain the clinical trial inventory and the IDeA institution database
  • Costs for developing collaborations between sponsors/CROs and IDeA institutions

A budget of approximately $1,200,000 annual direct costs for the Clinical Research Coordinator Development Program that includes subawards for participants and for sites of the immersive components, and should include:

  • Salary support and levels of professional effort for personnel who manage the Program
  • Funds to support the instructor(s) to develop and deliver the didactic components of the curriculum
  • Funds for the recruitment of Program participants and institutions to provide the immersive components
  • Costs to host institutions that provide the immersive components
  • Up to 75% salary plus fringe benefits per participant (each participant may be supported for up to 24 months), and other allowable expenses incurred as part of the immersive experience
  • If extensive ramp-up time is needed to develop the didactic curriculum, the Year 1 budget for participants and immersive components should be reduced accordingly

For all personnel, the Budget Justification must provide a summary of the person’s total committed annual level-of-effort in person-months and a breakdown by budget area.

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: Outline Specific Aims for the proposed Resource Center along with the main benchmarks for their realization.

Research Strategy: The Research Strategy must consist of both Subsections A and B, as defined below.

Subsection A: Overview

Describe the applicant’s overall vision and general plan for I-CRRC. Describe the applicant institution’s expertise, track record, and existing infrastructure relevant to clinical trials and/or complex observational studies and the specific charges of I-CRRC in strengthening communication and developing collaborations between IDeA institutions and clinical trial sponsors, and in developing clinical research coordinators. Explain how the expertise and skills of the PD/PI(s) and the leadership team will contribute to the development and operation of I-CRRC.

Describe the operational plan for I-CRRC including the organizational structure of the Center and strategies to work with partners and/or stakeholders. Define the roles and responsibilities of key personnel, including the PD/PI(s), and if applicable, the Program Coordinator. Describe a plan for the establishment and operation of the Steering Committee, but do not contact potential Steering Committee members or provide their names in the application.

Subsection B. Key Services and Activities of I-CRRC

Describe detailed plans for each required element described in Section I.

Clinical Trial Service Core: Provide an overview of the Core, including descriptions of its organization and the activities of the key personnel who will manage the Core. Describe the design of the inventory that will be developed to capture upcoming and ongoing clinical trials, including the types and sources of information to be collected, methods and strategies to collect the information, and methods and strategies to curate the information. Describe the proposed design of the database of IDeA institutions, which should include their areas of clinical trial expertise, capacities, patient care catchment regions, and patient population characteristics. Describe strategies and approaches to reach and engage clinical trial sponsors, CROs, IDeA institutions, and clinical researchers for effective dissemination of the information in the inventory and database. Describe methods and strategies to screen the inventory and clinicaltrials.gov for clinical trials suitable for IDeA-state populations. Describe methods and strategies to match trial sponsors/CROs and IDeA institutions for possible collaborations on appropriate trials. Describe methods to track the numbers of participating trial sites and enrollments in clinical trials resulting from the matching efforts.

Clinical Research Coordinator Development Program: Provide an overall plan for the Program, including descriptions of its learning objectives and the key competencies that participants are expected to acquire. For the didactic component, describe the mode(s) of delivery, the duration of the component, and the qualifications of the instructor(s). If the content is to be delivered through more than one didactic module, specify the number of modules and the duration of each. Provide a plan for the immersive component, including descriptions of the selection criteria for clinical trial or complex observational study programs that will administer the immersive component, strategies to vet and recruit these programs, strategies to develop guidelines in collaboration with each program to ensure that the immersive components provide hands-on experience in the key competencies, oversight strategies that ensure adherence to the guidelines, strategies to match participants with the appropriate research programs, and strategies to evaluate the immersive experiences. It is recommended that participants be matched with trial programs with strong mentoring capacity within commutable distance of their home institutions. Describe how I-CRRC will advertise the Coordinator Development Program and work with IDeA-CTR awardees and other IDeA institutions to attract and recruit participants, and secure their home institution’s support for their participation in the Program. If the immersive component will include more than one module, specify the number of immersive modules and the duration of each. It is recommended that an individual participant’s immersive experience be conducted with one trial program. However, if a participant’s immersive experience requires multiple modules with different trial programs, separate guidelines should be developed with each of these programs. Describe plans to award participants who complete at least one didactic module and one immersive module with Clinical Research Coordinator Certificate(s) of the I-CRRC Program.

Applicants are encouraged to include proposed syllabi for the didactic component of the curriculum; see the specific instructions given in the prior section SF424(R&R) Other Project Information: Other Attachments.

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.

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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 I-CRRC institution and its PD/PI(s) must have all the requisite skills and operational capabilities to facilitate and coordinate the Center’s key activities with multiple stakeholders.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed Resource Center address the needs of the clinical research programs that it will serve? Is the scope of activities proposed for the Resource Center appropriate to meet those needs? Will successful completion of the aims build the capacity for clinical trials and complex observational studies at IDeA institutions?

Investigator(s)

Are the PD/PI(s) and other personnel well suited to their roles in the Resource Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing clinical research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? Do they have the needed skills in training clinical research coordinators and curriculum development?  Do the PD/PI(s) demonstrate in-depth knowledge of a) the needs of and challenges faced by IDeA institutions and investigators in conducting clinical research, b) sponsors of clinical trials, c) NIH-funded programs that support clinical research, clinical trials, and complex observational studies in IDeA states, and d) management of programs involving multiple stakeholders? Are appropriate plans for the establishment and operation of the Steering Committee proposed? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Resource Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the programs the Research Center will serve?

Approach

Are the overall strategy, operational plan, and organizational structure well reasoned and appropriate to accomplish the goals of the programs the Resource Center will serve? Are the proposed plans to develop an inventory of upcoming clinical trials and a database of IDeA institutions and dissemination plans well-conceived to effectively facilitate information exchange, enhance mutual understanding, and match potential sponsors/CROs with the appropriate IDeA institutions? Are the recruitment and vetting plans of both potential participants and host sites for the immersive component for the Clinical Research Coordinator Development Program feasible and appropriate? Are the proposed didactic and immersive components of the Clinical Research Coordinator Development Program appropriate to build the participants’ knowledge base and obtain hands-on experience in clinical trial and/or complex observational study management? Are potential problems, alternative strategies, and benchmarks for success presented? Are an appropriate plan for work-flow and a well-established timeline proposed? 

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIGMS, 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.

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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

The 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, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 recipients for the project, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

  • Overseeing the operation of the Resource Center.
  • Determining the approaches, designing and setting project milestones and implementing workflows.
  • Ensuring that interactions with eligible institutions, their research administration staff, PD/PI(s), and participating organizations are consistent with the goals of the Program.
  • Creating a website describing the activities offered by the Resource Center along with any online content proposed for its Core and Program.
  • Leading the outreach efforts to recruit participants and sites for immersive experiences for the Clinical Research Coordinator Development Program.
  • Developing individualized guidelines for the immersive experiences.
  • Serving as a voting member on the Steering Committee.
  • Scheduling, facilitating, and developing the agenda and content for the Steering Committee's conference calls and annual meetings, and preparing concise minutes or summaries of meetings for distribution.
  • Adhering to the decisions and recommendations of the Steering Committee to the extent compatible with applicable grant regulations.
  • Taking the lead role in developing strategies to promote the Resource Center.
  • Collecting and tracking Resource Center utilization information.
  • Providing information to the NIH Program Officer(s) and NIH Project Coordinator(s) concerning progress, upon request.
  • Sharing knowledge, data, research education materials, and any other resources with stakeholders.

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

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

A designated NIGMS Program staff member will have substantial involvement as NIH Project Coordinator for the Resource Center. The role of the NIH Project Coordinator will be to facilitate, but not to direct, the Resource Center activities. The specific roles of the substantially involved NIGMS staff member(s) include the following activities:

  • Serving as a voting member of the Resource Center Steering Committee, as described below in "Areas of Joint Responsibility."
  • Identifying relevant NIH expertise and/or resources related to NIH and NIGMS funding mechanisms and initiatives related to clinical trials and clinical research, and other resources, expertise, or skills that may be relevant to optimizing the activities of the Resource Center, including designing the strategies to reach targeted audiences.
  • Assisting the Resource Center team with the promotion of the program and reaching the targeted Program participants, institutions and investigators.

While Resource Center recipients will retain custody of the data and resources developed under these awards, NIGMS will have access to the measures, metrics, and reported data and may periodically review it.

Additionally, an NIGMS program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The program official will not participate in the Steering Committee meetings for the Center.

NIGMS reserves the right to reduce the budget or withhold an award in the event of substantial recipient underperformance or other substantial failure to comply with the terms of award.

Areas of Joint Responsibility include:

A Steering Committee will be convened to serve as the Resource Center main governing board. Members will be selected by the PD/PI(s) and, at a minimum, the Steering Committee will be composed of the following voting members:

  • The PD/PI(s) of the Resource Center who will collectively have one vote and who will chair the committee (if multi-PD/PI, the contact PI will chair the committee).
  • One or more senior institutional officials from IDeA institutions, who will each have one vote.
  • One or more PD/PI(s) from IDeA-CTRs, who will each have one vote.
  • A clinical research coordinator from an IDeA institution, who will have one vote.
  • The NIGMS Project Coordinator, who will have one vote.

Additional staff members of the Resource Center may participate in Steering Committee meetings as non-voting members.

The Steering Committee may decide to establish sub-committees for specific purposes. The NIGMS Project Coordinator may serve on such sub-committees as the Committee deems appropriate.

The Steering Committee will meet once during the first year and at least quarterly by teleconference thereafter.

Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:

  • Serving as the main body overseeing the realization of the goals of the Resource Center.
  • Ensuring that the content of all materials developed and delivered to stakeholders meets the goals of the program.
  • Monitoring the program, identifying impediments to success, and developing appropriate strategies to overcome the problems.
  • Reviewing and approving policies and procedures for the recruitment of participants and host institutions and the immersive components of the Clinical Research Coordinator Development Program.
  • Approving the final report of the Resource Center.

Dispute Resolution:

Disagreements between award recipients and the NIH that arise regarding matters related to the scientific direction of the funded program may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be: 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 Steering Committee without NIH staff or the recipient voting. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

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

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

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

4. Evaluation

In carrying out stewardship of grant programs, NIGMS will periodically evaluate the IDeA Clinical Research Resource Program, employing the representative measures identified below. In assessing the effectiveness of research capacity building investments, NIGMS may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of the grant period for updates on participants’ subsequent outcomes.

The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

  • Indicators of increased clinical trial capacity building in IDeA states, such as:
    • Recruitment and development of clinical trial coordinators o Engagement in clinical trials
  • Measures of resource distribution and utilization, such as:
    • Publicizing the services provided by the Center to IDeA participants o Information about the size and characteristics of the userbase
  • Characteristics of the participants (both applicants and those selected) such as:
    • Geographic distribution of participating institutions
    • Demographics of participants
  • Outcome measures for participants, such as:
    • Research experiences obtained o Subsequent employment in the clinical trial workforce

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Lumy Sawaki-Adams, M.D., Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: lumy.sawaki-adams@nih.gov

Peer Review Contact(s)

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: stephanie.constant@nih.gov

Financial/Grants Management Contact(s)

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Email: christy.leake@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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