Part 1. Overview Information

Key Dates

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

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

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This is a non-competitive funding opportunity intended to fund a single award. Through this single source, cooperative agreement NOFO, the National Cancer Institute (NCI) under the NCTN Program solicits an application to fund a single award to the American College of Radiology for maintaining the Network Radiotherapy and Imaging Core Services Center for the Network. The goal of the Center is to provide scientific and technical expertise for incorporating integrated quality assurance/control and image data management for applicable NCTN trials involving interventions with radiotherapy and/or imaging modalities. In addition, the Center has the capacity to provide similar services for other approved NCI-supported clinical trials network programs (e.g., the NCI/Division of Cancer Treatment and Diagnosis (DCTD) early phase clinical trial network program and the NCI/Division of Cancer Prevention (DCP) NCI Community Oncology Research Program).

This Notice of Funding Opportunity Announcement (NOFO) is one of six NOFOs that support the comprehensive effort by the National Cancer Institute (NCI) to provide the infrastructure for the conduct of national clinical trials through the National Clinical Trials Network (NCTN). The primary goal of the NCTN is the conduct of multi-center, late-phase, clinical treatment trials (i.e., randomized phase 2 and phase 3 trials) and advanced imaging trials across a broad range of cancers, modalities, and diverse patient populations as part of the NCI's overall clinical research program for adults, adolescents and young adults, and children with cancer. The NCTN also conducts, as necessary, preliminary studies needed for development of definitive trials, especially umbrella/basket trials and rare tumor trials, when an extensive, national patient catchment area is required.

The NCTN Program supports the following clinical trials infrastructure components through individual awards made under the respective NOFOs indicated below:

• NCTN - Network Group Operations Centers under RFA-CA-24-030 (U10)
• NCTN - Network Group Statistics and Data Management Centers under RFA-CA-24-031 (U10)
• NCTN - Canadian Collaborating Clinical Trials Network under RFA-CA-24-032 (U10)
• NCTN - Network Lead Academic Participating Sites under RFA-CA-24-033 (UG1)
• NCTN - Network Radiotherapy & Imaging Core Services Center under RFA-CA-24-034 (U24) - this NOFO
• NCTN - Network Group Integrated Translational Science Centers under RFA-CA-24-035 (UG1)

Background

The NCI National Clinical Trials Network (NCTN) was established for the conduct of large-scale, national, oncology treatment and advanced imaging clinical trials in an era of precision medicine.

Recent advances in deciphering the cancer genome, along with the emergence of successful targeted agents, immunotherapies, and cellular therapies, have fundamentally changed our approach to cancer treatment and have introduced new challenges to performing clinical trials. Due to the low incidence of certain molecular abnormalities, the development of targeted therapies often requires an infrastructure for the conduct of clinical trials that can screen large numbers of patients with the same or different cancer type to identify those patients whose tumors contain the distinct molecular targets of the therapies being tested. Immunotherapeutic approaches also present a similar challenge in that not all tumor types respond to this approach, and selecting the cancer types most likely to respond is critical for success.

The NCTN's integrated and collaborative network infrastructure has allowed the Program to meet the challenges of evaluating emerging therapies within its broad investigator base drawn from NCI-designated Cancer Centers, the NCI Community Oncology Research Program (NCORP), Minority/Underserved NCORPs, and other academic and community hospitals and private practitioners across the U.S. and internationally. The primary focus of the NCTN is the conduct of multi-center, late-phase, clinical treatment trials (i.e., randomized phase 2 and phase 3 trials) and investigation of new advanced imaging techniques; however, appropriate preliminary studies needed for development of potential definitive trials, especially umbrella/basket trials and rare tumor trials oriented to discovery, are also conducted when an extensive, national patient catchment area is required. With its state-of-the-art clinical trials infrastructure, the NCTN can implement and completes trials rapidly. The NCTN has streamlined trial registration, data management, and tumor banking processes. It has a Cancer Trials Support Unit (CTSU) to provide online access to all necessary study materials and a Central Institutional Review Board (CIRB) to make ethics review easier and less redundant across the country. The NCTN also has appeal for industry partners such as biotechnology and pharmaceutical companies that collaborate on NCTN trials, including precision medicine trials harnessing next generation DNA and RNA sequencing methods to inform treatment choices. NCTN's resources are ideal for screening large numbers of patients to identify patients whose tumors exhibit the molecular features that may be responsive to new, targeted treatments and/or immunotherapy approaches. In addition, biospecimens collected from patients on NCTN trials are available to help determine the underlying biological reasons for response and resistance to therapy.

The NCTN also promotes the evaluation of multi-modality treatments, including surgery and radiotherapy in combination with novel agents, and has a commitment to the conduct of trials in special populations (e.g., children, adolescents, young adults, and underserved populations) as well as in rare tumor types. This focus allows the NCTN Program to complement, rather than duplicate, research conducted by the private sector. Annual accrual to NCTN trials has remained in the 17,500 to 22,000 patient range in mostly large phase 2 and phase 3 trials, but with a larger number of patients screened on study to determine whether they might benefit from the therapy under evaluation.

Each of the key components of the NCTN Program is described briefly below.

• Network Group Operations Centers: The Operations Centers provide scientific leadership for developing and implementing multi-disciplinary, multi-institutional trials in a range of diseases and special populations with specific scientific strategy and goals. The Operations Centers' scientific goals may include strategic innovation in advanced technology for specific research areas (e.g., advanced imaging methods/agents, radiotherapy) and the testing of innovative concepts and tools in prospective, multi-institutional clinical trials. Operations Centers are responsible for trial operations including timely protocol development and management, compliance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) regulatory and patient protection requirements, audits, training, quality assurance, and site support. The Operations Centers are expected to be closely integrated with their corresponding Statistics and Data Management Center in all aspects of trial operations through jointly developed policies and procedures for clinical trial development and conduct. The Operations Centers are also responsible for Network Group administration, including financial management, monitoring of member institution/site performance, coordination of biospecimen collection from patients on clinical trials, and adherence to all applicable NIH/NCI policies and regulations. Network Group Operations Centers may also provide trial operations for NCI Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (NCI/DCTD, approved, multi-center phase 2 and phase 3 trials originating outside the Network Groups in special situations.
• Network Group Statistics and Data Management Centers: These Centers are responsible for providing the statistical expertise required to ensure effective scientific design and conduct of clinical trials as well as leadership in innovation in statistical methodology. These Centers are also responsible for data management, data analysis, and statistical analysis for NCTN trials led by their affiliated Network Group Operations Center as well as for translational and other ancillary studies associated with the trials.
• Network Group Integrated Translational Science Centers - These awards provide support for leadership and expertise to facilitate incorporating translational science into Network Group clinical trials.
• Network Lead Academic Participating Sites: These academic institutions/sites provide scientific leadership in development and conduct of clinical trials in association with one or more adult U.S. Network Groups as well as substantial accrual to clinical trials conducted across the entire NCTN.
• Network Radiotherapy and Imaging Core Services Center: This institution/organization provides scientific and technical expertise for incorporation of appropriate, integrated quality assurance/control and image data management for applicable clinical trials conducted by the NCTN that require specialized quality assurance/control or imaging data management and/or assessment for radiotherapy and imaging interventions. In addition, the Center may also provide similar services for other approved NCI-supported clinical trials network programs (e.g., NCI/DCTD/CTEP early phase clinical trial network program and the NCI Division of Cancer Prevention (NCI/DCP) NCI Community Oncology Research Program (NCORP).
• Canadian Collaborating Clinical Trials Network: This Canadian organization is a non-profit clinical trials organization capable of being a full partner with the U.S. Network in the conduct of large-scale, multi-site clinical trials that have relevance for U.S. cancer patient populations. Incorporation of a Canadian Clinical Trials Network as a collaborating partner brings an additional advantage as U.S. Network Groups are anticipated to have Canadian member sites. A Canadian network can help reduce duplicative regulatory staff at U.S. NCTN Group Operations Centers.

Interactions with Other NCI-supported Programs. In addition to the six key components of the NCTN that are described above that are directly funded by the NCTN Program, other NCI grant and contract-supported Programs and their awardees as well as NCI Advisory Committees have important supporting roles in carrying out the research objectives of the NCTN Program. Thus, the NCTN awardees are expected to interact as appropriate with such entities/programs as the NCI Clinical Trials Tumor Banks, the NCI Community Oncology Research Program (NCORP) and Minority/Underserved NCORPs, the NCI Cancer Trials Support Unit, the pediatric and adult NCI Central Institutional Review Boards, and NCI Advisory and Scientific Committees, including the NCI Scientific Steering Committees.

Main Research Objectives and Requirements of this NOFO

The Network Group Radiotherapy and Imaging Core Services Center application must include the following 3 functional components:

Radiotherapy Core Services Program - This functional component should provide specific services for NCTN trials involving radiotherapy (RT) interventions, including policies and procedures for various types of RT quality assurance and credentialing.

Imaging Core Services Program - This functional component should provide specific services for NCTN trials involving imaging interventions/assessments, including policies and procedures for various types of imaging quality assurance and credentialing.

Program for Collaborations, Participation in Collective Network Management, and Support for Other NCI-Supported Clinical Trials Networks - This functional component should provide support for key collaborations with the Network Group Operations Centers and associated Statistics and Data Management Centers, especially with respect to development of standards and harmonization of processes and data collection for NCTN trials involving radiotherapy and imaging and participation in the collective management of the NCTN Program. This component should also provide support for other NCI-supported clinical trials network programs.

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 NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Only the following applicant may apply for this single source funding: American College of Radiology

Federal Governments

• 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

Only the current Network Radiotherapy and Imaging Core Services Center recipient supported under RFA-CA-17-060 is eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019, and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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 How to Apply - Application Guide.

The named PDs/PIs for applications for NCTN Network Radiotherapy and Imaging Core Services Center cannot be named as PDs/PIs on applications for:

• NCTN - Network Group Operations Centers (RFA-CA-24-030)
• NCTN - Network Group Statistical and Data Management Centers (RFA-CA-24-031)
• NCTN - Canadian Collaborating Clinical Trials Network (RFA-CA-24-032)
• NCTN - Network Lead Academic Participating Sites (RFA-CA-24-033)

However, an individual who is designated as a PD/PI on the application for the NCTN Radiotherapy and Imaging Core Services Center can, if appropriate, be listed as key personnel on applications for the NCTN Network Lead Academic Participating Sites, but not on applications for the other RFAs listed above.

Only the PIs/PDs associated with the award issued under RFA-CA-17-060 to the American College of Radiology are eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Only a single award will be issued to the American College of Radiology under this single source funding opportunity. Please refer to Section I. Notice of Funding Opportunity Information for more details.

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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Margaret Mooney, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-6006
Email: [email protected]
 

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

For this specific NOFO, the Research Strategy section is limited to 30 pages.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Facilities and Other Resources: In addition to standard aspects, provide a detailed description of the special facilities and equipment used for radiotherapy and imaging services.

Other Attachments: Applicants must provide the following additional materials specified below in support of their application. Each attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks).

Attachment 1. Summary of NCTN Clinical Trials Using RT Core Services (use filename RTCore).

In this attachment, provide documentation of RT Core services previously and currently being provided on NCTN clinical trials. Two tables should be provided detailing the NCTN clinical trials for which the applicant has provided RT Core Services - one table for all active trials that are still open to accrual (or only temporarily closed to accrual) for which the applicant is providing RT Core Services and one table for all trials closed to accrual for which the applicant is currently providing RT Core Services. The column headings for each table should include trial phase, major disease category (e.g., "breast cancer"), NCTN Group leading the trial, trial #, trial name, trial status (e.g., active, temporarily closed to accrual), # patients accrued to date on the trial, and a brief description of type of service (e.g., "RT Quality Assurance/Control"). The table should be sorted in the order listed: by trial phase and then by major disease category, Lead NCTN Group, and trial #. The timeframe for the period of services should be provided as a sub-heading for each table (e.g., March 1, 2019 through August 31, 2024).

Attachment 2. Summary of NCTN Clinical Trials Using Imaging Core Services (use filename ImagingCore). In this attachment, provide documentation of Imaging Core services previously and currently being provided on NCTN clinical trials. Two tables should be provided detailing the NCTN clinical trials for which the applicant has provided Imaging Core Services - one table for all active trials that are still open to accrual (or only temporarily closed to accrual) for which the applicant is providing Imaging Core Services and one table for all trials closed to accrual for which the applicant is currently providing Imaging Core Services. The column headings for each table should include trial phase, major disease category (e.g., "breast cancer"), NCTN Group leading the trial, trial #, trial name, trial status (e.g., active, temporarily closed to accrual), # patients accrued to date on the trial, and a brief description of type of service (e.g., "Imaging Quality Assurance/Control"). The table should be sorted in the order listed: by trial phase and then by major disease category, Lead NCTN Group, and trial #. The timeframe for the period of services should be provided as a sub-heading for each table (e.g., March 1, 2019 through August 31, 2024).

Attachment 3. Summary of Other Clinical Trials Using RT Core Services and/or Imaging Core Services (use filename OtherTrialsCore). In this attachment, provide documentation of RT Core Services and/or Imaging Core services previously and currently being provided on clinical trials from other approved NCI-supported clinical trials network programs (e.g., NCI/DCP NCI Community Oncology Research Program, NCI/DCTD early phase clinical trials network program) if such services were provided under this grant in the previous project period. This information can be provided in a table like the ones described above for NCTN trials or in narrative form.

Attachment 4. Key Standard Operating Procedures for RT and Imaging Quality Assurance/Control, Imaging Data Management, and Credentialing (use filename QASOPs). In this attachment, provide updated key standard operating procedures (SOPs) for RT and Imaging Quality Assurance/Control as well as the key SOPs for Image Management and Credentialing for both areas.

Attachment 5. Security and Confidentiality (use filename Security). In this attachment, provide documentation as to how the Center will ensure security and confidentiality of patient data.

Attachment 6. Conflict of Interest (use filename COIPolicy). In this attachment, provide documentation on the Conflict of Interest Policy for the Center to ensure that there is no reasonable expectation that any investigator or staff member at the Center involved in the design, conduct, or reporting of research conducted by the Network Group Operations Centers and their associated Network Group Statistics and Data Management Centers will be biased by any conflict of interest (using the definition of investigator provided in the NIH grants policy).

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

The following additional instructions apply for this NOFO.

a) Budget Breakdown. The application for this NOFO consists of a single budget with the major budget categories (i.e., Personnel, Supplies, Travel, Other Expenses) showing the amounts for the entire application; however, a budget breakdown (general total amounts - not formal separate budgets) should be provided for the three main cores/activities of this application, including coordination activities, as this award will be made with restricted general budget allocations for each of these core activities.

1. RT Core Services for NCTN Clinical Trials;
2. Imaging Core Services for NCTN Clinical Trials; and
3. RT and Imaging Core Services for Other NCI-supported Clinical Trials Network Programs (e.g., NCI/DCP NCI Community Oncology Research Program, NCI/DCTD early phase clinical network trial program).

b) PD/PI Effort Commitment. The minimal effort commitment for the Contact PD/PI must be 1.8 person-months per year. The effort commitment for the other PDs/PIs (if multiple) must be a minimum of 1.8 person-months per year. These effort commitments cannot be reduced in later years of the award.

c) Travel Expenses. Applicants must budget travel funds for two persons (two PDs/PIs or one PD/PI and an additional senior investigator) to attend one NCTN Leadership Management Committee in-person meeting or other NCTN meeting per year in additional to other travel expenses.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: Outline the scope of the core radiotherapy and imaging services to be provided and their relevance/importance to the conduct of NCTN clinical treatment and advanced imaging trials (and oncology trials conducted by the other NCI-supported clinical trials networks).

Research Strategy: Organize the overall Research Strategy section with sub-sections in the specified order and using the instructions provided below. Start each sub-section with the appropriate sub-section heading: Sub-section A. Overview; Sub-section B. Radiotherapy (RT) Core Services Program; Sub-section C. Imaging Core Services; Sub-section D. Collaborations, Participation in Collective NCTN Network Management, and Support for Other NCI-Supported Clinical Trials Network Programs, and

E. Overall Progress Report.

Sub-Section A. Overview - Address the following areas:

• Outline the multi-disciplinary scientific and technical expertise provided by the Center staff as a whole for the RT and imaging services, including its senior leadership team, and the organizational structure, governance policy, decision-making, and prioritization policies for trials with NCTN Group input, and general facilities for the Center. Summarize the main collective strengths of team members in the context of the Center’s goals. Explain how the diverse expertise of the team members increases the capacity for innovation, ability to anticipate new directions, and flexibility to redirect RT and imaging services for research in clinical trials when needed. Describe key accomplishments of the research team.
• Summarize how the RT and Imaging Cores interact with various Network Group Operations Centers and Network Group Statistics and Data Management Centers and how these organizations are represented on the Center's senior leadership team to enhance coordination of services for all NCTN trials starting at design of proposed trials through development and conduct.
• Describe how the Center complies with NIH, NCI, and other federal regulations regarding study monitoring and clinical research as well as how the Center coordinates with the NCTN Groups to provide data for the NCTN Groups' onsite auditing programs. Describe how the activities of the radiotherapy core will be coordinated with the imaging core, especially with respect to interoperability of IT services and image management as well as development of standards and harmonization of processes and data collection. Address how the Center works with the key components of the NCTN to provide electronic exchange of digital planning data, images, and software tools for data review/image review by NCTN trial study chairs.       
• Describe how the Center provides maintenance of its hardware and IT networks to ensure operational integrity and security of core services, including how the Center provides safeguards to protecting medical/clinical patient information.

Sub-Section B. Radiotherapy (RT) Core Services Program - Address the following areas:

• Outline the general approaches used and the specific RT services that are provided for NCTN trials, including the types of quality assurance and site credentialing provided (including RT dose by photons, electrons and protons, brachytherapy, use of anthropomorphic phantoms for complex treatment delivery). Address how the functional needs for collection, distribution, analysis and storing/archiving of RT treatment delivery data for applicable NCTN trials are/will be met, including remote review of 3D and 4D images and RT objects.
• Describe how new techniques and types of radiotherapy in clinical research trials are being addressed (e.g., dosimetry, rapid volumetric treatment data, physical dose assurance). Key ongoing plans and accomplishments related to RT services provided for NCTN clinical trials should be highlighted in this section.

Sub-Section C. Imaging Core Services Program - Address the following areas:

• Outline the general approaches used and the specific Imaging services that are provided by for NCTN trials, including the types of quality assurance, credentialing, and imaging data management provided, including site and scanner qualification and calibration, assessment of acceptability of imaging data for protocol compliance as well as central review/analysis of imaging. Describe how remote central imaging reads are provided to NCTN Group investigators, both “real-time” and “post-review” of images, as well as “emergency” reviews, and how the Center provides expertise on the best approach to NCTN Groups for particular trials.
• Address the plans/actions taken for participation in the development of NEMA DICOM-RT standards and in support of trials which merge imaging from different platforms such as FDG PET, CT, MRI, and other platforms. Address how the functional needs for collection, distribution, analysis and storing/archiving of imaging data for applicable NCTN trials are/will be met.
• Describe how new areas of imaging research in clinical trial such as radiomics are being addressed. Key ongoing plans and accomplishments related to services provided for NCTN clinical trials should be highlighted in this section.

Sub-section D. Collaborations, Participation in Collective Network Management, and Support for Other NCI Supported Clinical Trials Network Programs – Address the following:

• The Center should describe how it works with Network Group Operations Centers and associated Statistics and Data Management Centers with respect to development of standards and harmonization of processes and data collection for NCTN trials, including the Center's capacity for interoperability with the common data management system (CDMS) of the NCTN Program to collect clinical trial data and link it to Center data.
• The Center should describe its ability to work with the NCTN Program tools and services employed for regulatory support and patient enrollment (i.e., the Regulatory Support System (RSS) and the Oncology Patient Enrollment Network (OPEN) for all NCTN clinical trials.
• The Center should describe its capacity to provide core services to NCTN trials that have registration/licensing intent and/or result from collaborations between the Network Groups and outside organizations as well as the Center's ability to collaborate with other NCI-supported clinical trials network programs (e.g., NCI/DCP NCI Community Oncology Research Program, NCI/DCTD early phase clinical trials network programs).
• In addition, the Center should describe its plans for participation in the collective management of the overall NCTN Program, including participation in appropriate NCTN Program activities and initiatives.

Sub-section E. Overall Progress Report: This Progress Report should cover the period of March 1, 2019, through August 31, 2024, and should include a summary of the most significant achievements of the Radiotherapy and Imaging Core Services Center in terms of providing harmonized services for standards and quality assurance for radiotherapy and advanced imaging techniques for applicable NCTN trials in a timely manner. This Progress Report should summarize how the Center's has provided real-time user support (e.g., "Help Desk") to collect feedback for continual improvement of functionality of the core services for sites participating in applicable NCTN trials. This Progress Report should also highlight the Center's major contributions to the collective management of the NCTN Program and any significant collaborations with other NCTN Groups and other NCI-sponsored programs.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. 

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

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

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 How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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 NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

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.

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.

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.

Specific to this NOFO

With respect to RT services:

• How adequately does the plan for providing support services for radiotherapy in clinical trials address the key functional needs such as collection, distribution, analysis, and storage/archiving of all primary and adjunct radiotherapy treatment delivery data for applicable NCTN trials?
• Does the Center have the appropriate infrastructure to provide appropriate uniform quality assurance (QA) procedures and review for advanced radiotherapy trials, including dosimetry, digital data capture, rapid analysis of volumetric treatment planning data, and physical dose assurance capabilities?
• Does the Center have the infrastructure and ability to provide appropriate quality assurance support for the following elements associated with multi-institutional clinical trials involving RT: radiation dose delivery by photons, electron and protons for external beam radiotherapy and brachytherapy, use of anthropomorphic phantoms for complex treatment delivery, archiving and remote review of digital data including 3D and 4D images and RT objects?
• Does the Center provide uniform credentialing of institutions that might participate in applicable NCTN trials including trials which use advanced radiotherapy treatment?

With respect to Imaging services:

• Does the Center have adequate and appropriate plans for future participation in the development of NEMA DICOM-RT standards and in the support of trials which merge imaging from different platforms such as FDG PET, CT, MRI, and other platforms? Are potential problems, alternative strategies, and benchmarks for success presented?
• Does the plan for providing support services for imaging in clinical trials adequately address the key functional needs for an Imaging Core Services Center, including collection, distribution, analysis, and storage/archiving of all primary and adjunct imaging delivery data for applicable NCTN trials?
• How well does it appear the Center would be able to provide quality assurance/control for imaging-related activities in applicable NCTN trials, including site and scanner qualification/calibration, review of imaging data for acceptability and protocol compliance as well as central analysis and evaluation of images?
• How well is the Center able to maintain processes and procedures to allow NCTN Group investigators to conduct remote central imaging reads?
• Is the Center able to provide expertise to the NCTN Group investigators as to the best approach for a particular trial with respect to "real-time" versus "post-review" of images?
• How well does it appear the Center can provide reviewers with the required scientific expertise to perform central reads of images on an emergency basis if the image review cannot be done by the assigned NCTN Group investigator?

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, in accordance with NIH peer review policies and practices, 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.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

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 (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

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

 Development of an overall strategy to provide scientific and technical expertise for incorporating integrated quality assurance/control and data management (including image collections) for applicable NCTN clinical trials that involve interventions with radiotherapy and/or imaging modalities as well as for similar trials conducted by NCI-supported clinical trials network programs (e.g., NCI/DCTD early phase clinical trials network program, NCI/DCP NCI Community Oncology Research Program).

• Implementation of the strategy to support applicable clinical trials with quality assurance/control, credentialing, and image data management for radiotherapy and imaging interventions.
• Compliance with Part 1 of the NCI National Clinical Trials Network (NCTN) Program Guidelines/Handbook dated December 15, 2012 (https://ctep.cancer.gov/initiativesPrograms/docs/NCTN_Program_Guidelines.pdf) and any subsequent updated versions of the Guidelines/Handbook.
• Recipients will comply with NCI/DCTD CRADA agreements and with the Intellectual Property Option to Collaborators (https://ctep.cancer.gov/branches/rab/intellectual_property_option_to_collaborators.htm) for NCTN trials and other clinical trials conducted under a NCI/DCTD Investigational New Drug (IND) Application and/or Investigational Device Exemption (IDE).
• 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 HHS, PHS, and NIH policies

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

• Working with the Center recipients to collaboratively manage major issues associated with the coordination of their RT and Imaging services with the Network Groups and helping to coordinate and prioritize services across the Network trials.
• Informing the PD(s)/PI(s) of the Center of scientific opportunities resulting from NCI-supported clinical research programs and facilitating collaborations among the Center, NCTN, and other NCI-sponsored programs.
• Facilitating the Center recipients' scientific and technical involvement in radiation oncology and advanced imaging research associated with NCTN trials at an early stage in trial development.
• Serving as scientific liaisons to the Center recipients and participation in scientific meetings of the Center recipients.
• Review of compliance with applicable DHHS, FDA, OHRP, NIH, and NCI regulations for clinical research involving human research subjects.
• Monitoring the progress and performance, including auditing of data if appropriate, of the Center recipients.
• NCI will have access to all data (including imaging data) collected and/or generated under this Cooperative Agreement and may periodically review the data. NCI may also review all records related to recipients' performance under the award for appropriate collection, review, and distribution of images and data collected in association with NCTN trials.
• Designated NCI staff with RT and Imaging expertise will have substantial involvement as Project Scientists. Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• General aspects of Center governance and collaboration with respect to quality assurance/control for radiotherapy and imaging in NCTN trials and other trials during trial development and conduct especially with respect to compliance with federal regulations for clinical trial research (and with respect to ensuring that when new avenues of cancer therapy involving investigational approaches are pursued, trials are designed, when appropriate, such that the clinical information obtained, including imaging and radiotherapy data, would be acceptable to the FDA for inclusion in a potential licensing application), development of collaborative trials and international trials, collective management of the NCTN including participating in the NCTN Leadership Management Committee that makes recommendations to NCI for modifications to the Program as well as to standard NCTN common tools and services.
• Review of recommendations from the NCI Clinical Trials and Translational Research Advisory Committee (CTAC) on strategic directions for the NCTN Program related to RT and imaging services.

Dispute Resolution:

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

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. 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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs 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 2 CFR Part 200.301.

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: https://www.era.nih.gov/need-help (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: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

For general research programmatic and administrative information:
Margaret Mooney, M.D.,
National Cancer Institute (NCI)
Telephone: 240-276-6006
Email: [email protected]
 

For inquiries related to radiotherapy services information: 
Bhadrasain Vikram, M.D.
National Cancer Institute (NCI)
Telephone: 301-496-6111
Email: [email protected]
 

For inquiries related to imaging services information: 
Lalitha Shankar, M.D., Ph.D.
National Cancer Institute (NCI)
Telephone: 301-451-9531
Email: [email protected]
 

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]
 

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277301
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 2 CFR Part 200.