Part 1. Overview Information

Key Dates

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

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

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The objective of the NIDDK Hematology Centers Program is to increase access to critical research resources and collaboration in the national multidisciplinary research effort to combat nonmalignant hematologic diseases and/or to study normal hematopoiesis. It aims to provide state-of-the-art equipment, resources and expertise, and serve as a national resource for nonmalignant hematology research, including enhancing the research of scientists just beginning their careers in the field and attracting established investigators from other domains.

The NIDDK Hematology Centers Program will consist of up to four Cooperative Centers of Excellence in Hematology (CCEHs) and a Hematology Central Coordinating Center (HCCC). The overall goal of the HCCC is to organize and facilitate the activities of the NIDDK Hematology Centers Program, including development, support, and execution of a Pilot and Feasibility Program. The NIDDK CCEHs are comprised of Biomedical Research Cores, an Administrative Core, and an Enrichment Program. Usually, three to five Biomedical Research Cores are included in a CCEH. Biomedical Research Cores are defined as shared resources that enhance productivity, provide uniform quality control, impart an economy of scale, or in other ways benefit a group of investigators working to accomplish the stated goals of the CCEH. The reagents, resources or expertise from all Biomedical Research Cores will be made available nationally. Examples of such resources include functional genomics, bioinformatics, generation of transgenic animals, and cell preparation facilities. Applications for CCEHs are solicited through a separate, companion FOA (RFA-DK-19-005). Investigators with appropriate expertise may apply to both RFA-DK-19-005 and RFA-DK-19-013.

Objectives and Scope

The overall goal of the HCCC is to organize and facilitate the activities of the NIDDK Hematology Centers Program, under the direction of the NIDDK Hematology Centers Program Steering Committee, to achieve the following objectives:

1. Facilitate sharing of resources and data within the NIDDK Hematology Centers Program and with the wider nonmalignant hematology research community,
2. Develop a multipronged communication plan for disseminating the information about the research resources and methods offered through the CCEHs to the wider nonmalignant hematology research community,
3. Support and facilitate the education and outreach activities of the NIDDK Hematology Centers Program,
4. Develop, support and execute the Pilot and Feasibility (P&F) Program to encourage junior investigators in the nonmalignant hematology field and to attract established investigators from other domains who bring in new technologies and approaches,
5. Develop and manage a program-wide website for internal and external communication,
6. Plan, organize and support at least one annual face-to-face meeting for the NIDDK Hematology Centers Program, including investigators supported by the P&F Program and an External Evaluation Panel,
7. Provide centralized administrative support, including coordination of any relevant agreements (e.g., data use, material transfer, etc.) across the Program, and
8. Schedule and coordinate web-based conference calls and webinars.

Research Objectives

Research areas addressed by projects supported by the NIDDK Hematology Centers Program, including the P&F Program, must be in line with the research mission of the NIDDK Hematology program (see https://www.niddk.nih.gov/about-niddk/research-areas/hematologic-diseases). Some examples of these research areas are:

• Molecular and cellular biology of hematopoiesis and hematopoietic stem cell (HSC) biology, including ex vivo expansion of HSCs, definition of the niche in which HSCs thrive and relationships (cross-talk) between components of the niche and HSCs
• Hematopoietic growth factors and erythropoietin
• Use of primitive and/or definitive stem cells, including induced pluripotent stem cells (iPSCs) as a resource to study gene and cell therapy tools for hematopoietic disorders, or to use hematopoietic stem cells as cell therapy tools for other disorders (non-hematopoietic)
• Use of NIH-approved human embryonic stem cell (hESC) lines to explore development into primitive and/or definitive (adult) HSCs and their use for cell therapy
• Expressed erythroid molecular biological components and creation of reagents useful for study of the erythroid cell lineages
• Blood cell receptor biology and signaling
• Computational biology approaches to accurately predict effects of distortion in a biochemical network
• Blood cell metabolism; membrane biology and ion transport; heme metabolism; responses to environmental fluxes
• Globin biosynthesis, including its genetic regulation and its control for therapeutic purposes
• Iron absorption, storage and metabolism; pathophysiology of iron overload, and strategies for therapeutic intervention
• Development of approaches and techniques for gene therapy using hematopoietic cells

Program Organization

The coordinated efforts of the CCEHs and the HCCC will be overseen by the NIDDK Hematology Centers Program Steering Committee composed of CCEH Directors, the HCCC Director(s), and NIDDK Program staff. The NIDDK Hematology Centers Program will meet at minimum once yearly for a face-to-face meeting in the Bethesda, MD area that will be coordinated by the HCCC. The first meeting will be held in the Fall of 2020 and all CCEH Directors, Biomedical Research Core Directors, and the HCCC Director are required to attend. The NIDDK will utilize an External Evaluation Panel (EEP) to monitor research efforts and advise the Institute on the progress of the NIDDK Hematology Centers Program.

Applicants are encouraged to consult with the NIDDK Scientific/Research staff listed below concerning plans for the development of a HCCC, on the organization of the application, and regarding the NIDDK Hematology mission.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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)

• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply Non-domestic (non-U.S.) components of U.S. Organizations are 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 SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

The HCCC Director is required to have an established record of external funding and research accomplishment but is not required to have a background in nonmalignant hematology research.

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

Only one application per institution (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. This means that the NIH will not accept:

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

John F. Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKletterofintent@mail.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

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

Other Attachments:

Statement of Willingness: Please title this attachment "Willingness to Participate". Applicants should provide a statement indicating a willingness to:

• Work with the NIDDK and NIDDK Hematology Centers Program to participate in the initial and annual meetings thereafter during the course of the grant award;
• Cooperatively interact with the NIDDK and NIDDK Hematology Centers Program in support of the projects and activities;
• Work collaboratively with the CCEHs to develop and execute any relevant agreements to permit sharing of resources, biological specimens and de-identified patient data;
• Actively seek input from the NIDDK and NIDDK Hematology Centers Program regarding resource or expertise needs that may arise during the performance of the project; and
• Participate in monthly conference calls.

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

The HCCC Director is required to have an established record of external funding and research accomplishment but is not required to have a background in nonmalignant hematology research.

R&R Budget

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

The minimum level of effort for the HCCC Director is 1.2 person months (10% effort). An Associate Director(s) may be named as well, but the total, combined Directorship efforts may not exceed 2.4 person months. The HCCC may also include an administrative assistant(s) and specialized support personnel (e.g., website developer) that must be fully justified.

The budget must include at least $500,000 direct costs per year to fund P&F projects. This budget should support about 5-10 P&F projects per year, administered as subcontracted awards. The budget to support the HCCC, including personnel, travel, consortium meeting expenses and supplies, are expected to be approximately $150,000 direct costs per year. The budget must include support for the annual NIDDK Hematology Centers Program face-to-face meeting with a minimum of $20,000 in direct costs specifically devoted to travel awards for trainees, junior investigators, and investigators outside of the nonmalignant hematology research field. These travel funds may also support the activities outlined in Section I, including travel support of investigators to learn new laboratory techniques, develop new collaborations, or engage in scientific information exchange. Additionally, the budget must include funds to support travel of the HCCC Director attend face-to-face meeting, as outlined in Section VI.

Budget Justification: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For years 2-5 of support requested, justify any significant increase or decrease in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts.

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

Specific Aims: The specific aims should reflect the integrated approach that clearly presents a pathway to reach the goals of the NIDDK Hematology Centers Program.

Research Strategy:

The overall goal of the HCCC is to provide leadership, in collaboration with the CCEHs, in organizing and facilitating the activities of the NIDDK Hematology Centers Program under the direction of the NIDDK Hematology Centers Program Steering Committee and in response to annual input from the External Evaluation Panel. The HCCC should provide a plan for administrative coordination of the Program activities, that will be executed in partnership with the CCEHs. Specifically, the HCCC should describe a plan to:

• Organize and facilitate sharing of the NIDDK Hematology Centers Program resources within and outside of the Program. An example of sharing may be, but not limited to, developing a standard operating procedure and/or quality control metrics for a technique that is used across two or more CCEHs and disseminating these protocols and results via the website.
• Devise an innovative and multipronged communication strategy to ensure that the resources of the NIDDK Hematology Centers Program are widely known and effectively utilized within and outside the Program. The strategy may also include a plan to widely disseminate and highlight any publications arising from the Program investigators or P&F projects and promote opportunities for joint publications on behalf of the Program.
• Facilitate and promote educational and enrichment activities for the NIDDK Hematology Centers Program. The Enrichment Programs of the CCEHs will aim to expand the pool of investigators who utilize the NIDDK Hematology Centers Program resources and are drawn into the field of nonmalignant hematology research. It is expected that the HCCC will creatively reach out to a larger research community and provide a means for inclusion of new disciplines into nonmalignant hematology research.
• Administer the solicitation, review, and selection of projects to be funded under P&F Program designed to increase the capacity of the nonmalignant hematology research community by leveraging resources supported by the NIDDK Hematology Centers Program. Award subcontracts and provide fiscal oversight for P&F Projects. The P&F projects are limited to (a) junior investigators or (b) established investigators not previously involved in nonmalignant hematology research. The P&F Program is not intended to support or supplement ongoing research of an established nonmalignant hematology investigator. It is expected that P&F projects will generate preliminary data to support future research applications, such as NIDDK investigator-initiated R01s and may serve to pilot high-risk/high-reward concepts. Basic and translational research projects are encouraged. P&F projects are anticipated to be on the order of $50,000-75,000 direct costs, and the program is expected to support 5-10 projects per year. P&F project proposals will be assessed by independent content experts selected by the NIDDK Hematology Centers Program Steering Committee. These experts will provide comments on scientific merit for submitted P&F applications to be shared with the applicants, NIDDK Hematology Centers Program Steering Committee, NIDDK, and EEP. The NIDDK Hematology Centers Program Steering Committee is responsible for making final award decisions, with approval by the EEP, based on review, the availability of funds, and the Program goals and interests.
• Develop an easily navigated website to highlight and update the available resources within the NIDDK Hematology Centers Program and utilize all relevant avenues and modes of communication with the wider research community to ensure that a wide range of investigators are aware of and are encouraged to use the resources of the NIDDK Hematology Centers Program. Develop a transparent method to track requests for models, cells, molecules, genes and data. Post videos of lectures, seminars, or hands-on technical demonstrations, provided by the CCEHs.
• The HCCC should provide a plan to organize and support an annual, face-to-face meeting of the NIDDK Hematology Centers Program, including the P&F awardees and EEP.
• The HCCC is also expected to organize the monthly, web-based conference call of the NIDDK Hematology Centers Program Steering Committee.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

• All applications should include a Data Sharing Plan.
• All applications are expected to provide plans that address sharing and demonstrate commitment to making resources, models, reagents, tools and methods available to the NIDDK Hematology Centers Program and the broader nonmalignant hematology research community. The terms and timelines for sharing within the NIDDK Hematology Centers Program, validation of models and methods and sharing with the broader research community will be established by the Steering Committee in a manner consistent with achieving the goals of the program and NIH policies. All participants are expected to adhere to these terms as a condition of award.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

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

Significance

Does the proposed HCCC address the needs of the NIDDK Hematology Centers Program that it will serve? Is the scope of activities proposed for the HCCC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the NIDDK Hematology Centers Program?

Specific to this FOA:

Does the application describe an outward focus of the HCCC rather than merely an inward organization strategy?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the HCCC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing nonmalignant hematology research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? 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 HCCC? 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 NIDDK Hematology Centers Program the HCCC will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the NIDDK Hematology Centers Program the HCCC will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the NIDDK Hematology Centers Program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the NIDDK Hematology Centers Program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the NIDDK Hematology Centers Program? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Specific to this FOA:

Is the organization appropriate to address the need for collaboration within the? NIDDK Hematology Centers Program ?and? with the outside research community? Does the HCCC have a plan to respond to those outside the NIDDK Hematology Centers Program who request resources and methods? Does the applicant describe an innovative communication strategy for the NIDDK Hematology Centers Program?

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

Environment

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

Specific to this FOA:

Is the proposed team willing to work cooperatively with the NIDDK and the NIDDK Hematology Centers Program to further the overall goals of the Program?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS). Reviewers should comment on whether applicants provide adequate plans that address sharing and demonstrate commitment to making resources, models, reagents, tools and methods available to the NIDDK Hematology Centers Program and the broader nonmalignant hematology research community.

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, convened by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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:

• 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.

• Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council.

The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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.

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

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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

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

• Pursuing research objectives consistent with the research scope of this FOA and favorably recommended by peer review; collecting, analyzing and disseminating the resulting data;
• Accountability towards the applicant organization officials and to the NIDDK for the performance and proper conduct of the research supported by the project in accordance with the terms and conditions of the award;
• Tracking the usage of CCEH and HCCC resources, providing usage data to the Steering Committee, and making efforts to expand CCEH and HCCC outreach and resource usage nationwide;
• Sharing all standard operating procedures, other protocols, and quality control metrics with research community, to support the conduct of research at no charge other than the costs of reproduction and distribution, consistent with achieving the goals of this program.
• Serving as voting members of the Steering Committee, and attending annual (in-person) and bi-weekly (virtual) meetings of the Steering Committee;
• Sharing research results and CCEH and HCCC plans with the Steering Committee, the NIDDK and the External Evaluation Panel (EEP) as required for approved activities;
• Submitting progress reports as needed to the NIDDK and the EEP for distribution to members of the NIDDK Hematology Centers Program. Such reports are in addition to the required annual noncompeting continuation progress report;
• The PD(s)/PI(s) will agree to: 1) accept the coordinating roles of the Steering Committee, which includes evaluating objectives and research goals of the NIDDK Hematology Centers Program, and recommending modification, deletion or addition of projects within a CCEH or HCCC; 2) follow any common protocols in which they participate for multicenter projects that are approved by the Steering Committee; and 3) accept the cooperative nature of the group process, including the establishment, where appropriate, of smaller collaborative subcommittees comprised of interacting subprojects and/or Cores.
• Awardees 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.
• Any third-party (including industry, academia, and foundations) collaboration should be governed by a research collaboration agreement (e.g. Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network studies between grantee and third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network policies. Further, at the request of the NIDDK Program staff, any other network-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions , and Section 8.5.2, titled: Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support , noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.
• Any involvement of a third-party (including industry, academia, and foundations) in the study and network activities that includes access to any network study data and biosamples, or study results that are not publicly available, or using the name of the network or study or the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.

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

• NIDDK will form an External Evaluation Panel (EEP), comprised of the outside advisors with relevant expertise to the goals of the NIDDK Hematology Centers Program, and selected by the NIDDK. The EEP will convene annually to review and assess the program and to advise NIDDK Project Staff of scientific developments and opportunities that may enhance the achievement of the NIDDK Hematology Centers Program goals.
• The NIDDK Project Scientist(s) will participate in the overall coordination of the NIDDK Hematology Centers Program and serve as a voting member(s) of the Steering Committee. This includes efforts to improve and strengthen intra- and inter-Center cooperation amongst the CCEH and HCCC, and among other funded NIDDK programs as it pertains to cross-fertilization of basic research disciplines. As a means of improving collaboration, the Project Scientist(s) will directly participate in the activities of the collaborative subcommittees as established by the Steering Committee. These may include activities of the Pilot & Feasibility Program administered by the HCCC, access to Biomedical Research Cores, and outreach to the greater hematology research community.
• The Project Scientist(s) will, as required, help reprogram biomedical research efforts, including options to modify or terminate them, by mutual consent between the NIDDK Hematology Centers Program PD(s)/PI(s) and NIDDK. In the event of disagreements among Program participants, the Project Scientist will assist in forming an arbitration panel as discussed below.
• NIDDK Project Scientist(s) will interact with each individual CCEH and HCCC awardee towards evaluating objectives and research goals of that particular Center, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The Project Scientist(s) will assist and facilitate this process and not direct it. The Project Scientist(s) will also assist in reviewing and commenting on all major transitional changes of an individual center’s activities prior to implementation to assure consistency with required goals of the NIDDK Hematology Centers Program.
• NIDDK retains the option to recommend the withholding of support from a CCEH Core or other component of a CCEH or HCCC materially failing to meet the technical performance requirements established by this NIDDK Hematology Centers Program. This includes identifying jointly with participants of the Steering Committee the need to add additional service/reagent preparation/equipment Cores to CCEH or to phase out a service/reagent preparation/equipment Core when performance standards have not been met; and
• To participate, where warranted, in data analyses, interpretations, and the dissemination of study findings to the greater research community and health care recipients including, co-authorship of the publications arising from results generated in research conducted by the CCEH.

In addition, a separate NIDDK Program Official identified in the Notice of Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions. Additional responsibilities include:

• Interacting with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor progress. Monitoring may include: regular communications with the PD(s)/PI(s) and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at the Steering Committee and related meetings.
• The NIDDK Program Official will monitor progress of the CCEH and HCCC and may request that a component be closed for reasons including: a) poor progress; b) patient safety and regulatory concerns (if applicable); c) emergence of new information that diminishes the scientific importance of that component.
• Making recommendations for continued funding based on: a) overall project progress; b) cooperation in carrying out the research and evidence of collaboration (e.g., attendance at the Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high-quality research product that has potential to fill a national need.

Areas of Joint Responsibility include:

• The Steering Committee will consist of the PD(s)/PI(s) from each of the participating CCEH funded through RFA-DK-19-005 and the HCCC funded through RFA-DK-19-013, as well as the NIDDK Project Scientist(s). A Chairperson of the Steering Committee, other than a NIDDK Project Scientist, will be selected by the NIDDK. Each full member of the Steering Committee will have one vote. The Steering Committee will be the main, governing body of the NIDDK Hematology Centers Program and voting members will be required to attend annual (in-person) meetings in Bethesda, MD. In addition, the steering committee will convene bi-weekly via teleconference.
• The Steering Committee will document progress in written reports to the NIDDK Program Official and will provide periodic supplementary reports upon request.
• The purpose of the Steering Committee will be to discuss and evaluate concerns and cooperative activities of the NIDDK Hematology Centers Program, including (but not limited to) the Pilot & Feasibility Program, Biomedical Research Cores, and the Enrichment programs. The Steering Committee will establish working subcommittees as necessary and provide feedback to the subcommittee leaders at least bi-annually. The Steering Committee reserves the right to implement changes in subcommittee membership or direction if needed. Awardees will be required to accept and implement policies approved by the Steering Committee.
• The annual, in-person meeting will include the External Evaluation Panel. These meetings are separate from any regular conference calls. The purpose of these meetings is to share scientific information, assess scientific progress, identify new opportunities and potential avenues of collaborations such as with industry, private foundations, non-NIDDK Hematology Centers Program members of the research community and/or NIH intramural scientists, establish priorities that will accelerate achievement of the goals of the NIDDK Hematology Centers Program, and reallocate resources.
• As needed, the Steering Committee will develop a publication policy regarding joint authorship of research reports derived from such collaborative efforts.

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: 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

Terry Rogers Bishop, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7726
Email: terry.bishop@nih.gov

Cindy N. Roy, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8805
Email: cindy.roy@nih.gov

Ann A. Jerkins, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-2242
Email: ann.jerkins@nih.gov

Norma DeGuzman
National Institute of Diabetes and Digestive, and Kidney Diseases (NIDDK)
Telephone: 301-480-1810
?Email: norma.deguzman@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. 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.