It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

Objective

ORIP uses the P40 mechanism to support Animal and Biological Material Resource Centers in a variety of areas of biomedical science. Animal and Biological Material Resource Centers create, collect, develop, characterize, preserve, and distribute special colonies of high-quality laboratory animals and animal-related models. Special colonies of research animals are defined as animals that are valuable for biomedical research but are not generally available to investigators. Collecting, generating and distributing such animals render these resources more accessible to the research community and eliminate costly redundant efforts. Other types of Animal and Biological Material Resource Centers provide informatics tools, data, analytical expertise, biological materials, tools, or services that support research projects that will enhance and expand an animal model system. Of special interest are resources that emphasize use of broadly applicable, interdisciplinary validation tools to increase predictability of animal models, such as approaches to compare and determine relatedness and usefulness of a disease associated network/pathway/physiological process between an animal model and a human patient. Applications that heavily focus on building and maintaining genomic or phenotyping databases for individual animal species will not be considered for funding. Details concerning current Division of Comparative Medicine (DCM) Animal and Biological Material Resource Centers can be found at the following link: https://orip.nih.gov/comparative-medicine/programs.

All applicants are strongly encouraged to consult with DCM Program staff on the appropriateness of the intended resource plans for this program, competitiveness of a potential application, and whether the proposed application meets the goals and mission of the DCM/ORIP and is broad enough to serve needs of the wide biomedical community. Resource applications that are deemed limited to a narrow biomedical research community will not be considered for funding.

Examples of an inappropriate request are resources that exclusively maintain and distribute animals or biological materials for cancer, heart disease, neurological disorders, or other specific disease research areas. Projects involving threatened or endangered species will not be supported under this FOA.

Animal and Biological Material Resource Centers should have the following characteristics:

1) There should be a demonstrated need for the resource in the wide biomedical research community. Evidence of the depth and breadth of impact on a scientific community must be provided. Examples could include up to 15 letters of support from institutions, individuals, groups, or consortia; website usage; a statement from a scientific society; and/or a published white paper. Applications exceeding number of letters limit will be administratively withdrawn without review;

2) The Centers should serve the needs of investigators in a variety of research areas where work is sponsored by multiple NIH ICs. If the user community is very narrow or limited to a research area supported by one NIH IC, support for the animal resource should be sought from the appropriate NIH IC. Furthermore, applications proposing creating resources that are related predominantly to the interest of one NIH IC and only peripherally to the interests of other ICs are not considered acceptable;

3) The Centers must be available and utilized by investigators on a local, regional, and national basis;

4) The Centers should ensure the quality and welfare of distributed animals and describe how their activities assist and promote optimization and enhancement of scientific rigor, transparency and experimental reproducibility of biomedical research;

5) The Centers must have an Applied Research Component to generate new approaches or enhance existing ones that will improve the resources and services provided to the community. Hypothesis driven R21- or R01-like research is not considered applied research. The Applied Research Component may comprise no more than 10 percent of the direct costs associated with the P40 grant;

6) The Institution submitting the P40 application must be committed to the Center being proposed. Evidence of such support must be provided. The application should include a letter(s) of support from the Institution;

7) A critical component of improving scientific reproducibility of the research is to develop approaches for unique identification of research resources in public databases, including publications. The Centers should register catalogs of their resources with current resource tagging and identification initiatives, such as FORCE 11 (https://www.force11.org/group/resource-identification-initiative). These Centers should also work with the investigators to encourage the use of a resource identification system in their publications and reports;

8) The Center should have a disaster plan to minimize total loss of resources in the event of a catastrophic disaster, such as loss of power, fire, flooding, or data breach;

9) The Center should develop an active program for monitoring and collecting information on the impact of their ongoing activities on biomedical research. Such information should also be included in their progress reports to the NIH.

Additional Information

The P40 application is a multi-component application, with an Overall Component that is the aggregate of the major Resource Component and the minor Applied Research Component.

Multiple PDs/PIs for the Overall grant are allowed. Typically, one or more of the PDs/PIs of the Overall application also serves as the Core Lead(s) of the Resource Component and can serve as the Project Lead(s) of the Applied Research Component. The applied research is typically conducted at the applicant institution and not subcontracted.

It is expected that Animal and Biological Material Resource Center grants will progress toward self-sufficiency. In general, this means that Renewal (a.k.a. Type 2) applications should recover in the initial year of the proposed grant cycle a greater percentage of operating costs from Program Income than for the last year of the previous grant cycle. In addition, each of the up to 4 following years in the proposed grant cycle should reasonably expect to recover a greater percentage of operating costs from Program Income than the previous year. Costs specifically associated with the establishment, improvement, or expansion of animal or material distributions and long-term resource maintenance should be recovered from users through a charge schedule acceptable to the NIH. Significant growth of Animal and Biological Material Resource Centers should result from Program Income and not from an ever-increasing P40 award. Note that the Center's use of Program Income is governed by the NIH Grants Policy statement, Section 8.3.2: (http://grants.nih.gov/grants/policy/policy.htm).

Most Centers cannot afford to accept all possible donor deposits if the future demand for these materials cannot justify the expense associated with quality control, expansion and archiving of animals and biological materials. For this and additional reasons, Centers must have an External Advisory Board of experts and users who advise the PDs/PIs on which potential new animals and biological materials should be accepted for archiving and future distribution. The External Advisory Board must be comprised of a minimum of 4 members and must meet a minimum of once per year. The External Advisory Board should provide its annual report to the PD/PI and NIH. If a specific External Advisory Board member receives a salary from the P40 grant, s/he should be a non-voting member. Tele- or videoconferencing is encouraged to decrease costs unless the budgeted expense of face-to-face meetings is justified in the application.

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

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

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)
• 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

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

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

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

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.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

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

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

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	6
Core (Use for Resource component)	12
Project (Use for Applied Research component)	6

Additional page limits 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 a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required
• Resource: 1 required, maximum of 2
• Applied Research: 1 required, maximum of 2

When preparing your application, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: State concisely the goals of the proposed project and summarize the expected outcome(s), including the impact that the results of the proposed resource will exert on the research field(s) that it supports.

Research Strategy: Follow the instructions in the SF424 (R&R) Application Guide. In addition, generally describe and justify the need for the Overall Center in the research community, including possible alternatives. Describe how the activities of the Center will enhance reproducible use of animal models and biological materials it will provide. Describe how the Center will serve the needs of investigators in a variety of research areas where work is sponsored by multiple NIH ICs. Describe how Center activities will assist and promote optimization and enhancement of scientific rigor, transparency and experimental reproducibility of biomedical research. Describe how the Center will be made available to investigators on a local, regional, and national basis. Regarding the plans for the operation and maintenance of the Overall Center, describe how the resources generated by this project will be made available rapidly and efficiently to the NIH-supported research community. Describe how the Center will provide transparency and reproducibility for the information, services, products, and models to be shared. Describe the institutional support for the Overall Center, including plans for long-term continuity. Describe how the Center would be continued beyond this potential grant award. Describe Center efforts for monitoring and collecting information on the impact of their ongoing activities on biomedical research. Such information should also be included in their progress reports to the NIH.

Letters of Support: Letters of Support should be included in the Overall Component (rather than in the Resource or Applied Research Component). Include a Letter of Support from any institution providing space, resources, or financial support other than Program Income from distribution of resources or services.

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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.

When preparing your application, use Component Type Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: State concisely the goals of the proposed resource and summarize the expected outcome(s), including the impact that the results of the proposed resource will exert on the research field(s) that it supports.

Research Strategy: Follow the instructions in the SF424 (R&R) Application Guide.

In addition, describe in detail the resources the Center will create, develop, characterize, preserve, and distribute. Describe what quality control procedures will characterize the resources to be provided. Describe in detail how requests for the resources will be handled, including periodic assessments of performance, including milestones and timelines. Describe plans for protocol/methods dissemination to the greater research community, if appropriate.

Describe the Center’s support structure regarding: coordination of the Center’s mission; monitoring the timelines for achieving milestones; coordinating and integrating Center activities; implementing a plan for regular evaluation of scientific progress; working with the applicant institution to enhance the visibility and effectiveness of the Center; and ensuring appropriate prioritization of activities, including needed course corrections and problem identification and resolution.

Provide a table that shows how the Center is currently funded, including support from any current P40 grant, Program or Center Income, and other sources such as institutional funds, if applicable. Provide a financial plan, including how the Resource will progress toward becoming self-sufficient. Different Centers have grown at various rates and have accumulated different resources. Therefore, Centers may be at various stages regarding the amount of Program Income that can be generated, which depends on the size and marketability of the resource. The sum of the direct costs requested plus Program Income and Institutional commitment, if applicable, should equal the costs associated with all the functions of the Center. Support for the Center from sources other than the grant and Program Income is not required. The requirement for support in addition to that provided by the grant can be waived by the DCM Director in exceptional circumstances.

Describe the planned meeting format for the Center's External Advisory Board, frequency of meetings, and functions. For Renewal applications, applicants must name and briefly describe the qualifications of their Board members. For New applications, describe the types of expertise that would be sought. New Grantees should contact their potential Board members after their grant is awarded. Potential members of the Board should not be contacted, named, or selected until an award has been made. This stipulation will allow a wider pool of potential reviewers of the applications.

Marketing Plan: The Center should present an effective marketing program, aimed at increasing the awareness of the scientific community regarding its program. It is also incumbent on the Centers to assist the wider community to effectively access and use animals, biomaterials and informatics resources created by the program. The development of new marketing methods based upon evaluation of researcher interest via surveys and methods to analyze interactions with the user interface is highly encouraged. Describe approaches for development of additional methods to raise visibility of resources available from the Center, including social media, targeted publications, and development and implementation of a resource tagging system.

Community Outreach: The Center will also develop a plan to provide community training to enhance the use and utility of the resource. Seminars, presentations, posters or workshops can be an element of this effort. The Center should implement mechanisms that solicit regular feedback and opinion from the user community, including comment boxes and online flash-surveys, and then regularly analyze the results. The Center will also track and report to NIH users numbers, web hits and traffic as well as assist in other tracking metrics.

Describe a disaster plan to minimize total loss of resources in the event of a catastrophic disaster, such as loss of power, fire, flooding, or data breach.

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, with the following modification:

Resource Sharing Plans should be consolidated in the Overall Component.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

Applied Research

When preparing your application, use Component Type Project.

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

SF424 (R&R) Cover (Applied Research)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Applied Research)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Applied Research)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Applied Research)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Applied Research)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Applied Research)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Applied Research)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: State concisely the goals of the proposed Resource Section and summarize the expected outcome(s), including the impact that the results of the proposed Applied Research component will exert on the ability of biomedical researchers at research centers, academic institutions, the NIH and other federal agencies to advance scientific knowledge in broad areas.

Research Strategy: Follow the instructions in the SF424 (R&R) Application Guide. In addition, describe how the Applied Research Component will generate new information, services, products, and models that will improve the Resource. Describe how a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions will be achieved. Describe how the scientific rationale for the Applied Research will develop or apply new methodologies to the functions of the Resource Component. Examples of projects include, but are not limited to: improvement of methods for animal reproduction, preserving germplasm, health monitoring, testing for animal pathogens, assisted reproductive technologies, phenotyping, developing new models of human diseases, or genotyping services. Describe how the Resource and Applied Research Components synergize beyond what could be achieved through a traditional research project.

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, with the following modification:

Resource Sharing Plans should be consolidated in the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Applied Research)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

This initiative is not subject to intergovernmental review.

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

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

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

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.

The P40 application is a multi-Component application, with an Overall Component that is the aggregate of the Resource Component and the Applied Research Component. Standard numerical scoring will be applied to the Center's Overall Impact, Significance, Investigators, Innovation, Approach and Environment. Scores should emphasize the resource aspect of the Center. In addition, "Merit Descriptors" will be provided in individual Reviewer’s critiques for individual elements of the Resource and Applied Research Components indicated below. The three potential Merit Descriptors are outstanding, acceptable, or unacceptable.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Overall Center 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 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Does the Overall Center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is there a demonstrated need for the Overall Center in the research community? Could the need have been easily satisfied in other ways? Will the Center support progress in the field? Does the Center serve the needs of investigators in a variety of research areas where work is sponsored by multiple NIH ICs? Do Center activities assist and promote optimization and enhancement of scientific rigor, transparency and experimental reproducibility of biomedical research? Will the Center be available to investigators on a local, regional, and national basis? Is there appropriate institutional support for the Overall Center, and are plans for continuity appropriate for the scientific field’s needs?

Are the PD(s)/PI(s), key personnel and collaborators well suited to the Overall Center? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Are the PD(s)/PI(s), Core Lead(s), and Project Lead(s) appropriately trained and well suited to manage a national resource? Is the work proposed appropriate to the scientific and managerial experience level of the PDs/PI(s) and other researchers? To what extent have collaborations been established or consultants identified to provide the appropriate depth and breadth of scientific and managerial expertise necessary?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the design of the Overall Center and the method of providing information, services, products and models innovative? Are there innovative features in the planned Overall Center's interactions with users of the resource, and within the internal and external decision making processes?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Overall Center? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Center 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?

Are the plans for the operation and maintenance of the Overall Center adequately developed and described? Will the resources generated by this project be made available rapidly and efficiently to the NIH-supported research community? Are appropriate plans in place for assurance of quality control? Are appropriate procedures in place for handling requests for the resources, and for the adequate distribution of the resources? Are the timeline and milestones clear and feasible? Are the plans for transparent protocol and methods dissemination to the greater research community appropriate? Is outside scientific expertise available to advise on governance, management, and function of the Resource? Are the planned meeting format of the Center’s External Advisory Board, frequency of meetings, proposed expertise, and functions adequate? Are there reasonable plans for the Center to become self-sufficient? Does the financial plan for each of years 2 through 5 of the proposed support periods include appropriate Program Income? Is it likely that the financial plan will meet the stated objectives, and move the Center toward self-sufficiency? Does the application describe a plan to track the impact of the proposed resources or resource-related research on broad research areas? Does the Center have an effective disaster plan to minimize total loss of resources in the event of a catastrophic disaster, such as loss of power, fire, flooding, or data breach?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Is there evidence of institutional support for the Overall Center? Is the form of this commitment (space, resources, plans for long-term continuity) appropriate? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling? Is continuation of the Resource beyond this award anticipated and planned for? If so, is an adequate plan to transition to other sources of support presented?

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.

Resource Component

The Resource Component will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects the following considerations:

• The scientific importance of the resources the Center will create, develop, characterize, preserve, and distribute.
• How well the requests for the resources will be handled, including periodic assessments of performance, including milestones and timelines.
• How well the plans for protocol/methods will be disseminated to the greater research community.
• How well the support structure will: coordinate the Center’s mission; monitor timelines for achieving milestones; coordinate and integrate Center activities; implement a plan for regular evaluation of scientific progress; work with the applicant institution to enhance the visibility and effectiveness of the Center; and ensure appropriate prioritization of activities, including needed course corrections and problem identification and resolution.
• Is the financial plan appropriate for a P40-funded resource? Will the financial plans serve the scientific community, in the near and long-term future?
• Are plans for the External Advisory Board scientific and managerial input appropriate?
• Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed?
• Are potential problems, alternative strategies, and benchmarks for success presented?
• If the Center is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource?
• Does 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?

Applied Research Component

• The Applied Research Component will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects the following considerations:
• Will the Applied Research Component generate new information, services, products and models that will improve the Resource? Are refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? How sound is the scientific rationale for the Applied Research for developing or applying new methodologies to the functions of the Resource Component?
• Will the Resource and Applied Research Components synergize appropriately?
• Have the investigators presented adequate plans to ensure there is a strong scientific premise for the Component and consideration of relevant biological variables, such as sex, for studies of vertebrate animals or 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 subject 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.

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.

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

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period. The progress should be evaluated for accomplishment of objectives for the Overall Center. Is there still demonstrated need for the Center in the research community? Could the need be satisfied in another way? Did the Center support progress in the field? Did the Center serve the needs of investigators in a variety of research areas where work is sponsored by multiple NIH ICs? Was the Center available to investigators on a local, regional, and national basis?

Have investigators clearly and concisely described the previous specific aims, and whether they were achieved? Were resources generated by this project made available rapidly and efficiently to the NIH-supported research community? Were appropriate plans in place for assurance of quality control? Were appropriate procedures in place for handling requests for the resources, and for the adequate distribution of the resources? Was there progress toward financial self-sufficiency via Program Income in the last grant cycle?

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the Center and two components 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.

Not Applicable

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).

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 .

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by Center for Scientific Review 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 NIH Council of Councils. 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.

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.

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

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

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

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

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

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.

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.html; and https://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.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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.

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: 301-637-3015

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

Oleg Mirochnitchenko, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0748
Email: oleg.mirochnitchenko@mail.nih.gov

Elena Smirova, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-357-9112
Email: smirnove@mail.nih.gov

Nicole Franklin
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-8682
Email: nicole.franklin@nih.gov

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.