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

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. 

The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

This FOA will support educational activities with a primary focus on:

• Courses for Skills Development

Specifically, this FOA will support the development of modules of genomics-related curriculum to be incorporated into programs that train the entry-level research workforce through collaborations between lead and partner sites, as described below in Programmatic Approach.

Key Terms for this FOA:

• Entry-level research workforce: For the purposes of this funding announcement, the entry-level research workforce is composed of positions that do not require a bachelor’s degree, but often require dedicated training and specific skills, such as assistants in the medical, nursing, genetic counseling, research, and laboratory fields. While some of these workers are in the field of genomics, many are in other fields such as primary care, oncology, pharmacy, or perinatology, where genomics is applied. These positions may also be identified as paraprofessionals.
• Participants: The individuals at the partner sites who are trained using the modules.
• Lead site: A site with expertise in genomics and education. Each lead site will identify three to five partner sites to work with to identify their genomic curriculum needs, develop modules to meet those needs, and assist partner sites in implementation. Lead sites will also have primary responsibility for providing genomics expertise, evaluating the modules, and providing overall administrative, fiscal, and programmatic management of the award. If a lead site has a training program for the entry-level research workforce, it may be both a lead and a partner site.
• Partner site: Sites that train the entry-level research workforce through programs such as certificate, vocational, and continuing education programs at community, technical, and tribal colleges; universities; employers; or professional organizations. These programs should be focused on the entry-level workforce (i.e., not require bachelor’s degrees or higher for entry, nor result in the attainment of one of these degrees). Partner sites will collaborate with a lead site to ensure that lead sites understand their genomic curriculum needs and will be supported by the lead sites to implement the curriculum into their program. Support can include, but is not limited to, lead sites providing financial support, training instructors in genomics, or providing technical support to implement technology-based curricula. Partner and lead sites may belong to the same institution and multiple partner sites may belong to the same institution.
• Modules: Stand-alone units of genomics-related curriculum. The modules will be implemented in the partner sites’ entry-level training programs, such as medical, nursing, genetic counseling, research, and/or laboratory assistant programs. Modules can include, but are not limited to, online coursework, lesson plans for in-person classes, suggested readings, tests, quizzes, and/or activities to reinforce lesson objectives.

Background Information and Need for the Program

In 2020, NHGRI engaged the scientific community to identify future research priorities and opportunities in human genomics, resulting in the 2020 Strategic Vision for Improving Health at the Forefront of Genomics. This vision outlined the guiding principles and values for human genomics, including championing a diverse workforce which includes individuals from groups that are not well represented in biomedical research (see Notice of NIH's Interest in Diversity: NOT-OD-20-031), embracing interdisciplinary teams in genomic research, and increasing access to genomic medicine.

The entry-level workforce is an integral part of laboratories and clinics and assist researchers in every facet of the genomic research enterprise. Currently, the educational programs for most entry-level positions do not include genomics. Members of this workforce could benefit from additional genomic specific training. By having this background knowledge, they will have a better understanding of the genomic aspects of the research in which they are involved. They will also be able to incorporate the knowledge and skills into their work.  

Comparison of the demographics of the entry-level research workforce shows that it is composed of a much higher percentage of individuals from underrepresented populations than in traditional disciplines of the genomics workforce, such as genetic counseling and medical genetics. Individuals in the research workforce from different backgrounds bring different perspectives, exchange innovative ideas, and increase the objectivity in generating new data and in its interpretation, which leads to knowledge that is more reliable. A lack of diversity can negatively impact the scope, integrity, and applicability of research.

Historically, NIH’s training efforts have focused on the baccalaureate, post-baccalaureate, doctoral, and post-doctoral levels. NHGRI’s 2020 Strategic Vision acknowledges the need to enhance genomic literacy at all career stages. Thus, this FOA focuses on providing training for positions that do not require a bachelor’s degree, but often require dedicated training and specific skills, referred to as “entry-level” in this FOA.

Thus, the goal of this FOA is to develop, implement, and evaluate modules of genomics-related curriculum for the entry-level research workforce.

Programmatic Approach

This FOA is intended to support collaborations between a lead site and its partner sites. Lead and partner sites will develop new curricula to be implemented in programs that train the entry-level research workforce. If implementing the modules would create additional needs, such as the need to develop or refine competencies, that activity would be considered within the scope of this program. However, funds requested should be focused primarily on the development and implementation of the modules.

Additionally, awardees will have the opportunity to engage with each other and collaborate. NHGRI Program Office will facilitate yearly virtual meetings among the awardees where plans and progress can be shared. Awardees are encouraged to collaborate beyond these annual meetings; for example, awardees may want to collaborate to create evaluation surveys or develop a plan to share the modules with the wider community at the end of the award.

Awardees will be expected to share their modules with each other during the award period, so that each lead/partner site pair has a larger range of modules from which they can choose to implement. All sites implementing a particular module will be expected to participate in the evaluation of that module.

Institute Specific Considerations

National Human Genome Research Institute (NHGRI)

NHGRI is interested in supporting modules that focus on genomics, as reflected in the areas of its research mission in genomics, which include:

• Resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes
• The genomics of disease
• The implementation and effectiveness of genomic medicine
• Computational genomics and data science
• The impact of genomic technology, advances, and implementation on health disparities and health equity
• Ethical, legal, and social issues related to genomic advances.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 

NICHD is interested in supporting modules directly relevant to its research mission and its priority populations, including women; pregnant and lactating persons; children and adolescents; and individuals with physical, intellectual, and/or developmental disabilities across the lifespan. 

NICHD has a specific interest in modules that provide individuals in entry-level/paraprofessional positions with an introduction to the following concepts:

• Genomic issues that impact reproductive care and pregnancy, including fertility, prenatal testing and newborn screening
• The role of genomics in the diagnosis and/or treatment of a range of neonatal, pediatric, obstetric and gynecologic conditions
• Implementation of pharmacogenomics in NICHD priority populations, including the importance of considering clinical context 
• Social and behavioral genomics
• The importance of enhancing the inclusion of persons from marginalized groups in genomic and other research
• Distinctions between race and ancestry, and how better understandings of both can address health disparities and health equity
• Ethical, legal and social issues in genomics specific to NICHD priority populations. 

Non-Responsive Applications

Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed:

• Program at a partner site is not entry-level (i.e., the program requires a bachelor’s degree or higher for entry, or results in the attainment of one of these degrees).
• Applications that are not accompanied by letters of support from the partner sites that include a commitment to meet the deadlines that would be needed to develop and deploy the modules.
• Applications that do not have a plan for assessing the success of the modules.
• Proposed curriculum is not genomics focused.

Pre-Application Webinar

NHGRI will hold a pre-application webinar for potential applicants on Tuesday, April 11, 2023 at 2:00 pm ET. Participation in the webinar is optional and not required to submit an application. Information about the webinar can be found at: https://www.genome.gov/event-calendar/2023-ELM-Webinar. The webinar connections will open 15 minutes in advance of the start time. During the webinar, NIH staff will give an overview of the FOA and application submission process and field questions from potential applicants. Attendees can ask questions during the webinar and are encouraged to email questions in advance to Renee Rider at [email protected].

For those who cannot attend, a recording of the webinar will be posted on the above website.

Frequently Asked Questions

Questions and answers from the webinar and other frequently asked questions will be posted here: https://www.genome.gov/event-calendar/2023-ELM-Webinar/faq.

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

Section II. Award Information

Other Award Budget 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

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

Federal Governments

• 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

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

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.

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. 

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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 per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

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

Program Faculty

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate. Faculty should have experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

Participants

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents.

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 will not be reviewed.

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:

Renee Rider, JD, MS, CGC
Telephone: 301-443-4336
Email: [email protected]

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.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

Other Attachments.

An Institutional Advisory Committee is not required for this R25 Research Education program. However, if an applicant would like to develop one, please provide a plan for the Institutional Advisory Committee. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Institutional Advisory Committee will evaluate the overall effectiveness of the program. Proposed Institutional Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Please name your file “Advisory_Committee.pdf”.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

• Use Section E on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program, including tuition and education costs.
• Applicants may include funds for costs for dissemination of modules to the broader community, program evaluation costs, and other program-related expenses.
• Budgets may also include expenses incurred at the partner sites, such as travel, training, and salary for their faculty as appropriate.
• Participant, dissemination, and evaluation costs must be itemized in the proposed budget.

Follow all instructions provided in the SF424 (R&R) Application Guide.

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

Research Strategy

Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:

• Proposed Research Education Program
• Program Director/Principal Investigator
• Program Faculty
• Program Participants
• Institutional Environment and Commitment
• Recruitment Plan to Enhance Diversity
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan
• Dissemination Plan

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

To develop an application for this FOA, applicants should engage with 3-5 partner sites and work with them to gain an understanding of their need for genomics-related curriculum and their educational environment to get an idea of the types of modules (e.g., online, in-person, lecture based, project based) that would meet the needs of their participants.

Specific Attributes and Requirements for Modules

Applicants for lead sites should work with their proposed partner sites when preparing the application to gain an understanding of the genomics-related gaps in the entry-level programs at the partner sites and how to best design curricula to fill those gaps. The application must describe the rationale behind each of the modules proposed, how it can fit into the programs at the partner sites (i.e., which course the module will be added to or if a new course will be created), the goals and objectives of the proposed modules, and the modality of the module (i.e., online coursework, lesson plans for in-person classes, suggested readings, and/or activities to reinforce lesson objectives). Examples of potential modules related to genomics include, but are not limited to:

• Taking and documenting a family history
• Creating pedigrees
• Basic genomic concepts such as DNA, genes, chromosomes
• Types of genetic variation (epigenetic, somatic, germline)
• Screening vs. diagnostic testing
• Preconception, preimplantation, prenatal, and newborn screening and testing
• Direct-to-consumer testing
• Genomic testing strategies (targeted variants, single gene, panel, exome, genome)
• Genomic and other -omic testing methodologies
• DNA sequencing technology approaches
• Genetic Information Nondiscrimination Act of 2008 (GINA) and its protections
• Cascade screening
• Mitochondrial DNA
• Genomic based therapeutics (i.e., RNA vaccines, gene therapy, antisense oligonucleotides)
• Pharmacogenomics
• Distinctions between race and ancestry
• Bioinformatics/computational issues in genomics
• Social and behavioral genomics
• Ethical, legal, and social implications of genomics research

Modules must be focused on the needs of the entry-level research workforce, which means they must be appropriate for individuals with little-to-no prior genomic knowledge. Because not all partner sites will have the same programmatic needs, all modules do not need to be implemented at each site.

Modules developed by each awardee will be shared with all awardees for deployment at their partner sites. All partner sites will have an opportunity to provide feedback on the modules and the developers will have time to refine and adjust their modules before final dissemination. Applicants should also include a plan about how they plan to train the partner sites staff on the material that will be implemented.

At the end of the award, modules will be made freely available beyond the lead and partner sites; awardees may collaborate to develop a common dissemination method. Awardees will also be encouraged to collaborate with each other to share ideas for evaluation and a sharing plan to make the modules freely available.

Timeline

The proposal should detail a three-year plan.

• Year 1:

It is anticipated that most lead/partner sites will be on an academic calendar that starts in late August/early September. Sites on different academic calendars may modify the timeline to allow time to use the modules in their classes.

Investigators will come together for an annual virtual meeting to discuss the year’s activities, share plans, and exchange ideas. Investigators are encouraged to maintain contact with each other if working together would improve their final product. Synergies sites could develop include, but are not limited to, coordinating content, sharing software for making online modules, sharing information about the needs of other recipient's partner sites, or discussing options for hands-on activities.

Through the development of the application, grantees will have already identified gaps in their partner sites’ curriculum and planned modules. However, it is anticipated that during Year 1, grantees may decide to devote the first ~3-5 months to refining that plan so that their modules may also address the needs of other grantee partner sites. Module development is expected to begin as soon as plans are finalized and last for ~9 months. Development of the modules may continue into Year 2 of the grant.

• Year 2:

Investigators will come together for the annual virtual meeting to discuss the year’s activities. Synergies sites could develop include, but are not limited to, sharing completed modules and discussing plans for implementation and evaluation.

Module development may continue in the ~1-2 months of Year 2. Assuming a late August/early September start date for their academic year, lead/partner sites will be encouraged to share their modules and material with other sites several months prior to the start of the academic year to give other sites the opportunity to implement any of these additional modules. The lead sites will also use the first ~5 months until the start of the academic year to provide training to their partner sites and support the implementation of the modules. Based on each site’s academic year, there may be several implementation phases corresponding to different semesters or terms. Use of the modules is expected to occur over the academic year and span Years 2 and 3.

Once the modules are implemented, the lead and partner sites should remain in close contact to provide additional support, training, or refinement of the modules as necessary.

• Year 3:

Investigators will come together for the annual virtual meeting to discuss the year’s activities. Synergies sites could develop include, but are not limited to, sharing implementation progress and discussing plans for program evaluation and dissemination.

Assuming programs are operating on a traditional academic year, the start of Year 3 will continue the use and refinement of the modules.

The last ~7 months, after the first academic year has concluded, is expected to be dedicated to evaluation of the modules and program, refinement of the modules based on feedback, and final dissemination of the modules to the wider community. Sites are encouraged to continue to use the modules for a second academic year and continue to refine them as needed.

This timeline may vary for lead sites working with partner sites on different academic calendars. All modules should have been implemented, utilized at least once, and evaluated by the end of the award period.

Promoting Diversity, Equity, Inclusion, and Accessibility in the Partner Site Training Programs

Lead sites should consider ways to promote diversity, equity, inclusion, and accessibility in the genomics workforce. For example, to help reduce barriers to entry, the lead site could consider providing funds to support tuition and education costs for participants at the partner sites. Applications would need to include information on the proposed number of participants to be supported, the participant selection process, and a justification for how they will promote diversity, equity, inclusion, and accessibility at the partner sitesthe entry-level research workforce.

Collaboration

Applications should demonstrate that the applicant will engage in collaboration between the lead and partner sites, and with other awardees. For example, lead sites are expected to share modules with other sites.

All lead sites will be expected to attend the annual virtual investigator meeting; attendance is optional for partner sites. Recipients will be encouraged to collaborate outside these meetings, if mutually beneficial.

Program Director/Principal Investigator. Describe arrangements for administration of the program.  Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

Program Faculty. Faculty from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty at both the lead and partner sites.

• Faculty at the lead site should have genomics and/or education expertise, experience relevant to the proposed program, and demonstrate a history of, or the potential for, their intended roles.
• Faculty at the partner sites will be those with expertise and experience relevant to implementing curriculum at entry-level programs.

Without repeating biosketches, briefly summarize the characteristics of the participating faculty in terms of their abilities to produce curricula, facilitate a collaboration between the lead and partner sites, support the deployment of the modules, assist faculty at the partner sites, and/or evaluate and refine the modules.

Program Participants. Program participants are the individuals at the partner sites who are trained using the modules (i.e., the students/trainees in the partner site programs).

Applications must identify each partner site program and the career levels and program type for which the proposed program is planned. Include information on programs they are in, such as the job(s) for which participants are being prepared (e.g., medical assistant, laboratory assistant), the type of institution and academic level (e.g., high school vocational program, associate degree at a community college), and expected outcome (e.g., certificate, diploma). Applications should also include the number and demographics of the participants who will engage with the modules.

Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under “Facilities & Other Resources” or the required “Institutional Commitment Letter of Support,” described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.

Likewise, describe the institutional environment of the partner sites. Evidence of the partner sites’ commitment to the educational program is required and Letters of Support must be attached (see below). Appropriate institutional commitment at the partner sites should include the provision of adequate staff, facilities, and resources that can contribute to the planned research education program. Applicants will need to provide assurance that partnerships between the sites can occur on the timeline allowed for the award and that the partner sites plan to continue to use the modules after the award period is complete.

Where appropriate, describe any unique features, such as prior existing collaborations between the lead and partner sites, that may be leveraged to the advantage of the proposed curriculum development.

Recruitment Plan to Enhance Diversity  (NOT-OD-20-031):

The applicant must provide a Recruitment Plan to Enhance Diversity. Include outreach strategies and activities designed to recruit prospective participants from diverse backgrounds, e.g. those from groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.

Applications lacking a Recruitment Plan to Enhance Diversity will not be reviewed.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019 and NOT-OD-22-055. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Applicants should obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

The evaluation plan should include an evaluation of both the module content and the programmatic goals.

• Module Content

Each application should include a plan for evaluating and refining the content of the modules. All lead sites and partner sites, even partner sites working with other lead sites, should have the opportunity to provide feedback on all modules. The plan should include multiple opportunities for providing feedback.

• Programmatic Goals

Basic metrics should be reported, such as which modules were implemented, the number of participants who have trained on each module, and education levels and demographic characteristics of participants. Participants’ feedback on the program should be solicited. Additional information is encouraged, such as information about participant employment status (e.g., the hire rates, application rates to other education, and positions participants have acquired) and measures to gauge the success of the modules in achieving its objectives.

Dissemination Plan. A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program. Course materials must be made available and easily accessible to the public electronically. For example, grantees could develop a website which includes the course description, instructional materials (e.g., syllabi, suggested readings, videotaped lectures, and/or online modules), and acknowledgement of NIH funding.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above:”Institutional Environment and Commitment."

A letter of support should be provided by each of the partner sites, which should:

• Describe their academic program and include information such as the job(s) for which participants are being prepared (e.g., medical assistant, laboratory assistant), the type of institution and academic level (e.g., high school vocational program, associate degree at a community college), and expected outcome (e.g., certificate, diploma) of their program.
• Provide information about the curriculum gaps to be identified, readiness for collaboration with the lead and other partner sites, and evidence of the partner sites’ commitment to the educational program including the provision of adequate staff, facilities, and resources that can contribute to the planned research education program.
• Provide assurance that partnerships with the lead sites can occur on the timeline allowed for the award.
• Confirm that the partner site intends to continue to use the modules after the award period.
• Outline the experience of their program faculty who will engage with the planned research education program.
• Describe any unique features, such as prior existing collaborations between the lead and partner sites, that may be leveraged to the advantage of the proposed curriculum development.

Resource Sharing Plan
Note: Effective for due dates on or after January 25, 2023, a Data Management and Sharing Plan is not applicable for this FOA.

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:

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the 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.

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name(s), and title of the application.

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The goal of this R25 program is to support educational activities that complement and/or enhance the training of the entry-level research workforce by supplementing it with additional curricula in genomics.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this R25 Education Program, 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.

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

2. Review and Selection Process 

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions consistent with applicable law:

• 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.
• Relevance of the proposed project to the goals of the R25 program.
• Relevance of the proposed project to the priorities of co-funding components.
• Consideration of geographic and institutional distribution.
• Consideration of programmatic distribution, such as education modalities (e.g., online vs in-person), choice of module topics, and program focus (e.g., medical assistant, laboratory assistant)

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 all 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. 

2. Administrative and National Policy Requirements

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

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee Diversity Report, in accordance with the RPPR Instruction Guide.

Awardees must submit the NRSA Training Table 8B: Program Outcomes: Short-Term in Section B.4 of the Research Performance Progress Report (RPPR). Sample and table description can be found at https://grants.nih.gov/grants/forms/data-tables.htm.

NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

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 recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

In accordance with the regulatory requirements 45 CFR Part 75 and 2 CFR Part 200 and Appendix XII to 45 CFR Part 75.113 and 2 CFR Part 200.113, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Other Reporting Requirements

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

A final RPPR 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.

5. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below.  In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves.  Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants’ subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

In evaluating this research education program, NIH expects grantees to use the following evaluation measures:

For Courses for Skills Development:

• Aggregate number of participants trained at each site
• Educational levels and demographics of participants
• Which modules were implemented at each site
• The number of participants at each site who have trained on each module
• Participant employment status, which may include the hire rates, application rates to other education, and positions participants have acquired
• Participants' feedback on the program

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Renee Rider, JD, MS, CGC
National Human Genome Research Institute (NHGRI)
Telephone: 301-443-4336
Email: [email protected]

Tracy M. King, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-1822
Email: [email protected]

Mariam Eljanne, PhD
National Cancer Institute (NCI)
Telephone: 240-276-7607
Email: [email protected] 

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: [email protected]

Monika Christman
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7860
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.