Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
R25 Education Projects
Reissue of PAR-17-485 - NIMH Research Education Mentoring Program for HIV/AIDS Researchers (R25)
See Notices of Special Interest associated with this funding opportunity
June 27, 2024 - This PAR has been reissued as PAR-24-233
September 22, 2023 - Notice of Change in the Expiration Date for PAR-21-228. See Notice NOT-MH-23-395.
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.
September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.
August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169.
August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109
July 22, 2019 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109
PAR-20-080 - NIMH Mentoring Networks for Mental Health Research Education (R25 Clinical Trial Not Allowed)
PAR-20-094 - NIMH Research Education Programs for Psychiatry Residents (R25- Independent Clinical Trial Not Allowed)
PAR-20-096 - NIMH Short Courses for Mental Health Related Research (R25 -Independent Clinical Trial Not Allowed)
93.242
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. 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.
To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:
Both research experiences and mentoring activities are required. These Research Education Mentoring Programs are expected to enhance the professional development of the mentees and foster career trajectories towards independent research to reduce the incidence of HIV worldwide and to decrease the burden of living with HIV. The terms participant and mentee are used throughout this FOA to refer to individuals who are enrolled in the research education program.
30 days before application due date
Only accepting applications for the AIDS Application Due Date(s) listed below.
September 7, 2021; September 7, 2022; September 7, 2023
All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
November 2021, November 2022, November 2023
January 2022, January 2023, January 2024
April 2022, April 2023, April 2024
Not Applicable
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.
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 goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.
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.
Additionally, the program goal is to advance the priorities outlined in the Office of AIDS Research (OAR) Strategic Plan and the research program priorities of the NIMH Division of AIDS Research (DAR). Programs supported by this FOA should advance the objectives and strategies of the Training, Infrastructure and Capacity Building Area of Emphasis from the Office of AIDS Research (OAR) Strategic Plan.
Specifically, the NIMH is interested in the development of research education programs that have a thematic concentration in behavioral and social science research priorities (e.g., HIV prevention and care continua; understanding and addressing HIV-related health disparities; dissemination and implementation science research), and/or HIV neuroscience research (e.g., HIV/CNS neuropathogenesis; genetics and therapeutics; HIV/CNS latency and cure strategies). To accomplish the stated over-arching goal, this FOA will support creative educational activities with a combined focus on:
An example of program structure might include but is not limited to: (1) short-term, intensive research education experiences in a laboratory and/or field setting designed for optimal mentee experience; and (2) generation/utilization of national mentoring networks comprised of a qualified pool of faculty serving as mentors across the nation. Proposed research education programs must include both activities noted above.
While there is no singular, effective approach to scientific mentoring, it is widely recognized as an important element for career development. Recommendations made by the National Advisory Mental Health Council (NAMHC) Workgroups on Research Training and Transformative Neurodevelopmental Research in Mental Illness encourage the NIMH to support programs that provide state-of-the-art, pedagogical opportunities for individuals during the formative stages of their careers. The NAMHC Workgroup reports also acknowledge the important role that mentors play in the career development of scientists.
Program Considerations
This FOA will support the development, implementation, and evaluation of innovative research education mentoring programs encompassing HIV research topics; didactic content; and mentoring expertise that reflect the research priorities of the NIMH. Proposed activities should address the goal of developing a highly skilled and diverse biomedical HIV research workforce. HIV clinical trial networks and multi-site HIV cohort studies may provide a strong scientific environment in which mentoring programs can be embedded, taking advantage of existing resources, stable infrastructure, ongoing research projects, network longevity, rich databases, and accessibility of senior mentors. Such environments are especially primed to support research experiences and mentoring of individuals interested in pursuing behavioral and/or social science research related to HIV and/or neuroscience of HIV.
Participants may include undergraduate students, graduate/medical students, medical residents, postdoctoral fellows, and/or early-career faculty. Proposed programs may include individuals from a single career stage if it is targeting graduate/medical students, medical residents, postdoctoral fellows, and/or early-career faculty. Programs may also propose to bridge several career stages. If a program proposes to include undergraduate students, then the program is required to also include participants at another career stage. Depending on the target participants, the proposed programs may target individuals either with existing HIV research experience or those who are considering a career in an area relevant to HIV research. Research educational programs should provide intellectual, technical, theoretical and/or practical knowledge to promote the conduct of mentored HIV scientific inquiry and in turn advance the research career development of participants. Research Education Programs should be designed to develop a multidisciplinary mentoring team in an HIV thematic concentration consistent with current NIMH/DAR research priorities. Programs are also encouraged to assist mentees and mentors in developing their own mentoring skills.
The NIMH expects all programs to foster the participation of individuals from diverse backgrounds, including individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and women. Mentees should be actively engaged in the program for a period of no less than one year, maintaining regular contact with mentors and peers within the program during that time. Expected outcomes for those mentees participating in the mentoring program include subsequent involvement in research, subsequent employment in an HIV research field, authorship of scientific publications, and/or subsequent independent research grant support from NIH or other sources.
Mentoring programs may be national or regional, or designed to link two or more complementary organizations or institutions. An applicant organization may wish to partner with other organizations to develop a national mentoring program. As noted in the recommendations of the NAMHC Workgroup on Research Training, national scientific professional organizations may be effective partners in efforts to establish national mentoring programs.
The scope of a mentoring program should be broad enough to accomplish a set of goals rather than a single goal. For example, the program could advance the broad career goals of mentees; facilitate scholarly writing and grantsmanship; provide access to a network of skilled mentors who are outstanding researchers but not available at the home institution of the mentee; promote successful transitions from one career stage to another; provide leadership development; help to identify potential collaborators; and help to establish interdisciplinary or translational collaborations. However, it is expected that an over-arching goal of any mentoring program is to facilitate the professional success of mentees as independent researchers and members of the research community.
Consistent with the NIH global health research mission, NIMH is committed to developing clinical research expertise and sustainable research infrastructure both outside and within the United States. Although this research education opportunity is primarily for domestic programs, NIMH also encourages U.S.-based applications with Low- and Middle-Income Country (LMIC) sites. Inter-institutional collaborations could be useful when domestic institutions with foreign sites are involved and should build upon the pairing of mentors from different locations for an integrated approach.
Proposed programs should provide new and complementary opportunities that are substantially different from existing mentoring, networking, or research education programs within academic institutions, or pre-existing networks or educational collaborations among institutions. There should be a clearly defined value added from the proposed programs. Also, the proposed programs should have sufficient faculty mentors with varying scientific expertise to support a well-balanced program and research context for proposed program mentees.
Programs should include:
Applicants are strongly encouraged to contact the listed Scientific/Research Contact(s) for current information about priorities and policies before preparing an application.
Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trial(s).
Note: Appointed participants are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets may not exceed $200,000 in direct costs annually and are expected to reflect the actual needs of the proposed project.
The total project period for an application may not exceed five years.
Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds).
Personnel costs (administrative and clerical costs, as well as salaries of the PD/PI and other investigators/faculty) associated with directing, coordinating, administering, and implementing the program should be well-justified, reasonable, and may not exceed 35% of the total direct costs in any year.
Participants may be compensated for participation in activities specifically required by the proposed research education program, if sufficiently justified. Participant costs must be itemized in the proposed budget.
Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.
While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition and other education-related expenses.
Expenses for foreign travel must be exceptionally well justified.
Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by an R25 program, as participants, but may not receive salary or stipend supplementation from a research education program.
Because the R25 program is not intended as a substitute for an NRSA institutional training program (e.g.,T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.
Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.
Consultant costs may not be used to substitute for Personnel costs. While well-justified costs for supplies are allowable, "seed" or pilot funds to support research project activities are not allowable costs.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement.
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
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
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 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.
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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
The PD/PI should have a strong track record as an educator and mentor in an area relevant to the scientific focus of the proposed mentoring program and have a history of NIH funding.
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:
Program Faculty
Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.
Participants
Participants (i.e., mentees) are limited to undergraduate students, graduate/medical students, medical residents, postdoctoral fellows, and/or early stage investigators. Proposed program participants may include individuals that bridge several career stages, or from a single career stage (except when including undergraduate students; if an application proposes to include undergraduate students then the application must propose to include participants from another career stage as well). Depending on the target participants, the proposed programs may target individuals at different career stages, who have either existing HIV research experience or those who are considering a career in an area relevant to HIV research. Participants should be actively engaged in the mentoring and research experience , maintaining regular contact with mentors and peers within the program during that time.
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.
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.
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:
The letter of intent should be sent to:
Email: [email protected]
Note: Effective for due dates on or after January 25, 2023 a Data Management and Sharing Plan is not applicable for this FOA.
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 Advisory Committee is not a required component of a Research Education program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. 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:
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:
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.
The description should include the educational and/or career level(s) of the planned participants. The career stage focus of the proposed program should be justified along with the need for/degree of prior HIV research experience required for participation.
Applicants should propose a program that includes mentoring, resources, and interactive opportunities in a specific scientific content area as the framework for the proposed research experience and mentoring program. Describe the rationale for the mentoring model and the scientific content area chosen, as well as the relationship of the scientific content area to the priorities outlined in the Office of AIDS Research (OAR) Strategic Plan and the research program priorities of the NIMH Division of AIDS Research (DAR). The chosen content area should be of sufficient breadth to provide reasonable assurance of the ability to recruit a high-quality pool of potential participants annually and to ensure that a critical mass of mentors and mentees is involved in the program. The program should enhance the participants' professional development and foster their career trajectories towards independent HIV research.
Describe the framework for, and the components of, the proposed research experience and mentoring program, e.g., their rationale, the grounding in experience and pedagogical theory, and the justification in terms of the long-term goals of the proposed research experience and mentoring program. Describe how state-of-the-art approaches to mentoring, research education, and scholarship will be employed in the program.
Describe the scientific need for and timeliness of the program, how the program complements existing training or didactic opportunities (as appropriate), how educational goals and objectives relate to the mission and current research priorities of the NIMH, and the rationale for the career stage(s) of the participants in the proposed research experience and mentoring program. Provide programmatic detail on the specific activities proposed (e.g., curricula, seminars, involvement in hands-on research activities at the mentee’s home institution), and how the accomplishment of objectives will be measured. Describe expected processes for (a) planning and implementing the proposed educational activities, (b) selecting mentors for participants, and (c) if applicable, coordinating among existing training or research activities available at a site or across multiple sites. Note that there should be a clear value added from the proposed, R25-supported research experience and mentoring program. Describe how the research experience and mentoring program may be modified over time depending upon the outcome of initial progress, feedback from participants and mentors, and/or new developments in the field, in order to ensure that the research education continues to be at the cutting edge.
Describe the proposed structure of the program. It is expected that a combination of didactic interactions (e.g., in the form of summer institutes of weekly to monthly duration and/or regularly occurring webinars), one-on-one, and small group discussions will be components of any proposed research experience and mentoring program. Both formal and informal interactions between mentors and participants are expected. Applicants are encouraged to take advantage of contemporary communication strategies (e.g., distance learning and social networking), as appropriate for the goals of their program.
The application must describe how mentors will provide participants with an introduction to the principles underlying rigorous and reproducible research during the course of their research experience (see the NIMH page on rigorous study design and reporting). To the extent feasible in a research experience program, mentors are encouraged to foster participants' education in quantitative reasoning, experimental design, statistics, and analytic techniques.
Since collaborative mentoring occurs at a group level to strengthen the practice of mentoring and share new resources, applications should include an integrated combination of research and academic interactions, defined to include but not be limited to summer institutes of weekly to monthly duration or regularly occurring webinars; individual and small group discussions; and formal and informal interactions between mentors and participants. Proposed programs are expected to incorporate research educational opportunities that will help individuals move a step forward towards productive careers as HIV research scientists.
A plan for program leadership must be provided. The plan should describe leadership team responsibilities, frequency of meetings, and other relevant information. This plan must not overlap with the Multiple PD/PI plan, if applicable. The plan should describe the leadership team, including composition, roles and responsibilities, frequency of meetings, and other relevant information. Describe the process by which the leadership team will review and select participants, provide oversight for the program components, and evaluate the overall effectiveness of the program. Key leadership team members, including PD/PIs or leaders from each participating institution or organization, should be identified in the application; other leadership team members may be appointed at a later date. However, in renewal applications, leadership team members should be named.
The proposed program must include each of the two types of activities: Mentoring Activities and Research Experiences. The emphasis on both activities does not need to be equal and the application should include a justification for the level of emphasis placed on each activity.
Mentoring Activities: The mentorship plan must include:
Research Experience: The plan for research experiences must include:
For Renewal Applications, the Progress Report should describe:
The description of the proposed program for the next funding period must document a clear need for continued support, and should highlight how the program continues to offer quality scientific education as well as any changes in activities that are planned to maintain the currency of the research education offered. Renewal applications should describe the continuing need for the existing program to advance NIMH's goal of a well-trained pool of researchers with state-of-the-art knowledge and skills essential for achieving the Institute's research priorities.
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. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles. The application should include the anticipated number of mentors who will participate in the mentoring network and their desired qualifications. The application should document availability and access to qualified faculty mentors and to research resources. Describe the planned recruitment for mentors as well as eligibility, selection, evaluation, and removal criteria. Describe the responsibilities of mentors. Mentors should have research expertise and experience relevant to the proposed program, a track record of mentoring individuals at the career stage(s) proposed in the application, and a record of leadership related to training and career development programs or activities.
Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned along with a rationale for the selected career level(s). Provide details about plans for recruiting and selecting participants. Describe the pool from which participants will be selected regionally and/or nationally (including the anticipated size of the pool, expected qualifications of the applicants, and source(s) of this pool). Describe plans for announcing and advertising the program nationally or regionally, application procedures, and criteria for evaluation and selection of participants including information about plans to recruit and select participants whose research interests intersect with the strategic objectives of the Division of AIDS Research. Describe how participants will be matched with mentors. Describe planned methods for reviewing the progress of participants and for identifying and addressing any problems.
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.
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.
Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies.
Applications lacking a diversity recruitment plan 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. 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. Wherever appropriate, applicants are encouraged to obtain feedback from participants and mentors to help identify weaknesses and to provide suggestions for improvements.
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, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops.
Letters of Support
A letter of institutional commitment must be attached as part of Letters of Support (see section above: Institutional Environment and Commitment.")
Resource Sharing Plans
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
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:
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.
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). 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.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
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, NIH. Applications that are incomplete or non-compliant will not be reviewed.
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 will enhance the mentees professional development and foster their career trajectories towards independent HIV research. Applications should be characterized by state-of-the-art approaches to mentoring and research education, scholarship, and documentation of a strong need in the research community for the proposed mentored research education program. Renewal applications should also demonstrate a continuing need for the existing program to advance NIMH's goal of a well-trained pool of researchers with state-of-the-art knowledge and skills essential for achieving the Institute's research priorities.
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.
Significance
Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?
To what extent will implementation of the proposed program enhance the professional development of the mentees and foster their career trajectories towards HIV research independence?
Investigator(s)
Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? 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?
Is the caliber of program leadership and participating faculty, in terms of their research interests, expertise, mentoring records and research education leadership in the area of the proposed program, appropriate for their roles on the project?
Innovation
Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?
Does the proposed program have unique "value added" beyond other career development supported efforts at the applicant institution or available elsewhere?
Approach
Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?
Is the approach feasible and appropriate to achieve the stated research education goals? Is the balance between the two required activities (mentoring activities, research experiences) adequately described and justified with appropriate weights to each based on objectives of the proposed program? Is sufficient interaction planned between faculty/mentors and mentees to achieve the goals of the program? Is there adequate description of the sources of the pool of expected mentees and their qualifications? Are the stated plans for announcing and advertising the program, recruiting mentees regionally or nationally, application procedures, and criteria for evaluation and selection of mentees appropriate to achieve a highly qualified cohort of mentees? Does the evaluation plan adequately describe how outcomes will be determined and evaluated? Is there a well-defined plan to disseminate program-generated materials to the broader scientific community? Are potential problems and alternate strategies adequately discussed?
Environment
Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?
If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate) as well as coordination among other training or career development programs (if applicable)?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
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.
Revisions
Not Applicable
Renewals
For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in attracting individuals from diverse populations, including populations underrepresented in biomedical, behavioral and clinical research on a national basis.
The committee will also consider whether the outcomes demonstrate success in advancing career trajectories towards independence in HIV-related research.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review, and a Data Management and Sharing Plan is not applicable for this FOA.
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.
Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective participants from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Training in the Responsible Conduct of Research
Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups; 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. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.
If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:
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 recipient’s business official.
Awardees 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.
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. 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
When multiple years are involved, awardees 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.
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.
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 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.
Other Reporting Requirements
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.
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, NIMH expects to use the following evaluation measures:
For Research Experience and Mentoring Programs Involving the Following Groups:
Undergraduate Students:
Graduate Students:
Postdoctorates and Early Career Investigators:
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: [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
Susannah Allison, PhD
National Institute of Mental Health (NIMH)
Telephone: 240-627-3861
Email: [email protected]
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]
Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]
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.