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

Applications that do not comply with these instructions will not be reviewed

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

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 over-arching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet biomedical, behavioral and clinical research needs; (2) enhance the diversity of the biomedical, behavioral and clinical research workforce; (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 over-arching goal of this Fogarty International Center Health-Professional Education Partnership Initiative (HEPI) R25 program is to support educational activities that complement and enhance the training of a workforce to meet the biomedical, behavioral and clinical research and health care service needs of Ethiopia, Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia, and Zimbabwe. By strengthening the clinical and research capacity of health professions education institutions, these countries should be better able to address their HIV epidemic and its associated co-morbidities and to improve the health of their populations.

Major objectives of this FOA are to (1) expand and enhance innovative medical and/or nursing education models that have the potential to improve the quality of clinical education and clincial care in countries in sub-Saharan Africa; (2) develop strategies that enable graduating health professional students to remain in their home country to practice, serve as faculty, and/or conduct research related to the implementation of PEPFAR and other public health priorities; (3) increase the quantity and retention of health professionals post-training where they are most needed within the country, including in neglected rural areas; (4) evaluate and disseminate best educational practices, including introducing and evaluating innovative training modalities and approaches; (5) enhance the capacity of African health professional students to conduct locally-relevant health research as an integral part of their professional training, for example in implementation science and/or clinical, health services, and operations research, with an emphasis on HIV/AIDS and its comorbidities; (6) build the human and institutional resources needed to support biomedical, behavioral, clinical, and operational research at the institution; (7) articulate and address national needs with respect to the health professional workforce, through consultation with appropriate stakeholders such as the Ministries of Health and Education (e.g. the need for decentralized health professional education, or for critical health specialties that are poorly represented in the current workforce); (8) enhance the recruitment and retention of qualified academic faculty; and (9) strengthen a national network of African health professions education and research institutions and departments that can share educational resources, expertise, knowledge, and training opportunities to help build capacity more widely within the country.

Health Professions focus and inter-professional experiences: While primary curricular and other activities may be focused within either Medicine or Nursing Education, applications must propose some inter-professional medical-nursing activities such as joint courses, problem-based practicums, research opportunities, or skills development workshops to prepare health professionals to function as effective teams in later practice. These may also include other allied health professions as appropriate and feasible. In addition, recognizing the complex nature of health issues, which frequently require novel and integrated solutions, applicants are also encouraged to incorporate multi-disciplinary perspectives within the education program and may include exercises with departments outside the health professions. It is expected that initiatives proposed to build institutional capacity to support research and faculty development will benefit all health disciplines within the institution.

Enabling Environment: The proposed program should provide faculty and students with an environment that will challenge them to try novel approaches and seek out unfamiliar or emerging technologies and complementary expertise to incorporate into innovative solutions that have the capacity to be transformative and sustainable. It is expected that this will require innovative training models and new partnerships within and beyond the university community and Sub-Saharan Africa.

Partnerships: Each applicant institution must partner with at least one additional health professional institution within their country, and are encouraged to partner with other African, U.S., or other international institutions that can provide expertise needed to achieve the objectives of this FOA. Applicants are also encouraged to partner with other health professional schools or departments within their own institutions for inter-professional activities and initiatives.

Background: From 2010-to 2015, the Office of the U.S. Global AIDS Coordinator (OGAC) at the Department of State, the National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA), supported the Medical Education Partnership Initiative (MEPI: https://www.fic.nih.gov/Programs/Pages/medical-education-africa.aspx), a coordinated effort to build health research workforce capacity in high HIV-burden African countries. MEPI was supported by funds provided to the NIH and HRSA under the "Tom Lantos and Henry Hyde United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008," Public Law 110-293 (known as the U.S. President's Emergency Plan for AIDS Relief [PEPFAR]). MEPI supported 13 African Universities in 12 countries within a network of 32 participating African institutions and 20 partnering U.S. institutions. These institutions were supported to address PEPFAR's goals to increase the number of new health care workers, strengthen medical education systems in recipient countries, and build clinical and research capacity in Africa to nurture and retain medical school faculty. In conjunction with these awards, through the NIH Director's Common Fund and individual NIH Institutes, Centers, and Offices, NIH provided additional "linked awards" to MEPI institutions to support research and research training opportunities in specific NIH research mission areas.

In parallel, through PEPFAR funds, HRSA led the Nursing Education Partnership Initiative (NEPI: https://www.pepfar.gov/partnerships/initiatives/nepi/) which, under the Ministry of Health-led NEPI Advisory Boards in those countries, supported 22 nursing schools to improve nursing education and training, leverage collaborative academic-practice partnerships, and implement innovative clinical learning strategies with the goals of increasing the number, quality, and retention of nurses and midwives in six African countries.

One of the most important outcomes of these programs was the creation of a network of institutions in Africa that formed a community of practice for medical and nursing education, with shared information and increased discussion and collaboration on issues of common interest.

In 2015, NIH issued a new solicitation for five-year programs for research training and career development of junior faculty in African institutions that participated in the MEPI network, and issued eleven awards (https://www.fic.nih.gov/Programs/Pages/mepi-junior-faculty.aspx). As with the prior MEPI programmatic and linked awards, these awards emphasize the critical importance of research in creating vibrant and effective schools for health professional education that can improve health on the continent.

HEPI will build on the achievements and lessons learned from MEPI and NEPI by further enhancing educational and research programs, as well as partnerships and networks, formed by prior MEPI and NEPI support and/or by expanding to new Health Professional Schools and departments. Prior participation in MEPI or NEPI awards is not required.

Special Considerations: Examples of potential activities are provided in five areas, each of which should be addressed in the application. Different applicant institutions will be at different stages of building their health professions education and research capacity, so it is expected that different applicants will give different weight to each of these areas, depending on their needs. These are examples only and each applicant should consider the specific activities that will best help their institutions address the over-arching goal and major objectives stated above.

• Courses for Skills Development: For example, innovative, hands-on community-based training, problem-based learning, inter-professional practicums, and clinical preceptorships; advanced courses in clinical procedures, simulations, new technologies, or specialized clinical and research techniques; training in core capabilities for institutional support of research (such as ethical review, grants management, and financial management); videocast and interactive grand rounds and seminar series. Skills training may take the form of practicums, short or long courses, workshops, summer institutes, and eLearning. Priority should be given to courses that address HIV/AIDS topics such as- but not limited to- stigma and discrimination, nurse initiated and managed ART (NIMART), data management and use for decision-making, and quality improvement of HIV/AIDS service delivery. Participants may also be sent to partner institutions for specialized skills development not available at the grantee institution.
• Research Experiences: Research experiences must be an integral part of the educational program with expectations for high quality, scientifically rigorous, mentored research that might impact health practice in the associated field. Research topics should be locally-relevant and address health priorities of the country. Opportunities for inter-professional and/or multi-disciplinary research experiences, or creating research tracks where they are not currently available (for example by providing options for nurse-scientist training), are particularly encouraged. Where possible, priority should be given to research activities focusing on addressing barriers to HIV/AIDS service delivery.
• Mentoring Activities: Effective Mentorship should be an explicit goal of the proposed program, both to provide high quality supervision in research and clinical education, and to provide career guidance for health professional students, post-graduates, and junior faculty. Training in Mentorship and Leadership (i.e. how to become Mentors and Leaders) may be considered at all career stages.
• Curriculum or Methods Development: For example, development of novel instructional approaches or computer-based educational tools, including eLearning approaches and resources. Priority should be given to curricula and methods that strengthen HIV/AIDS service delivery at all levels of the health system. Creative approaches to curriculum should also consider national goals for the health workforce, such as decentralization of health professional education and retention of professionals after their degree where they are most needed in the country, or education in under-represented specialties. Where new or innovative approaches are proposed, educational experiments to determine their effectiveness in meeting the objectives of the program are encouraged.
• Outreach: For example, collaborative activities between schools and departments within or outside the institution and the development of tools, such as electronic platforms and distributed learning models, to facilitate interaction, shared teaching, and sharing resources; dissemination of biomedical, behavioral and clinical research findings through oral presentations and publications; engagement with governmental and other stakeholders; engaging host country civil society organizations (CSO); and other communication and collaborative activities. Applicants must include at least one health professional school outside their institution as part of a consortium.

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 U.S. government support.

See Section VIII. Other Informationfor award authorities and regulations.

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

Higher Education Institutions

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

Other

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Eligibility is restricted to Medical and Nursing Schools in the following low resource countries in sub-Saharan Africa with a significant HIV burden: Ethiopia, Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia, and Zimbabwe. Applicant institutions should have the demonstrated capacity to develop and implement programs to improve health professional education and research, as well as demonstrated ability to manage international global health grants, contracts, or cooperative agreements. All institutions in these countries that meet these criteria are eligible, regardless of whether they received a previous MEPI or NEPI award. Applicants must collaborate with at least one eligible institution in the same country outside the applicant institution, and may collaborate with a consortium of eligible institutions, that provide education for the same health profession. In addition, to meet the requirement for inter-professional activities, collaboration with a School or department that serves a different health profession (for example, departments within the same or the collaborating university) is also required for those specific activities. Applicants are also encouraged to engage partners from any country, including the US, that can assist them in meeting the goals of this FOA.

Since this initiative is funded by PEPFAR, applicant and all collaborating institutions must meet the requirements of the Policy on Protecting Life in Global Health Assistance:

https://grants.nih.gov/policy/protecting-life-global-health-assistance.htm.

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 U.S. government-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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from 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 contact PD/PI must be employed by the African institution submitting the application where the proposed educational program will be established and must have citizenship in an African country. Other Multiple PDs/PIs with relevant expertise from partner institutions in Africa must also be African citizens. Multiple PDs/PIs should have a documented history of collaboration relevant to the proposed program. The contact PD/PI and the applicant organization should have demonstrated ability to develop and implement programs to improve health professions education and research.

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

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

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

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

Educators and Researchers from diverse fields, training, and backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have teaching and 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. Applicants are encouraged to include partners from U.S. or other international institutions that bring special and needed expertise to the educational program.

This educational program is intended for the education of African citizens. Applicants are encouraged to recruit participants from diverse health disciplines and specialty interests and from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women.

Buttons to access the online ASSIST system or to download application forms 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 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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, preferably electronically through email, should be sent to:

Flora N. Katz, Ph.D.
Fogarty International Center
Telephone: 301-402-9591
Fax: 301-402-0779
Email: [email protected]

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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. Provide a plan for the appointment of an Advisory Committee to monitor progress of the research and clinical 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. 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 the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
• Budget should be provided for the PD(s)/PI(s), and potentially other key faculty, to attend an annual network meeting at rotating awardee institutions each year within sub-Saharan Africa.

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

The 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
• 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. Applicants should describe the major goals of the proposed program, as it aligns with the stated objectives of this FOA, and how they will achieve those goals through the five activity areas listed under the Funding Opportunity Description, above. Applicants should describe expected outputs in products and processes by the end of the five year program, as well as the expected outcomes that will result from implementation of the program.

Some inter-professional activities are required. While there is an assumption that such interaction pre-practice will improve health care and perhaps create some economies in education, there is no evidence. All initiatives should be accompanied by a means to evaluate an explicit value proposition.

Applicants should describe why particular partnerships with other institutions, departments, or other entities were chosen, what each contributes, what roles each will play, how efforts will be coordinated to achieve the goals of the program, and the mutual benefit expected from the collaboration.

Applicants at institutions that directly received prior MEPI programmatic, linked, or MEPI Junior Faculty awards, or NEPI Awards, should describe what was achieved under that award, how the present application differs, and how they will leverage the achievements and insights gained from previous support. For these applicants, the application should include new activities and objectives that will significantly advance the capacity, maturity, and excellence of the educational program at the institution and within the participating consortium. The applicant should not propose to merely sustain an initiative already in place. Where relevant to the application, applicants should also describe how they might leverage other PEPFAR- or NIH-funded programs at the participating institutions.

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. As applicants are expected to propose some inter-professional activities and/or courses, Program Faculty should include individuals with expertise in the associated fields. For institutions included within a consortium, faculty leads should be named for each participating institution.

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. Fostering diversity in the scientific research and medical workforce is a key goal of the NIH. Every facet of the scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds, life experiences, and health disciplines bring different perspectives, creativity, and individual enterprise to address complex scientific and medical problems. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences.

Institutional Environment and Commitment. Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under "Facilities & Other Resources"), that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support (see below). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Plan for Instruction in the Responsible Conduct of Research. For participants in research experiences and mentoring activities, 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. 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 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, interactive visits, or other means.

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, with the following 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 all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Failure to follow the instructions on inclusion of Appendix material could result in rejection of the application.

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

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

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 and responsiveness by the Fogarty International Center. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical, behavioral, and clinical research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to 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? Is the proposed program likely to increase capacity for health professions education and research in the applicant and participating institutions in order to increase the quality, quantity, and retention of health professionals in their countries?

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? Are there investigators representing both medicine and nursing, and potentially other Allied health professions, as appropriate to the activities proposed? Where U.S. or other international partners have been engaged, do they have clear roles that add value to the program? Does the PD(s)/PI(s) have demonstrated ability to develop and implement programs to improve health professional education and research?

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 program promote and support innovation that will strengthen medical and nursing education and research? Where novel or innovative approaches or methodologies are proposed, does the applicant propose a means of assessing their effectiveness in achieving the goals of the educational program? Does the proposed program create an enabling environment that will encourage faculty and students to seek out novel approaches and partnerships in practice and research to generate innovative solutions to clinical and research challenges?

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? Does the application include outreach and inclusion of at least one other school within the country, to facilitate joint capacity development for health professions education and research? Does the application include inter-professional components that will contribute to building capacity for nurses and physicians, and possibly other allied health professionals, to work together effectively in practice and to improve health care delivery? Does the application present a reasonable plan to enhance the research support infrastructure at the participating institutions, where such capacity is needed? Does the application include baseline metrics that will form the basis for an evaluation plan? Does the application prioritize HIV/AIDS focus areas? For those applicants that had prior MEPI or NEPI support, do the applicants explain how this application differs from and will leverage the achievements of previous support?

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?

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 six 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 six 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 Children

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 children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Recruitment Plan to Enhance Diversity

Not Applicable

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the proposed research education component of the program and 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 (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 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) convened by{the Center for Scientific Review }, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

Applications will be assigned to the Fogarty International 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 Fogarty International Center Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic distribution of awards
• Priorities of the participating organizations
• Balance of Health Professional Specialities across the Program

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

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

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

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

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

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

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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, 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 grantee 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.

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 [FIC] expects to use the following evaluation measures:

For Courses for Skills Development:

• Aggregate number and demographic characteristics of participants
• Educational level of participants
• Content
• Participants' feedback on the program
• New knowledge or skills acquired
• Number and quality of courses or practica designed to enhance participants' capacity to develop, implement and evaluate evidence-based practices and standards of care, with an emphasis of HIV/AIDS and its co-morbidities
• Number and nature of courses or workshops for skills development related to the capacity of the institution to support the research activities of its faculty and students
• Number and types of inter-professional educational activities

For Programs Focusing on Curriculum or Methods Development:

• Aggregate number and demographic characteristics of participants exposed to the new curricula or methods
• Number of curricula developed/revised
• Number of curricula developed/revised that focus on HIV/AIDS
• General educational level of participants
• Effectiveness of the new curricula or methods assessed by skills/competencies gained compared to existing curricula or methods, or by the number of students reached
• Number and nature of inter-professional curricula or courses
• Number and nature of multidisciplinary exercises and disciplines engaged
• Success of strategies to retain health professionals in areas of greatest need, such as rural clinics
• Success of strategies to retain professionals within the country
• Success in recruiting and retaining qualified faculty
• Ability of curricula to address national workforce needs
• Dissemination and/or adoption of the new curricula or methods

For Outreach Programs:

• Numbers, types, and rationale for institutional and departmental partners
• Aggregate number and demographic characteristics of individuals reached
• Educational levels of participants
• Number of Civil Society Organizations (CSO) engaged
• Inter-professional outreach and activities
• Assessment of increased awareness, knowledge, or understanding of science-, research-, or health professions-related concepts, processes, or careers within the applicant institution and among its consortium partners

For Research Experience and Mentoring Programs Involving the Following Groups:

Health Professional Degree Level Students:

• Aggregate number and demographic characteristics of participants
• Local relevance of research topics and alignment with national health priorities
• Impact of research experience as evidenced by presentations, publications, and impact on policy
• Subsequent educational/career progress, including:
• Successful completion of a health professional degree
• Enrollment in an advanced degree program in a clinical or STEM field
• Number of research activities or practica focusing on HIV/AIDS

Masters and Doctoral Students:

• Aggregate number and demographic characteristics of participants
• Local relevance of research topics and alignment with national health priorities
• Subsequent educational/career progress of participants, including:
• Successful completion of a STEM or clinical graduate program
• Subsequent participation in a formal research training or career development program in a STEM field
• Subsequent participation in research
• Subsequent employment in a research or research-related field
• Subsequent authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source
• Number of research activities or practica focusing on HIV/AIDS

Postdoctorates, Residents, and Early Career Investigators, including junior faculty:

• Aggregate number and demographic characteristics of participants
• Local relevance of research topics and alignment with national health priorities
• Subsequent educational/career progress of participants, including:
• Subsequent participation in research
• Subsequent employment in a research or research-related field
• Subsequent authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source
• Number of research activities or practica focusing on HIV/AIDS

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Flora Katz, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-402-9591
Email: [email protected]

Robert Freund, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1050
Email: [email protected]

Kasima Garst
Fogarty International Center (FIC)
Telephone: 301-496-5710
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.