National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Funding Opportunity Title
Postbaccalaureate Research Education Program (PREP) (R25)
R25 Education Projects
Reissue of PAR-12-056
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
This Funding Opportunity Announcement (FOA) issued by the National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), encourages Research Education Grant (R25) applications from institutions that propose to develop recent baccalaureate science graduates from diverse backgrounds underrepresented in biomedical and behavioral sciences so that they have the necessary knowledge and skills to pursue PhD or MD-PhD degrees in these fields. The program provides support for well-designed academic enhancements and extensive research experiences aimed at preparing individuals from diverse backgrounds to complete PhD or MD-PhD degree programs in these disciplines.
January 10, 2013
Open Date (Earliest Submission Date)
February 14, 2013
Letter of Intent Due Date(s)
Application Due Date(s)
March 14, 2013, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date
March 15, 2013
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This Funding Opportunity Announcement (FOA) issued by the National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), encourages Research Education Grant (R25) applications from institutions that propose to develop recent baccalaureate science graduates from diverse backgrounds underrepresented in biomedical and behavioral sciences so that they have the necessary knowledge and skills to pursue PhD or MD-PhD degrees inthese fields. The program provides support for well-designed academic enhancements and extensive research experiences aimed at preparing individuals from underrepresented backgrounds to complete PhD or MD-PhD degree programs in these disciplines.
The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.
There is abundant evidence that the biomedical and educational enterprise will directly benefit from broader inclusion. Recent studies have supported the argument that diversity enhances the quality of education in multiple settings. Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from minority groups into clinical trials. Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings. There is no question that the need for a diverse workforce permeates all aspects of the nation's health-related research effort.
Although the NIH currently provides multiple opportunities to develop research careers and improve participation for individuals from groups with low representation in the biomedical and behavioral sciences, reports from the National Science Foundation (NSF), (see http://www.nsf.gov/statistics/wmpd/) and others provide strong evidence that the lack of diversity remains an important problem that the entire research enterprise must actively address. As part of its mission (see the NIGMS Strategic Plan at http://publications.nigms.nih.gov/strategicplan/strategicplan.pdf), NIGMS actively supports programs that would increase the pool of scientists who are members of groups underrepresented in the biomedical and behavioral sciences (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27), including African Americans, Hispanic Americans, Native Americans, Alaska Natives, Hawaiian Natives, natives of the US Pacific Islands, and persons with disabilities. The data clearly show that populations of these groups have historically experienced difficulty gaining access to biomedical and behavioral sciences disciplines, and continue to be underrepresented in those fields.
The objective of the Postbaccalaureate Research Education Program (PREP) is to prepare individuals from backgrounds underrepresented in biomedical and behavioral sciences who have recently obtained their baccalaureate degrees for successful completion of PhD or MD-PhD training programs. An additional objective is to increase the diversity of awardee institutions' PhD and/or MD-PhD programs. For the purposes of this funding opportunity, recent baccalaureate graduates are those who have graduated from an accredited U.S. college or university no more than 36 months prior to applying to a PREP and are not currently enrolled in a degree program. In order to increase their acceptance into rigorous graduate programs, PREP participants will receive extensive research training and academic preparation through a one- to two-year apprenticeship, to further develop their scholarly potential and improve their research skills. NIGMS expects that this program will lead to a steady supply of exceptional PhD and MD-PhD students from underrepresented groups. NIGMS also expects that the program will lead to more diverse and therefore stronger PhD and/or MD-PhD programs at awardee institutions.
PREP applications are institutional in nature and therefore they should reflect the plans and priorities of the participating institutions. Institutional PREPs should generate carefully designed, individualized student development plans (IDPs) that are compatible with the students’ curricular needs and experience, combined with research projects mentored by faculty members who have active and extramurally funded research programs. The development plans will typically be designed within the context of a one-year apprenticeship to provide the necessary skills to prepare the students for rigorous PhD and/or MD-PhD programs. Students should not be appointed for less than a year. NIGMS recognizes that each student has individual needs and that a one-year program may not be sufficient for some to fully prepare to be competitive for graduate school. A second-year apprenticeship is allowable at the discretion of the PREP Program Director and if within the awarded costs of a particular program. This does not require NIGMS pre-approval, but should be used selectively for those students who would benefit from a second year in the program. The second-year apprenticeship must enhance students’ competitiveness to enter a rigorous PhD and/or MD-PhD program and not simply allow students more time to decide if they wish to obtain a graduate degree, to explore other career options, or to provide them job opportunities. This program is not intended to support individuals earning Master's degrees. Applications may request between five and ten postbaccalaureate positions for each year of the grant (i.e., up to 40 participants for a four-year grant period), for individuals to engage in student development activities and mentored research studies.
As apprentice scientists, the participants will be involved in independent research projects that will allow them to experience the fulfillment of discovery as scientists. They are expected to learn to develop their own hypotheses and design experiments to test these hypotheses. The research environment should be supportive and favorable to learning and include opportunities for the participants to interact with their peers, postdoctoral researchers, and other investigators who could contribute to their growth and will allow them to thrive in highly rigorous PhD or MD-PhD programs. PREP participants will be required to work as research apprentices at 9 person-months (75% full-time effort) and the other 3 person-months (25% full-time effort) will be for further academic development.
The academic preparations may include courses, workshops, seminars, supplemental instruction, or lectures that will enrich the quantitative and analytical skills of the participants. The courses to be taken should be appropriate to the requirements rigorous PhD or MD-PhD programs.
In addition to developing IDPs for each participant, PREPs should include group activities that will complement or augment the individualized plans and allow for interactions among participants. The group activities should be appropriate to the resources of the institution and integrated well with the overall program plan. These activities should enrich the participants’ verbal, analytical and critical thinking abilities and build their academic credentials to support their completion of PhD and/or MD-PhD degrees. While constructed and conducted with PREP support, these activities may include non-PREP participants and thereby convey benefit more broadly throughout the institution. Existing activities within the institution should not be duplicated. Rather, efforts should be made to integrate the PREP participants into the institutional activities. Plans to connect the PREP with other institutional student training programs, such as NIH-funded training grants, should be provided.
It is expected that upon completion of apprenticeship, PREP participants will apply to high-caliber PhD or MD-PhD programs. It is also anticipated that institutional PREPs will help awardee institutions in achieving greater diversity in their PhD and/or MD-PhD programs, either through institutional change fostered by experience with the PREP program and/or through recruitment of successful PREP participants into those programs.
Since PREP students should have the interest in obtaining a PhD and/or MD-PhD degree as a condition of enrollment in the program, NIGMS expects that a successful PREP will provide the knowledge and skills such that at least 75% of its participants go on to such programs. Furthermore, with this expertise and experience, NIGMS expects that at least 75% of the students who enter these programs will obtain the degree(s). Thus, applicant institutions should design the strategies and interventions, as well as set the goals and measurable objectives for their PREPs, within the context of the NIGMS’s expectations and in line with their institutional settings and missions.
The NIH Research Education (R25) grant mechanism is designed to support the development of creative and innovative research education programs for the development of biomedical, behavioral, and clinical researchers, or for public education and outreach on health-related research to a variety of audiences. Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine their effectiveness. A plan must be provided for program evaluation and/or dissemination.
Applicant institutions may utilize various strategies to attain the PREP objectives. Whatever the strategies employed, each program must be able to assess its effectiveness. It is important to determine the efficacy of a given intervention or activity through assessment of program (1) implementation, (2) impact, and (3) outcomes. The impact of the program may be measured or described as benefits to the institution, faculty members in both participating and non-participating departments, and non-PREP as well as PREP students. Program outcomes are based on the specific measurable objectives set by the institutional PREP. The assessment component should include a strategy that will allow follow up of participants after they finish their apprenticeships.
One purpose of the assessment of the program is to provide useful information to the institutional program directors and the institutions for improving their PREPs. The resulting assessment should help inform the institutional leadership in deciding which elements of the PREP could be institutionalized. It is also anticipated that program assessments will be useful to NIH in making future modifications to the PREP.
The proposed research education program may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and can not be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NIGMS intends to commit $2.5 million (total costs) in FY 2013.
Although the size of award may vary with the scope of the research education program proposed, it is expected that applications will stay within the following budgetary guidelines: total direct costs are limited to $375,000 annually.
Award Project Period
The total project period for an application submitted in response to this funding opportunity may not exceed 4 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 students/participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds). Salary support for the PD(s)/PI(s) (or combination of multiple PD(s)/PI(s)) may be requested up to 1.8 person-months (15% full-time) effort per year. Salary for a program coordinator may be requested to assist the PD(s)/PI(s) in the day-to-day administration of the program. The role of the program coordinator in the implementation of the program should be clearly defined and be significantly different from the PD(s)/PI(s). The duties and responsibilities of the program coordinator should be included in the budget justification. The salary of the coordinator is limited to a maximum of 50% time.
Remuneration for PREP participants is through salary and wages. PREP participants will be paid a salary of $27,200. The total compensation package, which includes fringe benefits and tuition remission and fees (if applicable) a PREP participant must not exceed $35,000/year from the grant. Institutions can supplement PREP student salary and benefits with non-federal funds if needed and if they follow their guidelines for wages for employees in similar positions at the applicant institution. PREP participants will be required to work as research apprentices devoting a minimum of 9 person-months (75% of full-time professional effort), and the remaining 3 person-months (25% effort) will be for further academic development. In order for the participant to receive this compensation, the following conditions must be met:
TUITION REMISSION: The applicant institution may request tuition remission for a course it deems necessary to enhance the preparedness of a PREP scholar for graduate studies; tuition remission must be specifically justified. However, tuition remission may not exceed the in-state tuition cost at institutions that also have out-of-state tuition charges.
TRAVEL: Applicants may request support for travel of PREP scholars to attend or present scientific papers at domestic scientific conferences. Requests for PREP scholars travel to scientific meetings or workshops must be justified carefully and specifically.
Other Program-Related Expenses
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.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), 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 in response to this FOA.
Higher Education Institutions
The applicant institution must be a research-intensive institution that has a significant number of faculty mentors with active and extramurally funded (such as R01 or equivalent) research programs to support adequate research and academic training of the participants. It must be an institution with strong PhD and/or MD-PhD degree programs in biomedical and/or behavioral sciences that could provide excellent and challenging, but supportive, peer groups for the PREP participants to interact and network with and also serve as peer mentors.
Directors/Principal Investigators (PD(s)/PI(s)) must also work with their
institutional officials to register with the eRA Commons or ensure their
existing eRA Commons account is affiliated with the eRA Commons account of the
All registrations must be completed by the application due date.
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 NIH support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
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(s)/(PI(s) must have a regular, full-time appointment (i.e., not adjunct, part-time, retired, or emeritus) at the applicant institution and should have research, teaching, student counseling and/or academic administrative experience and an interest in promoting biomedical and behavioral science education among students from underrepresented groups.
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.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
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.
The applicant institution will select the PREP participants who will receive salary support and it is the responsibility of the institution to establish the qualifications of the students before they are supported by the program. In order to receive salary support, students must be considered underrepresented in biomedical or behavioral research, have a baccalaureate degree in a biomedically relevant science from an accredited U.S. college or university awarded no more than 36 months prior to applying to a PREP, and must not be currently enrolled in a degree program.
For the purpose of this FOA, individuals underrepresented in the biomedical and behavioral sciences include the following:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, Native Americans, Alaska Natives, Hawaiian Natives, and natives of the US Pacific Islands. Individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
Institutions are required to develop selection plans and criteria to identify eligible students who are interested in pursuing a career in biomedical or behavioral research. Selection of program supported participants should take into consideration whether the student’s participation would help achieve the overall goals/objectives of the proposed institutional program and the PREP goals. All individuals selected as participants should intend to apply for a PhD and/or M.D.-Ph.D. program in the biomedical or behavioral sciences, immediately following completion of apprenticeship.
PREP participants must be U.S. citizens, nationals, or permanent residents.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following 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.
Advisory Committee (Uploaded via the Other Attachments section)
An Institutional Advisory Committee for the PREP is recommended. This committee may provide counsel and assistance to the PD(s)/PI(s) and institutional officials in meeting the goals of the PREP. Representatives from various institutional offices, including those involved in graduate admission, student advising, business office, and central administration, may make up this committee. Student representatives among the PREP participants or graduate students as well as faculty members from one or two participating departments are also appropriate. Other committee members may include individuals or faculty members from other institutions who may be able to provide insights to further the goals and specific measurable objectives of the program.
The following are some typical functions of an advisory committee: (1) advise and assist the PD(s)/PI(s) in the development and implementation of program procedures and practices, (2) assist the PD(s)/PI(s) in establishing criteria and procedures for the admittance/retention of students and selection of faculty mentors, (3) help monitor progress of program activities and student participants, (4) assist the PD(s)/PI(s) in designing IDPs, (5) advise on rebudgeting of funds, (6) help expand the present effort by identifying internal and external funding sources, (7) assist in monitoring compliance with NIH policies and regulations, and, if necessary, (8) address faculty and student grievances related to the PREP, and (9) assist in selecting a new PD(s)/PI(s) if it becomes necessary.
If an advisory committee will be used, composition, responsibilities, frequency of meetings, and other relevant information should be included. Identify the role and the desired expertise of Advisory Committee members. A plan for Advisory Committee approval and selection of members should be included. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program. Note that proposed Advisory Committee members should not be named in the application, particularly if they include individuals from outside the institution. Renewal applications with Advisory Committees should list existing advisors. 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 with the following modifications:
A single consolidated budget for PREP is required, with each item clearly justified. The following items are unallowable costs for the PREP.
Other costs prohibited by OMB Circular A-21. See:http://www.whitehouse.gov/omb/circulars/a021/a021.html.
All instructions in the SF424 (R&R) Application Guide must be followed, with the additional instructions described below:
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, Institutional Environment and Commitment, Program Director/Principal Investigator, Program Faculty/Staff, Program Participants, Plan for Instruction in the Responsible Conduct of Research, and Evaluation Plan.
Proposed Research Education Program (Component of Research Education Program Plan)
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 the applicant
organization should clearly describe the distinction between the intended
participants in the proposed research education program and the research
training supported by the training program. The information should include a
description of the education and/or career levels of the planned participants.
It is anticipated that several departments, e.g., Biological Sciences, Behavioral Sciences, Mathematics, Chemistry, Physics, Computer Sciences, etc., will be involved in the institutional PREP. Hence, the Research Plan component of the PREP application should be organized to reflect the institutional scope of the proposed program. The Research Plan should describe an integrated set of activities that include individualized student development plans (IDPs) and group activities that would enhance academic excellence and promote the timely progression of participants to the next academic/career step. It should also describe how these activities could contribute to faculty awareness and commitment to a diverse workforce and student body within the institution. Any benefits to the community because of PREP activities should be addressed. Include the following items in this section:
1) Institutional Setting and Current Status of the Graduate Biomedical Science-Related Academic Programs: Provide a brief description of the mission of the institution and its academic components. Provide evidence of the institution's commitment to diversity, particularly in the hiring of faculty from diverse groups, especially in the participating science departments. Describe the current academic programs and counseling/mentoring services, as well as the size of the graduate student body (PhD and MD-PhD level) in the biomedically relevant sciences.
2) Student Enrollment, Graduation, and Career Paths: Provide the institutional data on the PhD student enrollment from the last four years, and indicate the percentage of individuals from underrepresented groups. Provide the number of PhD and or MD-PhD students (overall and underrepresented groups) majoring in the participating departments or programs, their graduation rates, and the subsequent career paths of the students for the last four years. Present this data in table format.
3) Preliminary Studies/Progress Report: For new applications, briefly describe and summarize any institutional analysis of outcomes for underrepresented students at the participating institution. Describe and summarize institutional and externally sponsored programs that have encouraged and helped train underrepresented students at the participating institution institution within the last five years.
Also, briefly describe and summarize any significant achievements within the last five years of any programs at the institution that have encouraged and helped retain underrepresented students, postdoctoral researchers, and faculty in the PREP-participating departments.
For renewal applications, a detailed Progress Report must be included. State the original and specific measurable objectives, anticipated milestones, and outcomes. In table format, provide participant information including the: 1) number of participant slots awarded, 2) number of participants appointed, 3) number of PREP participants appointed for a second year, 4) number of PREP participants who authored peer-reviewed publications, 5) number of PREP participants who applied to PhD or MD-PhD programs at research-intensive institutions, 6) number of past PREP participants currently enrolled in PhD or MD-PhD programs, and 7) number of past PREP participants granted PhD or MD-PhD degrees. Also provide institutional data, including number of PhD and or MD-PhD students (overall and underrepresented groups) majoring in the participating departments or programs, their graduation rates, and their support on competitive predoctoral training/fellowship grants.
In a second table, list the names of the participants during the two most recent four-year funding periods, if applicable, that applied to, enrolled in, or completed (as applicable) the PhD or MD-PhD degree in biomedical and/or behavioral research fields. Also include in this table the participant's current training or employment status, including institution/department affiliation, and type and year of degree earned.
Suggested table templates can be found at: http://www.nigms.nih.gov/Research/FeaturedPrograms/Minority/Special/PREP/prepsampletables_competing.htm
List any grant applications or publications written or co-authored by the participants. Describe any significant honors and awards given to these students (provide specific dates) that were related to, or resulted from, involvement in activities supported by the PREP.
In addition, provide in narrative and/or tabular form, a summary of the accomplishments of the PREP program during the previous four-year project period, with reference to student participation in research and/or other PREP-supported development activities, e.g., workshops, scientific meetings, or lectures. Describe the effect of the PREP program activities on the enrollments, academic environment, and graduation rates of underrepresented students and other related aspects of the institution. Describe what has been learned through the program assessment and any changes made in the program because of the assessment.
4) Proposed Student Development Activities: Describe the strategy that will be used to develop the appropriate IDP for each participant in order to meet his/her specific needs and improve his/her academic credentials for pursuing the PhD or MD-PhD degree. Describe the type of activities for the IDPs that the participants will be engaged in (e.g., enrollment in specific courses, research, and research-related activities), the rationale for these activities, and measurement of outcomes as a result of participating in these activities.
Describe how student progress will be monitored while they are in the PREP. Provide information on the contribution of the faculty mentors or other personnel in the development of the students. A plan for monitoring the previous PREP participants’ progress in predoctoral and postdoctoral programs as well as their subsequent employment should be included. This should also include descriptions on how the previous participants can continue to contribute to the PREP, how communications between the PREP and previous participants can be maintained, and how feedback can be obtained as they progress in their PhD or MD-PhD studies.
Describe the proposed research activities of the PREP participants and how the research results will be disseminated or presented.
Describe the proposed group activities (e.g., grant-writing exercises, institutional visits, application to graduate schools, journal club, service learning, social activities, etc.) in which the PREP cohort will participate. Describe how other institutional programs will be made available and utilized by the PREP participants. Describe what strategies will be employed to enhance the PREP participants’ verbal abilities, writing and communication skills, as well as critical and analytical thinking. Describe how these activities will further increase the PREP participants’ competitiveness in completing PhD or MD-PhD degrees. Describe how the PREP students will be integrated into the institution’s graduate programs. Describe how the proposed PREP will be associated with other institutional student training programs, such as the NIH training grants. Describe the expected outcomes.
Describe the type of peer group that the PREP participants will have in the institution and how this group will help prepare the PREP participants for the rigors of PhD and/or MD-PhD program requirements.
The selection strategy and criteria for appropriate faculty mentors should be explained. A general faculty-mentoring plan should be provided to ensure that all PREP participants are given high-quality mentorship. The plan should include the mentors’ (1) research plan or outline for the PREP participants, (2) availability for consultation and discussion of research project results, (3) role in students’ application process to graduate schools, (4) plan to introduce the students to their professional networks, and (5) assistance in other non-academic issues. It is expected that the faculty mentors will serve as points of contact after the students leave the lab for graduate studies.
Institutional Environment and Commitment (Component of Research Education Program Plan)
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. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. Evidence of institutional commitment may include but is not limited to increasing efforts to have a more diverse faculty and student body, which may help in providing role models to the PREP participants. Methods such as workshops or retreats for faculty mentors, to increase their awareness and commitment to increasing diversity in the science workforce, and rewarding faculty members who have been involved in the training and mentoring of individuals from underrepresented groups to ensure diversity in the workforce, could also be employed. Another example could be the participation of institutional officials in various activities that support increasing the number of individuals from underrepresented groups in the sciences. If an application proposes additional program activities or resources that will not be supported by PREP, this should be clearly indicated, along with a description of how these activities will be supported.
Program Director/Principal Investigator (Component of Research Education Program Plan)
Describe arrangements for administration of the
program, provide evidence that the Program Director 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, as
well as evidence of institutional and community commitment and support for the
The PD(s)/PI(s) is the principal contact with NIGMS at the institution and is responsible for the administration and management of the institutional PREP. The PD(s)/PI(s) is responsible for insuring that the PREP participants are placed in highly productive laboratories with faculty mentors who will provide the proper guidance and instruction for the students. In consultation with the advisory committee, the PD(s)/PI(s) should oversee the preparation and development of an IDP for each student participant, as well as design program activities that will further enhance the academic preparation and research skills of the participants. The PD(s)/PI(s) should ensure that other institutional programs will complement the PREP activities, and allow sufficient occasion for the participants to interact with PhD candidates as peers. The PD(s)/PI(s) is also responsible for the preparation and submission of required reports (e.g., annual progress reports, changes in the program, etc.) in a timely manner.
Program Faculty/Staff (Component of Research Education Program Plan)
Describe the characteristics and responsibilities of
the participating faculty; provide evidence that the participating faculty and
preceptors are actively engaged in research or other scholarly activities
related to the mission of NIH.
The PREP faculty mentors are expected to have strong research programs supported by NIH or other extramural funds. They are also expected to have previous experience in training students and be committed to supporting a diverse scientific workforce. They should provide a positive learning and working environment, which will foster productive interactions between the PREP participants, their own development as mentors, and excellent peer and mentoring groups.
Provide relevant information on the proposed faculty members who would be research mentors and, in addition, those faculty and/or staff who would conduct the student development activities. Provide their biographical sketches (see SF424 Research & Related Senior/Key Person Profile, above), emphasizing their teaching and/or research achievements, extramural research support, and their record in training and mentoring students, particularly those who belong to underrepresented groups.
Program Participants (Component of Research Education Program Plan)
Where the proposed program involves participants, provide
details about the pool of expected participants, their qualifications,
recruitment strategies and sources of applicant pool, etc.
Provide the criteria and strategy as to how the PREP participants will be selected. The selection of participants should be in line with the objectives of the PREP, which include providing extensive research training to baccalaureate graduates from underrepresented groups who have received little or no previous research training. Institutions with PREPs may request from five to ten postbaccalaureate positions. This number should not exceed ten per year for each year of the grant, or 40 participants for a four-year grant period. Explain what criteria and strategy will be used for matching PREP participants with faculty mentors.
Student participants must be U.S. citizens, nationals, or permanent residents. They must also belong to groups considered to be underrepresented in the biomedical and behavioral research fields. (See definitions in section III. 3.)
Plan for Instruction in the Responsible Conduct of Research (Component of Research Education Program Plan)
Every participant supported by this Research
Education grant must receive instruction in the responsible conduct of
research. All applications must include a plan to provide such instruction. The
plan must address five components (format; subject matter; faculty
participation; duration of instruction; and frequency of instruction) as
detailed in NOT-OD-10-019.
Renewal (Type 2) applications must, in addition, describe changes in formal
instruction over the past project period and plans for the future that 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. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.
Evaluation Plan (Component of Research Education Program 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. The emphasis of the assessment of activities should be on (a) assessment of the overall impact of the program on the institution’s baseline numbers and efforts to accomplish its proposed goals of diversifying the institutional pool of students that complete PhD and/or MD-PhD degrees in biomedical and/or behavioral sciences, (b) improvement of the overall program outcome, and (c) informing the senior leadership in deciding which elements of the PREP should be institutionalized.
Resource Sharing Plans
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies(GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications via 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.
Applicants are responsible for viewing their application before the deadline 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.
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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:
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 and behavioral 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 exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Does the proposed research education program address an important problem or critical question in research education or other critical issues? How will implementation of the proposed program advance the objectives of the proposed program? How will the proposed academic enhancements and research training increase the competitiveness of the participants to enter and complete a PhD and/or MD-PhD degree? Will achievement of the aims/objectives of the program improve the education, research training and career preparation of diverse students in the participating department(s), college(s), and institution?
Are the PD(s)/PI(s), collaborators, and other researchers appropriately trained and well suited to the proposed research education program? Is the PD/PI 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 research education program? If Early Stage Investigator or New Investigator, or in the early stages of an independent career, does the PD/PI have appropriate experience to lead the program? 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 there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives? Is the composition of the advisory committee (if one is proposed) appropriate and consistent with the scope of the proposed research education program? Is there an adequate pool of research mentors who are extramurally funded and experienced in training students in research? Does the proposed evaluator have the appropriate background and credentials?
Is the proposed research education program characterized by innovation and scholarship? Does the proposed program challenge and seek to shift current research education paradigms or clinical practice, or address an innovative hypothesis or critical barrier to progress in the field? Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area? Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere? Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If called for, is the proposed plan for evaluation and/or dissemination of the education program sound and likely to provide data on the effectiveness of the education program? Is there evidence that the program is based on sound research concepts and educational principles? Is the approach feasible and appropriate to achieve the stated research education goals? If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool?
Does the strategy to be used for determining the IDPs
take into consideration the academic and research backgrounds of the
participants? Is there evidence that the group activities designed to increase
analytical and critical thinking, verbal reasoning, and communication skills
will enable the participants’ admission and retention in rigorous PhD and/or
MD-PhD programs? How are the group activities integrated with the
institution’s graduate students’ activities and other institutional training
programs? Are the proposed research activities likely to enable the
participant to gain admission to and complete a rigorous PhD and/or MD-PhD
program? Are the proposed mechanisms for monitoring participants’ progress
during and after they leave the program sufficient?
If the program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success? Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of appropriate collaboration 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)? Are the proposed activities consistent with the resources of the institution?
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
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Inclusion of Women, Minorities, and Children
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period. In addition, the committee will consider the following:
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 & Retention Plan to Enhance Diversity
Training in the Responsible Conduct of Research
Taking into account the specific characteristics of the research education program, level of participant experience, and the particular circumstances of the participants, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe how faculty will participate in the instruction? Do the plans ensure participants will receive instruction (or in the case of more senior level participants, provide instruction) for an appropriate amount of time given the length of the research education experience? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Applications from Foreign Organizations
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
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 NIGMS , 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:
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 General Medical Sciences Council.. The following will be considered in making funding decisions:
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
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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.
3. ReportingThe Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. The Progress Report should provide information on the development and implementation of the proposed research education program, modifications to the research education program as originally proposed, updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program. Programs should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the PHS 2590 Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards.
The annual progress report should include a statement of the goals, measurable objectives, and milestones, as proposed in the application and correlate the outcomes to the objectives. The report should describe the major student development activities that contributed in achieving the goals set by the program, and should discuss the challenges faced by students when applying to PhD and/or MD-PhD training programs. Since the PREP is an institutional program, it should also describe any impacts of the program on the institutional graduate admission policies, changes in the diversity profile in both the student body and the faculty, particularly within the participating academic units or departments. The report should also include the total number of PREP students as well as the number of students who were not supported by PREP but participated in the program activities, and what benefits were derived from such activities. A report on the current status of PREP participants should be provided including their major accomplishments or awards (e.g. publications, predoctoral fellowships or awards), the PhD and/or MD-PhD institutions they applied and got admitted to, or where they actually matriculated in (including the specific department), and the research area that they are working in. The progress report should also indicate the number of students going on for a second year of internship, the reasons for the need for a second year in the program, and what are the expected outcomes or accomplishments.
Publication and Sharing of Research Education Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ________. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”
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.
A final progress report 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 may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
Within ten years of making awards under this program, NI will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NI will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.
The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Michael Bender, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Ms. Lori Burge
National Institute of General Medical Sciences (NIGMS)
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 Parts 74 and 92.
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