Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Aging (NIA)

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

National Institute of Dental and Craniofacial Research (NIDCR)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

Special Note: Not all NIH Institutes and Centers participate in Parent Announcements. Applicants should carefully note which ICs participate in this announcement and view their respective areas of research interest and requirements at the Table of IC-Specific Information, Requirements and Staff Contacts website. ICs that do not participate in this announcement will not consider applications for funding. Consultation with NIH staff before submitting an application is strongly encouraged.

Funding Opportunity Title
HEAL Initiative: National K12 Clinical Pain Career Development Program (K12 Clinical Trial Not Allowed)
Activity Code

K12 Physician Scientist Award Program (PSA)

Announcement Type
New
Related Notices
  • April 13, 2022 - Notice of Intent to Publish a Funding Opportunity Announcement for Emergency Awards: HEAL Initiative: Coordinating Center for National Pain Scientists Career Development (R24 Clinical Trial Not Allowed). See Notice NOT-NS-22-094.

Funding Opportunity Announcement (FOA) Number
RFA-NS-22-045
Companion Funding Opportunity
RFA-NS-22-046 , R24 Resource-Related Research Projects
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.853, 93.866, 93.865, 93.393, 93.213, 93.121
Funding Opportunity Purpose

The purpose of this FOA is to invite applications to the NIH HEAL Initiative’s Clinical Pain Career Development Program (HCPDP). The HCPDP supports the NIH HEAL Initiative’s long-term goals of providing effective non-opioid options for the treatment of pain by addressing the increased need for clinical pain researchers.

The HCPDP will support early-career pain management researchers by developing a structured mentorship and career development program. The goal of this program is to ensure that a diverse pool of highly trained clinician-scientists is available to expand and enhance the clinical pain management workforce. In support of this goal, this FOA will provide the mentoring, oversight, support and training required to advance the careers of early-stage clinical pain researchers.

The HCPDP established under this FOA will support early career clinical pain scientists’ development as a means to enhance the clinical pain research workforce. The awarded HCPDP national program will provide the selected scholars with the experience, research support, and protected time for research and funding necessary to initiate a sustainable research program. In addition, the awarded HCPDP national program will create a K12 Advisory Committee (AC) whereby scholars will have the opportunity to interact with both experienced pain researchers and pain patients. The FOA will develop a national network of mentors and scholars.

A companion RFA, Coordinating Center for National Pain Scientists (CCNPS) (R24) (RFA-NS-22-046), has been released. The CCNPS will be a central facilitator for integrating training and mentoring across a network of mentors and early-stage investigators funded by NIH (e.g., NIH trainees, NIH fellows, and Career Development Awardees). The main purpose of the CCNPS is to enhance the training experience of new pain researchers across the continuum of basic, translational, and clinical research and create a vast network of NIH-funded pain researchers to promote multidisciplinary collaborations in pain research. The CCNPS will create and run a coordination center to connect NIH-funded pain researchers with each other with the goal of enhancing the innovation, relevance, and practical application of pain management research, as well as increase communication among pain management researchers across all disciplines. The K12 scholars and K12 AC will be expected to participate in the CCNPS annual meeting and networking events.

Key Dates

Posted Date
January 10, 2022
Open Date (Earliest Submission Date)
February 24, 2022
Letter of Intent Due Date(s)

30 days before application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
March 24, 2022 Not Applicable Not Applicable July 2022 October 2022 December 2022

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
March 25, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Training (T) 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.

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The goal of the NIH Research Training and Career Development programs is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the nation’s biomedical, behavioral, and clinical research needs. More information about career programs may be found at the NIH Extramural Training Mechanisms website.

This FOA seeks applications to establish a national clinical menoring program as part of the NIH HEAL Initiative’s Clinical Pain Career Development Program (HCPDP). The goal of this program is to ensure that a diverse pool of highly trained clinician-scientists is available to expand and enhance the clinical pain management workforce. In support of this goal, the HCPDP established under this FOA will provide the mentoring, oversight, support and training required to advance the careers of early-stage clinical pain researchers. The HCPDP will provide a national institutional career development program, with structured research experiences and mentorship.

The HCPDP supports the NIH HEAL Initiative’s long-term goals of providing effective non-opioid options for the treatment of pain by addressing the increased need for clinical pain researchers. The Interagency Pain Research Coordinating Committee (IPRCC) has identified the following factors that could hinder clinical pain research in the future: 1) a limited pipeline of clinical pain researchers in earlier career stages; 2) challenges to entry into the field of clinical pain research, which has constricted growth in the field of clinical pain management, and 3) a high departure rate of senior investigators and mentors from the field. IPRCC members discussed a crucial need for a new generation of mentors in clinical pain research to help ensure a future with no shortage of well-trained clinical pain investigators. In addition, the IPRCC also identified a need for more structured opportunities for early-stage investigators to learn from and be mentored by experienced investigators who might work outside of their home institutions.The IPRCC also found that aspiring clinical pain researchers experience difficulty devoting time necessary to become successful research scientists. Clinicians engage in fellowships, residencies, and post-doctoral training that take a long time to complete and involve a heavy clinical load. Thus, when clinical pain management specialists obtain their first faculty position at an institution different from their training institution, clinical duties often prevent them from having protected time required to advance a mentored research project to the stage where they can successfully compete for their own research funding. In response to the need to increase the number of highly trained scientists in field of clinical pain management, and protect clinical pain management time, the NIH HEAL Initiative is releasing FOAs to help increase the clinical pain management workforce.

Under this award, promising early-career clinician-scientists will have access to high-quality mentorship that will promote their successful transition to independent research careers in academic settings. The scholars selected for this new mentoring program will be clinicians (e.g., doctors, psychologists, dentists, physical therapists, and nurses) in their last year of residency/fellowship/post-doctoral training, or in their first year of an independent faculty position. Potential participants will apply to the awarded HCPDP national program for support. Scholar support is intended to begin during their first or second faculty year. The national-mentoring program is intended to primarily support clinicians who leave their training institution for a faculty position at another institution. Under some circumstances (see Program Scholars below) a candidate who remains at their residency institution for their faculty position may be supported. The awarded HCPDP national program will provide the selected scholars with the experience, research support, and protected time for research and funding necessary to initiate a sustainable research program. In addition, the awarded HCPDP national program will create a K12 Advisory Committee (AC) whereby scholars will have the opportunity to interact with both experienced pain researchers and pain patients. The program will:

  • Recruit and evaluate promising pain clinicians (from multiple disciplines) who have completed their clinical training and who have promising research potential and, if selected for the program, evaluate the K12 scholars’ mentors at their local institution (e.g., established mentors with a strong record of mentorship and research productivity) and match the K12 scholar with two mentors from the K12 AC.
  • Ensure a high-quality mentorship by developing guidelines for mentoring and career development.
  • Provide necessary training in ethics and rigor.
  • Work in coordination with the Coordinating Center for National Pain Scientists Program (RFA-NS-22-046) to ensure that awardees participate in the network, collaborative events, and basic clinical science integrations.
  • Provide support to up to 3 scholars per year for up to 3 years each.
  • Provide travel funds for scholas to attend the Coordinating Center for National Pain Scientist Career Development Program activities (which is required and administered through an accompanying R24).

Preparation of future leaders

The awarded HCPDP national program should, as part of its career development mission, incorporate programmatic activities that will help develop the leadership potential of scholars. Similarly, the awarded HCPDP national program should design a process within the HCPDP organizational structure to foster the transition of junior investigators who achieve individual research funding into faculty and/or leadership positions within the HCPDP.

The HCPDP Program

The HCPDP K12 award provides five years of funding to the applicant organization to support a national career development program. Although the K12 award will be housed at the home institution of the PD/PI(s), it is not intended to only support scholars from that institution. The PD/PI(s) will solicit applications from multidisciplinary candidates at institutions from across the country, and the selected scholars will proceed with their career development and research plans at their home institutions with a local mentor. The scholar’s home institution will be expected to have the infrastructure to support an outstanding career development program for the scholar, which would include resources, faculty and research expertise appropriate for the scholar. The institution that houses this K12 is just one of the institutions at which research career development activities can occur. The leadership of the awarded HCPDP national program consists of the PD/PI(s) and a committee of advisors (the National Advisory Committee or K12 AC) selected by the PD/PI(s) to help guide the program. The K12 AC will consist of clinicians and researchers from a variety of disciplines, as well as pain patients. The PD/PI(s) together with the NAC and, if applicable, co-directors (faculty members assigned significant programmatic roles) will advise potential applicants and provide feedback on their applications, review candidates, make appointments to qualified individuals, monitor the progress of each scholar, conduct site visits at scholar institutions, attend an annual meeting organized by the Coordinating Center for National Pain Scientists (RFA-NS-22-046), and ensure that program policies and requirements are followed. In general, the PD/PI(s), co-directors and K 12 AC will define the process by which candidates apply for support. However, the selection process must include a written research plan, career development plan, and interview.

The awarded HCPDP national program will act as a governing board of the multidisciplinary senior clinical pain researchers and pain patients, from across the United States. The awarded HCPDP national program will develop recruitment strategies and objective evaluation criteria for the scholars. The awrded HCPDP national program will review mentee applications and match selected mentees with mentors or serve as mentors. Program management will develop guidelines for mentoring and career development to promote the successful transition of the candidates to successful independent research careers in academic settings.

The K12 Program will support 3 new candidates per year over a 3-year period. The K12 will provide scholars with 3 years of financial support for salary, travel and career development. The scholar’s Department or Division Chair and Institution must commit to providing the candidate with a minimum of 75% of full-time professional effort towards the research and career development outlined in their application in order to be eligible for HCPDP support. In advance of obtaining support, the scholar will develop a research and career development plan suitable to launch an independent research career for the study of a clinically significant research topic in conjunction with their mentor(s). The plan must explicitly describe the anticipated accomplishments of the scholar that will lead to the transition to individual funding on an appropriate schedule. This plan, and the scholar’s progress, will be reviewed annually by the awarded HCPDP national program leadership, with continued funding dependent on appropriate scholar progress and adherence to program requirements.

The awarded HCPDP will form a single national program designed to foster the development of the dual clinical and research careers of pain management clinicians. The program will include the following critical components:

  • An advisory committee to the HCPDP PD/PI(s) that consists of multidisciplinary pain management researchers and pain patients. The advisory committee should have expertise in clinical research, should include clinician and non-clinician scientists, should include scientific leaders in the field of pain management, should contain appropriate gender-balance and should contain diverse representation with regard to racial/ethnic background, geographic location of their home institutions, residency/fellowship training institutions and areas of expertise. Clinical research members of the advisory committee should have a history of research funding and the stature necessary to conduct site visits to scholars’ institutions and effectively carry out the HCPDP oversight function.
  • A plan for negotiation and coordination with participating institutions, departments, and chairs to ensure that scholars obtain appropriate research support, appropriate protected time for research (a minimum of 75% of full-time professional effort) and have opportunities for appropriate career advancement given a combined research and clinical career.
  • A plan for recruitment of applicants and dissemination of publicity intended to attract applications from the best candidates in diverse research areas from institutions around the country.
  • A plan for the selection of applicants who would most benefit from this program and who hold strong promise of a successful, combined research and clinical career. The awarded HCPDP national program must establish an application process that, at a minimum, includes a written research plan, career development plan, and interview. It is expected that the program will utilize a rigorous, objective, and fair procedure for application to the program and selection of individuals to be funded.
  • A plan for monitoring progress of the scholars and a mechanism to ensure both progress and compliance with program policies.
  • The K12 program will work in coordination with the Coordinating Center for National Pain Scientists (R24) (RFA-NS-22-046) to ensure that scholars participate in the R24 network, collaborative events, the annual meeting, and basic clinical science integrations.
  • All scholars should obtain, early in their HCPDP career development program, a comprehensive appreciation of the principles of experimental design, statistics and scientific rigor (see, for example: http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf and https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-103.html.) It is critical that the awarded HCPDP national program include activities designed to provide foundational education on these principles and not rely exclusively on scholars' prior experience or planned coursework to cover these topics. In addition, the HCPDP must ensure that all scholars complete responsible conduct of research training, in accordance with the NIH policies set out in NOT-OD-10-019, at their home institution.
  • A plan to have the HCPDP program regularly evaluated internally and rigorously evaluated by an expert external panel at least once. Moreover, the program is expected to have a defined process by which the comments and recommendations that result from these evaluations will be considered for the purpose of iteratively improving the program.
  • A dissemination plan and/or scientific outreach plan to highlight the research, mentoring activities, and training being completed within the HCPDP.

Role of the PD/PI(s)

The PD/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI(s) have responsibility for the day-to-day administration of the program, are responsible for appointing members of the K12 AC, proposing scholar selection criteria/processes, and dissemination of information and results generated from the K12. In addition, the PD/PI(s) are responsible for determining, to the extent possible, that scholars appointed to the HCPDP K12 intend to develop research programs supported by individual career development (e.g. NIH K08, K23 or NINDS K02 awards) or research grants that they pursue as PD/PI. The K12 grant will provide PI/PD(s) 50% protected time to run the HCPDP. PD/PIs cannot serve as mentors to scholars in the K12 program.

It is expected that the PD/PI(s) will provide detailed information about the specific goals and expectations of the HCPDP to each primary mentor, and when appropriate, Department Chairs, and ensure that the mentors and Chairs are in agreement with the goals, expectations and requirements of the HCPDP. The PD/PI(s) will provide necessary oversight to ensure that scholars, mentors and Chairs work to achieve the goals of the HCPDP. It is also expected that the PD/PI(s) will have a strong, formal mechanism in place to ensure that the scholar maintains the required yearly protected time for research and career development.

The PD/PI(s) may wish to assign significant programmatic roles to faculty members (e.g., name co-directors) or administrative staff who do not serve as PD/PI(s). These individuals should agree to perform the described duties and should have sufficient, documented time to commit to the program.

The PD/PI(s) are required to submit annual progress reports, in the Research Performance Progress Report (RPPR) format, and financial statements as required in the NIH Grants Policy Statement. The PD/PI(s) of the Coordinating Center for National Pain Scientists (R24) (RFA-NS-22-046) will complete an evaluation of the K12 at the end of the program (year 5). The PD/PI(s) of the K12 will complete any necessary tasks for the evaluation.

K12 Advisory Committee (AC)

The K12 AC, chaired by the PD/PI(s), is a select group of multidisciplinary scientists who have established records both of research, and of fostering the research expertise and accomplishments of clinician-scientists. The committee should include approximately 10 established research investigators as well as at least 5 patient representatives as members. This committee must be diverse in nature, with respect to scientific interests, geographic location and prior training affiliations (i.e., multidisciplinary). The K12 AC also should have appropriate representation of individuals from underrepresented racial and ethnic groups and women . The PD/PI(s) may also wish to add additional individuals who are more junior clinician-scientists who are clearly outstanding for their career stage (i.e., individuals who have published high quality research and recently received their first R01). It is also recommended that prior HCPDP scholars who have developed successful, funded research programs, including individuals from underrepresented racial and ethnic groups, and women who have recently developed successful research programs, be included. Note that not all members of the K12 AC must have identical roles in the program. A subset of the NAC members (investigators and patients with lived pain experience) should contribute to the review of HCPDP applicants, while some K12 AC members may contribute as faculty and/or mentors but not be involved in applicant evaluation. The K12 AC evaluates all applicants to the program (this will include the evaluation of written applications and conducting interviews), pairs scholars with mentors, monitors the progress of current scholars and provides feedback to scholars as appropriate. Each application should be reviewed by at least one patient with lived pain experience and each scholar should have at least one patient with lived pain experience as a co-mentor. K12 AC members may be asked to perform site visits at scholar institutions (if necessary, these may be done virtually). NAC members are expected to attend and participate in all annual meetings of the HCPDP program. The duration of service of individual K12 AC members to the HCPDP program will be negotiated between individual members and the PD/PI and should generally be a minimum of 3 years. K12 AC members may be primary mentors or secondary mentors but must avoid any conflict-of-interest in the scholar selection process.

The composition, including name, expertise, current affiliation, and prior training affiliations, as well as their roles and responsibilities, and other relevant information, should be included in the application. Describe how the NAC will function in providing oversight of the development, implementation, and evaluation of the recruitment strategies, the recruitment, selection and retention of candidates, and the evaluation of the overall effectiveness of the program. If any members of the K12 AC are to have special roles (e.g., serve as part of an executive committee or as co-directors or be responsible for specific functions of the program), this should be explained. A biosketch for each NAC member should be included in the application. Letters should be provided (in the “Letters of Support” section; see below) from each proposed NAC member confirming their understanding of the goals of the HCPDP and their willingness to serve on the NAC for a minimum of 3 years. NIH program staff will review the composition of the K12 AC prior to awarding the grant and will have the ability to request changes to the composition of the K12 AC, if deemed appropriate. K12 AC members should be paid a yearly honorarium for their participation in the HCPDP. K12 AC honoraria should be in line with NIH guidelines of a maximum of $400 per meeting.

Program Scholars

Scholar selection to the HCPDP

Clinical pain researchers from any educational institution or professional organization in the U.S. that combines both clinical and research activities are eligible to apply for support as scholars. Eligible candidates for initial application to the program include those in the last year of residency training, fellowship training, post-doctoral training and those who are within one year of starting their faculty position. It is intended that scholar support from this program would begin during the first year of a faculty appointment. An individual who has served as a PD/PI on an NIH research grant (R01, R03, R21, P01, etc.), an individual career development award (K01, K02, K08, K23, K99, etc.), other non-training NIH grants (e.g., U-type or P-type grant, etc.), contract (N01) or Project Leads of program project (P01) grants may not be considered for support by the awarded HCPDP national program. Scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.

In order to be selected for support by the awarded HCPDP national program, scholars must have a well-thought out research plan that, (1) is relevant to the NIH HEAL Initiative’s pain management mission, (2) has intrinsic research significance, (3) is founded on strong scientific premise (see relevant sections of http://grants.nih.gov/reproducibility/faqs.htm for a discussion of rigor and scientific premise), (4) will serve as a suitable vehicle for learning the methodology, theories, and concepts required of a well-trained, independent clinician-researcher and (5) will provide data and/or publications that will be useful in the submission of subsequent individual research applications. Moreover, strong consideration should be given to selection of scholars for whom the HCPDP is likely to provide the critical mentored research experience that will enable them to successfully compete for subsequent independent funding.

The awarded HCPDP national program should have an anticipated timeline by which scholars will apply for the program, be selected, and receive funding. The program should utilize a selection approach, and subsequent oversight process, to ensure that, prior to appointment to the HCPDP, and continuing through the period of support, scholars have a well-articulated research project and career development plan that would reasonably be expected to lead to transition to an individual funding mechanism by the end, or shortly after the end, of the HCPDP support period. Ideally, the awarded HCPDP national program would include a method to monitor scholar progress on a semi-annual basis as an aid to the scholar’s continuing progress and to ensure that obstacles to success are overcome quickly.

Evaluation of scholars

Scholars funded by the awarded HCPDP national program must be conducting research that falls within the NIH HEAL Initiative’s clinical pain management mission. Research should be clinical in nature, relevant to pain management and potentially applicable to clinical practice. It is expected that this research will integrate with the scholar’s clinical activities and that their clinical and research activities will inform each other.

The metric by which the awarded HCPDP national program will be judged is the extent to which scholars and, to a lesser extent, applicants, obtain future individual research funding and launch successful, dual careers as clinicians and researchers. Therefore, it is critical that scholar applications are clear regarding how their research and career development plans will help them launch a successful, individual research program. Similarly, the candidate selection process should be clearly described as including a written application and interviews by the PD/PI and members of the K12 AC.

As part of the recruitment effort, the awarded HCPDP national program should make every effort to broadly advertise the program. The program must actively seek out qualified women and individuals from diverse backgrounds, including individuals from underrepresented groups. See, Notice of NIH's Interest in Diversity, NOT-OD-20-031.

Scholar commitment to the HCPDP

For each scholar, a three-year career development program will be supported by the awarded HCPDP national program – financially as well as through the infrastructure of the program. The scholar’s chair of the department is encouraged to allow the scholar to devote up to 18 months after leaving the K12 program to devote 50% effort to research. The scholar receives three years of financial support directly from the HCPDP award for salary, training related travel and training expenses. Scholars are highly encouraged to apply for individual grants (e.g., K awards) as soon as they are ready. If the scholar applies, and receives, an individual grant prior to the third year in the K12 program, the scholar will exit the K12 program to enable the awarded HCPDP to support a new scholar.

The scholar will be paired with a mentor and embark on a focused career development program that will include research, skill development and any necessary education, under the auspices of a mentor who has an outstanding record of research productivity and training. In conjunction with the mentor, the scholar will develop a research and career development plan suitable to launch an independent research career to investigate a clinically significant research topic. This plan, and scholar progress, will be reviewed annually by the awarded HCPDP national program PD/PI(s) and K12 AC. Provided they make appropriate progress during each year, as judged by the PD/PI(s) and K12 AC, scholars are renewed for additional years (maximum of three years of support). Although the awarded HCPDP national program is intended to support up to 3 years of research career development activities for each scholar, the program should encourage scholars to transition to individual awards as soon as they are ready.

During each year scholars will be expected to devote 75% (9 months) of their professional time to conducting research and pursuing their research career development. Additionally, scholars must submit an annual progress report to the awarded HCPDP national program PD/PI(s), attend the annual meeting (organized by R24 awardees), and present their research in a public forum at the annual meeting

Preceptors/Mentors

Primary mentor. Although the identity of future mentors will not be known at the time of application, the mentors of successful scholar applicants to the awarded HCPDP national program should fulfill some general requirements. The primary mentor need not be a clinician-scientist. Potential scholar candidates should be encouraged to obtain a mentor who is most appropriate to their scientific needs, regardless of degree or subspecialty. Although mentors must demonstrate a commitment to the awarded HCPDP national program and scholars, they cannot receive salary, fringe benefits or research support for this role on the K12 grant.

HCPDP Advisory Committee for the scholar. The awarded HCPDP national program should appoint at least 2 individuals (at least one clinical-scientist and one pain patient) from the K12 AC to serve as a program mentor/advisor to selected scholars. The awaded HCPDP national program should define the goals and minimum frequency interactions between the HCPDP mentors and scholar.

Local advisory committee for the scholar. Linkages of scholars to other departments, potentially through choice of mentors, should be encouraged, as they enhance career development and facilitate collaborative efforts. Scholars are particularly encouraged to develop interactions with a plurality of clinical specialists and non-clinicians, as this can facilitate multidisciplinary research and the development of novel ideas and approaches. Although local mentors must demonstrate a commitment to the HCPDP program and scholars, they cannot receive salary, fringe benefits or research support for this role on the K12 grant.

Scholar candidates should also be encouraged to include, as mentors, researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women. Diverse representation among mentors can bring different information, opinions, and lead scholars to new perspectives on research approach and scientific thinking, while providing role models to challenge stereotypes around careers in pain management. The HCPDP as a community-wide program has an underlying aim to increase innovation and problem solving by considering diverse representation in all aspects of   pain research.

Institutional Environment and Commitment to the Program

An important goal of the aarded HCPDP national program is to ensure that scholars funded by the K12 obtain and retain critical institutional support. The Chair of the scholar's home department plays a key role in the success of the scholar. The awarded HCPDP national program is designed to directly support relatively few scholars, with the goal that all of those supported will go on to successful, dual careers in clinical pain management and productive, well-funded research. To launch such a career, scholars need a period of outstanding training and mentoring as well as resources and adequate protected time to successfully conduct high quality research and obtain independent funding. Consequently, for a successful application to the awarded HCPDP national program, chairs are required to write a letter allowing the scholar to devote 75% effort to research for up to three years.In their letters, department chairs are strongly encouraged to discuss plans to foster candidates’ research interests and skills after the completion of the HCPDP national program, through support from an individual K award, an NIH research grant, or other source. In addition, the awarded HCPDP national program should ensure that chairs make every effort to provide appropriate resources and support, in whatever form needed, to facilitate the success of the scholar.

The awarded HCPDP national program is expected to make at least one site visit, either in-person or virtual, to each scholar's home department to discuss with the scholar, mentor(s), Chair and others involved in the scholar's activities, the scholar's progress, needs and any other relevant issues. This would typically occur approximately 6 months after the start of scholar support but should be arranged as appropriate. All individuals associated with the scholar’s research career development at the scholar’s institution are expected to participate in the site visit.

Annual National Pain Scientists Career Development Program Meeting (R24)

Coordinating Center for National Pain Scientists (CCNPS) (R24) awardees will create a network of early-career pain scientists, pain trainees, and mentors (RFA-NS-22-046). The CCNPS will work to improve the collaborative nature of the basic, translational, and clinical researchers who generally do not regularly collaborate or work together. One aspect of the CCNPS program will be to put on an annual meeting for established scientists as well as early career pain investigators. This meeting will facilitate creation of a network of pain research mentors and mentees as well as foster communication between scientists and clinicians of different disciplines, provide enhanced mentorship, leadership courses, and any additional trainings that maybe necessary for early-career scientists. K12 awardees (PD/PIs, K12 AC, and K12 scholars) will be required to attend these meetings. The awarded HCPDP national program will provide financial support for meeting attendance. The PD/PIs and the K12 AC should schedule a workshop at the CCNPS annual meeting where the K12 scholars can be provided any in-person trainings or mentoring experience they have not already received.

In addition, K12 scholars are highly encouraged to participate in all other aspects of the CCNPS program– networking experiences and classes.

HEAL

This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://heal.nih.gov/.

In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, 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 that are underrepresented in the biomedical, clinical, behavioral and social sciences. Please refer to Notice of NIH's Interest in Diversity NOT-OD-20-031 for more details.

The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.

NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.This Funding Opportunity Announcement (FOA) does not allow appointed scholars to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Note: Appointed Trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.

Need help determining whether you are doing a clinical trial?

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.

NIH/HEAL intends to fund 1 award, corresponding to approximately $1,363,000.00 direct costs, for fiscal year 2022. Future year amounts will depend on annual appropriations.

HEAL intends to commit $1,924,000.00 (direct costs) in FY 2023; $2,485,000.00 (direct costs) in FY 2024, $2,485,000.00 (direct costs) in FY 2025, and $2,485,000.00 (direct costs) in FY 2026.

Award Budget

Application budgets are not limited, but need to reflect the actual needs of the proposed project.

Award Project Period

The project period is 5 years.

Other Award Budget Information

Personnel Costs

The K12 grant will provide PI/PD(s) 50% protected time to run the HCPDP.

Individuals designing, directing, and implementing the career development program may request salary and fringe benefits to support up to 4 person-months (33% effort total for all individuals). In addition, if extensive coordination is required to achieve the educational goals of the program, an additional 4 person-month salary, and 1.2 person-months of IT/technology support may be requested to support an HCPDP leadership position designed to accomplish these goals. 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 scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.

The salaries of administrative and clerical staff should normally be treated as indirect (F&A) costs. Direct charging of these costs may be appropriate only if all of the following conditions are met: (1) Administrative or clerical services are integral to a project or activity; (2) Individuals involved can be specifically identified with the project or activity; (3) Such costs are explicitly included in the budget or have the prior written approval of the Federal awarding agency; and (4) The costs are not also recovered as indirect costs. When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget. It is anticipated that support will not exceed 9.2 person-months for administrative support, which can only be requested for work directly performed for the HCPDP program.

Scholar Costs

Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget. Funds may be used to support scholar salary and fringe benefits. This HEAL K12 program will provide, up to $100,000 salary per year, plus associated fringe benefits, may be provided to each scholar. NIH will contribute $50,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. These funds may be used for the following expenses: (a) tuition and fees related to career development; (b) research-related expenses, such as supplies, equipment and technical personnel; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time. Funding may not be used for mentor salaries or other expenses incurred by mentors or scholar institutions.

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.

Honoraria for reviewing grants, attending meetings, and funds for travel may be requested for members of the K12 AC. K12 NAC honoraria should be in line with NIH guidelines of a maximum of $400 per meeting. In addition, funds may be requested for site visits and attendance of visiting faculty to the HCPDP meeting for the purpose of providing special expertise via workshops or presentations.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, 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 from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Governments

  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • U.S. Territory or Possession

Other

  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

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.

The applicant institution must have a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.

Foreign Institutions

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.

Required Registrations

Applicant Organizations

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

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
  • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI(s) of the HCPDP should possess the scientific expertise, demonstrated leadership capabilities, stature in the pain management community and administrative capabilities required to implement, coordinate and supervise a national, multidisciplinary research career development program for clinicians. The PD/PI(s), together with the K12 AC and, if applicable, co-directors, will be responsible for the selection and appointment of scholars to the HCPDP, and for the overall direction, management, administration, and evaluation of the program. The PD/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI(s) have responsibility for the day-to-day administration of the program and are responsible for appointing members of the K12 AC and using their recommendations to determine the appropriate allotment of funds. Any appointed co-directors should also have the qualifications necessary to guide an institutional training program designed for clinical pain management.

If proposing an MPI leadership plan, each MPI should have a defined role in the program, in addition to sharing overall oversight responsibilities.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

K12 Advisory Committee

A K12 Advisory Committee, the “K12 AC,” is a required component of the HCPDP program. The proposed K12 AC members must be selected in advance and listed in the application. K12 AC membership should be composed of multidisciplinary pain specialists and pain patients. The appropriateness of the committee, both with respect to each individual selected and the overall composition of the committee, will be evaluated by the peer review process. NIH program staff will review the composition of the K12 AC prior to awarding the grant and will have the ability to requestchanges the composition of the K12 AC, if deemed appropriate.

Preceptors/Mentors

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including demonstrating that former trainees have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Primary mentors must be tenure-track faculty (or equivalent) who have an established record of research productivity, competitive grant support and successful fostering of research expertise and accomplishment of clinician scientists. A primary mentor should have a strong research program in an area relevant to clinical pain management. Mentors should have research expertise and experience relevant to the scholar’s proposed research and must be committed to continuing their involvement throughout the total period of the mentee’s participation in this award.

Scholars

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

Clinical pain researchers from any educational institution or professional organization in the U.S. that combines both clinical and research activities are eligible to apply for support as scholars. Eligible candidates for initial application to the program include those in the last year of residency training, fellowship training, post-doctoral training and those who are within one year of starting their faculty position. Eligible scholars should be U.S. citizens. It is intended that scholar support from this program would begin during the first year of a faculty appointment. An individual who has served as a PD/PI on an NIH research grant (R01, R03, R21, P01, etc.), an individual career development award (K01, K02, K08, K23, K99, etc.), other non-training NIH grants (e.g., U-type or P-type grant, etc.), contract (N01) or Project Leads of program project (P01) grants may not be considered for support by the awarded HCPDPHCPSCDP national program. Scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Laura Dover Wandner, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Email: Laura.Wandner@nih.gov

Page Limitations

All page limitations described in the SF424 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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research career development program, as well as key activities in the program designed to foster successful pain researchers. Indicate the planned duration of appointments, the projected number of scholars, including their levels (i.e. first year faculty) and intended scholar outcomes.

K12 Advisory Committee (K12 AC). This information should all be uploaded as a separate pdf file attachment.

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.

SF424(R&R) Senior/Key Person Profile Expanded

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

PHS 398 Cover Page Supplement

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

PHS 398 Training Subaward Budget Attachment(s)

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

Research and Related (R&R) Budget

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

  • Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
  • Do not complete the section on Participant/Trainee Support Costs.

PHS 398 Research Training Program Plan

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

Training Program

Program Plan

Program Administration:

Describe the strengths, leadership and administrative skills, scientific expertise, and training experience of the proposed HCPDP national program PD/PI(s). Particular attention should be paid to the qualifications of the PD/PI(s) to lead and oversee this national training program. Include discussion of PD/PI leadership activities at a national level. Describe the strategy and administrative structure planned that is designed to oversee and monitor the program and the scholar progress and research career development.

If the HCPDP program will have co-directors, these individuals should be identified, and their roles, and qualifications to carry out these roles, discussed. All proposed participating individuals, including co-directors and K12 AC members, should provide a letter documenting their willingness to serve in their proposed capacity. The letters should be included in the “Letters of Support” section.

Program Faculty:

Describe the expertise and experience expected of scholars’ mentors. Describe the plan for monitoring local mentorship and ensuring successful mentorship of scholars. If applicable, describe the plan for mentorship beyond the scholar’s local mentors, for example, by members of the K12 AC. Because the identity of local mentors cannot be known in advance, there is no need to name potential local mentors.

Proposed Career Development:

Research Career Development. Describe the immediate and long-term objectives of the program and describe the instructional and/or career development activities that will be used by the national K12 to ensure that the objectives of the program are met. Include information about planned activities that will be incorporated into the overall awarded HCPDP national program, and what activities will be expected of the local institution. Describe how the awarded HCPDP national program will broadly prepare scholars to become future leaders within the community and describe any specific career development activities designed to increase the participation and retention of individuals from underrepresented groups (See, e.g., NOT-OD-20-031) in research and community leadership.

Stakeholder Engagement. Describe how the program will educate scholars on the role of stakeholder and community engagement in all levels of scientific research. Describe community stakeholder activities and trainings planned as part of the program. How will the program leverage the patient members of the K12 AC to reinforce the value of stakeholder engagement in scientific research?

Scientific Methodology. Describe how, as a national program, the HCPDP will ensure that all scholars receive thorough instruction in experimental rigor with respect to experimental design, statistical methodology and data analysis and interpretation. Describe education in scientific methodology scholars are expected to receive at the home institution and how the awarded HCPDP national program will monitor the quality and achievement of this education. Describe any planned activities that the awarded HCPDP national program will provide directly to scholars in Scientific Methodology.

Discrimination, Bias, Cognitive Bias and Ethics. Describe how the awarded HCPDP national program will ensure that applicants and scholars understand the role of discrimination (see, e.g., Civil Rights Protections in NIH-Supported Research, Programs, Conferences and Other Activities, NOT-OD-15-152), bias (including unconscious bias), cognitive bias and ethical issues in research studies and scientific reporting, with regard to both basic research and clinical research studies.

Communication. Describe formal activities intended to provide experience and facilitate excellence in both written and oral communication, for different scientific purposes and to different audiences.

Laboratory Management. Describe any other instruction the scholars are expected to receive, such as in mentoring or laboratory-, project-, and time-management skills, and how this will be achieved under the auspices of the awarded HCPDP national program (i.e., will the awarded HCPDP national program provide this education directly, and if not, how will the awarded HCPDP national program ensure that scholars receive education in these areas at the local level or in another venue).

Site visits. Describe structural plans for site visits by the awarded HCPDP national program to each scholar's home department to discuss the scholar’s progress, needs and any other relevant issues with the scholar, mentor(s), Chair and others involved in the scholar's activities (i.e., who will do the site visit, how will it be organized, when will it occur, etc.).

Leadership. Describe the plan for using the awarded HCPDP national program to contribute to the development of future leaders within the pain management community, with particular attention to fostering the success of women and members of other underrepresented groups in research.

Scholar Candidates:

K12 applications must describe the approach to recruitment of outstanding scholar applicants to the program from nationally available candidates, including specific plans for achieving successful, comprehensive dissemination of the K12 opportunity.

Define the process by which candidates will apply to the program. Describe how the program will select and appoint scholars who would most benefit from this program, and who hold strong promise of a successful, combined research and clinical career. Describe the objective criteria and process by which applications will be evaluated for these criteria. Note that this process must include both a written and live (in-person or virtual) interview application component. The application should include a description of how the awarded HCPDP national program will inform scholars, mentors and Chairs of their responsibilities, a plan for monitoring scholar progress, and a mechanism to ensure both progress and compliance with program policies.

Institutional Environment and Commitment to the HCPDP Program

The PD/PI’s sponsoring institution must assure support for the proposed awarded HCPDP national program including assurance that sufficient time will be allowed for the PD/PI(s) to contribute to the proposed program, and that full protected time for scholars selected for the program (a minimum of 9 person-months per year, equivalent to 75%) will be maintained during the HCPDP program.

The application should describe plans for ensuring and monitoring appropriate commitments of the scholar’s institution to the scholar, including appropriate research support, protected time for research, and opportunities for advancement given a combined research and clinical career.

HEAL Data Sharing

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. It is expected that data generated by HEAL Initiative-funded projects will be submitted to study-appropriate domain-specific or generalist repositories in consultation with the HEAL Data Stewardship Group to ensure the data is accessible via the HEAL Initiative Data Ecosystem. Additional guidance on data related activities can be found at https://www.healdatafair.org/.

To maximize discoverability and value of HEAL datasets and studies, and facilitate data integration and collaboration, applications submitted in response to this FOA are strongly encouraged to incorporate standards and resources where applicable:

  • Applicants are encouraged to ensure that data collected by the study conform to Findable, Accessible, Interoperable, and Reusable (FAIR) principles.
  • Applicants are specifically encouraged to incorporate into their planning, an alignment with the guidelines, principles and recommendations developed by the HEAL Data Ecosystem, including but not limited to preparing data to store in selected specified repositories, applying minimal metadata standards, use of core HEAL Clinical Data Elements (CDEs, https://heal.nih.gov/data/common-data-elements), and other necessary requirements to prepare data to connect to the HEAL Data Ecosystem.
  • All new HEAL clinical pain studies are required to submit their case-report forms/questionnaires to the HEAL Clinical Data Elements (CDE) Program. The program will create the CDE files containing standardized variable names, responses, coding, and other information. The program will also format the case-report forms in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C § 794 (d)), which “require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities.” HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. For additional information, visit the HEAL CDE Program.

The NIH notices referenced below provide additional NIH guidance that should be considered in developing a strong data management and sharing plan. The list is instructive but not comprehensive.

  • Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014)
  • NIH has provided guidance around selecting a repository for data generated by NIH-supported research and has developed desirable characteristics for all data repositories (NOT-OD-21-016).
  • NIH encourages the use of data standards including the PhenX Toolkit (www.phenxtoolkit.org) (for example, see NOT-DA-12-008, NOT-MH-15-009)
  • NIH encourages researchers to explore the use of the HL7 FHIR® (Fast Healthcare Interoperability Resources) standard to capture, integrate, and exchange clinical data for research purposes and to enhance capabilities to share research data (NOT-OD-19-122). The FHIR® standard may be particularly useful in facilitating the flow of data with EHR-based datasets, tools, and applications.
  • NIH encourages clinical research programs and researchers to adopt and use the standardized set of data classes, data elements, and associated vocabulary standards specified in the United States Core Data for Interoperability (USCDI) standards, as they are applicable (NOT-OD-20-146). Use of the USCDI can complement the FHIR® standard and enable researchers to leverage structured EHR data for research and enable discovery.

Recipients conducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-15-086).

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

Training Data Tables are not required for this program. Applicants can summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.

?????Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.

Program Faculty.

If any mentors will supervise a Scholar proposing to gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

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

Study Record: PHS Human Subjects and Clinical Trials Information

DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must complete a Delayed Onset Study.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. NIH will not accept late applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

7. Other Submission Requirements and Information

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Webinar

In order to learn more about this RFA and to have the opportunity to ask questions, a pre-application webinar will be held on February 14th from 12:00-1:00pm EDT (9:00-10:00am PDT). Information on how to join the webinar is provided below.

RFA-NS-22-045: Heal National K12 Clinical Pain Career Development Program

To join the web presentation:

1.Go to https://nih.zoomgov.com/j/1602892813?pwd=UzRMVW81WHV4b3ovSUQrR2lFVGdiZz09

2. Click "Join Now"

For audio you can follow the prompts on your monitor, or

Call-in number (US): 551 285 1373

Meeting ID: 160 289 2813

Passcode: 294303

Post Submission Materials

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.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Career Development Program and Environment

  • Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers?
  • Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?
  • Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate? Do the program activities foster the development of skill and expertise in transparent, rigorous, and reproducible research methodologies, including relevant areas of data science?
  • Are appropriate timelines indicated for career progression and transition to independence?
  • Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success?
  • Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?
  • Is the institutional commitment to the proposed program appropriate?
  • If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?
  • Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities?
  • When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

  • Do the PD/PI(s) have the experience to develop, direct and administer the proposed program?
  • Does the leadership team bring complementary and multi-disciplinary expertise to the program?
  • Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
  • Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?
  • Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
  • Does the PD/PI have a strong plan for disseminating results of program scholars to the scientific community and the public?
  • For applications designating multiple PDs/PIs: Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?
  • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

Mentors

  • Are there plans for ongoing evaluation of mentors chosen by the scholars? Are there plans to assess the mentor’s engagement in the scholar’s training? Will this evaluation process ensure high quality mentorship and successful research career development of the scholars?
  • Is there evidence that the HCPDP PD/PI and K12 AC will be able to ensure appropriate and successful mentorship of the scholars?
  • Are there plans to assess the mentor’s mentoring record and training experience?
  • If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?

Scholars

 

  • What is the quality of plans to identify, recruit, and select candidates who have a commitment to research relevant to the pain management mission of HEAL and the potential to develop as independent researchers?
  • Is there evidence that the HCPDP is designed to contribute significantly to the scientific and professional development of the scholars?
  • Does the scholar recruitment plan include a thoughtful process of disseminating information about the HCPDP opportunity to a national pool of candidates to enable selection of the best applicants from across the country?
  • Does the recruitment and selection plan adequately address the need for fairness and diversity in the selection of scholars, with respect to departmental affiliations, research areas and clinical subspecialties?
  • Is there an appropriate, affirmative, and adequate plan to recruit a diverse group of scholars (e.g., including scholars with diverse training, from diverse locations and socioeconomic backgrounds, who are differently abled, and who will enhance gender and racial/ethnic diversity)?
  •  
Additional Review Criteria
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 Individuals Across the Lifespan

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Career Development in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide career development in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the scholars?

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. See, Notice of NIH’s Interest in Diversity, NOT-OD-20-031. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR career development in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

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).

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit. As part of the scientific peer review, all applications will receive a written critique.

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke Council.

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
3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

2. Administrative and National Policy Requirements

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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

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

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.

Other Reporting Requirements
  • The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the training grant for 8 weeks or more. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
  • Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement. Evaluation results should be included as part of the final RPPR.

4. Evaluation

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.

Evaluation Of the Program

PD/PI(s) should submit annual progress reports to NIH. Progress reports should describe all relevant outcomes related to awarded HCPDP national program activities over the years funded by the K12. This should include a detailed description of all scholars supported, including their institution, clinical specialty, research specialty, publications and other known funding obtained since the start of their HCPDP support, as well as any other relevant achievements. Progress reports should describe how the awarded HCPDP national program has evolved in response to changes in relevant scientific and technical knowledge, educational practices or experiences gained from previous program iterations. Progress reports should describe efforts to evaluate the program, and any changes made to the program based on these evaluations. Any perceived imbalances in subspecialties represented among applicants and scholars, and if needed, efforts to address these imbalances should be discussed in progress reports. Also, describe in general terms the makeup of the K12 NAC.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

Laura D Wandner, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: Laura.Wandner@nih.gov

Linda Porter, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: PorterL@ninds.gov

Devon Oskvig, Ph.D.
National Institute On Aging (NIA)
Phone: (301) 496-9350
E-mail: devon.oskvig@nih.gov

Helena Ahn, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: (301) 827-3207
Email: helena.ahn@nih.gov

Lanay M. Mudd, Ph.D., FACSM
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: lanay.mudd@nih.gov

Leslie A Frieden, PhD
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: 301-496-4263
E-mail: friedenla@mail.nih.gov

Nastaran Zahir, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6333
Email: nas.zahir@nih.gov
Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email:ChiefGrantsManagementOfficer@ninds.nih.gov

Jeni Smits
National Institute On Aging (NIA)
Phone: (301) 827-4020
E-mail: jeni.smits@nih.gov

Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: shelley.headley@nih.gov

Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: dr258t@nih.gov

Sean Hine
National Cancer Institute (NCI)
Telephone: 301-276-6291
Email: hines@mail.nih.gov

Section VIII. Other Information

Authority and Regulations

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

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