Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

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.

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.

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.

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.

2. Cost Sharing

3. Additional Information on Eligibility

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.

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: [email protected]

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

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.

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)?

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

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.

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.

• 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

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

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.

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:

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS 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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

Not Applicable.

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.

• 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.

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.

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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Laura D Wandner, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Linda Porter, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Devon Oskvig, Ph.D.
National Institute On Aging (NIA)
Phone: (301) 496-9350
E-mail: [email protected]

Lanay M. Mudd, Ph.D., FACSM
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: [email protected]

Leslie A Frieden, PhD
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: 301-496-4263
E-mail: [email protected]

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

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email:[email protected]

Jeni Smits
National Institute On Aging (NIA)
Phone: (301) 827-4020
E-mail: [email protected]

Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: [email protected]

Section VIII. Other Information

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.