Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, or eRA Commons Administrative Supplement User Guide) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

The purpose of the NIDCR Administrative Supplement to National Center for Advancing Translational Sciences (NCATS) supported Clinical and Translational Science Awards (CTSA) program is to develop a pipeline of qualified investigators conducting clinical and translational research to improve dental, oral, and craniofacial health.

The CTSA program supports a national network of medical research institutions, called hubs, that work together to improve the translational process. The program, as a whole, supports the full spectrum of clinical and translational research and has an overarching goal to enhance the capacity to get more treatments to more patients more quickly. The program is envisioned to be an integrated research and training environment for clinical and translational sciences that aims to dramatically improve efficiency and quality across the translational research spectrum.

To meet the particular training and career development needs of translational science, NCATS encourages innovative research training and career development programs that impart the knowledge, skills, and attitudes particular to translational science. One of the overarching goals of the program is to promote team science, and the development of a well-trained and skilled translational research workforce. The translation of basic research discoveries to implementing interventions that improve public health requires teams of scientists, clinicians and other stakeholders with wide-ranging expertise and perspectives. Early exposure to collaboration leveraging disparate areas of expertise will better prepare investigators to tackle current and emerging challenges facing clinical research.

NCATS CTSA KL2 Program

The KL2 Institutional Career Development Core supports research career development goals of the CTSA program, and is expected to foster high-impact research careers in translational research. Career development across a CTSA hub is expected to be harmonized, and to integrate clinical and translational science across multiple departments, schools, and clinical research institutes. The hubs promote a team science approach to research collaboration that includes a range of disciplines (including medicine, dentistry, nursing, pharmacy, public health, epidemiology, biostatistics, bioinformatics or bioengineering).

The KL2 component of the CTSA has a separate PD/PI to lead, manage and oversee the core, and has program faculty to serve as mentors. KL2 awards support clinical research scholars for 2-5 years. The CTSA-funded institution selects KL2 scholars, providing them with a rich career development experience in a multidisciplinary setting. KL2 appointees referred to as Clinical Research KL2 Scholars come from a variety of fields (e.g., medicine, dentistry, nursing, the behavioral sciences, biostatistics and epidemiology) and can receive up to five years of career development support.

The KL2 program combines formal course work with direct research experience, and an opportunity to pursue additional advanced degrees. All scholars, including those at CTSA partner institutions, have access to CTSA research facilities, which may include:

• Training courses, seminars and workshops
• Use of specialized core facilities, laboratories, and databases
• Access to a team of clinical research mentors
• Administrative and regulatory support for research protocols
• Funding for pilot research projects

The goal of this NIDCR KL2 administrative supplement program is to enhance and to foster the participation of scholars pursuing clinical and translational research training to improve dental, oral and craniofacial health. This program is in response to the Advisory Committee to the NIH Director’s Physician-Scientist Workforce (PSW) Working Group recommendation #9: Leverage the Existing Resources of the CTSA Program to Obtain Maximum Benefit for Training and Career Development, which questions whether this resource is being optimally utilized, encourages testing of innovative pilot programs, and encourages extending the resources to non-MD aspects of the PSW. For the full report of the Advisory Committee to the NIH Director’s PSW Working Group, see PSW Working Group Report June 2014.

The goals of this KL2 administrative supplement program are consistent with the NIDCR Strategic Plan 2014 2019:

• Objective 1-3: Conduct translational and clinical investigations to improve dental, oral, and craniofacial health;
• Objective 2-1: Support research toward precise classification, prevention, and treatment of dental, oral, and craniofacial health and disease; NIDCR encourages leveraging existing clinical research infrastructure supported by other NIH Institutes and Centers. One important resource is the NIH Clinical and Translational Science Award (CTSA) program, which aims to accelerate translation of laboratory discoveries into treatments for patients, to engage communities in clinical research; and
• Objective 4-3: Support research, training, and career development programs that value team science, transformative approaches, and diversity at all levels.

This KL2 administrative supplement program encourages formation of interdisciplinary research teams with the required expertise to conduct high quality studies. The NIDCR supported KL2 scholars will become members of a large collaborative research network prepared to tackle the biomedical challenges of today and tomorrow to improve human health.

NIDCR Programmatic Requirements

Program Directors/Principal Investigators of active NCATS KL2 programs will recruit and nominate scholars for NIDCR KL2 administrative supplement awards. PD/PIs are also encouraged to identify scholars who will enhance diversity on a national basis. The applications are expected to propose an individualized program of translational science education and career development that leverage the infrastructure support, curriculum, and mentorship expertise of the CTSA program. Additional mentors required for dental, oral and craniofacial expertise in translational or clinical research should be included, if appropriate for the scholar's research and career goals. The scholars proposed research experience must be integrated with the KL2 career development core, and align with the NIDCR Strategic Plan 2014 2019.

The research experience supported under this FOA is intended to enhance the scholar's transition to an independent research career as a principle investigator or as an investigator providing expertise in a collaborative team science approach. In addition, this program is intended to provide a foundation for subsequent grant applications and support for continued research training, or for independent research funding from NIH or other sources. KL2 PD(s)/PI(s) should encourage scholars to submit applications for fellowships, individual career development awards, research grants, and other sources of independent support before the supplement period ends.

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

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

This announcement is for administrative supplements to existing KL2 Institutional Career Development Core projects funded in response to PAR-15-304 and RFA-TR-14-009. To be eligible, the KL2 award must be active and the research training proposed in the supplement must be accomplished within the competitive segment.

• All organizations administering an eligible parent award may apply for a supplement under this announcement.

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

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

Applicant Organizations

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

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

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.

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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

Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center. Support under the supplement is not transferable to another individual or transportable to another institution.

NIDCR will support up to two KL2 scholars per CTSA Hub. More than one application may be submitted per CTSA hub, although each administrative supplement application for NIDCR KL2 scholar support must include a request for support of only one scholar.

Eligible scholars must have a research or health-professional doctoral degree or its equivalent.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Individuals on temporary or student visas are not eligible.

At the time of award, scholars must have a full-time position at the application institution or a partnering institution.

Former PD/PIs on NIH research project (R01), program project (P01), center grants, FIRST Awards (R29), sub-projects of program project (P01) or center grants are not eligible. Former PD/PIs on NIH career development awards (K awards), or the equivalent, are not eligible, EXCEPT for Dentists who were awarded an NIDCR K08 to support dissertation research that resulted in a PhD, who remain eligible for KL2 support. Former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.

At the time of award, the scholar may not have pending an application for any other PHS mentored career development award (e.g., K08, K23) that duplicates any of the provisions of the KL2 administrative supplement. In keeping with the type of mentoring and career development being provided by the CTSA, a KL2 scholar who is already in the process of applying for an independent mentored career development grant, a P01 grant, or R01 grant is likely too senior for the KL2 award.

Scholars are encouraged to apply for individual mentored K awards (e.g., K08, K23) and independent awards (R01, R03, R21) during their KL2 support; if successful, the KL2 appointment would be terminated and funding received from the new individual K or R award.

For this KL2 supplement award, scholars must be pursuing clinical and translational research in dental, oral or craniofacial science that aligns with the mission of the NIDCR. Scholar appointments must be a minimum of two years in duration.

Applicants must prepare applications using current forms in accordance with the Application Guide.

For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this announcement, or use the eRA Commons streamlined submission process.

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide or eRA Commons Administrative Supplement User Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed, with the following exception:

PHS 398 Research Training Program Plan Form:

Program Plan: 12 pages

Administrative supplement requests for most single-project activity codes can be submitted using either paper or electronic submission processes.

Instructions for Electronic Application Submission through Grants.gov

Use the Apply button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

• R&R Cover form: Select Revision in the Type of Application field.
• R&R Other Project Information Form

Facilities and Other Resources: Describe how the scientific environment in which the research training will be done contributes to the probability of the scholar's success (e.g., institutional support, physical resources, and intellectual rapport). For CTSA Hub Training Resources, describe the training resources that are available to the scholar.

• R&R Project/Performance Site Location Form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the location(s) in the fields provided.
• R&R Senior/Key Person Profile (Expanded) Form: List the PD/PI(s) as the first person (regardless of their role on the supplement activities). List Senior/Key Personnel who will be serving as members of the scholar's mentoring team. List the scholar proposed to be added through this supplement.

Scholars for this supplement support must have an eRA Commons account and the scholar's Commons Username must be entered in the Credential field.

Biographical sketch Senior/Key Personnel: Include a biographical sketch of the KL2 PD/PI(s) and of each of the individuals who will comprise the scholar's mentoring team. The personal statement of the individuals who will serve on the scholar's mentoring team should include a description of his/her specific role in mentoring the scholar, how the mentoring will occur (e.g., frequency and mode), and how the scholar's progress will be monitored during the supplement award period.

Biographical sketch Scholar: The personal statement of the scholar's biographical sketch should include a description of his/her research objectives and career goals, and why their experience and qualifications make them particularly well-suited to receive an NIDCR KL2 supplement award. Relevant factors include previous training and research accomplishments in dental, oral and craniofacial research and any source(s) of current funding.

• R&R Budget Form: Only include funds requested for the additional supplement activities.
• PHS 398 Research Training Program Plan Form:

Program Plan

Background: Include a summary or abstract of the funded parent award project. Provide the rationale for the proposed supplement program and its alignment with dental, oral and craniofacial translational research.

Research Career Development Program Plan (Institutional Program Plan)

Program Faculty: Provide information about the program faculty who will be involved in the supplement activities, including the complementary expertise and experiences, active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stage. If any co-mentor is not located at the sponsoring institution, describe the frequency and type of communication that will be used to engage the scholar.

Proposed Research Career Development Plan (Proposed Training): The proposed research career development plan should align with the mission of the NIDCR and the KL2 program. The research experience should challenge the scholar's scientific curiosity while introducing a creative, novel, and clinically significant approach to dental, oral or craniofacial research. The plan should augment the scholar's research development yet be individualized to their scientific discipline and expertise. Describe key activities during the supplement, including mentored team science activities, didactic coursework, and technical training to enhance skills and proficiency in conducting translational research. Address specific training in dental, oral, or craniofacial clinical disease and describe how it will be incorporated into the research career development plan. Present a timeline for activities and potential publications and grant applications for independent research support.

Institutional Environment and Commitment to Training: Include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned KL2 supplement program. The letter should provide assurance that the scholar will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to their KL2 research career development program. The remaining effort should be devoted to activities related to the development of the scholar’s career as an independent investigator or clinician-scientist, e.g., clinic responsibilities, teaching and administration, and/or additional research activities.

Letters of Support: Attach appropriate letters from all individuals confirming their roles in the proposed supplement program.

Human Subjects: Complete this section if the scholars will design and conduct their own independent human subjects research and indicate that the proposed research experience was approved by the human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component

Vertebrate Animals: Complete this section if the scholars will design and conduct their own independent vertebrate animal research and indicate that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) at the grantee institution.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User s Guide for submitting through this system is available, with the following additional guidance:

• Note: Scholars for this supplement support must have an eRA Commons account and the scholar's Commons Username must be entered in the Credential field.
• Budget information should be entered for the grantee institution in the tabs provided for each selected budget period.
• Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
• Use the Add Other Attachments function to include the following PDF documents:
• Project /Performance Site Location(s): Identify the site(s) and location(s) where the proposed supplement activities will be performed.
• Facilities and Other Resources: Describe how the scientific environment in which the research will be done contributes to the probability of the scholar's success (e.g., institutional support, physical resources, and intellectual rapport). For CTSA Hub Training Resources, describe the training resources that are available to the scholar.
• Biographical sketch: Include a biographical sketch of the KL2 PD/PI(s) and of each of the individuals who will comprise the scholar's mentoring team. The personal statement of the individuals who will serve on the scholar's mentoring team should include a description of his/her specific role in mentoring the scholar, how the mentoring will occur (e.g., frequency and mode), and how the scholars progress will be monitored during the supplement award period.
• Biographical sketch Scholar: The personal statement of the scholar's biographical sketch should include a description of his/her research objectives and career goals, and why their experience and qualifications make them particularly well-suited to receive an NIDCR KL2 supplement award. Relevant factors include previous training and research accomplishments in dental, oral and craniofacial research and any source(s) of current funding.
• Program Plan: Provide a description of the training program plan for the supplement activities. The plan should include the following:
• Background: Include a summary or abstract of the funded parent award project. Provide the rationale for the proposed supplement program and its alignment with dental, oral and craniofacial translational research
• Research Career Development Program Plan:

-Program Faculty: Provide information about the program faculty who will be involved in the supplement activities, including the complementary expertise and experiences, active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stage. If any co-mentor is not located at the sponsoring institution, describe the frequency and type of communication that will be used to engage the scholar.

-Proposed Research Career Development Plan: The proposed research career development plan should align with the mission of the NIDCR and the KL2 program. The research experience should challenge the scholar's scientific curiosity while introducing a creative, novel, and clinically significant approach to dental, oral or craniofacial research. The plan should augment the scholar's research development yet be individualized to their scientific discipline and expertise. Describe key activities during the supplement, including mentored team science activities, didactic coursework, and technical training to enhance skills and proficiency in conducting translational research. Address specific training in dental, oral, or craniofacial clinical disease and describe how it will be incorporated into the research career development plan. Present a timeline for activities, such as potential publications and grant applications for independent research support.

-Institutional Environment and Commitment to Training: Include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned KL2 supplement program. The letter should provide assurance that the scholar will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to their KL2 research career development program. The remaining effort should be devoted to activities related to the development of the scholar’s career as an independent investigator or clinician-scientist, e.g., clinic responsibilities, teaching and administration, and/or additional research activities.

• Letters of Support: Attach appropriate letters here from all individuals confirming their roles in the scholar's proposed program.
• If applicable, attach documents indicating that the scholar's proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

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

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit electronic 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.

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

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide. Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted using the instructions specified above.

Applicants must complete all required registrations prior to submission. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission contact the Application Submission Contacts in Section VII.

Important reminders:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Not Applicable

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

NIH staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase the parent award’s overall impact within the original scope of award:

• Will the administrative supplement increase the likelihood that the award will enhance the scholar's potential for, and commitment to, a productive, independent scientific research career in dental, oral or craniofacial translational science?
• Will the administrative supplement increase the likelihood for the scholar to develop a strong clinical and translational research program, or to develop collaborative expertise and contribute as a strong member in team science approaches?
• Do the proposed mentors have the appropriate research qualifications, including experience, expertise and research accomplishments, in the area of the proposed research?
• Is active research funding available to support the scholar's proposed research project?
• Is there clear commitment of the sponsoring institution to ensure that the required minimum of the scholar’s effort will be devoted directly to the research training and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities, if applicable?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, NIH staff will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, NIH staff will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

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

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

Not Applicable

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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

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

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

Cooperative Agreement Terms and Conditions of Award

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required in the NIH Grants Policy Statement.

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 KL2 training grant. Grantees 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.

A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.

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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Lynn Mertens King, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5006
Email: lynn.king@nih.gov

Not Applicable

Dede Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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