Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
See Notices of Special Interest associated with this funding opportunity
PAR-18-360, K22 Career Transition Award
PAR-19- 151, K22 Career Transition Award
93.121
The purpose of the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22) program is to provide highly qualified dentists in NIH Intramural postdoctoral fellowship positions with opportunity to transition from mentored research experiences in the NIH Intramural program to extramural institutions as new investigators with independent research funding.
This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion Clinical Trial Required FOA (PAR-18-360). Applicants proposing basic experimental studies in humans referred to in NOT-OD-18-212 as prospective basic science studies involving human participants" should apply to the companion Basic Experimental Studies with Humans FOA (PAR-19-151).
January 8, 2019
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Standard AIDS dates apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
The objective of the Career Transition Award (K22) is to provide support to outstanding, newly trained basic or clinical investigators to develop their research skills through a two phase program: an initial period involving an intramural position at the NIH and a subsequent period of support at an extramural institution. The award is intended to facilitate the establishment of a record of independent research by the candidate in order to sustain or promote a successful, independent research career.
The goal of the NIDCR Career Transition Award (K22) is to provide support to outstanding dentists, to develop their independent basic or clinical research skills through a two phase program, an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. The award is intended to facilitate the establishment of a record of independent research by the candidate in order to sustain or promote a successful, independent research career. This FOA supports the NIDCR Strategic Plan 2104-2019 , Goal 4: Ensure that a strong research workforce is dedicated to improving dental, oral, and craniofacial health.
To achieve this goal, the program is structured to provide two years of mentored research training in an NIH intramural laboratory (Phase 1) followed by three years support (Phase 2) to conduct biomedical research as an independent scientist. During the intramural training phase of the K22 (Phase 1), support will be provided by the candidate's NIH intramural laboratory or branch. Funds from the K22 award may be used to support Phase 2 at an extramural sponsoring institution/organization to which the individual has been recruited, has been offered, and has accepted a tenure-track full-time assistant professor position (or equivalent). This allows the individual to continue to work toward establishing his/her own independent research program and prepare an application for research grant support, such as an R01, or equivalent grant support.
Candidates should select a mentor from the NIH intramural program with whom the candidate can consult in preparing and submitting the application for the NIH intramural mentored phase of the award. Candidates may work with their current mentor, or with another intramural investigator, provided the research experience proposed in this application will enhance the candidate’s scientific career. The K22 application should describe the research activities planned during both the mentored and independent phases of the program (up to 5 years). The application will be peer reviewed and receive an overall impact score. Applications approved for funding will receive an approval letter from the NIDCR to initiate the intramural NIH research training (Phase 1) that will be supported through NIH intramural funds. The approval letter will include the terms and conditions to activate the funds from the K22 award at an extramural institution/organization (Phase 2).
A transition application from the extramural institution/organization on behalf of the K22 awardee will be required to begin the activation process. Activation of the extramural phase of the award is not automatic. Approval to activate the extramural phase will be based on an administrative review of the transition application by the NIDCR, and will consider the success of the awardee’s research performance progress during the intramural phase and the satisfactory response to the programmatic requirements of the K22, which include achieving an independent tenure-track (or equivalent) position at an extramural institution. The details of the transition application process are described in Section VI. Award Administration Information.
Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial , a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants proposing a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion FOA (PAR-18-360).
NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." ( NOT-OD-15-015).
Applicants proposing basic experimental studies involving humans , otherwise referred to in NOT-OD-18-212 as prospective basic science studies involving human participants, that fall within the NIH definition of a clinical trial and also meet the definition of basic research should apply to the companion FOA (PAR-19-151).
Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Intramural Phase 1:
Support for the intramural phase is provided by the candidate's NIH intramural laboratory or branch. Support for the intramural phase may not exceed two years in duration. The salary support will be consistent with that provided by the NIH intramural program for other investigators in the same position and with similar levels of postdoctoral experience.
Extramural Phase 2:
Support for the extramural phase will be provided to the extramural institution. Support for the extramural phase may not exceed three years in duration. The total cost for the extramural phase may not exceed $249,000 per year, including salary, fringe benefits, research support allowance, and applicable facilities and administrative (F&A) costs (see Indirect Costs below).
The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.
Intramural Phase 1:
Research-related expenses for the intramural phase are provided by the candidate's NIH intramural laboratory or branch.
Extramural Phase 2:
Total expenses for the extramural phase may not exceed $249,000 per year, including salary, fringe benefits, research support allowance, and applicable facilities and administrative (F&A) costs (see Indirect Costs below).
Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
NIH intramural laboratories and other eligible agencies of the Federal Government are eligible to apply for the mentored phase of the K22 mechanism on behalf of intramural candidates. They are not eligible to apply for the independent phase.
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.
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 candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and 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. Multiple PDs/PIs are not allowed.
Candidates for the K22 award must have earned a clinical dental doctoral degree (DDS, DMD or equivalent) or a combined dental and research doctoral degree (PhD or equivalent). At the time of application, the candidate must be in an NIH intramural postdoctoral fellowship position and have demonstrated potential for a productive basic or clinical research career.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:
Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.
Individuals are eligible for a K22 award if they have been, or currently are, the PD/PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the specific aims or research goals of an R03 or R21 grant. Individuals are NOT eligible to apply if they have pending an application for any other PHS career development award, an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00). Individuals are not eligible to apply if they have been or are currently a PD/PI on an NIH research grant (such as R01, R29, P01) or a subproject leader on a Program Project (P01) or Center Grant (P50), or a non-NIH equivalent to these grants/awards.
Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.
After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details.
Mentor(s)
Before submitting the application, the candidate must identify a mentor in the NIH Intramural Research Program who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. While the principal mentor must be a member the NIH Intramural Research Program, co-mentors and consultants from extramural organizations are allowed. Phase 2 of the K22, transition to independence, does not require mentored research training and career development. However, the candidate’s mentor(s) may continue to collaborate with candidate during this phase.
Both Phase 1 and Phase 2 applicant institutions must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Project Summary/Abstract
Include a description of your current intramural research and the research you propose to continue in the independent phase.
Phase 1: An itemized budget is not required for the K22 intramural phase (Phase 1); a total requested amount for each budget period is acceptable. Support for the intramural phase is provided by the candidate's NIH intramural laboratory or branch; therefore the Direct and Indirect Costs should specify $0. The applicant should indicate 12 person-months effort for him/herself for each project period during Phase 1.
Phase 2: An itemized budget is not required in the initial application for the K22 independent phase (Phase 2); a total requested amount for each budget period is acceptable. The applicant should indicate a minimum of 9 person-months effort for him/herself for each project period. The exact amount of direct and indirect costs does not need to be specified; however, a line item in section F: Other Direct Costs titled Independent Phase requesting $249,000 should be added for each period during Phase 2. At the time of transition to the independent K22 phase (Phase 2), the applicant extramural institution will submit a detailed budget for the K22 Phase 2 project period.
Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional Commitment to the Candidate
Other Research Plan Sections
Appendix
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate Information and Goals for Career Development
Candidate’s Background
Career Goals and Objectives?
Candidate’s Plan for Career Development/Training Activities During Award Period
The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline, including publications, is strongly encouraged. The mentor and any co-mentor may form a mentoring team (or an advisory committee) to assist with the development of a program of study or to monitor the candidate's progress through the career development program.
The career development plan must be tailored to the needs of the individual candidate, incorporating the candidate's goals, current activities, prior experience, and the ultimate goal of achieving independence as a researcher.
Include a plan to obtain the necessary research experience to launch an independent research career. Suggested activities include, but are not limited to, those designed to improve skills and understanding in grant writing, clinical trials methodology, research design and management, statistical analysis, and bioethics.
Candidates must justify the need for both the mentored phase and the independent phase, and provide a convincing case that the proposed period of support (1-2 years as a mentored scientist followed by up to 3 years as an independent scientist) will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem.
The candidate and intramural mentor must describe a plan, including a timeline with milestones, for evaluation of the candidate's progress during the intramural mentored phase and plans for the transition to the independent extramural phase.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
If the applicant is proposing to gain experience in a clinical trial, ancillary clinical trial, or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.
Training in the Responsible Conduct of Research
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Plans and Statements of Mentor and Co-mentor(s)
Letters of Support from Collaborators, Contributors and Consultants
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Description of Institutional Environment
.
Institutional Commitment to the Candidate’s Research Career Development
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 the SF424 (R&R) Application Guide instructions.
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Reference Letters
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Only the review criteria described below will be considered in the review process. Applications submitted in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Career Development Plan/Career Goals and Objectives
Research Plan
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Consultant(s), Collaborator(s)
Environment & Institutional Commitment to the Candidate
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
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 individuals of all ages (including children and older adults) 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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not Applicable
Not Applicable
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
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 level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.
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).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Transition to the Independent Phase Transition from the intramural phase (Phase 1) to the extramural phase (Phase 2) is intended to be continuous in time. Support for Phase 2 is not automatic and is contingent upon the K22 awardee obtaining an appropriate extramural position at an eligible institution, an appropriate start-up package, and the successful NIDCR programmatic review of the tenure-track (or equivalent) faculty position the candidate has accepted and the institutional commitment to the candidate. In order to submit a independent Phase 2 application, individuals must have been offered and accepted a research faculty position at an eligible institution that has both appropriate infrastructure to support the proposed research program and a history of external research funding. To avoid potential problems, candidates are strongly encouraged to contact their NIDCR Program Official as soon as plans to apply for, or assume, an independent position develop. At that time, individuals should discuss plans for transition to, and the transition application for, the Phase 2 award. The application for the Phase 2 award should be submitted no later than 2 months prior to the proposed start date of the Phase 2 award. The extramural phase institution will submit an application on behalf of the candidate for the Phase 2 award using the PHS 398 Application. The application must include:
A new Form Page 1 (face page) signed by the Phase 2 institutional representative;
An updated Form Page 2 (project summary page) that reflects current plans for the Phase 2 award;
Form Page 3 (table of contents);
Form Pages 4 and 5 (Budget for Initial and Entire Proposed Project Periods): Detailed budget pages for a non-modular budget and narrative justification for all requested funds for each budget year, including:
The name, role on project, and level of effort for all project personnel (salaried and unsalaried) and a narrative justification for each person;
The name and organizational affiliation of all consultants and a description of the services to be performed;
Biographical sketches for the PD/PI and any other Key Personnel;
A new Resources Format Page including a description of specific resources committed by the sponsoring institution to support the Candidate’s research; research facilities; and the availability of appropriate educational opportunities, including collaborating faculty, if appropriate.
A brief description of progress made during Phase 1 that will serve as the Final Progress Report for the initial phase.
Updated Specific Aims that reflect current plans for the Phase 2 project;
An updated Research Plan (not to exceed 5 pages);
Letters of Support (e.g., Consultants): if previously unnamed consultants/collaborators are added, provide letters of commitment from these individuals;
A Letter of Institutional Commitment from the Department or Division Chairperson that describes the sponsoring institution's commitment to the candidate’s scientific independence (see additional details below);
Updated Protections for Human Subjects and Inclusion of Women, Minorities and Children (as appropriate);
Updated Vertebrate Animals (as appropriate);
Updated Biohazards (as appropriate)
Updated Resource Sharing Plan (as appropriate); and
A new checklist.
Letter of Institutional Commitment: A letter of institutional commitment is required at the time of the Phase 2 application and is typically provided by the Department or Division Chairperson. This letter should satisfy the criteria described in the Career Development Award Section 7 of the SF424 Application Guide. The letter should describe the following: A detailed description of the candidate’s position, responsibilities, and duties: The institution’s tenure-track policy should be defined, or a description should be provided of the equivalent arrangements for institutions without a formal tenure-track. The start-up and salary package and other evidence of institutional support must be described and must be comparable to that provided to other, recently hired faculty who did not have a grant at the time they were hired. K22 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for faculty who are hired without grant support. Commitment to providing adequate resources, an appropriate institutional environment, and protected research time: Describe the quality and relevance of the institutional environment for the scientific and professional development of the candidate. In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must demonstrate a commitment to the candidate by providing a minimum of nine person-months (75% full-time professional effort) of protected research time for at least the duration of the K22 award. Consequently, teaching, clinical duties and other non-research activities should be reduced during the K22 award period. Institutional commitment to fostering the candidate's career development: Discuss how the institution will foster and support the candidate's efforts to secure independent research grant (R01) support during the K22 award period. NIDCR will not make a K22 award if the institutional commitment is deemed inadequate. These materials should be sent directly to the NIDCR. The original application plus one copy (preferably in PDF format) are to be are to be mailed or e-mailed directly to the NIDCR Financial/ Grants Management contact person listed in the PD/PI's eRA Commons account. The K22 transition application will be evaluated by extramural Program staff of the awarding component for completeness and responsiveness to the program. Applicants who are approved to transition will receive a Notice of Award reflecting the dollar amount and the recipient organization. Candidates who are not approved to transition will receive written notification from the NIDCR communicating the rationale for the disapproval. This notification typically will be transmitted within 60 days of receipt of the Phase 2 application. Although the financial plans of the NIDCR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
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.
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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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.
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: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Leslie A. Frieden, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-4263
Email: [email protected]
Janice Lee, DDS, MD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4591
Email: [email protected]
Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: [email protected].
Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]
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.