Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Allergy and Infectious Diseases (NIAID)
Funding Opportunity Title	NIAID Career Transition Award (K22)
Activity Code	K22 Career Transition Award
Announcement Type	Reissue of PAR-09-068
Related Notices	September 12, 2014. This PAR has been reissued as PAR-14-341. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. May 7, 2014 - Notice of Clarification of Application Submission Instructions for PAR-12-156. See Notice NOT-AI-14-056. November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.
Funding Opportunity Announcement (FOA) Number	PAR-12-156
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.855, 93.856
Funding Opportunity Purpose	The purpose of the NIAID Research Scholar Development Award (CTA) program is to increase and maintain a strong cohort of new and talented NIH-supported independent investigators that will address the health needs of the Nation. The NIAID CTA is specifically designed to facilitate the transition from a postdoctoral research position to an independent research position.

Posted Date	April 10, 2012
Open Date (Earliest Submission Date)	May 12, 2012
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Standard dates apply , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates apply by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	New Date September 12, 2014. This PAR has been reissued as PAR-14-341. (Original Expiration Date: September 08, 2015)
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), 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 overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the of the NIAID CTA is to support postdoctoral fellows transitioning to positions of assistant professor or equivalent, and initiate a successful biomedical career as an independent research scientist.

NIH believes that the creativity and innovation of new independent investigators in their early career stages play an integral role in addressing our Nation’s biomedical, behavioral, and clinical research needs. However, the average age of first-time (new) Principal Investigators obtaining R01 research funding from the NIH has risen to 42 years for Ph.D. degree holders and 44 years for M.D./Ph.D. degree holders. The intent of the NIAID K22 program is to help alleviate this trend and to assist new investigators in transitioning to stable independent research positions at an earlier age and with an enhanced probability of success in obtaining independent NIH or other independent research support.

Nature of the career/research transition opportunity

The K22 award will provide two years of support to conduct biomedical research as an independent scientist at an extramural sponsoring institution/organization to which the individual has been recruited, been offered and has accepted a tenure-track full-time assistant professor position (or equivalent). This support is to allow the individual to continue to work toward establishing his/her own independent research program and prepare an application for regular research grant support (R01).

The postdoctoral fellow, also referred to as a candidate, submits a K22 application from the institution where s/he currently pursues his/her postdoctoral research training. The application will be peer reviewed and assigned an overall impact score. Successful candidates (i.e. whose application has received a fundable overall impact score) will receive an approval letter from NIAID that will include the terms and conditions to activate the K22 award. In order to activate the K22 award, the candidate will need to secure a tenure-track full-time assistant professor position within a year of the receipt of the approval letter. Once the assistant professor position has been secured, the candidate will submit updated information about the K22 application with the support of the sponsoring institution. The sponsoring institution can be the same as the post-doctoral institution, though it is most likely a different institution from the original submission of the K22 application. The updated information of the transition to an assistant professor position at the sponsoring institution will be evaluated by senior NIAID staff to ensure that all programmatic requirements are met prior to the activation of the K22 award. The details of the requirements for the activation of the K22 award are described in Section VI of this announcement.

Funding Instrument	Grant
Application Types Allowed	New Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period	The total project period may not exceed 2 years. .

Salary	NIH will contribute no more than $50,000 plus fringe benefits per year toward the salary of the career award recipient. The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.
Other Program-Related Expenses	In the first year of the K22 award, NIAID will contribute up to $150,000 (total direct cost), and in the second year up to $100,000 (total direct cost) toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. The PI will have discretion to utilize the award as needed by the research described in the application. However, no more than $50,000 per year of the award may be utilized to support the Principal Investigator’s salary. Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
Indirect Costs	Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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

Higher Education Institutions

• 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

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)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

NIH intramural laboratories and other eligible agencies of the Federal Government are eligible to submit a K22 application on behalf of intramural candidates. In order for an intramural postdoctoral fellow to activate the K22 award, the candidate must transition to an assistant professor position at an extramural institution.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch16.htm#_Toc271265275

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

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 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 Principal Investigators are not allowed.

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).

Candidates for this award must have earned a terminal clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD, or equivalent doctoral degree), or a combined clinical and research doctoral degree.

Individuals affiliated with an NIH Intramural Laboratory may apply (specific information is available for intramural candidates on the Electronic Submission Intranet link available only to users internal to NIH).

Individuals not affiliated with an organization may apply (specific information is available for unaffiliated candidates).

Individuals are NOT eligible if they:

• Have currently or previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or
• Have more than 5 years of related postdoctoral research experience at the time of the relevant standard receipt date for the initial application or resubmission; or
• Have been an independent principal investigator on NIH research grants (e.g. R01 or equivalent), NIH career development awards (e.g., K01, K07, K08, K23, K25), or other peer reviewed NIH or non-NIH research grants over $100,000 direct costs per year, or project leaders on sub-projects of multi-project applications (e.g. P01, U19).
  

Some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that the position s/he is in complies with the intent of this eligibility requirement. Evidence for non-independence may include:

• The candidate’s research is entirely funded by another investigator’s grants.
• The candidate’s research is conducted entirely in another investigator’s assigned space.
• According to institutional policy, the candidate cannot hire postdoctoral fellows or be the responsible supervisor of graduate students.
• The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.

Conversely, evidence for independence, and therefore lack of eligibility, includes:

• The candidate has a full-time tenure track assistant professor position (or equivalent).
• The candidate received a startup package for support of his/her independent research.
• The candidate has research space dedicated to his/her own research.
• The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire postdoctoral fellows.

Clinicians (including those with MD, DDS, DVM and other licensed professionals) in positions not designated as postdoctoral positions:

Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K22 award and should contact the NIAID Scientific/Research (see below) for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Such individuals may also wish to consider other career awards (e.g., K08, K23) available for junior faculty development.

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 application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed. An individual may not have two or more competing NIH career development applications pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Individuals are eligible for a K22 award if they have been, or currently are, the PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the provisions 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 PI on an NIH research grant (such as R01) or a subproject leader on a Program Project (P01) or Center Grant (P50), or a non-NIH equivalent to these grants/awards.

At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. 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. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

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

Candidate’s Background (Component of Candidate Information)

• Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate.
• Provide evidence of the candidate's potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and letters of reference.
• Describe the candidate’s commitment to a career in a biomedical or behavioral research field relevant to the scientific mission of the NIAID (http://www.niaid.nih.gov/Pages/default.aspx ).

Career Goals and Objectives (Component of Candidate Information)

• Describe a systematic plan that shows a logical progression from the candidate's prior research and training experiences to the research and career development experiences of the current position and subsequently then to independent investigator status.
• Describe the candidate’s current as well as long-term research and career objectives

Career Development/Training Activities During Award Period (Component of Candidate Information)

• The candidate is responsible for the preparation of the career development plan and consultation with the current postdoctoral advisor is highly encouraged. A timeline including publications is strongly encouraged.
• The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher. This plan should describe activities such as those that will lead to new and/or enhanced research, grant-writing, communication and laboratory management skills and knowledge.
• The candidate should describe how the career development plan will promote the candidate's success and scientific independence.
• The candidate must describe the plan of his/her transition to the independent investigator status.

Training in the Responsible Conduct of Research (Component of Candidate Information)

• Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as provided in Chapter 7 of the SF424 (R&R) Application Guide

Statements by Consultants, Contributors (Component of Statements of Support)

• Signed statements must be provided by each collaborator/consultant confirming their participation in the project and describing their specific roles. Information should be provided that clearly documents expertise in the proposed area(s) of collaboration/consultation. Any other opportunities for the candidate’s professional growth should also be documented in these statements.
• Since this is not a mentored award, a statement by the current postdoctoral advisor should not be included unless s/he will serve as a consultant or contributor during the K22 award.

Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)

• Due to the nature of this award, the candidate may not have identified a sponsoring institution at the time of submitting the K22 application. Describe how the current institutional research environment is supportive in the development of the candidate's research career and transition to an independent investigator.

Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)

• For activation of the K22 award the sponsoring institution must provide a statement of commitment to the candidate’s development into a productive, independent investigator and to meeting the requirements of the award. The sponsoring institution must provide the candidate with the appropriate facilities and other resources to carry out the proposed Research Plan.

Research Strategy (Component of Research Plan)

• A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research.
• The application must also describe the relationship between the current postdoctoral advisor's research and the candidate’s proposed research plan. The application should describe how the candidate will gain independence from his/her current mentor(s) and achieve separation of his/her scientific research program from that of the postdoctoral advisor (s).
• The candidate should include a description of the research conducted during the candidate’s tenure as a postdoc and a detailed description of the research planned during the K22 award. This narrative should also describe what the candidate will accomplish during the K22 award period that will enable her/him to compete successfully for independent research support beyond the K22.

For the NIAID K22 application complete ALL sections the SF 424 Research and Related (R&R) Forms with the following modifications:

• For period of support, indicate the total period of support being requested: 2 years.
• For the project summary, briefly describe the research you propose during the two year K22 award period.
• Follow the budget format instructions as described in Section III of the PHS 398 application.
• The maximum direct cost budget is $150,000 in year 1 and $100,000 in year 2. No detailed budget information is required at the time of application for Phase 1.
• A Budget Justification does not need to be provided at the time of submission of the K22 application.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the Notice). 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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted electronically following the instructions described in the SF 424 (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.

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 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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The objective of the of the NIAID CTA is to support postdoctoral fellows transitioning to positions of assistant professor or equivalent, and initiate a successful biomedical career as an independent research scientist. The K22 award will provide two years of support to conduct research as an independent scientist at an extramural sponsoring institution/organization to which the individual has been recruited, been offered and has accepted a tenure-track full-time assistant professor position (or equivalent). This support is to allow the individual to continue to work toward establishing his/her own independent research program and prepare an application for regular research grant support (R01).

Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Candidate

Does the candidate have the potential for becoming a successful independent investigator who will contribute significantly to a chosen health-related research field? Will the prior research experiences prepare the candidate to transition successfully to an independent research scientist? Do the letters of reference from at least three well-established scientists address the candidate’s potential for becoming an independent investigator?

Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring

What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence? Are the candidate's prior training and research experience appropriate for this award? Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?

Research Plan

Is the proposed research project appropriate for the candidate’s stage of research development and as a vehicle for development of the research skills described in the career development plan? Are the scientific and technical merits of the research question, design, and methodology appropriate in the context of prior training and experience? Is the proposed research relevant to stated career objectives?

Consultant(s), Collaborator(s)

Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration? Have the proposed consultant(s) and collaborator(s) provided evidence of commitment to the candidate and the candidate’s project? Do the proposed consultant(s)/collaborator(s) provide the required expertise for successful conduct of the research project?

What evidence is provided that the candidate's current institution is strongly committed to fostering the candidate s development and transition to become an independent investigator?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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, 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 six 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

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.

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/priority score.

Training in the Responsible Conduct of Research

Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction 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.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s),convened by the NIAID in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all 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/priority score.
• Will receive a written critique.

Applications will be assigned to NIAID. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Councill. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

There will not be a formal Notice of Award (NoA) associated after peer review of K22 applications. NIAID will transmit to the successful candidate an approval letter that will include the terms and conditions of the activation of the NIAID K22 award, as well as expectations for the transition to the independent investigator position.

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. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.

If the candidate receives a fundable overall impact score after the review of the K22 application, s/he will be notified in writing of NIAID's commitment to make an award. The candidate will then have a period of up to 12 months to identify a suitable position as an assistant professor or equivalent at a domestic academic institution and negotiate an acceptable start-up package. As soon as negotiations between the candidate and the institution are complete, the updated information about the K22 application must be submitted.

The sponsoring institution will submit the updated information on behalf of the candidate for the K22 award using the PHS398 Application.

The updated information about the K22 application must include:

• A new face page signed by the sponsoring institutional representative;
• Detailed budget pages for a non-modular budget;
• Budget Justification
• A new Resources page;
• An updated career development plan
• A new checklist.
  

In addition, a letter from the sponsoring Department or Division Chair describing the sponsoring institution’s commitment to the candidate and plans for his/her career development should be submitted (i.e. percent effort, laboratory space , start-up funding; see also below).

These materials should be sent directly to NIAID. The original application plus one copy (preferably in a PDF format) are to be mailed to the NIAID Financial or Grants Management contact person (see below). The updated information about the K22 application will be evaluated by extramural program staff of NIAID for completeness and responsiveness to the program.

An institutional commitment agreement will be required at the time of activation of the K22 award. This agreement should satisfy the criteria described in the Career Development Award Section of the SF424 (R&R) Application Guide.

In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must provide protected research time (minimum of 9 person-months [75% full time professional effort]) at least for the duration of the K22 award. The start-up package and other institutional support must be described and should be comparable to that given to other faculty recently hired into tenure-track or equivalent positions. Institutions must provide a startup and salary package equivalent to that provided to a newly hired faculty member who does not have a grant; K22 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for tenure-track (or equivalent) assistant professors who are hired without grant support. The K22 sponsoring institution should describe the candidate’s academic appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent). The sponsoring institution must foster and support the awardee’s ability to apply for and secure independent research grant (R01) support.

The K22 award requires that a minimum of 9 person-months (75% full time professional effort) be devoted to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the K22 award period. NIH staff may review start-up packages and other commitments between the institution and candidate prior to activating of the K22 award. It is suggested that the applicant and/or the hiring institution discuss the institutional commitment with the relevant NIAID program official prior to submission of the updated information about the K22 application. NIAID will not issue the K22 award if the institutional commitment is deemed inadequate. Applicants who are approved will receive a Notice of Award for the K22 award.

The K22 award is intended to facilitate successful transition to independence. Consequently, a requirement for activation of the K22 award is successful completion of this transition. Applicants are encouraged (but not required) to apply for independent positions at departments and institutions different from where they conducted their postdoctoral research. It is important for all applicants, but especially so for applicants who intend to stay at their postdoctoral institution for the independent phase, to provide a plan by which they will separate from their postdoctoral advisor and advance to independence. Awardees are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of NIAID.

Candidates who are not approved to transition will receive written notification from NIAID communicating the rationale for the disapproval. This letter typically will be sent within 60 days of receipt of the updated information about the K22 application.

Although the financial plans of the NIAID provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed.

A final progress report, 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 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.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Katrin Eichelberg, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-0818
Email: [email protected]

Edward Schroder, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-8537
Email: [email protected]

Chernay Mason
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-2068
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.