Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP) National Center for Research Resources (NCRR) (IC removed per NOT-OD-12-059)
Funding Opportunity Title	Midcareer Investigator Award in Mouse Pathobiology and Comprehensive Phenotyping Research (K26)
Activity Code	K26 Midcareer Investigator Award in Biomedical and Behavioral Research
Announcement Type	Reissue of PAR-09-053
Related Notices	September 19, 2012 - The purpose of this notice is to expire PAR-12-021. See Notice NOT-OD-12-156. March 1, 2012 - See Notice NOT-OD-12-059. Notice of Change in Participation of NIH Institutes and Centers.
Funding Opportunity Announcement (FOA) Number	PAR-12-021
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.351
FOA Purpose	This Funding Opportunity Announcement (FOA), using The Midcareer Investigator Award in Mouse Pathobiology and Comprehensive Phenotyping Research Award (K26) issued by NCRR, NIH, seeks to support established, outstanding scientists by providing protected time for mouse pathobiology research and comprehensive phenotyping of genetically modified mice as well as mentoring of junior investigators, thus relieving them of time-consuming institutional service obligations and administrative responsibilities.

Posted Date	November 17, 2011
Open Date (Earliest Submission Date)	January 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)	Not Applicable
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	September 21, 2012 per NOT-OD-12-156 (Original Date: January 8, 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, especially 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 are 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.

Research Career Objectives

This ongoing Funding Opportunity Announcement (FOA) for the Midcareer Investigator Award in Mouse Pathobiology Research (K26) is being reissued under the new title, Midcareer Investigator Award in Mouse Pathobiology and Comprehensive Phenotyping Research. This FOA replaces PAR-09-053, which was published December 17, 2008.

The NIH continues to be interested in increasing the number of scientists trained to conduct high-quality mouse pathobiology and comprehensive phenotyping research.

This initiative was launched originally in response to recommendations established at the NIH meeting on "Priority Setting for Mouse Genomics and Genetics Resources," (http://www.nih.gov/about/director/reports/mgenome.htm) to increasing pressures created by the growing number of genetically-altered mice being used by the biomedical research community, and to burgeoning opportunities for mouse pathobiologists in the biomedical research environment.

Pathobiology in the context of this funding opportunity is defined as the study of the essential nature of disease, especially of the changes in body tissues and organs that cause or are caused by disease or genetic manipulation, with greater emphasis on the biological than on the medical aspects. From a practical point of view mouse pathobiology represents a unique primary screen that requires labor-intensive analysis by the expert with detailed knowledge of laboratory mouse anatomy, physiology and genetics.

Over the past five years, large scale projects involving genetically-modified mice have been funded that require comprehensive analysis of mutant mouse phenotypes, including but not limited to clinical pathology, behavior studies, sensorimotor and immune function and morphological parameters together with other physiological functions. Among those projects are large-scale chemical mutagenesis projects, the Collaborative Cross initiative and the Knockout Mouse Repository and Phenotyping Projects (KOMP and KOMP2). The vision of KOMP2, is to provide phenotypic information on a knockout mouse line from every gene in the mouse genome. KOMP is currently on target to complete the goal of producing 8,500 knockout mutant embryonic stem (ES) cell lines by the end of 2011. In parallel, the European Conditional Mouse Mutagenesis Program (EuCOMM) and the North American Conditional Mouse Mutagenesis Program (NorCOMM) are on track to complete their goals of producing an additional 9,000 knockout mice by the end of 2011. The three programs will thus produce a comprehensive resource of mutant mouse ES cell lines. They have coordinated their efforts through the formation of the International Knockout Mouse Consortium (IKMC) (http://www.knockoutmouse.org/).

The next steps in this project will focus on phenotyping. The NIH held a KOMP Phenotyping Conference in Bethesda, MD in October 2009, at which a group of researchers representing diverse scientific backgrounds expressed their unanimous enthusiasm and support for a proposed effort to conduct high-throughput and comprehensive phenotyping of the resource being produced by the members of the IKMC (meeting report available at www.komp.org). The phenotyping data would be rapidly and freely released to the public, with mice being archived for distribution to the biomedical community for research investigations. These recommendations were highly similar to those that have come from other efforts to solicit input from the US national research community.

Planning activities for the KOMP2 were held in 2010 and the KOMP program will began in September 2011. It is clear that there is a need to develop more comprehensive phenotyping expertise as well as challenge tests at the high throughput level to uncover clinically relevant and biologically significant phenotypes. The shortage of the pathobiologists and researchers capable of conducting comprehensive phenotyping of laboratory mice remains an obstacle to the continued progress of utilizing genetically-engineered rodent models.

The goal of this FOA is to support established, outstanding pathobiologists by providing protected time for mouse pathobiology and comprehensive phenotyping research as well as mentoring of junior investigators, thus increasing the number of future qualified pathobiologists.

The target candidates are scientists engaged in mouse pathobiology research and phenotyping who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers, and commitment to mentoring the next generation of mouse pathobiologists.

The Midcareer Investigator Award in Mouse Pathobiology and Comprehensive Phenotyping Research is intended for experienced, midcareer scientists with objectives to:

1. Provide protected time for intensive, focused mouse pathobiology research and comprehensive phenotyping by relieving these investigators from time-consuming institutional service; this protected time will advance their skills in such areas conducting independent biomedical research.

2. Increase their mentoring of junior investigators in mouse pathobiology and comprehensive phenotyping to build up the pool of skilled mouse investigators who can fill the growing need for trained professionals, and to contribute in the exciting discoveries being made using genetically-altered mice for biomedical research.

3. Conduct state-of-the-art biomedical research in mouse pathobiology and comprehensive phenotyping. This Award will enable candidates holding a Doctor of Veterinary Medicine, a qualified Doctor Medical Degree or Doctor of Philosophy (see ELIGIBILITY REQUIREMENTS below) to undertake a minimum of three and up to five years to conduct enhanced mouse pathobiology and phenotyping research, thereby further developing their research skills, devoting significant time to mouse pathobiology and phenotyping research, and acting as mentors and role models for junior investigators.

The prospective candidate for the Midcareer Investigator Award in Mouse Pathobiology Research should propose a period of research consistent with his/her research and/or clinical experience and with the proposed further development of his/her research skills. The proposed program should be tailored carefully to meet the individual needs of the candidate and must include a description of meritorious past research projects that meet the definition of mouse pathobiology research and comprehensive phenotyping. In addition, the candidate should have a demonstrated record of mentoring and should describe mentoring activities that will involve pathobiology and phenotyping investigators who have little or no research experience. The trainees will be exposed to comprehensive mouse pathobiology through hands-on training in diverse biomedical disciplines and supervised interaction with principal investigator. They eventually will become skilled mouse investigators who can fill the growing need for such professionals.

At the time of application, the candidate should have a demonstrated record of significant, ongoing peer-reviewed research support in the field of mouse pathobiology and/or comprehensive phenotyping, either as a Principal Investigator or co-investigator.

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 5 years.

Salary	NIH will contribute for up to 50% effort at the current NIH extramural salary cap in FY2011 $199,700 per annum; i.e., a maximum of $99,850 for 50% of effort, 6 person months) 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	The NCRR will provide generally up to $25,000 per year for the following expenses: (a) research expenses, such as supplies, equipment and technical personnel for the principal investigator and his/her mentored investigators; (b) travel to research meetings or training courses; and c) statistical services including personnel and computer time. 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 grants 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

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 Director(s)/Principal Investigator(s) (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 four (4) 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(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 PD(s)/PI(s) 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)

Degree and Research: Most candidates for this award will have a Doctor of Veterinary Medicine degree (or equivalent) from an institution recognized by the American Veterinary Medical Association (AVMA). In addition, individuals holding other clinical (such as the MD) or research (such as the PhD) degree(s) may apply for the award if they have been certified or have demonstrated the necessary expertise to perform high quality, funded research in mouse pathobiology and comprehensive phenotyping. Candidates must have completed their specialty or research training within 15 years of submitting the application, and there is no age limit for candidates. In exceptional circumstances, the period of eligibility may be extended if it can be demonstrated that candidates had an interruption in their career progression due to family or personal circumstances.

Candidates must be working in a research environment, conducting mouse pathobiology and comprehensive phenotyping research, and have significant peer reviewed research support. This support can be as a principal or co-investigator, and needs to involve a significant project with biomedical relevance.

Effort and Other Support: Candidates must be willing to spend a minimum of 3 person months (25% full-time professional effort) up to 6 person months (50% full-time professional effort) conducting mouse pathobiology research and mentoring. Candidates must describe a research and mentoring program that will meet their individual needs and capabilities.

A candidate for the Midcareer Investigator Award in Mouse Pathobiology and Comprehensive Phenotyping Research (K26) may not concurrently apply for any other PHS award that duplicates the provisions of this award. Recipients of this award are required to hold independent research support as PD(s)/PI(s), either Federal or private, during the whole period of this award.

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. Applicants should not submit more than one application, unless the combined effort two K26 applications do not exceed 50% effort (6 person months), and each application is scientifically distinct and provides appropriate mentoring.

Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

Candidates must be willing to spend up to a minimum of 3 person months (25% full-time professional effort) up to 6 person months (50% full-time professional effort) conducting mouse pathobiology research and mentoring. Candidates must describe a research and mentoring program that will meet their individual needs and capabilities.

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)

• Evidence of the candidate's ability to conduct high-quality mouse pathobiology and comprehensive phenotyping research.
• A description of his or her immediate and long-term career objectives, explaining how the award will contribute to their attainment.
• A description of how the candidate will use the relief from institutional service or administrative duties to expand his or her expertise in mouse pathobiological and comprehensive phenotyping research.
• A description with evidence of the candidate's commitment to a career in mouse pathobiology and comprehensive phenotyping research.
• This description of the candidate should not exceed three pages of the 12-page limit. One page should be devoted to the candidate's background (high quality mouse research), and two pages to the candidate's immediate and long-term career goal and commitment to a career in mouse pathobiology and comprehensive phenotyping research.

Career Goals and Objectives (Component of Candidate Information)

• Describe the candidate’s career goals and objectives under this award, including prior experience, and current research support.

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.

Applications must include a description of a plan for instruction in responsible conduct of research. This section should document prior instruction in or the nature of the applicants participation in responsible conduct of research instruction (lecturer, discussion leader, etc.) during the applicants current career stage (including the date of last occurrence) and propose plans to participate in instruction in responsible conduct of research. Such plans must address four instructional components (format, subject matter, duration of participation, and frequency of participation), as outlined and explained in NOT-OD-10-019. The plan may include career stage-appropriate, independent scholarly activities that will enhance the applicants understanding of ethical issues related to their specific research activities and the societal impact of that research. Applications lacking a plan for participation or instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.

Mentoring Plan (Component of Candidate Information)

• This required component should include a description of the availability of appropriate beginning investigators (e.g. graduate students, residents, post-doctoral fellows, visiting scientists) for mentoring; their previous training and specialization; plans for recruitment, selection and supervision; the types of educational and research experiences that will be provided; and the capacity in which the candidate for the career award will serve as a mentor.
• A demonstrated record of mentoring or training beginning investigators (e.g., graduate students, residents, post-doctoral fellows, visiting scientists) or a demonstration of the capability to provide mentoring to beginning investigators.
• A description of plans for providing mentoring opportunities to beginning investigators, including a description of the types of investigators that could be mentored, plans for recruiting and selecting such individuals, and the training and educational experiences to be provided.
• This description of the mentoring plan should not exceed two to three pages. Approximately one page should be devoted to previous mentoring or training of beginning investigators, and one to two pages should describe the plans for identifying, training and mentoring the next generation of mouse reseachers.

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

• Describe the sponsoring institution’s scientific environment including the resources and facilities that will be available to the candidate.
• The sponsoring institution must document a strong, well-established mouse pathobiology and comprehensive phenotyping research and training program related to the candidate's area of interest including a high-quality research environment.

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

• The sponsoring institution must provide a statement of commitment to enhancing the candidate's ability as a productive, independent investigator.
• The sponsoring institution must provide documentation that the candidate will be relieved from other duties, i.e. animal care, facility management, administrative, etc., to allow him/her to devote time to the mouse pathobiology research program.
• Provide assurances that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be provided.

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 research.
• A description of the candidate’s ongoing mouse pathobiology and/or comprehensive phenotyping research. The research plan should (briefly) describe the specific aims, background and significance, and the Approach of the study. Emphasis should be given to the initial three years of the award.
• This description of the research plan should not exceed 6 to 8 pages of the 12-page limit that includes the description of the candidate, and the mentoring plan. One page should be devoted to the state the hypothesis and specific aims; one to two pages should state the background, significance, and the rationale; and one to two pages should summarize previous studies and their results.
• Documentation that appropriate and adequate resources, both in terms of support and facilities are available to the candidate, to conduct the research program. This must include a description of other monetary support that will be utilized to conduct the research program.
• Statement of Support

Statement by Consultants, Contributors (All statements/letters should be appended to each other and uploaded as a single pdf document):

• Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided that clearly documents expertise in the proposed area(s) of consulting/collaboration.

Appendix

No appendix is allowed.

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(s)/PI(s) 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.

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

Is there evidence of the candidate s capabilities and commitment to serve as a mentor for new investigators in the conduct of mouse pathobiology and comprehensive phenotyping-oriented research? Is there evidence of ongoing high-quality mouse pathobiology and/or comprehensive phenotyping research? Does the application demonstrate that the proposed program and protected time will relieve the candidate from non-research institutional service and administrative duties and allow him/her to devote additional time and augment his/her capabilities in mouse pathobiology and comprehensive phenotyping research? Does the application demonstrate a record of independent peer-reviewed support for mouse pathobiology and comprehensive phenotyping research that is likely to continue during the K26 award?

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

What is the likelihood that the award will contribute substantially to the continued scientific development and productivity of the candidate? Are the career goals and objectives consistent with the candidate s career goals? Is there evidence that the award will enable the candidate to devote full time (at least the required minimum percentage of full-time professional effort) to research and related duties by release from teaching, administration, clinical work, and other responsibilities? Are the plans to provide mentoring or supervising beginning investigators, undergraduates, graduate students, residents, junior professionals, and/or visiting scientists in mouse pathobiology and phenotyping oriented research adequate? Is an appropriate level of effort proposed for the mentoring component?

Not Applicable Consultant(s), Collaborator(s)

Are the proposed collaborations with other active investigators and other opportunities for professional growth appropriate and of high quality? Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?

Environment & Institutional Commitment to the Candidate

Is the level of the applicant institution’s commitment to the scientific development of the candidate appropriate? Is the level of assurance from the institution that they intend the candidate to be an integral part of its pathobiology and comprehensive phenotyping research program adequate? Are the research facilities, resources and educational opportunities available to the candidate appropriate and adequate? Are the size and quality of the pool of investigators to be mentored by the PD(s)/PI(s) adequate? Are the quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing pathobiology and comprehensive phenotyping research appropriate and adequate? Is the commitment from the sponsoring institution to provide protected time for the candidate to conduct the research program adequate?

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 the more senior level of experience of candidates for this award, 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 that the candidate will participate in? 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 candidate’s role in the participation in instruction in RCR? 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) appropriateScientific Review Group(s) convened by the National Center for Research Resources, 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:

• Mayl 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 compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Research Council (NCRR). 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.
• Relevance of the proposed career development program, prior training and commitment of the applicant to becoming an independent researcher.

After the peer review of the application is completed, the PD(s)/PI(s) 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.

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.

Consultation with the applicable NCRR program staff is strongly encouraged when either termination or a change of institution is being considered.

A change of grantee request normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PD(s)/PI(s) plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the awardee is moving to another eligible institution, career award support may be continued provided:

A relinquishing statement is submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review by NCRR staff.

The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program, and that a new sponsor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee's research program.

All conditions of the award are met at the new institution.

The period of support requested is no more than the time remaining within the existing award

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the NoA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision period.

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. Accordingly, recipients are hereby notified that they 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.

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.

Evaluation of the awardee’s progress will encompass the following:

• A description of how the K26 award has contributed to the recipient’s immediate and long-term career objectives.
• Updated listing of active and pending research support using the OTHER SUPPORT pages from PHS Form 398. Clearly denote the recipient’s role in each of these grants or projects. Asterisk those active/pending sources of support that are a result of the protected time provided by the K26 award. Describe plans for obtaining mouse pathobiology and phenotyping oriented research support during the next funding period.
• A description of the research activities conducted during the reporting period. This description should clearly distinguish research activities utilizing the protected time provided by the K26 award from other research activities.
• A description of the mentoring activities during the prior award period directly resulting from the protected time provided by the K26 award. Include the names of the individuals mentored; degree(s), professional specialty(ies) and staff positions; publications resulting directly from the K26-supported mentoring; current positions; and mentoring activities for each of these individuals.
• Describe plans for mentoring new mouse pathobiology and phenotyping oriented research oriented investigators during the next funding period.

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.

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]

Oleg Mirochnitchenko, Ph.D.
Division of Comparative Medicine
National Center for Research Resources
6701 Democracy Boulevard
Bethesda, MD 20892-4874
Telephone: (301) 435-0744
FAX: (301) 480-3819
Email: [email protected]

Sheri Hild, Ph.D.
Scientific Review Officer
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Blvd., Room 1082
Bethesda, MD 20892-4874
Courier service zip code 20817
301-435-0810 (direct line)
301-435-0811 (Office of Review)
301-480-3660 (fax)
http://www.ncrr.nih.gov

Courtney Tardd-Wright
Grants Management Specialist
NIH, NCRR
6701 Democracy Blvd., Rm. 1041
Bethesda, MD 20892-8502
Phone: (301) 496-9441
Fax: (301) 480-3777
[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.