Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Eye Institute (NEI)

Funding Opportunity Title

The NEI Mentored Clinical Scientist Development Program Award (K12)

Activity Code

K12 Physician Scientist Award (Program) (PSA)

Announcement Type

Reissue of PAR-09-083

Related Notices

  • 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-12-002

Companion FOA

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.867

FOA Purpose

The goal of this FOA is to expand and strengthen the community of investigators engaged in clinical vision research.  An increase in the number of well-trained clinical researchers is necessary to achieve a pool of scientists with contemporary, multidisciplinary expertise able to leverage recent advances in ocular genetics, therapeutics, bioengineering, and bio-behavioral research in order to enhance patient treatment and to increase scientific momentum in these fields.  The FOA is expected to increase the number and diversity of clinical investigators trained in the sciences relevant to clinical vision research; to facilitate the mentoring of this group of scientists; and to form a robust research community bringing new scientific expertise to address the Nation's biomedical, behavioral, and clinical research needs in vision research.  The FOA is expected to facilitate and support the career development of clinical vision scientists who have made a commitment to independent research careers.

Key Dates
Posted Date

October 13, 2011

Open Date (Earliest Submission Date)

April 14 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

May 14, 2012; 2013; and 2014, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2012, 2013, and 2014

Advisory Council Review

January 2013, 2014, and 2015

Earliest Start Date(s)

April 2013, 2014, and 2015

Expiration Date

May 15, 2014

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 the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, except where 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.


A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://www07.grants.gov/contactus/contactus.jsp.
Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development programs 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 needs.  More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

This FOA encourages applications from organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NEI.

The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.

Purpose:

The purpose of the NEI Mentored Clinical Scientist Development Program Award (K12) is to support the career development of vision clinical scientists who have made a commitment to independent vision research careers. An increase in the number of well-trained researchers is necessary to reach a critical mass of clinical scientists capable of translating recent basic science advances in order to enhance patient treatment and to advance scientific momentum in the field.  The objectives of this FOA are to 1) increase the number of clinical investigators who are trained in vision sciences research, 2) facilitate and improve the mentoring of this new group of clinician scientists, and 3) bring new scientific expertise to vision related research.  The expected outcomes of this Initiative will be 1) an increase in the number of clinician scientist research leaders who will apply for and obtain independent funding support, and 2) an increased number of multidisciplinary research teams led by junior investigators or investigators new to vision research related fields.  These new teams will form a robust research community applying novel approaches to vision research that will enhance our understanding of the visual disorders and lead to effective new treatments for patients.  These new teams will thrive in academic research centers that foster an environment for developing new collaborative, multidisciplinary, and interdisciplinary clinician scientists with skills and expertise that can be applied to the most intractable topics in vision research.

Background:

Eye disease is a major public health problem in the United States, causing significant suffering, disability, loss of productivity, and diminished quality of life for Americans.  Conditions such as dry eye, diabetic retinopathy, age-related macular degeneration, amblyopia, glaucoma, myopia, strabismus, and cataract affect over 150 million people in the US.  And the economic impact of visual disorders and disabilities is over $40 billion each year.

The NEI has supported the highest-quality laboratory and clinical research aimed at increasing our understanding of the eye and visual system in both health and disease.  While there has been tremendous progress over the last three decades, the means to prevent or successfully treat some of the most devastating eye diseases are still elusive.  Inherent in the NEI mission is the application of knowledge gained through research to benefit those who suffer from diseases of the eye and disorders of vision.  Because such translational research focuses on preventing disease and developing new treatments and diagnoses for disease, the scientific principles on which it is based may vary in depth.  Thus, a collaboration between basic scientists and clinicians is essential for more rapid translational accomplishments.

Scope of the problem:

The NEI National Plan for Eye and Vision Research, see http://www.nei.nih.gov/strategicplanning/national_plan.asp, calls for strengthening the pipeline of clinical researchers dedicated to vision research.  Integral to this goal, this FOA seeks (1) Program Directors/Principal Investigators (PD/PIs) with a strong history of training program development and administration, a superior record of preparation of scholars for independent research, proven mentoring skills, leadership, and scientific expertise required to coordinate and supervise multidisciplinary research and career development programs; and (2) mentors who will interact closely with and who will be dedicated to the development of a group of new scholars/investigators throughout their training in an institutional career development program.  The scholars in this program should be junior investigators contemplating a career in clinical vision research who show promise of becoming independent principal investigators, managing their own multidisciplinary research group, and obtaining independent funding for vision research.

This FOA specifically seeks mentor teams of individuals with a strong background in vision research and individuals with expertise in complementary scientific areas, such as molecular/cellular biology, genetics/genomics, computational biology, bioengineering and bio-behavioral research, and other relevant areas. Mentorship teams composed of faculty from broader academic health centers are encouraged. Mentors must have a demonstrated commitment to, and experience in, mentoring postdoctoral fellows and junior faculty. The mentors will lead by example in fostering an environment of multi-disciplinary research for the scholar. Strong institutional support for such a mentoring program is paramount.  It is expected that individuals appointed to the program will subsequently apply for their own Mentored Clinical Scientist Development Award (K08), the Mentored Patient-Oriented Career Development Award (K23), or a Research Project Grant (R01), to continue their research training (see “Research Career Objectives”).  The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
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

Application budgets need to reflect actual needs of the proposed project.  Total Direct Costs are limited to $1,125,000 per year.

Award Project Period

The scope of the proposed project should determine the project period.  The maximum period is five years.

Other Award Budget Information
Personnel Costs

Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program.  Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap.  If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds. Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles.  For institutions covered by OMB Circular A-21, this type of training program may qualify as a “major project” where administrative salaries are allowable as a direct cost.  When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.

The PI(s)/PD(s) may request up to a maximum of 0.6 person months of salary and fringe benefits per year for the duration of the program, regardless of whether the PD(s)/PI(s) is also a mentor.  The responsibilities of the PD(s)/PI(s) include program development, implementation, management, reporting, outreach, and recruitment of Scholars, curriculum development, and evaluation.

No funds may be requested for salary support of mentors.   

Participant Costs

Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program.  Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds.  These expenses must be itemized in the proposed budget.  It should be noted that the NEI does not impose any salary restriction beyond that imposed legislatively.  The institution may supplement the NEI contribution; however, supplementation may not be from Public Health Service funds.  Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award.  The total salary requested must be based on a full-time, 12 month staff appointment for at least 75% effort.

Other Program Related Expenses

Up to $30,000 per candidate may be requested for the following types of expenses:  consultant costs, research supplies, equipment, and technical personnel; tuition, fees, and books related to didactic courses or career development; travel for key personnel to attend research meetings or training; and statistical services including personnel and computer time.  These costs must be justified as specifically required for each proposed candidate and must be specifically and directly related to the candidate's research activities and individualized career development program.   Costs cannot be pooled and used for advertising, recruitment, or other programs unrelated or indirectly related to the research activities of individual candidates or appointees.  These expenses must not duplicate items generally available at the applicant institution.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

Governments

Other

 Foreign Institutions

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.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

The applicant institution must have a strong and high quality research programs in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals. Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs.

Required Registrations

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.

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.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) 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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD(s)/PI(s) should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. 

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number of NIH IPF number) is allowed.  NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Mentors

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Each candidate appointed in the program must have a primary or lead mentor who is recognized as an accomplished investigator, is actively involved in basic or clinical research, and has a successful record of providing the type of training required under this award.  The primary mentor will assist the scholar in developing an individualized career plan based on the candidate's research experience.  For example, a candidate with limited research experience would require a structured, phased developmental program, including a block of time devoted to didactic training followed by a period of mentored research.  Because a critically important aspect of the training should include mentoring in grant writing, and because scholars are expected to apply for independent grants, the lead mentor should also have a strong track record in obtaining NIH funding for research.  If the primary mentor's research funds come primarily from outside the NIH system, scholars should have a co-mentor with a strong history of NIH support.

Participants

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended.  Appointees must hold a clinical doctorate (such as DO, DVM, MD, MD/PhD, OD, or PhD) and must have completed their clinical training (i.e., completed residency/fellowship and are board-eligible).  Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award, with the remainder devoted to developing other clinical and teaching pursuits consonant with the objectives of the award.

Details on citizenship requirements are available in the NIH Grants Policy Statement.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Required and Optional Components

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.

Page Limitations

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

SF424 (R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) with the following modification:

Project Summary /Abstract

Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements of the career development plan, and brief descriptions of planned research training program. Include the rationale and design of the program, the planned duration and projected number of scholars, including their levels (i.e., predoctoral, postdoctoral, faculty).

Advisory Committee (Uploaded via the Other Attachments section)

A plan must be provided for the appointment of an Advisory Committee to monitor progress.  Composition, responsibilities, frequency of meetings, and other relevant information should be included.  Describe the composition of the Advisory Committee, identifying the role and the desired expertise of members.  A plan for Advisory Committee approval and selection of participants should be included.  Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program.  Note that Advisory Committee members should not be named in the application, particularly if they include individuals from outside the institution.  Please name your file “Advisory_Committee.pdf”

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

SF 424(R&R) Senior/Key Person Profile Expanded Component PHS398 Cover Page Supplement, PHS398 Checklist, PHS398 Training Subaward Budget Attachment(s) Form

Research and Related (R&R) Budget Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

PHS 398 Research Training Program Plan

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the additional instructions described below:

Program Administration (Component of Program Plan)

Describe the acknowledged strengths, leadership and administrative skills, and scientific expertise of the Training PD(s)/PI(s). Include active research and the planned strategy and administrative structure to be used to oversee and monitor the program. For applications with multiple PD(s)/PI(s), address the Leadership Plan and how the combined knowledge, skills and experience of the individual PD(s)/PI(s) will enhance the likelihood of success of the program. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Program Faculty (Component of Program Plan)

Describe the complementary expertise and experiences of the proposed mentors for the scholars. Include active research and other scholarly activities in which the mentors are engaged, as well as track records of mentoring and training.

Proposed Training (Component of Program Plan)

Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including training or career development activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities. Institutions with existing training or career development programs must explain what distinguishes this application from the others, how the programs will synergize, if applicable, and make it clear that the faculty, potential scholars, and resources are robust enough to support additional programs. The description should include planned strategies to be used to ensure that the objectives are met. The Training PD(s)/PI(s) should also describe past research career development activities/experiences including those of mentors, documenting the success of former scholars in establishing independent productive scientific careers. 

Program Evaluation (Component of Program Plan)

Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing scholars’ career development and progression, including metrics such as degree completion (if applicable), publications, and subsequent positions. Specified evaluation metrics should be tied to the goals of the program. Evaluation results should be included in future competing continuation (renewal) applications and as part of the Final Progress Report.

Trainee Candidates (Component of Program Plan)

Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective scholars. Describe plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the criteria to be used for candidate evaluation in the selection of scholars. Provide brief summaries of training plans that the program will employ. The application should contain a description of how training plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences, and should distinguish the plan from fellowship training.

Institutional Environment and Commitment to the Program (Component of Program Plan)

The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PD(s)/PI(s), other faculty and mentors, and the required protected time for scholars (9 person months, equivalent to 75%) selected for the program.

Recruitment and Retention Plan to Enhance Diversity

Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide. 

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide. 

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.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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.

In order to expedite review, applicants are requested to notify the NEI Referral Officer by email at {esl@nei.nih.gov} when the application has been submitted.  Please include the FOA number and title, PD(s)/PI(s) name, and title of the application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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.

Career Development Program and Environment

Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers?  Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support? Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate?  Are appropriate timelines indicated for career progression and transition to independence?  Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success?  Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is the institutional commitment to the proposed program appropriate?  If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?  Is there sufficient assurance that the required effort of the PD(s)/PI(s), mentors and scholars will be devoted directly to the research training, career development, and related activities?  When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

Do the PD(s)/PI(s) and Research Administrator (if applicable), have the experience to develop, direct and administer the proposed program?  Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives? Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program? Are the PD(s)/PI(s) currently engaged in vision research relevant to the scientific area of the proposed program?

Mentors

Do the mentors have expertise and experience in vision research, as well as track records of past mentoring and training? Are the quality and extent of the mentors’ roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?

Candidates/Scholars

Is a recruitment plan proposed with strategies likely to attract high quality scholar candidates? Are there well-defined and well justified recruitment and selection strategies? Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of career development program?   Is there an appropriate plan for the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates? What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars? Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?

Training Record

Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?  Is there evidence that the program has produced clinician scientists who are pursing vision research with independent funding? 

Additional Review Criteria

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

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Inclusion of Women, Minorities, and Children 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

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

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment and Retention Plan to Enhance Diversity, and Training in the Responsible Conduct of Research.  Does the application describe the program’s accomplishments over the past funding period(s)?  Are changes proposed that would improve or strengthen the career development experience?  Is there evidence of a successful past training record of the PD(s)/PI(s) and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers?

Revisions

Not Applicable.

Additional Review Considerations

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.

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. The review panel’s evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the career development program, level of scholar experience, and the particular circumstances of the scholars, 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 how faculty will participate in the instruction?  Does the plan meet the minimum requirements for the Responsible Conduct of Research, 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).

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NEI, 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:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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.

2. Administrative and National Policy Requirements

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

The Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Other Reporting Requirements

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.

4. Evaluation

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.

Within ten years of making awards under this program, NIH will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program.  Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program. 

Evaluation will be based on the following criteria:

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Scientific/Research Contact(s)

Neeraj Agarwal, Ph.D.
Training Director
Division of Extramural Research
National Eye Institute
Suite 1300, 5635 Fishers Lane
Bethesda, MD  20892-9300
Telephone:  301-451-2020
Fax:  301-402-0528
Email: agarwalnee@mail.nih.gov

Peer Review Contact(s)

Annie E. Schaffner, Ph.D.
Chief, Scientific Review Branch
Division of Extramural Research
National Eye Institute
Suite 1300, 5635 Fishers Lane
Bethesda, MD  20892-9300
Telephone:  301-451-2020
Fax:  301-402-0528
Email: aes@nei.nih.gov

Financial/Grants Management Contact(s)

William W. Darby
Chief, Grants Management Branch
Division of Extramural Research
National Eye Institute
Suite 1300, 5635 Fishers Lane
Bethesda, MD  20892-9300
Telephone:  301-451-2020
Fax:  301-496-9997
Email: darbyw@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.