Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
 

Components of Participating Organizations

National Institute on Aging (NIA)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Paul B. Beeson Patient-Oriented Research Career Development Award in Aging (K23)

Activity Code

K23 Mentored Patient-Oriented Research Career Development Award

Announcement Type

Reissue of RFA-AG-12-004

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-AG-13-012

Companion Funding Opportunity

RFA-AG-13-011, Paul B. Beeson Clinical Scientist Development Award in Aging (K08) 

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.866, 93.853

Funding Opportunity Purpose

The National Institute on Aging (NIA),working in part with funds contributed by the John A. Hartford Foundation (http://www.jhartfound.org/)and The American Federation for Aging Research (http://afar.org/), are pursuing this initiative to encourage and assist the development of future leaders in the field of aging by supporting clinically trained (primarily physician) faculty members early in their careers to gain additional research training and to establish independent programs in aging research.

Key Dates
Posted Date

October 3, 2012

Open Date (Earliest Submission Date)

November 6, 2012

Letter of Intent Due Date

November 6, 2012

Application Due Date(s)

December 6, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2013 

Advisory Council Review

May 2013

Earliest Start Date(s)

July 2013

Expiration Date

December 7, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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 program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career Development programs may be found at the NIH Extramural Training Mechanisms website.

1. Research Career Objectives

The National Institute on Aging (NIA), working in part with funds contributed by the John A. Hartford Foundation (http://www.jhartfound.org/), and The American Federation for Aging Research (http://afar.org/), are pursuing this initiative to sustain and promote the research careers of clinically trained individuals who are pursuing research careers in aging. The numbers of physicians and other clinically trained individuals who are committing to and sustaining independent research careers in the biomedical sciences remain inadequate to address the opportunities for translational research, interdisciplinary collaboration, and groundbreaking basic research being generated by advances in genetics, biomedical engineering, and other life sciences. Within the field of aging research the small numbers of individuals receiving training in geriatrics, and the smaller numbers pursuing research on aging remain inadequate to address the burgeoning needs of the rapidly growing older population. These needs require a substantial investment in current and future faculty who will devote their careers to advancing knowledge of effective prevention and management of illness and disabilities, and to inspire successive generations to do the same.

The program is named after Dr. Paul B. Beeson who profoundly influenced the career paths of many physicians, including several who now form the core leadership in geriatric medicine. Dr. Beeson was Chairman of Medicine at Emory and Yale Medical Schools, Nuffield Professor at Oxford University and Professor and distinguished VA Physician at the University of Washington. He chaired the first Institute of Medicine study on "Aging and Medical Education" in 1978. His leadership as an editor of the Cecil Textbook of Medicine greatly influenced medical education. From his research and patient care base, he grew increasingly interested in the process of aging, and this interest led to a commitment that included his editorship of the Journal of the American Geriatrics Society. Dr. Beeson died in August 2006 at the age of 97.

The aims of the Paul B. Beeson Career Development Awards in Aging (BCDA) program are:

Clinically relevant research on aging, as broadly defined, includes maintenance of health and independence in old age; diseases and disabilities of old age; issues in clinical management and systems of care for the elderly; and research where there is apparent clinical relevance e.g., the use of animal models of disease. Overall, the program will foster the independent research careers of clinically trained investigators whose research will enhance overall health and quality of life of Americans, particularly older people.

2. Program

The objective of the NIH Mentored Patient-Oriented Research Career Development Award (K23) program is to provide salary and research support for a sustained period of “protected time” (3-5 years) to ensure a future cadre of well-trained scientists working in Patient-Oriented Research (POR). The K23 award is expected to help research-oriented clinicians to develop research skills and gain experience in advanced methods and experimental approaches needed to become an independent investigator conducting POR. Clinicians investigating clinically relevant research, broadly defined as work in the basic sciences including animal models of aging, or the use of secondary data analyses where there is apparent clinical relevance should refer to the companion RFA: Paul B. Beeson Clinical Scientist Development Award in Aging (K08) RFA-AG-13-011.

For the purposes of the K23 award, Patient-Oriented Research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes: 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials; and 4) the development of new technologies. Studies falling under Exemption 4 for human subjects research are not included in this definition. See also the NIH Directors Panel on Clinical Research Report.

Other examples include but are not limited to:

Additional information on research programs supported by the NIA can be found at http://www.nia.nih.gov/research.

K23 candidates (applicant, i.e., PD/PI) must hold a doctoral degree, and must commit a minimum of 9 person-months (75% of full-time professional effort) conducting research and relevant career development activities during the period of the award. The sponsoring institution must demonstrate a commitment to provide the environment, resources and the protected time required for the candidate to perform the activities included in the proposed research and career development plans. Each Research Career Development Award must be tailored to meet the individual needs of the candidate.

The BCDA provides support to clinically trained faculty members in strong research environments to enable them to gain skills and experience in clinically relevant aging research and to establish an independent program of research in these fields. K23 candidates must identify a mentor(s)who is a senior researcher in aging and/or geriatrics and who agrees to commit time to supervising and guiding the candidate during the period of the award.

The BCDA is intended to provide l candidates with the resources and time to establish themselves as independent and funded investigators whose research focuses on topics in aging. It is targeted primarily at individuals who have had some prior training in research coursework, methods, and resources related to aging and who have received initial funding for research such as through Small Grant support from the NIH, through similar support from other federal agencies, or through foundation funding. As a career development award it will allow the candidate time to expand his/her research training as well as pursue activities consistent with the expectation of future leadership in the candidate’s chosen field. These activities may include symposia, workshops or other activities in which the candidate has played a leading role in enhancing her/his fields’ academic medical/health and research accomplishments and visibility. The candidates’ career development plan should reflect a detailed strategy to advance both the research training and leadership goals of the BCDA.

Relatively junior candidates (who have not yet received initial research support) may apply if they have shown clear evidence of early leadership potential through academic honors and awards and early research accomplishment. The career development plan should be tailored to the candidate’s particular career goals, current level of experience, and the environment (including mentors) in which the candidate’s career development will take place. Junior candidates with limited prior research training and research experience and more advanced candidates who are changing or expanding research areas will more likely need longer periods of support on the BCDA, and more didactic coursework and guided research experiences than those with more research training and experience in their proposed field of study. More advanced candidates who are now expanding their prior research efforts within their chosen field of study and transitioning to full independence should clearly state their specific career goals and how these goals will be realized through the proposed program of career development under this award. For all candidates, it is particularly important to show those career development activities that are essential to advance to independence, that complement the research planned, and that could not be accomplished through research support alone. Similarly it is important to show that the mentoring available through this award will clearly benefit the candidate’s emergence as a leading researcher in his/her chosen field.

All candidates and their primary mentors should commit to attending one of the annual Beeson meetings as a condition of accepting a BCDA. Annual meetings are a valuable forum for scientific and professional networking opportunities for current Beeson awardees, Beeson alumni and mentors. (Applicants should budget funds for travel to and from the meeting, the location of which will vary from year to year.)

To accommodate these differences in prior experience or intended direction the initial BCDA may be from three to five years. The candidate’s program must be tailored to his/her individual needs and ensure that the candidate will gain the experience, knowledge and skills necessary to carry out high quality clinically relevant aging research. The candidate and the selected mentor(s) are jointly responsible for the preparation of the plan for this program.

The candidate may devote the remainder of his/her effort to activities that are consistent with the purpose of the award and which allow him/her to develop the necessary experience, knowledge and skills to become an independent researcher in a clinically relevant field of aging. The BCDA program allows support for the candidate’s salary, fringe benefits, and research/research development expenses to be used for research and training.

The proposed training and research must focus on aging or the aged. For this FOA, the candidate’s project may be in any of a broad range of patient-oriented research areas relevant to aging. The full range of research methods appropriate to completing the proposed investigation is encouraged provided that the application makes clear the clinical relevance of the proposed work.  We expect that BCDA scholars will contribute significantly to the research and scientific literature associated with the field of aging research.

Mentor(s): The candidate must name a primary mentor, who together with the candidate is responsible for the planning, direction, and execution of the program. Mentor(s) will also be responsible for providing an annual evaluation of the candidate's progress (as required) in the awardees' annual progress report. The mentor should be an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. The candidate may also nominate co-mentors as appropriate to the goals of the program. It is important that research expertise in the fields of aging and an appropriate funding history of support for aging research be well-represented among the mentors. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.

Primary mentors should commit to attending one of the annual Beeson meetings with the awardee as a condition of accepting a BCDA. Annual meetings are a valuable forum for scientific and professional networking opportunities for current Beeson awardees, Beeson alumni and mentors. (Applicantsshould budget funds for  travel to and from the meeting, the location of which will vary from year to year).

Environment: The sponsoring applicant institution must have a well-established research and clinical career development program with an emphasis or specialty in geriatrics, or other topical areas within aging research. It must have faculty qualified in aging research to serve as mentors. The institution must demonstrate a commitment to the candidate’s development as a productive, independent investigator in aging-related research. Such commitment may be expressed in terms of the expected distribution of resources (for example, an independent laboratory) as the candidate progresses through the BCDA.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

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 National Institute on Aging intends to commit approximately $1 million in FY 2013 to support 5 to 7 awards.  The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

The John A. Hartford Foundation and the American Federation for Aging Research (AFAR) have agreed to contribute to this initiative by providing separate supplemental awards to increase the number of candidates funded and/or by making independent awards and by sponsoring an annual meeting of the funded investigators and primary mentors. NIA strongly encourages applicants to share their application with these foundations and to share the results of peer review with them. Applicants may send their application to the American Federation for Aging Research (AFAR) at the address below. AFAR will share it with the other listed foundation:

American Federation for Aging Research
Attn: Paul B. Beeson Career Development Awards in Aging Program
55 West 39th Street, 16th Floor
New York, NY 10018
odette@afar.org  

Award Budget

Award budgets are composed of salary and other program-related expenses, as described below.

Award Project Period

Awards will be made for three, four or five years.

Other Award Budget Information
Salary

Applicants (Candidate, i.e., PD/PI) may seek up to $200,000 (direct costs) per year. Direct costs requested across all years may be no more than $600,000 for three year awards; $700,000 for four year awards; and $800,000 for five year awards.

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

NIH will contribute $up to $200,000 per year towards the award. Candidates may propose a budget appropriate to the research and related needs (e.g., travel to one of the annual Beeson meetings) within this limit.


Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs

 Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.  

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

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

For-Profit Organizations

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.
http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch16.htm#_Toc271265275

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

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).

Former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), sub-projects of program project (P01), sub-projects of center grants (P50), other career development awards (K–awards), or the equivalent are not eligible. Former principal investigators of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.

Candidates for this award must have a health-professional doctoral degree. Such degrees include, but are not limited to, the MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), as well as a doctoral degree in nursing research or practice. Candidates with PhD degrees are eligible for this award if the degree is in a clinical field and they usually perform clinical duties. Individuals with the PhD or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. Individuals holding the PhD in a non-clinical discipline but who are certified to perform clinical duties should contact the appropriate Institute concerning their eligibility for a K23 award. Candidates also must have completed their clinical training, including specialty and, if applicable, subspecialty training prior to receiving an award. However, candidates may submit an application prior to the completion of clinical training. 

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

An individual may not have two or more competing NIH career development applications pending review concurrently.

Resubmissions will be accepted for applications submitted in response to the prior Beeson solicitations RFA-AG-11-009 "Paul B. Beeson Patient-Oriented Research Career Development Award in Aging (K23)" and RFA-AG-12-004 "Paul B. Beeson Patient-Oriented Research Career Development Award in Aging (K23)" but unfunded. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the provisions of the career award application.  K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement or as project leader on a competing multi-project award as described in NOT-OD-08-065.  

Level of Effort

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

Mentor(s)

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. The mentor, or a member of the mentoring team, should have a successful track record of mentoring. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the principal mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.

The mentor should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The description of the career development plan should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g., grant-writing and making effective presentations, is strongly encouraged. The mentor and any co-mentors are also expected to provide an assessment of the candidate’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described.

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Dr. Ramesh Vemuri, Scientific Review Branch, Division of Extramural Activities
National Institute on Aging
7201 Wisconsin AVe, Room 2C212, MSC 9205
Bethesda, MD 20892-9205 or Bethesda, MD 20814 (for express mail)
Telephone: 301-496-9666
Email:vemuri@nia.nih.gov

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.

PHS 398 Career Development Award Supplemental Form

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

Candidate’s Background (Component of Candidate Information)

Career Goals and Objectives (Component of Candidate Information)

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

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

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

Statements by Mentor, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)

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

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

Research Strategy (Component of Research Plan)

The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.

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.

Letters of Reference

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the Notice). Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

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/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at VemuriR@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI 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 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.

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.

Candidate

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

Research Plan

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Environment & Institutional Commitment to the Candidate

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

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.

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.

Training in the Responsible Conduct of Research

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. 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 appropriate Advisory Councils. 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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

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

3. Reporting

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. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

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. 

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.

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)

Chyren Hunter, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9322
Email: Hunterc@mail.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, MD 20892
Telephone: (301) 496-9666
Email: VemuriR@nia.nih.gov

Financial/Grants Management Contact(s)

Lesa McQueen
National Institutes on Aging (NIA)
Telephone: (301) 496-1472
Email: McqueenL@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.


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