Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
Office of Dietary Supplements (ODS), (http://ods.od.nih.gov)

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

Announcement Type
This is a reissuance and modification of RFA-AG-09-012.

Update: The following update relating to this announcement has been issued:

Request for Applications (RFA) Number: RFA-AG-10-011

NOTICE: Applications submitted in response to Request for Application must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This RFA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and candidates are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.866, 93.859, 93.853

Key Dates
Release Date: November 5, 2009
Opening Date: December 14, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: December 14, 2009
Application Receipt Date: January 14, 2010
Peer Review Date: June-July, 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 1, 2010
Additional Information to be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 15, 2010

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Career Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description



1. Research Career Objectives


The National Institute on Aging (NIA), the National Institute on Mental Health (NIMH), National Institute on Neurological Disorders and Stroke (NINDS) and the NIH Office of Dietary Supplements (ODS), 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:

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.

To deepen the commitment of research institutions to academic research in aging and to translating research outcomes to geriatric medicine by involving mentor and recipient in establishing and advancing the recipient's career in aging research.

Clinically relevant research on aging, as broadly defined includes work in the basic sciences, including animal models of aging where there is apparent clinical relevance; maintenance of health and independence in old age; diseases and disabilities of old age; and issues in clinical management and systems of care for the elderly. The BCDA program also includes additional support for clinically trained scientists who wish to pursue careers dedicated to research on Alzheimer’s disease and other neurodegenerative diseases, formerly supported by the Alzheimer’s Disease Clinical Scientist Development Award announcement. Up to three additional awards each year will be dedicated to investigators planning careers in neuroscience related to aging and neurodegenerative 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.

Program:

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. If you are such a faculty member and wish to apply for this program you must identify a mentor or mentors. These individuals should be senior researchers in aging, mental health and/or geriatrics or psychiatry who agree to commit time to supervising and guiding you during the period of the award.

The BCDA is intended to provide you with the resources and time to establish yourself as an independent and funded investigator whose research focuses on clinically relevant 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 (R03) support from NIH, through similar support from other federal agencies, or through foundation funding. As a career development award it will allow you time to expand your research training and skills to permit your emergence as a leader in aging research. As such your career development plan should reflect a detailed strategy to advance your research skills that complements the research that you will be undertaking.

Junior candidates (who have not yet received initial research support) may apply where you 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 your particular career goals, your current level of experience and the environment (including mentors) in which your career development will take place. Junior candidates with limited prior research training and research experience or more senior candidates who are changing or expanding research areas will more likely need longer periods of support on the BCDA, didactic coursework, and guided research experiences than those with more research training and experience in their proposed field of study. More senior candidates who are now expanding their 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. 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 your emergence as a leading researcher in your chosen field.

To accommodate these differences in prior experience or intended direction the initial BCDA award may be from three to five years. In addition, clinically trained candidates with limited research experience are eligible for an up to two year renewal (formerly competing continuation) of the BCDA as described under Funds Available (Section II.2). Candidates who have a research doctorate earned prior to receiving the BCDA are not eligible for this renewal. Your program must be tailored to your individual needs and ensure that you will gain the experience, knowledge and skills necessary to carry out high quality clinically relevant aging research. You and your mentor(s) are jointly responsible for the preparation of the plan for this program.

You must devote at least nine person-months (75%) of your full-time professional effort to the goals of this award. You may devote the remainder to activities that are consistent with the purpose of the award and which allow you 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 your salary, and for research/research development expenses to be used for research and training.

The proposed training and research must focus on clinically relevant, patient-oriented research on aging, the aged or those aged with psychiatric needs. Your research project may employ primary or secondary data analysis as well as clinical and patient-focused methods. 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. NIMH is interested in supporting investigators who will pursue clinical or health services research in mental disorders of late life, especially studies aimed at hastening the translation of behavioral science and neuroscience advances into innovations in clinical care. NIMH has particular interests in research on how the aging process interacts with the etiology and pathophysiology of mental illness in older adults, including studies of the mechanisms underlying psychiatric and behavioral disturbances in neurodegenerative disorders, in studies identifying risk and protective factors and their relationship to the development of various mental disorders in later life, and in research to better define the neurobiological trajectories of chronic mental illnesses across the lifespan. NIMH also encourages outcome studies on innovative biomedical and psychosocial interventions for older persons with mental disorders, studies determining moderators and predictors of both intervention response and side effects and pursuing other avenues to personalizing the choice of treatment approaches for the individual older adult, and research on optimal methods of adapting mental health interventions for effective delivery to diverse populations and in typical geriatric care settings. ODS has particular interests in the roles of dietary supplements in preventing and reducing risk factors for disease and in enhancing physical and mental health and performance. The ODS is also interested in research exploring the biochemical and physiological effects of supplements and in improved scientific methods for the study of dietary supplements. Research on these interests as they relate to the health and performance of older adults is particularly encouraged. The BCDA program also now includes funding for up to three additional positions formerly allocated to the NIA Alzheimer’s Disease Clinical Scientist Development Award program and therefore encourages additional applications addressing innovative approaches to neuroscience research that would have relevance to brain aging, Alzheimer’s disease and other neurodegenerative diseases.

Mentor(s): You must name a primary mentor, who together with you is responsible for the planning, direction, and execution of the program. Your mentor should be an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. You 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 your mentors. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.

Your institution must have a well-established research and clinical career development program with an emphasis or specialty in geriatrics, psychology, psychiatry or other topical areas within aging research. It must have faculty qualified in aging research to serve as mentors. Your institution must demonstrate a commitment to your development as a productive, independent investigator in aging-related research. Such commitment may be expressed in terms of the expected distribution of resources to you (for example, an independent laboratory) as you progress through the BCDA.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will utilize the Mentored Patient-Oriented Research Career Development Award (K23) mechanism).

The Project Director/Principal Investigator (PD/PI) (also referred to as the Candidate) and his/her mentor will be responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses non-modular budget format.

The candidate should follow the instructions for budget information described in Section IV (6.F) as well as in PHS 398 Career Development Award Supplemental form Section 7.4.6 of the R&R 424 instructions, and budget justification information.

The program must be tailored to meet the individual needs of the candidate. Candidates may request 3 to 5 years of support. The actual duration of the award will depend upon the number of years of prior research experience, the demonstrated need for additional mentored experience to achieve research independence, and the policy of the awarding Institute. Awards are not transferable from one PD/PI to another. Some awards may be renewable."

2. Funds Available

The National Institute on Aging, the National Institute of Neurological Disorders and Stroke, National Institute of Mental Health, and the Office of Dietary Supplements intend to commit (in combination) approximately $1 million in FY 2010;

The John A. Hartford Foundation, and the American Federation for Aging Research have agreed to contribute to this initiative by providing 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 NINDS and NIMH strongly encourage you to share your application with these foundations and to share the results of peer review with them. You may send your application to the American Federation for Aging Research (AFAR) at the address below. AFAR will share it with the other listed foundations:

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

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIA, NIMH, NINDS, and ODS provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Some awardees may be eligible for a renewal of the Beeson award. Clinically trained applicants with no prior NIH career development or similar award from other sources prior to the initial BCDA may seek support for one renewal of the BCDA. This renewal may not request support for more than two additional years. The two year direct costs are limited to $300,000 with no more than $200,000 allowed in any one year. However, if you possess a research doctorate you are not eligible for the two year continuation.

2.A. Allowable Costs

1. Salary: The NIA, NIMH, NINDS, and ODS will provide salary and fringe benefits. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at your 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 K23 award.

Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Confirmation of salary may be required prior to the issuance of an award. Fringe benefits, based on the sponsoring institutions rate and the percent of effort, are provided in addition to the salary. The salary awarded may be no more than the legislative cap in effect at the time of award See http://grants.nih.gov/grants/policy/salcap_summary.htm. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056.

At least nine person-months( 75%) of full-time effort must be devoted to the goals of this award. Because the salary amount provided by this award is based on your full-time institutional salary, other PHS funds may not be used to supplement the salary. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the BCDA. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale provided that the resulting salary is within the current legislative cap. The remaining effort may be devoted to clinical, teaching, or other research pursuits and activities consistent with the objectives of the award.

BCDA K23 award recipients are encouraged to obtain funding from NIH or other Federal sources either as a named PD/PI on a competing research grant award or cooperative agreement or as sub-project director on a competing multi-project award (see NOT-OD-08-065). Within the last two years of a K23 award the effort required may be reduced to no less than 6 person-months (50% full-time professional effort) at the grantee organization and replaced by effort from the research award so that the total level of research commitment remains at 9 person-months (75% full-time professional effort) or more for the duration of the K23 award. To be eligible for salary support from peer-reviewed research awards from any Federal agency:

2. Research Development Support: Examples of these expenses include: (a) tuition, and fees, related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; (d) statistical services including personnel and computer time.

3. Ancillary Personnel Support: Salary for mentors, secretaries and administrative assistants is not allowed.

4. Facilities and Administrative Costs: NIA, NIMH, NINDS, and ODS will reimburse these costs at 8 percent of modified total direct costs. The participating foundations do not pay facilities and administrative costs.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Project Director/Principal Investigator (PD/PI): Also referred to as the Candidate, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities are invited to work with their mentor and sponsoring institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support. Awards are not transfereable from one PD/PI to another. Some awards may be renewable." For the BCDA program, the following additional eligibility requirements apply to individuals who seek to become BCDA recipients (PDs/PIs).

Citizenship and Residency: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Degree and Research: Candidates for this award must have a clinical doctoral degree, (e.g. MD, DO, DDS) or its equivalent. Candidates also must have completed their clinical training, including specialty and subspecialty training prior to receiving an award. However, candidates may submit an application prior to the completion of clinical training. Note that individuals with a doctoral degree that requires a dissertation or thesis may apply for the BCDA Program. These may include individuals holding both MD and PhD degrees as well as individuals with PhDs in clinical fields where they usually perform clinical duties (such as clinical psychology, nursing or physical therapy). However, such individuals are not eligible for a competing renewal of the BCDA.

Level of Effort: Candidates must be able to commit a minimum of 9 person-months (75% of full-time professional effort) conducting research career development activities associated with this award. The remaining 3 months (25% effort) can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of an NIH K23 Award, i.e., the candidate’s development into an independent investigator. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056.

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 NIA, NINDS or NIMH staff prior to preparing an application to discuss their eligibility.

We strongly encourage you to apply for independent research grant support (such as an R01 or similar award) during the period of this award to maximize your chances of obtaining uninterrupted funding as you transition to full independence.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications: Candidates may only have one individual Career Development Award application pending peer review at any time.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals: Generally competing renewal awards are not allowed. See Section II.2.where a special exception is described. Also awards are not transferable from one PI/PD to another.

Individuals are eligible for a K23 award if they have been, or currently are the PI of an NIH small grant (R03) or exploratory/developmental grant (R21) or a PHS or non-Federal award that duplicates the provisions or research goals of an R03 or R21 grant.

Current and former recipients of Clinical Associate Physicians Award (CAP) support may apply for the K23 provided they've had no more than 3 years of CAP support by the time of the K23 award. The combined total of CAP plus K23 support must not exceed 6 years.

Individuals are NOT eligible if they:

SPECIAL REQUIREMENTS

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, go to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

The PD/PI should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

The PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: If a PD/PI is also an NIH peer-reviewer the DUNS number obtained and used in the reviewer role may NOT be used and is not applicable to any Grant Application to the Federal Government. This DUNS number is different from the DUNS number used by the applicant organization. The individual DUNS number should be used only for the purposes of personal reimbursement.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions “ Application Guide, Electronic Submission of Grant Applications

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Senior/Key Person
Research & Related Other Project Information
SF424 (R&R) Detailed Budget
PHS398 Cover Letter
PHS398 Cover Page Supplement
PHS398 Career Development Award Supplemental Form
PHS398 Checklist

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Opening Date: December 14, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: December 14, 2009
Application Receipt Date: January 14, 2010
Peer Review Date: June-July, 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 1, 2010

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 NIA staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Chyren Hunter, Ph.D
Division of Extramural Activities
National Institute on Aging
7201 Wisconsin Avenue, Room 2C218, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-9322
FAX: (301) 402-2945
Email: HunterC@nia.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and for responsiveness by.the National Institute on Aging. Incomplete or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

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.

Citizenship: Candidates must meet the citizenship requirements as described in the Eligibility section of this announcement (see Section III) at the time of award.

Concurrent Awards: Candidate must be aware of the NIH policies associated with other federally sponsored support (see: NOT-OD-08-065).

Salary Support: The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the applicable department.

NIH policy allows NIH mentored career development award recipients in the final two years of their award to receive salary support from both their K award and a research grant from any Federal agency (see NOT-OD-08-065). The K-award recipient must be a named PD/PI of a competing research project grant (R01, R03, R15, R21, R34, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.), at the time of peer review. See the Notice for full details.

Research Development Support: The research development support costs allowed for this program must be justified and be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. Salary for ancillary personnel support, such as mentors, secretarial and administrative assistants is not allowed.

Pre-Award Costs: Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement NIH Grants Policy Statement.

6. Other Submission Requirements

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements (see http://grants.nih.gov/grants/funding/424/index.htm):

PD/PI Credential (e.g., Agency Login): The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE “Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS: The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions “Application Guide, Electronic Submission of Grant Applications."

Cover Letter: The PHS398 cover letter must include the list of referees (including name, department affiliation, and institution.

The following information must be included in the application in accordance with the Supplementary Instructions for Research Career Awards in the SF424 (R&R) Application Guide (See Part I.7.5).

PHS 398 Career Development Award Supplemental Form Component Sections: Items 2-5 (Candidate Information) and 10-13 (Research Plan) are limited to a total of 25 pages. While each section of the Candidate Information and Research Plan components needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Candidate Information component and the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Appendix Materials: Candidates must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

6.A. Candidate Information and Career Development Plan

Candidate’s Background:

Career Goals and Objectives:

Career Development/Training Activities:

Training in the Responsible Conduct of Research:

6.B. Research Plan

The research plan should follow instructions outlined in PHS 398 Career Development Award Supplemental form, including sections on Specific Aims, Background and Significance, Preliminary Studies/Progress Report, Research Design and Methods. The candidate should consult with the mentor(s) regarding the development of this section.

6.C. Statement of Support

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

6.D. Environment and Institutional Commitment to the Candidate

Description of Institutional Environment:

Institutional Commitment to Candidate’s Research Career Development:

6.E. Letters of Reference

Electronic submission of reference letters is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons and do not use Grants.gov. Therefore, candidates must follow the Supplemental Instructions in the SF424 R&R Application Guide for Research Career Awards (Instructions, Part 7.3) (see http://grants.nih.gov/grants/funding/424/index.htm).

Letters of reference are an important component of the application for the mentored career award. Candidates for this career award must arrange to have at least three (but no more than five) letters of reference submitted on their behalf to the NIH eRA Commons Web site at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new. The letters should be from well-established scientists (referees) addressing the qualities of the candidate as well as their potential for becoming an independent investigator. These letters should be from individuals not directly involved in the application, but who are familiar with the candidate’s qualifications, training, and interests, including advisory committee members (if applicable).

The mentor/co-mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters. Resubmission applications must include new letters of reference.

Applications that are missing the required letters of reference may be delayed in the review process or not accepted.

6.F. Budget for the Entire Proposed Period of Support

Budget Component (Section 4.7): Use the SF424 (R&R) Detailed Budget component and review the instructions found in Part I.4.7(R&R Budget Component) of the Application Guide. However for K applications only limited budget information is required; therefore, candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental Instructions for Career Development Awards], noting the special instructions that modify Section 4.7. In budget section A (Senior/Key Persons) include base salary, person months and requested salary and fringe benefit information for only the candidate. Base salary, and requested salary and fringe benefits should reflect actual levels. Any adjustments based on NIA, NINDS or NIMH policy limits will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

6.G. Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Not Applicable.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, candidates seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute on Agng and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

Review Criteria

The overall goal of NIH-supported career development programs is to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator.

The application does not need to be strong in all categories to receive a high impact/priority score. These criteria are listed in logical order and not in order of priority.

Candidate:

Career Development Plan:

Research Plan:

Mentor(s), Consultant(s), Collaborator(s):

Environment and Institutional Commitment to the Candidate:

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the rating:

Training in the responsible conduct of research: Does the application include appropriate and adequate documentation in prior instruction, or plans for training in the responsible conduct of research?

Resubmission(s): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R), part I, 5.5.

Inclusion of Women and Minorities in Research: The adequacy of plans to include subjects from both genders and all racial and ethnic groups (and subgroups), as appropriate, for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R) part I, 5.5.

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R), part I, 5.5.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: Is the proposed budget and period of support appropriate in relation to the proposed research and the career development needs of the candidate? The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plans

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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 NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the candidate. JIT includes, but is not limited to, updated salary information and confirmation, current Other Support as well as Human Subjects and Animal certifications. Activation of the JIT link in the eRA Commons is not an indication of a request for Just in Time information. The applicant organization will be contacted by NIH grants administration staff if this information is required. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Section IV.5 Funding Restrictions.

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.

The following related administrative policies apply to NIH Research Career Award (K) programs:

A. 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. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

B. Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

Usually, funds budgeted in an NIH supported research grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

C. Leave Policies: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. Details on the process for submission of prior approval requests can be found in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH component Institute or Center and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.

D. Percent Effort Policies: Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent (equivalent to 9 person months). Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50 percent effort (equivalent to 6 person months). The nature of the circumstances requiring a change in the appointment status or percent effort might include personal or family situations such as parental leave, child care, elder care, medical conditions, or a disability. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75 percent effort as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

E. Changes in Research or Career Development Program: Consultation with the applicable NIH funding Institute or Center Program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered.

Individual awards are made for career development in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH Institute or Center. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by staff of the awarding IC to ensure that the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

In rare cases where a mentor must be replaced, the institution must submit a letter from the proposed mentor and awardee documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for the PD/PIs continued career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. Staff within the NIH funding component will review the request and will notify the institution of the results of the evaluation.

F. Change of Institution or Termination: Consultation with the applicable NIH funding Institute or Center program and/or grants management staff is strongly encouraged when either termination or a change of institution is being considered.

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

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

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

3. Reporting

Awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. (Note that the instructions for Research Career Development applications must be followed for this program).

The Progress Report must include Sections (A) through (F) as described in Section 2.2.6 (Progress Report Summary) in the general PHS form 2590 instructions, as well as sections G through J as described in Section 5 of the 2590 instructions. Evaluation of the awardees progress will encompass the following:

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential candidates. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

National Institutes on Aging:

Chyren Hunter, Ph.D.
Division of Extramural Activities
7201 Wisconsin Avenue, Rm. 2C218
Bethesda, MD 20892-9205
Phone (301) 496-9322
E-mail: Hunterc@nia.nih.gov

National Institute of Mental Health:

Mark Chavez, Ph.D.
Division of Adult Translational Research & Treatment Development
6001 Executive Blvd., Room 7101
Bethesda, MD 20892-9632
Phone: (301) 443-8942
Email: mchavez1@mail.nih.gov

National Institute on Neurological Disorders and Stroke:

Stephen Korn, Ph.D.
Director of Training and Career Development
6001 Executive Blvd, Room 2186
Bethesda, MD 20892
Phone: (301) 496-4188
Email: korns@ninds.nih.gov

Office of Dietary Supplements:

Mary Frances Picciano, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd, 3B01
Bethesda, MD 20892-7517
Telephone: (301) 435-3608
FAX: (301) 480-1845
Email: PiccianM@mail.nih.gov

2. Peer Review Contact(s):

Ramesh Vemuri, Ph.D., Chief
Scientific Review Branch
National Institute on Aging
7201 Wisconsin Avenue, Room 2C212
Bethesda, MD 20892-9205
Telephone: (301) 496-9666
FAX: (301) 402-0066
Email: VemuriR@nia.nih.gov

3. Financial/Grants Management Contact(s):

National Institutes on Aging:

Lesa McQueen
Grants management Branch
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205

Phone: (301) 496-1472
Email: McqueenL@mail.nih.gov

National Institute of Mental Health:

Rita Sisco
6001 Executive Blvd.
Room 6120, MSC 9605
Bethesda, MD 20892-9605
Phone: (301) 443-2805
Email: siscor@mail.nih.gov

National Institute on Neurological Disorders and Stroke:

Mutema Nyankale
Grants Management Branch
6001 Executive Blvd., NSC/Rm. 3250
Bethesda, MD 20892-9537
Phone: (301) 496-6506
Email: nyankalem@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection: Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan: Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS): NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms: NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research ? (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Required Education on the Protection of Human Subject Participants: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC): Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement: In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information: The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices: All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs: NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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NIH Funding Opportunities and Notices


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