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)

Title:  Neuroeconomics of Aging (R21)

Announcement Type

New

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance 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 FOA 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 applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-AG-06-011

Catalog of Federal Domestic Assistance Number(s)
93.866

Key Dates
Release/Posted Date: July 31, 2006
Opening Date:  September 27, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 30, 2006
Application Submission/Receipt Date: November 27, 2006
Peer Review Date(s): February-March, 2007
Council Review Date(s): May 2007.
Earliest Anticipated Start Date(s): July 1, 2007
Expiration Date: November 28, 2006

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The purpose of this FOA is to stimulate investigations in the area of Neuroeconomics of Aging.  The National Institute on Aging (NIA) invites applications examining the social, emotional, cognitive, motivational processes and neurobiological mechanisms of economic behavior as these (1) influence social, financial, and health-related decisions affecting the well-being of middle-aged and older adults, and (2) inform the development and refinement of integrative economic theories of utility, learning, and strategic choice relevant to aging.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
3. Reporting

Section VII. Agency Contact(s)
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 Objectives

Purpose  

The purpose of this funding opportunity announcement (FOA) is to stimulate investigations in the area of Neuroeconomics of Aging. The National Institute on Aging (NIA) invites applications examining the social, emotional, cognitive, motivational processes and neurobiological mechanisms of economic behavior as these (1) influence social, financial, and health-related decisions affecting the well-being of middle-aged and older adults, and (2) inform the development and refinement of integrative economic theories of utility, learning, and strategic choice relevant to aging.  Of particular interest are applications exploring the neurobiological underpinnings of economic behavior associated with life cycle decisions in domains such as health care, health and long-term care insurance, health behaviors, savings, and retirement, as well as those investigating age differences in socioeconomic phenomena that govern expenditures of social and economic capital, such as fairness, altruism, and trust. 

Note: For the purposes of this FOA, economic behaviors are defined as those related to the individual allocation of financial, temporal, social, and physical resources for the purpose of influencing the subjective or objective well-being of individuals, social groups, or institutions. Well being in the context of this FOA is based on utility theory in neoclassical economic models of behavior, in which utility is an ordinal or cardinal measure of well being derived from consumption of goods or leisure. Recently, the bridging of economics and psychology has led to recognition of the need to expand traditional conceptualizations of utility to include the contribution of affective, temporal, and social factors that influence well-being. Thus references to well being are intended to reflect the common understanding across psychology, economics and neuroscience regarding the concept of utility.

Research priority areas include: (1) investigation of age differences in reward processing, inter-temporal choice, preference formation, and motivation associated with economically relevant behaviors, with a focus on both the psychological and behavioral manifestation of these differences and differences in the underlying neurobiological mechanisms; (2) development of innovative methods for measuring economic choices of relevance to middle aged and older adults in the laboratory, field, and neuroimaging environments; (3) incorporation of neurobiological and behavioral measures of economic behaviors into longitudinal studies of aging; (4) investigation of social, affective, and contextual factors influencing the economic behavior of middle aged and older adults, and the neurobiological correlates thereof.

Background

The emerging interdisciplinary field of neuroeconomics applies the theories and methodologies of behavioral economics, game theory, psychology, and cognitive, social and affective neuroscience to the study of economically relevant behavior. Neuroeconomics seeks to explain economic behavior in terms of the psychological mechanisms that guide economic behaviors and the neurobiological mechanisms that underlie them.  Fueled by methodological advances in neuroscience, including the development of neuroimaging technologies, and new methods for studying the role of neuromodulatory (hormones, neurotransmitters, etc.) and genetic factors in behavioral processes, neuroeconomics provides opportunities for a systematic investigation of the neurobiological mechanisms involved in economic behaviors. Recent investigations in neuroeconomics have focused on the neural correlates of economic behaviors including reward processing, temporal discounting, subjective and objective valuation, overconfidence, delay of gratification, decision-making under risk and uncertainty, and affective influences on choice.  The neuroeconomics perspective is also being applied to important social phenomena involved in the motivation of economic behavior including altruism, cooperation, competition, greed, revenge, empathy, fairness, persuasion, trust and reciprocity. These functions implicate the involvement of neural mechanisms associated with reward processing, motivation, affect, and social cognition. 

Recent functional Magnetic Resonance Imaging (fMRI) studies of humans engaged in behavioral economic tasks have implicated a variety of brain areas as neural substrates for distinct components of economic behavior. This research has been almost exclusively conducted with young adults, and little data exists on whether brain activation patterns differ as a function of age, or whether age differences in economic behavior are related to differences in underlying brain structure or function. Key systems involved in the processing of monetary rewards include structures in the midbrain dopamine system and areas involved in mediating emotional responses, including the amygdala, insula, and orbital and medial prefrontal cortex (e.g., Rogers et al.,1999; Elliot, Friston, & Dolan, 2000; Breiter et al., 2001; Knutson et al., 2001a, 2001b;  O'Doherty, et al., 2001; Zink et al., 2004; Kuhnen & Knutson, 2005).  Reward mechanisms and emotion processing circuitry are also strongly implicated in socioeconomic tasks, where concerns about fairness and reciprocity often trump purely economic interests (Sanfey et al., 2003; de Quervain et al., 2004; Rilling et al., 2002).  These findings suggest that the common currency for the calculation of utility or well-being may be the affective response one has to an incentive, a social partner, or social exchange context. Meanwhile, evidence is accumulating that older age is associated with distinct social motives and affect-processing profiles (Mather & Carstensen, 2005; Carstensen, Isaacowitz, & Charles, 1999). Yet there is little understanding of the impact of these age differences on the economic behaviors of middle aged and older adults.

In addition, dorsolateral and medial prefrontal mechanisms involved in cognitive control and social cognition are engaged when people evaluate others’ intentions, choose between competing rewards, or between fair and unfair offers (Sanfey et al., 2003; Rilling et al., 2004; McClure et al., 2004).  Finally, the recent finding that the neuropeptide oxytocin increases trust behaviors in humans in economic contexts (Kosfeld et al., 2005) highlights the importance of considering the variety of neurochemically-mediated pathways that modulate socioeconomic behaviors, and raises questions about whether there are age differences in their function. 

The ability of neuroimaging research on economic behavior to directly shed light on economic models of relevance to aging is exemplified in a recent study of intertemporal choice (McClure et al., 2004). Traditional economic models used to explain life cycle savings and consumption behaviors have assumed an exponential discount function with an implied stability of preferences over time, an interest in maximizing one’s long range prospects, and a discounting of future rewards as a function of time.  Recent alternative theories of intertemporal choice, based on behavioral economic data, suggest that individuals have an impulsive bias to prefer immediate over delayed rewards, but otherwise discount exponentially over rewards delayed in time, suggestive of a quasi-hyperbolic discount function (Laibson, 1997). McClure and colleagues (2004), using fMRI, identified two separate neural systems involved in intertemporal choice: a primarily limbic/reward system that values immediate rewards, and a separate fronto-parietal system associated with making choices regardless of time delay. This finding suggests that the brain functions in a manner more consistent with quasi-hyperbolic economic models of temporal discounting. Such findings have direct implications for economic modeling of savings behavior, retirement planning, and insurance and investment decisions that impact the well being of middle aged and older adults.

To date, however, there has been little investigation of these phenomena in the context of aging.  Understanding age-related changes in motivation and socioemotional influences on decision making are among the top research priorities identified in a recent National Research Council report from the Committee on Aging Frontiers in Social Psychology, Personality, and Adult Developmental Psychology, entitled “When I’m 64”, (Carstensen & Hartel, 2006) (http://www.nap.edu/catalog/11474.html). How changes in  emotional, cognitive, and physical capacities at different life stages, in combination with life course changes in motivation and goals, impact economic behaviors at different life stages remains unknown, with even less known about changes in the neurobiological underpinnings of these interactions. Extending the neuroeconomics approach to behavioral and social research on aging offers the opportunity for study of how the neurobiological changes associated with aging influence or are influenced by these social, emotional, cognitive, and motivational factors. Thus, the neuroeconomics approach has potential to improve predictive models of life course economic behavior by revealing the neurobiological mechanisms involved. 

General Characteristics of Responsive Applications

Exploratory/developmental research applications (R21) are encouraged to explore, from an aging perspective, (1) the social, cognitive, affective, and/or motivational processes that influence economic behavior; and (2) the neurobiological mechanisms (e.g., metabolic, hemodynamic, electrophysiological, neuroendocrine, autonomic, or genetic) that underlie economic behavior. 

Interdisciplinary approaches to aging-relevant research questions framed at the behavioral or social level and examining the relation between behavior and neurobiological and/or genetic processes are particularly encouraged.  Research teams must include expertise in economics.

Applicants to this FOA need not have an established history of research on aging.  Use of the R21 mechanism is intended to encourage innovative research likely to lay the foundations for future research proposals in neuroeconomics of aging.

Resources for Applicants

Applicants are invited to access reports from recent workshops and teleconferences on Neuroeconomics and Aging held by the National Institute on Aging at the following url: (http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/ConferencesAndWorkshops.htm).  

Publications and resources on the economics of aging are available through the National Bureau of Economic Research at the following url:   (http://www.nber.org/programs/ag/cahr/publications.html)

Information on NIA-sponsored longitudinal studies of aging is available at: (http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/Resources.htm)

Responses to frequently asked questions concerning this FOA will be posted at (http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/), under Current Funding Opportunities. 

Sample Research Topics

Research questions may focus on age differences in mechanisms of economic behavior such as risk attitudes, reward processing, inter-temporal choice, and preference formation, or age differences in socioeconomic motives such as trust and cooperation. Also pertinent are applications to real world economic behaviors of relevance to aging such as savings decisions, decisions by proxy, health care allocations, and retirement planning, and to the social factors that shape them.  The following sample topics are intended as examples only.  Research applications on other topics that fall within the priority areas are also welcomed.

Age differences in economic behavior, such as:

Social and contextual factors in economic behavior, such as:

Methodological advances, such as:

References

Breiter, H.C., Aharon, I., Kahneman, D., Dale, A., & Shizgal, P. (2001). Functional imaging of neural responses to expectancy and experience of monetary gains and losses. Neuron, 30, 619-39.

Carstensen, L.L., Isaacowitz, D.M., & Charles, S.T. (1999). Taking time seriously: A theory of socioemotional selectivity. American Psychologist, 54 (3), 165-81.

De Quervain, D.J., Fischbacher, U., Tryer, V., Schellhammer, M., Schnyder, U., Buck, A., & Fehr, E. (2004). The neural basis of altruistic punishment. Science, 305 (5688), 1246-7.

Elliot, R., Friston, K.J., & Dolan, R.J. (2000). Dissociable neural responses in human reward systems. The Journal of Neuroscience, 20 (16), 6159-6165.

Kahneman, D. (2003). A perspective on judgment and choice; Mapping bounded rationality.  American Psychologist, 58 (9), 697-720.

Kahneman, D. & Tversky, A. (1979). Prospect theory: An analysis of decisions under risk. Econometrica, 47, 263-291.

Knutson, B., Fong, G.W., Adams, C.M., Varner, J.L., & Hommer, D. (2001a). Dissociation of reward anticipation and outcome with event-related fMRI. Neuroreport, 12 (17), 3683-3687.

Knutson, B., Adams, C.M., Fong, G.W., & Hommer D. (2001b). Anticipation of increasing monetary reward selectively recruits nucleus accumbens. The Journal of Neuroscience, 21, 5472-5476.

Kosfeld, M., Heinrichs, M., Zak, P.J., Fischbacher, U., & Fehr, E. (2005). Oxytocin increases trust in humans.  Nature, 435 (7042), 673-6.

Kuhnen, C.M. & Knutson, B (2005). The neural basis of financial risk taking. Neuron, 47 (5), 763-70.

Laibson, D.I. (1997). Golden eggs and hyperbolic discounting. Quarterly Journal of Economics, 62, 443-77.

Mather, M. & Carstensen, L.L. (2005). Aging and motivated cognition: the positivity effect in attention and memory. Trends in Cognitive Sciences, 9 (10), 496-502.

McClure, S.M., Laibson, D.I., Loewenstein, G., Cohen, J.D. (2004). Separate neural systems value immediate and delayed monetary rewards. Science, 306, 503-507.

O'Doherty, J., Kringelbach, M.L., Rolls, E.T., Hornak, J., & Andrews, C. (2001). Abstract reward and punishment representation in the human orbitofrontal cortex. Nature Neuroscience, 4 (1), 95-102.

Rilling, J.K., Gutman, D. A., Zeh, T.R., Pagnoni, G., Betas, G.S., & Kilts, C.D. (2002). A neural basis for social cooperation. Neuron, 35, 395-405.

Rilling, J.K., Sanfey, A.g., Aronson, J.A., Nystrom, L.E., & Cohen, J.D. (2004). The neural correlates of theory of mind within interpersonal interactions. Neuroimage, 22, 1694-1703.

Rogers, R.D., Owen, A.M., Middleton, H.C., Williams, E.J., Pickard, J.D., Sahakian, B.J., & Robbins, T.W. (1999). Choosing between small, likely rewards and large, unlikely rewards activates inferior and orbital prefrontal cortex. The Journal of Neuroscience, 20 (19), 9029-38.

Sanfey, A.G., Rilling, J.K., Aronson, J.A., Nystrom, L.E., & Cohen, J.D. (2003). The neural basis of economic decision-making in the Ultimatum Game. Science, 300 (5626), 1755-8.

Zink, C.F., Pagnoni, G., Martin-Skurski, M.E., Chappelow, J.C., & Berns, G.S. (2004). Human striatal responses to monetary reward depend on saliency. Neuron, 42 (3), 509-17.

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 use the NIH R21 award mechanism.   The applicant will be solely responsible for planning, directing, and executing the proposed project.

The R21 mechanism is intended to encourage new exploratory and developmental research projects.  For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research.  Another example could include the unique and innovative use of an existing methodology to explore a new scientific area.   These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism.   Applications submitted under this mechanism should be exploratory and novel.  For example, long-term projects, or projects designed to increase knowledge in a well-established area, would not be appropriate for R21 awards. These studies should break new ground or extend previous discoveries toward new directions or applications.  Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism through the regular review cycle.  Information on the R03 program can be found at http://grants.nih.gov/grants/funding/r03.htm.

This FOA uses “Just-in-Time” information concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

2. Funds Available

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 provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 3 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project. Direct costs are limited to $350,000 over a three-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $350,000 for the combined three-year award period.

The R21 mechanism limits the research plan to 15 pages and does not allow for renewals.

The National Institute on Aging intends to commit approximately $1,500,000 dollars in FY2007 to fund approximately 4-6 new applications.

NIH grants policies as described in the NOT-OD-05-004, November 2, 2004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

Applicants may submit more than one application, provided each application is scientifically distinct.

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, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

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

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

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.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

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 in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and 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 (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, 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/PI’s 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 is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist 
PHS398 Modular Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: September 27, 2006 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): October 30, 2006
Application Submission Date(s): November 27, 2006
Peer Review Date(s): February-March, 2007
Council Review Date(s): May, 2007 
Earliest Anticipated Start Date(s): July 1, 2007

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Lis Nielsen, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax: (301) 402-0051
Email: nielsenli@nia.nih.gov

A letter of intent is not required for this funding opportunity.

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/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

In order to expedite the review, applicants are requested to notify the National Institute on Aging Scientific Review Office by email (NekolaM@nia.nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any 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 business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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.

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 of a new award if such costs: are necessary to conduct the project, and 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 of a new award.

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 the NIH Grants Policy Statement.

6. Other Submission Requirements

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. 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 “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Research Plan Component Sections

The R21 mechanism limits the research plan to 15 pages.  While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct 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

The following materials may be included in the Appendix:

Plan for Sharing Research Data

Not applicable  

Sharing Research Resources

Not applicable  

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

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute on Aging in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important scientific health problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

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

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 item 6 of the Research Plan component of the SF424 (R&R).

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 item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

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: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

Not Applicable.

2.D. Sharing Research Resources

Not applicable.

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/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 applicant. 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.

3. Reporting

When multiple years are involved, 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.

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Lis Nielsen, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax: (301) 402-0051
Email: nielsenli@nia.nih.gov

2. Peer Review Contacts:
Dr. Mary Nekola, Chief
Scientific Review Office 
National Institute on Aging
7201 Wisconsin Ave., #2C/212
Bethesda, MD 20814
Telephone: (301) 402-7702
Fax:  (301)402-0066
Email:  NekolaM@nia.nih.gov 

3. Financial or Grants Management Contacts:

Mr. Richard Proper, Grants Management Specialist
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Ave., #2N/212
Bethesda, MD 20892-N9205
Telephone: (301) 402-7735
Fax (301) 402-3672
Email:  ProperR@nia.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).

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.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

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) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 or Health Systems Agency review. 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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