Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Aging (NIA)
Funding Opportunity Title	Mid-life Reversibility of Early-established Biobehavioral Risk Factors (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	January 31, 2014 - NIH and AHRQ Extend Due Dates for Applications Due Jan 31-Feb 3 to Feb 4. See Notice NOT-OD-14-047. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	RFA-AG-14-006
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.866
Funding Opportunity Purpose	The purpose of this funding opportunity announcement (FOA) issued by the National Institute on Aging (NIA) is to solicit two-year Research Project Grant (R01) applications that propose to explore the potential for midlife plasticity of biobehavioral or psychological systems affected by early life disadvantage. In order to speed the development of novel intervention strategies, applicants are encouraged either to use existing human cohort data to identify circumstances that mitigate or exacerbate the effects of early adversity or to use human and/or animal models to test the feasibility of developing interventions aimed specifically at increasing malleability in adulthood of risk persistence mechanisms.

Posted Date	July 17, 2013
Open Date (Earliest Submission Date)	January 3, 2014
Letter of Intent Due Date(s)	January 3, 2014
Application Due Date(s)	Extended to February 4, 2014 per NOT-OD-14-047 (previously February 3, 2014), by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	May 2014
Advisory Council Review	August 2014
Earliest Start Date	October 2014
Expiration Date	February 4, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

A rapidly growing literature has established that early life adversity, both pre-natal and post-natal, can have a dramatic impact on later life outcomes, with early adversity in particular conferring specific and negative health consequences beginning in midlife. To further our understanding of these processes and potentially discover ways to reverse the effects of early life adversity in midlife, more research is needed to elucidate the specific risks, mechanisms, and mitigating factors involved and develop interventions.

The purpose of this funding opportunity announcement (FOA) issued by the National Institute on Aging, is to solicit research applications exploring the potential for midlife plasticity of biobehavioral or psychological systems that can be targeted to reverse effects incurred by early life disadvantage. This requires studies that: 1) conceptualize and estimate the extent of long term effects of childhood environmental adversity on trajectories of aging; 2) identify specific risk mechanisms in the social environment that account for the persistent effect of childhood adversity on trajectories of aging; 3) elucidate the biological gateways and mechanisms through which childhood adversity affects trajectories of aging; and 4) explore the potential for reversibility of persistent risk mechanisms in order to develop novel strategies for preventive interventions in midlife and beyond.

Two approaches closely tied to the development of novel intervention strategies are encouraged. The first involves the use of existing human cohort data to 1) more precisely conceptualize and estimate the risk to impaired psychological, social, or physical health attributable to early adversity; and 2) identify circumstances that mitigate or exacerbate the effects of early adversity on adult psychological, social, and physical health outcomes, particularly those that provide clues for possible preventive interventions. The second uses human and/or animal models to test the feasibility of developing interventions aimed at specific malleable properties of biological or psychological mechanisms that account for the persistence of risk from early childhood adversity to adult life.

Human and animal studies document long lasting effects of adverse early environments, including low socioeconomic status, poor parent-offspring relationships (especially child abuse and neglect), and prenatal or early exposure to stress, on trajectories of physical, social, and psychological aging. The mechanisms through which these early adverse experiences exert influences on physical and mental health in later adulthood are becoming better understood. Recent evidence from animal studies indicates that these risk mechanisms are reversible suggesting the possibility for intervention, and preliminary evidence from human studies attempting to reverse these mechanisms of persistence is promising.

Recent research points to a number of behavioral and social mechanisms that could account for the persistence of these risk factors across many decades in the life of the individual. These include maladaptive personality processes, participation in dysfunctional social relationships, and dysregulation of numerous biobehavioral systems, such as the HPA axis and the affective systems responsible for stress reactivity and behavioral control. Additional mechanisms include the cellular processes related to telomere structure and function that have been associated with psychosocial stress, and gene expression profiles that have been associated with adverse experiences such as childhood poverty, gestational maternal stress, or inadequate postnatal parental care. Animal and preliminary human studies suggest that some of these risk persistence mechanisms are malleable, and thereby provide opportunities for interventions that may ameliorate the negative effects such dysregulation can have on trajectories of health in adults. Thus, preliminary work to lay the foundations for interventions is timely, given recent advances in uncovering plasticity in these biobehavioral systems. However, proof of principle is required before large-scale interventions can be considered.

This FOA solicits studies designed to explore the potential for plasticity of biobehavioral and psychological systems in midlife using two approaches that are closely tied to the development of novel intervention strategies as described below.

The first strategy involves the use of existing human cohort data to identify adults who are at particular risk for adverse psychological and physical health outcomes and seeks research to a) more clearly conceptualize links between early adversity and late life in order provide better estimates of risk attributable to early adversity and b) identify more precisely the circumstances that mitigate or exacerbate the effects of early adversity. These studies may include the following:

1. Combining data from existing cohorts to better clarify early sensitive periods; identify moderating circumstances in both childhood and adulthood that provide clues to intervention strategies; relate effects of early adversity to psychological, social and biological pathways that would provide insights into the persistence of childhood risk into adult life and potential intervention targets; and improve methods of identifying both positive and negative cascades initiated early in development, including techniques for developing taxonomies of life histories;

2. Combining early-life and later-life data within and across cohorts to clarify the importance of two-hit or multiple-hit models where the impact of early adversity is manifest only when adversity in later life occurs.

3. Following up on prior intervention studies to help define windows of malleability, moderating mechanisms, and clues to mechanisms of risk persistence.

The second strategy involves the support of feasibility testing for either human or animal interventions aimed specifically at exploring the malleability of risk persistence mechanisms, including the following:

1. Testing of animal interventions exploring the malleability of biobehavioral systems in adult animals associated with early social adversity via indicators that may include measures of neural activity, neuroendocrine function, gene expression profiles, telomere length and telomerase activity, and quantification of immune and inflammatory processes. Interventions may involve a range of approaches, including pharmacological, cognitive and social enrichment.

2. Use of existing animal data to clarify strategies for distinguishing whether an intervention reverses the risk engendered by early adversity or compensates for these adversity-induced risk mechanisms.

3. Experimental studies involving novel human intervention approaches to explore the plasticity of biobehavioral systems associated with early social adversity. These could include systems implicated in, e.g., low attachment and empathy, delay discounting, high sensitivity to aggression, high stress reactivity, as well as those associated with low conscientiousness or behavioral self-control, which have been associated with risk for maladaptive aging trajectories.

Applications must specify and include assessments of early social environments/exposures, must specify and directly assess hypothesized biobehavioral or psychological risk mechanisms, and (for exploratory intervention approaches) must include assessments of aging-relevant behavioral, psychological, social or health-related outcomes. For the purposes of this FOA, aging-relevant research is that which addresses issues of importance to the well-being and health of either mid-life or older adults, and can include data spanning the entire life course.

Animal or human subjects should be drawn from normal (as opposed to clinical or disease-model) populations, and findings should be applicable to the general population. Applications with a primary focus on risk mechanisms specific to Post-Traumatic Stress Disorder, other major psychiatric disorders, or neurodegenerative diseases will not be considered responsive to this FOA.

Applicants need not have a prior history of conducting research in aging.

The UK Economic and Social Research Council has expressed interest in independently funding components of applications submitted under this initiative. To be eligible for ESRC support, applications must be submitted to the ESRC and include a UK component and UK investigator. NIA welcomes collaborative US/UK projects and strongly encourages applicants to share their applications with the ESRC and to share the results of peer review with them. You may send your application to the Economic and Social Research Council (ESRC) at the address below:

Economic and Social Research Council
Attn: NIA Collaborative Program on Reversibility
Polaris House
North Star Avenue
Swindon
SN2 1UJ
UK
Email address: ESRCNIAreversibility@esrc.ac.uk

Further information on what constitutes a 'UK component' from the perspective of the ESRC is detailed in the FAQ document (see link below). ESRC decisions regarding support to any applications submitted under this RFA will be fully independent of the NIA decision-making process.

Applicants are encouraged to review summaries of two recent NIA workshops on Reversibility at: http://www.nia.nih.gov/research/dbsr/featured-reports/

Answers to any frequently asked questions regarding this FOA will be posted at: http://www.nia.nih.gov/research/dbsr/faq-reversibility-r01

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The National Institute on Aging intends to commit $1.8 million in FY2014 to support approximately 6 awards. The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Applications may request up to $200,000 in direct costs per year.
Award Project Period	The scope of the proposed project should determine the project period. The maximum project period is 2 years.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

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

The letter of intent should be sent to:

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

A copy of the letter of intent can be sent to: Email address: ESRCNIAreversibility@esrc.ac.uk

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

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed,

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute on Aging, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have the potential to advance progress toward one or more of the following FOA goals: 1) to more precisely conceptualize and estimate the risk to impaired psychological, social, or physical health attributable to early adversity; 2) to identify circumstances that mitigate or exacerbate the effects of early adversity on adult psychological, social, and physical health outcomes, particularly those that provide clues for possible preventive interventions; or 3) to explore the feasibility of developing interventions aimed at specific malleable properties of biological or psychological mechanisms that account for the persistence of risk from early childhood adversity to adult life?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Are proposed measures of early life social environments/exposures and hypothesized biobehavioral or psychological risk mechanisms adequate to address the aims of the project? For projects involving feasibility testing for interventions, are there adequate assessments of aging-relevant behavioral, psychological, social or health-related outcomes?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIA in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Lis Nielsen, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-4156
Email: nielsenli@nia.nih.gov

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: Vemuri@nia.nih.gov

Jeff Ball
National Institute on Aging (NIA)
Telephone: 301-402-7732
Email: ballj@nia.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.