Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title

Secondary Analyses of Existing Data Sets and Stored Biospecimens to Address Clinical Aging Research Questions (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PA-09-265

Related Notices

  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PA-13-168

Companion Funding Opportunity

Not Applicable

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.866

Funding Opportunity Purpose

This funding opportunity announcement (FOA)) invites applications employing secondary analysis of existing data sets or stored biospecimens, to address clinically-related issues on aging changes influencing health across the life span, and/or on diseases and disabilities in older persons. This FOA will support activities addressing specific hypotheses in clinical aging research and/or to inform the design and implementation of future epidemiologic or human intervention studies, or current geriatric practice in maintenance of health, management of disease, and prevention of disability. Existing data sets may also be used to develop and test new statistical analytical approaches. Costs for archiving of data to be made publicly available may be included in the budget, as long as the archival activities are pertinent to the proposed secondary analyses.  

Key Dates
Posted Date

March 29, 2013

Open Date (Earliest Submission Date)

May 5, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, 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)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply.

Advisory Council Review

Standard dates apply.

Earliest Start Date

Standard dates apply.

Expiration Date

May 8, 2016

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.


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Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Background

Clinical trials and epidemiologic research projects (case-control or cohort studies) typically generate data with potential utility beyond the specific hypotheses and questions for which they were originally designed. There is considerable potential in using secondary analyses of existing clinical data sets and biorepositories to explore important research issues regarding biological changes affecting health across the life span and on disease and disability in old age. Secondary analyses of existing data sets and stored biospecimens are also a cost-effective means to explore new hypotheses on such issues and for informing the design of future studies in clinical aging research.  

In addition to data bases and biospecimen repositories generated by clinical research, information collected through health administration activities may also provide a rich source of data relating to health maintenance and disease prevention practices; the incidence and prevalence of chronic conditions and diseases (including multiple morbidities); patterns of geriatric care and medication use; health outcomes (including disabilities) resource utilization (including comparative effectiveness research) and economic impact. These administrative data sets have potential advantages in availability; large size and representativeness; breadth of medical and demographic information; localization of care (community, hospital, and long-term facilities); and suitability for linkage with other data sets. In some settings, such as disease prevention or screening programs, results of clinical studies or stored specimens may also be available.

This funding opportunity will support activities addressing specific hypotheses in clinical aging research and/or inform the design and implementation of future epidemiologic or human intervention studies, or current geriatric practice in maintenance of health, management of disease, and prevention of disability. Applicants are encouraged to use data from a variety of sources, including those supported through investigator-initiated research activities, cooperative agreements, and contracts from public or private sources. Examples include:

Longstanding observational cohorts, with periodic assessments and/or biospecimens, investigating a broad range of risk/protective factors or pathophysiological mechanisms related to chronic diseases of the elderly (e.g., Alzheimer's disease) or to functional and cognitive decline in aging.

Observational cohorts assembled to address a specific question and followed prospectively over time with periodic assessments and/or biospecimens (e.g., Study of Osteoporotic Fractures, Study of Women's Health Across the Nation, Multicenter Osteoarthritis Study, Health ABC, etc.).

Family-based studies. Observational studies of siblings, parent-offspring, and twin pairs.

Cohorts from large clinical trials testing disease prevention or screening interventions (e.g., WHI); behavioral or medical interventions targeting disease management; or multi-component interventions to ameliorate geriatric conditions or disability trajectory.

Data set and stored biospecimens from a clinical trial of sustained caloric restriction in humans (i.e., CALERIE trial; Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy).

Groups identified by disease or non-disease status for comparison analyses (e.g., hip fracture patients) either retrospectively for risk factors (e.g., case-control studies) or prospectively for health-related outcomes.

Groups defined by administrative data bases to explore specific hypotheses regarding aging changes across the lifespan or diagnosis and management of medical conditions common among the elderly (e.g., CMS data, managed and/or accountable care organization data, health insurance data bases, electronic health records, etc.)

Specialized data sets collected to address specific questions (e.g. FDA Critical Path Initiative drug data bases to evaluate analgesic efficacy.)

Investigators are also encouraged to augment existing data sets as appropriate and feasible to address their study hypotheses. For example, new analyses performed on existing biospecimens, electronic linkage with or among administrative data bases, or primary collection of new information could increase the utility of the data for answering relevant clinical questions. Comparison between existing data bases or within merged data sets (e.g., young adults with mid-life, mid-life with older adults, etc.) is also encouraged as appropriate to address the study question, especially to address specific research hypotheses related to aging changes across the life span.

Costs for archiving of data to be made publicly available may be included in the budget, as long as the archival activities are related to the proposed secondary analyses. Plans for creation of a publicly archived database must include adequate data set documentation and instructions for use by investigators not affiliated with the original study. Provision for easy accessibility of archived datasets is required.

Potential applicants may also wish to review the following links to identify observational cohorts or clinical trials from which valuable data and/or biospecimens may be analyzed to address clinical aging research questions:

NIH Clinical Trials.gov: http://clinicaltrials.gov/

NIA Trial- Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy (CALERIE) http://calerie.dcri.duke.edu/

NIA Population Studies Database: http://nihlibrary.ors.nih.gov/nia/ps/niadb.asp

The Osteoarthritis Initiative (OAI): http://oai.epi-ucsf.org/datarelease/

NIH Research Portfolio Online Reporting Tools (RePORT): http://projectreporter.nih.gov/reporter.cfm

NCI Surveys and studies:  http://appliedresearch.cancer.gov/surveys/

The Kaiser Permanente Resource for Genetic Epidemiology Research in Adult Health and Aging: https://rpgehportal.kaiser.org

Applicants are responsible for adhering to the individual study policies governing ancillary projects and access to clinical trials data and/or biorepository samples. The application should include a letter of support from the relevant study committee granting access to data sets and/or repository (if application involves analysis of stored samples) and approval of the proposed secondary analysis study.

Research Objectives

Secondary analyses of clinical data sets or stored biospecimens may include, but are not limited to:

Physiological factors affecting aging changes (e.g., endocrine, musculoskeletal health, reproductive aging) at different points in the life span, including factors contributing to healthy aging across the life span.

Variability in rates of aging changes and its determinants (e.g., genetic and other factors influencing slow rates of change in body composition/muscle mass, bone density, etc., with age).

Genetic and other determinants of exceptionally healthy aging, such as protective factors that prevent or slow common adverse age-related changes or events.

Differences in risk factors for age-related conditions at different ages, at different stages of disease progression, and in the presence or absence of co-existing conditions.

Early-life changes (e.g., during pubertal transition, adolescence) that influence health, either increased or decreased risk for diseases, in young adulthood or at later stages of life.

Complex effects of sustained caloric restriction in humans on protective and risk factors for aging processes and diseases associated with aging.

Physiologic, molecular, cellular and genetic mechanisms of sustained caloric restriction in humans.

Long-term health effects of interventions that are administered over a large part of the life span (e.g., antihypertensives, lipid lowering agents, analgesics).

Long-term effects of physical activity and lifestyle on health and functional outcomes throughout the life span.

Factors contributing to decline in functional status, development of disability, and loss of independence that are potential targets for interventions (1) in different care settings (community/outpatient; acute-care/hospital; long-term care facilities) and transitions between settings, and (2) in sub-groups of elders with special needs (e.g., cognitive impairment, vision or hearing loss, economic hardship).

Effects of specific combinations of two or more comorbid conditions or combinations of medications on risks for specific beneficial and/or adverse health outcomes.

Public health and cost impact of specific combinations of two or more chronic conditions.

Differences in health outcomes (effectiveness and safety) between alternative treatment regimens or health care management strategies for older patients with specific common conditions in old age, or with specific combinations of two or more chronic conditions.

Interactions among medications, disease processes, and health outcomes in complex older patients with multiple chronic conditions.

Validation, revision, or development of new phenotypes for geriatric syndromes and conditions in older populations and population subgroups.

Occurrence and management of geriatric complaints, syndromes, or multi-factorial problems (e.g., fatigue, pain, frailty, unexplained anemia, urinary incontinence, falls, mobility disorders).

Potential differential effects of interventions due to age, race, gender or other factors through subgroup analyses of data from completed clinical trials.

Exploratory analyses, including assays on stored biospecimens, to explore effects of interventions on additional outcomes.

Analysis and meta-analysis of existing data sets to inform designs of future clinical trials (e.g., to determine prevalence of a disease or condition, or a combination of conditions in a population of interest; to estimate effects size of an intervention and duration of treatment in a population of interest, etc.)

Analysis or meta-analysis of existing data sets to explore opportunities for and determine the need for comparative effectiveness clinical trials in a topic area.

Methodology development.  Single or multiple data sets may be used to develop and test new analytic approaches for any of the above topics. Methodological studies that address inferential issues in observational data on treatment effects, such as confounding by indication.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

 

New
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum period is 5 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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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.

Required Registrations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

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.   

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

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:

Section IV. Application and Submission Information


1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Page Limitations

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

Required and Optional Components

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

PHS 398 Cover Letter

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: Plans for creation of a publicly archived database must include adequate data set documentation and instructions for use by investigators not affiliated with the original study. Provision for easy accessibility of archived datasets is required.

Letters of Support: Applicants are responsible for adhering to the individual study policies governing ancillary projects and access to clinical trials data and/or biorepository samples. The application should include a letter of support from the relevant study committee granting access to data sets and/or repository (if application involves analysis of stored samples) and approval of the proposed secondary analysis study.

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.

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 Institutions

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.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the 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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

Overall Impact

Reviewers will provide an overall impact 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).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. 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?  

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? 

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? 

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

2. Review and Selection Process

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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)
Phone: 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 Phone: 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 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Direct general inquires and questions about proposed projects related to health and disease in the aged, and research on aging over the human life span, including its relationships to health outcomes to:

Chhanda Dutta, PhD
National Institute on Aging (NIA)
Telephone: 301-435-3048
Email: Duttac@mail.nih.gov

Direct questions related to research on neurosciences and aging, cognitive changes and Alzheimer's disease to:

Dallas Anderson, PhD
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: Andersda@mail.nih.gov

Inquiries concerning proposed work in behavioral and social research on aging including cognition, psychosocial and sociodemographic factors, long term care, caregiving, behavioral medicine, retirement, economic status and well-being over the life course should be directed to:

Partha Bhattacharyya, PhD
National Institute on Aging (NIA)
Telephone: 301-496-3131
Email: Bhattacharyyap@mail.nih.gov  

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Richard Proper
National Institute on Aging (NIA)
Telephone: 301-402-7735
Email: Properr@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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NIH Funding Opportunities and Notices



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