Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Nursing Research (NINR)
Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

Design and Development of Novel Technologies for Healthy Independent Living (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

PAR-11-021

Companion FOA

PAR-11-020 R01s

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.286; 93.866;  93.865; 93.361    

FOA Purpose

This FOA issued by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD),  National Institute of Nursing Research (NINR), and the Office of Research on Women’s Health (ORWH) encourages Exploratory/ Developmental Research Project (R21) applications for design and development of novel technologies to monitor health or deliver care in a real-time, accessible, effective, and minimally obtrusive way.  These may be novel sensor or monitoring systems, home-use point-of-care devices, home or mobile therapy or rehabilitation tools, or information systems and should have the goal of fostering healthy and independent living.  The development of such technologies has the potential to significantly improve the quality of life for people with disabilities, people aging with mild impairments, as well as individuals with chronic conditions.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

December 19, 2010

Letter of Intent Due Date

30 days before the receipt date

Application Due Date(s)

January 19, 2011; May 19, 2011; September 19, 2011; January 19, 2012; May 18, 2012; September 19, 2012; January 18, 2013; May 17, 2013; September 19, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates

Advisory Council Review

Standard dates

Earliest Start Date(s)

Standard dates apply

Expiration Date

September 20, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose/Research objectives:

The average age of Americans is increasing and chronic conditions are becoming more prevalent.  There is a need to improve the effectiveness of disease-prevention, to improve access to healthcare, and to sustain healthy independent living. At the same time there is an increased availability of new technologies and an ever-improving health information technology infrastructure.  Advances in bioengineering coupled with the aforementioned needs of society suggest a ripe opportunity for the design and development of home or mobile technologies that enable functional independence and can improve quality of life for people with disabilities, chronic conditions, or mild impairments associated with aging. Home-health and mobile-health technologies are expected to function not only as monitoring devices, but as essential components in the delivery of healthcare.

This FOA encourages Exploratory/Developmental Research Project Grant (R21) applications for research and development of novel technologies that monitor health, inform clinical decisions, or deliver therapies in a real-time and minimally obtrusive way.  These are technologies that enable monitoring of personal motion, vital signs, and physiological measures in a manner that minimizes disruption to an individual’s daily routine and at all times protects their privacy, dignity and comfort.  These systems are expected to integrate, process, analyze, communicate, and present data so that the individuals are engaged and empowered in their own healthcare with reduced burden to care providers.  Effective application of home-based and mobile technologies has the potential to increase adherence to rehabilitation and medical regimens, reduce incidence of avoidable post-acute complications, and improve self-care management of chronic conditions.  Proposals to refine or enhance existing systems or to evaluate them in particular settings are referred to the companion FOA for R01s [Technologies for Healthy Independent Living (R01)]. 

Health care and medicine rely on effective detection and characterization of a person's physical and mental states and of significant changes to those states.  Current methods to assess these indicators of well-being are performed at the convenience of the care provider and usually assume that observations during an office visit represent typical function.  Furthermore, these methods may involve contrived or burdensome tests or depend heavily on recall.  Thus, current methods may miss significant acute events or important signals of declining function or may poorly characterize detected events.

Technologies designed for home and mobile monitoring are intended to overcome these limitations.  They have the potential to capture rare, irregular, or transient events; symptoms that are difficult for a patient to report; and changes in condition that evolve slowly over time.  These improvements, in turn, could yield more accurate and earlier detection of changes that may interfere with healthy and independent living.

Specific Areas of Research Interest:

Projects that address a specific and well-characterized clinical need will be considered of high potential impact.  In designing technology solutions, applicants are advised to consider the context in which their technology will be used and the needs of the expected users.  In many cases this will mean involving the end-users -- whether people with disabilities, elderly people with mild impairments, or people with chronic medical conditions -- in the research and development process.  It is expected that many of these projects will be collaborations between engineers and computer scientists; and nurses, physical therapists, doctors, and other clinicians.  Behavioral scientists may also be involved in identifying the best approaches to ensure adoption of the approach and patient engagement and motivation.

The technologies developed with funding through this FOA are expected to interoperate with other home-based or mobile technologies and communicate with existing health information technology systems, as appropriate. Some other technical features that are expected to lead to successful systems are: reliability, robustness (i.e. ability to function in a variety of operating environments), safety, simplicity, reliance on the appropriate baseline information, contextual awareness, inclusion of software to support decision-making, and consideration of power consumption. Furthermore, systems will ideally integrate information from multiple sensors, appropriate clinical information, and ambient data such as temperature or global position. Proposed systems should incorporate existing standards and consider the regulatory environment where appropriate.

Furthermore, successful technologies that are likely to achieve wide-spread dissemination must consider human factors.  That is, they should: be reliable, robust, safe, and simple (four traits also found as technical features); be aesthetically acceptable and unobtrusive; uphold patient’s privacy preferences; be easy to use and have intuitive user interfaces with consideration for user disability or impairment; provide feedback in meaningful forms, whether auditory, visual, or tactile; maintain or promote social engagement; and address a heterogeneous population where one size does not fit all.  Perhaps most importantly, a system for healthy independent living should engage, empower, and motivate the individual with respect to his/her own healthcare.

The objective of any home-based or mobile monitoring system that includes an alarm or alert feature is that it be sensitive (avoid false-negatives) and specific (avoid false-positives) as appropriate to the situation and how the system is used.  Ideally, the alerts or cueing of the system will be customized to the needs and preferences of the user.

Some examples of appropriate topics for this FOA include but are not limited to:

Applicants are encouraged to collaborate with federally funded programs such as the NCRR Clinical and Translational Science Awards (CTSAs), the NIBIB Point-of-Care Technologies Network (POCTRN), the NICHD Medical Rehabilitation Research Infrastructure Network, the NIH Basic and Behavioral & Social Science Opportunity Network (OppNet), the NIH National Centers for Biomedical Computing (NCBC), the Agency for Healthcare Research and Quality (AHRQ) Practice Based Research Networks (PBRNs), the AHRQ Patient Safety Network (PSNet), the AHRQ Evidence-based Practice Centers (EPC), and the AHRQ Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network.  If collaborating with such a program, applicants should describe how the collaboration would enhance performance and productivity to explore, develop, and integrate novel technologies for supporting healthy independent living.  Applicants are advised to provide a letter of agreement that identifies the level of support from the Principal Investigator or Program Director of those centers.

Applicants may also consider consulting the above programs or other publicly-available resources to benefit from prior efforts to identify and characterize clinical and health-related needs.  The available information may provide valuable input into the development of technical solutions.  For example, AHRQ's EPC program and DEcIDE Network release evidence reports, research gap report, and technical briefs that summarize published findings on health care delivery issues.  These can be found via the Effective Health Care Program site.

ORWH works in partnership with the NIH institutes, centers, and offices to ensure that women’s health research and research on sex/gender differences are part of the scientific framework.  Priority areas for ORWH research support are found in the Strategic Plan:  A Vision For 2020 For Women’s Health Research (http://orwh.od.nih.gov/ORWH_Strategic-Plan_Vol_1_508.pdf).   For this PAR, applications that address Goal #2 (Incorporate Findings Of Sex/Gender Differences In The Design And Application Of New Technologies, Medical Devices, And Therapeutic Drugs), and Goal #3 (Actualize Personalized Prevention, Diagnostics, And Therapeutics For Girls And Women) would likely be most relevant. 

The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research. 

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. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. 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. Information on the R03 program can be found at http://grants.nih.gov/grants/funding/r03.htm.

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

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

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

Award Budget

Direct costs are limited to $275,000 over the two years of the R21 award, 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 $275,000 for the combined two-year award period.

Award Project Period

 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.

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) 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.

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 SF 424 (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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Brenda Korte, Ph.D.
Program Director, Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering/NIH/DHHS
6707 Democracy Blvd, Suite 200
Bethesda, MD 20892
Telephone: (301) 402-1231
FAX: (301) 480-4973
Email: kortebr@mail.nih.gov

Required and Optional Components

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

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plans

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) Sharing Plan) 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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

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.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Applications submitted for this funding opportunity are expected to propose the exploration or development of a novel technology for supporting healthy independent living that, if successful, could be easily integrated into existing systems.  Applicants are advised to consider carefully the context in which their technology will be used, the needs of the expected users, interoperability with other home-based technologies, and interaction with existing health information technology systems.

Overall Impact

Reviewers will provide an overall impact/priority 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?  Does the application make a compelling case for the need for the development of this technology?  Are human factors such as the abilities, comfort, dignity, and privacy of care-givers and care-receivers appropriately addressed? What is the likelihood that this technology will ultimately see widespread adoption if the development is successful? 

Investigator(s)    

Are the PD/PIs, 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? Are persons with disabilities and/or experts familiar with their circumstances members of the investigative team?   

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?  Is the approach sensitive to the existing technical and social context into which the proposed system will be introduced?  Has interoperability been appropriately addressed and existing standards incorporated where relevant?  Is the design approach one that considers a whole system of health maintenance and care delivery? Are persons with disabilities appropriately involved in the design process? Are efficacy, safety, accessibility and usability by persons with disabilities addressed? Was the approach to determining the need for the proposed technology suitable?

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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Renewals are not allowed for this FOA.

Revisions

Revisions are not allowed for this FOA.

Additional Review Considerations

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

Provision of Family Care Facilities

Are the plans to inform attendees about family care resources adequate?

Applications from Foreign Organizations

Applicants from foreign organizations are not allowed in response to this FOA.

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  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

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

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 submitted in response to this FOA . 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 business official.

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of AwardNot Applicable

3. Reporting

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Brenda Korte, Ph.D.
Program Director, Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering/NIH/DHHS
6707 Democracy Blvd, Suite 200
Bethesda, MD 20892
Telephone: (301) 402-1231
FAX: (301) 480-4973
Email: kortebr@mail.nih.gov

Lyndon Joseph, PhD
Division of Geriatrics and Clinical Gerontology
National Institute on Aging (NIA)
7201 Wisconsin Avenue, Suite 3C307
Bethesda, MD 20892-9205
Phone: 301-496-6926
Email: Josephlj@nia.nih.gov     

Ralph Nitkin, Ph.D.
Director, Biological Sciences and Career Development Program
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Building 6100E/Room 2A03
6100 Executive Blvd MSC 7510
Bethesda, MD 20892-7510
Phone: 301-402-4206
Email: rn21e@nih.gov

Paul A. Cotton, PhD, RD
Program Director, Health Behavior & Minority Health
Division of Extramural Activities
National Institute of Nursing Research (NINR)
6701 Democracy Blvd, Ste. 710
Bethesda, MD 20892-4870
Phone: 301.402.6423
Email: Paul.Cotton@nih.gov

Dennis Mangan, Ph.D.
Office of Research on Women’s Health, Office of the Director
Democracy II, Room 400
6707 Democracy Boulevard
Bethesda, MD  20892-5484
Telephone:  (301) 496-9006
Email:  Dennis.Mangan@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)

Eunica D. Haynes
Grants Management Specialist
National Institute of Biomedical Imaging
and Bioengineering, NIH
6707 Democracy Blvd., MCS 5469
Suite 900, Democracy ll
Bethesda, MD 20892-5469 (Regular Mail)
Bethesda, MD 20817 (Fedex and Courier Services)
Phone: 301-451-4791
Fax: 301-451-5735
haynese@mail.nih.gov

Jillian Morris
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205
Phone: (301) 496-8986
Fax: (301) 402-3672
morrisjil@mail.nih.gov

Randi Freundlich
Grants Management Specialist
Office of Grants Management National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-5974
Fax: (301) 402-4502
Email: Freundlichr@mail.nih.gov  

Bryan S. Clark, M.B.A.
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health
6100 Executive Boulevard,
Room 8A01A, MSC 7510
Bethesda, Maryland 20892-7510 (Rockville, Maryland 20852 for non USPS/courier service)
Telephone: (301) 435-6975
Fax: (301) 402-0915
E-Mail: clarkb1@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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