Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
U.S. Army Medical Research and Materiel Command (USAMRMC)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)
Office of Behavioral and Social Sciences Research (OBSSR)
Telemedicine and Advanced Technology Research Center (TATRC)
Eunice Kennedy Shriver National Institute of Child Health and Human Development  (NICHD)

Funding Opportunity Title

Virtual Reality Technologies for Research and Education in Obesity and Diabetes (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • 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.
  • July 6, 2011 - See Notice NOT-HL-11-152 Notice of Publication of FAQs.

Funding Opportunity Announcement (FOA) Number

PA-11-211

Companion FOA

PA-11-212 - R21 - Exploratory/Developmental Grant
RFA-HL-12-020 - STTR R43/R44- Phase I, Phase II, and Fast Track
RFA-HL-12-024 - STTR R43/R44- Phase I, Phase II, and Fast Track

Number of Applications

See Section III. 3. Additional Information on Eligibility

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

93.837, 93.838, 93.839, 93.233, 93.865

FOA Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage submission of hypothesis-testing research applications that capitalize on the unique capabilities of Virtual Reality (VR) technologies to visualize outcomes, teach, motivate, and to extend the health care and learning environments, in order to foster to foster desirable eating, physical activity, self-care, and other health-related behaviors necessary for prevention and management of obesity and diabetes.

Of highest interest are well-designed multidisciplinary projects drawing on expertise in VR technologies and biomedical behavioral and pedagogical sciences.  The overall goal is to develop the potential of VR technologies as research tools for behavioral science-oriented studies in diabetes and obesity, and as practical tools for clinical and public health-level prevention and management of obesity and diabetes.

Key Dates
Posted Date

May 10, 2011

Open Date (Earliest Submission Date)

May 16, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

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

AIDS Application Due Date(s)

Standard 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(s)

Standard dates apply

Expiration Date

May 8, 2014

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

BACKGROUND AND RATIONALE:

The public health infrastructure is being overwhelmed by problems related to over-eating and under-exercising, and it has become clear that many, perhaps most, people have difficulty assimilating and implementing information on optimal diet and physical activity. Furthermore, the emotional, cognitive, and logistical complexities of diabetes management have resulted in a situation where a large fraction of patients are in sub-optimal glycemic control, leading to poor clinical outcomes and high expenses. Even if individuals are willing to adhere to professional and public health guidance, it is hard to navigate the emotional demands, environmental choices and opportunity cost issues that present themselves at the point of decision. This is the cause of failure for many approaches seeking to promote positive behavioral changes, which is of particular concern for individuals with obesity and diabetes. 

Virtual Reality (VR) technologies might prove useful in bridging the gap between information (healthy population guidance or therapeutic lifestyle change guidance for obesity and diabetes) and sustainable behavior change. VR technology allows users to interact with (rather than simply observe) computer-simulated environments, typically with adapted flat-screen monitor displays or stereoscopic goggles, but also sometimes with tactile (“haptic”) or other sensory feedbacks including taste and smell. Online communities and virtual worlds with avatars (animated characters representing oneself or others) are increasingly a component of the everyday social world for many people.
 
VR applications are currently in development and use for a number of health- and medicine-related issues, notably rehabilitation medicine (stroke, Parkinson’s disease, pain control in burn victims), behavioral medicine (phobias, post-traumatic stress disorder, drug addiction, autism), and surgery (technical training, robotics, remote site treatment). However, except for small studies in clinical eating disorders (anorexia, binge eating), there has been almost no development of the field in relation to common issues of food intake, food choice and encouragement of physical activity among the broader population.

VR technology could be used to complement motivational interviewing, assess emotional states of readiness for behavioral change, and help patients to grapple with their emotional reactions to food choices. The visual presentations could assist patients in adjusting their distorted assessments of portion sizes; correcting their unrealistic expectations of the rate of weight loss; managing sensory experiences that occur as a result of behavior change, such as hunger or satiety from altered consumption patterns, or delayed muscle soreness from unaccustomed exercise; and enhancing their sense of self-efficacy by giving them successful experiences in navigating virtual environments.

VR also might be suitable for addressing adherence barriers in cardiovascular exercise rehabilitation (particularly for coronary artery disease, heart failure, and peripheral arterial disease) such as perceived exertion, anxiety, and capacity to walk to a prescribed duration and intensity.  Another clinical use of VR might be in the provision of non-judgmental support for patients with various medical conditions through virtual coaches, and it might be especially suitable for housebound or reclusive individuals with social anxieties or mobility restrictions due to morbid obesity or other medical conditions. VR could be used in the therapeutic setting as a component of patient visits, to help guide and select educational materials and strategies and timelines. It might be an especially suitable modality for children, adolescents and young adults, who already are becoming familiar with VR as an entertainment technology.  VR could also be applicable to individuals with low verbal or numerical literacy who may be more oriented to pictorial (vs. written or abstract) information.

An evolving body of evidence indicates that poor sleep behaviors and insufficient sleep may be causally linked with disordered endocrine and appetite regulation and with risk of metabolic syndrome, diabetes, hypertension and clinical cardiovascular disease.   VR technology presents new opportunities to apply recent advances in sleep research in relation to obesity and diabetes risk by objectively evaluating individual sleep and alertness status, delivering personalized guidance on healthy sleep behaviors, implementing physician-recommended treatments (e.g., positive airway pressure devices, light therapy), and assessing treatment outcomes in terms of changes in sleepiness, psycho-motor vigilance, and ocular markers of sympathetic tone.  Sleep parameters (e.g., schedules, phasing, quality and quantity), perceptive and affective aspects of sleepiness (e.g., cognizance of sleepiness, self-monitoring of sleep habits), and sleep deprivation consequences (slower reaction times and impairments in memory, cognition, emotional processing, judgment, and decision-making) are all amenable to study with VR.

VR has some unique characteristics as a research tool. The virtual environments can be designed to address specific hypotheses, and data on the study participant’s response to the intervention can be collected in high detail without additional intrusiveness. Phenomena that are amenable to study, and also treatment, include cue responsiveness and extinction through virtual exposure, a feature that has been used to advantage in treatment of phobias and addictions. Visual presentations can be tailored to the user, along with therapeutic guidance to modify affective reactions and choices, and can prepare the user for future “real-world” encounters, thus making VR suitable for role-playing and training. Performance feedback, an essential component of learning and skill acquisition, can occur in real-time; thus VR can be used as a teaching tool and also to study cognitive processing of information presented in increasingly complex (‘hierarchical”) environments, a research approach that often is not practical in “real world” settings. Also, the capability to distribute identical virtual environments across multiple locations gives new meaning to the concept of multi-site data collection.

For researchers, an advantage is that the VR approach can simultaneously deliver an intervention and collect data on how it is utilized, particularly with regard to the cognitive and emotional processes involved.  Study design and methodology challenges include: identification of appropriate control groups and control conditions, and of characteristics of rigorous efficacy and effectiveness studies of VR;  exploration of ethical issues with different types of studies such as direct comparison designs (Standard of Care [SOC] vs. VR) and additive designs (SOC vs. SOC+VR); characterization of how participant traits (such as age, literacy and numeracy level, motivation and other cognitive and psychosocial traits), and previous gaming experience moderate technology usability and study outcomes; development of well-defined metrics for assessment of interventions and outcomes, including actual as well as intended VR “dose;” development of  VR research tools that could be used in group or multi-site formats (e.g. classrooms); and development of methods for mining data from existing health games for research purposes.

SELECTED RESEARCH EXAMPLES:

There is a need for both developmental VR research leading to new methods and technologies and marketable commercial products.  There is also the need for research that provides a venue for well-powered effectiveness trials of the new interventions.  Progress in the field will be enhanced by multidisciplinary collaborations between the technology industry and academia, and among researchers with diverse expertise in biomedical sciences (such as endocrinology, nutrition, and exercise physiology), behavioral science and pedagogical disciplines, and computer sciences including VR technologies.  There is a need to document and evaluate currently available off-the-shelf programs.  Projects will need to be clearly defined with regard to:  research questions, technical approach, VR platforms, target population (by age, health condition, psychological status, education or literacy level, etc), and research outcomes. Many projects can be usefully conducted taking advantage of already existing tools, games, and software, although there is also a need to develop unique technologies. 

U.S. Army Medical Research and Materiel Command (USAMRMC)

The Telemedicine and Advanced Technology Research Center (TATRC) has substantial in-house subject matter expertise and experience in the application of information technologies, virtual reality, augmented reality, and gaming technologies for healthcare.  If the applicant would like to have the research project considered for supplemental funding from TATRC, a paragraph defining the military relevance should be included as such. Note that NIH grants policies as described in the NIH Grants Policy Statement will apply to all applications submitted and awards made in response to this joint-agency FOA.

Applications should involve development, use or adaptation of immersive or non-immersive VR environments.  Those projects focusing only on electronic means of research data collection (so-called “e-tools”), without VR components, will not fit the research objectives of this FOA.

Potential areas for hypothesis-testing research, and for exploratory, developmental or evaluation research, include (but are not limited to):

Using VR to foster desirable eating, physical activity, and other health-related behaviors:

Using VR to motivate by “fast-forwarding” to the future:

Utilizing motivational and teaching aspects of VR technology:

Using VR to extend the availability and capacity of health care providers:

Social networking capabilities of VR, including:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
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.

In addition, pending availability of funds and identification of suitable projects, TATRC may decide to co-fund collaborative projects through offsets or administrative supplements when such opportunities arise. Funds would be transferred through MIPR mechanisms (equivalent to Interagency Agreement). TATRC has requested $250,000 for such use.

Award Budget

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

Award Project Period

Up to five 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 not 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 (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program 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.

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 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 modification:

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.  Applications that are incomplete will not be reviewed.

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 SF 424 (R&R) Application Guide.

Types of research and experimental approaches that are being sought to achieve the objectives of this FOA

Applications responding to this FOA should contain multidisciplinary research strategies drawing on expertise in VR technologies, biomedical sciences (such as endocrinology, nutrition, exercise physiology, cardiology), and behavioral sciences. Projects should be clearly defined with regard to aspects such as the research question to be answered, the technical approach, VR platform, target population (by age, health condition, psychological status, education or literacy level, etc), and research outcomes. Many projects can usefully be conducted taking advantage of already existing tools, games, and software, although applications also could seek to develop unique technologies. Applications focusing only on electronic means of research data collection (so-called “e-tools”), without VR components, will not be considered to fit the objectives of this FOA.

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/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?

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?   

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/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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

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.

Applications from Foreign Organizations

Not Applicable

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), in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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 NHLBI National Advisory Council. 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 Award

Not 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)

Abby G. Ershow, Sc.D.
Division of Cardiovascular Sciences,
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 8160 (MSC 7956)
Bethesda, MD 20892 (Express Zip Code: 20817)
Telephone: 301-435-0550
Fax: 301-480-3667
Email: ErshowA@nhlbi.nih.gov

Lynne Haverkos, M.D., MPH
Pediatric Behavior and Health Promotion Program
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room  4B05G
Bethesda,  MD 20892-7510
Rockville, MD 20852 (for FEDEX)
Phone: 301-435-6881
Fax: 301-480-0230
Email: haverkol@mail.nih.gov

Charles Peterson, M.D.
Department of Defense
Telemedicine and Advanced Technology Research Center (TATRC)
Building 1054 Patchel Street,
Fort Detrick, MD 21702-5012
Telephone: 301-619-4197
Email: charles.peterson@tatrc.org

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)

Teresa Marquette
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 7128 (MSC 7926)
Bethesda, MD 20892 (Express Zip Code: 20817)
Telephone: 301-435-0166
Fax: 301-435-5462
Email:marquettet@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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