and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Heart, Lung, and Blood Institute (NHLBI) |
|
Funding Opportunity Title |
Virtual Reality Technologies for Research and Education in Obesity and Diabetes (R41/R42) |
Activity Code |
R41/R42 Small Business Technology Transfer (STTR) Grants - Phase I, Phase II, and Fast-Track |
Announcement Type |
New |
Related Notices |
Telemedicine and Advanced Technology Research Center (TATRC)
|
Funding Opportunity Announcement (FOA) Number |
RFA-HL-12-024 |
Companion FOA |
RFA-HL-12-020 Virtual Reality Technologies for Research and Education in Obesity and
Diabetes (R43/R44) |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.837, 93.838, 93.839, 93.233, 12.420 |
FOA Purpose |
The purpose of this Funding Opportunity Announcement (FOA) is to encourage the small business research community to submit applications that capitalize on the unique capabilities of Virtual Reality (VR) technologies to teach, motivate, visualize outcomes, and to extend the health care and learning environments for patients with obesity and diabetes. The VR technology proposed should 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 Virtual Reality 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. |
Posted Date |
May 10, 2011 |
Open Date (Earliest Submission Date) |
June 11, 2011 |
Letter of Intent Due Date |
June 13, 2011 and June 11, 2012 |
Application Due Date(s) |
July 11, 2011 and July 11, 2012, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
October/November 2011 and October/November 2012 |
Advisory Council Review |
January 2012 and January 2013 |
Earliest Start Date(s) |
April 2012 and April 2013 |
Expiration Date |
July 12, 2012 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
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.
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. 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.
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 VR 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.
Applications must 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 be considered responsive.
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 social network capabilities of VR:
Utilizing motivational and teaching aspects of VR technology:
Using VR to extend the availability and capacity of health care providers:
Funding Instrument |
Grant |
Application Types Allowed
|
New (Phase I) The OER Glossary and the SF424 (R&R) SBIR/STTR 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. NIH intends to fund approximately 10 awards for a total of $1,900,000 for fiscal year 2012 and another 10 awards for a total of $1,900,000 for fiscal year 2013. Future year amounts will depend on annual appropriations. NIH and other components may award additional grants under this announcement subject to programmatic interest and availability of funds. |
Award Budget |
According to statutory guidelines, total funding support
normally may not exceed $100,000 for Phase I awards and $750,000 for Phase II
awards. Applicants are encouraged to propose a budget that is reasonable and
appropriate for completion of the research project. |
Award Project Period |
According to statutory guidelines, award periods normally may not exceed 1 year for Phase I and 2 years for Phase II. Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project. |
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.
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
1. Is organized for profit, with a place of business
located in the United States, which operates primarily within the United States
or which makes a significant contribution to the United States economy through
payment of taxes or use of American products, materials or labor;
2. Is in the legal form of an individual proprietorship, partnership, limited
liability company, corporation, joint venture, association, trust or
cooperative, except that where the form is a joint venture, there can be no
more than 49 percent participation by foreign business entities in the joint
venture;
3. Is at least 51 percent owned and controlled by one or more individuals who
are citizens of, or permanent resident aliens in, the United States,
or it must be a for-profit business concern that is at least 51%
owned and controlled by another for-profit business concern that is at least
51% owned and controlled by one or more individuals who are citizens of, or
permanent resident aliens in, the United States, except in the case of a joint
venture, where each entity to the venture must be 51 percent owned and
controlled by one or more individuals who are citizens of, or permanent
resident aliens in, the United States; and;
4. Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR 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.
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 the STTR program, the PDs/PIs may be employed with the SBC or the single, partnering non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual. Each PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration
The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit 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 SF424 (R&R) SBIR/STTR Application Guide.
A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.
In Phase I and Phase II, at least 40% of the work must be
performed by the small business concern and at least 30% of the work must be
performed by the single, partnering research institution. The basis for
determining the percentage of work to be performed by each of the cooperative
parties will be the total of direct and F&A/indirect costs attributable to
each party, unless otherwise described and justified in Consortium/Contractual
Arrangements of the PHS398 Research Plan component of the SF424 (R&R)
application forms.
A small business concern may subcontract a portion of its STTR award to
a Federally Funded Research and Development Center (FFRDC), either in its
capacity as the Research Institution or as a participant in the STTR project in
another capacity. However, STTR funds may not be used to pay for laboratory
resources of non-FFRDCs, and no STTR funds may be used to pay for
subcontracting any portion of the STTR award back to the issuing agency or to
any other Federal government unit unless a waiver is granted by the Small
Business Administration.
The basis for determining the percentage of work to be
performed by each of the cooperative parties in Phase I or Phase II will be the
total of the requested costs attributable to each party, unless otherwise
described and justified in Consortium/Contractual Arrangements of the PHS398
Research Plan component of SF424 (R&R) application forms.
Additional details are contained in the SF424 (R&R) SBIR/STTR
Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR 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.
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:
Director, Office of Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214 (Express Mail Zip:
20817)
Fax: 301-480-0730
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
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) SBIR/STTR Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) SBIR/STTR 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) as provided in the SF424 (R&R) SBIR/STTR Application Guide.
Appendix
Do not use the appendix to circumvent page limits. Note that Phase I SBIR/STTR Appendix materials are not permitted, unless requested specifically by NIH SBIR/STTR The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide.
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) SBIR/STTR Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Instructions. 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) SBIR/STTR 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.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Reviewand responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/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).
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? Is the project clearly defined with regard to over-eating, under-exercising and sustainable behavior change? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)
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? Does the project take advantage of already existing tools, games, and software while also proposing to develop unique technologies?
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? Is the project 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?
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 arrangement?
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.
Phase II Applications
For Phase II Applications, how well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?
Phase I/Phase II Fast-Track Applications
For Phase I/Phase II Fast-Track Applications,
reviewers will consider the following:
1. Does the Phase I application specify clear, appropriate, measurable goals
(milestones) that should be achieved prior to initiating Phase II?
2. To what extent was the applicant able to obtain letters of interest,
additional funding commitments, and/or resources from the private sector or
non-SBIR/STTR funding sources that would enhance the likelihood for
commercialization?
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 Phase IIB Applications (formerly called Phase II Competing Renewals), the committee will consider the progress made in the last funding period.
Revisions
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by NHLBI Review 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 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 NHLBI Advisory Council. The following will be considered in making funding decisions:
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.
Information regarding the disposition of applications is available in the NIH Grants
Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee 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.
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.
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.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.
Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.
For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF424 (R&R) SBIR/STTR Application Guide.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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 301-710-0267
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
Abby G. Ershow, Sc. D., FAHA
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0550
Email:ershowa@mail.nih.gov
Charles Peterson, M.D.
United States Army
Telemedicine and Advanced Technology Research
Tel. 301-619-4197
Email:charles.peterson@tatrc.org
Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214 (MSC 7924)
Bethesda, MD 20892 (Express Zip Code: 20817)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
Teresa
Marquette
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7128 (MSC 7926)
Bethesda, MD 20892 (Express Zip Code: 20817)
Telephone: 301-435-0166
Email:marquettet@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) and P.L. 102-564 (Small Business Research and Development Act).The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.
The STTR Program is mandated by the Small Business Reauthorization Act of 1997 (P.L. 105-135), and reauthorizing legislation, Small Business Technology Transfer Program Reauthorization Act of 2001 (P.L. 107-50). The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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