and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute on Aging (NIA) |
|
Funding Opportunity Title |
T1 Translational Research on Aging: Small Business Innovation Awards (R43/R44) |
Activity Code |
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-AG-12-009 |
Companion FOA |
RFA-AG-12-010, SBIR R43/R44 Phase I, Phase II, and Fast Track |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.866 |
FOA Purpose |
The involvement of small businesses in translational aging research could hasten the pace at which scientific advances are transformed into commercial products to improve or maintain the health and functional independence of older adults. Therefore, this funding opportunity announcement (FOA) is intended to support innovative research conducted by small businesses to advance the availability of novel devices, products, health care practices and programs with the potential for commercial success and the likelihood to benefit the lives of older adults. For the purposes of this FOA, T1 translational research on aging is defined as the application of basic and clinical biomedical or basic behavioral and social research findings towards the development of new strategies for prevention and treatment of age-related pathologies. T1 translational research approaches could include the development of new or existing technologies to diagnose, prevent or treat age-related conditions, functional decline and disability or for the promotion of health and well-being in mid- and later life. |
Posted Date |
August 4, 2011 |
Open Date (Earliest Submission Date) |
October 4, 2011 |
Letter of Intent Due Date |
October 4, 2011 |
Application Due Date(s) |
November 4, 2011, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not applicable. |
Scientific Merit Review |
February/March 2012r |
Advisory Council Review |
May 2012 |
Earliest Start Date(s) |
July 1, 2012 |
Expiration Date |
November 5, 2011 |
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:
The involvement of small businesses in translational aging research could hasten the pace at which scientific advances are transformed into commercial products to improve or maintain the health and functional independence of older adults. Therefore, this funding opportunity announcement (FOA) is intended to support innovative research conducted by small businesses to advance the availability of novel devices, products, health care practices and programs with the potential for commercial success and the likelihood to benefit the lives of older adults.
For the purposes of this FOA, T1 translational research on aging is defined as the application of basic and clinical biomedical or basic behavioral and social research findings towards the development of new strategies for prevention and treatment of age-related pathologies. T1 translational research approaches could include the development of new or existing technologies to diagnose, prevent or treat age-related conditions, functional decline and disability or for the promotion of health and well-being in mid- and later life. For example, SBIR grant applications may be submitted for the development of novel diagnostic assays, diagnostic or assistive devices, point- of-care technologies, as well as the pre-clinical development of therapeutics involving small molecules, biologics and devices, for normal cognitive aging, Mild Cognitive Impairment (MCI) and Alzheimer’s disease (AD).
Applicants interested in proposing translational research projects relating to the development, evaluation or dissemination of scientific findings into new health care practices and community programs for older adults, and development of new technologies to enhance productivity in aging research should refer to the companion RFA on T2 research (RFA-AG-12 010). Additional information on NIA funding considerations for RFA-AG-12-009 and RFA-AG-12-010 is available at: http://www.nia.nih.gov/GrantsAndTraining/FundingOpportunities/TranslationalResearch.htm .
RESEARCH OBJECTIVES:
Eligible small businesses are invited to submit grant applications (including Phase I, Phase II and Fast Track SBIR applications) proposing to develop and deliver technologies or products appropriate to the needs of midlife or older adults and to clinicians responsible for their care. Responsive applications will include a description of the specific healthcare requirement or need of the older population being addressed.
Applicants should also include a timeline and milestones for projects submitted in response to this FOA. All types of applications whether they are Phase I, Phase II or Fast Track should include a timeline with project stages, milestones, etc., but the nature of the timeline should be appropriate to the work proposed. The timeline should delineate a series of project stages, identify criteria for completion of work stages and provide contingency plans for each work stage. It is important that the applicant includes the criteria and contingency plans that will be used to determine milestone completion before proceeding to the next stage of the project.
T1 translational topics include but are not limited to:
Creation and validation of screening assays for therapy development. The assays may be intended for primary or secondary screening efforts at any level of throughput.
Creation of animal models of MCI, AD and normal cognitive aging for therapy development. Animal models that will be used for basic research are outside the scope of the program.
Validation of putative therapeutic targets that are mechanistically linked to cognitive aging, MCI and AD.
Identification of candidate therapeutics, including primary or secondary screening efforts at any level of throughput.
Development of preliminary proof-of-principle data on the efficacy of candidate therapeutics.
Development and/or testing of novel methods to identify phenotypes with different AD risk profiles (imaging, biochemical and cognitive biomarkers, individually or in combination).
Non-invasive or minimally obtrusive technology for monitoring specific physiologic outcomes (e.g., pulmonary function, metabolism) in a free-living setting.
Portable diagnostic or therapeutic systems (e.g., devices for point-of-care diagnosis, adaptation of existing interactive video games to train older individuals for mobility problems).
Development of assistive technologies for age-related mobility problems.
Development and testing of new vaccine formulations to improve vaccine response in older adults.
Development of stem cell-or progenitor cell- based interventions to repair or rejuvenate aged tissues.
Development of technologies or products to relieve skin conditions associated with prolonged immobilization (e.g., sores or wounds resulting from long-term confinement to a bed).
New sampling and data collection methodologies for use in large population-based household surveys and behavioral interventions of relevance to aging. These include:
Experience sampling and new devices for real-time collection of data.
Performance based measures for cognitive or physical functioning as well as new instruments for cognitive testing, sleep quality, assessment of basic decision-making domains, or assessments of social behaviors.
Improvements to blood spot technology for biological data collection (this includes the development of multiple and reliable assays for limited blood spot specimens).
Development of Survey/Archiving/Database support, including:
Development of new databases and database support to satisfy data and research needs in aging as well as the development of innovative data archives to make current statistical and epidemiological data more accessible and policy relevant.
Development of data extraction web tools for public use databases.
Development of innovative methods and software to provide improved access to complex longitudinal studies or surveys that cannot be placed in open data archives because of confidentiality issues.
Development of innovative methods and software to facilitate analysis of personal data linked to geocoded data, biological, cognitive or genetic measures, with improved protection for confidentiality.
Development of data infrastructure and tools for assessing the economic impact of federally-funded research.
Funding Instrument |
Grant |
Application Types Allowed
|
New (Phase I, Phase II, Fast-Track) 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. NIA intends to commit an estimated total of $2.0 Million in FY2012 for meritorious projects responsive to this FOA.. |
Award Budget |
According to statutory guidelines, total funding support normally may not exceed $150,000 for Phase I awards and $1,000,000 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 6 months 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.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.
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.
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, normally, a minimum of two-thirds or 67% of the
research or analytical effort must be carried out by the small business
concern. The total amount of all consultant and contractual arrangements to
third parties for portions of the scientific and technical effort generally may
not exceed 33% of the total amount requested (direct, F&A/indirect, and
fee).
In Phase II, normally, a minimum of one-half or 50% of the research or
analytical effort must be carried out by the small business concern. The total
amount of consultant and contractual arrangements to third parties for portions
of the scientific and technical effort generally may not exceed 50% of the
total Phase II amount requested (direct, F&A/indirect, and fee).
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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Chhanda Dutta, PhD
Division of Geriatrics and Clinical Gerontology
National Institute on Aging
7201 Wisconsin Ave, Suite 3C-307
Bethesda, MD 20892-9205
Telephone: 301-435-3048
Email: DuttaC@mail.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 submission of applications for this FOA. 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 and responsiveness by NIA. Applications that are incomplete and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIA Referral Office by email at VemuriR@nia.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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? 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? Is the translational research objective(s) clearly stated and address the specific healthcare requirement or need of the older population?
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? Is the overall plan for intervention/device/product development feasible and of high quality? Are the proposed project milestones adequate and feasible?
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.
For this particular announcement, the following additional criteria will apply as appropriate to the focus of the proposed project:
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
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/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 (an) appropriate Scientific Review Group(s) convened by NIA, 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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.
Information regarding the disposition of applications is available in the NIH Grants
Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
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.
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 301-710-0267
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
Chhanda Dutta, PhD
National Institute on Aging (NIA)
Telephone: 301-435-3048
Email: DuttaC@mail.nih.gov
Ramesh Vemuri, Ph.D.
National Institute on Aging
Telephone: (301) 496-9666
Email: VemuriR@nia.nih.gov.
Linda Whipp
National Institute on Aging (NIA)
Telephone: 301-402-7731
Email: WhippL@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.
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NIH Funding Opportunities and Notices
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