and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
Funding Opportunity Title |
Immunity in the Elderly (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
Reissue of RFA-AI-08-012 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-AI-12-038 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.855; 93.856; 93.866 |
Funding Opportunity Purpose |
The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Aging (NIA) invite applications to define the mechanisms for induction, development, and maintenance of protective immunity in the elderly in response to infections with or vaccinations against NIAID Emerging and Re-emerging Infectious Diseases (http://www.niaid.nih.gov/topics/emerging/Pages/list.aspx). The goal of this FOA is to develop a better understanding of the immune mechanisms involved during the aging process that contribute to impaired immune responses resulting in severe infections and dampened responses to vaccines in this population. This FOA requires human studies, to gain insights into immune changes in elderly individuals. Thus, at least one aim of the project must focus fully on human studies; appropriately justified animal work may be included in additional aims to conduct mechanistic studies that are not possible in humans. |
Posted Date |
September 28, 2012 |
Open Date (Earliest Submission Date) |
January 18, 2013 |
Letter of Intent Due Date |
January 18, 2013 |
Application Due Date(s) |
February 20, 2013, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
June, 2013 |
Advisory Council Review |
October, 2013 |
Earliest Start Date(s) |
March, 2014 |
Expiration Date |
February 21, 2013 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
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
The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Aging (NIA) invite applications from eligible organizations to define mechanisms for induction, development, and maintenance of protective immunity in the elderly in response to infections with or vaccinations against NIAID Emerging and Re-emerging Infectious Diseases (http://www.niaid.nih.gov/topics/emerging/Pages/list.aspx). This FOA builds on a previous initiative, "Rejuvenating the Aged Immune System" (RFA-AI-08-012), which focused on elucidating the mechanisms of thymic involution and defining approaches to reverse its effects in aged animals. The goal of the new FOA is to develop a better understanding of the immunological changes that occur during the aging process and contribute to impaired immune responses to infections or vaccines. The information gained from these studies may be used in the long-term to improve immune status and reduce the burden of infection-related morbidity and mortality in the elderly. This FOA will include a focus on human studies, to gain insights into immune changes in elderly individuals. Thus, at least one aim of the project must focus fully on human studies; appropriately justified animal work may be included in additional aims to conduct mechanistic studies that are not feasible in humans.
According to the United Nations Population Division, the number of people in the world ages 60 and above will total approximately 1 billion by 2020. Longer life expectancy has increased the proportion of the elderly in both developed and developing countries. The elderly have an increased susceptibility to and prolonged recovery from infectious disease, and poor responses to vaccination. Thus, it is critical to understand the defects and changes in the immune system that are responsible for an observed decline in function, and the mechanisms that lead to this decline. Studies that contribute to a mechanistic understanding of immune defects in the elderly may allow the development of strategies to improve responses to infectious diseases and to increase vaccine efficacy in aging individuals.
Studies in both animals and humans demonstrate numerous changes in the immune system with advancing age. Many of these changes are often associated with important clinical manifestations such as increased susceptibility to infection, weakened responses to vaccinations, and vulnerability to cancers and autoimmune conditions. Infectious diseases in this population are likely to be more severe, and have a great impact on health outcomes, such as morbidity, disability, quality of life, and mortality. For example, death from pneumonia occurs more than twice as often in older adults compared with younger adults. Moreover, the capacity to respond to new potential pathogens appears to diminish throughout life. Studies have shown that older individuals respond at a lower rate to vaccines against influenza, hepatitis B, and pneumococcal polysaccharides. Decreases in immune responsiveness observed in elderly populations are associated with diminished thymic output and a reduction in the proportion of circulating na ve T cells, accompanied by an increase in the number of memory T cells with a reduced diversity of the T cell antigen receptor repertoire. Other functional changes include impaired T cell proliferative capacity, a progressive increase in the proportion of T lymphocytes that are CD28 negative, decreased persistence of IgG antibodies, accumulation of memory B cells with restricted diversity, fewer na ve B cells, and a chronic inflammatory state.
The innate immune system, the body’s first line of defense against infections, also displays impaired responses in the elderly. Declining functional capabilities in cells such as macrophages and dendritic cells include phagocytosis, altered chemokine and cytokine secretion, decreased expression of pattern recognition receptors and dysregulation of their signaling cascades, and waning antimicrobial defenses. Defects have been reported in Toll-like receptor (TLR) expression, TLR-induced CD80 expression, and production of interleukin (IL)-6 and tumor necrosis factor-alpha (TNF-alpha) in monocytes and macrophages from older individuals compared to young adults. In contrast, several studies have demonstrated an increase in pro-inflammatory cytokine concentrations with age. Hence, understanding the mechanism(s) by which inflammatory cytokines secreted from monocyte/macrophages interact during an infection is essential for determining their role in mediating poor outcomes during infections in the elderly.
Studies have shown an increase in natural killer (NK) cell number in aging individuals; however, functional defects in cytotoxicity and impaired production of cytokines and chemokines were observed. NKT cells also exhibited altered responses. In vitro studies using invariant NKT cells revealed a shift from a Th1 to a Th2 cytokine profile in elderly individuals compared to young individuals. Neutrophils play an important role in the clearance of bacterial infections, and aspects of neutrophil function, such as phagocytic activity, chemotaxis, and opsonization, were found to be decreased in the elderly. These changes have important implications in the elderly not only for the clearance of infections but also for the resolution of inflammation. In addition, impairment of inflammasome function has been reported during viral infections such as influenza.
Changes affecting the innate and adaptive immune systems in the elderly result in a reduced ability to respond to pathogens and vaccines. Characterizing and understanding the mechanisms underlying these immunological changes will be critical for reducing the incidence and severity of infectious diseases in the elderly, and subsequently, the morbidity and mortality in this group of individuals.
This FOA builds on a previous initiative, "Rejuvenating the Aged Immune System" (RFA-AI-08-012), which focused on elucidating the mechanisms of thymic involution and defining approaches to reverse its effects in aged animals. The goal of this FOA is to gain a better understanding of the induction, development, and maintenance of protective immunity in the elderly in response to infections with or vaccines against NIAID Emerging and Re-emerging Infectious Diseases (http://www.niaid.nih.gov/topics/emerging/Pages/list.aspx). Information obtained from these studies may contribute to improving the immune status of, and reducing the burden of infection-related morbidity and mortality in the elderly.
Since the definition of the term "elderly" depends on numerous factors, each applicant must provide a description of the population(s) being studied and a justification for defining it as elderly (required for both human and animal studies).
Human studies must constitute at least one aim of the project. Appropriately aged animal models (e.g. rodents, nonhuman primates) may be used in additional aims to dissect mechanisms using approaches that may not be feasible in humans. The human studies may include: the use of samples obtained from human subjects immunized with licensed vaccines, where the vaccine is administered according to the product label instructions; samples collected in independent ongoing clinical trials; or samples obtained from repositories such as the Baltimore Longitudinal Study on Aging (BLSA; http://www.grc.nia.nih.gov/branches/blsa/blsa.htm). In this case, interested applicants are expected to establish collaborations with investigators responsible for these repositories prior to submitting the application for this FOA.
Applicants proposing to use aged rodents will be given access to the NIA aged rodent colonies (http://www.nia.nih.gov/research/scientific-resources#rodent) upon award. Therefore, applicants may assume they can obtain animals as available from this resource for their proposed studies. Investigators wishing to make use of aged nonhuman primate (NHP) models should provide a plan for accessing the appropriate number and age of animals that will be needed for the study (for a list of available NHP aging resources, please see http://dpcpsi.nih.gov/orip/cm/primate_resources_researchers.aspx and http://www.nia.nih.gov/research/nonhuman-primate-tissue-bank-handbook).
Examples of research areas supported by this FOA include but are not limited to those listed below:
The following research areas are NOT supported by this FOA. Applications proposing research in these areas will be considered non-responsive and will not be reviewed.
Annual Meetings
To assist in the overall evaluation of the research program, all awardees will participate in a kickoff meeting and subsequent annual meetings arranged by the NIAID and NIA program officers, to be held after award in the Bethesda, MD area. The purpose of these annual meetings is to discuss individual program progress and foster collaborations among the funded investigators. All investigators are expected to attend these annual meetings, together with additional scientific staff from their research groups when appropriate, and are expected to give oral presentations on current and planned activities and projects. Applicants should include travel costs in their applications to attend these meetings. The program progress meetings are open to investigators supported under this FOA and to NIH extramural staff.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
New 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 following NIH components intend to commit the
following amounts in FY2014: |
Award Budget |
Direct costs for each application are expected to be $300,000 or less per year, plus appropriate F&A costs. Budgets should be commensurate with the proposed studies and adequately justified. |
Award Project Period |
Scope of the proposed project should determine the project period. The maximum period is 5 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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 Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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(s)/PI(s))
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 6 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 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.
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 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.
Renewal applications from the "Rejuvenating the Aged Immune System" program are permitted in response to this FOA, since some of the research areas supported by the Rejuvenating the Aged Immune System program are within the scope of this new FOA. All renewal applications must comply with the current FOA requirements for inclusion of human studies as the focus of one research aim, and may include appropriate animal studies in additional aims.
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) 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:
Barney Duane Price, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
(NIAID)
Room 3139, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
For Express Couriers: 20817-1824
Telephone: 301-451-2592
Email: [email protected]
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) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims
Human studies must constitute at least one aim of the project. Appropriately aged animal models (e.g. rodents, nonhuman primates) may be used in additional aims to dissect mechanisms using approaches that may not be feasible in humans. The human studies may include: the use of samples obtained from human subjects immunized with licensed vaccines, where the vaccine is administered according to the product label instructions; samples collected in independent ongoing clinical trials; or samples obtained from repositories such as the Baltimore Longitudinal Study on Aging (BLSA; http://www.grc.nia.nih.gov/branches/blsa/blsa.htm). In this case, interested applicants are expected to establish collaborations with investigators responsible for these repositories prior to submitting the application for this FOA.
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.
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout 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) 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 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(s)/PI(s) 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 and responsiveness by NIAID and NIA, 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?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the investigators demonstrate experience with the proposed techniques?
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?
For the human studies, are sufficient numbers of subjects included and is there a high likelihood that the samples needed for the proposed studies will be obtained? Are appropriate controls included for the proposed subjects? Are the descriptions of the population(s) being studied and the justification for defining it as elderly adequate and reasonable? Is the sample size adequate for data interpretation? Are the source and procedures for the collection of clinical samples clearly described and are all the logistics and feasibility issues addressed and adequately justified? Does the preliminary data provided demonstrate project feasibility and experience with the proposed techniques?
For projects involving animal models, are sufficient numbers of animals included? Is the animal model adequately justified with respect to its relevance to human responses and the scientific goals and research strategy proposed? Are the descriptions of the proposed animal population(s) being studied and the justification for defining it as elderly adequate and reasonable? Are appropriate controls included? Are the source of the animals and the procedures for the collection of samples clearly described and are all the logistics and feasibility issues addressed and adequately justified? Does the preliminary data provided demonstrate project feasibility and experience with the proposed techniques?
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?
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
Not Applicable.
Renewals
For 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.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources. .
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS)..
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIAID, 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:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
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 appropriate national Advisory Council or Board. 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.
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.
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.
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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
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: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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: [email protected]
Mercy PrabhuDas, Ph.D., M.B.A.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
(NIAID)
6610 Rockledge Drive, Room 6402
Bethesda, MD 20892-6601
Telephone: 301-496-7551
Email: [email protected]
Rebecca Fuldner, Ph.D.
Division of Aging Biology
National Institute of Aging (NIA)
7201 Wisconsin Ave, Suite 2C231
Bethesda, MD 20814-4808
Telephone: 301-496-6402
Email: [email protected]
Barney Duane Price, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
(NIAID)
Room 3139, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
For Express Couriers: 20817-1824
Telephone: 301-451-2592
Email: [email protected]
Donna Sullivan
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
(NIAID)
6700B Rockledge Drive, Room 2112
Bethesda, MD 20892-7616
Telephone: 301-594-6361
Email: [email protected]
Jillian Morris
Grants Management Program
National Institute on Aging (NIA)
Gateway Building, Room 2N212
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: 301-496-8986
Email: [email protected]
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.
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