and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
Funding Opportunity Title |
Therapeutics for Neurotropic Biodefense Toxins and Pathogens (R21/R33) |
Activity Code |
|
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-AI-11-027 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.855; 93.856 |
FOA Purpose |
To support basic to translational research focused on development of new therapeutic strategies for neurotropic intoxication or infection caused by select biodefense pathogens. |
Posted Date |
May 27, 2011 |
Open Date (Earliest Submission Date) |
September 24, 2011 |
Letter of Intent Due Date |
September 23, 2011 |
Application Due Date(s) |
October 24, 2011, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
February, 2012 |
Advisory Council Review |
May, 2012 |
Earliest Start Date(s) |
July, 2012 |
Expiration Date |
October 25, 2011 |
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
There is a critical need for therapeutics that target toxins or pathogens in neural tissues. Treatment of neurotropic intoxications and infections is often compromised by neuronal delivery limitations and/or the protective role of the blood-brain barrier, which serves to restrict passage of many molecules into the brain. Development of therapeutics for neurotropic toxins and pathogens requires a detailed understanding of neural-specific host-pathogen interactions and the inherent challenge of delivering candidate therapeutics across the blood-brain barrier and/or into neural tissues. Current therapeutic strategies for neurotropic toxins and pathogens include passive immunotherapy, anti-binding or anti-replication agents, drugs that alleviate symptoms caused by pathogen replication in the brain or neural tissues, agents that affect host immune system activities, and neutralizing molecules capable of transport into neurons or across the blood-brain barrier. Therapeutic strategies involving combinations of passive immunotherapy and anti-replication agents or vaccines have also been developed. For many neurotropic intoxications or pathogens, these therapeutic approaches, which are often effective only in the early stages of an infection, provide limited efficacy due to misdiagnosis and/or rapid localization of a toxin or pathogen into the protected neural tissues. The objective of this Funding Opportunity Announcement (FOA) is to support research focused on development of therapeutic strategies that target select biodefense toxins or pathogens in neural tissues.
This initiative seeks to stimulate basic and early-stage translational research focused on development of novel therapeutic strategies that address intoxication or infection of the brain and/or neurons by select biodefense toxins and pathogens. Responsive applications will define and address a therapeutic need specific to a targeted neurotropic toxin or pathogen; applications that focus on development of novel or adjunctive technologies to facilitate transport of new or existing therapeutics across the blood-brain barrier or into affected neurons are of particular interest.
Examples of areas to be studied under this initiative include, but are not limited to:
Responsive applications must address discovery and/or development of new therapeutics against one or more of the following neurotropic agents:
Clostridium botulinum toxin
West Nile Virus (WNV)
Japanese Encephalitis Virus (JEV)
Eastern Equine Encephalitis Virus (EEEV)
Rabies Virus
Nipah Virus
Coccidioides immitis
Coccidioides posadasii
Projects that include non-listed pathogens in addition to a listed pathogen are responsive. Non-responsive applications will not be reviewed.
This FOA will use the NIH Phased Innovation Award (R21/R33) that couples the Phase I (R21) and Phase II (R33) Exploratory/Developmental Research Grant award mechanism. The combined R21/R33 application offers two advantages over the regular application process: (1) single submission and evaluation of both the R21 component and the R33 component as one application; and (2) minimal or no funding gap between the R21 and R33 phases.
The R21 phase provides up to two years of funding for innovative hypothesis-driven projects supported by limited or no preliminary data to allow investigators to demonstrate feasibility of candidate technologies using milestones. Although preliminary data are not required, applicants are urged to supply preliminary data when possible, and in lieu of preliminary supporting data, are urged to provide sufficient information to allow assessment of the rationale for the proposed hypothesis or concept. The R33 award provides a second phase for the support of additional innovative exploratory research initiated under the R21 mechanism for a period of up to three years, for a total period of support of five years.
Transition of the R21 to the R33 phase will be expedited and is dependent on the completion of negotiated milestones. Milestones will be evaluated in the peer review process and negotiated with NIAID program staff prior to award of the R21 phase. Once they are achieved, the R33 phase will be considered.
Although applicants are solely responsible for planning, directing, and executing the proposed project, the transition from the R21 feasibility phase, and eligibility for award of the R33 development phase, will be determined by NIAID program staff. Eligibility for transition to the R33 phase will be based on successful completion of the negotiated milestones, program priorities, and availability of funds.
Under this FOA, applicants may only submit for the combined R21/R33 (Phased Innovation Award). Applications for R21 or R33 support alone are not responsive to this FOA. Investigators seeking support solely through the R21 mechanism are encouraged to apply for the NIH-wide R21 Exploratory/Developmental Research Grant Program (see http://grants2.nih.gov/grants/guide/pa-files/PA-06-181.html, or other announcements).
Funding Instrument |
Grant |
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 NIAID intends to commit $4 million in total costs in FY2012 to fund 15 to 20 applications in response to this FOA. |
Award Budget |
Support for the R21 phase cannot exceed two years and direct costs are limited to $275,000 over the R21 two-year period, with a maximum of $200,000 in direct costs allowed in any single year. The R33 award phase is limited to $300,000 in direct costs per year and cannot exceed three years. The NIAID anticipates that a maximum of fifty percent (50%) of the funded R21 phase awards will progress to the R33 award. |
Award Project Period |
The total project period for an application submitted in response to this FOA cannot exceed five years. Awards will support milestone-driven exploratory/feasibility proof-of-concept studies (two-year R21 phase), with possible rapid transition to expanded development (three-year R33 phase). |
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
Foreign (non-U.S.) components of U.S. Organizations 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/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 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. NIH will not accept any application that is essentially the same as one already reviewed.
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.
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:
Lianyong Gao, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3246, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (Express Couriers: 20817-7616)
Telephone: (301) 443-8115
Fax: (301) 480-2408
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 application submission. 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:
Research Strategy
In addition to the instructions in the SF424 (R&R) Application Guide, the Research Strategy must include:
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.
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) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations 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/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIAID, 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.
For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
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/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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.
Milestones
Given the critical nature of the milestones for the potential R21 to R33 transition, are the proposed Milestones well-defined with quantifiable measures that are appropriate for assessing the success of the R21 phase of the application? Do the Milestones have specific quantifiable criteria that will enable clear decisions about their attainment? Is it clear how the R33 phase of the study will develop and expand once the R21 Milestones are achieved? Given the potential benefits of the proposed research, do the milestones support the transition and will the overall project advance the compound, target, technology or strategy?
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.
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 National Institute of Allergy and Infectious Diseases , 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 National Advisory Allergy and Infectious Diseases Council l. 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.
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.
It is strongly recommended that applicants contact
institute staff at an early stage in application
development to discuss programmatic responsiveness of the proposed project.
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]
Dr. Marian Wachtel
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5122, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 451- 3754
Email: [email protected]
Dr. Michael Schaefer
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3613, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 451-3758
Email: [email protected]
Lianyong Gao, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3246, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (Express Couriers: 20817-7616)
Telephone: (301) 443-8115
Fax: (301) 480-2408
Email: [email protected]
Devon Bumbray-Quarles
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
(NIAID)
Room 2261, MSC 7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-6213
E-Mail: [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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