National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Funding Opportunity Title
Partnerships for Biodefense (R01)
R01 Research Project Grant
Funding Opportunity Announcement (FOA) Number
Catalog of Federal Domestic Assistance (CFDA) Number(s)
This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), invites research applications for projects that support preclinical development of lead candidate vaccines, therapeutics, adjuvants or diagnostics against NIAID Category A, B, or C priority agents. Applications must include a Product Development Strategy attachment and demonstrate substantive investment by at least one industrial participant.
March 7, 2011
Open Date (Earliest Submission Date)
April 27, 2011
Letter of Intent Due Date
April 27, 2011
Application Due Date(s)
May 27, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date(s)
May 28, 2011
Due Dates for E.O. 12372
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), National Institutes of Health (NIH), supports extramural research focused on understanding, controlling and preventing diseases caused by virtually all infectious agents. In response to threats presented by bioterrorism and emerging infectious diseases, the NIAID Division of Microbiology and Infectious Diseases (DMID) has established research programs to facilitate development of countermeasures for certain pathogens and toxins.
Through this FOA, the NIAID invites research applications for projects focused on preclinical development of lead candidate vaccines, vaccine technologies, adjuvants, therapeutics, immunotherapeutics and/or medical diagnostics that address one or more NIAID Category A, B, or C priority pathogens and toxins (agents) (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm). For the purpose of this FOA, “lead candidate” is defined as a candidate (vaccine/vaccine technology, adjuvant, therapeutic, or diagnostic/diagnostic technology) for which proof-of-concept data have been obtained; “preclinical development” is defined as all activities beyond lead candidate identification (vaccines, adjuvants, therapeutics) or assay/platform/prototype development (diagnostics). Examples of research areas may include: lead optimization; safety evaluation; stability testing; manufacturing; adaptation of platform technologies or products to biodefense applications; development of broad spectrum platforms and/or production technologies; optimization of products; process development; scale-up; production of quantities sufficient for preclinical regulatory requirements; and diagnostic validation.
All applications submitted to this FOA must demonstrate substantive investment in the project by at least one industry participant. For the purpose of this FOA, "industry" is defined as large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and chemical companies. “Substantive investment" is defined as a significant commitment of one or more resources including, but not limited to: product development support/guidance, personnel, in kind contributions of materials and/or reagents (i.e. chemical libraries, innovative biotechnology platforms, scale up of GMP chemical synthesis or production, etc.), provision of animal or other laboratory models for evaluation, subcontracts, data management resources, regulatory support, or alterations/renovations of facilities or provision of equipment to address biohazard concerns. The Principal Investigator of the project may be affiliated with either industry or an academic organization; however, if the PD/PI is from academia, an industrial partner must be identified in the application. Since academic organizations are often the source of new candidate products, collaborative partnerships between researchers from academic (or non-profit) and industrial disciplines are encouraged.
The NIH and other agencies in the Department of Health and Human Services (DHHS) support development of countermeasures to protect the public from bioterrorist threats and emerging infectious diseases. The biological agents deemed to pose the greatest threat are prioritized in the NIAID Category A, B and C priority agents list. The initial NIAID Strategic Plan for Biodefense Research was published in 2002 and followed by research agendas for Category A agents and Category B and C agents(http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/about/Pages/strategicplan.aspx). In 2007, the DHHS Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) published an Implementation Plan (http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html), outlining strategies for identifying medical countermeasure requirements and establishing priorities for their research, development and acquisition.
In 2007, NIAID published an updated Strategic Plan for Biodefense Research (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Documents/biosp2007.pdf) that is consistent with the DHHS PHEMCE Implementation Plan and related components of the national biodefense strategy. The updated plan continues to focus on translation of basic research to product development, but with an emphasis shift from the current “one bug-one drug” approach towards a more flexible, broad spectrum approach. This approach is centered on development of countermeasures that are effective against multiple pathogens or toxins, development of technologies that can be widely applied to improve classes of products, and developing platforms that can reduce the time and cost of creating new products. The broad spectrum approach recognizes the expanding range of biological threats and the limited resources available to address each individual threat.
Research Goals and Objectives
The objective of this FOA is to support preclinical research that will advance the development and/or production of lead biodefense countermeasures (vaccines, vaccine technologies, adjuvants, therapeutics, immunotherapeutics, and medical diagnostics) specific for NIAID Category A, B, or C priority agents. To meet the objectives outlined in the NIAID Strategic Plan for Biodefense Research, it is imperative that lead candidates/technologies are transitioned rapidly to preclinical product development. Applicants are encouraged to read the updated NIAID Strategic Plan for Biodefense Research (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Documents/biosp2007.pdf) before preparing an application.
As part of the Research Strategy section, each application must propose a research and development project whose goal is to advance an already identified lead candidate vaccine, adjuvant, therapeutic and/or diagnostic focused on one or more NIAID Category A, B or C agents. It is not necessary to propose to complete the product development process up to the point of readiness for clinical trials within the time frame of this project. Applications that would significantly advance a specific product toward clinical or field usefulness are responsive. Research projects are not required to result in a "final" product but must advance the development of a candidate product. Descriptions of each of the priority areas and examples of possible research project are discussed below.
NOTE: While clinical development strategies may be included within an overall project, this FOA will NOT support clinical trials; applications requesting support for clinical trials will be deemed unresponsive to this FOA and will not be reviewed. Utilization of human-derived material in pre-clinical studies in support of compliance with regulatory requirements is permitted and encouraged.
Note: PD/PIs are strongly encouraged to obtain expertise in regulatory matters associated with product development. Expertise may be retained as defined effort or may be include as periodic consultation on specific issues.
Vaccines for Biodefense
Vaccines are the most effective method of protecting the public against infectious diseases. Applications for preclinical development of a lead candidate vaccine against a NIAID Category A, B, or C agent are invited. Note that development of vaccines against bacterial Category A pathogens and toxins, orthopoxviruses and influenza viruses is currently well represented within the NIAID biodefense research portfolio; accordingly, this FOA encourages applications for preclinical development of vaccines against other Category A, B or C agents. For all vaccine projects, approaches should consider the ultimate potential of a candidate vaccine to quickly induce safe and protective responses in a diverse civilian population.
The NIAID Strategic Plan for Biodefense Research emphasizes development of broad spectrum vaccines against biological threat agents. Vaccines characterized by broad spectrum activity include cross-protective forms, which induce an immune response against constant components of two or more microbes, and multiple component forms, which include elements that protect against microbes that are different, but closely related. Applications for preclinical development of either a broad spectrum vaccine against multiple NIAID Category A, B, or C agents, or a broad spectrum vaccine against a non-listed agent that would also protect against a listed NIAID Category A, B, or C agent, are highly encouraged.
The NIAID Strategic Plan for Biodefense Research also emphasizes development of vaccine technologies. Applications focused on advanced (beyond proof-of-principle) development of vaccine technologies such as delivery platforms, stability, production and formulation methodologies, are encouraged.
Vaccine projects may include, but are not limited to, one or more of the following product development activities:
Adjuvants for Biodefense
The development of an enhanced immune response may require the administration or co-administration of an adjuvant or immunostimulatory compound. Applications for development of novel adjuvants that could be used in conjunction with specific pathogen components are invited. Adjuvants are broadly separated into two classes based upon their primary mechanism of action: vaccine delivery systems (e.g., emulsions, microparticles, immune stimulating complexes, and liposomes) that target associated antigens to antigen presenting cells, and immunostimulatory adjuvants (e.g., LPS, MLP, or CpG DNA) that directly activate innate immune responses. In order to advance the development of vaccine adjuvants against NIAID Category A, B, or C priority agents, this solicitation focuses on optimization and preclinical testing of prospective lead compounds that previously showed promise in early stages of discovery and development.
Adjuvant and immunostimulatory projects may include, but are not limited to, one or more of the following product development activities:
Therapeutics for Biodefense
Development of safe and effective antimicrobials against biodefense agents and emerging pathogens is a high priority. Applications for preclinical development of a therapeutic that targets a NIAID Category A, B, or C priority agent are invited, with particular interest in therapeutics targeting antibiotic-resistant pathogens and/or pathogens for which no standard clinical treatment exists.
The NIAID Strategic Plan for Biodefense Research emphasizes development of broad spectrum therapeutics. An anti-infective characterized by broad spectrum activity might target a common, invariable, or essential component of different classes of microbes and potentially be effective against traditional and non-traditional agents. Applications for development of either a broad spectrum anti-infective against multiple NIAID Category A, B, or C agents, or a broad spectrum anti-infective against a non-listed agent that would also protect against a listed NIAID Category A, B, or C agent, are encouraged. Applications proposing development of a therapeutic against a non-listed antibiotic-resistant pathogen must focus on development of a broad-spectrum therapeutic. For these projects, applicants must clearly describe the broad-spectrum capability of the proposed therapeutic technology.
Therapeutics projects may include, but are not limited to, one or more of the following product development activities:
Immunotherapeutics for Biodefense
Applications for preclinical development of immune-based therapeutics, including both broad-spectrum (innate immunity) and pathogen- or toxin-specific (antibodies) immunotherapeutics that target a NIAID Category A, B, or C agent are invited. Major objectives for lead candidates developed under this research program include prevention of infection or intoxication in the face of an immediate threat, protection of immunocompromised individuals, and post-exposure treatment to suppress infection and disease. Projects focused on compounds that directly affect pathogens/toxins and/or approaches to stimulate non-specific immunity are encouraged. Passive treatments may be especially valuable during the acute emergence of infectious diseases and may complement the use of antimicrobial drugs or vaccination programs to optimize protection.
Immunotherapeutics projects may include, but are not limited to, one or more of the following product development activities:
Diagnostics for Biodefense
This initiative will support development of diagnostics to rapidly identify NIAID Category A, B or C agents and their resistance profiles. Diagnostics are needed to identify infectious agents or toxins in diverse clinical samples (swabs, sputum, blood, serum, cerebrospinal fluid, urine, stool, etc.) from individuals at multiple stages of infection/intoxication. Thus, diagnostics applications must focus on detection and identification of biological threat agents in human clinical samples. Multiplexed diagnostics, as well as those able to provide diagnostic information on potential early, non-specific symptoms are particularly encouraged. Medical diagnostics that use platforms to simultaneously detect multiple agents and their drug sensitivities in clinical specimens and to rapidly distinguish whether an individual is infected/intoxicated with a biological threat agent or a common infection with similar, generalized symptoms are of high priority. It is anticipated that the medical diagnostics developed through this initiative will aid healthcare providers in diagnosing individuals exposed to and/or infected/intoxicated with aforesaid agents and will be developed with the eventual and ultimate goal of obtaining FDA clearance. However, FDA clearance need not be the final result of the proposed research project period.
Features of proposed medical diagnostics:
To be eligible for this FOA, applicants must propose development of a previously identified candidate diagnostic technology and include corresponding proof-of-concept data demonstrating feasibility. Applications for diagnostics in the final design stage(s) of product development in preparation for manufacture and validation are especially encouraged. All applications for research projects focused on diagnostics should include in the Research Strategy:
Diagnostic platforms/technologies projects may include, but are not limited to, one or more of the following areas:
NOTE: Applications proposing research in the following areas will be considered non-responsive and will not be reviewed:
Application Types Allowed
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 $20.2 million in total costs in FY2012 to fund 15 to 20 applications in response to this FOA
Budgets for direct costs of up to $750,000 per year may be requested. In addition, applicants may request up to a total of $300,000 for major equipment in the first year of the award to ensure that research aims can be met and biohazards can be contained. Prior consultation with NIAID is strongly encouraged for applicants requesting budgets in excess of these amounts. If the proposed application does not meet the goals of the mission of NIAID and this FOA, applicants will be strongly encouraged to apply for other Funding Opportunities Announcements.
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
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
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 Project 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
Number and title of this funding opportunity
The letter of intent should be sent to:
Frank S. De Silva, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive
Room 3144, MSC-7616
Bethesda, MD 20892-7616
(Express mail zip code 20817)
Phone: (301) 594-1009
Fax: (301) 480-2408
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:
ADDITIONAL APPLICATION COMPONENTS
Product Development Strategy
Applicants are required to include a Product Development Strategy as a separate attachment to Item #12 in the Research and Related Other Project Information Component of the application (See the Application Guide SF424 Adobe Forms Version B, Section 4.4 “Other Project Information Component”). The Product Development Strategy attachment must be in pdf format with a filename of “Product_Development_Strategy.pdf.” Applications lacking a required component of the Product Development Strategy section will be deemed non-responsive and will not be reviewed. The Product Development Strategy must include two sections entitled, “Milestones and Timeline”, and “Product Development Plan”. The overall Product Development Strategy is limited to 12 pages. See below for more information on these required components. (Note: Applicants should not add attachments to Item #12 in the Research and Related Other Project Information Component to circumvent page limits.
Milestones and Timeline
Applicants are required to provide detailed project performance and timeline objectives in a section entitled “Milestones and Timeline.” This section must be no more than 5 pages and must include:
Product Development Plan
Applicants are required to provide detailed development plans in a section entitled “Product Development Plan”. This section must be no more than 7 pages and must include:
Additionally, the Product Development Plan must include descriptions pertaining to preclinical product development activities pertaining to the product proposed. For the purpose of this FOA, “preclinical” is defined as all activities beyond lead candidate identification or diagnostic assay/platform/prototype development or vaccine technology proof-of-principle. Please see below for a list of points to be discussed as part of the Product Development Plan based on the type of product proposed.
Product Development Plans for vaccine, therapeutic or adjuvant projects should summarize:
Product Development Plans for diagnostics projects should summarize:
When appropriate and as part of the Product Development Plan, applicants must document compliance with guidelines that govern GLP, as defined by 21 CRF (58), and cGMP, as defined by 21 CRF (211), manufacturing and/or IND/IDE enabling studies that will be performed under the project award as they would be applicable to eventual product licensure in the U.S. Applications for projects involving cGMP manufacture should ensure inclusion of appropriate personnel to provide regulatory guidance before, during and after manufacture.
Applicants may request up to a total of $300,000 for major equipment to ensure that research aims can be met and biohazards can be contained. Funds for equipment must be included in the first year requested budget with justification, and are in addition to the $750,000 direct cost limit. Unapproved equipment requests that exceed $300,000 will not be considered for funding.
Biosafety and Biocontainment
In addition to addressing select agent requirements,
applicants must address issues related to physical or facility security and
biocontainment and biosafety pertinent to the specific agent(s) of interest.
Guidance on appropriate biocontainment and biosafety measures can be found in
the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
as found on the CDC website: http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm.
Guidelines for Institutional Biosafety Committees are available at: http://oba.od.nih.gov/rdna_ibc/ibc.html
A mandatory 1 day progress review meeting will be held annually at the NIAID, or at a site designated by the NIAID Program Official, during which the Principal Investigator and appropriate Key Personnel will present project accomplishments. Requested budgets must include funds for travel by the Principal Investigator and key personnel to an annual meeting in Bethesda, Maryland (USA), or to a relevant scientific meeting, as determined by NIAID Program staff. The NIAID Program Official will be present. A critical determinant of success will be the degree of communication between the Principal Investigator, Project Leaders and other significantly involved parties. Therefore, in addition to the one meeting listed above, additional meetings, which may be necessary for coordination of project activities, may be scheduled if justified. Regular telephone and written communication with the NIAID Program Official is considered to be very important and is strongly encouraged.
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.
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide Please see: (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-077.html.
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.
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 the 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.
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.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is this project likely to significantly advance the development of a vaccine, adjuvant, therapeutic or diagnostic against one or more of the specific biologic threat agents identified in this initiative? If the aims of the application are achieved, are important biomedical agents or products likely to result?
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? Do the regulatory personnel possess the appropriate expertise to guide cGMP manufacture and/or related processes (if applicable)?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the research proposed in each project leverage multi-disciplinary involvement to accelerate vaccines, adjuvants, therapeutics, immunotherapeutics, or diagnostics product development, many aspects of which may not be inherently innovative? In addition, does the approach represent the best use of current or emerging technologies and appropriate collaborations to achieve the research objectives?
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
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?
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.
Product Development Strategy
Does the Product Development Strategy adequately address the specific areas described in the FOA? Are the Milestones appropriate and feasible? Is the proposed Product Development Plan feasible and appropriate for proposed and future product development? Is the Plan consistent with achieving the goals of this program?
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.
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.
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.
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 (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
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 Allergy and Infectious Diseases Council . The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
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
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
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)
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
Frank S. De Silva, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
6700-B Rockledge Drive
Room 3144, MSC-7616
Bethesda, MD 20892-7616
(Express mail zip code 20817)
Telephone: (301) 594-1009
Cassandra L. Fields
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 2245, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
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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