Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
U01 Research Project Cooperative Agreements
Reissue of RFA-AI-16-001 - Immunity in Neonates and Infants (U01)
May 4, 2021 - Notice of Change in Key Dates for RFA-AI-20-077. See Notice NOT-AI-21-048.
RFA-AI-20-078 - Immune Development in Early Life (IDEaL) (U19 Clinical Trial Not Allowed)
93.855; 93.113, 93.865
The purpose of this Funding Opportunity Announcement is to support research to define the mechanisms regulating the establishment, development and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or commensal microbes or vaccination against infectious diseases, allergens or environmental pollutants on immune ontogeny and function. This program will establish collaborations among immunologists, neonatologists, pediatricians, systems biologists, and microbiologists to expand our knowledge of the developing immune system. Knowledge obtained through this program may be applied to the design of improved vaccines and immunotherapies to combat infections or treat/prevent immune-mediated diseases in this vulnerable population.
30 days prior to the application due date
New Date June 18, 2021 as per NOT-AI-21-048
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
New Date June 18, 2021 as per NOT-AI-21-048
All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
October 2021
January 2022
March 2022
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.
Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to support research to define the mechanisms regulating the establishment, development, and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or commensal microbes or vaccination against infectious diseases, allergens, and environmental pollutants on immune ontogeny and function. This program will establish collaborations among a diverse set of experts (e.g., immunologists, neonatologists, pediatricians, systems biologists, and microbiologists) to investigate the dynamics and drivers of immune development, regulation, and function throughout childhood (birth to less than 18 years old). Studies may include SARS-CoV-2, cytomegalovirus (CMV), herpes simplex virus (HSV), congenital syphilis, human immunodeficiency virus or acquired immunodeficiency syndrome (HIV/AIDS), tuberculosis (Mycobacterium tuberculosis), and other infections that affect children within this age range. Awardees will partner with other researchers to conduct longitudinal studies of existing cohorts of mother-infant dyads and/or children from birth to less than 18 years of age. The ultimate goal of this program is to expand knowledge of immune development and functionality in children that will provide foundational information to improve immune health and vaccine efficacy in this vulnerable population.
Background
Rapid changes occur during the development of the human immune system in early life when there is an increased risk of infection and associated morbidity and mortality. Globally, 85% of deaths among children and young adolescents in 2018 occurred in the first five years of life, accounting for 5.3 million deaths (WHO). Of these, 23% of neonatal deaths were due to infections such as sepsis, meningitis, pneumonia, tetanus, and diarrheal diseases. In contrast, in approximately 1 million children aged 5-14 years (WHO 2018 estimate), the leading causes of death included injuries and lower respiratory tract infections; by comparison, in the United States, adolescents and youth comprised approximately 21% of new HIV diagnoses.
The immune system in children is distinct from that of adults and is characterized by a suboptimal response to infections and vaccines predominantly in the first two to three years of life. The current severe acute respiratory syndrome coronoavirus-2 (SARS-CoV-2) pandemic, for example, has brought to light some differences in disease susceptibility, severity, and manifestation in children. While children of all ages may become ill with SARS-CoV-2, most do not develop severe disease. However, several infected children develop a condition known as multisystem inflammatory syndrome in children (MIS-C), a clinical presentation that is observed in children with a median age of 8 years, and infrequently reported in adolescents and adults. The ability of an infectious agent, like SARS-CoV-2, to induce distinct disease manifestations stratified by age highlights the importance of characterizing immune developmental and functional stages throughout childhood. In addition, while immune function in children appears to be sufficient to allow survival to adulthood, impaired responses to a range of pathogens and vaccines do result in susceptibility to severe disease in a significant proportion of this population. For example, young children are at increased risk of severe disease from influenza viruses, HIV, and other infections. Worldwide, polysaccharide-encapsulated bacteria (Streptococcus pneumoniae, Haemophilus influenza type b and Neisseria meningitidis) are the leading causes of serious bacterial infection in young children. Although vaccines are available to protect against these organisms, a huge burden of disease and death is still present. Furthermore, there are currently no vaccines for certain childhood pathogens, such as respiratory syncytial virus, that commonly cause very serious infections in infants and young children.
The immune differences that render young children susceptible to infections also reduce their immune responses to most vaccines. A mechanistic understanding of how immune ontogeny and functionality in early life transition from neonatal to adult functional capacity in the context of vaccines or other preventive interventions remain to be clearly elucidated. There is scant characterization of immune development in healthy young children beyond the first few years of life. Much remains to be learned about age-dependent maturation of immune components in different populations. Whereas longitudinal age-related changes in the numbers and function of immune cells in tissues that include the skin, gut, and respiratory mucosae are beginning to be investigated, functional maturation of different cell types (e.g. eosinophils, basophils), postnatal ontogeny of pattern recognition receptors and their responses to cognate ligands, and environmental influences upon immune developmental processes require further investigation.
A safe and effective HIV vaccine remains a critical need in the fight against the HIV pandemic, especially to prevent emerging infections in infants, adolescents, and young adults. Recent studies highlighting the differences in immune responses between adults and children have suggested that implementation of an HIV vaccine or non-vaccine biomedical HIV prevention interventions during early life may afford an opportunity to protect prior to the vulnerable period of adolescence and sexual debut. Studies evaluating viral and bacterial vaccines also have shown that vaccine-induced immunity wanes rapidly after vaccination in infancy and requires multiple booster injections to induce long-term protection. For example, routine diphtheria, tetanus toxoid, acellular pertussis (DTaP) vaccination provides moderate protection during the first year and wanes within the subsequent 2-3 years, reducing protection from pertussis outbreaks in adolescents. Thus, understanding the immunological mechanisms in children will help inform the design and development of improved vaccine strategies that contribute to durable immune responses and maintenance of immunological memory in these populations.
Different exposures early in life, such as a farm environment, caesarean section, breast-feeding, birth history or environmental pollutants, can alter the risk of allergic diseases and asthma. Understanding the impact of such exposures on immune function and potential immunological mechanisms that either protect from or predispose to immune-mediated disease would provide strategies for the development of preventive approaches. The immune system can be a target for toxic effects caused by a wide variety of environmental agents. Heavy metals, polychlorinated biphenyls (PCBs), polybrominated biphenyls (PBBs), and certain air pollutants may cause immune dysregulation and contribute to increased rates of immune-mediated or infectious diseases. Children are susceptible to such perturbations that may not necessarily lead to immediately detectable clinical manifestations. Environmental factors may act on the host for many years before clinical disease becomes apparent. Additionally, clinical disease may only become evident after the immune system is challenged by other factors such as viral infection. Although immune development has not been completely characterized, there is increasing evidence that immune-associated diseases are dependent upon specific windows of early life exposure, sex of the offspring, and epigenetic influences among others. Children's susceptibility to environmental toxicants such as per- and polyfluoroalkyl substances (PFAS) not only increases their propensity for asthma in their youth, but may also affect vaccine responses as adults, lowering their resistance to disease.
The Immunity in Neonates and Infants program began in 2012 and was renewed in 2017 to support U01 cooperative agreement awards. While the program has supported several advances that contribute to our understanding of the immune landscape in the first year of life, knowledge gaps remain. This initiative, Immune Development in Early Life (IDEaL) (U01) and the companion initiative, Immune Development in Early Life (IDEaL) (U19), collectively referred to as the IDEaL research program, will facilitate a collaborative effort with shared resources to address known gaps in knowledge and expand the understanding of the fundamental mechanisms of immune maturation, function, and regulation beyond the first year of life through adolescence. For example, research might focus on studies that investigate how metabolic changes support or influence immune cell function; explore mechanisms of immunological memory in innate cells; address the role of epigenetic changes in regulating immune development and function; and the application of new assays and technologies to enable the assessment of immune cell populations and interactions in systems that closely reflect their physiological environments.
Research Objectives and Scope
The ultimate goal of the IDEaL research program is to expand knowledge of immune development and functionality in children that will provide foundational information to improve immune health and vaccine efficacy in children from birth through adolescence (defined as birth to less than 18 years of age). The program will support mechanistic, hypothesis-driven studies that focus on defining fundamental aspects of immune development and function in response to vaccines and other prevention strategies, pathogenic infections, commensal microorganisms, allergens, and/or environmental pollutants. Interdisciplinary research teams with expertise in immunology, pediatrics, infectious diseases, vaccinology, and immune-mediated diseases, may be established to address areas of interest. It is important to understand the development and expression of immune system using longitudinal assessments, either through establishment and follow-up of a new cohort or by following an established cohort over the course of several years to understand how intrinsic and extrinsic exposures affect immune maturation and functional capabilities. The population of interest for this FOA are infants, children, and adolescents ages birth to less than 18 years, though subsets within this age range can be the focus of a particular application. Applications are expected to examine immune system development over the course of several years in distinct starting populations/age range human cohorts. An application may include different pathogens or commensal microbes, vaccines, allergens, or environmental pollutants to investigate common immune pathways or mechanisms; or may analyze different aspects of the immune response to the same vaccine, infection, allergen, or environmental pollutant. Animal studies (small and/or large animal models) may be included to extend or guide mechanistic analyses of human samples; note that HIV research studies that include animal models may only use non-human primates.
Examples of research areas of interest include, but are not limited to:
Applications proposing the following studies or topic areas will be considered non-responsive and will not be reviewed:
Awardees under this FOA will participate in the IDEaL Research Program including participation in the Annual Program Progress Meetings, service on the IDEaL Steering Committee (and subcommittees), and review by the External Scientific Group. These activities are described below.
IDEaL Annual Program Progress Meeting: All awardees will participate in an annual one and a half to two-day programmatic meeting arranged by NIH and held after award in the Rockville, MD area. The purpose of these annual meetings is to discuss individual program progress and foster collaborations among the PDs/PIs, scientific staff and other project personnel funded by the IDEaL research program of U01 and U19 awardees. The annual meetings are open to investigators supported under this FOA and to NIH extramural staff.
IDEaL Steering Committee: A Steering Committee (SC) will be established by NIH to serve as the governing body of the IDEaL research program. The purpose of the SC is to coordinate and facilitate the research and activities of the IDEaL research program; review the progress of awardees; identify scientific opportunities, emerging needs and challenges; ensure the timely release of data through publications; facilitate access and use of ImmPort; develop guidelines for the publication of collaborative research project results; facilitate resources sharing; prepare cumulative research program progress reports; promote scientific collaboration and exchange of scientific findings among the awardees; develop and implement sub-committees to facilitate and promote common IDEaL-wide collaborations and procedural harmonizations such as data sharing, data harmonization, integration and analyses; and to develop/follow policies and procedures enacted by the SC with concurrence of the NIH Project Scientist(s).
Membership of the SC will consist of individuals from the U01 and U19 awards, NIH extramural staff, and other subject matter experts, as determined by NIH. Awardees of the U01 will provide one PD/PI (only one individual if multi-PDs/PIs leadership) and awardees of the U19 will provide one PD/PI (only one individual if multi-PDs/PIs leadership) to serve as voting members of the IDEaL Steering Committee. NIH extramural staff from the NIH ICs funding the IDEaL research program will be non-voting members of the Steering Committee and will participate in all Steering Committee activities. Members of the SC will participate in all SC activities, and attend the Annual Program Progress meeting, and other SC meetings or teleconferences, as determined by NIH.
IDEaL External Scientific Group: An External Scientific Group (ESG) will be established by NIH in consultation with the IDEaL awardees to provide external perspective and informed guidance for accomplishing the goals of the program. The purpose of the ESG is to review progress and provide recommendations to the awardees regarding the current status of the research, the progress related to stated goals or outcomes, and address concerns about the focus or direction of the research. The ESG members will attend the Annual Program Progress meeting with awardees and NIH staff. DO NOT NAME OR CONTACT potential members of the ESG either within the application (name) or before, during or after application submission (contact), respectively.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
Issuing IC and partner component intend to commit an estimated total of $7.6M in FY 2022 to fund 3 - 4 awards.
Application budgets are limited to $500,000 in direct costs per year and must reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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
Local Governments
Federal 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
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 SF424 (R&R) Application Guide.
An individual may serve as PD/PI on a single PD/PI application or a PD/PI on a multi-PDs/PIs application on either an IDEaL U19 or U01 application, but not both. PDs/PIs may serve as Project leaders, Core leaders or collaborators on an application where they are not the PD/PI on a single PD/PI application or a PD/PI within a multiple PDs/PIs application.
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Letter of Intent
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:
Tara Capece, PhD, MPH
Telephone: 301-761-7854
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followedwith the following additional instructions:
Within the Budget section, include funds for the following activities:
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: List the broad, long-range objectives and goals of the proposed project.
Research Strategy:
Letters of Support: Provide letters of support from collaborators that are applicable to the project, including a Memorandum of Understanding (MOU) or Materials Transfer Agreement (MTA) that documents availability and/or access to human materials for each source (i.e. sample availability and timeline to acquire).
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date 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 SF424 (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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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 SF424(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. See Section III of this FOA for information on registration requirements.
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 System for Award Management. 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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact 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? Is the prior research that serves as the key support for the proposed project rigorous? 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?
Specific to this FOA:
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA:
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 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 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 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 Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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 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) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 National Institute of Allergy and Infectious Diseases (NIAID), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Information regarding the disposition of applications is available 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff (Project Scientist) have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
A final RPPR, 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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Mercy Prabhudas, Ph.D., M.B.A.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3534
Email: [email protected]
Que Dang, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-6181
Email: [email protected]
Anjali Singh, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3030
Email: [email protected]
Michael C. Humble, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3272
Email: [email protected]
Tara Capece, PhD, MPH
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7854
Email: [email protected]
Ashley Ranellone
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-594-8541
Email: [email protected]
James Williams
National Institute of Environmental Health Science (NIEHS)
Telephone: 984-287-3338
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 Part 75.