It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
- Use the NIH ASSIST system to prepare, submit and track your application online.
- Use an institutional system-to-system (S2S) solution to prepare and submit your application
to Grants.gov and eRA Commons to track your
application. Check with your institutional officials regarding availability.
- All stages of vaccine technology and/or platform research and development through facilitation of proof-of concept studies with appropriate animal models (e.g., NHP, human immunoglobulin knock-in or transgenic mice) with minimal down-selection of the final lead candidate alone or in combination with adjuvant(s). Studies in NHPs limited to immunogenicity studies without a challenge component to determine efficacy are encouraged. Efficacy and challenge studies in NHP are not a priority area for support through the IPCAVD Program. Investigators should seek other resources to conduct such efficacy/challenge studies in NHPs. E.g., NIAID's Simian Vaccine Evaluation Units.
- All product development stages including technology transfer, development of in-process tests, qualification or validation of release assays, formulation studies, CGMP manufacturing, fill-finish, and product delivery that are guided with a risk assessment plan to mitigate risks that may impact product integrity.
- Stability testing program based on FDA and ICH Q1A (R2) guidance, and CGMP, product release and storage.
- IND-enabling studies, e.g., Good Laboratory Practices (GLP) toxicity studies for regulatory submissions.
- HIV immunogens designed to elicit bnAbs, preferably heterologous neutralization, systemically or at mucosal sites, alone or in combination with the innate and or adaptive cellular immune responses
- Stabilized envelope native-like trimers or other protein HIV immunogens designed to minimize the immune response to off-target envelope epitopes
- Novel proof of concepts with Nanoparticles or viral vectors as HIV immunogens
- Platforms such as mRNA, self-replicating RNA, DNA, or others that offer advantages such as dose sparing or accelerated manufacturing processes.
- A Product Development Plan is required in the Product Manufacturing Project.
- A Clinical Development Plan is required. Applicants must identify a clinical partner that is suitable to conduct early-stage vaccine clinical trials and work with them to develop a Clinical Development Plan for the application. This early involvement of the clinical partner will ensure decisions made during the product development stage and used in manufacturing are aligned with the requirements for clinical trials. Investigators are expected to initiate a clinical trial(s) under other support mechanisms no later than Year 5 of this award.
- A Milestone Plan with Go/No-Go criteria is required to support product development from the vaccine concept through process and product development, preclinical studies, quality systems audit, and CGMP manufacturing. Specific Go/No-Go criteria must be met by the end of the Year 2 of the award to allow manufacturing to begin no later than Year 3.
- Although applicants will apply for five years of research support, at the end of Year 2, the progress of research towards the stated Go/No-Go criteria for CGMP manufacturing will be evaluated by NIH Program staff. Three additional years of funding, for a total of five years, will be available for those who successfully meet their criteria. Grantees not meeting No/No-Go criteria for CGMP manufacturing will have budget periods for Year 3, 4 and 5 adjusted and may be at a reduced rate.
- A Product Storage and Stability Program is required describing how product storage and stability programs will be managed in compliance with CGMP regulations and ICH guidance for the duration of early phase clinical trials. Products developed under this program are intended for use in clinical trials with funding outside of the IPCAVD funding mechanism. It is expected that the grantee institution will assume responsibility of supporting stability programs that fall outside the duration of the IPCAVD funding.
- Studies proposing undefined boost immunogen (s) and / or those that are dependent on outcomes from clinical trials that are being planned or ongoing
- Immunogens designed to primarily elicit binding or functional non-neutralizing antibodies other than bnAbs
- Applications proposing only the CGMP manufacture of adjuvants
- Development and manufacture of therapeutic interventions
- Product Development Plan
- Milestone Plan
- Clinical Development Plan
- Product Storage and Stability Program
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Non-domestic (non-U.S.) Entities (Foreign Institutions)
-
System for
Award Management (SAM) Applicants must complete and maintain an active
registration, which requires renewal at least annually. The renewal
process may require as much time as the initial registration. SAM registration
includes the assignment of a Commercial and Government Entity (CAGE) Code for
domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
- Overall: required
- Administrative Core: required, 1
- Scientific Core(s): optional
- Research Projects: required, minimum of 2 of which one research project must be Product Manufacturing
- The scientific question(s) or concepts that are being addressed in the application.
- The research design that summarizes and integrates the activities in the individual projects.
- Description of the multi-disciplinary team of investigators that will support an integrated effort through the product development and up to the start of a clinical trial, without duplicating information provided in the biosketches.
- Documentation of the overall scientific and technical expertise of the team and organization to design and conduct the proposed studies and analyze product development activities, analytical assay, and assay qualification/validation, including CGMP vaccine candidate production, quality assurance oversight, GLP toxicology studies, product labeling, stability testing program per FDA guidance, and IND-enabling studies for regulatory submission, as applicable.
- Demonstration of the PD/PI’s leadership skills, experience and effort that contribute to the management, coordination, and leadership of the program. Describe the skills and contributions of the key personnel to the Program as a whole and the integration of those efforts to achieve the goals of the proposed research, without duplicating information provided in the biosketches.
- A summary of the Product Development Plan that is described in detail in the Product Manufacturing Project.
- Provide a Milestone Plan with clear delineation of goals with quantifiable metrics for the overall program, including detailed quantitative and qualitative criteria for Go/No-Go decisions to support the advancement of vaccine concepts into clinical studies within the first five years of award. The plan must include Go/No-Go criteria to be met at the end of Year 2 of the award to begin manufacturing no later than Year 3 of the award.
- Provide a Clinical Development Plan that describes the general clinical strategy and identifies a clinical partner such as the HIV Vaccine Trials Network (http://www.hvtn.org/) or another clinical partner to initiate the clinical trial no later than Year 5 of the award. The plan should include an overview of the clinical protocol outline including clinical strategy e.g., prime boost strategy, dosage, choice of adjuvant, timelines and major milestones, general regulatory strategy, proposed primary clinical endpoints, critical assays, and statistical considerations. The clinical development plan must be included in the Overall component and must not be included as a separate project or a core component or as specific aim within a Project or Core.
- Provide a summary of the Product Storage and Stability Program to manage short and long-term storage and stability programs of products needed to support early phase clinical trials The plan should cover storage for materials including but not limited to cell/plasmid/viral banks, drug substance and products, retain samples from interim and final manufacturing runs.
- Dispute Resolution Plan: A program dispute resolution plan related to publications, patents etc. is required for all aspects of the proposed research.
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
- In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
- In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
- Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
- If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
- In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
- In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
- Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
- If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
- In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
- In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
- Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
- If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
- Is there evidence of collaborative relationships between the investigators that will support an integrated effort?
- Does the PD/PI have the leadership and scientific ability to develop and sustain an integrated and focused research program?
- Are the overall program goals clear, well-defined, and appropriately focused?
- Will the integration of the individual projects into a single program be more beneficial than pursuing each project independently?
- Milestone
Plan
- Are the overall Timelines and proposed Milestones, including the Product Development and Clinical Development Plans, well-defined with quantifiable measures and criteria that are appropriate for enabling clear Go/No-Go decisions and assessing the success of the individual projects, cores, and overall program?
- Do the milestones support the goal of starting manufacturing by Year 3 of the award?
- Is there an adequate plan for activities related to IND-enabling studies for regulatory submission?
- Do the milestones support the goal of advancing vaccine concepts into clinical studies within the five years of the award?
- Clinical
Development Plan:
- Considering the clinical strategy, proposed clinical partner, and the clinical development plan how feasible is it that the program will result in implementation of a clinical trial in year five of the award?
- Does the clinical development plan adequately describe plans to implement a clinical trial in Year 5 of the award?
- Does the application identify an appropriate clinical partner needed to conduct the trial?
- Is there adequate consideration for a Risk Assessment Plan for CGMP manufacturing related activities e.g., Quality Systems Audits of vendors and CMOs?
- Does the plan for short- and long-term storage and stability testing based on FDA and ICH guidance show a clear understanding of the obligations of the sponsoring institution for the maintenance of the product?
- Is there adequate documentation of appropriate facilities for all activities including CGMP manufacturing?
- Is the administrative and organizational structure appropriate and adequate to the attainment of the objective(s) of the proposed overall program?
- Is the management plan for fiscal accountability and communication within the program appropriate?
- Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate?
- Are the experience, level of commitment, and availability of the Program Director/Principal Investigator serving as the Administrative Core Leader and his/her administrative staff adequate to manage the program?
- Does the Communication Plan support the coordination, administration, and supervision of the other projects and cores?
- Are the plans for resolving conflicts appropriate?
- Does each Scientific Core make a strong contribution to the Research Projects, well justified, and provide needed resources?
- Are the qualifications, competence, and commitment of the Core Leader and key personnel appropriate?
- 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.
- Will receive a written critique.
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
- For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
- Defining the research objectives, approaches, and details of the projects within the guidelines of the FOA and for performing the scientific activities.
- Annual Site Visit Review: Each recipient is required to coordinate an annual site visit. The site visit will provide an update and progress of the grant to date and allow discussion of the plans for immediate and longer term of the grant. The site visit will be attended by the PD/PI, key personnel, the External Advisory Committee (see below under Collaborative Responsibilities) members, the NIAID/DAIDS Project Scientist (see below) and NIAID Program Official (see below). An update and summary of the results generated on each project will be presented by the PD/PI, Co-Investigators, and/or pertinent staff. These presentations should include summaries of all goals or milestones (refer to Other Submission Requirements section of the FOA) and a description of all problems encountered that may have an impact on the achievement of future goals and milestones.
- Intellectual Property: The successful development of tools for the evaluation of a prophylactic HIV/AIDS vaccine will require substantial investment and support of private sector industries and may also involve collaborations with multiple organizations, including academic and/or non-profit research institutions. It is the intent of this initiative to support the formation of the appropriate public-private partnerships that are essential to meet this critical public health need. NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end: the recipient is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed to perform the project.
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 development of a safe and effective vaccine against HIV/AIDS is a priority of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Numerous experimental prophylactic HIV vaccines have been tested in phase I clinical trials, some of which were supported through NIAID s Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD). Highlighting that broadly neutralizing antibody prophylaxis can be effective, the Antibody Mediated Prevention trials (HVTN 703, NCT02568215/704, NCT02716675) demonstrated that VRC01, a broadly neutralizing monoclonal antibody, could protect against infection when the HIV-1 strains were highly sensitive to neutralization. Recent efficacy studies of the ALVAC-HIV vaccine plus bivalent gp120 protein adjuvanted with MF59 (HVTN 702, NCT02968849) and an Adenovirus type 26-based mosaic vaccine plus an aluminum phosphate-adjuvanted monomeric clade C gp140 protein vaccine (HVTN 705, NCT03060629) did not prevent infection calling into question non-neutralizing antibody strategies and reliance on Non-Human Primates (NHP) studies to predict efficacy in humans. Thus, the HIV vaccine field is at a crossroad and new approaches for HIV immunogen design and delivery are needed. The goals of this FOA are to advance promising and innovative HIV vaccine platforms that elicit broadly neutralizing antibodies (bnAbs) alone or in combination with other vaccine platforms or prevention modalities for evaluation in early clinical trials and to leverage the experience gained through the development and manufacture of various COVID-19 vaccines.
The objective of the IPCAVD Program is to facilitate the translation of vaccine technologies and platforms for the development of HIV vaccines for clinical trials. The Program will support a multi-disciplinary consortium of experts in vaccinology, animal models, molecular biology, cell biology, immunology, manufacturing, and adjuvant biology. Activities to be supported include HIV vaccine research and development to enable down-selection of final HIV immunogens, preclinical testing and vaccine and immunogenicity optimization studies, upstream and downstream process and product development, toxicity studies, generation of cell/plasmid/viral master banks, immunogen/adjuvant formulations, IND-enabling activities such as, safety/toxicity studies, for submission to regulatory agencies, stability testing programs per U.S. Food and Drug Administration (FDA) and International Council of Harmonisation (ICH) guidance, CGMP manufacturing and plans for managing stability programs and short- and long-term storage of generated products and materials. Applicants may choose to partner with Biotech/Pharma or with a CMO to facilitate process development and manufacturing.
Specifically, the IPCAVD award will support:
Specific areas of interest include but are not limited to:
IPCAVD Program Requirements
The Research Programs funded under this FOA will be comprised of multiple components. These are:
Administrative Core: An administrative core led by the Program Director provides overall management, coordination, and supervision of the Program. This Core administers the plan provided in the application to address the short- and long-term management of the Program.
Research Projects: Each application must propose a minimum of two projects. One project must focus on the strategy for product manufacture. To advance HIV vaccines through process and product development, applicants may choose to partner with Biotech/Pharma or with a CMO. A Quality Systems Audit will be required and managed by DAIDS in coordination with the grantee for acceptability and regulatory compliance of the proposed manufacturing facility before initiation of CGMP activities. Other research project(s) should be well integrated into the overall program.
Scientific Core(s): One or more optional Scientific Cores may be proposed as a resource to the proposed multi-project program, and each of the proposed Cores must support at least two research projects.
External Advisory Committee (EAC): An External Advisory Committee (EAC), consisting of at least 3 independent experts in the areas of research that the Program addresses, will be identified soon after award. The EAC, together with the PD/PI, will be responsible for determining progress of the PD/PI and other investigators during the annual site visit. Do not contact or recruit EAC members prior to award, or name potential members in the application.
Applications Not Responsive to this FOA
Applications that propose to conduct research in the following areas will be considered non-responsive and will not be reviewed.
Applications without the following will be considered non-responsive and will not be reviewed.
Applicants are highly encouraged to contact the program official listed under Scientific/Research Contact(s) in Section VII to discuss their applications prior to submission.
See Section VIII. Other Information for award authorities and regulations.
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
Governments
Federal Government
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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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.
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 per 2.3.7.4 Submission of Resubmission Application.". This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:
The letter of intent should be sent to:
Poonam Pegu, Ph.D.
Telephone: 240-292-0719
Email: [email protected]
|
Available Component Types |
Research Strategy/Program Plan Page Limits |
|
Overall |
12 pages |
|
Admin Core |
6 pages |
|
Core (use for Scientific Core) |
6 pages each |
|
Project (use for Research Projects) |
12 pages each |
Additional page limits 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 a multi-component application.
The application should consist of the following components:
When preparing your application, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Follow standard instructions.
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment of the Overall Component in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.
Specific Aims: List in priority order, the broad, long-range overall objectives and goals of the proposed Program. Concisely and realistically describe the hypothesis or hypotheses to be tested.
Research Strategy: This narrative section should provide a scientifically compelling summary of the overall research strategy. The multi-project application consists of interrelated research projects and cores, each capable of standing on its own scientific merit, but complementary to one another. Describe the coordination and synergy of individual Projects and Cores. This important section provides the multi-disciplinary group of investigators an opportunity to give conceptual wholeness to the overall program by defining the general concept and by laying out a broad strategy for approaching the questions to be tested. As the strategy develops, each Project and Core should be briefly described as to its place in the overall scheme. Summarize the features in the environment and/or resources that make this application strong or unique. Describe how the program goals are aligned with the goals in the FOA. Describe the advantages or likely benefit of combining these Projects and Cores together as a Program rather than individual applications to accomplish the goals of the FOA.
The Overall component of the multi-project application MUST include:
Letters of Support: Do not include letters of support in the Overall Section. All letters of support should be provided in the Administrative Core.
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Overall)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed
Delayed Onset Study
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.
When preparing your application, use Component Type Admin Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: List in priority order, the broad, long-range objectives, and goals of the Administrative Core. State the Core’s relationship to the multi-project program goals and how it relates to the Research Projects and any other Cores in the application.
Research Strategy: An Administrative Core, led by the Program Director, is a resource to the Program, providing overall management, coordination, administration, communication, and supervision of the Program to ensure attainment of program objectives. Propose a Communication Plan that will address interrelationships, scientific information sharing, material and reagent sharing across the Program. As part of the Administrative Core, describe the structure and plans for coordination, administration, fiscal accountability, allocation of funds and other resources., problem identification and resolution, and training.
External Advisory Committee (EAC): The Administrative Core will coordinate the effort of an EAC. It is strongly recommended that at least 3 independent experts in the areas related to the Program be identified soon after award to form the EAC. The EAC, together with the Program PD/PI, will be responsible for determining Program progress during the annual site visit. EAC members will attend the annual meetings, sponsored by the recipient, to review the progress of all Projects and Cores, provide a summary meeting report, and make recommendations for the direction of the Program to the PD/PI.
Applications may include the areas of expertise to be represented on the EAC. Potential EAC members should not be named in the application nor recruited or contacted prior to award.
Letters of Support: All letters of support should be provided under the Administrative Core. A letter of support from the clinical partner including the strategy for funding the trial is encouraged; however, it does not take the place of the Clinical Development Plan in the application.
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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
Delayed Onset Study
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
When preparing your application, use Component Type Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: List in priority order, the broad, long-range objectives, and goals of the
Proposed Scientific Core. Describe the hypothesis or hypotheses, if any, to be tested. In addition, state the Scientific Core’s relationship to the multi-project program goals and how it relates to the Projects or other Cores in the application.
Research Strategy: Each Scientific Core must directly support at least two of the proposed Projects and must indicate the specific Projects that it will support. This section of the application should present a clear picture of the facilities, techniques, and skills that the Core will provide and describe the role of the Scientific Core Leader and each of the key participants.
Letters of Support: Do not include letters of support in the Scientific Core Section. All letters of support should be provided in the Administrative Core.
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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
Delayed Onset Study
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.
When preparing your application, use Component Type Project.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Facilities and Other Resources: Include a thorough description of the infrastructure, facilities, and resources for both production of the vaccine under CGMP and performance of IND-enabling preclinical animal studies under Good Laboratory Practices (GLP), 21 CFR Part 58.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
The budget for the Product Manufacturing Research Project needs to reflect the actual requirements for the project in each year. While total direct costs are limited to $3,000,000 per year for the 1st and 2nd years of the award, costs for the CGMP manufacturing in Years 3,4, and 5 may increase the overall direct costs for the program above $3,000,000. Funding is dependent on satisfactory progress and availability of funds.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Project. Describe the hypothesis or hypotheses to be tested. In addition, state the Project's relationship to the multi-project program goals and how it relates to other Projects or Cores.
Research Strategy: Use this section to describe how the proposed research will contribute to meeting the Program's goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the Project's relevance to the primary theme of the application.
The Product Manufacturing Research Project must include a Product Development Plan that should address the following but is not limited to: (1) a description of the conceptual framework, design, and iterative evaluation of the vaccine concept with rationale for how the proposed research strategy differs from existing approaches that are being tested in the HIV vaccine field; (2) a description of the proposed vaccine candidate, its stage of development and consideration of plans for inclusion of adjuvant(s) and formulations early in the planning stages; (3) data resulting from research conducted to date with respect to the potential for the proposed advanced down-selected vaccine candidate to elicit the desired bnAb responses; (4) integration of the necessary process development and CGMP skill sets and requirements into the Program (e.g., partnership with a Biotech/Pharma or a CMO); (5) a clear delineation of the proposed product development and CGMP activities to be undertaken; (6) a Risk Assessment plan with a discussion of potential limitations/obstacles in achieving project objectives; proposed alternative methods to deal with anticipated limitations/challenges; (7) proposed steps for the maintenance of Quality Assurance/Quality Control oversight throughout the implementation and operation of the project including qualification of
vendors, CMOs, and Quality Systems Audits of vendor facilities; (8) Fill-Finish, reference standard, drug substance and or drug product stability testing program based on FDA and ICH guidance, as applicable; (9) a description of IND-enabling activities; and (10) a Product Storage and Stability Program to manage short- and long-term storage and stability of inventory generated from the IPCAVD award. Products developed under this program are intended for use in clinical trials with funding outside of the IPCAVD funding mechanism. It is expected that the sponsoring institution will assume responsibility for storage and stability testing requirements that fall outside the duration of the IPCAVD funding.
Milestones and Timelines: As part of the requirements for each individual Project, the
application must include Milestones and Timelines. This will include a clear delineation of goals with measurable milestones, including detailed quantitative and qualitative criteria for Go/No-Go decision-making, and a timeline for the attainment of each goal and milestone and should be reflected in the Milestone Plan for the overall Program.
Letters of Support:
Do not include letters of support in the Research Project Section. All letters of support should be provided in the Administrative Core.
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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
Delayed Onset Study
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
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) using ASSIST or other electronic submission systems. 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.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier 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.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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 program 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 program 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 program that by its nature is not innovative may be essential to advance a field.
Does the program 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 program 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?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the program? 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?
Specific to this FOA:
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 program? Have 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:
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?
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for theproject to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored 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 research 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?
Are the Project Leads(s), collaborators, and other researchers well suited to the research 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?
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 research project? Have 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 research 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 research 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 for the Product Manufacturing Project
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 research project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this FOA for the Product Manufacturing Project
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the
Core to exert a sustained, powerful influence on the research field(s) involved, in consideration of
the following:
Administrative Core
The merit of the Administrative Core will be assessed based on the following questions:
Scientific Core(s) (if applicable):
The merit of the Scientific Core(s) will be assessed based on the following questions:
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.
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.
When the proposed program 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.
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.
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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not applicable
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.
Product Storage and Stability Program
Is the short-and long-term storage and stability program, to manage products and materials after the award period ends, adequately addressed?
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.
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).
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 .
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.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Allergy and Infectious Diseases in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.
Recipients 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: Recipient 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 recipient 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, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, 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 (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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.
Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Cooperative Agreement Terms and Conditions of Award
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 andHuman 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 recipients 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
Recipients will retain custody of and have primary rights to the products and materials produced and to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
Recipients will ensure that products and materials are maintained as required for clinical trial use in compliance with FDA and ICH guidance. This may include managing documentation to meet regulatory requirements, short- and long-term storage, and stability testing and reporting beyond the grant project period.
NIH staff will have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below:
The NIAID Project Scientist will provide technical assistance, advice, and coordination, and interact with the PD/PI on a regular basis to monitor study progress, regulatory compliance, and quality assurance to ensure the production of high-quality, unbiased results. Monitoring may include: (1) regular communication with the PD/PI and staff, (2) periodic site visits for discussions with recipients' research teams, and (3) observation of manufacturing activities, and quality control, fiscal review, and other relevant matters, as well as (4) attendance at and participation in annual site visit meetings and/or External Advisory Committee meetings. NIAID retains the responsibility to periodic review of progress prior to and during manufacturing. Such review and monitoring may be conducted through organizations contracted by, and acting on behalf of, NIAID.
The NIAID Project Scientist will serve as a resource with respect to concurrent NIAID research and research support activities that may be relevant to the IPCAVD project, to facilitate compatibility, avoid unnecessary duplication, and potentially forge collaborations that may enhance the quality and breadth of the study.
The NIAID Project Scientist will provide substantial assistance in design and coordination of preclinical research activities and clinical testing for recipients, including: (1) advice on the planning, management, and technical performance of the investigators, (2) access to and use of reagents and assays, and other resources available through NIAID contractors and grantees, including the independent non-clinical evaluation of the candidate vaccine, (3) technical advice and assistance for meeting Food and Drug Administration requirements for investigational drugs, (4) providing guidance (e.g., submission of the required documentation, etc.) for the NIAID clinical protocol review process.
At the end of Year 2 of the award, the Program Official, with assistance from the NIAID Project Scientist, will assess the readiness for CGMP manufacturing and likelihood of initiation of a clinical study by Year 5 of the grant through the accomplishment of the milestones, the immunologic parameters of the vaccine candidate as an efficacious HIV/AIDS vaccine, and the feasibility to manufacture. The assessment will be based on the first two annual reports, the milestones included in the application and negotiated with the recipient prior to award, and any additional information that the PD/PI elects to submit.
The release of funds for initiation of the manufacturing will be contingent upon the successful completion of a CGMP Quality Systems Audit for GMP audit of the manufacturing facility and proof of concept, including preclinical and other analytical attributes of the down-selected product.
Additionally, an agency Program Official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibilities include:
The PD/PI and the NIAID Project Scientist shall share responsibility for the organization of an EAC. The composition and membership of the EAC shall be determined by consensus between the PD/PI and the NIAID Project Scientist. The EAC will consist of a minimum of 3 members not directly affiliated with the research being conducted by the recipient. The EAC, together with the PD/PI, will be responsible for determining progress of the PD/PI/co-investigators during the annual site visit. Each EAC member will have one vote. Recipients will be required to accept and implement policies approved by the EAC. The NIAID Project Scientist(s) and Program Official will participate as non-voting members of the EAC.
Product Storage and Stability Program: No later than the end of project year 4 the PD/PI, Project Scientist, and Program Official will review the Product Storage and Stability Program, identify materials and products to be retained past the project period, identify suitable storage repository(ies) and make arrangements for appropriate long-term storage and any ongoing stability studies.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened composed of three members: a designee of the Steering Committee, one NIH designee, and a third with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the recipient'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.
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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: https://grants.nih.gov/support/index.html(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]
Sujata Vijh, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7713
Email: [email protected]
Poonam Pegu, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-0719
Email: [email protected]
Lanni Hall
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 406-363-5957
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 and 2 CFR Part 200.
and Human Services (HHS)
