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.
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
Background
The development of a safe and effective prophylactic vaccine against HIV/AIDS is one of the highest priorities of the 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). Of the four HIV vaccine efficacy trials completed to date, only the RV144 trial in Thailand demonstrated modest 31% efficacy at preventing HIV infection. These results, together with promising Non-Human Primate (NHP) vaccine efficacy studies, provided some evidence that a HIV vaccine may be within reach. An efficacy trial, designed to follow up on the findings in RV144 in Southern Africa (HVTN 702) and the HVTN 705 trial, to test another candidate HIV vaccine (Janssen/Johnson & Johnson's Ad26 Mosaic prime/gp140 protein boost), are ongoing. Results from these trials will not be available until 2021 and 2022, respectively. Additional large neutralizing monoclonal antibody passive transfer studies, the Antibody-Mediated Prevention (AMP) study that include both, HVTN 703/HPTN 081 and HVTN 704/HPTN 085, also are ongoing. It is hoped that these studies will provide proof-of-concept that neutralizing antibodies can protect against human infection with HIV-1. Thus, the two goals that NIAID aims to achieve through this FOA are to: 1) support studies to confirm and extend the results of RV144; and 2) continue the advancement of promising and innovative HIV vaccine platforms alone or in combination with different prevention modalities for evaluation in early clinical trials. This FOA is designed to support these goals through the translation of diverse innovative HIV vaccine platforms up until, but not including, the point of testing in human clinical trials.
The objective of the IPCAVD Program is to facilitate the translation of vaccine technologies and platforms for the development of prophylactic HIV vaccines towards readiness for clinical trials. The Program will support a multi-disciplinary consortium of experts in animal models, molecular biology, cell biology, immunology, manufacturing, and adjuvant biology. To achieve the goal of readiness for clinical testing, additional activities in the application may include HIV vaccine research, down-selection of final HIV immunogens, preclinical testing and vaccine optimization studies, process and product development, toxicity studies, adjuvant formulations, IND-enabling activities for submission, stability testing programs per FDA guidance, and CGMP manufacturing. Applicants may choose to partner with Biotech/Pharma or with a Contract Manufacturing Organization (CMO) to facilitate process development and manufacturing.
This FOA will support a 5-year project period. The award will support advancement of vaccine concepts to readiness for clinical trials. Milestones with go/no go decisions to support product development from the vaccine concept through process development, preclinical studies, and manufacturing to readiness for clinical trials within the first 5 years are required. A Clinical Development Plan is required to outline steps toward readiness for the initiation of a clinical trial in year 5 and to demonstrate integration between the product development and requirements for clinical trials. Specifically, the IPCAVD award will provide support for: (1) all stages of vaccine technology and/or platform research and development through facilitation of proof-of concept studies appropriate animal models (e.g., Non-Human Primate (NHP), human Immunoglobulin knock-in or transgenic mice) for the down-selection of the final lead candidate including adjuvant(s); (2) all product development stages including technology transfer, development of processes and qualified assays, CGMP manufacturing with a Risk Assessment Plan, and formulation studies; (3) a stability testing program based on FDA guidance, product release and storage; and (4) support for all IND-enabling studies, e.g. Good Laboratory Practices (GLP) toxicity studies for regulatory submissions. The IPCAVD award will not support clinical trials. However, investigators are expected to begin a clinical trial(s) under other funding mechanisms no later than Year 5 of this award. Applicants must identify a clinical partner that is suitable to conduct early stage vaccine clinical trials. The relationship with the clinical partner will ensure that decisions made during the product development process are aligned with the clinical development plans for human trials.
Applications consisting of preclinical research alone without a direct pathway to clinical testing will not be supported.
The Research Programs funded under this FOA will be comprised of multiple components. These are:
Administrative Core: An administrative core 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 provide a strategy for CGMP product manufacture, as described below under Research Strategy for Projects. To advance HIV prophylactic vaccines through process development applicants may choose to partner with Biotech/Pharma or with a Contract Manufacturing Organization (CMO). A Quality Systems Audit will be required for acceptability of the facility design of the proposed manufacturing facility before initiation of CGMP activities. Other research projects should be well integrated into the program overall.
Scientific Core(s): One or more optional Scientific Cores may be proposed as a resource to the multi-project grant, 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, recruit, or name potential EAC members in the application.
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
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- 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)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- 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
Other
- 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)
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.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- 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.
- o 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.
- eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.
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.
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:
- 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 NOT-OD-11-101).
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:
- 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
The letter of intent should be sent to:
Kumud K. Singh, Ph.D.
Telephone: 301-761-7830
National Institute of Allergy and Infectious Diseases (NIAID)
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 |
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:
- Overall: required
- Administrative Core: required, 1
- Scientific Core(s) (SC): optional
- Projects: required, minimum of 2; one must be a Product Manufacturing Project
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.
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.
The Program Overview of the multi-project application MUST include:
- 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.
- A brief summary of the Product Development Plan that is described in detail in the Product Manufacturing Project.
- A collaborative team of investigators that will support an integrated effort through the product development and up to the start of a clinical trial.
- 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 development and assay qualification, including CGMP vaccine candidate production, quality assurance oversight, GLP toxicology studies, labeling, stability testing program per FDA guidance, and IND-enabling studies for regulatory submission, as applicable, without duplicating information in the biosketches.
- 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 in the biosketches.
- The Clinical Development Plan that describes the general clinical strategy and identifies a clinical partner such as the HIV Vaccine Trials Network (www.hvtn.org) or other clinical partners to conduct 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 section, and must not be included as a separate project or a core component or as a specific aim within a Project or Core.
- Documentation of appropriate facilities for all activities including CGMP manufacturing.
- Overall Timelines and Milestones 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 5 years of award. NIAID Program staff will assess accomplishment of go/no go milestones no later than the end of the third year of funding to determine whether large scale manufacturing is warranted. If manufacturing milestones are not met, funds related to manufacturing, toxicology studies, activities/studies related to regulatory submission, activities to support translational studies will not be provided. Plans for the remainder of the years will be negotiated between NIAID staff and the grantee.
Dispute Resolution Plan: A dispute resolution plan related to publications, patents etc. is required for all aspects of the proposed research.
Letters of Support: 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. All letters of support should be provided under 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:
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
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.
- 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.
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 is a resource to the Program, providing overall management, coordination, communication and supervision of the Program to ensure attainment of program objectives. Propose a Communication Plan that will address the interrelationships, scientific information sharing, material and reagent sharing across the Program. As part of the Administrative Core, provide a program management plan that includes a discussion of the structure and roles of administrative staff not included in key personnel, coordination, problem identification and resolution, training and experience of proposed staff. Describe the functions to be performed; fiscal accountability, allocation of funds and other resources.
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 PD/PI, will be responsible for determining progress of the PD/PI and other investigators during the annual site visit. EAC members will attend the annual meetings, sponsored by the awardee, 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.
Do NOT contact, recruit, or name potential EAC members. Applications may include the areas of expertise to be represented on the EAC.
Letters of Support: A letter of support from the clinical partner addressing the strategy for funding the trial is encouraged; however, it does not take the place of the clinical development plan in the application.
A letter of support should also be included to document institutional support for the program and should address laboratory and office space, equipment, and administrative resources.
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:
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
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.
- 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.
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 Core. Describe the hypothesis or hypotheses, if any, to be tested. In addition, state the 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.
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.
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:
- Applicant Information
- Type of Applicant (optional)
- Descriptive Title of Applicant’s Project
- Proposed Project Start/Ending Dates
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. Briefly address the plan and process for Quality Systems Audit of the proposed manufacturing facility that will be conducted to assess acceptability of the facility design before initiation of CGMP activities.
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.
- 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.
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 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 Project must include a Product Development Plan. This should include: (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; (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 vaccine candidate to elicit the desired responses; (4) a plan for providing the necessary process development and CGMP skill sets into the Program (e.g., Biotech/Pharma or a CMO); (5) a clear delineation of the proposed product development 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/obstacles; (7) proposed steps for the maintenance of Quality Assurance oversight throughout the implementation and operation of the project including qualification of Vendors and CMOs and Quality Systems Audits of Vendor facilities; (8) a description of drug substance and or drug product stability testing program based on FDA guidance; and (9) a description of IND-enabling activities.
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.
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.
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 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.
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 (SAM). 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, NIH. Applications that are incomplete or non-compliant 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 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 program 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 program?
Specific to this FOA:
- 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?
- Will the PD/PI and other Project/Core Leaders devote adequate time and effort to the program?
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 program 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:
- 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?
- Are the administrative plans for the management of projects, including plans for resolving conflicts, appropriate?
- Is there adequate consideration for a Risk Assessment Plan for CGMP manufacturing related activities e.g. Quality Systems Audits of Vendors and CMOs?
- Are there adequate consideration and well-defined plan for a stability testing program based on FDA guidance?
Milestones:
- Are the overall Timelines and proposed Milestones, including the Product Development Plan and Clinical Development Plan, 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 advancing vaccine concepts into clinical studies within the first 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?
- Does the application identify an appropriate clinical partner needed to conduct the trial?
- Is there an adequate plan for activities related to IND-enabling studies for regulatory submission?
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 program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this FOA:
- How well do identified facilities for the CGMP project align with the needs of the program and the project period?
- How well does the institutional support meet the requirement of the program in terms of laboratory space, equipment and other resources?
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 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 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 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 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 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?
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 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:
- Is the administrative and organizational structure appropriate and adequate to the attainment of the objective(s) of the proposed 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 Contact Program Director/Principal Investigator serving as the Administrative Core Leader and his/her administrative staff adequate to manage the program?
Scientific Core(s) (if applicable):
The merit of the Scientific Core(s) will be assessed based on the following questions:
- Does each Scientific Core make a strong contribution to the Projects, well justified and provided with needed resources?
- Are the criteria for core prioritization and usage appropriate?
- Are the qualifications, competence, and commitment of the Core Leader and key personnel appropriate?
As applicable for the program 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.
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:
- 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.
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 appropriate national Advisory Council or Board . The following will be considered in making funding decisions:
- 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.
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 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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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.
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 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:
- 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 awardee is required to coordinate an annual site visit. The site visit will provide an update and progress of the grant in the last budget year and allow discussion of the future year plans. 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 awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed to perform the project.
- Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
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 in order 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 awardees research teams, and (3) observation of field data collection and management techniques, 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. The NIAID retains, as an option, periodic review of progress. 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 awardees, 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 mid-point of the cooperative agreement (no later than the third year), the Program Official with assistance from the NIAID Project Scientist, will assess the 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 prophylactic HIV/AIDS vaccine, and the feasibility that manufacture. The assessment will be based on the first two annual reports, the milestones included in the application and negotiated with the awardee prior to award (included in the Terms of 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 DAIDS-contracted 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:
- Awardees and the NIAID Project Scientist shall share responsibility for the organization of an External Advisory Committee (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 awardee. 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. Awardees will be required to accept and implement policies approved by the External Advisory Committee. The NIAID Project Scientists and Program Officials will participate as non-voting members of the EAC.
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 EAC, one NIH designee, and a third designee with expertise in the relevant area that is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This 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.
When multiple years are involved, awardees 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.
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]
Sujata Vijh, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7713
Email: [email protected]
Kumud K. Singh, Ph.D.
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-761-7830
Email: [email protected]
Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
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 Human Services (HHS)
