Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of PAR-14-122

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

PAR-15-330

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.855, 93.856 

Funding Opportunity Purpose

The goal of the Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) Funding Opportunity Announcement (FOA) is to facilitate the translation of sufficiently advanced, innovative and promising vaccine candidates into early clinical testing. The IPCAVD program is designed to enable a multi-disciplinary team of investigators to complete all steps necessary from down-selection of a vaccine candidate through CGMP manufacture/testing/product release and into clinical trials.  A preclinical research application alone is not sufficient for this announcement.  Awards will provide the critical resources to allow the advancement of vaccine concepts to clinical trials within the project period of the award.  However, this funding opportunity will not provide funds for conducting the clinical studies; applicants are encouraged to collaborate with NIAID-supported clinical trial networks or to develop other relationships to support the clinical studies. Investigators are expected to begin clinical studies by the end of the award.    

Key Dates
Posted Date

August 14, 2015

Open Date (Earliest Submission Date)

February 9, 2016; February 9, 2017; February 9, 2018  

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

March 9, 2016; March 9, 2017; March 9, 2018, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on these dates .

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

March 9, 2016; March 9, 2017; March 9, 2018 local time of applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

July 2016; July 2017; July 2018  

Advisory Council Review

October 2016; October 2017; October 2018  

Earliest Start Date

December 2016; December 2017; December 2018 

Expiration Date

March 10, 2018  

Due Dates for E.O. 12372

Not Applicable 

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

Problems accessing or using ASSIST should be directed to the eRA Service Desk.
Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

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, part of the National Institutes of Health (NIH).  To date 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).  Only three large-scale HIV vaccine efficacy trials have been completed to date.  Two of these trials provided no evidence of efficacy, despite the fact that the vaccines induced an immune response in many trial participants.  Recently, vaccines tested in a third trial, in Thailand (RV144), demonstrated modest efficacy at preventing HIV infection.  These results, together with promising Non-Human Primate (NHP) vaccine efficacy studies, provide some evidence that a HIV vaccine may be within reach.  Therefore, one of the goals of the NIAID is to support studies to confirm and extend the results of RV144.  Another major goal of the NIAID is to continue the advancement of promising and innovative HIV vaccine platforms, unrelated to those used in RV144, for evaluation in early clinical trials.  This IPCAVD FOA is designed to support both of these NIAID goals through the translation of innovative HIV vaccines of various types to the point of testing in human clinical trials.

Objective and Scope

The objective of the IPCAVD program is to facilitate the translation of advanced, innovative, and promising vaccine platforms for the development of prophylactic HIV vaccines towards clinical research studies by providing the support necessary for achieving this goal.  This Program will provide the critical resources necessary for achieving the goal of advancing vaccine concepts into clinical studies within the project period of the award. Specifically the IPCAVD award will provide support for: (1) all stages of vaccine platform research and development through facilitation of Non-Human Primate (NHP) proof-of concept studies and down-selection of the final lead candidate; (2) all product development stages including processes development, CGMP manufacturing and formulation; and (3) support  for all IND-enabling studies and regulatory submissions. The IPCAVD will not support clinical trials. However, investigators are expected to begin clinical studies under other funding mechanisms no later than year five of this award.  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 is a resource to the program, providing 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.

Projects:  Research and Product Manufacture Projects. Each application must propose a minimum of two projects and one of the projects must perform product manufacture as described below. The Program will support the funding of a multidisciplinary consortium of experts in animal models, molecular biology, immunology, and manufacturing.  Specific activities in the application may include basic HIV vaccine research, preclinical testing and vaccine optimization, product development and CGMP manufacturing; and parallel NHP efficacy studies. 

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 independent experts in the areas of research that the project 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.  

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIH intends to fund an estimate of 1-2 awards, corresponding to a total of $2.8 million, for fiscal year 2017.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project. As a guideline, the approximate range of funding in direct costs is expected to be $1.5 to $2.5 million per year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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:

    • 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 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)
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.

Required Registrations

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) (formerly CCR) – 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.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

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).
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • 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:

Paul (Chris) Roberts, Ph.D.
Telephone: 240-669-5053
Email: paul.roberts@nih.gov  

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12 pages

Admin Core (Use for Administrative Core)

6 pages

Core (Use for Scientific Cores)

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.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

  • Overall: required
  • Administrative Core: required
  • Scientific Cores (SC): optional
  • Projects: required, minimum of 2, including at least one Product Manufacturing Project.
Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

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.

Research & Related Senior/Key Person Profile (Overall)

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.

Budget (Overall)

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.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision 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 should be viewed as a confederation 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 is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program – by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.  As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme.  Summarize the special 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 funding these projects and cores together to accomplish the goals of the FOA.

The Program Overview of the multi-project application MUST include:

  • The scientific question(s) or concepts that are being addressed in the application.
  • A Research Design and a Product Development Plan, including timelines that summarize and integrate the activities in the individual projects. 
  • Documentation of the overall scientific and technical expertise to demonstrate the ability of the team and organization to design, conduct and analyze the proposed studies and developmental activities, including GMP vaccine production, quality assurance oversight; and GLP toxicology studies, if applicable.
  • Discussion of how the PD/PI leadership skills, experience and effort proposed will contribute to the management, coordination and leadership of the program. Describe the 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.
  • The plan for clinical development that describes approaches and identifies a clinical trial partner to allow a clinical trial to begin no later than year five of the award.  The plan must include a clinical protocol outline including timelines, cost estimates, major milestones, general regulatory strategy, proposed primary clinical endpoints, and statistical considerations.
  • Overall Milestones and Timelines with clear delineation of goals and measurable milestones for the entire overall program including detailed quantitative and qualitative criteria for go/no go decisions to move to the next phase of product development. NIAID Program staff will assess accomplishment of go/no go milestones no later than the end of the third year of funding to determine if increased funding for large scale manufacturing is warranted; if manufacturing milestones are not met, funds for manufacturing will not be provided and NIAID program staff will consider plans for the last 2 years of funding.

A complete dispute resolution plan 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.  While a letter of support from a clinical partner is encouraged it does not take the place of the plan for the clinical development in the application.

Documentation of the institutional support to be provided for the program in laboratory and office space, equipment, and administrative resources should be included as a letter of support.   

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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.

Project /Performance Site Location(s) (Administrative Core)

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.

Research & Related Senior/Key Person Profile (Administrative Core)
  • The contact PD/PI of the application must serve as the Administrative Core Leader.
  • 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 (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Include funding for the overall administrative efforts, services, expenses for publications, and communication expenses.

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.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission and Revision 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 or 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.  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 plan that includes a discussion of the structure and roles of administrative staff not included in key personnel, including the training and experience of proposed staff and the functions to be performed; prioritization of fiscal, budgets and other resources, their allocation, and management.

External Advisory Committee (EAC): The Administrative Core will coordinate the effort of an EAC. EAC members will be required to attend annual meetings, sponsored by the grantee, to review the progress of all projects and cores and provide guidance for the future direction of the U19, to the PD/PI and Program Staff.

For a new or resubmission application, do NOT contact, recruit, or name potential EAC members.  For a renewal or revision application, provide the names of current and former members but do NOT contact, recruit or name potential NEW EAC members.    

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Scientific Core

When preparing your application in ASSIST, use Component Type ‘Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Scientific Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Scientific Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific Core)

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.

Project /Performance Site Location(s) (Scientific Core)

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.

Research & Related Senior/Key Person Profile (Scientific Core)

  • 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 (Scientific Core)

Budget forms appropriate for the specific component will be included in the application package.

Each Scientific Core should include the apportionment of budget that will be required to support each research project.

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.

PHS 398 Research Plan (Scientific Core)

Introduction to Application: For Resubmission and Revision 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 research projects or other cores in the application.

Research Strategy: Each Scientific Core must directly support at least two of the proposed research 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Scientific Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Scientific Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide

Projects

When preparing your application in ASSIST, use Component Type ‘Project.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Projects)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Projects)

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: The applicant should include a thorough description of the infrastructure, facilities, and resources for both production of the vaccine under Current Good Manufacturing Practices (CGMP) and performance of IND-enabling preclinical animal studies under Good Laboratory Practices (GLP), 21 CFR Part 58.  An audit of the proposed manufacturing facility before initiation of CGMP activities will be conducted to assess quality systems and facility design.

Project /Performance Site Location(s) (Projects)

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.

Research & Related Senior/Key Person Profile (Projects)

  • 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 (Projects)

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.

PHS 398 Research Plan (Projects)

Introduction to Application: For Resubmission and Revision 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; (2) a description of the proposed vaccine candidate and its stage of development; (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 clear delineation of the proposed product development activities to be undertaken; (5) a discussion of potential limitations/obstacles in achieving project objectives, and proposed alternative methods to deal with anticipated limitations/obstacles; and (6) proposed steps for the maintenance of quality oversight throughout the implementation and operation of the project.

As part of the requirement for each individual Project, the application must include Milestones and Timeline. 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Projects)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Projects)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign Institutions

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.

3. Submission Dates and Times

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.  

6. Other Submission Requirements and Information

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: https://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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

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).

Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and provide an overall impact score, but will not give separate scores for these items.

  • Is the program scientifically compelling as a whole?
  • Are there coordination and synergy of the individual research projects and cores towards the achievement of the central objectives of the program?
  • Are the overall program goals significant and focused on studies that meet the objectives of the FOA?
  • Will the integration of the individual projects into a single program be more beneficial than pursuing each project independently?
  • Does the PD/PI have the leadership and scientific ability to develop an integrated and focused research program?
  • Will the PD/PI and other Project/Core Leaders devote adequate time and effort to the program?
  • Is there adequate evidence of sufficient institutional support for the PD/PI in terms of laboratory space, equipment and other resources?
  • For applications designating multiple PDs/PIs, is the Leadership Plan both adequate and appropriate to ensure that there will be sufficient coordination and communication among the PDs/PIs? 
  • Is there adequate consideration of requirements to allow a clinical trial to begin no later than year five of the award?
  • Do the overall Product Development Plan and plan for clinical development have realistic timelines with measurable Go/No Go milestones?
  • Are the administrative plans for the management of projects, including plans for resolving conflicts, appropriate?
Overall Impact- Individual Projects

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).

Scored Review Criteria - Individual Projects

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?   

Investigator(s)

Are the Project Lead(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-Project Lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves 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 children, justified in terms of the scientific goals and research strategy proposed?    

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Overall Impact – Individual Cores

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 review criteria and additional review criteria (as applicable for the core proposed).

Review Criteria – Individual Cores

Reviewers will consider each of the review criteria below, as appropriate for the proposed Core, in the determination of scientific merit and provide an overall impact score for each Core, but will not give separate scores for these items.

Administrative Core 

  • 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 Cores (if applicable):

  • Is provision of resources and core services for the individual Research Projects critical and justified?
  • Is the relationship of a scientific core to the central focus of the overall program strong?
  • Are the quality of the relevant facilities or services provided and criteria for prioritization and usage appropriate?
  • Are the qualifications, competence, and commitment of the Core Leader and key personnel appropriate?   
Additional Review Criteria - Overall, Cores and Projects

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.

Milestones

Are the proposed Milestones well-defined with quantifiable measures that are appropriate for assessing the success of the individual projects and overall Program application? Do the Milestones have specific criteria that will enable clear decisions about their attainment? Do the milestones support the goal of advancing vaccine concepts into clinical studies within the first five years of the award?   Does the application describe a collaboration to support a clinical trial and is there a plan to conduct a clinical trial as described in the overall Research Plan? Is there a plan for clinical development that describes approaches and identifies a clinical trial partner to allow a clinical trial to begin no later than year five of the award?  

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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 children to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

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.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

As applicable for the program proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by National Institute of Allergy and Infectious Diseases  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.  
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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:

The Program Director(s)/Principal Investigator(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 a progress report and allow discussion of the future year plans.  The site visit will be attended by the PD/PI, all co-Investigators, 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 shall 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. 

No later than the third year of the award the Program Officials with assistance from the NIAID Project Scientist will assess the accomplishment of the milestones as a measure of progress, the immunologic parameters of the vaccine candidate as an efficacious prophylactic HIV/AIDS vaccine, and whether the feasibility of manufacture as reported will allow, with high probability, initiation of a clinical study within the duration of the grant.  The assessment will be based on the first two annual reports and any additional information that the PD/PI elects to submit.

The PD(s)/PI(s) will be responsible for the timely submission to the NIAID of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in whole or in part under this Cooperative Agreement.  The PD(s)/PI(s) are requested to provide manuscripts to the NIAID Program staff at the time of acceptance by a Journal so that an up-to-date summary of program accomplishments can be maintained.  Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the PD(s)/PI(s) and appropriate Research Project and Core Leaders and will require appropriate acknowledgement of NIAID support.  Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and report to the NIAID or other mechanisms consistent with laws, regulations, and NIH policies. 

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, adherence to clinical protocol, 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.  NIAID retains the right to independently monitor any clinical trial to ensure adherence to regulatory requirements.  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) serving as the point of contact between the PD/PI and NIAID for initiating the NIAID review process of all clinical protocols (per the NIAID Clinical Terms and Conditions of Award), (5)  providing guidance (e.g., submission of the required documentation etc.) for the NIAID clinical protocol review process, and (6) providing guidance and oversight throughout the clinical trial to ensure that the awardee is in full compliance with all human subjects research as delineated in the NIAID Clinical Terms and Conditions of Award.

At the mid-point of the cooperative agreement (No later than the third year), the NIAID Project Scientist, will assess the accomplishment of the milestones as a measure of progress, the immunologic parameters of the vaccine candidate as an efficacious prophylactic HIV/AIDS vaccine, and whether the feasibility of manufacture as reported will allow, with high probability, initiation of a clinical study within the duration of the grant.  The assessment will be based on the first two annual reports and any additional information that the PD/PI elects to submit.  Based on comments from the peer reviewers, the NIAID Project Scientist may wish to revise the milestones included in the application through negotiation with the awardee.  The revised milestones will be included in the Terms of Award.

The decision to release 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.

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:

In addition to the interactions defined above, 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.

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, all awardees understand and acknowledge the following:

The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for applicant to perform the project;

Before, during, and subsequent to the award, the U.S. Government is not required to obtain for awardee any proprietary rights, including intellectual property rights, or any materials needed by awardee to perform the project;

Awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified at 35 U.S.C. Sect. 202 (Bayh-Dole Act).  In addition, awardees are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goal of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit.

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.

3. Reporting

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 progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Michael Pensiero, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-3749
Email: mpensiero@niaid.nih.gov

Peer Review Contact(s)

Paul (Chris) Roberts, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5053
Email: paul.roberts@nih.gov

Financial/Grants Management Contact(s)

Lauren E. Early
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2961
Email: earlyle@niaid.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.

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