and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
Funding Opportunity Title |
Beyond HAART: Innovative Approaches to Cure HIV-1 (U19) |
Activity Code |
U19 Research Program Cooperative Agreements |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-AI-14-004 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.855, 93.856, 93.839, 93.242 |
Funding Opportunity Purpose |
This Funding Opportunity Announcement (FOA) invites applications from institutions/organizations to participate in the "Beyond HAART: Innovative Approaches to Cure HIV-1" initiative. The purpose of this FOA is to encourage investigators to work together on innovative approaches to eliminate HIV-1 and leverage the expertise and resources of the participating Institutes. Research topics of interest are as follows: cell therapies, including those based on hematopoietic stem cells; novel gene therapy approaches; and the development and delivery of non-traditional antiviral strategies (e.g. miRNAs, siRNAs, gene-editing enzymes). Applications are expected to include basic science/preclinical research as well as translational activities such as test-of-concept studies in animal models or humans. Applications must be designed as collaborative efforts between academia and the private sector. |
Posted Date |
January 24, 2014 |
Open Date (Earliest Submission Date) |
June 28, 2014 |
Letter of Intent Due Date(s) |
June 28, 2014 |
Application Due Date(s) |
July 28, 2014, by 5:00 PM local time of applicant organization. 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) |
July 28, 2014 by 5:00 PM local time of applicant organization. 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 |
September 2014 |
Advisory Council Review |
January 2015 |
Earliest Start Date |
March 2015 |
Expiration Date |
July 29, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
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.
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
During the 3 decades of the HIV-1 epidemic, therapeutics research has largely focused on drug-based strategies to inhibit viral replication. With the advent of potent combination drug regimens and more sensitive ways to quantitate residual virus, it has become clear that HIV-1 can be well controlled by drugs but not eliminated. Interest in other, potentially curative strategies has grown out of basic research findings and their application. The finding most relevant to this initiative is that persons who have a homozygous, naturally occurring 32 base pair deletion (∆32) in the viral co-receptor CCR5 are healthy, and if exposed to HIV-1, are resistant to infection. This discovery has led to the following instructive experiments in humans with hematopoietic malignancies: allotransplantation of ∆32 donor stem cells into an HIV-1 infected subject, resulting in an apparent HIV-1 cure; allotransplantation of ∆32 cord blood cells into an HIV-1 infected child, who died shortly after the transplant due to complications; allotransplantation of donor cells with no CCR5 deletion into 2 HIV-1 infected subjects, resulting in a prolonged loss of detectable HIV-1 DNA and RNA; and transplantation of autologous CD34+ cells transduced with a lentiviral vector carrying several anti-HIV-1 moieties, including a ribozyme targeting CCR5. In addition to these stem cell approaches, other studies used CD4+ T cells in which CCR5 was disrupted by gene-editing enzymes (Zn finger nucleases). The number of subjects who participated in each of these studies ranged from 1 to less than 30 due to the complex nature of the treatments. The importance of cell-based approaches is that they offer, potentially, lifetime protection from viral rebound, or in the best case, cure of HIV-1 infection. Due to the cost and complex nature of delivering cell therapies, research in this area may not have broad public health implications at the present time but could provide a scientific basis for approaches that might be effective and feasible in the future. This FOA seeks new approaches, as well as research to understand, simplify and improve upon current cell-based approaches.
Traditional gene therapy approaches for HIV-1 have been pursued for over 20 years, beginning with studies using one anti-HIV-1 gene delivered in a retroviral vector and evolving to delivery of up to three inhibitory genes by lentiviral vectors. Relevant to the present FOA, these approaches have the potential of providing long term protection of HIV-1 target cells but are not designed to permanently rid the body of HIV-1. Targets have included viral and host genes, and inhibitory modalities have ranged from dominant-negative effectors, intrabodies, antisense oligonucleotides, therapeutic peptides, RNA-based strategies (ribozymes, RNA decoys, and siRNA), alone and in combinations. Many of these approaches showed potential in vitro and in some cases in animal studies. With regard to the latter however, experiments were carried out in uninfected animals with subsequent virus challenge rather than in infected or infected, drug-treated animals. Several clinical studies have been done using these traditional gene therapy approaches, yielding evidence of safety/tolerability and evidence of transgene expression but not efficacy. This FOA encourages applicants to explore new host and viral targets, inhibitory modalities, and delivery platforms with the goal of suppressing HIV-1 long term, in the absence of antiretroviral drugs, or eliminating HIV-1.
The next generation approach to traditional vector-based delivery of anti-HIV-1 genes utilizes nucleases (e.g., Zn finger, TALENs, homing endonucleases, CRISPR/Cas) to disrupt host or viral sequences. Research on these enzyme systems is ongoing but there are a number of unmet challenges: in vivo delivery, off-target cleavage, bi-allelic disruption of genes, and specific targeting to latently infected cells, to name a few. Similar challenges exist for other new agents that are included within the scope of this FOA: noncoding RNAs that have regulatory or targeting functions and that may be useful HIV-1 cure strategies. There will be a need for investigators to develop and test new gene-editing platforms and explore the ability of RNA-based modalities to target HIV-1.
This Funding Opportunity Announcement (FOA) invites applications from institutions/organizations to participate in the "Beyond HAART: Innovative Approaches to Cure HIV-1" initiative. The goal of this initiative is to encourage investigators to work together on innovative approaches to eliminate HIV-1 and to leverage the expertise and resources of the participating Institutes. Research areas of interest include: cell therapies, including those based on hematopoietic stem cells; novel gene therapy approaches; and the development and delivery of non-traditional antiviral strategies (e.g. miRNAs, siRNAs, gene-editing enzymes). Applications are expected to include basic science/preclinical research as well as translational activities such as test-of-concept studies in animal models or humans. Applications must be designed as collaborative efforts between academia and the private sector.
NIAID has used the multi-project program award since 1987 to stimulate therapeutics discovery and development for HIV-1 infection. Previous programs were: the National Cooperative Drug Discovery Groups for the Treatment of HIV-1 Infection (NCDDG), the Strategic Program for Innovative Research on AIDS Treatment (SPIRAT), HIV-1 Novel Therapies: Integrated Preclinical/Clinical Program (IPCP), and Beyond HAART: Innovative Therapies to Control HIV-1. While the scope of these programs varied from small molecule drug discovery to biologically based therapies, the common elements have been multidisciplinary research, participation of the private sector, and for all but the first program, research spanning the spectrum from basic research to animal or pilot human studies in a single multi-project award. NHLBI brings to this initiative a long-standing interest in gene- and cell-based therapies for heart, lung, and blood diseases and a portfolio of resources that facilitate the translation of research findings to the clinic.
The objective of this FOA is to encourage research that will explore non drug-based approaches to eliminate HIV-1. The approaches sought here are not scalable or easily delivered at the present time. For this reason, the NIH seeks new approaches, as well as research to understand, simplify and improve upon existing cell- and gene-based strategies to eliminate HIV-1.
Areas of interest include, but are not limited to:
NIMH will co-fund applications which contain projects or cores of interest to their mission. Examples of areas of interest to the NIMH include, but are not limited to the following:
The following types of research are not included within the scope of this FOA. Applications proposing research in the areas listed below are non-responsive to this FOA and will not be reviewed:
The intent of this FOA is to explore new ideas/concepts, rather than to support strategies already under intense investigation. Applicants are strongly encouraged to discuss the proposed approach, concept, or strategy with Scientific/Research staff listed under Agency Contacts to determine responsiveness to this FOA and to consult the Q&A website (http://www.niaid.nih.gov/researchfunding/qa/Pages/RFA-AI-14-004.aspx) for questions, submitted by other potential applicants, and answers from the NIH.
A key component of this initiative is the formation of partnerships between academia and the private sector. For the purpose of this FOA, the term private sector comprises large and small, domestic and foreign, not-for-profit and for-profit organizations. Each application must be composed of a minimum of three interrelated individual Research Projects and an Administrative Core; one or more Scientific Cores may be proposed. At least one Research Project must originate from an academic institution, and one, from the private sector.
Examples of private sector partners appropriate to this FOA include biotechnology, pharmaceutical, bioengineering, stem cell, and chemical companies. The private sector partner must: propose a research plan that contributes intellectually to the overall goals and objectives of the program, contribute expertise and/or resources not generally available in academia, and have a record of past successes moving concepts to practical applications. These characteristics will be evaluated in determining whether or not the proposed partnership meets the goals of the FOA. Activities that could be proposed by private sector partners include, but are not limited to, development of:
This FOA will support test-of-concept studies in animals and humans. Such studies must be directly linked to the basic research and/or preclinical development performed under the award, and must be initiated prior to the final year of the award. Investigators proposing animal models are encouraged to perform pilot studies with small numbers of animals prior to full scale test-of-concept. Studies in humans are anticipated to be few in number, must be of small size (<30 subjects), and are subject to review by the Scientific Advisory Panel (SAP: an independent advisory body that acts as a resource for the PD(s)/PI(s) and the NIH team) and the appropriate NIH Institute protocol review committee prior to implementation (for more information, see Section VI.2: Administrative and National Policy Requirements Cooperative Agreement Terms and Conditions). Such translational studies are not expected to provide definitive, powered statistical assessments of the concept or strategy being evaluated but an early indication of whether the concept is safe and worthy of being pursued further on a larger scale.
In light of the collaborative nature of this FOA, applicants are encouraged to reach consensus with any proposed partners regarding intellectual property, data sharing, and other legal matters that may arise during the period of the award in order to ensure that the goals of the overall project will be met. In addition, applicants are expected to exercise their Bayh-Dole rights in a manner that is consistent with meeting the goals of the award and the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit.
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 The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The following NIH components intend to commit the following amounts in FY 2015: NIAID, $5.5 million, NHLBI, $5.5 million, NIMH, $0.25 million, for a total of 3-6 awards |
Award Budget |
Application budgets are limited to $1.5 million in direct costs per year and should reflect the actual needs of the proposed project. |
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.
Multiple PDs/PIs may be designated on the overall application. However, only one Project Leader (PL) or Core Leader (CL) may be designated for each project or core, respectively.
An investigator may not serve concurrently as the PD/PI for more than one Beyond HAART application or award at any time. However, a PD/PI may serve as a Project Leader and/or Scientific Core Leader on one or more applications provided their total effort does not exceed 12 person months and there is no scientific overlap.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
The application may be composed of research projects and cores from the same or multiple institutions/organizations as long as the basic requirement for one individual research project from academia and one individual research project from the private sector is met.
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.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise 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.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Betty Poon, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
6700B Rockledge Dr Rm 3131
Bethesda MD 20817
Telephone: 301-402-6891
Fax: 301-480-2408
Email: [email protected]
Component Types Available in ASSIST |
Research Strategy/Program Plan Page Limits |
Overall |
12 |
Admin Core |
6 |
Core |
6 |
Project |
12 |
Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
The application should consist of the following components:
When preparing your application 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.
Facilities and Other Resources: Do not include a Facilities and Other Resources attachment in the Overall Component. Instead upload a separate attachment containing only the information relevant to each individual Research Project and Core within that component of the application.
Equipment: Do not include an Equipment attachment in the Overall Component. Instead upload separate attachments containing only the information relevant to each individual Research Project and Core within that component of the application.
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)
Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed overall program. Concisely describe the hypothesis or hypotheses to be tested.
Research Strategy: The narrative section summarizes the overall research plan for the multi-project, U19 application. The application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit but complementary to one another. This is an important section as 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 and timeline for attacking the problems. Include a discussion of how the proposed strategy represents an improvement over current antiretroviral drug treatments for HIV-1 and how it meets the definition of a cure strategy, i.e. a strategy that can effect either long-term remission in the absence of antiretroviral treatment or elimination of HIV-1. Each individual research project and core should be cited briefly as to its place in the scheme of the overall research project. Summarize special features in the environment and/or resources that make this application strong or unique. Describe the private sector involvement, the unique expertise and resources it brings to the program and how it will be integrated into and benefit the proposed multi-project program. While hard milestones are not required, the application should identify significant research outcomes, with timelines, for the purpose of measuring progress of the program toward stated goals.
In securing services and common resources to support the needs of the program, it is expected that applicants will leverage existing government-funded resources and/or programs whenever possible, such as:
Documentation must be provided in the application that such services and resources have been explored.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.
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.
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:
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.
Project /Performance Site Location(s) (Administrative Core)
List all performance sites that apply to the specific component.
Research & Related Senior/Key Person Profile (Administrative Core)
Budget (Administrative Core)
Budget forms appropriate for the specific component will be included in the application package.
Funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications related to the program, and communication expenses should be requested here. Expenses related to the travel of external experts (Scientific Advisory Panel members) to the annual meeting of the Beyond HAART awardees should be included in the Administrative Core budget. Assume travel for 2 unnamed Panel members.
No additional travel funds may be requested for attendance of scientific meetings or conferences other than the mandatory annual program meeting.
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)
Specific Aims: List in priority order the broad, long-range objectives and goals of the core. Discuss the core’s relationship to the individual research projects it serves and the program as a whole.
Research Strategy: Discuss how this core will function as a resource to the grant, providing for the management, coordination, and supervision of the overall project. Provide an administrative plan that discusses: the structure of the core and roles of administrative staff, including the training and experience of proposed staff for functions to be performed; how fiscal accountability and other resources will be prioritized, allocated and managed; how communications including program will be facilitated; and how research related travel and training will be budgeted.
Describe how the following will be managed by the core: internal data dissemination, including the tools that are available to facilitate communication among members of the team and program; presentation and publication policy for data generated by the overall and individual projects; tracking of project and core progress; meeting NIH reporting requirements related to research and clinical trials (if applicable); and internal dispute resolution. Describe how you will establish and maintain a strong collaborative environment. Address institutional support for intellectual property management and contingency plan for replacing the PD/PI(s), if needed.
A Scientific Advisory Panel (SAP) will be constituted post award from recommendations put forward from each program awarded. Describe the internal procedures that will be developed for evaluating and responding to recommendations from the SAP. Applicants must not name potential SAP members or include letters of support from potential SAPs.
Letters of Support: Include letters of support, if applicable.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.
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.
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:
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.
Facilities & Other Resources: Include information on resources available for the core. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities for working with biohazards or other potentially dangerous substances. Include a description of how the scientific environment in which the resource resides will contribute to the likelihood of success (institutional support, physical resources, and intellectual milieu).
Equipment: Include information on equipment available for the core.
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)
Budget (Scientific Core)
Budget forms appropriate for the specific component will be included in the application package.
Expenses related to participation of personnel in the annual meeting of the Beyond HAART awardees should be included in the budget of the respective Scientific Core.
No additional travel funds may be requested for attendance of scientific meetings or conferences other than the mandatory annual program meeting.
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)
Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed core.
Research Strategy: Clearly describe the techniques and skills that the core will provide. As each Scientific Core must serve at least two individual research projects, indicate the specific individual research projects to be served by each Scientific Core.
Use this section to describe how the proposed core activities will contribute to meeting the goals and objectives of the research program proposed in the application and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims.
Letters of Support: Include letters of support, if applicable.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.
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.
Each application must include at least three related individual research projects that share a common central theme, focus, and/or overall objective. Each project should reflect distinct, separate, scientifically meritorious research led by an independent investigator, the Project Leader. In addition, the individual projects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual projects separately.
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 (Research Project)
Complete only the following fields:
PHS 398 Cover Page Supplement (Research Project)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Research Project)
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.
Facilities & Other Resources: Provides information on resources available for the project. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities for working with biohazards or other potentially dangerous substances. Include a description of how the scientific environment in which the resource resides will contribute to the likelihood of success (institutional support, physical resources, and intellectual milieu).
Equipment: Include information on equipment available for the project.
Project /Performance Site Location(s) (Research Project)
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 (Research Project)
Budget (Research Project)
Budget forms appropriate for the specific component will be included in the application package.
Expenses related to participation of personnel in the annual meeting of the Beyond HAART awardees should be included in the budget of the respective individual research project.
No additional travel funds may be requested for attendance of scientific meetings or conferences other than the mandatory annual program meeting.
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 (Research Project)
Specific Aims: List specific aims in priority order. Concisely describe the hypothesis or hypotheses to be tested.
Research Strategy: Use this section to describe how the research of the individual research project will contribute to the overall goals and objectives of the proposed research program and how the individual research project relates to the other projects and cores within the application. Describe the research design, methodologies, and analyses to be used to carry out the specific aims. Describe any novel concepts, approaches, or tools to be utilized.
While small test-of-concept studies in humans conducted within the United States (US) are responsive, those proposed to be conducted at non-US sites will not be supported under this FOA. As specified under Objectives and Scope, the studies are anticipated to be small, with <30 subjects. Studies will be carried out under an IND unless not required by the FDA. If an IND is necessary, applicants must be ready to provide full regulatory support for the trial and are responsible for naming the party/institution who will serve as the IND holder. The NIH funding component(s) will not hold the IND.
For test-of-concept studies, include a brief description of the study in the Approach section, including elements such as study design, endpoints, and rationale for choice of animal model or study population. No detailed study plan (or document such as a protocol) should be submitted with the application since it would be based on research results that cannot be anticipated at the time of submission.
The private sector must propose a research plan that contributes intellectually to the overall goals and objectives of the program. It is anticipated that such projects may be applied in nature rather than hypothesis-driven.
Letters of Support: Include letters of support, if applicable.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.
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 (Research Project)
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 (Research Project)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
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.
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 Applying Electronically.
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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
As applicable for the project proposed, reviewers will evaluate the following items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). Reviewers will assess the relationship of the individual research project to the overall goals of the program and how the project relates to the other projects and cores.
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 PD(s)/PI(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-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
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?
Reviewers will provide an overall impact score for the individual cores to reflect an assessment of the likelihood that the core will contribute in an important way to the success of the program.
Reviewers will consider each of the review criteria below, as appropriate for the individual core, in the determination of merit and will give an overall impact score for each Core but will not give separate scores for each criterion.
Is the administrative and organizational structure appropriate and adequate to the achievement 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 Administrative Core Leader and staff adequate to manage the program?
Is the 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? Is 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?
As applicable for the project or core proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the 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
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
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
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIAID, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
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 submitted in response to this FOA. 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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
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 the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
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:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
Intellectual Property:
The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the awardee to perform the project. Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project. The awardee is required to report to the U.S. Government all inventions made in performance of the project, as specified by 35 U.S.C. Sect. 200-212 (Bayh-Dole Act).
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.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or 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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]
Sandra Bridges Gurgo, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-8198
Email: [email protected]
Shimian Zou, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0074
Email: [email protected]
Jeymohan Joseph, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-6100
Email: [email protected]
Betty Poon, Ph.D.
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-402-6891
Email: [email protected]
Anneliese Galczynski
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-8328
Email: [email protected]
Anthony Agresti
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0186
E-mail: [email protected]
Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
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 Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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