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)
National Institute of Mental Health (NIMH))

Funding Opportunity Title

Beyond HAART:  Innovative Therapies to Control HIV-1 (P01)

Activity Code

P01 Research Program Projects

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-11-012

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.855; 93.856; 93.242 

FOA Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH), NIH encourage applications from institutions/organizations to participate in this Funding Opportunity Announcement (FOA),  Beyond HAART:  Innovative Therapies to Control HIV-1.  This initiative will support program project applications to develop therapeutic approaches that could allow HIV-1 infected persons to discontinue current HIV-1 treatments for a sustained period without viral rebound.  Approaches of interest include therapeutic vaccines, gene therapies, cell therapies, antibodies, and other targeted interventions.  Awardees will perform basic research on the chosen approach, as well as engage in translational activities such as test-of-concept studies in animal models or humans.  Research program project applications must be designed as collaborative efforts between academia and the private sector.

 
Key Dates
Posted Date

April 20, 2011

Letter of Intent Due Date

June 20, 2011

Application Due Date(s)

July 19, 2011  

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November, 2011  

Advisory Council Review

January, 2012 

Earliest Start Date(s)

April, 2012 

Expiration Date

July 20, 2011 

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Research Objectives

Purpose

This Funding Opportunity Announcement will support program project applications to develop therapeutic approaches that could allow HIV-1 infected persons to discontinue current HIV-1 treatments for a sustained period without viral rebound.  Approaches of interest include therapeutic vaccines, gene therapies, cell therapies, antibodies, and other targeted interventions.  Applicants are expected to have an identified strategy that is based on a solid scientific rationale and supported by preliminary data.  Awardees will perform basic research on the chosen approach, as well as engage in translational activities such as test-of-concept studies in animals or humans.  Research program project applications must be designed as collaborative efforts between academia and the private sector.

Background

Combination antiretroviral drug therapy (ART) is very effective at suppressing HIV-1 replication.  ART reduces viral load from millions of copies of HIV-1 RNA per ml of plasma to single copy levels, where it can be maintained indefinitely.However, numerous studies have demonstrated that long- term ART, in any number of potent combinations, does not result in a cure.  In most infected persons, virus rebound occurs within weeks once drug treatment is interrupted.  In order to make progress towards a cure, different or complementary approaches are needed that take into account the existence of latent HIV-1 and occult viral reservoirs in drug-treated individuals.

Finding a cure for HIV-1 infection is one of the highest, long-term priorities of the NIAID.  As a consequence, the NIAID is issuing a series of initiatives to stimulate research into the problem of HIV-1 persistence and how it relates to the development of strategies to effect long-term control of HIV-1 in the absence of ART (functional cure) or complete eradication of persistent virus (cure).  PA-09-152 (http://grants.nih.gov/grants/guide/pa-files/PA-09-152.html), issued in 2009, focuses on characterizing viral reservoirs in treated persons and on developing tools and assays that could facilitate future clinical interventions.  RFA-AI-10-009 (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-10-009.html), issued in 2010, solicits a collaborative effort to design and test cure strategies.  The current FOA addresses the intermediate goal of developing strategies that will control HIV-1 in the absence of ART, through immunological means or by the use of novel technologies.  A functional cure would be expected to delay or eliminate rebound of virus when ART is interrupted, reduce exposure to drugs and consequent toxicities, free infected persons from the complexities of continuous drug taking, decrease the potential to transmit virus, and perhaps lower levels of immune activation and resulting long-term morbidities.

Objectives and Scope

Many basic questions remain regarding why and how HIV-1 persists in the face of potent antiretroviral drug treatment.  Translational research efforts may provide insights.  The objective of this FOA is to encourage investigators to begin considering the kinds of strategies that might effectively convert HIV-1 infected persons on highly active antiretroviral drug regimens into elite controllers, a term used to describe a subset of HIV-1 infected individuals who can suppress viral load (to single copy levels) in the absence of antiretroviral drugs.  The mechanism or, more likely, mechanisms responsible for the elite controller phenotype is unknown but current research points to the importance of host genetic factors and immune responses.  For this reason, the current FOA encourages research on immunological approaches to control HIV-1.  Novel technologies/concepts that might be brought to bear on this problem  are also of interest.  New ideas about how to control viral replication at a molecular level and how to reduce latent reservoirs will be of value in the search for a functional cure.

Responsive applications to the FOA will propose (and justify) a concept for achieving a functional cure and provide a plan to advance the concept toward testing in an animal model or in humans.  This will be achieved through multidisciplinary research, including basic research and translational activities, and will involve both academic and private sector collaborators.

Approaches of interest include, but are not limited to, those listed below:

This FOA will support test-of-concept studies in animals and humans.  Such studies must be directly linked to basic research and/or preclinical development performed under the award, and must be initiated prior to the final year of the award.  Clinical studies in humans are anticipated to be few in number and of small size (less than 50 subjects), and are subject to prior review by the Scientific Advisory Panel and the NIAID/DAIDS Clinical Sciences Review Committee (CSRC) (for more detailed information, see Section VI.2. Administrative and National Policy Requirements).  Larger scale clinical studies will not be supported under this FOA. 

The following types of research are not included within the scope of this FOA, since they are either well represented within the NIAID research portfolio or more appropriate for support under other programs or funding mechanisms.  Applications proposing research in the areas listed below will be deemed non-responsive to this FOA and will not be reviewed:

Applicants are strongly encouraged to discuss the proposal approach, concept, or strategy with Program staff listed in Section VII. Agency Contacts to determine if the approach, concept, or strategy meets the stated responsive criteria.

Partnerships

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 such as pharmaceutical, biotechnology, bioengineering, and chemical companies.

Each application must be composed of a minimum of two interrelated individual research projects and an Administrative Core.  The Project Leader of at least one individual research project of the P01 must be employed by, and represent, a private sector entity, and another Project Leader must be employed by a university or other academic institution.  The applicant institution may be either a private sector entity or an academic institution.  Applications not meeting the above described composition will be considered non-responsive and will not be reviewed.

The private sector partner should propose a research plan that contributes materially and intellectually to the overall goals and objectives of the P01, contribute expertise and/or resources not generally available in academia, and have a record of past successes moving concepts to practical applications. 

For the purpose of this FOA, the following list of activities, alone or in combination, will not be considered sufficient to meet the requirement for private sector participation: 

providing access to intellectual property, chemical libraries, or novel experimental therapeutics or providing fee-for-service type activities such as routine in vitro assays, cell processing and preparation, standard pharmacology and toxicology tests.

Intellectual Property

In light of the collaborative nature of this initiative, 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 program project in order to ensure that the goals of the overall program 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.  Finally, applicants are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID or other mechanisms.  See NIH Data Sharing Policy and Implementation Guidance and related NIH sharing policies (at http://sharing.nih.gov) for guidance related to appropriate sharing of research data and resources, consistent with NIH policies, laws, and regulations.

Additional Information Related to the Program Project Application

Research Projects:  Required (minimum of two).  The P01 program project application must propose at least two individual research projects for the application to be considered responsive.  As stated above, one project must originate from an academic institution and one, from the private sector (see Partnerships section).  The P01 may be composed of research projects and scientific 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.

Administrative Core:  Required.  Each application must include an administrative core headed by the contact PD/PI.  This core is a resource to the program project grant, providing for the management, coordination and supervision of the overall program project.  The Administrative Core section of the application should provide an administrative plan that discusses the structure and roles of administrative staff, including the training and experience of proposed staff and the functions to be performed; how fiscal and other resources will be prioritized, allocated and managed; how communications will be facilitated; and how research related travel and training will be budgeted.  Funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses should be requested here.  Expenses related to the participation of external experts serving on the Scientific Advisory Panel should be included in the Administrative Core budget.

Scientific Core(s):  Optional.  A scientific core is a resource to the program project grant as a whole and must support at least two of the proposed individual research projects.  The application must indicate the specific individual research projects to be served by the Scientific Core(s).  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.  The apportionment of dollars or percentage of dollars that will be required to support each component research project that will utilize each scientific core should also be presented.

Annual meeting: An annual face-to-face meeting is required for each P01.  The purpose of the meeting is to review progress, plan and design research activities, and establish priorities.   Participants should include at a minimum the PD/PI(s), Leaders of each individual research project and core, the NIAID Program Official, an NIMH program representative, as appropriate, and members of the Scientific Advisory Panel (see below).   Applicants should include expenses related to participation in the annual meeting in the budget of the respective individual research project or core applications. See Section VI.2. Administrative and National Policy Requirements.

Scientific Advisory Panel:  Following award, the PD/PI(s) of each P01 award (in consultation with the NIAID Program Official) will invite 3 or more experts working in relevant research areas to form a Scientific Advisory Panel (SAP) for the P01.   These individuals will be unaffiliated with the application and will provide an independent perspective on the research activities of the P01.  The members of the SAP will not be involved in the day to day activities of the P01  but are expected to attend one Annual meeting per year throughout the award period.   They will assist in the review of program activities and evaluate progress toward the proposed goals, adherence to the original time frames, and the continued relevance of each project and scientific core to the overall goals of the research program.  The SAP may recommend new directions as appropriate.  The SAP will provide the PD/PI(s) and the NIAID Program Official with a comprehensive written evaluation of the program’s activities, including the Panel’s recommendations, after each annual meeting.  For awards involving clinical trials, the SAP may be asked by the NIAID Program Official to help determine whether sufficient scientific data has been generated by the Program to warrant proceeding to clinical trial.  See Section VI.2. Administrative and National Policy Requirements.

Members of the SAP may not be named in the application nor should individuals be invited to be a member in advance of the award.  Applications that name potential members of the SAP will not be reviewed. 

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the PHS398 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 2012:

National Institute of Allergy and Infectious Diseases (NIAID)/Division of AIDS, $4.5 million, 2-3 awards.

National Institute of Mental Health (NIMH)/Division of AIDS Research, $0.5 million, for support of research relevant to the priorities of the NIMH AIDS program. .

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

The scope of the proposed program project application should determine the award 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:

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

Foreign (non-U.S.) components of U.S. Organizations are notallowed.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to serve as primary applicants for this FOA.  However, a research project(s) or scientific core(s), originating at a foreign organization, may be submitted as part of a program project application submitted by a domestic institution or organization.

The applicant institution or organization may be from academia or the private sector.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

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/Principal Investigator (PD/PI) 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 PHS398 Application Guide.

Note that the multiple PDs/PIs option may be used only for the overall program project.  The multiple PDs/PIs option is not available for the leadership roles of the individual research projects or cores within the program project application.   

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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
FedEx Zip: 20817-7616
Telephone: 301-496-8426
Fax: 301-480-2310
Email: PJackson@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
FedEx Zip: 20817-7616
Telephone: 301-496-8426
Fax: 301-480-2310
Email: PJackson@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide  must be followed, with the following exceptions or additional requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Supplemental Instructions for the Preparation of a Program Project Application

The following section supplements the instructions found in Form PHS 398 for preparing a program project grant application.  Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for program project applications consisting of research projects interrelated by a common theme. 

Applicants should follow the instructions in the PHS398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html), incorporating the following deviations from the PHS398 instructions noted under the specific headings below for the overall program project application, the individual research projects and the cores.  All applications must be submitted on Form PHS 398.  The program project application should be assembled and paginated as one complete document.

Instructions Specific for the Overall Program Project Application

Face Page (Form Page 1) - Overall Program Project Application

Description/Performance Site/Key Personnel and other Significant Contributors (Form Page 2) - Overall Program Project Application

Table of Contents (Form Page 3) - Overall Program Project Application

Composite Budget for Entire Proposed Period of Support - Overall Program Project Application

EXAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Invest.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2. Study

125,000

130,000

135,200

140,608

146,232

677,040

Project 3. Develop.

100,000

104,000

108,160

112,486

116,985

541,631

Core A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core B. DNA

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850

 

 

 

 

 

 


Biographical Sketch (Biographical Sketch Format Page) - Overall Program Project Application

Resources (Resources Format Page) - Overall Program Project Application

Research Plan (Continuation Format Page)- Overall Program Project Application

Specific Aims (Limited to 1 page.)

Research Strategy (Overview, Research Objectives and Strategic Plan) (Limited to 12 pages)

Checklist (Checklist Form Page) - Overall Program Project Application

Instructions Specific to the Individual Research Project(s)

Cover Page--Individual Research Project(s)

Description/Performance Site/Key Personnel and other Significant Contributors (Form Page 2) - Individual Research Project(s)

Table of Contents (Form Page 3) -- Individual Research Project(s)

Detailed Budget for Initial Budget Period (Form Page 4) - Individual Research Project(s)

Budget for Entire Proposed Project Period (Form Page 5) - Individual Research Project(s)

Research Plan (Continuation Format Page) - Individual Research Project(s)

Specific Aims (Limited to 1 page.)

Research Strategy (Limited to 12 pages.)

Resources (Resources Format Page) - Individual Research Project(s)

Instructions Specific to the Core(s)

Cover  Page - Core(s)

Description/Performance Site/Key Personnel and other Significant Contributors (Form Page 2) - Core(s)


Table of Contents (Form Page 3) - Core(s)

Detailed Budget for Initial Budget Period (Form Page 4) - Core(s)

Budget for Entire Proposed Project Period (Form Page 5) - Core(s)

Research Plan (Continuation Format Page) - Core(s)

Specific Aims (Limited to 1 page.)

Research Strategy (Limited to 6 pages.)

Resources (Resources Format Page) - Core(s)

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 PHS398 Application Guide, with the following modification:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute of Allergy and Infectious Diseases, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

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 Program Project Applicationl

Reviewers will provide an overall impact/priority 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).

Is the overall program project (P01) as a whole scientifically compelling? Does the proposed strategy meet the definition of a functional cure?  If the Program is successful, is the outcome likely to change the current treatment paradigm for HIV-1 infection?  Is there coordination and synergy of the individual research projects and cores towards the achievement of the central objectives of the program?  Will the integration of the individual projects into a single program be more beneficial than pursuing each project independently?  Does the PI/PD(s) have the leadership and scientific ability to develop an integrated and focused research program?   Are the administrative plans for the management of projects, including plans for resolving conflicts, appropriate?  Did the private sector partner propose a research plan that contributes materially and intellectually to the overall goals and objectives of the Program; will the private sector partner provide expertise and/or resources not generally available in academia; does private sector entity have a track record of past successes moving concepts to practical applications?  Has the applicant described plans to leverage existing Government funded resources and provided documentation that these resources will be available to the P01 investigators?

 Overall Impact - Individual Research Projects

Reviewers will provide an overall impact/priority 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).

Scored Review Criteria – Individual Research 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 PD/PIs, 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)?

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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion 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?        

Additional Review Criteria - Overall Program Project Criteria-Overall Program Project Application, Individual Research Projects and Cores

As applicable for the program, project or core proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed program involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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.

Additional Review Considerations – Overal Program Project Application, Individual Research Projects and Coresl

As applicable for the program, project or core 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/priority 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.

Review Criteria – Cores

As applicable for the program project proposed, reviewers will evaluate the Administrative and all Scientific Cores and factor them into the determination of the scientific and technical merit of the entire program project. Separate Impact/Priority scores will be given for each Core; however, reviewers will not give separate criterion scores for cores.

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 administrative Core Leader and staff adequate to manage the program? 

Scientific Core(s)

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?  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?    

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s)  convened by the National Institute of Allergy and Infectious Diseases (NIAID) , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center and 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 l. The following will be considered in making funding decisions:

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 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Terms and Conditions of Award

Annual meeting: An annual face-to-face meeting is required for each P01.  The purpose of the meeting is to review progress, plan and design research activities, and establish priorities.   Participants should include at a minimum the PD/PI(s), Leaders of each individual research project and core, the NIAID Program Official, an NIMH program representative, as appropriate, and members of the Scientific Advisory Panel (see below).   Applicants should include expenses related to participation in the annual meeting in the budget of the respective individual research project or core applications.

Scientific Advisory Panel:   Following award, the PD/PI(s) of each P01 award (in consultation with the NIAID Program Official) will invite 3 or more experts working in relevant research areas to form a Scientific Advisory Panel (SAP) for the P01.  These individuals will provide an independent perspective on the research activities of the P01.  The members of the SAP will not be involved in the day to day activities of the P01 but are expected to attend one Program meeting per year throughout the award period.  They will assist in the review of all P01 awarded program activities and evaluate progress toward the proposed goals, adherence to the original time frames, and the continued relevance of each project and scientific core to the overall goals of the research program.  The SAP may recommend new directions as appropriate.  The SAP will provide the PD/PI(s) and the NIAID Program Official with a comprehensive written evaluation of the program’s activities, including the Panel’s recommendations, after each annual meeting.  For awards involving clinical trials, the SAP may be asked by the NIAID Program Official to help determine whether sufficient scientific data has been generated by the Program to warrant proceeding to clinical trial.  Members of the SAP may not be named in the application nor should individuals be invited to be a member in advance of the award.  Applications that name potential members of the SAP will not be reviewed.

NIAID/DAIDS Clinical Science Review Committee:  Protocols for clinical studies to be carried out under this FOA will require review and approval by the NIAID/DAIDS Clinical Science Review Committee.  This committee is responsible for the programmatic review of therapeutic protocols sponsored by DAIDS.  The review will include assessment of the scientific objectives, design, safety, ethics, and feasibility of proposed research protocols.  Scientific representatives from collaborating NIH Institutes and Centers participate as appropriate.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Sandra Bridges Gurgo, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:  301-496-8198
Email:  sbridges@mail.nih.gov

Jeymohan Joseph, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-6100
Email:  jjeymoha@mail.nih.gov

Peer Review Contact(s)

Peter R. Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-8426
Email: PJackson@mail.nih.gov

Financial/Grants Management Contact(s)

Anneliese Culley
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-8328
Email: ACulley@mail.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone:  301-443-2805
Email:  siscor@mail.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 Parts 74 and 92.


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