Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Centers of Excellence for Translational Research (CETR) (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

New 

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-12-044

Companion Funding Opportunity

None 

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.855; 93.856 

Funding Opportunity Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) invites new applications from single institutions and consortia of institutions to participate in the Centers for Excellence in Translational Research (CETR) program. The purpose of this FOA is to support multidisciplinary translational research centers focused on generating, validating and advancing medical countermeasures to NIAID Emerging and Re-emerging Infectious Diseases.

Key Dates
Posted Date

November 23, 2012

Letter of Intent Due Date(s)

February 26, 2013

Application Due Date(s)

March 26, 2013   

AIDS Application Due Date(s)

Not Applicable 

Scientific Merit Review

July, 2013   

Advisory Council Review

October, 2013 

Earliest Start Date

March, 2014 

Expiration Date

March 27, 2013 

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports extramural research focused on understanding, controlling and preventing diseases caused by virtually all infectious agents. In response to threats presented by emerging infectious diseases and bioterrorism, the NIAID Division of Microbiology and Infectious Diseases (DMID) has established complementary research programs to facilitate development of medical countermeasures for certain pathogens and toxins.

With this FOA, NIAID invites applications to establish Centers of Excellence for Translational Research (CETR) focused on the development of medical countermeasures and associated platforms/technologies targeting NIAID Emerging and Re-emerging Infectious Diseases (http://www.niaid.nih.gov/topics/emerging/pages/list.aspx), which includes NIAID Category A, B and C Priority Pathogens. For the purposes of this FOA, “translational research” is defined as research and developmental activities focused on transforming basic science outcomes (knowledge, technologies, infrastructure, etc.) into new and innovative approaches for prevention, diagnosis, and treatment of disease. Priority will be given to Centers that address the greatest clinical need. Emphasis will be placed on Centers that integrate current research knowledge and infrastructure with highly innovative and synergistic approaches to facilitate medical countermeasure development, and address related constraints, challenges or barriers to product development, licensure and usage. Clinical trials will not be supported under this program.

Background

The NIH and other agencies in the Department of Health and Human Services (DHHS) support development of medical countermeasures to protect the public from emerging infectious diseases and bioterrorist threats. In 2002, NIAID published the initial Strategic Plan for Biodefense Research (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/strategic_plan.pdf) and related research agendas (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/about/strategicplan.htm), outlining research and development objectives to address threats posed by Category A, B and C Priority Pathogens. A significant component of the Strategic Plan was the establishment of the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) program (http://www.niaid.nih.gov/labsandresources/resources/rce/Pages/default.aspx). The RCE program was initiated in 2003, renewed in 2008, and currently supports 11 Centers nationwide (http://www.niaid.nih.gov/labsandresources/resources/rce/Pages/default.aspx). The goal of the RCE program was to establish and maintain appropriate infrastructure and multifaceted research and development activities to provide scientific information and translational research capacity to facilitate discovery and development of the next generation of therapeutics, vaccines, and diagnostics against bioterror agents and emerging infectious diseases.

In 2007, NIAID published an updated Strategic Plan for Biodefense Research (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Documents/biosp2007.pdf). The updated Strategic Plan is consistent with the DHHS Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Implementation Plan (http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html), which outlined strategies for identifying medical countermeasure requirements and establishing priorities for their research, development and acquisition. The updated NIAID Strategic Plan continues to focus on translation of basic research to countermeasures, but with an emphasis shift from the “one bug-one drug” approach towards a more flexible, broad-spectrum approach. This approach is centered on development of countermeasures that are effective against multiple pathogens or toxins, development of technologies that can be widely applied to improve classes of products, and development of platforms that can reduce the time and cost of creating new products. The broad-spectrum approach recognizes the expanding range of biological threats and the limited resources available to address each individual threat. As one mechanism to achieve the goals of the updated Strategic Plan, the NIAID will establish the CETR program to facilitate innovative, interdisciplinary translational research efforts focused on countermeasure and/or related platform development.

The primary goals of the RCE program have been accomplished and the program will end in 2014. The CETR program will build upon the research and development accomplishments of the RCE program and other NIAID-supported programs, and is intended to complement and enhance ongoing translational and product development activities.

Research Objectives and Scope

The objective of this FOA is to establish a program of multi-project translational research Centers focused on advancing discovery, preclinical development, production, licensure and/or use of new or improved countermeasures (therapeutics, immunotherapeutics, vaccines, vaccine technologies, and medical diagnostics) or related technologies specific for NIAID Emerging and Re-emerging Infectious Diseases. Each Center will be organized around a single theme that addresses development and/or use of a targeted countermeasure or technology. NIAID anticipates considerable variety in Center themes and objectives, which can range from development of single or multiple countermeasures targeting a specific group of listed pathogens/toxins to development of new technologies or platforms that target a wide array of pathogens/toxins. Translational activities are anticipated to range from very early discovery-based efforts to late-stage preclinical development. Additionally, each Center must identify and address anticipated regulatory barriers for the countermeasure or technology and propose research and/or strategies to overcome these barriers. This is particularly important for new classes of medical countermeasures for which there are no precedents for FDA approval.

Examples of translational research themes include, but are not limited to, the following areas:

Each application must clearly define the proposed Center theme and the range of activities being pursued, and the significance of the Center theme in regard to countermeasure development, public health need, and benefit to public health of a successful effort. Additionally, each application must detail how each Research Project contributes to the theme and objectives as well as project interdependence.  Applications must outline expected synergies provided by the proposed center structure (see CETR Structure below). NIAID encourages Centers focused on development of medical countermeasures that are effective against a variety of pathogens and toxins, technologies that can be widely applied to improve classes of products, and platforms that can reduce the time and cost of creating new products. For this FOA, applications must focus translational activities towards development of one or more specific countermeasures or technologies as described below.

Note:  For the purpose of this FOA, broad-spectrum is defined as a countermeasure which is effective against multiple infectious disease agents where one or more is on the list of NIAID Emerging and Re-emerging Infectious Diseases.

Note: Translational research themes supported by this program must target listed NIAID Emerging and Re-emerging Infectious Diseases. Accordingly, all Center research and development activities must utilize the virulent form of a listed human pathogen under appropriate biosafety conditions, or a CDC-approved excluded strain that is an attenuated form of the human pathogen.

Note: While clinical development strategies and/or clinical studies (e.g. sample collection, strain isolation, etc.) may be included within an overall project, this FOA will NOT support clinical trials; applications requesting support for clinical trials are nonresponsive to this FOA and will not be reviewed. Utilization of human-derived material in pre-clinical studies is encouraged.

In order to be responsive, projects must focus on the following countermeasures and/or technologies:

Therapeutics

This FOA will support the development of therapeutics, including immune-based and host-targeted

therapeutics, with special interest in broad-spectrum therapeutics and those targeting antimicrobial resistant pathogens and/or pathogens for which no standard clinical treatment exists. 

Immune-based therapeutics may include both broad-spectrum (innate immunity, for example) and pathogen- or toxin-specific immunotherapeutics (antibodies, for example) that target listed pathogens/toxins. Of particular interest are immunotherapeutics that would enable prevention of infection or intoxication in the face of an immediate threat, protection of immunocompromised individuals, or post-exposure treatment to suppress infection and disease. NIAID encourages discovery and/or development of immunotherapeutics that directly affect pathogens/toxins and/or therapeutic approaches to stimulate non-specific immunity. Passive treatments may be especially valuable during the acute emergence of infectious diseases and may complement the use of antimicrobial drugs or vaccination programs to optimize protection.

This program will support discovery and development of therapeutics that target host-encoded functions required for infection, replication, spread and/or pathogenesis by one or more listed pathogens and potentially, additional non-listed pathogens. The development of therapeutics that target host-encoded functions provides a potential solution to emergence of microbial resistance and high developmental costs associated with treatments effective against only one microbe. Of particular interest are therapeutics that target specific host functions/pathways that are required for infection and pathogenesis by unrelated pathogens. For host-targeted intervention projects, applicants must clearly define the specific required host-pathogen interaction(s) for development of a corresponding targeted therapeutic(s).

Vaccines

This FOA will support the development of multivalent/universal vaccines and therapeutic vaccines.  The development of monovalent vaccines against many listed pathogens and toxins is currently well represented within the NIAID emerging infectious diseases research portfolio. Accordingly, vaccine research supported by this FOA aligns with current HHS priorities that emphasize development of the following broad-spectrum vaccine forms targeting emerging diseases:

Multivalent/Universal Vaccines

For this FOA, multivalent or universal vaccines are defined as broad-spectrum vaccines that provide protection against a group of taxonomically related pathogens, or two or more unrelated pathogens. Vaccines characterized by broad-spectrum activity in this class include cross-protective forms, which induce an immune response against constant components of two or more microbes, and multiple component forms, which include elements that protect against microbes that are different, and may or may not be related. Examples of a multivalent/universal vaccine include a universal influenza vaccine and a multivalent vaccine that protects against both X and Y.

Therapeutic Vaccines

For this FOA, therapeutic vaccines are defined as those vaccines that can be delivered after disease onset to simplify, reduce, and/or shorten, or eliminate complicated treatment regimens, or reduce development of antimicrobial resistance. Examples of therapeutic vaccines include forms used for combination treatment of infections caused by Mycobacterium tuberculosis or Burkholderia pseudomallei.

Note: Applications for centers focused on development of a vaccine that cannot be classified as a multivalent/universal or therapeutic form are nonresponsive and will not be reviewed.

Vaccine Technologies

This FOA will support Center activities focused on discovery and/or development of innovative vaccine technologies (including adjuvants), particularly those that would improve vaccine effectiveness and/or simplify vaccine delivery to patient populations during a natural outbreak of an infectious disease or following the intentional release of an agent. Proposed projects must pair the candidate technology with one or more appropriately mature, well-characterized vaccine(s)/antigen(s) (except those pertinent to HIV) for which models and assays exist to allow evaluation of the technology. Applications focused on development of technologies such as delivery platforms, antigen targeting, adjuvants, stability and cold-chain minimization, production characterization or formulation methodologies are encouraged.

Note: While this FOA will not support the development of a candidate monovalent vaccine, a project focused on development of a new vaccine technology or production platform may use a validated or licensed monovalent vaccine as the demonstration and/or development platform.

Diagnostic Technologies

This FOA will support development of new and innovative integrated, sample-to-answer, rapid, easy-to-use, sensitive, and specific diagnostic platforms and/or technologies that address clinical priorities/needs/challenges pertinent to emerging infectious diseases. These medical diagnostics are to be targeted for use in clinical settings, including hospital-based clinical microbiology laboratories, point-of-care, and/or public health laboratories and will enable clinicians to rapidly provide the appropriate therapy to patients. Applications must address methods for sample preparation, collection, and processing for the novel platform. The integrated medical diagnostic must be able to accept and process clinical sample volumes required for detection of targeted pathogen(s). Proposed novel, emerging diagnostic platforms may focus on detection of pathogen or host-specific targets. Successful projects will demonstrate the capability of the proposed platform to detect the targeted pathogens in valid infectious disease animal models (for in vivo technologies) or human clinical samples (for other technologies).

While it is not expected that proof-of-concept stage technologies should be ready for validation studies to enable FDA approval at the end of the project period, FDA approval would be an eventual long-term goal of projects supported under this program.

The following technologies/platforms are strongly encouraged:

Multiplex diagnostic technologies;

Technologies capable of identifying engineered or otherwise acquired genetic traits, such as patterns of antimicrobial resistance or enhanced virulence; and/or

Technologies that could be operational in non-traditional health care settings including rural and urban community health care clinics and temporary health care clinics (e.g., those established in response to a natural or man-made disaster).

Note: Applications focused on development of environmental, agricultural, industrial and/or workplace surveillance/detection technologies are nonresponsive and will not be reviewed.

CETR STRUCTURE

Each Center in the CETR program will be organized around a chosen theme focused on development and/or use of one or more countermeasures and/or technologies that target NIAID Emerging and Re-emerging infectious Diseases with the objective of translating research results to product development. Each Center will include individual Research Projects, an Administrative Core, and if necessary, Scientific Cores (see component descriptions below). NIAID anticipates considerable variety in Center themes and objectives, which can range from development of single or multiple countermeasures targeting a specific group of Emerging and Re-emerging Infectious Diseases to development of new technologies or platforms that target a wide array of pathogens/toxins. Additionally, translational activities are anticipated to range from very early discovery-based efforts to late-stage preclinical development.

As an example, a Center focused on discovery of new therapeutics that target select intracellular bacterial pathogens might have the following structure:

Research Project 1: Identification of Novel Therapeutic Targets in Pathogens

Research Project 2: Bioinformatic/Proteomic Approaches to Identify Essential Host Activities as Therapeutic Targets

Research Project 3: Screening for Small Molecule Effectors against Pathogen and Host Targets

Administrative Core

As a second example, a Center focused on an innovative broad-spectrum platform for production of vaccines might have the following structure:

Research Project 1: Production and Stabilization of a Smallpox Vaccine

Research Project 2: Production and Stabilization of Influenza Vaccines

Research Project 3: Production and Stabilization of a MRSA Vaccine

Administrative Core

Animal Model Core (Vaccine Efficacy Evaluation)

As a third example, a Center focused on development of countermeasures targeting a group of taxonomically related bacterial pathogens might have the following structure:

Research Project 1: Optimization and Preclinical Evaluation of Therapeutic X

Research Project 2: Optimization and Preclinical Evaluation of Immunotherapeutic Y

Research Project 3: Clinical Diagnostics for Targeted Bacteria and Antibiotic Resistance

Administrative Core

CETR COMPONENTS

Research Projects

Each Center must include at least three but not more than six interdependent translational Research Projects organized around the chosen theme; projects must focus on development and advancement of a new or improved medical countermeasure and/or associated platform/technology targeting one or more NIAID Emerging and Re-emerging Infectious Diseases. Each Research Project must contribute directly to the Center theme and objective(s). The Center Program Director/Principal Investigator (PD/PI) will monitor all Research Projects and promote efforts that foster integration, collaboration and synergy. Research Projects may be proposed for up to five years and each project leader must commit at least 1.2 calendar months effort to their project per year. Research Projects are expected to incorporate state-of-the-art technology and approaches and may include consortium arrangements for required activities. Applicants are encouraged to carefully consider the scope and range of research proposed and develop a Center that is coherent overall and consistent with available resources and personnel.

All Research Projects must include detailed project performance and timeline objectives (see Section IV. Application and Submission Information). Additionally, projects must identify and address anticipated regulatory barriers and propose research and/or strategies to overcome these barriers (see below). This is particularly important for new classes of medical countermeasures for which there are no precedents for FDA approval.

All Research Projects at the stage of preclinical product development must include a Product Development Strategy section (see Section IV. Application and Submission Information; Product Development Strategy). The Product Development Strategy must include both a Milestones and Timelines section detailing project performance and timeline objectives and a Product Development Plan. This plan should include the participation of consultants with expertise in technology transfer and the development of regulated products. Only those projects for which the mechanism of action of the candidate product is reasonably well understood, possible routes of administration and formulations suitable for scalable production identified, and assays to assess product quality that are well developed should be considered for support beyond Technology Readiness Level (TRL) 5 (https://www.medicalcountermeasures.gov/federal-initiatives/guidance/about-the-trls.aspx). In addition, animal models that are adequate to assess the ability of the product to induce a certain response and endpoints that will satisfy the Animal Rule (http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ProductSecurity/ucm110322.htm) should be identified and included for candidate products that may not be tested for efficacy in humans.

Administrative Core

Each Center must include an Administrative Core, under which all Center activities will be managed, coordinated, and supervised. A well-structured and run Administrative Core is integral to a Center’s success, and should be clearly described in the application. The PD/PI must be the director of the Administrative Core and must commit at least 0.6 calendar months effort per year to these responsibilities, in addition to his/her Research Project activities. An Administrative Core Associate should be a research administrator responsible for the daily administration and fiscal management of the Center. It is recommended that the Administrative Core Associate devote a level of effort ranging from 3 to 6 person months to the execution of the administrative details of the Center projects and to managing the day-to-day operations within the Center. Any additional Administrative Core personnel must be clearly justified. The Administrative Core budget may not exceed 5% of total direct costs requested.

The Administrative Core must include a Management Plan that identifies and discusses: the Administrative Core structure; the roles of Administrative Core personnel; the composition and duties of the Scientific Advisory Committee (see below); and the facilitation of communications throughout the Center and with NIAID staff. The plan should specifically address continual evaluation of research and development progress, communications, group meetings and teleconferences, presentation and publication of data, resource and model sharing, transmission of information and reagents, the identification and proposed resolution of problems and engagement of the NIAID Staff as appropriate. A description of how consortia (subcontracts) will be managed should be provided and should include how communications such as periodic meetings and conference calls will be organized, managed and documented. The plan should include a Core budget and should identify how research-related travel will be managed. The plan must also detail the process for periodic solicitation and review of CETR program-sponsored supplemental research applications (see Section IV. Application and Submission Information under Administrative Core: Supplemental Research Projects).

The PD/PI and Administrative Core staff are responsible for ensuring that all research activities are carried out in compliance with all federal and NIH regulations. A necessary component of a Center's success will be the availability of adequate access to BSL3/4 biocontainment facilities. Applicants must identify Research Projects that will require high level containment facilities and provide a description of facilities that are available currently or planned at consortium institutions.  A table listing each activity that requires BSL3/4 access and the likely facilities to be used should be included. The PD/PI and Administrative Core staff are also responsible for ensuring that appropriate systems are in place to provide for biosafety and security of materials, data, facilities and resources, including compliance with regard to Select Agent Regulations, Biosafety in Microbiology and Biomedical Laboratories (BMBL) Guidelines, Centers for Disease Control and Prevention and the National Institutes of Health, fifth Edition (http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm); U.S. Code of Federal Regulations 42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121 (http://www.cdc.gov/od/sap/).

Each Administrative Core must include the following components:

Scientific Advisory Committee

Each Center must establish a Scientific Advisory Committee that includes the PD/PI, some or all Research Project leaders, and at least 3 non-conflicted external advisors. For Centers engaged in preclinical product development activities, at least one of the external advisors must have demonstrated and relevant industry-level expertise. The Scientific Advisory Committee will be responsible for the annual scientific evaluation of all center research projects and Core activities. Additionally, the Scientific Advisory Committee will be responsible for soliciting and reviewing CETR program-sponsored Supplemental Research applications (see below).

Regulatory Expertise

All CETR program-supported countermeasure development must address anticipated regulatory requirements and challenges pertinent to Emerging and Re-emerging Infectious Diseases. Accordingly, each Center must include regulatory expertise appropriate for associated developmental activities. Regulatory expertise may be retained as defined effort or periodic consultation.

Programmatic Meetings

NIAID anticipates supporting an annual National CETR Program Meeting to highlight Center progress/activities, review progress, share knowledge of innovative technologies and methodologies, and encourage collaborations. The annual program meetings are expected to be attended by the PD/PI, some or all Research Project Leaders, Scientific Core Leaders, other appropriate key personnel and NIAID staff. These meetings are anticipated to be held at a location at/near Bethesda, MD or at another NIAID-approved site and will last for 1-2 days. Each Center application budget should include funds to travel and attend the annual meeting in Years 2-5 of the project period.

Each Center must participate in an annual reverse site visit to evaluate progress. The annual reverse site visit will be attended by the PD/PI, 1-2 appropriate Project Leaders, and NIAID staff. These reverse site visits are anticipated to be held at a location at/near Bethesda, MD or at another NIAID-approved site and will last 1 day. Each Center application budget should include funds to travel and attend the reverse site visits in Years 1-4 of the project period.

Supplemental Research Projects

In order to facilitate development and/or improvement of innovative translational platforms/technologies, NIAID anticipates having funds to support a limited number of short-term (2-3 years) Supplemental Research Projects throughout the award period. The Supplemental Research Projects will begin in the second year of the CETR program with approved projects phased in to the parent award period. Under programmatic guidance, Centers will solicit and review applications for research projects that complement or facilitate specific theme objectives. Total funding of a Supplemental Research Project may not exceed $200,000 in total costs in any year and the Supplemental Research Project Leader must commit at least 1.2 person months per year to the effort.

Applicants may not submit in their applications descriptions of the projects that would be supported by the Supplemental Research program; these will be solicited and reviewed post-award. Applicants must include in the Administrative Core section a plan that outlines procedures for soliciting, reviewing and identifying the most meritorious Supplemental Research Project applications. Funding of Supplemental Research Projects will be determined by NIAID Program leadership based on Center recommendations, project merit, programmatic priorities and available funds. Do not include funds for Supplemental Research Projects in the budget.

Scientific Cores

A Center may include development and maintenance of one or more core resources/facilities that are essential for the activities of two or more Research Projects. A scientific core must provide a unique service that cannot be obtained through institutional or commercial means. Cores are intended to serve the needs of Center project researchers and they may not conduct research independent of the served Research Projects. The role of each core in overall Center research activities must be clearly described and justified. Additionally, plans for staffing, managing, and prioritizing use of the cores must be provided, as well as plans for determining fees to users if charging fees is necessary.  

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIAID intends to commit $75 million in FY2014 to fund 10 to 20 awards.

Award Budget

Application budgets are limited to $4 million for FY2014 directs costs and need to reflect actual needs of the proposed project.

Award Project Period

Scope of the proposed project should determine the project period.  The maximum 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 Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 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(s)/PI(s)) 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 6 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(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 PHS 398 Application Guide.     

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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:

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 PHS 398 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:

The letter of intent should be sent to:

Lynn Rust, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3120, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20817-7616 (express mail), 20892-7616 (US mail)
Telephone:  301-402-3938
Email:  lrust@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:

Lynn Rust, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3120, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20817-7616 (express mail), 20892-7616 (US mail)
Telephone:  301-402-3938
Email:  lrust@mail.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and must be followed , with the following exceptions or additional requirements:

Supplemental Instruction for the Preparation of Multi-Project Applications

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

The following section supplements the instructions found in Form PHS 398 for preparing a multi-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 multi-project applications consisting of research projects interrelated by a common theme.  All applications must be submitted on Form PHS 398.  The multi-project grant application should be assembled and paginated as one complete document. Instructions for the Overall Component are presented first, followed by instructions for Research Projects, followed by instructions for Cores.  

Instructions for Overall Component

Form Page 1. Face Page (Overall)

Complete this page as instructed in the Application Guide. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

Form Page 2. Summary, Relevance, Project/Performance Site,Senior/Key Peronnel, Other Signficant Contrbutor, and Human Embroyonic Stem Cells (Overall)

Description:  Using Page 2 of Form 398; provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program.  Do not exceed the space provided.

Project/Performance Sites

List the performance sites where the research will be conducted.

Senior/Key Personnel (Overall)

Under "Key Personnel", list the PD/PI of the multi-project application, followed by the Project and Core Leaders of the component research projects and cores, and other key personnel and then other significant contributors.

Form Page 3. Table of Contents (Overall)

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core.  A page reference should be included for the budget for each project and each core.  Further, each research project should be identified by number (e.g. Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g. Core A), title, and responsible Core Leader.  The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."

Form Page 4. Composite Budget (Overall)

Do not use Form Page 4 of PHS Form 398.  Instead, using the suggested format presented below, prepare a Composite Budget for All Proposed Years of Support. (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)

SAMPLE: 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














Form Page 5. Total Direct Costs for the Entire Budget Period (Overall)
Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. Detailed budgets are required within the descriptions of each project and core (see below). 

Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed at the end of the application with the PD/PI first, followed by those of other key personnel in alphabetical order.

Resources Format Page

Do not complete.  Essential information is to be presented in the individual research project and core sections of the application.

Center Program Overview Reseach Plan (Research Objectives and Strategic Plan) Overall

Specific Aims

List in priority order, the broad, long-range objectives and goals of the proposed Program. Concisely and realistically describe the hypothesis or hypotheses to be tested.

Overall Research Strategy

This narrative section summarizes the overall research plan for the multi-project application and is limited to (12) pages. The multi-project 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 for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program – by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. Applicants should define the Center theme and the range of activities being pursued, the significance of the Center theme in regard to countermeasure development, public health need, and benefit to public health of a successful effort. Additionally, discussions of how each Research Project contributes to the theme and objectives as well as project interdependence should be included. Applications should outline expected synergies provided by the proposed center and summarize the special features in the environment and/or resources that make this application strong or unique.

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 PHS 398 Application Guide, with the following modification:

Checklist

One Checklist, placed at the end of the Overall component, is to be submitted for the entire application.

Appendix Materials

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Instructions for Research Projects

A minimum of three and not more than six individual Research Projects are required.

For each individual Research Project, include:

Cover Page (Reseach Projects)

The Face Page of the 398 Form should not be used as a cover page for individual research projects within a multi-project application.  Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project.  This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):

Form Page 2. (Research Projects)

Provide a Description (abstract) of the research proposed in the individual research project according to the instructions on Form Page 2 of PHS Form 398.  In addition, the abstract should contain a brief description of how the individual research project will contribute towards attainment of the multi-project Center objectives.

Project/Performance Sites (Research Projects)

List the performance sites where the research will be conducted.

Key Personnel (Research Projects)

Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.

Form Page 3. Table of Contents (Research Projects)

Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.

Form Page 4. and 5. Detailed Budget for Initial Budget Period (Research Projects)

Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.

Individual Research Project Research Plan (Research Projects)

Specific Aims

List, in priority order, the broad long-range objectives and goals of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual research project's relationship to the Program’s goals and how it relates to other projects or cores.

Research Strategy

Use this section to describe how the proposed research will contribute to meeting the Center’s goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application.

Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.  Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.  Preliminary Studies for new projects must be included as part of the approach section, and must be contained within the page limits of the Research Strategy section.

For all Research Projects (within the Research Strategy page limit), describe the research design conceptual procedures, and analyses to be used to accomplish the specific aims of the project. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss associations with clinical project(s). Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project. Describe how the research strategy is informed by an understanding of the regulatory process.  Describe anticipated regulatory barriers and propose research and/or strategies to overcome these barriers. Note: Each project leader must commit at least 1.2 person months effort to their project per year.

Product Development Strategy

In addition to the instructions above for all research projects, research projects directly involved in preclinical development of a candidate product must also include the following two components in a clearly labeled separate section immediately following the Research Strategy.

Milestones and Timeline. Applicants are required to provide detailed project performance and timeline objectives in a section entitled “Milestones and Timeline.” This section must be no more than 5 pages and must include:

Product Development Plan. Applicants are required to provide detailed development plans in a section entitled “Product Development Plan”. This section must be no more than 7 pages and must include:

Additionally, the Product Development Plan must include descriptions pertaining to preclinical product development activities pertaining to the product proposed. For the purpose of this FOA, “preclinical” is defined as all activities beyond lead candidate identification or diagnostic assay/platform/prototype development or vaccine technology proof-of-principle. Please see below for a list of points to be discussed as part of the Product Development Plan based on the type of product proposed.

Product Development Plans for therapeutic, vaccine, or adjuvant projects should summarize:

Product Development Plans for diagnostics projects should summarize:

When appropriate and as part of the Product Development Plan, applicants must document compliance with guidelines that govern GLP, as defined by 21 CRF (58), and cGMP, as defined by 21 CRF (211), manufacturing and/or IND/IDE enabling studies that will be performed under the project award as they would be applicable to eventual product licensure in the U.S. Applications for projects involving cGMP manufacture should ensure inclusion of appropriate personnel to provide regulatory guidance before, during and after manufacture.

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 PHS 398 Application Guide, with the following modification:

Resources Format Page (Research Projects)

Provide information on resources available for the project.  Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.)  For Early Stage Investigators, describe institutional investment in the success of the investigator.  If there are multiple performance sites, describe the resources available at each site.  Describe any special facilities used for working with biohazards or other potentially dangerous substances.

Biographical Sketch Format Page (Research Projects)

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents). 

Instructions for Core(s)

Each Center must include an Administrative Core. Scientific Cores are optional.

For each individual Core, include:

Cover Page (Cores)

The Face Page of the 398 Form should not be used as a cover page for cores within a multi-project application.  Instead, use the 398 continuation page to create a "Cover Page" containing selected data about each individual core.  This Cover Page will demarcate each core and should contain the following information items (which are a subset of the information provided on a Face Page - see PHS 398):

Format Page 2. (Cores)

Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the objectives.

Project/Performance Sites (Cores)

List the performance sites where the core activities and services will be conducted.

Key Personnel (Cores)

Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors. The PD/PI must be the director of the Administrative Core and must commit at least 0.6 person months effort per year to these responsibilities. An Administrative Core Associate should be a research administrator responsible for the daily administration and fiscal management of the Center. It is recommended that the Administrative Core Associate devote a level of effort ranging from 3 to 6 person months to the execution of the administrative details of the Center projects and to managing the day-to-day operations within the Center. Any additional Administrative Core personnel must be clearly justified.

Format Page 3. Table of Contents (Cores)

Prepare a Table of Contents for the core using page 3 of Form PHS 398. 

Format Page 4. and 5. Budget Pages (Cores)

Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.

The Administrative Core budget may not exceed 5% of total direct costs requested. Requests for funds to support required  travel may be included here.

Research Plan - Administrative and Scientific Cores

Specific Aims (Cores)

List in priority order, the broad, long-range objectives and goals of the proposed Administrative, or Scientific Cores. In addition, state the core’s relationship to the Program’s goals and how it relates to the individual Research Projects or other cores in the application.

Research Strategy for Admin Core (required)

The Administrative Core must include a Management Plan that identifies and discusses: the Administrative Core structure; the roles of Administrative Core personnel; the composition and duties of the Scientific Advisory Committee; and the facilitation of communications throughout the Center and with NIAID staff; and assurance that all research activities are carried out in compliance with all federal and NIH regulations. The plan should specifically address continual evaluation of research and development progress, communications, group meetings and teleconferences, presentation and publication of data, resource and model sharing, transmission of information and reagents, the identification and proposed resolution of problems and engagement of the NIAID Staff as appropriate. A description of how consortia (subcontracts) will be managed should be provided and should include how communications such as periodic meetings and conference calls will be organized, managed and documented. The plan should include a Core budget and should identify how research-related travel will be managed. The plan must also detail procedures for anticipated solicitation and review of Supplemental Research Projects applications. All CETR program-supported countermeasure development must address anticipated regulatory requirements and challenges pertinent to Emerging and Re-emerging Infectious Diseases. Accordingly, each Center must include regulatory expertise appropriate for associated developmental activities. Regulatory expertise may be retained as defined effort or periodic consultation.

In addition for Supplemental Research Projects, describe the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and guidelines for research involving human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight and funded projects, and plans for data and safety monitoring for clinical trials, if applicable. Total funding of a Supplemental Research Project may not exceed $200,000 in total costs in any year and the Supplemental Research Project Leader must commit at least 1.2 person months per year to the effort.

Research Strategy for Scientific Cores

Use this section to describe how the proposed core activities will contribute to meeting the Center's goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims.  In addition, this section should indicate the relevance of the core to the primary theme of the application. Provide details of the services or resources provided by the optional cores to at least two Research Projects and clarify how the optional cores are not duplicative of other services or facilities. Each Scientific Core should be headed by a Core Leader with at least 1.2 person months of effort committed to the Core.

Organize the section in the specified order as stated in the PHS 398 Application Guide.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.  Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.  Preliminary Studies for new cores and progress reports for renewals must be included as part of the approach section and must be contained within the page limits of the Core Services Plan section.

Resource Sharing Plan (Cores)

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 PHS 398 Application Guide, with the following modification:

Biographical Sketch Format Page (Cores)

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

Resources Format Page (Cores)

Provide information on resources available for the core.  Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.)  For Early Stage Investigators, describe institutional investment in the success of the investigator.  If there are multiple performance sites, describe the resources available at each site.  Describe any special facilities used for working with biohazards or other potentially dangerous substances.  A table listing each activity that requires BSL3/4 access and the likely facilities to be used should be included.

Foreign Institutions

Foreign (non-U.S.) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS 398 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 PHS 398 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 components of participating organizations, 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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center  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 Center  proposed).

Scored Review Criteria - Overall 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(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 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 Application, Individual Research Projects, and Cores

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For All Research Projects:

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 project  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 - Overall Application, Individual Research Projects, and Cores

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

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Scored Review Criteria – Cores

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

Administrative Core

For the Administrative Core, is the administrative and organizational structure appropriate and adequate to achieve the goals 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 plans for communication among the Centers adequate to facilitate collaborative activities? Do the PD/PI and Key Personnel commit sufficient time and effort to adequately manage the Program? Is the proposed membership on the Scientific Advisory Committee appropriate for the experience and expertise required for the planned scientific goals of the FOA? Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

Scientific Core

For the Scientific Core(s), is it sufficiently justified? Does it support at least two Research Projects? Is the core adequately connected to the central focus of the overall program? Are the facilities or services provided by the core (including procedures, techniques, and quality control) high quality? Will the services be used effectively? Are the core leader and key personnel well qualified and is there an adequate commitment of time?

2. Review and Selection Process

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 response to this FOA .

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 National Advisory Allergy and Infectious Diseases 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’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.

Prior Approval of Supplemental Research Projects

Awardee-selected projects that involveclinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation. 

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

PD(s)/PI(s), will have the primary responsibility for coordinating the Projects and Cores within the overall Program. Specifically, the PD(s)/PI(s) have primary responsibility as described below.

The PD(s)/PI(s) will be responsible for defining the research objectives, approaches and details of the projects within the guidelines of the FOA and retains primary responsibility for the planning, directing, and executing the proposed scientific activities.

In addition, the PD(s)/PI(s) will be responsible for:

The multi-disciplinary and collaborative nature of the Programs funded under this FOA creates an extraordinary opportunity for information exchange and scientific advancement of translational research applied to infectious diseases research.  Programs’ investigators are expected to take advantage of this opportunity by participating in both formal events established expressly for this purpose and informal investigator-initiated dialogues.

Federally Mandated Regulatory Requirements for Clinical Research

Each institution participating in clinical research is required to meet DHHS regulations for the protection of human subjects.  At a minimum, this includes:

Intellectual Property

The awardee is solely responsible for the timely acquisition of all appropriate propriety 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 propriety 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 the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).

Program Generated Data, Software and Other Resources

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 HHS, PHS, and NIH policies.

The Programs funded under this FOA are expected to follow the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (http://www.niaid.nih.gov/LabsAndResources/resources/dmid/gsc/Pages/data.aspx) as well as those in the Data Sharing Guiding Principles for the NIAID/DMID Systems Biology Program (http://www.niaid.nih.gov/LABSANDRESOURCES/RESOURCES/DMID/SB/Pages/DataReleaseGuidelines.aspx) Program-generated data and software should be made available through publicly accessible web and database sites, including the Web Portal, the BRCs (http://www.niaid.nih.gov/dmid/genomes/brc/default.htm), the NCBI (http://www.ncbi.nlm.nih.gov/) and/or other public repositories, as identified by the Steering Committee in consultation with the NIAID.

Program-generated data and software include, for example:

Whenever possible, the awardee shall provide software certified by the Open Source Initiative (http://www.opensource.org/licenses/), to guarantee the right of others to read, redistribute, modify, and freely use the software.

Program-generated novel reagents (e.g., expression vectors, mutant strains, libraries, protein clones), should be made available through NIAID-supported repositories, such as the NIAID BEI Resources (http://www.beiresources.org/) or in other repositories as identified by the Steering Committee in consultation with the NIAID.

Publications

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

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The role of the NIAID/NIH Project Scientist in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PDs/PIs.  The NIAID Project Scientist will work closely with the PD(s)/PI(s) and other Program member scientists to facilitate collaborations and to leverage the resources available to the Program.

The NIAID Project Scientist will monitor the progress of the Program, help coordinate research approaches among all Programs funded through the FOA, and contribute to the shaping of research projects or approaches as warranted. The NIAID Project Scientist will support and facilitate this process but will not direct it.

The NIAID Project Scientist will keep the Program informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in infectious diseases research.  The NIAID Project Scientist will coordinate access for the Program to other NIAID resources, as well as assist the research efforts of the Program by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.

The NIAID Project Scientist will review and make funding recommendations for Supplemental Research Project applications.

The NIAID Project Scientist will retain the option to recommend withholding or reduction of support from any cooperative agreement that substantially fails to achieve its goals according to the milestones agreed to at the time of the award or fails to comply with the Terms and Conditions of the award.

Additionally, a NIAID program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program official may also serve as the NIAID Project Scientist.

Areas of Joint Responsibility include:

The NIAID Project Scientist will provide overall coordination across all funded Programs, will coordinate with the PD(s)/PI(s) and hold regular program-wide discussions to facilitate the achievement of program goals. In the event that some members of the Programs develop common research interests working groups may be formed to pursue collaborative activities.

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.

3. Reporting

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. Progress reports should briefly describe status of Supplemental Research Projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.  

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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)

N. Kent Peters, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-8584
Email: petersn@niaid.nih.gov

Michael R. Schaefer, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-3758
Email: mschaefer@niaid.nih.gov

Peer Review Contact(s)

Lynn Rust, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:  301- 402-3938
Email:  lrust@mail.nih.gov

Financial/Grants Management Contact(s)

Theresa Mercogliano
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301- 402-5512
FAX: 301-493-0597
Email:  tmercoglia@niaid.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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NIH Funding Opportunities and Notices


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