Centers of Excellence in Translational Research (CETR)

Centers of Excellence in Translational Research (CETR) is sponsored by NIH NIGMS. Supports the development of centers that integrate basic and clinical research to accelerate the translation of biomedical discoveries into clinical applications.

Expired RFA-AI-12-044: Centers of Excellence for Translational Research (CETR) (U19) This notice has expired. Check the NIH Guide for active opportunities and notices.

of Health and Human Services Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title Centers of Excellence for Translational U19 Research Program Cooperative Agreements Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) 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 Letter of Intent Due Date(s) AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in 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 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 Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description 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 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 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, 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. Biodefense Research (http://www.

niaid. nih. gov/topics/BiodefenseRelated/Biodefense/Documents/biosp2007.

pdf) . 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. 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 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.

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 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 Examples of translational research themes include, but are not limited to, the following areas: New or improved therapeutics against antibiotic-resistant pathogens. Development of a broad-spectrum countermeasure or technology. Countermeasures targeting intracellular pathogens.

Development of a multivalent ("universal") or Host-targeted interventions as therapeutics. Development of broad-spectrum countermeasures against taxonomically-related viruses. Improved vaccine technologies or production platforms.

Co-development of a therapeutic and diagnostic that have 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. 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 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: 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 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). 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: 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. 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 Note: Applications for centers focused on development of a vaccine that cannot be classified as a multivalent/universal or therapeutic form are nonresponsive and 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 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.

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 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 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 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 As an example, a Center focused on discovery of new therapeutics that target select intracellular bacterial pathogens might have 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 As a second example, a Center focused on an innovative broad-spectrum platform for production of vaccines might have the following Research Project 1: Production and Stabilization of a Research Project 2: Production and Stabilization of Research Project 3: Production and Stabilization of a 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 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 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 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 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 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: 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). 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 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 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. 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 Section II.

Award Information 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 Glossary and the PHS 398 Application Guide provide details on these application Funds Available and Anticipated Number of Awards NIAID intends to commit $75 million in FY2014 to fund Application budgets are limited to $4 million for FY2014 directs costs and need to reflect actual needs of the proposed project. Scope of the proposed project should determine the project period. The maximum period is 5 years.

Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to Foreign components, as defined in the NIH Grants Policy Statement , are allowed. 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 Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam. gov Manage Entity function to manage your entity registrations.

See the Grants Registration User Guide at SAM. gov for additional information. 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 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 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility 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 Grants Policy Statement ), except for submission: To an RFA of an application that was submitted previously as an investigator-initiated application but not paid; Of an investigator-initiated application that was originally submitted to an RFA but not paid; or Of an application with a changed grant activity code.

Section IV. Application and Submission Information Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 2. Content and Form of Application Submission It is critical that applicants follow the instructions in 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.

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 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(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Division of Extramural Activities National Institute of Allergy and Infectious Diseases Bethesda, MD 20817-7616 (express mail), 20892-7616 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: Division of Extramural Activities National Institute of Allergy and Infectious Diseases Bethesda, MD 20817-7616 (express mail), 20892-7616 All page limitations described in the PHS 398