It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose

This Funding Opportunity Announcement (FOA) seeks applications in support of the Centers for Medical Countermeasures Against Radiation Consortium (CMCRC). Successful applicants will participate in a national network of research centers to develop effective and comprehensive medical countermeasures applicable to all subsets of the civilian population in the event of radiological or nuclear emergencies. Applications are sought that propose multidisciplinary basic and translational research to support the development of new medical products that will assess, diagnose, mitigate and/or treat the short-, delayed- and long-term consequences of radiation exposure during and following a radiation public health emergency (e.g. a radiological/nuclear terrorist incident or accident). The goals of this FOA are to: 1) develop new techniques and devices to measure radiation exposure in the human body; 2) follow biomarkers of tissue damage and recovery; and 3) further develop existing (e.g. products in clinical use) as well as novel therapies to minimize tissue damage, hasten tissue recovery, restore normal physiological function, and improve survival. This research program was originally established by NIAID in 2005 under RFA-AI-04-045 and renewed in 2010 under RFA-AI-09-036, and again in 2015 under RFA-AI-14-055. All qualified investigators are invited to apply; prior funding under this program is not required.

Background

Although several medical countermeasures have been approved to treat the hematopoietic complications of radiation exposure resulting from an unintentional exposure (Neupogen and Neulasta in 2015, and Leukine in 2018), relatively few medical products have been licensed/approved to counter other acute and long-term injuries from radiation exposures during a public health emergency. The threat of attack has grown in recent years, with increased activity of global terrorist organizations and a rise in illicit trafficking of radioactive materials. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) has been given the responsibility by the Department of Health and Human Services (HHS) to identify, characterize and develop new medical countermeasure products against radiological and nuclear attacks that may cause a public health emergency.

In 2005, the NIH published a Strategic Plan and Research Agenda for Medical Countermeasures Against Radiological and Nuclear Threats (https://www.niaid.nih.gov/sites/default/files/radnucstrategicplan.pdf) and in 2012, released an updated Radiological and Nuclear Threats Program Progress Report and Future Research Directions (https://www.niaid.nih.gov/sites/default/files/radnucprogressreport.pdf).  The agendas of both documents include product development focused on medical countermeasures for mitigation and treatment of acute radiation syndromes (ARS) and radionuclide decorporation agents, as well as biodosimetry platforms. Since program inception in 2004, many NIAID-supported contract and grant programs have been established to expand the medical options available to mitigate and/or treat radiation injury after a radiological/nuclear terrorist attack or accident. The CMCRC forms one part of this overall program, providing the early and intermediate stages of the product development pipeline. This program has yielded numerous lead candidates for mitigators/therapeutic agents and improved diagnostic tools to assess radiation exposure. Continued investment into the CMCRC program is needed to supply the Strategic National Stockpile with medical countermeasures, mitigators and/or treatments, biomarker assays and devices to improve survival after acute radiation exposure.

Under physiologic conditions, the hematopoietic, gastrointestinal, cardiovascular, and central nervous systems, as well as skin and mucosal tissues interact with each other to maintain physiological homeostasis. It is clear from data obtained from prior radiological and nuclear incidents that these homeostatic mechanisms may be severely disturbed due to the compromise and progressive physiological failure of these interdependent organ systems, potentially leading to multiple organ failure and mortality. In addition, the role of the vasculature in the evolution of multi-organ radiation injuries and their propagation is an area of increasing interest in the research community. The management of radiation casualties with multi-organ dysfunction syndrome is extremely complex and effective medical countermeasures are lacking. Therefore, there remains an urgent need to develop clinical tools and new treatment strategies to treat multiple organ failure and restore physiological functions of critical organs after exposure.

A significant burden of radiation-associated morbidity and mortality is attributable to delayed effects of acute radiation exposure, including persistent systemic inflammation, accelerated immune aging, lung pneumonitis and fibrosis, and increased frequency of cardiovascular and metabolic diseases. The understanding and elucidation of radiation-induced delayed effects are thus important to inform public health officials on future medical resources and capabilities that may be needed in the years and decades following a public radiation emergency.

Predicting the severity and specific manifestations of injury in irradiated individuals is also complex. Radiation injury can take days or weeks to present clinical manifestations, and some delayed radiation injuries (such as fibrosis) may not manifest clinically for months or years. Moreover, individuals may differ in their sensitivity to radiation for a variety of reasons, including age, body size, immune or disease status, and genetic background. Finally, severity of injuries to individual organs and tissues can vary with radiation dose rate, quality of radiation (low- versus high-linear energy transfer), the heterogeneity of exposure (partial- versus total-body), the source of exposure (external radiation versus internal contamination) and could also be modulated by factors such as bystander effect and the host s adaptive response to prior radiation exposure. Unfortunately, existing biodosimetry techniques and devices have limited ability to discriminate such variables and they do not necessarily predict the severity of injury sustained by specific organs and tissues. Diagnostics that take account of such variables could facilitate prompt organ- and tissue-directed medical treatments that might be provided by future medical countermeasures. Therefore, in addition to radiation dose assessment through biodosimetry tools and techniques, there is a need to develop radiation-exposure biomarkers and devices that will predict the early and/or delayed damage to specific organs and tissues, to facilitate precise and timely medical interventions, reduce morbidity, and save lives.

The overarching goal of the CMCRC is to address these unmet needs through an organizational framework of multidisciplinary extramural research centers, consisting of academic, commercial, and/or eligible government laboratories.  The specific objectives are to use basic and translational research to develop improved diagnostic tools to assess radiation exposure and biomarker assays of acute radiation injury to different organs/tissues; identify existing approaches that could be repurposed for a radiation indication, and identify new medical countermeasures, based on known targets for radiation injury; further develop and validate existing or new animal models or in vitro assays to evaluate medical countermeasures or underlying biology; and move candidate approaches through the United States Food and Drug Administration (FDA) medical countermeasures regulatory process (referred to as the Animal Rule (21 CFR 314.600-314.650 (drugs) or 21 CFR 601.90-601.95 (biologic products)). Candidate products with mitigation or treatment potential will be moved into characterization and investigational new drug (IND)-enabling, licensing studies such as those conducted by the NIAID’s Product Development Support contract (i.e., formulation development, proof of concept studies, and toxicology and efficacy studies to optimize formulation, dose, and dose scheduling) to facilitate eventual FDA licensure and potential inclusion in the Strategic National Stockpile.

Research Objectives and Scope.

The overall goal of this program is to develop and maintain a strong infrastructure, combined with the multidisciplinary research expertise and development capacity to generate new medical products that will protect against, mitigate the effects of, and treat the acute-, delayed-, and long-term consequences of radiation exposure from terrorist attacks or accidental exposure. To realize this goal, the CMCRC will support: 1) basic, translational, or applied research; 2) development and utilization and/or expansion of existing core facilities that support the research and development activities of an individual center; 3) utilization or development of translational research capacity to test and characterize radiation medical countermeasures for regulatory approvals; and 4) provide training and education materials in radiobiology research. Diverse research and development approaches are encouraged, but all projects must focus on medical countermeasures to assess, predict, mitigate or treat human injuries incurred during a radiation exposure emergency, and must describe their feasibility for human use under public health emergency conditions. Although clinical research is encouraged within this program where relevant, applications proposing clinical trials will not be accepted for review.

The CMCRC will consist of a consortium of centers focused on accelerating the development and production of medical countermeasures for use in the civilian population during and following a radiation public health emergency. Countermeasures could include approaches to treat injuries, or biomarker elucidation and biodosimetric methods and techniques to assess and triage individuals with suspected radiation exposure. Both treatment and biodosimetry methods must be able to be used 24 hours or later after radiation exposure to be of interest for this RFA. Applications from groups of investigators affiliated with different institutions are encouraged if collaborations will strengthen the proposed scientific program.

This program is milestone-based. It also permits the flexibility to recommend redirecting or modifying Research Projects in consultation with NIAID program staff, and within the original scope of the application. 

Within the Consortium, current candidate products with mitigation or treatment potential may be moved into validation and licensing studies to facilitate their stockpiling. There is a specific interest in the repurposing of approaches that are already in use in the clinic (either licensed or in advanced development). The program will support applied research to fulfill early product development stage studies. The program will also promote confirmatory screening studies, leading to the submission of IND applications to the FDA, including: 1) toxicology and efficacy studies consistent with Good Laboratory Practice (GLP) to test proof of concept, determine test article safety and to optimize formulation, dose, and dose scheduling; and 2) steps related to formulation development, manufacturing, and drug stability consistent with current Good Manufacturing Practices (CGMP). All grantees are strongly encouraged to confer with the NIAID staff and with staff at the U.S. FDA as soon as an appropriate product candidate or medical approach is identified.

Specific Areas of Research Interests

• Practical biodosimetry devices and techniques, biomarker assays, and other automated diagnostic systems to rapidly assess levels of radiation exposure and tissue damage early after an event and during the treatment and recovery phase;
• Research and development of animal models and medical countermeasures for the mitigation and/or treatment of acute and/or delayed radiation injuries to the hematopoietic, gastrointestinal (GI), cutaneous, pulmonary, renal, cardiovascular, and/or central nervous system of the body with the ultimate goal of increasing survival when administered 24 hours or later, post-irradiation. These animal models could involve, as appropriate, total body exposures, or the use of shielding of parts of the animal (e.g. partial-body irradiation);
• Further development (repurposing) of existing approaches already in clinical use (either licensed/cleared/approved for another indication, or products for which clinical data are available);
• Animal testing of therapeutic regimens with emphasis on broad efficacy, safety, and eventual ease of administration to healthy adults and at-risk populations (i.e., pediatric, geriatric, and chronically-ill groups);
• Products and regimens that mitigate and/or treat radiation combined injury (radiation injury plus burns, blast injuries, other wounds, and/or infections), multiple organ injuries, and/or injuries due to combined external and internal radionuclide exposure;
• Mechanism of action of potential medical countermeasures in irradiated animal models predictive of human responses;
• Characterization of and medical countermeasure use in animal models of radiation injuries, with relevance to highly susceptible human subpopulations including pregnant, pediatric, geriatric, and immune compromised persons;
• Manufacturing scale-up; GLP toxicology and pharmacology safety studies; pharmacokinetic (PK), pharmacodynamic (PD) and metabolism studies; development of GLP analytical methods for efficacy studies and product characterization; and completion of IND packages for FDA submission;
• Products and regimens that mitigate and/or treat normal tissue injury associated with internal contamination (e.g. via ingestion, inhalation or wound) and/or enhance the excretion (decorporation) of internalized radionuclides.

Applications that propose studies in any of the following areas will be considered non-responsive and will not be reviewed:

• Applications that propose development of medical products that must be administered prior to exposure or within the 24-hour period immediately after exposure to be effective in limiting morbidity or improving survival;
• Epidemiological studies;
• Studies testing the efficacy of countermeasures against injury produced by fractionated radiation protocols (such as those used in clinical radiotherapy);
• Clinical trials (all phases);
• Studies focused on HIV/AIDS-related research;
• Radiation-induced carcinogenesis;
• Non-biologically-based dosimetric methods and/or environmental testing/sampling devices (e.g. thermo-luminescent detectors (TLDs), fortuitous dosimeters, radiation portals, etc.);
• Characterization and validation of biomarkers of mutagenesis and carcinogenesis.

Organization of the CMCRC

The CMCRC will consist of: 3-5 Centers (each with a minimum of three Research Projects, one Administrative Core and optional Service Core(s)); two Consortium-Wide Cores (Consortium-Wide Coordinating Core (CCC), and Opportunities Fund Management Core (OFMC) - administered by institutions selected by the NIAID from the successful applicants); a Steering Committee (SC) and its subcommittees; a Consortium External Advisory Board (CEAB); and other committees as needed.

Each application will consist of the following Center and Consortium Components:

Center Components

Administrative Core (required)

The Administrative Core will support the coordination of efforts across the Research Projects and Service Cores within each center and will support activities to advance integration into the broader CMCRC. This core will be responsible for organization, management, decision-making, and periodic evaluations within the individual center, as well as protection of intellectual property, regulatory compliance, involvement of institutional and programmatic resources, and shared publications. This core is expected to create and implement administrative and leadership mechanisms that will foster effective interactions with other CMCRC PDs/PIs and institutions as well as within the individual group to promote synergistic research efforts. Applicants may wish to include their own, Center-specific advisory board (an External Scientific Advisory Group (ESAG) to help guide the Center's overall program;

Research Projects (3 required)

Research Projects must be multi-disciplinary, synergistic research/development projects focused on product development as a goal, even if development of licensed products will not be completed within the funding period. Basic discovery or mechanistic research is allowed, but it must contribute to the development of a product. Research projects incorporating studies on pediatric and geriatric populations are of interest but are not required. Each Research Project component must include explicit, quantitative, yearly milestones. A minimum of three Research Projects must be proposed.

Service Core(s) (optional)

Service Cores may be put forth to provide services such as clinical, statistical, dosimetry, technical, or other supportive activities, including the development of standard assays, reagents and technologies, the establishment and maintenance of repositories, the delivery of statistical, bioinformatics or any other services required to achieve the research/development goals of the program. Any proposed Service Core(s) must serve a minimum of two Research Projects.

Note: Although individual Centers may include a radiation dosimetry core as a Service Core, Service Cores and Research Projects of all awarded Centers that utilize radiation exposure devices will be expected to participate in a NIAID radiation program-wide dosimetry harmonization effort.

Required Consortium-Wide Components (each application must include the following) *

Consortium-Wide Coordinating Core (CCC) (required)

The CCC will be responsible for facilitating the administration, data and information sharing within the CMCRC and the research community, as well as organizing and maintaining web-based educational activities. The CCC will also be responsible for assisting assigned NIAID program staff with planning of the Annual CMCRC meeting, and coordination with the CMCRC CEAB.

Opportunities Fund Management Core (OFMC) (required)

The OFMC will be a management-only core with responsibility for oversight of funding for: 1) Pilot Projects to be awarded to applicants through a peer-review process (OFMC is responsible for convening the peer-review panel), and 2) Candidate Advanced Product (e.g. mitigators/treatments or biodosimetry approaches) Development Projects with a similar review process. Award decisions will be made by the Steering Committee.

Pilot project funding is intended to foster novel ideas within and outside awarded CMCRCs, to develop or incorporate new technologies as they become available, and to encourage collaborations among members of different Centers and between the CMCRC and investigators within and outside the US (although research collaborations with existing centers are not required for a Pilot Project application to be eligible for funding). The use of Pilot Projects permits maximum flexibility to advance exciting research directions that seem most scientifically fruitful and allow for a greater element of risk than is permitted in standard NIH funding opportunities. Pilot Projects must be within the scope of the FOA but may not be required to have preliminary data.

The funding for Candidate Advanced Product Development Projects is intended to provide additional assistance and/or technical expertise for IND-enabling studies and candidate product development activities in support of projects undertaken by CMCRC investigators.

*Note: The Consortium-Wide Nonhuman Primate Survivor Core, previously requested in RFA-AI-14-055, is now being competed separately, as a program servicing the entire NIAID-funded radiation portfolio (RFA-AI-19-010).

Other Aspects of the CMCRC Program

Steering Committee (SC)

A Steering Committee composed of one PD/PI from each funded Center (or their designate) will serve as the Consortium governing board and will coordinate and facilitate research activities for the overall program and foster synergy and efficiency within the Consortium. SC members will participate in all SC activities, meetings and teleconferences, and will determine policies and implement processes for quality assurance of any data and information disseminated through activities of the CCC. The SC will also be responsible for establishing and implementing a process for the selection of Pilot Projects and Candidate Advanced Product Development Projects for award using OFMC discretionary funds.

Consortium External Advisory Board (CEAB)

The NIAID, in consultation with the PDs/PIs of the awarded Centers, will appoint a CEAB of 3-5 members. This group (consisting of radiation and other subject matter experts from government, academia and industry), will be updated on progress and inform the Steering Committee and the NIAID on possible adjustments and future directions for the CMCRC Research Projects and Cores.

Milestones

While yearly milestones must be included for each Research Project component in the application, Individual Cores, and Consortium-Wide Cores (CCC and OFMC) do not need to provide yearly milestones.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

An individual may serve as PD/PI on only one application to this FOA but may be a Project Leader or Core Leader on more than one application.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Julio Aliberti
Telephone: 301-761-7322
Fax: 301-480-2310
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core (use for Administrative Core)	6 pages
Consort Coord Core (Consortium-Wide Coordinating Core (CCC))	6 pages
Opp Fund Manage Core (Opportunities Fund Management Core (OFMC))	6 pages
Core (use for Service Core(s))	6 pages
Project (use for Research Projects)	12 pages

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required, maximum of 1
• Consortium-Wide Coordinating Core (CCC): required, maximum of 1
• Opportunity Funds Management Core (OFMC): required, maximum of 1
• Service Core(s) optional: no minimum or maximum
• Research Projects: required, minimum of 3, no maximum

When preparing your application, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Describe the central scientific theme of the proposed research program, and list in priority order the broad, long-range objectives and goals of the proposed overall program.

Research Strategy: This narrative section summarizes the overall research plan for the multi-project application and explains how the proposed program satisfies the purpose and objectives of this FOA. Describe the central theme of the proposed program and explain how the proposed Research Projects are synergistic and fit under the overarching program theme. The multi-project application should be viewed as a confederation of interrelated 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. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Briefly summarize the special features in the environment and/or resources that make this application strong or unique. As applicable, describe the synergy and collaborations that are expected to occur. To highlight program synergy, applicants may describe how the individual components (projects and shared resource cores) will be coordinated and work together to address the overall goals and aims of the program. Include a schematic overview of the interactions and collaborations among the components (projects and cores), indicate collaborations among members and relevant publications co-authored by members of the program. Program synergy may also be addressed in other sections of the application, as appropriate.

The CEAB will be appointed by the NIAID, in consultation with the PDs/PIs from the awarded Centers. Applicants should not name possible CEAB members in their applications

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

This component, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Admin Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

•     In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
•     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
•     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
•     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

The budget request for this core should include the costs to cover the position of a project manager.  The budget request should also include travel funds for the Administrative Core Lead (or their representative) to participate in the annual CMCRC Steering Committee meetings (2 days per annual meeting in the Rockville, MD area) as well as the costs for travel of any External Scientific Advisory Group (ESAG) members to meet with center personnel on an annual basis, and any additional meeting costs.

Include the committed level of effort for the administrative and scientific staff for the core.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order the proposed activities and services of the Administrative Core. Concisely describe the work to be completed to address issues of program coordination, communication, and management.

Research Strategy: Provide a staffing and administrative plan that includes a discussion of the structure and roles of administrative and scientific staff for the core, including: the functions to be performed by all staff; and how resources will be prioritized, allocated, and managed. Provide a management plan for fiscal accountability and communication within the program.

External Scientific Advisory Group (ESAG): The Administrative Core may support an ESAG. Potential members of a proposed ESAG should NOT be named in the application and ESAG members must not be recruited or contacted prior to review and award. However, for renewal applications, any current or former ESAG member MUST be identified in the application. ESAG members could include individuals with expertise in areas of importance to the center. For example, these areas could include radiation biology, product development, regulatory interactions, radiation exposure scenarios, etc.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

This component, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Consort Coord Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

•     In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
•     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
•     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
•     Include individual(s) with statistics and data management experience, to oversee these activities within the CCC
•     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

In addition, the CCC application should request a budget for costs of the Steering Committee meetings, including an annual meeting of the Steering Committee (2 days per annual meeting in the Rockville, MD area), and conference calls for Subcommittee and Working Group meetings. Budget requests must include costs for the Core Lead and other essential members of the CCC to attend the initial meeting and the annual CMCRC meetings. The budget must also include the travel costs for four CEAB members to meet once annually with the Steering Committee in the Rockville, MD area.

The budget for this core is limited to $125,000 direct costs per year. For purposes of the application, assume that: one full-time administrator will be needed in the position of project manager and that substantial oversight effort will be needed from the Core Lead or other senior staff.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order the broad, long-range activities and services of the proposed Consortium-Wide Coordinating Core, indicating the core’s relationship to the program’s goals.

Research Strategy: Describe the ways the CCC will increase opportunities for the proposed research and maximize its benefits. Demonstrate within the CCC research plan the ability to interface with the scientific areas of investigation that are included within this consortium as well as the capacity and flexibility for meeting the needs of the consortium and the research community and for integration of information from the projects.

In addition, describe how the core will:

• Support: in vivo (animal) or in vitro study designs; data collection, cleaning, and tracking; database infrastructure; information management and monitoring; management of complex cross-sectional or longitudinal data; data sharing; sample size and power calculations; and statistical analysis methods.
• Transition and/or maintain (as appropriate) the existing web portal (CMCRC Radiobiology and Methods Public Textbook) dedicated to the CMCRC members, to provide information about the consortium and its activities as well as web-based information dedicated to the scientific community, in: 1) the principles of radiobiology; 2) use of assays, methods, reagents, animal models, or technologies to study radiobiology; and 3) the regulatory process required for the licensure of new products and technologies. The CCC should also provide a transition plan to facilitate the migration of the web portal to another awardee in the event of a future renewal of the CMCRC.

Because of the central roles of the CCC to facilitate the interactions within the Consortium among all PDs/PIs, this core will coordinate data collection and management, and create and maintain educational materials. Include a discussion of the scientific role of the CCC in its interactions with the Consortium; do no limit responses to the administrative role of the CCC.

The scope of the CCC is to maximize the exchange of scientific information, data, biomaterials, models, reagents, resources and methods within the CMCRC and with the research community.  The CCC will facilitate activities of the consortium and facilitate communication of research results, data and methods within the consortium and to the community. The CCC plan should include the following:

• Development and maintenance of means to cooperatively receive data, methods and information electronically from the Research Projects for central storage, curation and dissemination.
• Provision of statistical analyses as a service to the awarded centers, and to coordinate consortium-wide efforts.
• Development and maintenance of information security services.
• Timely submission of data and data analyses obtained under this award to the ImmPort database (www.immport.org).
• Development and maintenance of means for ongoing, rapid electronic exchange of information and discussion between members of the consortium.
• Development and maintenance of means to make current data and information electronically available to the research community.
• Coordination and administration of the activities and meetings (including conference calls) of the CMCRC, its Steering Committee, and its CEAB.
• Coordination and administration of the CMCRC annual meeting including all CMCRC scientists and ImmPort staff to present research progress and discuss potential collaborations among centers.
• Generation and maintenance of minutes from meetings of the CEAB, Steering Committee and CMCRC PDs/PIs as approved by the Chairs and membership of those committees.
• Web-based dissemination of information to all CMCRC members on availability and means to access validated resources generated by the Research Projects (to include models, biomaterials, resources and reagents).
• Compilation of validated methods developed through Research Projects and Pilot Projects to make them electronically accessible to all CMCRC members and the research community
• Integration of data, information, methods, materials and models generated through the Pilot Project subawards into the consortium, making them electronically accessible to all CMCRC members and the research community.

Administration of funds for the development of training and education materials, including web-based courses for the scientific community on: 1) principles of radiobiology and 2) use of assays, methods, reagents, animal models, or 3) technologies to study radiobiology and/or develop new products through the regulatory process.

Letters of Support: Provide any letters of support from collaborators that are specific to the CCC.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

This Component, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Opp Fund Manage Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

•     In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
•     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
•     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
•     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

Include the costs of administrative staff to manage the fund and any needed supplies or services. This core budget may be modified by NIAID after award, but for purposes of the application, assume that:

• Include justification and rationale for the time commitment of staff needed to oversee the proposed core activities;
• The proposed budget for administrative costs of the OFMC is capped at $2.8 million in direct costs per year. Of this $2.8 million, $2.5 million will be used to fund total costs (direct plus indirect) of Pilot Projects and Advanced Development Projects selected for award by the OFMC;
• Budget should include a minimum of 1.2-person months PD/PI effort as the OFMC Lead; A minimum of 3-person months salary for an OFMC administrator and a minimum of 3-person months salary for secretarial/clerical assistance; Travel for either the OFMC administrator or another staff member to attend the annual Steering Committee meeting in the Rockville, Maryland area.
• Support for each Pilot Project awarded by the OFMC may not exceed $100,000 in direct costs per year (plus applicable F&A costs for the sub-awardee).
• Each Pilot Research Project selected for award by the Steering Committee may be supported with OFMC funding for no more than two years, and one person may serve only once as a Pilot Project PD/PI during the center s total award period.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order the proposed activities and services of the OFMC. Concisely describe the work to be completed to address issues of program coordination, communication, and management.

Research Strategy: Describe how the OFMC will operate to serve the CMCRC program, including descriptions of: 1) an administrative structure; 2) process for advertisement/solicitation, receipt, review and funding of Pilot Projects or Advanced Product Development Projects selected for award by the CMCRC Steering Committee (Candidate Advanced Product Development awards are limited to funding of projects in awarded centers only); 3) methods of communication with the CMCRC Steering Committee, Pilot Project and Advanced Product Development awardees regarding the disbursement and tracking of funds; 4) methods for reporting the status of funds to NIAID; 5) establishing procedures for monitoring success and productivity of the funded Pilot and Candidate Advanced Product Development Projects, and 6) monitoring adherence to the NIH guidelines for the protection of human subjects and vertebrate animals, as well as NIH policies for any foreign Pilot Projects selected for funding. CMCRC applicants should not describe the science anticipated or propose Pilot or Candidate Advanced Product Development Projects in their applications.

Letters of Support: Provide any letters of support from collaborators that are specific to the OFMC.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

This component, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed

When preparing your application, use Component Type Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

•     In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
•     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
•     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
•     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order the proposed activities and services of the proposed Service Core. Concisely describe the work to be completed to address issues of program coordination, communication, and management.  In addition, state the core’s relationship to the program’s goals and how the core relates to the individual Research Projects in the application.

Research Strategy: Describe how the core will support at least two projects and explain why the core resources are not otherwise available. Provide a staffing and administrative plan as well as a discussion of the structure of scientific staff for the core, and how resources will be prioritized, allocated, and managed. Provide a management plan for fiscal accountability and communication within the program.

Letters of Support: Provide any letters of support from collaborators that are specific to the Service Core(s).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

This component, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed

When preparing your application, use Component Type Project.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: List the resources available to conduct the proposed studies including a local database, sample repository and statistical capability.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

•     In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
•     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
•     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
•     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
•     If applicable, include personnel with expertise in manufacturing scale-up.
•     Include personnel with adequate bioinformatics and statistics expertise to enable data management activities.

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

In cases where human samples are to be obtained from an independently-funded clinical trial, applicants can include in their budgets the costs of additional clinical trial-related activities such as the costs of re-consenting study participants, preparation of protocol or IND amendments, and additional sample collection, preparation, and shipping.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List the broad, long-range objectives and goals of the proposed project. Concisely describe the work to be completed. In addition, state the individual project’s relationship to the program’s goals and how the project relates to other projects or cores to create synergy.

Research Strategy: Projects must focus on either:  1) the development of new medical products to mitigate and/or treat the acute and delayed effects of radiation exposure, radiation combined injury (radiation plus burns, wounds, trauma, or sepsis), or radiation-induced multi-organ failure (products must be tested at time points beginning 24 hours or later after radiation exposure); 2) the establishment of biomarkers of tissue damage and recovery; or 3) the development of predictive biomarker assays and devices to assess early and/or delayed effects of acute radiation injury to different organs/tissues (devices must be capable of accurately assessing radiation exposure at time points 24 hours or later after irradiation). Although clinical trials will not be supported under this initiative, clinical studies may be conducted with human samples collected as part of the CMCRC project(s) or obtained from individuals participating in independently-funded human clinical trials. Projects involving animals should attempt to include research on both genders, unless justification is provided for the use of only one gender.

Describe manufacturing scale-up, GLP toxicology, pharmacokinetic (PK), pharmacodynamic (PD) and metabolism studies, product characterization, and completion of IND packages for FDA submission, if applicable. General milestones addressing completion of aims and sub-aims must be provided in the application as part of the experimental plan for each project including a detailed, quantitative description and a schematic representation (e.g. GANTT chart). In addition to describing how the proposed research will contribute to meeting the program’s goals and objectives, the project should address a common research and development theme such that synergy is clearly evident among all the proposed Research Projects.

Milestones: Briefly describe for all years of the award, specific, quantitative milestones that will be achieved in each year of the Research Project. Milestones must be specific. For example, it is not appropriate to state only that "countermeasure A will be tested for its ability to mitigate radiation damage", or that specific aim A studies will be initiated . An appropriate milestone might include, but not be limited to the following: "These studies will demonstrate a dose modification factor of 1.2 or greater when countermeasure A is administered subcutaneously at 24 hours post-exposure in an appropriate animal model". These milestones will be used by NIAID program staff to assess long-term planning by the PD/PI regarding development of the candidate radiation medical countermeasures. Milestones will also be used by NIAID program staff to assess yearly progress and recommendations of continued funding.

Letters of Support: Provide any letters of support from collaborators that are specific to the Research Projects.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

This component, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed with the following modification:

• For studies involving the use of identifiable human biospecimens collected from independently funded clinical research or clinical trials, applicants should include both historical and current study information that is clearly distinguishable within the information requested in the study record forms.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

• Are the proposed projects and Cores scientifically compelling?
• Are the overall center goals and scientific questions significant and focused on studies that meet the purpose and objectives of the CMCRC program?
• Does the PD/PI have sufficient time, effort, leadership ability, and scientific talent to develop a program of integrated research projects with a well-defined central research focus?
• Is there adequate evidence of sufficient institutional support for the PDs/PI(s) in terms of space, equipment and other resources?
• Are the individual research projects and cores well-coordinated, do they synergize towards achieving the central objectives of the center and will the scientific gains of the multi-project center be beyond those achievable if each project were pursued independently?
• Is the center cohesive in terms of the research projects and cores fitting into a common theme?
• For applications that designate multiple PDs/PIs, is the Leadership Plan adequate and appropriate to ensure that there will be adequate coordination and communication among the PDs/PIs?

Overall Impact Research Projects

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for each project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will 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.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?

Specific to this FOA

• What is the likelihood that the results of the study will be translated into important new knowledge for 1) the development of effective and comprehensive medical countermeasures that, when administered 24 hours or later post-irradiation, are applicable to all subsets of the civilian population in the event of radiological or nuclear emergencies, and/or 2) establishment of biomarkers and/or biodosimetry methods for assessing radiation exposure at time points 24 hours or later post-irradiation?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

Specific to this FOA

• Do the designated personnel have sufficient expertise to enable compliance with the data- and other resources-sharing requirements, as appropriate and consistent with achieving the goals of the program?
• Do the designated personnel have a sufficient level of effort? Is there adequate bioinformatics expertise?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA

• Is there a predominant focus on basic or translational research aimed at the development of medical countermeasures against radiation?
• Is the proposed research and development of medical countermeasures appropriate for mitigation and treatment of radiation injury when administered 24 hours or later post-irradiation?
• Is the proposed research and development of biodosimetry methods and/or identification of biomarkers appropriate for detection of radiation exposure at time points 24 hours or later post-irradiation?
• Will data collection and analysis methods be appropriate in terms of quantitation, controls, and management?
• Are the proposed milestones detailed, explicit, and quantitative, detailing an approach that is achievable each year of the Project?
• If applicable, are the plans for manufacturing scale-up, GLP toxicology, PK, PD, metabolism and other IND enabling studies appropriate?

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?

Specific to this FOA

• Do the available resources provide an adequate local database, sample repository, and statistical capability to conduct the proposed studies?

Overall Impact Individual Cores

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for each core to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the core proposed).

Review Criteria Individual Cores

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

Administrative Core

• Is provision of the proposed core services to the center described in sufficient detail?
• Is the staffing and administrative plan appropriate to facilitate attainment of the objectives of the proposed program?
• Are the experience, level of commitment, and availability of the Core Lead, Project Manager, and any additional staff adequate to manage the overall program?
• Is the plan to organize communications, group meetings, and teleconferences adequate and appropriate?
• Are the plans for coordination, problem identification and resolution, and establishment of a strong collaborative environment for the program appropriate?
• Are the plans for resource allocation within the program adequate and appropriate?
• Is the management plan for fiscal accountability and communication within the program appropriate?
• Are the plans for communication and collaboration with other centers adequate?

Service Core(s)

• Is provision of the proposed core services to the Research Projects critical and justified?
• Is the relationship of the core to the central scientific theme of the overall program strong?
• Are the quality of the relevant facilities or services provided (including procedures, techniques, and quality control) and criteria for prioritization of usage appropriate?
• Are the proposed personnel appropriate to lead and staff the Core?
• Is the commitment of the Core Leader and other staff sufficient?
• Is the management plan for fiscal accountability and communication appropriate?

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.

Consortium-Wide Coordinating Core (CCC)

• Is provision of the proposed core services to the CMCRC program described in sufficient detail?
• Are the experience, level of commitment, and availability of the Core Leader and Project Manager adequate to manage the Core?
• Are the proposed plans for accessibility of information and data from the Research Projects adequate to maximize the potential of the CMCRC research results to be of benefit to the consortium members?
• Are sufficient effort and expertise dedicated to both data management and data sharing requirements, as appropriate and consistent with achieving the goals of the program?
• Is there sufficient bioinformatics infrastructure to support the proposed activities?
• Are sufficient effort and expertise for study design, data management statistical analyses support included in the Core?
• Are sufficient effort and expertise dedicated to the development and management of the web-based infrastructure devoted to the electronic networking among all CMCRC participants?
• Are sufficient effort and expertise dedicated to the development and management of the web-based training materials?
• Are the proposed management methods appropriate?

Opportunities Fund Management Core (OFMC)

• Is the process whereby Pilot Project applications will be advertised/solicited, received, reviewed, selected for funding and awarded described in sufficient detail?
• Are the plans that are provided for interacting with Pilot Project award institutions adequate?
• Is information provided on how funded Pilot Projects will be monitored by core personnel to ensure success and productivity?
• Are the experience, level of commitment and availability of the Core Leader and other staff adequate to manage the Core?

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

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

Not Applicable

As applicable for the core or 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.

Not Applicable

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).

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

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Awardee-selected projects that involve greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 Part 75, 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:

• Defining the details and goals of the project as a whole within the guidelines of this FOA; Overseeing/performing the scientific activities.
• One PD/PI from each awarded Center (or their designate) will be a voting member of the Steering Committee; all PDs/PIs will follow the policies and procedures developed by majority vote of the Steering Committee. All CMCRC investigators will be required to accept and implement policies approved by the Steering Committee.
• While safeguarding the privacy of participants and protecting confidential and proprietary information, the PD/PI will be expected to make data publicly available promptly after collection of the last data point within a defined data set, or upon publication of that data in a scientific journal. Data set definitions and timelines for public release will be negotiated with NIAID as part of the data-sharing plan for the center.
• Ensure successful completion of the data- and other resource-sharing plans within the consortium negotiated with NIAID, as appropriate and consistent with achieving the goals of the program. Sharing plans within the consortium represents a commitment by the applicant institution to support and abide by the plan.
• Establish procedures within the center to ensure that all members of that center, including any scientists added via Pilot Project support and opportunity fund, conform to the data-sharing and other resource-sharing plans.
• Awarded Centers that utilize radiation exposure devices will be expected to participate in a NIAID radiation program-wide dosimetry harmonization effort.
• When appropriate and under the direction of the Program Officer, awardees will be expected to collaborate, share novel reagents, biomaterials, methods, models and resources, and share both positive and negative results that would help guide the research activities of other CMCRC members.
• Consortium-Wide Coordinating Core (CCC): The selected institution must agree to take responsibility for establishing an administrative structure to: 1) facilitate intra CMCRC communication and coordination of research activities; 2) coordinate data collection and management; and 3) transition and/or maintain a web-portal to disseminate information about the CMCRC and provide educational materials related to radiation biology and regulatory processes for the licensure of new products and technologies.
• Opportunities Fund Management Core (OFMC): The selected institution must agree to take responsibility for managing the funds, including the disbursement, administration, and reporting on the use of such funds as recommended by the Steering Committee and approved by NIAID. This institution must also agree to take responsibility for creating an administrative structure to establish, as recommended by the CMCRC Steering Committee, procedures, formats and timelines for the solicitation, receipt and referral of Pilot Project applications to the appropriate center; fund disbursement, and progress report submission to the NIAID.

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

A designated NIAID Project Scientist will provide programmatic oversight and will monitor progress and adherence to NIH policies. The NIAID will appoint the members of the CEAB, and the CEAB Chair. An additional NIAID Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

• One NIH Project Scientist will have substantial programmatic involvement as described below:
• Provide guidance for design and coordination of research activities and efforts.
• Evaluate the adequacy of data-sharing and other resource-sharing plans within the consortium when making funding recommendations. NIAID program staff may negotiate modifications of sharing plans with the applicant.
• Ensure that all consortium funded investigators conform to the CMCRC data-sharing and other resource-sharing policies.
• Participate in investigator and Steering Committee meetings as a non-voting member.
• Facilitate collaborations with and access to other NIAID-supported research resources and services.
• Facilitate negotiations with companies interested in participating in studies with CMCRC investigators.
• Advise in project management and technical performance
• Serve as liaison/facilitator among awardees and with the ImmPort database.
• Serve as a resource for scientific and policy information related to the goals of the awardees research.
• Provide assistance to the Steering Committee in the development of procedures for evaluating the performance of research studies
• Promote coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies.
• Provide guidance to the awardees with regard to compliance with Federal regulations, oversight and monitoring of collaborative research, feasibility of timely completion, and plans for incorporation of new technologies or other resources.
• After award, a Consortium External Advisory Board (CEAB) will be established to review, evaluate and prioritize the scientific progress of the individual awardees and the consortium.
• CMCRC funding levels will be determined annually based on scientific progress.

Areas of Joint Responsibility:

• The CMCRC will be governed by a Steering Committee to coordinate and facilitate research activities for the overall program; to ensure close coordination with the ImmPort database; to facilitate compliance with the data- and other resource-sharing policies; and to promote optimal research flexibility, synergy, and efficiency.
• The Steering Committee will include one PD/PI from each awarded Center as a voting member, each with one vote. In the case of projects with multiple PDs/PIs, only one PD/PI will be a member of the Steering Committee. The Steering Committee will also include the NIAID Project Scientist as a non-voting member.
• Research Project and Core Leaders and other CMCRC investigators may serve as non-voting members, as determined by the Steering Committee. NIAID may also appoint additional staff to serve on the Steering Committee as non-voting members.
• A Steering Committee Chair will be elected by majority vote from among the non-Government Steering Committee voting members. Selection of the Chair will be repeated yearly, by majority vote of the non-Government voting members.
• All research groups within the CMCRC will share responsibility for program development and resource coordination through the CMCRC Steering Committee. The NIAID, in concert with the CMCRC Steering Committee, will have the flexibility to negotiate redirecting research without change to the original scope of the research activities within the CMCRC grants if it is considered beneficial to the overall program.

Steering Committee responsibilities will include:

• Optimizing resources and communications among the centers, with other government or private organizations as well as the research community at large.
• Promoting synergistic interactions among the centers and with other relevant groups.
• Evaluating progress of the individual Research Projects and providing guidance.
• Evaluating plans to recommend redirecting or modifying without changing the original aims of the research activities.
• Coordinating resource sharing within the CMCRC.
• Assisting as required in preparing formal reports summarizing activities and/or progress within the CMCRC.
• Recommending procedures and timelines to solicit, evaluate and fund applications for Pilot Project funds; including:
• Developing a process for the solicitation, evaluation and funding of Pilot Project proposals.
• Make recommendations for procedures to set the goals, priorities, and evaluation criteria for the use of the Candidate Advanced Product Development fund. These recommendations will include:
• The size and content of the applications; the frequency of application; the timeline from solicitation to funding; and the process to be used to evaluate the applications.
• Activities supported by the fund may be carried out at a particular center or as sub-awards to other facilities or contracts.
• The Steering Committee may recommend use of the fund to support small validation screening studies through NIAID’s Product Development Support Services to facilitate future submission of an investigational new drug (IND) application to the FDA. These studies will include but are not limited to efficacy studies to optimize formulation, dose, and dose scheduling; pilot efficacy studies to inform the design of Good Laboratory Practice (GLP) pivotal efficacy study protocols; drug product stability studies; and drug product current Good Manufacturing Practice (cGMP).
• Recommending content for any CMCRC web-based training and educational materials.
• Defining needs for centralized resources such as standardized assays, bioinformatics expertise, or sample repositories.
• Promoting compliance of CMCRC members with the schedules for data- and other resource-sharing.
• Defining procedures for the publication and/or oral presentation of results or data collected collaboratively within the CMCRC.
  
  

The Steering Committee may establish subcommittees and working groups with discrete responsibilities and authorities to promote comprehensive data reporting, uniformity of practices, assay validation and standardization, data and sample sharing, interactions with the ImmPort database staff, and priority setting.

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 in front of a Dispute Resolution Panel composed of three members: a designee of the Steering Committee chosen, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Andrea DiCarlo-Cohen, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3492
Email: [email protected]

Julio Aliberti, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7322
Email: [email protected]

Trevor Alford
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-747-7398
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.