NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) on the Centers for Medical Countermeasures against Radiation Consortium (CMCRC) solicits applications to participate in a network of national 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- and long-term consequences of radiation exposure after a radiological/nuclear terrorist event or accidental exposure. The goals of this FOA are to: 1) produce new techniques and devices to measure radiation exposure in the human body; 2) follow biomarkers of tissue damage and recovery; and 3) develop 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. All qualified investigators are invited to apply; prior funding under this program is not required.

Very few medical products exist that have been shown to counter the acute and long-term injuries that can result from a nuclear or radiological attack or accident. 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) was given the responsibility by the Department of Health and Human Services (DHHS) 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 and in 2012, a Strategic Plan and Research Agenda for Medical Countermeasures against Radiological and Nuclear Threats Progress Report: 2005-2011 and Future Research Directions: 2012 - 2016. 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, and of biodosimetry platforms. Several NIAID-supported contract and grant programs (http://www.niaid.nih.gov/topics/radnuc/funding/Pages/default.aspx ) have been established to expand the medical options available to mitigate and/or treat radiation injury after any radiological/nuclear terrorist attacks or accidents. The CMCR Consortium forms one part of this overall program, providing the early and intermediate stages of the product development pipeline (http://www.niaid.nih.gov/topics/radnuc/Documents/CMCR_renewal_SCIENTIFIC_PROGRAM_DESCRIPTIONS.pdf). To date this program has yielded leading candidates for mitigators/therapeutic agents and improved diagnostic tools to assess radiation exposure, which are currently at different stages of maturity. Continued investment into the CMCRC program is needed to fulfill the ultimate goal of supplying the Strategic National Stockpile (SNS) with medical countermeasures, mitigators and/or treatments, biomarker assays and devices to improve survival after acute radiation exposure.

Under normal 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 accidents 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. The management of radiation casualties with multi-organ dysfunction syndrome is extremely complex and effective medical countermeasures are lacking. Therefore, there is 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.

Finally, a significant burden of radiation-associated morbidity and mortality is attributable to the delayed and late effects of acute radiation exposure (DEARE), including persistent systemic inflammation, accelerated immune aging, lung fibrosis and pneumonitis, and increased frequency of cardiovascular and metabolic diseases. The understanding and elucidation of DEARE 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 status, and genetic background. Finally, the severity of injury to individual organs and tissues varies 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 conceivably be modulated by such factors as the bystander effect and the host’s adaptive response to prior radiation exposure. Unfortunately, existing biodosimetry techniques and devices have limited, if any, ability to discriminate such variables and they do not predict the severity of injury sustained by specific organs and tissues. Diagnostics that take account of such variables would facilitate the prompt organ- and tissue-directed medical treatment that might be provided by future medical countermeasures. Therefore, in addition to radiation dose assessment through biodosimetry tools and techniques, there is a critical unmet 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 intervention, 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 new countermeasures; develop and validate new animal models or in vitro assays to evaluate countermeasures or underlying biology; and move candidate countermeasures through the FDA regulatory process to facilitate eventual licensure and potential inclusion in the SNS. 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 Services 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 SNS.

The overall goal of this program is the development and maintenance of 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-, short-, 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 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 mitigate or treat human injury incurred by radiological or nuclear attacks or accidents, or improved diagnostic tools to assess radiation exposure and must describe their feasibility for human use under public health emergency conditions. Although clinical research is encouraged within this program where relevant, clinical trials will not be supported.

The CMCRC will consist of a consortium of centers focused on accelerating the development and production of medical countermeasures against radiological or nuclear exposure of the civilian population. Applications from groups of investigators affiliated with different institutions are encouraged if the collaborations will strengthen the proposed scientific program.

This program is milestone-based, and includes the flexibility to quickly redirect or replace research projects during the funding period.

Within the Consortium, current candidate products with mitigation or treatment potential may be moved into validation and licensing studies to facilitate their inclusion in the SNS. The program will support applied research and studies to advance products through needed developmental stages when proposed by applicants with these capabilities. The program will also promote confirmatory screening studies, leading to the submission of an investigational new drug (IND) application to the Food and Drug Administration (FDA) to facilitate eventual licensure and potential inclusion in the SNS 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.

This FOA will support only the following research areas:

• Practical biodosimetry devices and techniques, biomarker assays, and other automated diagnostic systems to rapidly assess levels of radiation exposure and assess tissue damage early after an event and during the treatment and recovery phase.
• Research and development of medical countermeasures for the mitigation and/or treatment of acute and/or delayed radiation injuries to the hematopoietic, gastrointestinal, 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.
• Therapeutic regimens with emphasis on broad efficacy, safety, and ease of administration to at-risk populations (i.e., pediatric, geriatric, and chronically-ill groups).
• Medical countermeasures to treat radiation combined injuries (radiation exposure concomitant with burn, wound, infection, or other physiological trauma).
• Mechanism of action of potential countermeasures in irradiated animal models predictive of human responses.
• Characterization of injury and countermeasures for treating radiation injuries in highly susceptible 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, PK, and product characterization; and completion of IND packages for FDA submission.

Applications that propose studies outside these research areas or the development of medical products that must be administered prior to exposure or within the 24 hour period after exposure will be considered non-responsive and will not be reviewed.

Applications that propose clinical trials will be considered non-responsive and will not be reviewed.

The CMCRC will consist of: 5-7 Centers (each with a minimum of three research projects, one Administrative Core and optional Service Cores), four Consortium Cores (Coordinating Center Core, Opportunities Fund Management Core, Radiation Physics Core, and Radiation Survivor Core - all administered by institutions selected by the NIAID from the successful applicants), a Steering Committee and its subcommittees, a Consortium External Advisory Committee (CEAC), and other committees as needed.

Each application consists of the following Center and Consortium Components:

Center Components

Administrative Core

The Administrative Core will support the coordination of efforts across the research projects and Service Cores, 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. Each center may select an External Scientific Advisory Group (ESAG) to help guide the center s overall program and monitor research progress.

Service Core(s)

Service Cores will provide clinical, statistical, 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.

Research Projects

Research Projects must be multi-disciplinary, synergistic research/development projects focused on product development as an ultimate 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.

Consortium Components

Coordinating Center Core (CCC)

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. Activities of the CCC will be undertaken with input from and cooperation with NIAID, the Steering Committee and the CEAC.

Opportunities Fund Management Core (OFMC)

This FOA will provide support for: 1) Pilot Projects and 2) Candidate Medical Countermeasure (MCM) development. Pilot project funding is intended to foster novel ideas within and outside the CMCRC, 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. The use of Pilot Projects permits maximum flexibility to advance in the directions that seem most scientifically fruitful. Pilot projects must be within the scope of the FOA. The funding for candidate MCM development is intended to provide additional assistance and/or technical expertise for IND-enabling studies and candidate MCM product development activities in support of projects undertaken by CMCRC investigators.

Radiation Physics Core (RPC)

The RPC will be responsible for providing consortium-wide standards for the various research sites and sources used to conduct studies on irradiated animals to ensure that all such work conducted within the CMCRC is performed under standardized methodologies. The RPC leader will work with his or her counterparts at other centers to assure consistency of the procedures used to irradiate animals and dosimetry to determine that the desired radiation dose is delivered in the proscribed manner.

Radiation Survivor Core (RSC)

The RSC will be responsible for the clinical and pathologic assessment of humans and non-human primates (NHP) previously exposed to radiation.

Steering Committee (SC)

A Steering Committee will serve as the governing board and will coordinate and facilitate research activities for the overall program and foster synergy and efficiency within the Consortium. In addition, the Steering Committee will determine policies and implement processes for quality assurance of any data and information disseminated through activities of the CCC. The Steering Committee will also be responsible for establishing and implementing a process for selection of activities for funding with discretionary funds through the OFMC.

Consortium External Advisory Committee (CEAC)

The NIAID will appoint a CEAC of 3-5 members. This group will be updated on progress and inform the Steering Committee and the NIAID on adjustments and future directions for the CMCRC research projects and shared consortium cores.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• 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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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, 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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

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

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

• 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:

Paul Amstad, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3121, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817-7616 (for express/courier service; non-USPS service)
Telephone: 301-402-7098
Fax: 301-480-2408
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core	6 pages
Core (Use for Coordinating Center, Opportunities Fund Management, Radiation Physics, Radiation Survivor, and Service Cores)	6 pages each
Project (Use for Research Projects)	12 pages each

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; 1
• Administrative Core: required; 1
• Coordinating Center Core: required; 1
• Opportunities Fund Management Core: required; 1
• Radiation Physics Core: required; 1
• Radiation Survivor Core: optional; 1
• Service Cores(s): optional; no minimum or maximum, but each core must support at least two Research Projects
• Research Projects: required; minimum 3

When preparing your application in ASSIST, use Component Type Overall .

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

Specific Aims: 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 occurred. To highlight program synergy, applicants may describe in the Overview 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.

For renewal applications, also include in this section the progress made during the previous funding period as well examples of program synergy.

Letters of Support: Provide any institutional letters of support specific to the Overall Component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

Project Narrative: Do not complete. 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.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Administrative Core)

• 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.
• The PD/PI of the application must serve as the Leader of the Administrative Core. If multiple PD(s)/PI(s) are proposed, the PD(s)/PI(s) must select one PD/PI from amongst themselves to serve as the Administrative Core Leader
• Include a project manager in charge of the day-to-day coordination of all the activities of the center.

Budget (Administrative Core)

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 PD(s)/PI(s) and Project and Core Leaders to participate in the annual CMCRC Steering Committee meetings as well as the costs for travel of any 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.

PHS 398 Research Plan (Administrative Core)

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.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Administrative Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

Not Applicable

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (CCC)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (CCC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (CCC)

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.

Project /Performance Site Location(s) (CCC)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person (CCC)

• 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.
• Include a project manager in charge of the day-to-day coordination of all the activities of the center.

Budget (CCC)

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, anticipated to take place in Bethesda, MD, and conference calls for Subcommittee and Working Group meetings. Budget requests must include costs for the Core Leader and other essential members of the CCC including a project manager to attend the initial meeting and the annual CMCRC meetings. The budget must also include the costs for CEAC members to meet once annually with the Steering Committee.

The budget for this core is limited to $400,000 total cost per year. This core budget may be modified by NIAID after award, but 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.

PHS 398 Research Plan (CCC)

Specific Aims: List in priority order the broad, long-range activities and services of the proposed 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. The final plans of the CCC will be adjusted to accommodate the final projects undertaken by the consortium.

In addition describe how the core will:

• Support: study design; 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.
• Establish a web portal, dedicated to the CMCRC members, to provide information about the consortium and its activities as well as web-based training materials, 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.
• 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 CEAC.
• 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 CEAC, 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 subcontracts 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 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (CCC)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (CCC)

Not Applicable

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (OFMC)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (OFMC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (OFMC)

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.

Project /Performance Site Location(s) (OFMC)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (OFMC)

• 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.
• The OFMC key personnel should include a full time administrator.

Budget (OFMC)

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

The budget for this core is limited to $3.3M total cost per year. 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: one full-time administrator will be needed; significant oversight effort will be needed from the Core Lead or other senior staff;20-25 pilot project subawards and 5-7 candidate MCM subawards will be issued by this core annually. Total funding for each pilot project may not exceed $100,000 in direct costs. Furthermore, each Pilot Research Project may be supported for no more than two years and one person may serve only once as 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.

PHS 398 Research Plan (OFMC)

Specific Aims: List, in priority order, the proposed activities and services of the OFMC.

Research Strategy: Describe how the OFMC will operate to serve the CMCRC program, including descriptions of: 1) an administrative structure; 2) methods of communication with the CMCRC Steering Committee regarding the disbursement and tracking of funds; and 3) methods for reporting the status of funds to NIAID.

The scope of the OFMC is to administer set-aside funds to support: 1) Pilot Projects; and 2) Candidate MCM Development. The OFMC plan should include the establishment of an administrative structure to manage the fund; disbursement and tracking funds under the direction of the Steering Committee; implementation of plans for interacting with the institutions that will receive the funds; and the establishment of procedures, formats, and timelines for reporting on the status of the projects and expenditures of the Opportunities Fund to the CMCRC Steering Committee and the NIAID. In addition, with regard to the Pilot Projects fund, the plan should include implementing plans for interacting with the institutions that will receive pilot project funds if outside the CMCRCs; disbursing and tracking funds under the direction of each center; establishing procedures, formats, and timelines for reporting on the status of PPF projects and expenditures to the CMCRC Steering Committee and the NIAID; and establishing procedures for monitoring the success and productivity of the funded Pilot Projects, including terminating them or incorporating them within the center’s program; and monitoring adherence to the NIH guidelines for the protection of human subjects and vertebrate animals.

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (OFMC)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (OFMC)

Not Applicable

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (RPC)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (RPC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (RPC)

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.

Project /Performance Site Location(s) (RPC)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person (RPC)

• 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.
• The RPC key personnel should include a full time radiation physicist.

Budget (RPC)

The budget for this core is limited to $300,000 total cost per year. Include the costs associated with the: 1) travel of the RPC personnel to all other CMCRC sites to assess their radiation facilities and coordinate the implementation of irradiation and dosimetry SOPs; 2) annual dosimetry assessment of all centers by an independent service laboratory; and 3) travel for the Core Lead to participate in the annual CMCRC Steering Committee meetings. This core budget may be modified by NIAID after award, but for purposes of the application, assume that: one full-time administrator will be needed 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.

PHS 398 Research Plan (RPC)

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

Research Strategy: Explain how the core will serve the proposed research projects. For example, describe core activities to support the harmonization of experimental radiation procedures across the CMCRC. The scope of the RPC is to provide consortium-wide standards for the various research sites and sources used to conduct studies on irradiated animals. The RPC plan should include the following:

• Development of standard operating procedures (SOPs) for review and evaluation of irradiation and dosimetry procedures used at CMCRC sites at the time of award.
• Development of SOPs for irradiation and dosimetry to be used at all CMCRC sites.
• Analysis of dosimetry data relative to the proscribed dose and the observed biology, e.g. lethality and/or morbidity associated with the delivered dose of radiation.
• Verification implementation of irradiation and dosimetry SOP compliance at all CMCRC sites.
• Coordination of annual dosimetry assessment by an independent service laboratory.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (RPC)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (RPC)

Not Applicable

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (RSC)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (RSC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (RSC)

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.

Project /Performance Site Location(s) (RSC)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person (RSC)

• 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.
• Include personnel with the following expertise: human pathology and physiology, molecular biologic techniques, veterinary medical care, NHP pathology and physiology, and adaptation of molecular biologic techniques to the NHP model.

Budget (RSC)

The budget for this core is limited to $2.0M in total cost per year. Include the costs associated with the: 1) acquisition of NHP animals; 2) animal housing; 3) acquisition of samples of human and/or non-human primate origin; and 4) travel for the Core Lead to participate in the annual CMCRC Steering Committee meetings. This core budget may be modified by NIAID after award, but for purposes of the application, assume that: one full-time administrator will be needed; significant 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.

PHS 398 Research Plan (RSC)

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

Research Strategy: Explain how the core will operate to serve the CMCRC program, including descriptions of: 1) the administrative structure; 2) methods of communication with the CMCRC Steering Committee regarding the sharing of data and samples (when applicable).

The scope of the RSC is to conduct the clinical and pathologic assessment of humans and non-human primates (NHP) previously exposed to radiation. The RSC plan should include the following:

• Access to physiological samples from human long-term radiation cohort(s).
• Procedures for clinical and pathologic assessment of the human physiological samples.
• Acquisition and maintenance of previously irradiated, specific-pathogen-free non-human primates.
• Procedures for tissue (when applicable) and data sharing with other members of the CMCRC.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (RSC)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (RSC)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Service Cores)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Service Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Service Cores)

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.

Project /Performance Site Location(s) (Service Cores)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person (Service Cores)

• 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 (Service Cores)

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

Include the committed level of effort for the 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.

PHS 398 Research Plan (Service Cores)

Specific Aims: For each service core, list in priority order the broad, long-range activities and services of the proposed core. In addition, state the core’s relationship to the program’s goals and how the core relates to two or more 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 and roles of the 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.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Service Cores)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Service Cores)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide

When preparing your application in ASSIST, use Component Type Project.

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

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

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.

Project /Performance Site Location(s) (Research Projects)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Research Projects)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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 enough bioinformatics expertise to enable data management activities.

Budget (Research Projects)

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.

PHS 398 Research Plan (Research Projects)

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; 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. 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.

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. Describe data- and other resource-sharing requirements within the Consortium, as well as data management activities.

Protection of Human Subjects: For projects proposing the use of human samples to be obtained with funds from the CMCRC award, provide the information described in the SF424 (R&R) Application Guide.

When possible, it is strongly recommended that informed consent be used that allows broad use of de-identified stored samples and de-identified data for future studies, beyond the scope of the CMCRC study, including unrestricted sharing of the samples and data for use by other researchers, subject to IRB approval.

For projects proposing the use of human samples to be obtained from independently-funded clinical trials, supporting documents should be uploaded in the Appendix, as described in the instructions for the Appendix section below.

When clinical studies or trials are an aspect of the research proposed, the NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study (http://www.niaid.nih.gov/labsandresources/resources/toolkit/pages/standards.aspx. An updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

For projects proposing the use of human samples to be obtained from independently-funded clinical trials, the following materials should be included:

• A brief synopsis of the parent clinical trial protocol
• Informed consent forms for the parent clinical trial
• Informed consent forms for the proposed CMCRC studies
• Reference to the ClinicalTrials.gov citation, if applicable
• Table of events including the volume of blood, or amount of tissue, collected for the proposed CMCRC studies
• Memorandum of understanding from the clinical trial sponsors, IND holders, and Principal Investigators

Planned Enrollment Report (Research Projects)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Research Projects)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. Paste Other Components here

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NIAID, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

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

• Are the proposed projects and Cores scientifically compelling?
• Are the overall program 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 program and will the scientific gains of the multi-project program be beyond those achievable if each project were pursued independently?
• Is the program cohesive in terms of the research projects and cores fitting into a common theme?
• For applications designated multiple PDs/PIs, is the Leadership Plan adequate and appropriate to ensure that there will be sufficient coordination and communication among the PDs/PIs?

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

What is the likelihood that the results of the study will be translated into important new knowledge for the development of effective and comprehensive medical countermeasures, when administered 24 hours post-irradiation or later, applicable to all subsets of the civilian population in the event of radiological or nuclear emergencies?

Investigator(s)

Are the research project lead(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Are the designated personnel sufficient to enable compliance with the data- and other resources-sharing requirements?

Do the designated personnel have sufficient bioinformatics expertise to enable data management activities?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

In each Research Project, 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? 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?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Are adequate resources available to conduct the proposed studies, including a local database, sample repository, and statistical capability?

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).

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?

Reviewers will rate each core to reflect their assessment of the likelihood for the 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).

Reviewers will consider each of the review criteria below, as appropriate for the individual consortium core, in the determination of scientific merit and rate the Core Acceptable or Unacceptable, and will not give separate scores for these items.

Coordinating Center Core

• 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?
• Is there sufficient bioinformatics infrastructure to support the proposed activities?
• Are sufficient effort and expertise for study design and 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?

Radiation Physics Core

• 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 adequate to manage the core?
• Are the plans for coordination and dosimetry standardization, problem identification and resolution, and establishment of a strong collaborative environment within the CMCRC program appropriate?

Radiation Survivor Core

• 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 adequate to manage the core?
• Are the plans for animal acquisition and maintenance as well as health monitoring and assessment appropriate?
• Are the plans for sample acquisition, storage and analysis appropriate?
• Are the procedures for clinical and pathologic assessment of the human physiological samples appropriate?

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed 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 children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Reviewers will consider each of the review criteria below for the Opportunities Fund Management Core, in the determination of scientific merit and rate the core Acceptable or Unacceptable, and will not consider the evaluation of the core in providing an overall impact score for the application.

Opportunities Fund Management Core

• Is provision of the proposed core services to the CMCRC program described in sufficient detail?
• Is sufficient justification provided for the management methods proposed?
• With regard to the management of the Pilot Project funds, are the proposed plans adequate to support the following core activities: (1) program announcement, (2) application receipt and referral to the appropriate center, (3) fund disbursement, (4) progress report submission, and (5) communication with the Steering Committee and the NIAID?
• Are the personnel charged with managing the fund appropriate?

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the 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.
• Compliance with data- and resource-sharing policies within the Consortium.
• Awards will be based on scientific excellence and the need for programmatic balance to ensure the most comprehensive and efficient approach to achieving the objectives.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Awardee-selected projects that involve studies involving 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.

Cooperative Agreement Terms and Conditions of Award

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

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

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

• 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 U19 award will be a voting member of the Steering Committee; will participate in all Steering Committee activities, meetings and teleconferences; and 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 will be negotiated with NIAID as part of the data-sharing plan for the center.
  
  
• The PD/PI will ensure successful completion of the data- and other resource-sharing plans within the consortium negotiated with NIAID. Sharing plans within the consortium represents a commitment by the applicant institution (and its subcontractors, if any) to support and abide by the plan.
  
  
• The PD/PI will 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. The final versions of NIAID-approved sharing plans will become a condition of the award. Note that funding beyond the first year may be subject to downward negotiation depending on the progress made in meeting negotiated milestones within the data- and other resource-sharing plans, as well the successful implementation of irradiation and biodosimetry SOPs.
  
  
• When appropriate and under the direction of the Program Officer, U19 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.
  
  
• The PD/PI may convene an External Scientific Advisory Group (ESAG) for the individual center, to be formed after award at the discretion of the PD/PI. The ESAG would evaluate scientific progress and provide advice to the center on an annual basis. A member of the CMCRC may NOT serve as an ESAG member for a different center.
  
  
• Consortium Cores: after all grants have been awarded, one or more U19 grantee institution will be selected by NIAID to manage one or more of the following Consortium Cores for the entire CMCRC.
  
  
• Coordinating Center Core: 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) create and 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.
  
  
• Radiation Physics Core: The selected institution must agree to take responsibility for establishing an administrative structure to support: 1) the review and evaluation of irradiation and dosimetry SOPs at all centers; 2) the development and implementation of standardized irradiation and dosimetry SOPs within the CMCRC; 3) the coordination of an annual irradiation and dosimetry assessment by an independent service laboratory.
  
  
• Radiation Survivor Core: The selected institution must agree to take responsibility for creating an administrative structure to establish and maintain an animal colony of previously irradiated NHPs, monitor their health and assess their pathological and physiological status. The Core will also support studies aimed at assessing the long-term health effects of irradiation in human subjects.
  
  
• Opportunities Fund Management Core: 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 CEAC, and the CEAC Chair. The same or 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 input into the design of research activities.
• Play a key role in coordinating research 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 non-voting members.
• 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.
• Recommend which applications to fund and budget allocations, and monitor the progress of funded projects.
• 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.
• Have confidential access to data generated under this Cooperative Agreement for use in the preparation of internal reports on the activities of the awardees.
• Provide assistance to the Steering Committee in the development of procedures for evaluating the performance of research studies and for the removal, redirection, or replacement of ongoing research projects for NIAID approval.
• 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 of the grants, a Consortium External Advisory Committee (CEAC) will be established to provide guidance to NIAID by reviewing, evaluating, and prioritizing the scientific progress of the individual awardees and the consortium. CEAC members will be selected by NIAID and applicants should NOT contact any individuals for the purpose of serving on this CEAC, nor should they identify any such individuals in their applications. CEAC members will meet initially and annually with the Steering Committee in conjunction with the CMCRC annual meeting.

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.
  
  
• All research groups 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 option to redirect research activities within the CMCRC grants if it is considered beneficial to the overall program.
  
  
• Steering Committee responsibilities will include:
• Optimizing resources and communications within 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 for removal, redirection, or replacement of ongoing projects for NIAID approval.
• Developing a policy on publication and sharing of data obtained by the collaborative efforts of the centers.
• 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; Develop a process for the solicitation, evaluation and funding of pilot project proposals. Pilot project funds will be restricted until this process is established and agreed upon in writing by the Steering Committee. The Steering Committee and the NIAID will assess whether successfully completed pilot projects may mature and become full projects.
• Make recommendations for procedures to set the goals, priorities, and evaluation criteria for the use of the Candidate MCM 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. Monitoring compliance with these policies at different institutions is the responsibility of the OFMC and NIAID program staff. NIAID approval of expenditure of any portion of the funds will be restricted until a process for the solicitation, and evaluation of proposals is established and agreed upon in writing by the Steering Committee. 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 of the 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 will include one PD/PI from each awarded U19 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.
  
  
• 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 Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]

Francesca Macchiarini, M.S., Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3506
Email: [email protected]

Paul Amstad, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-7098
Email: [email protected]

Jay Colbert
National Institute of Allergy and Infectious Disease (NIAID)
Telephone: 301-827-9237
Email: [email protected]

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

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