Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Allergy and Infectious Diseases (NIAID)
Funding Opportunity Title	Development of Medical Countermeasures for Post-Exposure Mitigation/Treatment of Injuries Resulting from a Radiation/Nuclear Incident (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-AI-12-023
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.855, 93.856
Funding Opportunity Purpose	To support research on: 1) further development of candidate medical countermeasures with post-radiation exposure administration data showing efficacy to mitigate and/or treat radiation injury, including acute radiation syndromes, and/or the delayed effects of acute radiation exposure; and 2) elucidation of mechanisms of action of candidate medical countermeasures, necessary to meet product licensure requirements.

Posted Date	June 19, 2012
Open Date (Earliest Submission Date)	September 18, 2012
Letter of Intent Due Date	September 18, 2012
Application Due Date(s)	October 18, 2012 , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	February, 2013
Advisory Council Review	May, 2013
Earliest Start Date(s)	July, 2013
Expiration Date	October 19, 2012
Due Dates for E.O. 12372	Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

The Department of Health and Human Services (HHS) has charged the NIH with the responsibility to identify, characterize, and develop new medical countermeasures against radiological or nuclear attacks. On October 14, 2004, the NIH convened an expert panel to review the NIH Strategic Plan and Research Agenda for Medical Countermeasures against Radiological and Nuclear Threats (http://www3.niaid.nih.gov/research/topics/radnuc/default.htm). This strategic plan and research agenda outline a flexible, collaborative, and comprehensive NIH research and product development program focused on medical therapies and diagnostics to counter radiation injury. On behalf of the NIH, NIAID is charged with implementing this research agenda. The updated Radiological and Nuclear Threats Program Progress Report and Future Research Directions (2012) can be found at http://www.niaid.nih.gov/topics/radnuc/Documents/radnucprogressreport.pdf.

Concern about the threat of nuclear or radiological attacks has grown in recent years due to the increased activity of global terrorist organizations and documented illicit trafficking of radioactive materials. In addition, recent natural disasters, which have threatened the security of nuclear power facilities, highlight the need to stockpile countermeasures to treat radiation injuries in the civilian population. However, few licensed medical products exist to counter the variety of acute and long-term injuries that can result from nuclear or radiological attacks. To expand the options available to mitigate and/or treat radiation-induced injury, NIAID has established a program of translational research in this area. The overall goal of NIAID's program is the rapid development of safe and effective radiological/nuclear medical countermeasures for clinical use under emergency situations. NIAID’s Radiation and Nuclear Countermeasures Program places a strong emphasis on product development of treatments for radiation injury, which are effective when administered 24 hours or later after exposure (in the context of a radiation incident - accident or attack). NIAID's research and development program is already yielding new candidate mitigators and therapeutic agents, which are moving toward product licensure by the U.S. Food and Drug Administration (FDA). This FOA adds to this effort. Additional information about the mission of the Radiation and Nuclear Countermeasures Program, as well as areas of past and current funding can be found here: http://www.niaid.nih.gov/topics/radnuc/Pages/default.aspx.

The focus of this solicitation is to promote science leading towards treatments for mass casualty situations, with the ultimate goal of advancement of research on mitigators/treatments of short- and long-term consequences of radiation exposure for civilian populations in the event of a nuclear incident (accident or attack). Thus, studies ranging from investigations into the mechanisms of action for a candidate medical countermeasure to advanced product development are requested. Selection of radiation exposure type, dose level, and dose rates proposed for studies should be relevant to a radiological or nuclear incident.

Studies in animal models will be required to demonstrate efficacy of the medical countermeasure products. Applicants are strongly encouraged to justify the selection of their animal model, and its relevance to expected human responses (e.g., the model is expected to behave similarly to the human for both the radiation exposure and the medical countermeasure response). It is anticipated that in most cases licensure or approval of proposed medical countermeasures will occur in accordance with the FDA Animal Rule (see 21 CFR 314.600 Subpart I for drug products and 21 CFR 601.90 Subpart H for biologic products http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm).

The program will support in vivo animal research to advance medical products already licensed (for other indications) or approaches in early developmental stages for any indication (including radiation). All applicants must already have a lead medical countermeasure candidate. The applicants must provide preliminary, positive efficacy data when the countermeasure is administered only after (not before) radiation exposure. Medical radiation countermeasures that are effective when administered at times 24 hours or later after radiation exposure are required. If data are not already available for efficacy of the countermeasure when administered 24 hours after radiation exposure, studies proposed in the application must include testing at this time point (and not at earlier time points). Administration of the countermeasure at time points beyond 24 hours post-radiation exposure (to determine how long administration can be delayed while still retaining efficacy) is also encouraged.

Areas of research and development interest for this FOA include, but are not limited to, the following:

• Research and development of medical countermeasures to enhance survival (primary endpoint) in irradiated animal models predictive of human responses, when administered as a single or multiple-dose after radiation exposure (with administration of the first dose beginning at a minimum of 24 hours or later post-irradiation), with emphasis on broad activity (i.e., multi-syndrome, multi-organ). Countermeasures development must be targeted to treat radiation damage that leads to mortality or major morbidities. Research and development of medical countermeasures for the mitigation or treatment of potentially-lethal, acute and/or delayed radiation syndromes, including radiation injury to the hematopoietic, gastrointestinal, cutaneous, pulmonary, renal, cardiovascular and/or central nervous system compartments of the body;
• Testing of combinations of new and/or existing therapeutic products to enhance efficacy (e.g. lead countermeasure tested concomitant with expected standard of care such as antibiotics and/or growth factors);
• Medical countermeasures to treat radiation combined injuries (radiation exposure concomitant with burn, wound, infection or other physiological trauma);
• Formulations of products and/or improvements to existing products for civilian populations, that can be easily administered in a mass casualty scenario either by first responders or self-administered; (e.g. via oral, subcutaneous, trans-cutaneous, intramuscular or inhalation routes);
• Testing of candidate countermeasures in animal models that are representative of pediatric and/or geriatric human populations;
• Testing of small molecules, biologic and cell products for acute and/or delayed radiation syndromes;
• Identification of early surrogate markers of drug/therapy efficacy post-radiation exposure (e.g. in hematologic parameters, cytokine or enzyme profiles, histological markers, inflammatory responses) that could potentially be used as secondary endpoints/observations to support mechanisms of action and linkage of pharmacodynamic (PD) effects across species (note that this is not a request for biomarkers for the purpose of triage biodosimetry);and
• Product development efforts leading to the submission of an Investigational New Drug Application (IND) to the FDA to facilitate eventual licensure and potential inclusion in the Strategic National Stockpile. Examples include:
  • Efficacy studies to optimize formulation, dose, and dose scheduling;
  • GLP-pilot efficacy studies to inform the design of Good Laboratory Practice (GLP) pivotal efficacy study protocols;
  • Drug product stability studies;
  • Drug product current Good Manufacturing Practice (cGMP) manufacturing scale-up;
  • GLP toxicology and pharmacology safety studies;
  • Pharmacokinetic (PK), (PD) and metabolism studies;
  • Development of GLP analytical methods for efficacy studies, PK, and product characterization; and
  • Completion of IND packages for FDA submission.

These product development efforts will advance the development of medical countermeasures for radiation injury toward Phase I clinical trial safety studies and/or GLP animal model pivotal efficacy studies for FDA licensure (not supported by this FOA). Applicants are encouraged to begin the process early of partnering with industry on development of the proposed approach.

It is acknowledged that basic testing of compound efficacy and/or formulation work may not be considered inherently innovative.

This program will not support the following:

• Studies proposing testing for a radio-protectant (compound that must be administered prior to radiation exposure in order to be efficacious).
• Studies proposing administration of a candidate medical countermeasure at times earlier than 24 hours post-radiation exposure.
• Human clinical trials or Phase I clinical safety trials. Although research involving human subjects ( clinical research ) is encouraged within this program where relevant, clinical trials will not be supported. For the NIH definition of clinical research versus clinical trials, please see the Part II, Human Subjects Research Supplement at: http://grants.nih.gov/grants/funding/phs398/phs398.html.
• Applications proposing work in dose ranges or exposure parameters that are not relevant to a radiation accident or attack (e.g. studies using fractionated radiation exposures, unless well-justified).
• Biodosimetry devices and biomarkers to be used to determine radiation dose received (radiation triage).
• Studies to investigate medical countermeasures to mitigate and/or treat thermal-only burns, or radiation-induced carcinogenesis, cataractogenesis, and other ocular, reproductive, or muscular damage.

Applications proposing studies in the excluded areas will be considered non-responsive and will not be reviewed.

This U01 program is milestone-based and includes the flexibility to quickly redirect or replace specific aims during the funding period. Explicit, quantitative, yearly milestones must be included in each U01 application. Strength and appropriateness of submitted milestones will be an additional review criterion. Milestones must be specific. For example, it is not appropriate to state only that "countermeasure A will be tested for its ability to mitigate radiation damage". An appropriate milestone might instead be: "PD/PI will demonstrate a dose modification factor of 1.2 or greater when countermeasure A is administered subcutaneously to animal at 24 hours post-exposure." It is recognized that milestones may require revision and re-negotiation prior to award, and during the course of the project period. These milestones will be used by NIAID program staff to assess long-term planning, on the part of the PD/PI, for development of the candidate radiation medical countermeasure. Milestones will also be used by NIAID program staff to assess yearly progress and recommendations of continued funding. Funding beyond the first year will be contingent upon satisfactory progress in meeting negotiated milestones.

Funding Instrument	Cooperative Agreement
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIAID intends to commit $4.0 million in FY 2013 to fund 6-8 awards. .
Award Budget	Application budgets are limited to $350,000 direct costs per year and must reflect actual needs of the proposed project.
Award Project Period	The scope of the proposed project should determine the project period. The maximum period is 5 years.

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

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

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 eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

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.

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

Applicants must download 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.

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

The letter of intent should be sent to:

Barney Duane Price, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3139, MSC 7616
6700B Rockledge Drive
Bethesda, MD, 20892-7616
(Overnight Mail Only: Use Zip 20817-1821)
Telephone: (301) 451-2592
FAX: 301-480-2408
Email: pricebd@niaid.nih.gov

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

All applicants should include in their budgets for each year travel expenses for the PD(s)/PI(s) and any relevant staff to attend a one-day, yearly program meeting in the Washington, DC area (see section VI.2 Cooperative Agreement Terms and Conditions of Award).

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

Research Strategy

Milestones

Within 1/2 page maximum (subject to the 12 page limit for the Research Strategy section of the Research Plan), describe for all years of the award specific, quantitative milestones that will be achieved in each year of the Project. The proposed milestones will not be given an individual score by reviewers, but will be an additional review consideration for the application. If necessary based on reviewer feedback and programmatic concerns, milestones may be subject to negotiation with the NIH Project Scientist prior to award and during the course of the project period.

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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. 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 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 SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). 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 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-10-115.

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/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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 proposed studies will be successfully translated into new approaches and medical products for treatment of short- and long-term consequences of radiation exposure?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are appropriate expertise and level of effort included in the application (e.g. radiation biologist, dosimetrist, statistician, veterinarian, regulatory specialist, product development, project management, etc.)?

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? Does the research proposed advance the medical countermeasure toward licensure for the appropriate clinical indication?

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are there clear paths to translating findings from efficacy studies to development of medical countermeasures for treatment of radiation injuries? Does the applicant provide convincing preliminary, in vivo, post-radiation exposure data? Does the proposed mechanism of action of the countermeasure support that the candidate countermeasure would be effective when delivered at least 24 hours after radiation exposure? Is sufficient information provided on proposed radiation dosimetry and set-up (e.g. radiation dose and quality, dose rate, source, etc), such that the appropriate radiation dose will be delivered to the animal?

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?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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

Milestones.

Given the critical nature of the milestones to measure the success of the program, are the proposed Milestones well-defined with quantifiable measures that are appropriate for assessing the feasibility of use of the medical countermeasure?

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 NIAID in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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/priority 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 Disease Councill. The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD(s)/PI(s) 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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:

• Research design and protocol development, data collection, final data analysis and interpretation, preparation of publications, as well as collaboration with other awardees, and with assistance from the NIAID Project Scientist.
  
  
• Milestones: The applicants will describe explicit, quantitative, yearly Milestones for the Research. It is recognized that Milestones may require revision and re-negotiation prior to award and during the course of the project period. The NIH Program Official will negotiate the Milestones with the PD(s)/PI(s) and provide approvals. Release of each yearly funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon Milestones.
  
  
• Site Visits: The PD/PI will host site visits by NIAID program staff as requested by the program staff. These site visits may be held in conjunction with meetings of the U01 members.
  
  
• Intellectual Property: Awardees retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the applicant to perform the project.
  
  
• Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.
  
  
• The awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).
  
  
• Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID, or other mechanisms.
  
  
• Publications: The PD/PI will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Agreement.  The PD/PI is requested to submit manuscripts to the Project Scientist within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained and joint press conferences and press releases prepared. Publications or oral presentations of work performed under this Agreement are the responsibility of the PD/PI and will require appropriate acknowledgement of NIAID support. Timely publication of major findings is encouraged.
  
  
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• A program official from the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) will serve as the NIH Project Scientist for this program. In conjunction with other NIAID scientific program staff the NIH Project Scientist will provide advice and guidance on technical issues, such as reviewing progress or recommending changes. Administrative assistance will be provided by the NIH Project Scientist in conjunction with the NIAID Grants Management Office.  The NIH Project Scientist may also:  provide input into the design of activities; advise in the selection of sources or resources (e.g., determining where a particular reagent may be found); coordinate or participate in the collection and/or analysis of data; or advice in the management and technical performance.
  
  
• The NIH Project Scientist will schedule the annual meetings.
  
  
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Scientific Meetings: All awardees will participate together in an initial meeting, arranged by the NIAID Project Scientist, to be held within four months of award in the Washington, DC area; and will participate in face-to-face, one-day scientific meetings of all PD(s)/PI(s) to be held annually thereafter. All PIs are required to attend these meetings. The scientific meetings are open to members of the U01 program, appropriate NIH extramural staff and members of select U.S. Government agencies, and will serve as opportunities for members to provide the latest update on their research, exchange ideas and information, and discuss collaborations among program members. It will also be an opportunity for the program to provide guidance to the PD(s)/PI(s) on product development, sources of follow-on funding and FDA licensure pathways. Meeting participants will identify the group’s tangible resources, capabilities, and needs to advance overall program goals. The PD(s)/PI(s) are required to give oral presentations at the annual meetings on current progress and planned activities and projects.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and Federal Financial Reports (FFR) as required in the NIH Grants Policy Statement. Note: Special Reporting Requirements:

The annual progress report for the U01 should include a detailed description of the work done to achieve the specific Milestones for that funding year. If Milestones have not been met, an explanation of what has been accomplished and the alternatives, solutions, and/or problems that exist must be provided. If future year Milestones need to be modified, updated Milestones and associated timelines must be included in the report and reviewed with the Program Officer.  The Program Officer will determine if major changes are appropriate and provide approval. In addition, the awardees may be contacted during or after the completion of this award for information helpful in assessing the overall impact of the program.

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.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

Andrea DiCarlo-Cohen, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 5301, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 451-9199
FAX: 301-480-6587
Email: cohena@niaid.nih.gov

Barney Duane Price, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3139, MSC 7616
6700B Rockledge Drive
Bethesda, MD, 20892-7616
(Overnight Mail Only: Use Zip 20817-1821)
Telephone: (301) 451-2592
FAX: 301-480-2408
Email: pricebd@niaid.nih.gov

Vandhana Khurana, MBA
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2226, MSC-7614
6700B Rockledge Drive
Bethesda, Maryland 20892-7614
Overnight Mail Only: Use Zip 20817
Telephone: (301) 451-7380
FAX: 301-493-0597
Email: khuranav@niaid.nih.gov

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.