Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Office of the Assistant Secretary for Preparedness and Response (ASPR), (http://www.hhs.gov/aspr)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)
Biomedical Advanced Research and Development Authority (BARDA), (http://www.hhs.gov/aspr/barda/index.html)  

Title: BARDA/NIAID Medical Countermeasures to Mitigate and/or Treat Ionizing Radiation-Induced Cutaneous Injury: Project Bioshield (RC1)

Note: The Project BioShield Act of 2004, enacted on July 21, 2004, authorizes the Secretary, Department of Health and Human Services (DHHS), through the program carried out by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), to expedite peer review and award of grants, contracts, and cooperative agreements to perform, administer, or support research and development of countermeasures determined by the Secretary to be a priority to treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security, or adverse health consequences. Consistent with this authority, the NIAID is announcing a new grant initiative focused on the development of novel medical countermeasures to prevent or mitigate cutaneous injury, or restore morphology and function after exposure to ionizing radiation. 


Announcement Type
New

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov/) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number:  RFA-AI-07-037

Catalog of Federal Domestic Assistance Number(s)
93.855

Key Dates - New Dates
Release Date: December 27, 2007
Opening Date: February 11, 2008 (Earliest date an application may be submitted to Grants.gov)  
Letter of Intent Receipt Date:  February 11, 2008
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Receipt Date:  March 11, 2008
Peer Review Date:  May 2008 
Earliest Anticipated Start Date:  August 2008
Additional Information To Be Available Date:  Not Applicable 
Expiration Date:  March 12, 2008


Key Dates - Old Dates
Release/Posted Date: December 6, 2007
Opening Date: January 21, 2008(Earliest date an application may be submitted to Grants.gov
Letter of Intent Receipt Date January 21, 2008
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Receipt Date:  February 21, 2008
Peer Review Date:  May 2008
Earliest Anticipated Start Date:  August 2008
Additional Information To Be Available Date:  Not Applicable 
Expiration Date:  February 22, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The Department of Health and Human Services (DHHS) has assigned the NIH the responsibility to identify, characterize, and develop new medical countermeasures against radiological or nuclear attacks. A robust research and development program in this area will begin to yield new diagnostic tools, protectors, mitigators, and therapeutic agents to facilitate an effective response against radiological injury.  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 outlines a flexible, collaborative, and comprehensive NIH research and product development program focused on medical therapies and diagnostics to counter injury resulting from the exposure to ionizing radiation.  On behalf of the NIH, the NIAID is charged with implementing this research program.

On December 19, 2006, President George W. Bush signed into law the Pandemic and All-Hazards Preparedness Act (Public Law 109-417), referred to as PAHPA. Title IV of PAHPA established the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) to facilitate the research, development, and acquisition of medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) agents and emerging infectious diseases, including pandemic influenza, that threaten the U.S. civilian population. One of the central responsibilities of BARDA is to lead the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), which provides an integrated approach to the development and purchase of medical countermeasures for public health medical emergencies. The HHS PHEMCE consists of NIH, ASPR, FDA, and CDC, along with ex officio participation from other federal agencies. To guide progress toward the goal of public health preparedness, the HHS PHEMCE Implementation Plan provides insight into the current priorities for medical countermeasure development. The product development activities supported through this RFA will help identify medical countermeasures that are suitable for progression through the development pipeline toward licensure. The eventual goal is to enable the U. S. Government to stockpile these medical countermeasures to protect the American public.  BARDA welcomes the opportunity to partner with NIAID on this Request for Applications. For additional information on BARDA, the PHEMCE Implementation Plan, and Project BioShield, please visit http://www.hhs.gov/aspr/barda.

Exposure to ionizing radiation (e.g., from radiological or nuclear weapons) have the potential to cause life threatening radiation and non-radiation cutaneous injuries. Significant cutaneous radiation injury is an independent predictor of mortality. Furthermore, cutaneous radiation insults are frequently combined with mechanical, chemical, and thermal cutaneous trauma (cases where multiple mechanisms have contributed to the cutaneous injury are referred to in this solicitation as ‘combined skin injury’). In potentially non-lethal radiation exposures (< 8 Gy), injuries to the skin and bone marrow are the main determinants of mortality. While colony-stimulating factors are currently licensed for the mitigation and treatment of chemotherapy-induced hematopoietic injury and have been used to treat radiation-induced bone marrow injury, few if any specific treatments for cutaneous radiation injury have been developed. There is thus an urgent need to develop therapies to mitigate or treat cutaneous radiation or combined skin injury. The availability of new products that can protect, mitigate, and/or treat radiation induced skin injury will increase the medical management options to reduce potentially large numbers of casualties in a radiation exposure event.

The goal of this funding opportunity is to develop medical products that will rapidly and efficiently mitigate and/or treat cutaneous radiation injury and/or combined skin injury. This program will support research for the development of products that will mitigate and/or treat radiation or combined skin damage by preventing cellular depletion, inhibiting tissue break down, preventing bacterial translocation, and/or stimulating tissue repair with the ultimate goal of reducing major morbidity and mortality.  Applicants may propose the development of previously identified candidate products relevant to these goals. Product development under this initiative must directly involve the mitigation or treatment for restoration of cutaneous structure and function in the context of ionizing radiation damage, and be relevant to radiation damage caused by accidental or intentional exposures to ionizing radiation.

It is anticipated that candidates that prove efficacious will be advanced towards Food and Drug Administration (FDA) licensure through follow-on support from industry or other government-funded programs.  The NIAID will place a high priority on projects that demonstrate clear advantages over current treatments (such as ease of use in mass casualty settings, ability to deliver treatment post-exposure, and/or reduced toxicity) and have a feasible product development pathway for eventual FDA licensure.  Studies in animal models will be required to demonstrate efficacy of the products to minimize damage and/or restore normal function. It is anticipated that in most cases licensure 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).  Clinical studies using human tissue samples or data from irradiated patients may be included, if the results are likely to be relevant to the treatment of humans exposed to terrorist or accidental radiological or nuclear attack. Clinical trials will not be supported under this initiative.

Radioprotectors are defined as products given before radiation; mitigators are defined as products given after radiation but prior to the development of symptoms; and treatments are defined as products given based on clinical manifestations that appear after radiation exposure.

The principal investigator is to conduct research for the development of effective mitigators and/or treatments. Research to determine whether a potential mitigator or treatment can also act as a protector is permitted.  The product should preferably be easy to administer, have a long biological half-life and product shelf-life, and lack of significant toxicity.

All applicants must develop a scientifically sound rationale for the forward progression of the product through the product development pathway towards FDA licensure for the radiation medical countermeasure indication (See “Product Development Outline” in Section IV.6 [Other Submission Requirements] below).  It is anticipated that the eventual licensure of the medical countermeasure would follow the FDA Animal Rule (see 21 CFR 314.600 Subpart I for drug products and 21 CFR 601.90 Subpart H for biologic products). 

Applications must include the use of non-fractionated radiation to simulate exposure from an accidental or intentional radiological or nuclear attack.

Development activities that can be supported under this program include, but are not limited to, the following areas:

As mentioned above, this program will also consider products to treat or mitigate combined radiation-associated skin injury. Areas of research and development that are responsive may include, but are not limited to the following:

Research in the area of mitigators and/or treatments is a requirement. In addition, supplemental studies on the role of the product as a radioprotector may be proposed.

This program will not support the following:

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the NIH Challenge grant (RC1) award mechanism. The RC1 grant is used by NIAID to support accelerated product research and development efforts in targeted areas. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application. NOTE: Requested 18 month budget should be prepared using one set of SF 424  RESEARCH & RELATED BUDGET forms. All 18 months of funding should be requested within the INITIAL BUDGET PERIOD budget period.

2. Funds Available

NIAID/BARDA intend to commit approximately $4.0 million in FY 2008 to support research and development projects under this initiative. Applicants may request up to $1 million in total costs for a project period not to exceed eighteen months.  Although the financial plans of NIAID provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement NIH Grants Policy Statement

3. Other-Special Eligibility Criteria

A Principal Investigator (PI) may submit only one application. A Principal Investigator can serve as a collaborator in another application provided there is no scientific overlap. An institution may submit more than one application provided each application is scientifically distinct.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist 

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH RC1 uses ONLY the detailed Research & Related Budget. (Do not use the PHS398 Modular Budget.)

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.

Applications from foreign organizations must:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan:  For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates
Opening Date: January 21, 2008 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date:  January 21, 2008
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Receipt Date:  February 21, 2008
Peer Review Date:  May 2008
Earliest Anticipated Start Date:  August, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Quirijn Vos, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 3137, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616

Telephone: (301) 451-2666
FAX: (301) 402-2638
Email: qvos@niaid.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

In order to expedite the review, applicants are requested to notify the NIAID by email (qvos@niaid.nih.gov) and include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions


All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

SPECIAL SF 424 INSTRUCTIONS FOR APPLICATIONS FOR RC1 GRANTS:

4.2       Cover Component (APPLICATION FOR FEDERAL ASSISTANCE SF 424 (R&R))

For item 13. Start Date and Ending Date

Enter the proposed start date of the project in the Start Date field. Enter the proposed end date in the Ending Date field. Use the following format: MM/DD/YYYY. For this RC1 application, the interval between the Start Date and End Date may be up to, but may not exceed, 18 months.

4.7       R&R Budget Component

RESEARCH & RELATED BUDGET – SECTION A& B, BUDGET PERIOD 1

Budget Period

For this RC1 application, there will be only one budget period (Budget Period: 1). The budget period can be up to, but cannot exceed, 18 months. All Salary, Wages, and Fringe Benefits should be based on the full budget period of up to 18 months.

RESEARCH & RELATED BUDGET – SECTION C, D, & E, BUDGET PERIOD 1

The start and end dates must be the same as in section a & b for a single budget period of up to 18 months. All requested funds should be based on the full budget period.

RESEARCH & RELATED BUDGET – SECTION F-K, BUDGET PERIOD 1

The start and end dates must be the same as in section a & b for a single budget period of up to 18 months.

All requested funds should be based on the full budget period.

RESEARCH & RELATED BUDGET – Cumulative Budget

For this RC1 application, the cumulative budget data is for the single budget period of up to 18 months.

PHS398 Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts and with the following requirements specific to this FOA:

Research Plan. An application with a Research Plan of no more than twenty (20) pages; within the 20 page limit:

This section must describe how the work proposed in the application contributes to the further development of the candidate product(s).  Examples of activities that would be considered responsive to this request may include (but are not limited to) demonstration of efficacy in pertinent preclinical animal models; scale-up of medical countermeasure manufacturing towards cGMP production capability; formulation development; analytical methods development and validation; bulk medical countermeasure and product-as-formulated stability studies; optimization of dose, route, and schedule of administration; determination of radiation dose reduction factor; and evaluation of toxicology, safety pharmacology, pharmacokinetic, or absorption/distribution/excretion/metabolism parameters.  It is anticipated that in most cases licensure 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).  In discussing activities proposed for funding, applicants should therefore take available guidance on the application of the Animal Rule into consideration or explain why the Animal Rule does not apply in the case of the proposed countermeasure.

This section of the application must include a clear description of the goal(s) and product development milestones of the project proposed for funding, including the stage(s) of product development to be completed during the award period.  This section should also identify possible impediments that could require a revision in the work plan, and (where feasible) outline potential alternative approaches that could be pursued in the event such impediments are encountered.  Applicants may obtain documentation from a product’s corporate sponsor describing the company’s product development plan and the relevance of the work proposed under the application to such product development.            

Data Sharing Plan (does not count against page limit).  A data sharing plan or justification of not including one must be included in the grant application if the applicant is seeking more than $500,000 or more in direct costs in a single year (or $750,000 over an 18 month period).  The plan should be a brief paragraph to be placed immediately after the Research Plan Section so it does not count toward the application page limit. Additional information on data sharing might be included in other sections of the application, as appropriate. For example, if a large dataset that will become an important resource for the scientific community will be produced as a result of the proposed work, the applicant may wish to mention this fact in the significance section. If an applicant is requesting funds to prepare, document, and archive the data, he or she may want to include relevant information in the budget and budget justification sections. In the Human Subjects section of the application, applicants should discuss the potential risks to research participants posed by data sharing and steps that applicants will take to address those risks. http://grants.nih.gov/grants/policy/data_sharing/  

Model Organism Sharing Plan (does not count against page limit).  A plan, when applicable, should be included for sharing and distributing unique model organism research resources generated using NIH funding so that other researchers can benefit from these resources, OR state appropriate reasons for why such sharing is restricted or not possible. Unlike the NIH Data Sharing Policy, the submission of a model organism sharing plan is NOT subject to a cost threshold of $500,000 or more in direct costs in any one year, and is expected to be included in all applications where the development of model organisms is anticipated. (The NIH Final Statement on Data Sharing is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).

Applicants are also expected to address as part of the sharing plan if, or how, they will exercise their intellectual property rights while making model organisms and research resources available to the broader scientific community. At a minimum, the plan should address the following questions in a clear and concise manner:

Appendix Materials – No appendix is allowed for applications in response to this FOA.

Additional Instructions and Information

Intellectual Property

NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program.  To this end, the NIAID reminds the applicant that:

To the extent that the project will involve partners, applicants are encouraged to reach early consensus with their proposed partners regarding intellectual property and other legal matters that may arise during the project.  In addition, applicants are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goals of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit. Finally, applicants are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and web announcements. 

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID in accordance with the review criteria stated below.

As part of the initial merit review, applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PDs/PIs?  Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts? Does the product development plan define the potential ultimate product, proposed project goal, interim objectives (development goals), identify alternative approaches, and provide a timeline for goal attainment?  Does it focus on the further development and testing of the product in one of the above areas deemed responsive to this program?  Does the outline include a sound scientific rationale for the further development of the product?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

Applications will be reviewed on the basis of the scientific rationale and technical feasibility of the proposed project to develop medical countermeasures as described above, as well as the probability of technical success; the experience, expertise, and qualification of the project team; and the scientific environment and research facilities. Appropriateness in terms of the overall proposed project and stage of development, as well as the potential for further product development beyond that proposed in order to produce an FDA licensable radiation medical countermeasure, will also be assessed.

If applicable, the following items will also be considered in the determination of scientific merit and priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr, http://www.ott.nih.gov/policy/rt_guide_final.html), and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

If applicable, the adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II:  Terms and Conditions of NIH Grant Awards, Subpart A:  General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

Grantees must submit a final Financial Statement Report (FSR), final progress report, and Final Invention Statement and Certification within 90 days of the end of grant support. Failure to submit timely and accurate final reports may affect future funding to the organization or awards with the same PI. See NIH Grants Policy Statement http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Sharing Research Data:
If applicable, investigators submitting an NIH application are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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NIH Funding Opportunities and Notices


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