Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov).

Components of Participating Organizations
This Funding Opportunity Announcement (FOA) is developed as a NIH roadmap initiative (http://nihroadmap.nih.gov). All NIH Institutes and Centers participate in roadmap initiatives. This FOA will be administered by the National Institute of Neurological Disorders and Stroke (NINDS) on behalf of the NIH.

  
Title:  National Institutes of Health Rapid Access to Interventional Development (NIH-RAID Pilot) (X01)  

Announcement Type
New

Update: The following updates relating to this announacement have been issued:

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 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.

Program Announcement (PA) Number: PAR-07-358

Catalog of Federal Domestic Assistance Numbers
93.310

Key Dates
Release/Posted Date: April 19, 2007
Opening Date:  May 28, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Submission Date(s): May 28, 2007; August 14, 2007; December 15, 2007; April 15, 2008; August 15, 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 Submission Date(s): June 28, 2007; September 14, 2007; January 15, 2008; May 15, 2008, September 15, 2008  
Peer Review Date(s): 2 to 3 months following application receipt dates
Council Review Date(s): Not Applicable
Earliest Anticipated Start Date(s): 5 to 6 months following peer review dates   
Expiration Date: September 16, 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 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
         1. Letter of Intent
    B. Submitting an Application Electronically 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

Promising ideas for novel therapeutic interventions can sometimes encounter roadblocks in the pipeline for preclinical development.  Translation can be facilitated by alliances with corporate or other private sector partners, but high risk ideas or therapies for uncommon disorders frequently do not attract private-sector investment.  Where private-sector capacity is limited or not available, developmental resources provided by the federal government can bridge the gap between discovery and clinical testing so that more efficient translation of promising discoveries can occur.

The NIH Roadmap for Medical Research (http://nihroadmap.nih.gov/) has established a pilot program called the NIH-RAID Pilot (Rapid Access to Interventional Development; http://nihroadmap.nih.gov/raid/) to make available on a competitive basis certain critical resources needed for the development of new small molecule, oligonucleotide, and peptide therapeutic agents.  The NIH-RAID Pilot is intended to reduce some of the common barriers between laboratory discoveries and clinical trials of new therapeutic entities, and projects in both the early and late stages of preclinical development are suitable for NIH-RAID proposals.  Approved NIH-RAID projects are completed using resources of the National Cancer Institute’s (NCI) Developmental Therapeutics Program (http://dtp.nci.nih.gov/).

The NIH-RAID Pilot is not a grant program.  Successful projects gain access to government contract resources, and are assisted by the NIH in establishing and implementing a product development plan.  Projects are supported by the NIH Roadmap and individual Institutes and Centers within NIH.  Institutes and Centers may request the inclusion of specific project milestones as a requirement for co-sponsorship of NIH-RAID projects. 

Available Services

The services provided will depend upon the stage of the project and the strength of the preliminary data.  In some cases the NIH-RAID Pilot will support only one or two key steps for early stage preclinical development, while in other cases it may be possible to provide assistance with most of the development tasks needed to file an Investigational New Drug (IND) application to the Food and Drug Administration (FDA).  When the NIH-RAID Pilot does not provide all of the remaining services required for IND submission, it is expected that other resources will be in place to complete development steps not supported by NIH-RAID.  Available services include:

The NIH-RAID Pilot is not a complete drug development program or an unconditional commitment to develop a particular compound for the clinic.  Development will proceed sequentially, in a logical order, and the start of one segment of the process (e.g. toxicology) will depend on satisfactory completion of preceding tasks (e.g. formulation).  Insurmountable difficulties in one part of a project may result in the entire project being discontinued.

The NIH-RAID Pilot does not provide support for preparation of monoclonal antibodies, recombinant proteins, or gene therapy reagents, and does not provide either in vitro or in vivo efficacy testing. 

The NIH-RAID Pilot is not meant to support private-sector development projects in the absence of an academic partner, but academic investigators may have collaborations with for-profit partners.

The NIH-RAID Pilot does not provide materials for Phase II and III clinical trials.

Role of NIH Institutes and Centers

All NIH Institutes and Centers are participating in the funding of this Roadmap program.  The NIH-RAID Pilot projects are co-sponsored by the NIH Roadmap and one or more NIH Institutes and Centers.  Through this co-sponsorship appropriate resources and expertise are made available, and because the NIH-RAID Pilot fills gaps encountered during therapeutics development, but does not support the full developmental pipeline, partnership with a specific NIH Institute or Center may be important for subsequent translational efforts.  Applicants do not have to establish Institute or Center co-sponsorship prior to submitting a proposal, but may contact the NIH-RAID Pilot office or members of the Translational Research Cores Services Working Group to discuss possible Institute and Center co-sponsorship.  When preliminary work for a project has been supported by the NIH, applicants are encouraged to contact program staff of the Institute or Center that funded the preliminary work to discuss the suitability of the project for the NIH-RAID Pilot.  Several Institutes already support services like those provided by the NIH-RAID Pilot through other mechanisms, and have elected not to co-sponsor requests to this program in those areas.

Material Transfer

The output of NIH-RAID Pilot activities, both products and information, will be made fully available to the originating investigator institution (awardee institution), as appropriate, for support of additional studies, an IND application, or performance of clinical trials.  Data and products will be transferred to the applicant under the terms of a non-negotiable Material Transfer Agreement (MTA).

Drug product for clinical use will be delivered in a single shipment.  The NIH-RAID Pilot cannot distribute drug product in multiple shipments or on a per patient basis

Intellectual Property

It is expected that the originating investigator institution will have acquired or be in the process of acquiring appropriate intellectual property protection prior to application to the NIH-RAID Pilot.  All intellectual property relevant to the proposal should be fully described in the application.

As noted previously, most NIH-RAID Pilot tasks will be accomplished through the use of contracts in the NCI Developmental Therapeutics Program.  Normally, NCI will not acquire intellectual property rights to inventions made by its staff under the NIH-RAID Pilot, unless the originating investigator institution and NCI agree that to do so would be in the best interest of the project, consistent with NIH policies, law, and regulations.  If NCI does file a patent application, the originating investigator institution will be given the opportunity to negotiate for an exclusive license under procedures set forth in 37 CFR Part 404.

NCI contractors, under the Bayh-Dole Act, may elect to retain rights for a contribution they make that rises to the level of invention.  However, NCI contractors have, as a term of their funding agreements, agreed to offer a first option to the originating investigator institution for license negotiation.  Certain other contractors or subcontractors may be subject to a Determination of Exceptional Circumstances (DEC) through which their rights in subject inventions may be assigned to the originating investigator institution.

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

Section II. Award Information


1. Mechanism of Support

This FOA uses the NIH Resource Access (X01) award mechanism.  Investigators should not request funds.

Competing renewals are not applicable.

2. Funds Available

Through its funding of the NIH-RAID Pilot, NIH will support the costs of the requested tasks approved for completion.  Applications received in response to this FOA will not receive any additional funds.

The total number of X01s awarded will depend on the number of applications received, their relative scientific merit, and the availability of NIH Roadmap and Individual Institute and Center funds.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution/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 as the Project Director/Principal Investigator (PD/PI) 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.

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.

3. Other-Special Eligibility Criteria

Prior to peer review applications will be examined by NIH Program Staff to determine if they are responsive to this FOA.  Applications that are not responsive will be withdrawn from further consideration.

Applicants 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
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist 

Optional Components:
PHS398 Cover Letter File

2.A. General Instructions

Follow the instructions for completing the SF424 components found in the Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc) with the following special instructions below.

2.B. SF424 (R&R) Cover Component

This is a required component for any SF424 R&R-based application package. It contains all of the data elements found on the SF424 face page. This form has an advantage over the SF424 face page in that it explicitly recognizes and collects data (in block 15) regarding the principal investigator. Applications solicited under the X01 mechanism will receive standard validation for data consistency, with the following exceptions:

16. Estimated Project Funding. Enter zero for lines a, b and c. Since the X01 (Resource Access Award) results in the award of resources NOT funds, any non-zero value will be treated as an ERROR. No budget forms will be used in the X01 submission and applications are NOT expected to request specific funds or even estimate costs. A central function of NCI staff in the NIH-RAID Pilot Review Process will be to outline costs utilizing U.S. Government internal or external contract sources to achieve the desired goals.

2.C. SF424 Research & Related Other Project Information

6. Project Summary/Abstract. The Project Summary/Abstract ( i. e. “Description”) must state the application’s broad, long-term objectives and specific aims.

Attach Project Summary/ Abstract file in line 6, and the attachment must be a PDF format.

7. Project Narrative. Submit a clear statement of the tasks specifically being requested from the NIH-RAID Pilot.

9. Facilities & Other Resources. Not applicable. Do not include an attachment here.

10. Equipment. Not applicable. Do not include an attachment here.

2.D. Senior/Key Person Profile(s) Component

Provide a biographical sketch for the Senior/Key Person. Recommended information includes: Education and Training, Research and Professional Experience, Collaborators and Affiliations (for conflicts of interest), Publications and Synergistic Activities. Save the information in a single PDF file and attach by clicking Add Attachment. Biographical sketches should follow the format described below.

NIH and Other PHS Agencies Instructions for a Biographical Sketch

Use the sample format on the Biographical Sketch Format Page http://grants.nih.gov/grants/funding/424/SF424R-R_biosketch.doc to prepare this section for all grant applications. Include biographical sketches for all Senior/Key Personnel. The Biographical Sketch may not exceed four pages per person. This 4-page limit includes the table at the top of the first page.

If the individual is registered in the eRA Commons, include the assigned Commons User Name in the “Credential” field. For principal investigators, this data item is required.

2.E. PHS398 Cover Page Supplement

2. Human Subjects. Check “no” to both the Clinical Trial and Agency-Defined Phase III Clinical Trial questions.

2.F. PHS398 Research Plan
The following section contains the specific instructions for completing the research plan for this FOA. Page limitation for Research Plan: 25 pages single-spaced (excluding appendices).

This form allows the attachment of the various sections of the standard research plan. This form collects each major section separately so that bookmarks and table-of-contents can be automatically generated for each section, by the NIH software that downloads, validates, and generates a grant image using the data received from Grants.gov. The PHS 398 Research Plan includes:

2. Specific Aims: Provide a clear statement of the aims of the project, including the scientific rationale for use of the therapeutic agent under consideration and a description of the potential clinical application(s). The description of the critical preliminary data supporting the proposal should be detailed enough to permit peer review.

3. Background and Significance:

Background: Provide a brief summary of the field to allow appropriate understanding of the scientific and medical context from which the opportunity emerges.

Uniqueness: Discuss related or functionally similar molecules already under development, and why the NIH should undertake development in light of this.

Justification for NIH Investment: Address reasons why the project under consideration represents a particularly innovative or promising approach, and why public sector funds are needed to overcome translational barriers and meet needs not being met by private-sector support.

4. Preliminary Studies

In addition to describing the studies and data that support the proposed development tasks, applicants should present data that support the efficacy of the candidate therapeutic under development.

5. Research Design & Methods

Subsequent Development Plans: The investigator(s) should outline how they propose to approach the key steps in product development, including proposed milestones and decision points. For projects requesting either production of clinical lot and/or IND-directed toxicology, summarize briefly the plans for clinical testing, including methods to assess clinical efficacy. Include potential collaborators and institutional arrangements for oversight and IRB review.

Additional Support: a clear statement by the applicant of all current, anticipated, and hoped for sources of support for the project. This includes a summary of the status of past, planned, or ongoing negotiations with companies related to licensure or future development of the product. This section should also include information on any peer-reviewed grants and/or grant applications pertaining to the project. The applicant should be sure to indicate how NIH-RAID support would complement, not duplicate, other sources of support.

13. Letter of Commitment: All investigators requesting production of clinical lot and/or IND-directed toxicology should provide a letter of commitment from an academic institution prepared to provide a venue for clinical testing and oversight of human subjects protections in the early phase clinical testing. Individual NIH Institutes and Center may request documentation and specific details regarding the proposed clinical testing and the oversight of human subjects protections. The letter is intended to assure the reviewers and NIH that the products and data produced by the NIH-RAID Pilot have a clinical outlet, and as such the letter should indicate that the institution is committed to the filing of an IND and conduct of a clinical trial once the NIH-RAID Pilot activities are completed. In cases where IND-directed toxicology is requested, but no commitment for clinical testing has been obtained, the letter should indicate that the institution is committed to the filing of an IND and describe plans to identify and confirm a commitment for clinical testing.

14. Resource Sharing plan: No Resource Sharing Plan is required.

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 PHS398 Research Plan component), must be included. The governance and organizational structure of the research project should be described, including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, 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, including responsibilities for human subjects or animal studies as appropriate.

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.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: May 28, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Submission Date(s): May 28, 2007; August 14, 2007; December 15, 2007; April 15, 2008; August 15, 2008
Application Submission Date(s): June 28, 2007; September 14, 2007; January 15, 2008; May 15, 2008, September 15, 2008
Peer Review Date(s): 2 to 3 months following application receipt dates
Council Review Date(s): Not Applicable
Earliest Anticipated Start Date(s): 5 to 6 months following peer review dates

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 in Section IV.3.A.

The letter of intent should be sent to:

Tony Jackson
NIH-RAID Pilot Program Office
6001 Executive Boulevard, Room 2141
Bethesda, MD 20892
Telephone: (301) 594-4660
Email: nih-raid@mail.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. 

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. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. 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 FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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.

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. 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 “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

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 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.

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.

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Note: While each section of the PHS398 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 monitor better 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.

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

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

Not applicable.

Section V. Application Review Information


1. Criteria 

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

2. Review and Selection Process

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

As part of the initial merit review, all applications will:

Applications submitted in response to this funding opportunity will compete for available resources with all other recommended applications. The following will be considered in making funding decisions:

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 developmental tasks 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? 

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 PD/PIs and other key personnel 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 PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the applicant works 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?

The following special review criteria will be used in the evaluation of scientific merit.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

2.B. Additional Review Considerations

Applications from Foreign Organizations: Whether the project presents 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 will be assessed.

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

Not applicable.

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

Following peer review the PD/PI who submitted the proposal may be notified by NIH staff that the project will be considered for access to NIH-RAID Pilot resources.  If notified, the PD/PI will be invited to present a seminar on the compound and discuss the conditions of the award with NIH staff.  After the seminar, the PD/PI will receive final notification of the status of the application.

2. Administrative and National Policy Requirements

Not applicable.

3. Reporting

Not applicable.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research, and peer review:

1. Scientific/Research Contacts:

Tony Jackson
NIH-RAID Pilot Program Office
6001 Executive Boulevard, Room 2141
Bethesda, MD 20892
Telephone: (301) 594-4660
Email: nih-raid@mail.nih.gov

2. Peer Review Contacts:

George Chacko, Ph.D.
Chief, Bioengineering Sciences and Technologies IRG
Center for Scientific Review
6701 Rockledge Drive, Room 5170
Bethesda, MD 20892
Telephone: (301) 480-1245
Fax: (301) 480-1988
Email: gc141x@nih.gov

3. Financial or Grants Management Contacts:

Not applicable.

Section VIII. Other Information


Required Federal Citations

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.

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.

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.

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 Part 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 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.


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