Revised Requirements for the Completion of NIH-RAID Applications Using the Restructured Electronic SF 424 (R&R) Application Package

Notice Number: NOT-RM-10-008

Update: The following update relating to this announcement has been issued:

Key Dates
Release Date:  May 7, 2010

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Purpose

This Notice revises specific sections of PAR-09-027 to match the restructured electronic SF 424 (R&R) application package.

SF424 (R&R) Cover Component

12. Proposed Project. These dates will be determined by the duration of the tasks approved by the NIH. A general suggestion for the start and ending dates are 10 months and 3 years from the application’s submission respectively.

15. Estimated Project Funding. Enter zero for lines a through d. Because the X01 (Resource Access Award) results in the award of access to resources not funds, any non-zero value will be treated as an ERROR. Budget forms will not be used in the X01 submission and applicants are not expected to request specific funds or even estimate costs.

SF424 Research & Related Other Project Information

1. Are Human Subjects Involved? Check “no”.

2. Are Vertebrate Animals Used? Check “no”.

5. Is the research performance site designated, or eligible to be designated, as a historic place? Check “no”.

7. Project Summary/Abstract. The Project Summary/Abstract must state the application’s broad, long-term objectives and specific aims. The abstract should state explicitly which services are being requested from the NIH-RAID program.

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

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

12. Other Attachments.  Investigators requesting the production of a clinical lot 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 eventual clinical testing. Individual NIH Institutes and Centers 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 program 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 NIH-RAID 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. Letters of support are not requested from investigators who plan to employ a contract research organization to conduct the clinical trial.

PHS398 Research Plan Component Sections

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 additional requirements:

The PHS 398 Research Plan includes:

2. Specific Aims. Provide a clear statement of the tasks that are proposed for completion by NIH-RAID contractors. Include the scientific rationale for studying 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. Research Strategy. This section should cover three areas.

a. Significance. Provide a brief summary of the field that allows appropriate understanding of the scientific and medical context from which the opportunity emerges.  Address why public sector funds are needed to overcome translational barriers and meet needs not being met by private-sector support.

b. Innovation. Explain why the project under consideration represents a particularly innovative or promising approach. Discuss related or functionally similar molecules already under development, and why the NIH should undertake development in light of this.

c. Approach. In the approach sub-section the application should include:

Preliminary data: Describe the studies and data that support the proposed development tasks. Applicants should present data that support the efficacy of the therapeutic agent under development.

Subsequent development plans: Applicants are not required to outline an approach to the studies that will be supported by NIH-RAID, but may if they prefer. Prior to project approval, drug development experts at the NIH will prepare a preclinical plan that includes proposed milestones and decision points, if a plan is not included in the application. For projects requesting one or more NIH-RAID services, but not all of the services needed to prepare an IND application, applicants should outline in their approach the key steps in product development which would not be supported by NIH-RAID, including proposed milestones and decision points. For projects requesting either production of clinical lot or IND-directed toxicology, applicants should 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: State 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.

15. Resource Sharing plan. No Resource Sharing Plan is required.

Inquiries

Interested parties may contact:

Tony Jackson
NIH-RAID Program
6001 Executive Boulevard, Room 2141, MD 20892

EXPRESS/COURIER:  Bethesda Rockville, MD 20852

Phone: (301) 594-4660
Email:  nih-raid@mail.nih.gov


Weekly TOC for this Announcement
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