How to Contact Us
NIH-RAID Pilot Program Office
Room 2141
6001 Executive Blvd
Bethesda, MD 20892
Telephone (301) 594-4660
nih-raid@mail.nih.gov
Overview of Application and Approval Process
The NIH-RAID Pilot receives proposals three times per year (see
Critical Dates )
Once an application is received, it is reviewed for
responsiveness. If an application is deemed non-responsive, or it requests
services not available through the NIH-RAID Pilot, it may be declined without
review.
Within three months of the submission deadline, responsive
applications will be reviewed by a Special Emphasis Panel formed by the
NIH
Center
for Scientific Review (CSR). This panel will be comprised of external experts
in drug development and supplemented with ad hoc reviewers with expertise in
relevant science and disease areas.
After review, the applicants and Institutes and Centers (ICs)
are provided with review scores and summaries. At this point an IC may decline
an application or invite the applicant and his colleagues to present an
investigator seminar on the project. This seminar will allow the investigator
to update the NIH on the status of the project, respond to inquiries, and
discuss the plan for the future of the project. Cost assessments will be
developed internally based upon the results of the discussion.
Institutes will base their decision about co-sponsorship on
the seminar (if applicable), the review score and summary, and their assessment
of the need for public sector support in the topic area. All Institutes plan to
give priority to projects where they consider there to be a particular need for
NIH resources to overcome translational barriers, for example, for disorders
that do not attract extensive private sector research.
Applicants are encouraged to contact members of the
NIH-RAID Pilot Working Group to gauge IC interest in funding potential
projects. An applicant can submit a total of two resubmissions. After three
unsuccessful attempts, subsequent requests focusing on the same product will be
declined without review. Resubmitted proposals must include a response to
reviewer critiques of the previous proposal.
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Application Components
Please refer to the
Funding Opportunity Announcement for details regarding application
components and review criteria.
When submitting the application, investigators are encouraged to email to
nih-raid@mail.nih.gov a completed Technology
Transfer Form and Small
Molecule Questionnaire While these are not required at the time of
submission, these supplemental documents will be requested after review for
decision making purposes.
The Technology Transfer form is to be signed by an authorized
staff member overseeing intellectual property and/or technology transfer for
the affiliated institution. This form verifies that they have reviewed the
NIH-RAID request and that the technology is (or is not) eligible for
consideration by the NIH-RAID program. If the technology is found not to be
eligible for use in the NIH-RAID proposal, and is central to the investigator's
proposal, application to the NIH-RAID program is not encouraged.
The purpose of the Small Molecule Questionnaire is to obtain
information on the project relative to the current status of preclinical
development and future requirements for the compound of interest. The
information is used by the NIH to estimate drug requirements and project costs
plus identify potential development issues and avoid duplication of effort. The
questionnaire is to be filled out as completely as permitted by the available
information. Sections that do not
apply to the project should be marked with N/A (information not available or
applicable).
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Implementation and Oversight
The NIH-RAID Pilot uses the NIH Resource Access (X01) award
mechanism.
Through its funding of the NIH-RAID Pilot, NIH will support
the costs of the requested tasks approved for completion. Investigators should
not request nor will they receive any funds. Applications that are selected
will receive access to U.S. Government contract resources. A central function
of NCI staff in the NIH-RAID Pilot review process will be to outline costs
utilizing these internal or external contract sources to achieve the desired
goals.
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 IC funds.
Once a project has been approved, NIH staff from both the
co-sponsoring Institute and the NCI will interact directly with the Project
Leader in development of a plan for overall conduct of the project, a timeline,
and milestones. NCI contractors perform the NIH-RAID Pilot-approved tasks under
the direction of NIH staff. In the event of licensure to a for-profit entity,
the licensee will be welcome to participate in project meetings with the
permission of the Project Leader, but the NIH will at all times consider the
Project Leader the main point of contact for the project.
In the event that a NIH-RAID Pilot project is overrunning its
projected budget or unanticipated problems in implementation are encountered, a
status review group can be impaneled by the co-sponsoring Institute to
re-evaluate the project. The investigator and NCI staff will present progress
to date in a face-to-face forum to three to five extramural scientists
knowledgeable in the area. Following the presentations, the review group will
meet in closed session and determine whether NIH-RAID Pilot efforts should
continue with new project milestones or the project should be concluded.
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