|
How to Contact Us
NIH-RAID 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 accepts applications 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, it may be declined without
review.
Within four 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 Project Team
to gauge IC interest in funding potential projects. An applicant can submit one resubmission. After two
unsuccessful attempts, subsequent applications focusing on the same product will be declined without review.
Resubmitted proposals must include a response to reviewer critiques of the previous proposal.
 Up
to Top
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).
Up
to Top
Implementation and Oversight
The NIH-RAID program uses the NIH Resource Access (X01) award mechanism.
Through its funding of NIH-RAID, 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 NIH staff in the NIH-RAID 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 or NHLBI will interact directly with the principal investigator in development of a plan for overall conduct of the project, a timeline, and milestones. NCI and NHLBI contractors perform the tasks approved by the NIH-RAID program 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 principal investigator , but the NIH will at all times consider the principal investigator 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.
Up
to Top
|