CREATE Devices: Mechanism & Budget Guidance

CREATE Devices: Mechanism & Budget Guidance

Mechanism

The CREATE Devices program supports projects through cooperative agreements using the UH2/UH3 and U44 mechanisms. Cooperative agreements are a type of grant mechanism that allows for more interaction than usual between the NIH and the awardee. In addition, NIH will have a significant role in the assessment of annual milestone performance. The UH2/UH3 and U44 mechanisms are phased cooperative agreements. All applications will start with either the UH2 or U44 Phase I and the length of the first phase will depend on the maturity of the project at entry. Only those UH2 or U44 Phase I projects that have met specific criteria will be eligible for transition to the second UH3 or U44 Phase II after NIH administrative review.

Budget Guidance

The amount of years and how much funding someone can request depends on the type of device application.

For the UH2/UH3, application budgets are not limited but must reflect the actual needs of the proposed project. For the pre-clinical UH2 phase an applicant should rarely exceed $1M direct cost per year for up to 3 years. For the UH3 phase an applicant should rarely exceed up to $1.5M direct cost per year for up to 4 years. The combined UH2/UH3 phase may not exceed 5 years.   Additional justification is needed for exceptions.

The SBIR U44 utilizes the congressionally mandated budget set-aside for small businesses. For SBIR, only Fast-track (combined Phase I and II) are accepted through the CREATE programs. There is no direct to Phase II option through the CREATE program and Phase I applications that are not part of a Fast-track application are not permitted. NIH has received a waiver from the Small Business Administration (SBA) to exceed the SBIR hard cap for specific topics such as the translational programs CREATE and BPN. Generally, NINDS will not fund SBIR Phase I applications through this program requesting more than $2M total funding support, with no more than $1M total cost in any year or project periods greater than 2 years. In addition, NINDS does not generally fund Phase II applications through this program requesting more than $4.5M total funding support, with no more than $1.5M total cost in any year, or project periods greater than 3 years. Applicants are strongly encouraged to contact program staff before submitting an application.