August 21, 2023
- August 20, 2021 - Blueprint MedTech: Incubator Hubs (U54 Clinical Trial Not Allowed). See PAR-21-314.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
The notice updates allowable costs for the Innovator Core in the Blueprint MedTech: Incubator Hubs (U54 Clinical Trial Not Allowed) NOFO, PAR-21-314, to include Participant Support Costs, effective immediately.
Current Language:
Budget (Innovator Core)
Budget forms appropriate for the specific component will be included in the application package.
The budget should include a detailed justification for key personnel under this core. The person months for each member of the center staff related to this core should be included here. It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100%.
Include costs to administratively manage innovator subprojects. Include costs for any consultant or subcontractor directly supporting this core's activities (e.g., subject matter expert, project manager, information services, site visits).
Include costs for innovator subprojects to attend three quarterly meetings with the center and to attend the annual Blueprint MedTech consortium meeting.
As this core is expected to scale up and down over the course of the period of performance, based on available funding and approved subprojects, application budgets should assume a base level of activity needed to support three innovator subprojects per year. Describe in the justification how the core's budget would increase with each additional subproject.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Modified to read (changes are shown in bold italics):
Budget (Innovator Core)
Budget forms appropriate for the specific component will be included in the application package.
The budget should include a detailed justification for key personnel under this core. The person months for each member of the center staff related to this core should be included here. It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100%.
Include costs to administratively manage innovator subprojects. Include costs for any consultant or subcontractor directly supporting this core's activities (e.g., subject matter expert, project manager, information services, site visits).
Include costs for innovator subprojects to attend three quarterly meetings with the center and to attend the annual Blueprint MedTech consortium meeting.
As this core is expected to scale up and down over the course of the period of performance, based on available funding and approved subprojects, application budgets should assume a base level of activity needed to support three innovator subprojects per year. Describe in the justification how the core's budget would increase with each additional subproject.
Participant Support Costs will be considered for innovator subprojects that do not involve human subjects research or vertebrate animal research. The scope of such innovator subprojects is purely to receive mentoring and training from the incubator hubs on topics including, but not limited to, commercialization support, business model development, regulatory strategy, and reimbursement strategy. Only those participant costs directly related to these activities may be charged to the grant. Up to $50,000 direct cost per innovator subproject (inclusive of travel) is allowed for expenses that occur during the period of participation. Costs for material, supplies, food or beverages, or equipment are unallowable. Allowable participant costs are limited to:
- Included in this up to $50,000 direct costs, round-trip travel may be requested for no more than two meetings hosted by the incubator hubs for non-local participants.
- Stipends for participants
- Tuition cost, if applicable
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
All other aspects of the FOA (PAR-21-314) remain the same.
Michael B. Wolfson, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: Blueprint-MedTech@nih.gov
and Human Services (HHS)
