PRINT Frequently Asked Questions
To help provide timely information about all aspects of the program, this page is updated periodically in response to questions from potential performers. For full information about PRINT and the application process, please see the solicitation on SAM.gov.
GMP grade cell manufacturing and biobanking is a key milestone in TA2 Phase II to demonstrate the capability of GMP manufacturing and translatability of these cell protocols. The expectation is to produce at least enough cells at GMP grade for one large animal transplant using your respective solution. However, GLP grade cells and materials are acceptable to be used in both small and large animal studies in the PRINT program as GLP grade animal testing is required for these to be IND-enabling studies.
The PRINT team was initially looking to include ARMI | BioFabUSA as an independent verification & validation (IV&V) partner for the PRINT program, which would have prevented them from working as a collaborator on proposal submissions. We have since eliminated the use of IV&V from the PRINT program, to allow proposers the freedom to select sub proposers of their choosing (which may now include ARMI | BioFabUSA) and also given that independent IV&V is not necessary for the next transition steps. Rather we will be focusing our efforts on earlier FDA engagement to ensure alignment for successful future transition.
IRB approval does not need to be in place at the time of application submission. If at the time of award, the IRB is not in place, the award will be made with restrictions that will be lifted once IRB is approved.
Please find the link here: Vertebrate Animals Section | OLAW (nih.gov)
Due to accessibility issues with humanized large animal models, the phase II large animal requirement has been revised from using humanized large animals to severe combined immunodeficiency (SCID) pigs or equivalent.
For budgeting purposes, we estimate the start date will be Q2F2025 (JAN-MAR), however based on contract negotiations this estimate may be subject to change.
The SF-424A form can be found on the Grants.gov website under Forms.
The location of annual meetings has not yet been determined, but the proposal should include costs for one annual meeting per year. Location in DC is fine for the estimate.