All responsive applications will be issued scores and summary statements following the review of the applications. If your grant application received a favorable/competitive score you will be sent a cover memo and a Pre-Funding Certification Form (PCF) along with a copy of the Summary Statement. You will be required to complete and return the PCF and accompanying information (including your responses to the Summary Statement critiques, the current IRB approval letter, Federal Wide Assurance documentation, verification of product availability, etc.) by the date specified in the cover memo. This is not a guarantee that you will receive funding.
If you receive grant funding, you will receive a formal Notice of Grant Award. Your grant will be assigned an OOPD grant Project Officer (PO) who will be your main contact. You will be required to keep the PO informed throughout the grant of any issues and changes including request for approval of protocol changes by OOPD and the appropriate FDA Review Division under which the IND or IDE for the study is held, adverse events, changes in key study personnel, etc. If you have any questions or concerns about the grant or the study, you may contact the PO for assistance. Additionally, if you experience any difficulties in patient enrollment, OOPD may be able to assist or suggest options.
You will receive a congratulatory letter from the PO outlining your roles, responsibilities, and requirements as a grantee. You will be required to follow and be in compliance with Good Clinical Practices and Current Good Manufacturing Practices. You will be required to maintain regulatory requirements such as IRB approvals, up to date FWA, IND requirements including submission of IND annual reports (as applicable) and appropriate adverse event reporting, up to date clinicaltrials.gov information (for applicable or voluntarily registered trials), etc.
The program project officer will oversee grantees' activities periodically through telephone conversations, e-mails, or written correspondences. To assist in monitoring your grant, your PO will establish enrollment and progress goals for each funding year with you upon initial funding. You will also be required to submit Quarterly Reports and Annual Reports to OOPD to update OOPD on information such as study progress, enrollment, problems, changes in protocol, and study oversight activities. There will be at least one grant evaluation with OOPD during the lifetime of your grant to ensure extramural funded studies, which involve human subjects, are consistent with grant agreement terms and human subjects’ protection requirements. To ensure that funded studies support the long-term goal of product approval, regulatory milestone meetings will be initiated as needed. OOPD should be contacted before any protocol changes are made (including Key Personnel and Performance Site changes). Publication of study results is encouraged.
In addition, OOPD may hold periodic interactive webinars as part of the Orphan Grantees Unite Initiative to connect Clinical Trial and Natural History grantees and provide a forum to share useful information.
Quarterly Reports will be required typically every three months from the date the grant was issued. Information including, but not limited to, information regarding study progress, enrollment, problems, adverse events, changes in protocol, study monitoring activities, new collaborations, publications, financial and data leveraging, and changes in clinical guidelines based on the project will be requested. OOPD may request information related to the impact of this study on future approvals and other outcomes such as publications or data leveraging. For “applicable clinical trials” and voluntarily registered trials, updates on the ClinicalTrials.gov entry for the study will be requested.
Research Performance Progress Reports (RPPR) are required yearly for grants more than 1 year in length. These reports will include items such as progress made, budget information, updates on any revisions made, accomplishments, future goals, publications/presentations resulting from the award, and personnel updates.
A Final Report will be due within 90 days after the end date of the project period. Items that are needed include a Final Financial Status Report, Final Invention Statement Certification, and Final Performance/Progress report.