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  1. Orphan Products Clinical Trials Grants Program

Grant Award Next Steps

Pre-Funding/Post-Review:

What happens after the grant review is completed?

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.

Who will be my main contact within the Office of Orphan Products Development (OOPD) when I receive grant 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 protocol changes, 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.

After I receive grant funding, what can I expect as a grantee?

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. 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. There will be at least one grant evaluation with OOPD during the lifetime of your grant. OOPD should be contacted before any protocol changes are made (including Key Personnel and Performance Site changes). Publication of study results is encouraged.

Grant Oversight:

The program project officer will oversee grantees' activities periodically. The oversight may be in the form of telephone conversations, e-mails, or written correspondence between the project officer/grants management officer or specialist and the principal investigator. Information including, but not limited to, information regarding study progress, enrollment, problems, changes in protocol, and study oversight activities will be requested. OOPD may conduct grant evaluations to ensure extramural funded studies, which involve human subjects, are consistent with grant agreement terms and human subjects’ protection requirements.

What reports will be required once my grant is funded?

Quarterly Reports will be required typically every three months from the date the grant was issued. These reports should include an update on the overall progress of the study, monitoring of the study, and for “applicable clinical trials” and voluntarily registered trials an update on the ClinicalTrials.gov entry for the study. Additional information that should be reflected in these updates include but is not limited to enrollment, adverse events, changes in protocol, impact of the study, collaborations made, additional funding secured, publications, and presentations.

A Research Performance Progress Report (RPPR) is 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.

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