Notice of Special Interest (NOSI): NCI SBIR Administrative Supplements to Encourage the Participation of SBIR/STTR Awardees in the Early Payor Feedback Program at the Center for Devices and Radiological Health (CDRH)

Notice Number: NOT-CA-24-050

First Available Due Date: Monday, July 01, 2024
Expiration Date: Tuesday, June 30, 2026

 

Companies are strongly encouraged to discuss your Supplement request in advance with your Program Director. 

This administrative supplement opportunity is designed to provide financial support to medical device small businesses interested in participating in the Early Payor Feedback Program during the Q-submission meeting with the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). 

The Early Payor Feedback Program is a voluntary program that offers a unique platform for medical device manufacturers to interact with payor organizations early in the product development process to obtain payor input on pivotal clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. These interactions with payor organizations can occur during the Q-submission meeting with the FDA or in an independent meeting. By engaging with the FDA and payor organizations earlier in the product development process, medical device manufacturers can design their pivotal clinical trials to capture data that meets both regulatory and reimbursement requirements. This approach can significantly improve the chances of obtaining regulatory and reimbursement approvals efficiently, ultimately enabling patients to access safe, innovative, and effective medical devices.

For more information on the Early Payor Feedback Program and the list of payor organizations participating in the program, please visit: https://www.fda.gov/about-fda/cdrh-innovation/medical-device-coverage-initiatives-connecting-payors-payor-communication-task-force

Application and Submission Information

Applications to this NOSI can be submitted on a rolling basis using the following funding opportunity. 

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) 

Eligibility: Grantees with active NCI SBIR or STTR Phase II awards for developing technologies regulated by CDRH are eligible to apply. 

Budget: Applicants may request up to $50,000. The funds can be used to obtain support from Contract Research Organizations or regulatory or reimbursement consultants to prepare the documentation needed to support a Q-submission meeting request with the FDA and payors.

Evaluation: NCI SBIR Program staff will evaluate applications and consider whether the budget and the requested support period are fully justified and reasonable in relation to the proposed work. 

Preference will be given to applications where a Q-submission meeting with FDA/CDRH was proposed in the parent grant award. 

For more information about this funding opportunity, please contact swamy.tripurani@mail.nih.gov or loux@mail.nih.gov