New NEI Regulatory Assistance Program for SBIR and STTR Awardees

NEI is initiating a pilot Regulatory Assistance Program for its active SBIR and STTR Phase I and Phase II awardees. This program is designed to help grantees navigate the Federal regulatory pathway and to assist their companies in bringing innovative vision and eye care products to the market place. Both therapeutics and medical devices are eligible products.

The program will provide companies with up to 30 hours of regulatory consultant time, provided by Regulatory Affairs Associates (RAA). Selected companies will work with RAA in developing a comprehensive regulatory plan aimed at optimizing passage through the Food and Drug Administration (FDA) approval process.

This collaborative effort between the company and RAA will address and clarify the following points:

1. Identification of the company's goals for its product: Based on discussion with the company, what are the expected product, its intended use, and indication for use?
2. Identification of the regulatory path: Based on the company's goals, what specific regulatory path should be taken?
3. Development of regulatory strategy: What regulatory hurdles is the company likely to face given its product, the regulatory path and the company's current approach to navigating the regulatory landscape? What are RAA's recommendations--i.e. what specific protocols, experiments and other measures should the company implement to streamline and expedite the regulatory process (e.g. choice of species for toxicology studies, use of Good Manufacturing Practice (GMP) versus non-GMP material, etc.)?
4. Assessment of the success of the chosen regulatory strategy: What metrics will RAA and the company use to assess whether or not RAA's recommendations--i.e. specific experiments or the adoption of specific protocols and measures--are helping the company move towards achieving its regulatory goal under the phase II SBIR award (e.g. submission of IND)?
5. Follow-up schedule and progress review: Based on the activities above (1-4), RAA and the company shall establish a schedule to report the awardee's progress towards its regulatory goal(s), as well as any problems encountered. Specific questions that need to be mutually determined are: How often will the company keep RAA apprised of its progress? How will the company communicate with RAA (e.g. conference call; face-to-face meeting; e-mail)?

The consulting process will have three steps:

A) Initial Meeting (Not to exceed 12 hours per company): Within 3 months of the selection of awardees, RAA shall have an initial meeting with each of the selected companies to discuss and evaluate each company's project and overall goals within the context of regulatory approval. In order to facilitate a productive meeting, RAA shall request that all necessary documentation be provided by the awardee, including but not limited to preclinical data and the company's long-term goals and exit strategy. All information will be held confidential by RAA.

B) Development of a Regulatory Plan (Not to exceed 10 hours per company): Based on the findings and decisions of the initial meeting, including the company's goal for its product and the identification of the appropriate regulatory path, RAA shall provide guidance to the company for developing an optimal research and development plan (i.e. the regulatory plan) that will enable the company to achieve its regulatory goal. This process is expected to be iterative and involve the development of draft versions by the company, which are subsequently reviewed by RAA and refined until a final version is obtained. The finalized version of the regulatory plan shall serve as the roadmap to be followed by the company for achieving its regulatory objective. The final regulatory plan is expected to be completed within 6 weeks of the initial meeting.

C) Follow-up and Progress Review (Not to exceed 8 hours per company): After the finalization of the regulatory plan and initiation of the activities prescribed therein, RAA shall receive regular updates on the progress of the company based on the reporting schedule agreed to during the initial meeting). The reporting should be of such a nature to allow RAA and NEI to accurately assess the company's progress toward its regulatory goal.

NEI SBIR/STTR Regulatory Assistance Program Application Form (PDF*)

Last Reviewed: December 2011