The National Eye Institute (NEI) Offers SBIR/STTR Regulatory Assistance Program to Phase I and II Grantees


Notice Number: NOT-EY-12-001

Key Dates

Release Date:  January 23, 2012

Issued by

National Eye Institute (NEI)

Purpose

NEI announces the initiation of a pilot Regulatory Assistance Program for its active SBIR and STTR Phase I and II grantees.  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 marketplace.  Both therapeutics and medical devices are eligible.

The program will provide companies with up to 30 hours of regulatory consultant time in the therapeutics and medical device areas.  Consultant services will assist the selected companies in developing a comprehensive regulatory plan aimed at optimizing each company's passage through the Food and Drug Administration (FDA) approval process.  This plan will assist in identifying the company's goals for its product, the appropriate regulatory path, and a likely regulatory strategy.  The consultation will assess the likelihood for success of the chosen regulatory strategy and provide a follow up schedule and progress review.

An application form may be found at http://www.nei.nih.gov/funding.  Completed applications should be emailed to wujekjer@nei.nih.gov and will be accepted any time through Monday, March 5, 2012.  All submitted applications will undergo an administrative review and applicants will be notified of the outcome by April 2, 2012.

Inquiries

Please direct all inquiries to:

JEROME R. WUJEK, GROUP LEADER, SMALL BUSINESS INNOVATIVE RESEARCH PROGRAM
NATIONAL EYE INSTITUTE
1300/5635 FISHERS LANE
BETHESDA, MD 20892-9300
TELEPHONE:  301-451-2020
FAX:  301-402-0528
EMAIL:  wujekjer@mail.nih.gov
WEBSITE: www.nei.nih.gov/funding


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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