The National Eye Institute (NEI) of the National Institutes of Health (NIH) has a requirement for design and conduct pre-clinical toxicity studies to support an IND filing for a phase 1 clinical study in humans. The investigational product consists of an iPSC differentiated RPE monolayer grown on a biodegradable scaffold and needs to be administered in the subretinal space of the eye of RNU rats. This is a Small Business SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), Veteran-owned Small Business, Service-disabled Veteran-owned Small Business, HUBZone Small Business, Small Disadvantaged Business, and Woman-owned Small Business) to design and conduct pre-clinical toxicity studies to support an IND filing for a phase 1 clinical study in humans. The anticipated period of performance is June 12, 2015 through June 11, 2018. The anticipated contract will comprise one (1), one-year base period and two (2), one-year option periods which may be exercised unilaterally by the Government for a potential period of performance of 36 months. This is not a request for proposals, proposal abstracts, or quotations and does not commit the Government to any contractual agreement. Interested organizations that believe they possess the capabilities necessary to undertake this project should electronically submit (email) capability statements tailored to be responsive to the requirement described above. Capability statements shall be in PDF format. The contents of the capability statement shall be limited to twenty (20), 8.5x11 size pages with no less than 11 font Arial characters, no less than one inch margins and no less than single spaced. Capability statements exceeding the page limitation will not be considered. Capability statements should be submitted to kutal@od.nih.gov no later than Monday, March 19, 2015, 4:00 P.M., EST. Respondents will not be notified of the results of the evaluation. Information received will be considered solely for the purpose of determining whether sufficient small businesses possess the experience, expertise, and qualifications to ensure competition under a set-aside acquisition. A determination by the Government not to compete this requirement as a set-aside based upon responses to this notice is solely within the discretion of the Government. The NAICS code for this effort is considered to be 541990 -- Professional, Scientific, and Technical Services, All Other Professional, Scientific, and Technical Services. Draft Statement of Work is attached.
