Development, Statistical Design, Monitoring and Coordination of Vision Clinical Trials and Epidemiology Research

The National Eye Institute (NEI), National Institutes of Health (NIH), has a requirement for the development, statistical design, monitoring and coordination of vision clinical trials and epidemiology research. This is a Sources Sought Notice is 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 assist in the development, design, interpretation, and evaluation of clinical trails, epidemiologic and natural history studies and outcomes research involving eye diseases and visual disorders. This requirement shall include: 1) protocol navigation; 2) development of manuals of procedure, study forms and procedures; 3) data collection and storage; 4) study monitoring and communications; 5) data management and maintenance; 6) data analysis; 7) data reporting; 8) management and quality control; 9) reporting requirements; and 10) preclinical testing. This requirement also includes other types of support. The draft Statement of Work is posted herein. The anticipated period of performance is November 1, 2016 through October 31, 2017. The anticipated contract will comprise one (1), one-year base period and four (4), one-year option periods each of which may be exercised unilaterally by the Government for a potential total period of performance of 60 months (November 1, 2016 - October 31, 2021). 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 (email) submit capability statements tailored to be responsive to the tasks described in this announcement. Capability statements shall be in PDF format. The contents of the capability statements shall be limited to sixteen (16), 8.5x11 size pages with no less than 10 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 Thursday, December 17, 2015, 3:00 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 North American Classification System (NAICS) Code is 541712.