A -- HIV Microbicide Design and Development Teams

THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON RESPONSES RECEIVED FROM THIS SOURCES SOUGHT, THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE, NAICS CODE 541710, WITH A SIZE STANDARD OF 500 EMPLOYEES. The discovery, development, and evaluation of promising HIV microbicides is a high priority for the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). To augment the microbicide product pipeline, we are seeking opportunities to advance microbicide concepts toward the product stage via a focused, product development-based approach. Specifically, the long-range goal of this solicitation is the development of new safe and effective microbicide candidates that merit further evaluation in large human trials. The HIV Microbicide Design and Development Teams (HMDDT) solicitation seeks to fund consortia of scientists with product development experience from industry and/or academia that have 1) identified a promising microbicide concept, and 2) devised a plan for its targeted development into a product testable in humans. A microbicide product is defined here to be a material and its manner of administration that could reasonably provide protection against the sexual transmission of HIV safely, even when used repeatedly. The expectation is that the Teams advance their microbicide concepts along a well-defined development path in a timely manner to a microbicide product and into clinical testing within the five-year period of the award. Offerors are encouraged, but not required to conduct phase I/II trials in collaboration with the NIH/NIAID/DAIDS-supported HIV Prevention Trials Network (the HPTN; http://www.hptn.org). Support for Phase III studies will not be funded under this solicitation. Because the goal of this effort is the development of microbicide products, each Team will be required to demonstrate proven scientific and development expertise, and provide a comprehensive plan that lays out clearly defined objectives and milestones for the project's duration. Because the design and development path for any microbicide product cannot be entirely anticipated, the Team must articulate its vision of how new scientific findings will be integrated into the proposed goals and milestones. Offerors will be required to articulate and implement a strategic research plan that includes: (a) key development objectives and a detailed work plan describing proposed time schedules for achieving contract objectives and milestones, and maintaining quality control over the implementation and operation of the contract, (b) how decisions to proceed or not proceed will be made (i.e. specific qualitative and quantitative criteria for product advancement through each stage of preclinical, including IND-enabling, development and Phase I/II safety evaluations), (c) plans for GMP microbicide lot production and packaging, and (d) obtaining the necessary regulatory and human subjects approvals to proceed. This strategic plan shall articulate how the Team will efficiently allocate and utilize the resources, and redirect the focus (including reallocation of funds) depending upon the project's changing needs and emerging new knowledge. It shall, also, articulate how patent coverage and licensing of the resulting HIV microbicide will be obtained and the procedures to be followed for the resolution of potential legal issues that may arise. Interested small business organizations that believe they possess the capabilities necessary to undertake this project should submit two (2) copies of their capability statement addressing the areas above, to be received no later than 3:30 PM local time on February 2, 2004, to the attention of Anita Hughes at the address listed above. See Government-wide Numbered Note 22. NO COLLECT CALLS WILL BE ACCEPTED. FACSIMILE AND E-MAIL TRANSMISSIONS WILL BE ACCEPTED. Point of Contact Anita Hughes, Contract Specialist, Phone 301-451-3694, Fax 301-480-5253, Email anhughes@niaid.nih.gov; Sharon Kraft, Contracting Officer, Phone 301-496-0195, Fax 301-402-0972, Email skraft@niaid.nih.gov