A--Topical Microbicide Safety and Efficacy Evaluation in Nonhuman Primates

The Division of Microbiology and Infectious Diseases (DMID), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services is providing notice of the recompetition of contract N01-AI-95388. This current contract it titled, - Sexually Transmitted Diseases Prevention - Primate Unit. In this recompetition, the NIAID looks to further the development of topical microbicides aimed at the prevention and control of sexually transmitted infections (STIs) through pre-clinical testing in nonhuman primates. Also, the contract will expand to include testing for topical microbicide efficacy against Trichomonas vaginalis, SIV/SHIV, and other sexually-transmitted infectious organisms as new animal models are developed and validated. This contract will aid the development of candidate topical microbicides and prepare them for clinical trials and eventual licensesure by the Food and Drug Administration (FDA).The nonhuman primate animal models for STIs and Simian Immunodeficiency Virus/Simian-Human Immunodeficiency Virus (SIV/SHIV) infection represent a valuable paradigm for studying infection and disease, prevention strategies, and therapeutic interventions. This crucial, but limited, nonhuman primate model resource is reserved for: (1) studies that cannot be addressed in small animal models (parameters not feasible in small animals for prevention of sexual transmission); (2) topical microbicides or therapeutic prevention approaches where "proof of concept" in a primate model would provide critical information to stimulate further development and evaluation in clinical trials; and/or (3) testing of candidates that have proven most promising in small animal models, or candidates in an advanced stage of development that require further evaluation. Safety and efficacy evaluation in nonhuman primates of topical microbicides represents one step in the product development pipeline. DMID and the NIAID Division of AIDS (DAIDS) support an integrated product development program with the goal of developing topical microbicides for the prevention of HIV and STIs. Additional information on NIAIDs topical microbicide development program is provided in the following links: NIAID Topical Microbicide Strategic Plan - http://www.niaid.nih.gov/publications/topical_microplan.pdf; DMID/STI website - http://www.niaid.nih.gov/dmid/stds/; INTEGRATED PRECLINICAL/CLINICAL PROGRAM FOR TOPICAL MICROBICIDES - http://grants2.nih.gov/grants/guide/pa-files/PAR-03-137.html. The NIAID plans one (1) contract award for a term of seven (7) years on or about April 2, 2007. Should your firm be a small business, you are invited to submit two (2) copies of a capability statement to the contract person at the contracting office address above. No collect calls or facsimile transmissions will be accepted. 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 CAPABILITY STATEMENTS RECEIVED FROM THIS ANNOUNCEMENT, THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE WITH NAICS CODE 541710 AND WITH A SIZE STANDARD OF 500 EMPLOYEES.