Dual Implants for HIV Treatment and Prevention

The Center for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), the Antiretroviral Prophylaxis Team at Division of HIV Prevention (DHP), Laboratory Branch intends to award a sole source contract to the University of North Carolina/North Carolina State University (UNC/NCSU) Joint Department of Biomedical Engineering, 116 Manning Drive, 9212B Mary Ellen Jones Building, Chapel Hill, NC 27599-7362 for the purchase of an implant carrier that can accommodate two (2) antiretroviral drugs and can be used to prevent or treat HIV infection. The statutory authority for this sole source acquisition is 41 U.S.C 3304(a)(1) in accordance with FAR Part 6.302-1- only one responsible source and no other supplies or services will satisfy the agency requirement. The NAICS code for this procurement is 339112 Surgical and Medical Instrument Manufacturing. The purpose of this acquisition is to purchase an implant carrier that contains polymeric solid implants (PSIs) with Rilpivirine and Cabotegravir or an analogue of Cabotegravir. The contractor shall design an implant carrier that can accommodate the PSIs, investigate the performance of the implant carrier under laboratory conditions, and perform studies in mice to define implant integrity, body migration, and drug concentrations in blood plasma. The University of North Carolina/North Carolina State University Joint Department of Biomedical Engineering (UNC/NCSU-BME) has already designed polymeric solid implants containing anti-HIV drugs. These pellet-type solid implants meet the Government's target product profile since they are solid, safe, and have been formulated with the two anti-HIV drugs that are required for this work (Rilpivirine and Cabotegravir or analogues of Cabotegravir). UNC/NCSU is the only company that has solid implants with Rilpivirine. Additionally, UNC's solid implants do not require multiple administrations. Therefore, UNC/NCSU is the only company that can be used. As a result of this synopsis, no competitive solicitation will be posted on Sam.gov. We will issue only one solicitation to UNC/NCSU. However, firms that believe they can meet these requirements are encouraged to identify themselves and give written notice by providing a capability statement to the Contracting Officer by March 24, 2023. The Contracting Officer will not respond to verbal request. All requests must be in writing. A determination by the Government not to compete this proposed action will be based on responses to this notice and are solely within the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Inquiries shall be sent to Liubov Kriel by email at vyh1@cdc.gov and reference solicitation number 75D30123-R-72588 on the subject line.