Delivery of Biological Specimens from HIV-positive men who are under or initiating integrase inhibitor-based antiretroviral therapy

The Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP) intends to award a sole source purchase order for Delivery of Biological Specimens from HIV-positive men who are under or initiating integrase inhibitor-based antiretroviral therapy to Fenway Community Health, 1340 Boylston Street, Boston, MA 02215. The purpose of this acquisition is to develop and assess retroviral integrase. As integrase strand transfer inhibitor (INSTI)-based regimens are increasing in use, and long-acting formulations are being considered for PrEP/PEP and maintenance therapies, timely studies are needed to assess for evidence of drug resistance emergence in the semen, the potential for unsuppressed infectious virus and transmission of INSTI resistance. The statutory authority permitting other than full and open competition is 41 U.S.C. 253(c)(5) in accordance with the Federal Acquisition Regulation (FAR) Subpart 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements. The North American Industry Classification System (NAICS) is 541714, titled Research and Development in Biotechnology (except Nanobiotechnology).

This is a notice of intent and not a request for competitive quotations or proposals. No solicitation will be posted on the Federal Business Opportunity website. We will issue only one solicitation to the Fenway Community Health in Boston, MA. However, all interested parties who believe they can develop and assess retroviral integrase. As integrase strand transfer inhibitor (INSTI)-based regimens are increasing in use, and long-acting formulations are being considered for PrEP/PEP and maintenance therapies, timely studies are needed to assess for evidence of drug resistance emergence in the semen, the potential for unsuppressed infectious virus and transmission of INSTI resistance may submit their capability/qualifications and other supporting information in response to Germaine Mullins at gmullins@cdc.gov on or before Friday, August 10, 2018 at 10am Eastern Time.

Please reference Request for Proposal 75D30118Q68797 in the subject line of the email. Responses to this posting must be submitted in writing via e-mail only. All information received on or before Friday, August 10, 2018 at 10am Eastern Time of this notice will be considered by the Government to determine if the more than one firm can meet the Government's requirements and is capable of providing technically acceptable services. A determination not to compete the described requirement based upon responses to this notice is solely within the discretion of the Federal Government. Information received will be considered solely for the purpose of determining whether or not to conduct a competitive procurement.

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