In accordance with FAR subpart 6.302-1(c) (ii), the Centers for Disease Control and Prevention CDC), OID, NCHHSTP, Division of HIV/AIDS Prevention, Laboratory Branch, intends to issue a sole source purchase order to Wisconsin National Primate Research Center, Madison, WI. Project Title: Quantitative Hormone (Progesterone, Estrogen, Medroxyprogesterone tritiated, Levonorgestrel [LNG] and Ethinyl-estradiol [EE]) Testing analysis on Macaques specimens including wet feces (these samples may be infected with SHIV and/or monkey Herpes B virus). The Laboratory Branch supports DHAP's goals in HIV prevention as they pertain to clinical studies, viral transmission, diagnosis and incidence, intervention research with microbicides, vaccines, and chemoprophylaxis as well as investigates other human and zoonotic retroviruses. The Lab Branch requires assays for monitoring and quantitating hormone levels that may influence prophylactic treatment in our animal modeling system. The efficacy of topical microbicides and other delivery devices containing ARVs will likely depend on drug absorption through the vaginal/rectal mucosa. However, little is known on how physiological changes in the vagina that occur in response to hormonal shifts during a normal menstrual cycle (with or without contraceptive use), including changes in epithelial thickness and porosity, will affect absorption of ARVs. Like women, female macaques have monthly bi-phasic menstrual cycles that are regulated by hormonal changes and thus represent a good model to explore pharmacokinetics following vaginal dosing. Monitoring hormones associated with the menstrual cycle in macaques is a developed assay service and is necessary for the efforts of our work towards preventing HIV transmission. The Government requires Contractor to perform analysis assays of the Quantitative Hormone (Progesterone, Estrogen, Medroxyprogesterone tritiated, Levonorgestrel [LNG] and/or Ethinyl-estradiol [EE]) Testing on Macaque specimens including wet feces that will be provided and provide quantitative data for the Centers for Disease Control and Prevention (CDC), OID, NCHHSTP, Division of HIV/AIDS Prevention, Laboratory Branch. The Contractor shall perform macaque hormone testing assays to determine Progesterone, Estrogen, Medroxyprogesterone tritiated, LNG and/or EE levels in Macaque specimens including wet feces. The macaque specimens will be sent in batches during 12 month performance period. Note that these macaque samples may be infected with SHIV and/or monkey Herpes B Virus. It is the understanding of the Government that an award to any other source would cause unacceptable delays in meeting the requirements of the Government. Interested parties who feel that they possess the capabilities to provide the services described above should submit a capability statement demonstrating their abilities to provide the services. The information received in response to this notice will be considered solely for the purpose of determining whether or not to conduct a competitive requirement. Please send your documentation to Deborah Workman by fax (770) 488-8350, or email to
[email protected]. Documentation should be received within fifteen (15) days after the date of publication of this synopsis to be considered by CDC. A determination by the CDC not to compete this proposed contract, based upon responses to this notification, is solely within discretion of the government.