Progestin Testing

The Center for Disease Control and Prevention (CDC), National Center for National Center for Chronic Disease Prevention & Health Promotion (NCCDPHP), intends to award a sole source purchase order to The University of North Carolina Project-Malawi (UNC Project) to obtain expertise and technical assistance to support CDC's Division of Reproductive Health (DRH) Women's Health and Fertility Branch (WHFB). The statutory authority for this sole source acquisition is 10 U.S.C 2304(c)(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 541990, All Other Professional, Scientific, and Technical Services, with a size standard in millions of dollars $14M. The period of performance is a twelve month (12) months. The purpose of this procurement is to obtain expertise and technical assistance to support CDC's Division of Reproductive Health (DRH) Women's Health and Fertility Branch (WHFB). The Progestin Study is a collaboration between the University of North Carolina (UNC) at Chapel Hill and the Malawi Ministry of Health. All study activities in being conducted in Lilongwe, Malawi among women randomized to either Depot Medroxyprogesterone Acetate (DMPA) or Levonorgestrel (LNG) implant to: 1) assess the effect and compare the impact of type of progestin-containing contraception (injectable versus implant) on HIV viral shedding in the genital tract of HIV+ women, 2) assess the effect and compare the impact of type of progestin-containing contraception (injectable versus implant) on inflammatory/immune markers in the genital tract of both HIV+ and HIV- women, and 3) assess the interaction of progestin-based hormonal contraception and antiretroviral therapy (ART) by examining: i. contraceptive efficacy (measured by systemic hormone levels and pregnancy rate during follow-up), and ii. ART efficacy (by drug concentrations in blood and genital tract and HIV viral load response in the plasma in women on ART). The University of North Carolina at Chapel Hill is the only responsible source capable of meeting all of the Government's requirement because they are the only full service proficiency testing provider that administers a HIV RNA and HIV DNA testing. Additionally, The University of North Carolina at Chapel Hill conducted the original study in Malawi and is the only one in possession of the samples to be evaluated under this project. This laboratory is led by highly trained and experienced experts in the field of research and performs specialized pharmacology testing, including testing on genital tract samples. The UNC CFAR CPAC core laboratory is a state of the art HIV laboratory, among the best in the country and most reliable in performing such specialized assays. The lab has an established relationship with the study site where specimen collection took place and specimens are shipped regularly to the laboratory for storage. The critical advantage of performing the testing in the UNC CFAR CPAC core laboratory is that additional transport of specimens would not be required which reduces the risk of compromising the viability of the specimens and reduces costs. Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit capabilities statements to the Contracting Officer within 15 days from the posting date of this notice. The Government will review all capabilities statements submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement. The capability statements shall be submitted electronically via e-mail to the Contracting Specialist Matthew Ellington at mce8@cdc.gov on or before 2:00 pm (1400) EASTERN STANDARD TIME on April 8, 2016. All email responses to this notice must identify the RFQ#2016-Q-92835, in the subject line of the email. FAXED OR MAILED RESPONSES AND/OR QUESTIONS WILL NOT BE CONSIDERED.