NOTICE OF INTENT TO SOLE SOURCE: The Centers for Disease Control and Prevention (CDC), Coordinating Center for Infectious Diseases (CCID), National Center for HIV/AIDS, Viral Hepatitis, STD and TB (NCHHSTP), Division of HIV/AIDS Prevention (DHAP), Lab Branch (LB) announces its intention to negotiate a sole source follow-on contract with Emory University/Yerkes National Primate Research Center, Atlanta, GA, for the continued participation in the project entitled, "
Evaluation of Intravaginal Rings or Other Novel Devices for Delivery of Antiretroviral Drugs and In Vivo Evaluation of Topical Microbicide with Antiretroviral Drug Combination for the Prevention of SHIV in Pigtail Macaques." The anticipated performance period is 24 months. The purpose of this project is to continue to provide pre-clinical, topical microbicide intervention study to evaluate safety and/or efficicacy of several difference microbicide products for the prevention of mucosal SHIV transmission in a repeat challenge macaque model of HIV-infection. The Contractor will continue to maintain humane treatment of the female pigtail macaques in accordance with the Animal Welfare Regulation and Human Health Services policies and to perform and evaluate the following major tasks: 1) IVR/device with and without antiretroviral drugs for the prevention of mucosal SHIV transmission in a repeat challenge macaques model of HIV-1 infection; 2) the immunologic and pharmacologic kinetics at peripheral and mucosal sites; and 3) efficacy of topical microbicide gels containing antiretroviral drugs to block SHIV infection in a repeat-exposure macaque model of HIV-1 infection and compare with orally administered drugs used as a positive intervention control. All data generated from this project is the property of CDC.

Emory University/Yerkes Primate National Center‘s long-term experience with this study will help ensure the most efficient implementation of this project for the following reasons:

1) The Contractor has worked on this project for several years and is already intimately familiar with the study, agency's requirements, and past and ongoing information on the "existing" macaques.
2) Past participation and continued partnership is critical for resolving ongoing resolutions and/or remediation.
3) Time constraints imposed by CDC for restricted testing schedules.

It is critical to the study to continue to collect data from the original source than to any other source which would result in unacceptable delays in fulfilling CDC's requirement; therefore, a follow-on award with Emory University/Yerkes National Primate Center would be the most efficient and cost effective way to deliver services that are critical and essential to meet CDC's needs. CDC intends to negotiate this requirement under the authority of FAR 6.302-1, HHSAR 306.302-1. The intended procurement will be classified under North American Industrial Classification (NAICS) code 541720 with a small business size standard of $7 million.

This notice of intent is not a request for competitive proposals. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement should submit a capability statement demonstrating their abilities to meet this requirement. All responses should be received by November 10, 2009 at 2 PM Eastern Standard Time (EST). All responses must be in writing and can be sent via email to [email protected] or fax to 770-488-2868. No telephone calls will be accepted.

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