This process will be processed in accordance with simplified acquisitions procedures as stated in FAR Part 13 13.106-1(b)(1) and is exempt for the requirements of FAR Part 6. The North American Industry Classification System code is 541990 and the business size standard is $14.0 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. It has been determined there are no opportunities to acquire green products or services for this procurement.

Ultrasound tomography (UST) is being used to repeatedly assess volumetric breast density within the first year of tamoxifen therapy for 49 participants (referred to hereafter as "cases") with atypical lobular or ductal hyperplasia, ductal carcinoma in situ, lobular carcinoma in situ, or invasive breast cancer.  For comparison, a group of 103 age-, race-, and menopausal status-matched women without breast cancer were enrolled in order to assess changes in UST density over time without tamoxifen exposure.  The broader study objective is to assess the concept of breast density as a biosensor of tamoxifen response and UST as a useful tool for making this determination.

The project objectives are as follows: 1) To conduct participant follow-up visits according to the schedule and procedures outlined in the study protocol; 2) To manage and provide scientific oversight of data collected for all participant follow-up visits; 3) To collect mammographic images as per the study protocol for breast density assessment; and 4) To ensure transfer of participant data and biospecimens as per the study protocol to the NCI Contracting Officer's Representative (COR). 

The ultrasound tomography method used at Wayne State University (WSU) is suitable for performing closely timed repeated examinations without substantial risk. The device does not require breast compression and provides a three-dimensional tomographic image of breast parenchyma.  The device provides an objective quantitative measurement of a physical quantity, sound speed, with demonstrated correlations with breast density.   The device achieves excellent precision such that comparisons across serial examinations performed over time can be used to distinguish density changes related to tamoxifen from random fluctuations.  The UST prototype and related analytical algorithms developed at WSU/KCI represent the only approach for measuring breast density using sound speed, and therefore this organization is uniquely qualified to perform the analysis under this procurement. The Ultrasound Study of Tamoxifen was launched in 2011 at WSU, enrolling participants into a three-year field effort, and utilizing UST to define the time course of volumetric breast density changes that are associated with tamoxifen treatment.  This requirement will allow for completion of follow-up visits for participants previously enrolled into the Ultrasound Study of Tamoxifen.

This is not a solicitation for competitive quotations.  However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities.   All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein.  An original and one copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on, December 23, 2013.  No electronic capability statements will be accepted (i.e. email or fax), an original and one copy must be sent to the NCI Office of Acquisitions at the address stated above.  All questions must be in writing and can be faxed (240) 276-5401 or emailed to Gwennifer Epps, Contracting Officer at [email protected].  A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.  Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.  In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA), through sam.gov.  No collect calls will be accepted.  Please reference solicitation number N02RC46005-83 on all correspondence.