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 334516 (Analytical Laboratory Instrument Manufacturing). The size standard is 1000 employees.

The Government intends to purchase Hamilton HPLC columns needed by the Inorganic and Radiation Analytical Toxicology Branch (IRATB). The columns will be used to support of analyzing urine samples. This column is needed to sustain a heavily used Clinical Laboratory Improvement Amendment (CLIA) regulated analytical method that determines the content of arsenic species in urine. CDC laboratories are collaborating with the Food and Drug Administration (FDA) to provide analyses for over 10,000 urine samples on an annual basis. The CDC analyzes samples using this method on a daily basis. The analytical method this particular column is used for was developed over the course of several years. If the type of column is changed, the method has to be re-validated and the validation process can take several months to a year at a minimum.

Only Hamilton makes the Hamilton PRP X-100 Column. Hamilton specially makes these columns upon demand to exact specifications. The speciated arsenic in urine method became an established method in accordance with the CLIA in 2003. Out of all of the columns tested prior to this method becoming an established method used to analyze patient samples, the scientist developing and validating the method were able to achieve the needed scientific separation among species with the Hamilton PRP X-100. These columns are rugged enough to withstand the chemicals used during analysis on a routine basis. Also, the CDC laboratory was able to analyze more samples and obtained higher quality results with these specially made columns than others that were tested. Therefore, reducing the cost per analysis. Without these columns, the CDC cannot continue the analysis of samples for this study and the CDC will not meet our obligations to the FDA. Purchasing this specific column ensures the continuity of IRATB's analytical method and continual adherence to CLIA regulations.

No solicitation will be posted to FedBizOpps. We will only issue a solicitation to the Hamilton Company. The Hamilton Company is the only source available to provide this service that meets mission critical requirements. This notice of intent is not a request for proposal. A determination to compete this procurement based on response to this notice is solely within the discretion of the Contracting Officer.

Interested parties who believe they possess the capability to satisfy this requirement should submit a capability statement demonstrating their ability to meet this requirement. All responses must be sent in writing to Mr. Tim Williams via email to [email protected] using solicitation number 2016-Q-65372 in the subject line, no later than 12:00pm Eastern Time, July 12, 2016.