The statutory authority permitting other than full and open competition is 41 U.S.C. 253(c)(1) as cited in FAR 13.106-1(b)(1)(i). Roche Linear Array genotyping and detection kits for HPV testing comprise the only assay available to research labs for the purpose of identifying and genotyping 37 individual human papilloma virus (HPV)types. At present, Roche Linear Array is the only assay available that will identify 37 individual HPV types. The Cobas 4800 HPV Assay is necessary for processing NHANES specimens and is the only HPV DNA Assay in the country that is FDA-approved and simultaneously detects 14 high-risk HPV types as well as provides specific genotyping information for HPV Type 16 and 18. Prompt acquisition of these laboratory supplies is vital and urgent since one of our major national health projects (NHANES) would be interrupted and timely results reporting would be compromised.

Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contract Specialist, within 3 days from the posting date of this notice, their written capabilities statement, proposal or quotation which shall be considered by the agency. Please forward the capability statement and/or pricing information to the attention of Tonya S. Justice, Contract Specialist, Reference #2013-M-55508, Centers for Disease Control, Procurement and Grants Office, MS K-94, 2877 Brandywine Road, Atlanta, GA 30341; or via email at [email protected].

All vendors must be registered and active in the System for Award Management (SAM) prior to an award of a federal contract. The website is: www.sam.gov.

The Government will review any/all capabilities statements and pricing information 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 for these services in the future.

If no affirmative responses are received within 3 days, negotiations will be conducted with Roche Diagnostics Corporation, as the only source and a contract will be issued without any additional notices being posted.