Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E126, Bethesda, MD 20852, UNITED STATES.

DESCRIPTION

The National Cancer Institute (NCI), Division of Cancer Epidemiology & Genetics (DCEG), Epidemiology and Biostatistics Program (EBP), Infections and Immunoepidemiology Branch (IIB) plans to procure on a sole source basis follow-on services required to measure Longitudinal Analysis of Aflatoxin and Gallbladder Cancer from Johns Hopkins University, Bloomberg School of Public Health, Department of Environmental Health Sciences, Sidney Kimmel Comprehensive Cancer Center, 615 North Wolfe Street, Baltimore, MD 21205.

This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1).

Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract.

The North American Industry Classification System code is 541990 and the business size standard is $15.0M.

Period of performance will be twelve (12) months from date of award.

It has been determined that there is no opportunity to acquire green products or services under this contract.

OBJECTIVES AND PURPOSE

The purpose of this procurement is to measure AFB1-adduct levels in pre-diagnostic blood samples from GBC cases and non-cases in order to test the hypothesis that aflatoxin exposure is associated with GBC.

In 2012, gallbladder cancer (GBC) accounted for an estimated 178,000 new cancer patients and over 142,000 deaths globally. Geographically, GBC rates are strikingly variable, with the highest rates in south-central Chile and northern India. Although GBC is the most common biliary tract cancer, knowledge of GBC etiology remains limited. Gallstones are a major risk factor for GBC, but little is known about other risk factors that contribute to the development of GBC among gallstone patients.

Aflatoxin has been hypothesized to increase risk of GBC. Exposure to aflatoxin is associated with increased risk of liver cancer and has been shown to increase cellular proliferation in the biliary tract of monkeys and humans. The excretion of aflatoxin into bile can lead to high concentrations in the biliary tree, and aflatoxin exposure has been associated with gallbladder carcinogenesis in primates.

The NCI recently demonstrated a strong association between circulating aflatoxin B1 (AFB1)-lysine adducts and GBC in humans with odds ratios (OR) of 13.2 (95% confidence interval [CI]: 4.3-47.9) for GBC versus population-based controls and 9.4 (95% CI: 2.8 to 37.2). The NCI then verified and extended this novel association using samples from the Shanghai Biliary Tract Cancer Study focusing on the comparison between GBC and gallstones to demonstrate the association of aflatoxin with GBC independent of gallstones. Among 250 GBC patients and 250 controls with gallstones, AFB1-lysine adduct detection was nearly 3-fold higher in GBC patients (OR, 2.91; 95% CI, 1.87-4.54).

The NCI sees a consistent association between aflatoxin exposure and GBC in two independent populations. The NCI propose to evaluate the association prospectively using pre-diagnostic blood samples from two existing cohorts.

PLACE OF PERFORMANCE

The place of performance shall be at the Contractor's facility.

CONTRACTOR TASKS

The Contractor shall provide the following deliverables to the National Cancer Institute Technical Point of Contact, via email, in a format as listed below:

DELIVERABLE: Task 1

DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS: Encrypted data file (i.e.: pdf, excel, word etc.) showing AFB1-adduct levels/results from aflatoxin lysine analyses by MS for 805 human serum samples.

DUE DATE: 8 months after purchase order is issued.

INSPECTION AND ACCEPTANCE CRITERIA

The NCI Principal Investigator (PI) and technical point of contact The NCI will inspect the results during this time and discuss with the Contractor if there are any discrepancies in the results or if further clarification is needed.

This is not a solicitation for competitive quotations. However, if any interested parties, especially small businesses, believe 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. A copy of the capability statement must be received in the NCI Office of Acquisition on or before 7:00 PM EST on February 13, 2018. All questions must be in writing and can be faxed (240) 276-5401 or emailed to Kathy Elliott, Contract Specialist 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 on Sam.gov, www.sam.gov. No collect calls will be accepted. Please reference solicitation number N02CP82507-61A on all correspondence.