Intent to Sole Source -- The Genetic Contributions to Pre-term Birth Project

THIS IS NOT A SOLICITATION OR A REQUEST FOR PROPOSAL (RFP). IT IS NOT TO BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT TO ISSUE A SOLICITATION OR ULTIMATELY AWARD A CONTRACT. ANY COST INCURRED AS A RESULT OF THIS ANNOUNCEMENT SHALL BE BORNE BY THE INTERESTED PARTY (PROSPECTIVE OFFEROR) AND WILL NOT BE CHARGED TO THE GOVERNMENT FOR REIMBURSEMENT. Preterm delivery is a complex disorder caused by multiple genetic and environmental factors, which most likely interact to determine risk. Despite the general acceptance of the importance of gene-environment interactions on the risk of preterm birth, there have very few published studies that have examined the joint impact of environmental and genetic factors on the risk for preterm birth and there have been no studies examining the joint impact of any environmental and genetic factors on very preterm birth. The Division of Reproductive Health, Maternal and Infant Health Branch at CDC has been collaborating with the California Department of Public Health, Genetic Disease Screening Program (Contract #200-2008-M-26279; Procurement #00HCUCJB-2008-55408) to conduct a study to improve our understanding of gene-environment interactions that contribute to risk of very preterm birth and that underlie racial disparities in maternal and infant health. This population-based case-control study will examine the maternal and infant genetic contributions to preterm birth. Biological specimens from mother-infant pairs who participated in the California prenatal and newborn screening programs between November 1999 and April 2007 were included in this study. Samples were sent to Utah State University to conduct DNA extraction and amplification (PO #00HCUCJB-2008-55408) and then to Sequenom, Inc. for genotyping of up to 1500 polymorphisms in more than 90 candidate genes in three overlapping biological pathways (PO #00HCUCJB-2008-55408). Results from this study will allow a comparative assessment of the contribution of both maternal and fetal genotypes in a single study and will also assess potential maternal and/or infant gene-gene interactions (maternal-maternal, infant-infant, maternal-infant) and potential maternal and/or infant gene-environment interactions that modify the risk of preterm birth. The CDC intends to issue a contract to genotype approximately 128 single nucleotide polymorphisms (SNPs) that failed using the Sequenom platform. The vendor shall use the OpenArray instrument by BioTrove Inc., to conduct this analysis on the 4,000 newborn blood samples and maternal blood clots after whole genome amplification. This additional SNP information will fill-in linkage disequilibrium blocks left empty by the Sequenom analysis. The vendor shall provide all labor, materials, and equipment required to complete the tasks outlined below. The vendor may require communications with CDC to obtain guidance on the shipping and processing of specimens to be sent to the collaborating laboratories. The vendor shall perform the following tasks: (1) Use whole genome amplified DNA from approximately 4000 samples extracted newborn blood spots and genomic DNA extracted from maternal blood clots to conduct the genotyping; (2) Genotype approximately 128 single nucleotide polymorphisms (SNPs) provided by the California Preterm Workgroup that failed using the Sequenom platform; (3) Use the BioTrove or similar system to conduct the analysis and (4) Send genotyping results to CDC. This award will be made pursuant to FAR 6.302(a)(2), "when the supplies or services required by the agency are available from only one responsible source, or, for DoD, NASA, and the Coast Guard, from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for." The CDC has identified Utah State University, Centers for Persons with Disabilities, BioMedical Lab, located at 1400 Old Main Hill, Logan, UT 84322, as the sole source to provide the requirement. The period of performance of the contract ends four months after award. However, responsible sources who believe they can provide the required services may submit a written capability statement, via e-mail to Dyad Searcy at fzj1@cdc.gov and Teri Routh-Murphy at tnr3@cdc.gov no later than 15 days from the published date of this announcement, July 16, 2009. All responses are limited to 5 pages, single spaced, 12 font, Times Roman. The cover letter is not includes in the 5 page limit, however should be included in the body of the email response. Telephone inquiries will be considered non-responsive.