SOLICITATION NOTICE
A -- Determination of Genetic Susceptibility to Lung Cancer in Families from Southern Louisiana
- Notice Date
- 4/6/2016
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NIH-NHLBI-CSB-HG-2017-09-KC
- Archive Date
- 4/22/2016
- Point of Contact
- Stacy C. Turner,
- E-Mail Address
-
turners@nhlbi.nih.gov
(turners@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Pre-Solicitation Non-Competitive (Notice of Intent) Synopsis to award a contract without providing for full or open competition. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), on behalf of the National Human Genome Research Institute (NHGRI), intends to negotiate and award a contract to Louisiana State University Health Sciences Center (LSUHSC) without providing for full and open competition. The contract will continue a study currently conducted by LSUHSC titled "Determination of Genetic Susceptibility to Lung Cancer in Families from Southern Louisiana." The intended acquisition is classified under NAICS code 541712 with a size standard of 1,000 employees. This acquisition is conducted under the procedures prescribed in FAR Part 15-Contracting by Negotiation at an amount exceeding the simplified acquisition threshold ($150,000). This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). This project will continue work that has been performed by LSUHSC since the early 1990's and has been performed under contract with LSUHSC since 1996. LSUHSC is uniquely qualified to perform the work for this requirement. They have set up the only rapid ascertainment network for lung cancer in the State of Louisiana and the only successful genetic epidemiology family study of lung cancer patients in Louisiana, which involved years of work to achieve. No other researchers or entities in the State of Louisiana have such a network or the required experience in studying and enrolling lung cancer families into genetic studies. No other entity has access to the previously enrolled family members to allow them to successfully carry out this study in a timely manner in southern Louisiana. It is important that a lung cancer linkage study be performed in this southern Louisiana population because it is one of only two populations in which a segregation analysis has been performed. This segregation analysis gave evidence that an inherited susceptibility to lung cancer may exist in some families and the results of this analysis will be necessary for use in the linkage analysis. While these results could possibly apply to other populations, there is no guarantee that they do. Therefore, NIH investigators have the best chance of successfully locating a lung cancer susceptibility locus if they study this same southern Louisiana population. More importantly, the follow-up of the currently enrolled families is critical to the success of the study, since as the at-risk family members age, more of them become affected with lung cancer or reach an age where their cancer-free status is meaningful in the statistical analyses of the data. Lung cancer (LC) is one of the most common cancers in the United States and, despite advances in therapy, one of the most rapidly fatal. There is little doubt that the majority of lung cancer cases are attributable to (i.e. would not occur in the absence of) cigarette smoking and other behavioral and environmental risk factors. However, strong evidence suggests that genes are also involved in LC causation. Investigators at NHGRI and their collaborators have studied the genetic susceptibility to lung cancer for over 25 years, collecting medical information, smoking exposure history and biological samples on families with many affected individuals, as well as lung cancer patients with a family history and unaffected individuals who are matched to the lung cancer patients on age, gender and smoking history. Lung cancer is rapidly fatal. Therefore, many newly diagnosed patients are very ill. In order to enroll patients and their families into this study, newly diagnosed patients must be offered enrollment into the study very shortly after diagnosis. This requires a rapid ascertainment network - the contractor must work closely with all hospitals, oncologists, pathology departments and cancer treatment centers in southern Louisiana in order to attempt to enroll patients shortly after diagnosis (preferably no longer than 3 months after diagnosis). NHGRI's data collection site is in southern Louisiana. NHGRI intends to continue data collection in this area to facilitate ongoing research into genetic susceptibility and gene-smoking interactions that may increase the risk of this disease. The contractor will perform the following program requirements: 1) rapidly identify and contact all lung cancer patients newly diagnosed between December 1, 2016 and November 30, 2019 (hereafter called probands) within 27 parishes in southern Louisiana using a rapid ascertainment network and attempt to enroll them into the phase 1 interview portion of the study; 2) perform a brief phase 1 family history interview with these probands to determine how many of their relatives have ever had lung cancer; 3) collect phenotypic and detailed smoking and other environmental exposure data and biologic specimens from selected lung cancer patients (selected because they have a family history of lung cancer that was discovered during the phase 1 interview) and their families to be delivered to the Government so that the following analyses can be performed: genotyping, genetic linkage analyses, familial-case-control genome-wide and targeted association analyses, genome sequencing analyses, and genotype-phenotype correlation analyses. The contractor will complete enrollment of 3-9 new families with adequate data for use in the linkage study and 30-60 new probands with a family history for the association study from among the families ascertained during this contract period; 4) collect phenotypic and environmental exposure data and biologic specimens on approximately 30-120 new matched control (unaffected) individuals (frequency matched to the probands on age, smoking exposure levels, area of residence, race/ethnicity) who are biologically unrelated to the lung cancer patients for use in the analyses described above; 5) continue follow-up of previously enrolled lung cancer patients and their families to allow updating of new cancer diagnoses within the families; 6) provide a Statistical Geneticist to assist NHGRI staff with these types of methodological research, as well as to advise the data collection staff about prioritization of their data collection efforts (to ensure collection of the most powerful families), assist NHGRI staff with analyses of the data as needed, and perform evaluations of various statistical genetic methods needed to analyze this extremely complex trait; 7) verify all reported cases of cancer at any site in original patients and in affected relatives by review of hospital charts, pathologist or physician medical records, or death certificates (if appropriate) and information on histologic type whenever available; 8) maintain a database that contains all of the data generated from the study; and 9) provide biologic specimens including whole blood appropriate for DNA extraction, tumor samples and saliva samples to a central repository specified by NHGRI. To accomplish this work, Institutional Review Board (IRB) approval for the protection of human subjects is required from the current contractor's organization and the study will also have to be approved by the IRB's of hospitals and universities that participate in the rapid ascertainment network. IRB approval to recontact the currently enrolled lung cancer patients and their families will have to be obtained from the current contractor and demonstrated as part of the response to this notice. A cost-reimbursement contract for the period of December 1, 2016 - November 30, 2019 which includes a base year and two one-year options is anticipated. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research, specifically the review and evaluation of the responses to the two sources sought notices. On March 17, 2016 a Small Business Sources Sought Notice number HHS-NIH-NHLBI-SBSS-CSB-HG-2017-09-KC and a Research and Development Sources Sought Notice number HHS-NIH-NHLBI-RDSS-CSB-HG-2017-09-KC were posted in FedBizOpps. Both sources sought notices were titled, "Determination of Genetic Susceptibility to Lung Cancer in Families from Southern Louisiana. This synopsis is not a request for competitive proposals. However, interested parties that have demonstrated experience meeting the above requirements may submit a capability statement in response to this notice. Capability statements must document the following: 1) if applicable, evidence of the firm's status as a small business under NAICS code 541712 with a size standard of 1,000 employees; 2) ability to perform and experience in performing the requirements described above; 3) ability to coordinate and manage a contract of this type and experience in performing contracts of a similar nature; 4) demonstration of past success in recruiting patients from an existing cohort for participation in follow-up visits; 5) experience in the collection of data and biospecimens from individuals including in-home visits; 6) qualifications of personnel with training and experience in human genetics and/or genetic epidemiology/statistical genetics, and experience in the study of lung cancer, interview techniques, data collection, data management, computer simulation programs such as SIMLINK and G.A.S.P., and statistical genetics analysis programs such as GENEHUNTER, S.A.G.E., and PLINK; 7) experience obtaining IRB approval for the ethical conduct of human research and for recontacting the currently enrolled study participants; and 8) availability of the facilities, equipment, and resources necessary for the performance of the requirements identified above. 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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive acquisition. Respondents are advised that the Government is under no obligation to acknowledge receipt of information received or provide feedback to respondents with respect to any information submitted. All capability statements must be received by 4:00 p.m. EDT on April 21, 2016 and must reference number NIH-NHLBI-CSB-HG-2017-09-KC. Capability statements may be submitted electronically to turners@nhlbi.nih.gov or sent to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Rm. 6221, Bethesda, MD 20892-7902 (20817 for delivery services such as FedEx). Faxed capability statements will not be accepted.
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-
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(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NIH-NHLBI-CSB-HG-2017-09-KC/listing.html)
- Record
- SN04075138-W 20160408/160406234457-e4b65ab9df039f5bf455c227737679a1 (fbodaily.com)
- Source
-
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