MODIFICATION
B -- Continued Application of Statistical Methods to Calibrate and Season-Adjust Circulating Vitamin D Data Collected for the Pooling Project of Breast and Colorectal Cancer.
- Notice Date
- 8/13/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP52685-61
- Archive Date
- 9/12/2015
- Point of Contact
- KATHY D. ELLIOTT, Phone: 240-276-5570, Seena Ninan, Phone: 240-276-5419
- E-Mail Address
-
ELLIOTTK@MAIL.NIH.GOV, ninans@mail.nih.gov
(ELLIOTTK@MAIL.NIH.GOV, ninans@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Hormonal and Reproductive Epidemiology Branch (HREB) plans to procure on a sole source basis services for the continued application of statistical methods to calibrate and season-adjust circulating Vitamin D data collected for the Pooling Project of Breast and Colorectal Cancer from Harvard School of Public Health, 665 Huntington Avenue, Boston MA 02115-6021, USA. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541690 and the business size standard is $14.0 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The National Cancer Institute is pooling individual data on circulating 25-hydroxyvitamin D [25(OH)D], the accepted measure of vitamin D status, from 21 cohorts, which includes practically all the prospective data available worldwide. For some of the cohorts, the NCI measured 25(OH)D using a common laboratory and assay. For the other cohorts, which had already assayed their blood samples for 25(OH)D, there is a need to calibrate their assays, conducted in different laboratories with different techniques, to the current assay. In addition, 25(OH)D concentrations vary substantially throughout the year, with values peaking in the summer and dropping substantially during the winter. Therefore, the National Cancer Institute needs to season-adjust the 25(OH)D data so that controls are matched to the cases in each cohort and the various cohorts are comparable. In this pooling project, the NCI is analyzing absolute 25(OH)D concentrations, not study-specific quantiles, in order to examine risk over the full range of vitamin D exposure present around the world and to facilitate translation of results into clinical guidelines and public health guidance. This challenging approach has led to the development by NCI biostatisticians of novel statistical methods for calibration and adjustment for date of blood draw. These methods are necessary so that NCI can work with comparable absolute 25(OH)D concentrations from the various cohorts. These statistical methods and their application in the Vitamin D Pooling Project are serving as a model for other biomarker cohort consortia that will combine data from different assays conducted by different labs. This procurement has four objectives: 1) To identify and apply statistical methods for conducting aggregated analyses of the calibrated and season-standardized 25(OH)D data assembled from 21 cohorts in relation to risk of breast and colorectal cancer. Initial analyses were conducted by conducting analyses within each study and pooling study-specific results. However, to explore dose-response relationships across the full range of exposure using spline curves and to examine associations in population subgroups, the NCI needs to aggregate the data from the individual studies and develop analytic models appropriate for the entire consortium. 2) To identify and apply statistical methods to perform a two stage-calibration for circulating 25(OH)D data for two of the studies participating in the breast cancer analyses. By the time the last two breast cancer studies to join the consortium had provided replicate blood samples for calibrating their previously assayed 25(OH) data to the current chemiluminescence assay, the assay kits ordered for our pooling project had expired. Therefore, these two studies are being calibrated to a new 25(OH)D assay kit that will be linked to the chemiluminescence assay through a second calibration. 3) To identify and apply statistical methods to standardize the calibrated and season-adjusted circulating 25(OH)D data being utilized in the Pooling Project of Breast and Colorectal Cancer to the internationally recognized LC-MS/MS reference measurements conducted at the U.S. National Institute of Standards and Technology and Ghent University. Standardization will be based on 200 representative serum samples to be measured with the chemiluminescence assay at the Pooling Project laboratory and with a simplified LC-MS/MS method at the Centers for Disease Control that is linked to the reference measures. By doing this, the Pooling Project will be participating in the international Vitamin D Standardization Program (VDSP). Thus, national health surveys, such as NHANES in the United States, and clinical, research, and commercial laboratories also participating in VDSP will be able to relate their absolute 25(OH)D concentrations to ours. 4) To examine seasonal variation in circulating 25(OH)D levels overall and by age, sex, race/ethnicity, latitude, body mass index, and smoking status in the control populations in the studies participating in the Vitamin D Pooling Project of Breast and Colorectal Cancer. Given the wide seasonal variation in circulating 25(OH)D levels, the Pooling Project needs to understand whether the date on which blood samples are collected for vitamin D evaluation needs to be considered in the development of clinical and public health vitamin D guidelines. The circulating 25(OH)D data, along with cancer outcomes and covariates, from the 21 cohorts participating in the Vitamin D Pooling Project of Breast and Colorectal Cancer was sent to Harvard School of Public Health, stored on Harvard computer servers, and cleaned up and harmonized by Harvard staff under the direction of Dr. Stephanie Smith-Warner. The data transfer agreements signed with the various cohorts specified that the participant data had to remain on the Harvard computer servers and be analyzed under the direction of Dr. Smith-Warner. In particular, these agreements specified how the data would be anonymized. Therefore, the only institution with access to all the Vitamin D Pooling Project data, familiar with its description and development, and therefore able to continue to analyze the data, is Harvard T. H. Chan School of Public Health. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 11:00AM EST, on August 28, 2015. All responses and questions must be in writing and faxed 240-276-5401 or emailed to Kathy Elliott, Contract Specialist via electronic mail at Elliottk@mail.nih.gov. A determination by the Government not to compete this proposed requirement 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. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: N02CP52685-61on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CP52685-61/listing.html)
- Place of Performance
- Address: 9609 Medical Center Drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03836966-W 20150815/150813235049-98b6255b094a8865158fb3d71b088804 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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