SOLICITATION NOTICE
Q -- Autoimmune Biomarkers, Occupational Exposures and non-Hodgkin Lymphoma (NHL).
- Notice Date
- 8/26/2015
- Notice Type
- Presolicitation
- 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
- N02CP52694-61
- Archive Date
- 9/27/2015
- 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 Cancer Epidemiology & Genetics (DCEG) plans to procure on a sole source basis services to perform autoimmune biomarker assays on serum samples from approximately 2,350 subjects from University of Colorado Division of Rheumatology Clinical and Research Laboratory, 1775 Aurora Court, Campus Box B115, Aurora, CO 80045, 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 has conducted previous studies which suggested that autoimmune biomarkers, such as antinuclear antibodies (ANA) and rheumatoid factor, may be associated with the risk of non-Hodgkin lymphoma. Other studies observed associations between autoimmune biomarkers and exposure to pesticides and other agricultural exposures, suggesting a link between exposures to select chemicals and the development of autoantibodies. The aim of this study is to investigate the association between autoimmune biomarkers and non-Hodgkin lymphoma risk and to evaluate the association between autoantibodies and specific occupational exposures in highly exposed populations. This study will provide insight into the complex etiology of non-Hodgkin lymphoma and potential mechanisms by which occupational exposure may increase risk. This procurement has four specific objectives: 1. Conduct antinuclear antibody (ANA) tests on approximately 2,350 samples 2. Conduct anti-citrullinated protein antibody (ACPA) assays on approximately 2,350 samples 3. Conduct rheumatoid factor IgM assays on approximately 1,975 subjects 4. Report the results in electronic tabular format (MS-Excel) to the NCI Project Officer. The Contractor shall perform the following tasks. 1. Receive serum samples shipped overnight on dry ice by NCI and subsequently store the samples at -20°C. Samples will be sent in three batches with roughly one-third of the samples in each batch with the first batch arriving in early fall of 2015. When received, the samples shall be inspected for damage or thaw during shipment. Any problems shall be reported to the Project Officer. 2. Antinuclear antibody (ANA) tests shall be performed on all 2,350 samples using standard immunofluorescence ANA testing with commercial HEp-2 ANA slides followed by staining with anti-human IgG antibodies. Results shall describe both the cellular patterns and titer. 3. For subjects testing positive for the ANA test based on an ANA cut-off of >1:80 or 1:160, a standard ENA panel (e.g., double-stranded DNA, SSA, SSB, anti-Smith and anti-RNP) shall be performed. 4. Anti-citrullinated protein antibody (ACPA) assays shall be performed on all 2,350 samples using ELISA (CCP2 by Axis-Shield). Testing shall be performed in duplicate with the final result being a pooled average of the values. 5. Rheumatoid factor IgM assays shall be performed on the 1,975 subjects from the NHL study (N=1750) and TCE/formaldehyde studies (N=225). RF-IgM testing shall be done using ELISA (INOVA kits) in duplicate with the final result being a pooled average of the values. 6. If an assay fails for one or more batches of samples, the assay shall be repeated at no additional charge to the government if sufficient serum is available or NCI is able to send additional samples. 7. Any remaining, unmodified samples shall be shipped on ice and returned to the NCI biorepository in Frederick, Maryland upon request if not used for the molecular analyses described above. Samples shall be shipped on ice to the biorepository within six weeks of contract completion. The University of Colorado Division of Rheumatology Clinical and Research Laboratory has extensive experience conducting assays for autoimmune antibodies. The proposed laboratory has performed these assays for multiple projects funded by NIH, including a project using biological samples collected in the Agricultural Health Study by NCI investigators. The assay results for the Agricultural Health Study were received in a timely manner from this laboratory, and quality control blind duplicates showed high concordance, indicating highly reproducible results. If a different contractor is used, assay conditions, titers, and thresholds for determining positivity may be different than those used for the Agricultural Health Study, making it impossible to directly compare the results from the two studies. It is critical for some of our hypotheses that we obtain results that can be used to make comparisons with the Agricultural Health Study. 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 September 12, 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: N02CP52694-61on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CP52694-61/listing.html)
- Place of Performance
- Address: 9609 Medical Center Drive, Bethesda, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN03856122-W 20150828/150826235123-4293976d5363169ce887a53fa4b8a0f0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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