SOURCES SOUGHT
Q -- Circulating insulin-like growth factors and lobular involution of the normal breast in Caucasian and African American women
- Notice Date
- 8/13/2014
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 1050, Frederick, Maryland, 21702, United States
- ZIP Code
- 21702
- Solicitation Number
- SBSS-N02CP42626-62
- Point of Contact
- Tiffany D. Kittrell, Phone: 2402765434
- E-Mail Address
-
Tiffany.kittrell@nih.gov
(Tiffany.kittrell@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT NOTICE: Circulating insulin-like growth factors and lobular involution of the normal breast in Caucasian and African American women <img src="file:///C:\Users\KITTRE~1\AppData\Local\Temp\msohtmlclip1\01\clip_image001.gif" alt="" width="847" height="4" /> Notice Number: SBSS- N02CP42626-62 Issued By: National Cancer Institute (NCI), Office of Acquisitions (OA) http://www.nci.nih.gov or http://rcb.cancer.gov/rcb-internet/ Key Dates: Capability Statement Due Date: August 20, 2014 by 4:00 PM EST This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The purpose of this Sources Sought Notice is to identify qualified concerns including 8(a), HUB Zone or Service-Disabled Veteran-owned businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned North American Industry Classification System (NAICS) code 541380 with a size standard of $15 million employees is being considered. As a result of this Sources Sought Notice, the NCI may issue a Request for Quotation (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Sources Sought Notice or the NCI’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Greater degrees of terminal duct lobular unit (TDLU) involution have been linked to lower breast cancer risk; however, factors that influence this process are poorly characterized. The purpose of this procurement is to perform assays for insulin-like growth factor (IGF)-1 and IGF binding protein-3 (IGFBP-3) in serum to assess whether circulating IGF-1 and IGFBP-3, markers associated with cancer, are related to levels of TDLU involution of the breast. NCI has been approved to test serum samples in the Susan G. Komen Tissue Bank at the Indiana University Simon Cancer Center (KTB), and will specifically select up to 800 samples among 1938 women subjects whose Hematoxylin and Eosin have been reviewed. NCI has performed morphometric assessment of TDLUs and developed three reproducible quantitative measures that are inversely associated with TDLU involution: TDLU counts per standardized biopsy, median acini counts/TDLU and median TDLU span in order to identify factors associated with TDLU involution in normal breast tissues from the KTB. The women were participants in the KTB repository, and have given consent to participate in research. Blood levels of growth factors have been previously found to be positively related to breast cancer risk and mammographic density, primarily among premenopausal women; and analysis in the BREAST Stamp Project from HREB has shown an association with IGF-1 and IGFBP-3 and higher TDLU counts suggesting, that this may be an important pathway that inhibits TDLU involution. NCI investigators want to replicate this work and enhance the understanding of how IGF’s may influence TDLU involution, using the KTB study samples, a unique source of normal breast tissues, risk factor data, and blood from volunteers for research. Epidemiologic factors that lead to increased exposure to growth factors may alter the breast tissue microenvironment, and might lead to both increased epithelial tissue, specifically TDLUs, which might increase cancer risk. The NCI will test whether IGF-1, IGFBP-3, and the ratio of IGF-1/IGFBP-3 are related to morphometric measurement of TDLUs in a diverse population of both Caucasians and African Americans. The Contractor will perform enzyme-linked immunosorbent assays (ELISA) to measure serum levels of IGF-1 and IGFBP-3. The Contractor shall perform IGF-1 and IGFBP-3 ELISA assays on serum collected from ~800 participants in the KTB study in order to assess whether IGF-1, IGFBP-3, and the ratio of IGF-1/IGFBP-3 are related to TDLU involution in both African Americans and Caucasians. 1. The NCI will provide the Contractor with ~100 ul of serum from each of ~725 subjects and from each of ~75 masked quality control samples for a total of ~800 samples. The samples will be labeled with subject identification numbers only; patient identifiers will not be supplied. The NCI will ship the samples via Fed Ex frozen on dry ice. The NCI will provide a specimen manifest in the shipment. Upon receipt, the Contractor shall inventory the serum samples in order to confirm that the identification numbers, number of samples, and serum volumes match that in the specimen manifest. The Contractor shall notify the Contracting Officer’s Representative (COR) of any discrepancies between the specimen manifest and specimens received within one week of shipment receipt. 2. After receiving the specimens, the Contractor shall store the samples in-house at -70°C until analyzed, with appropriate storage facilities that include sufficient emergency power supplies to prevent the accidental or unintended destruction or thawing of the specimens. 3. The Contractor shall perform IGF-1 and IGFBP-3 ELISA assays on the stored serum samples provided by NCI. The Contractor shall perform IGF-1 and IGFBP-3 ELISA assays in duplicate. The Contractor shall perform all analyses of specimens in the order provided by the NCI COR and specified in the shipment manifest. 4. The Contractor shall perform all assays under conditions of careful quality control (QC), following the Contractor’s usual laboratory quality control procedures and providing all IGF-1 and IGFBP-3 internal quality control results to the NCI COR. 5. The Contractor shall notify the NCI COR within three days of the occurrence of any unusual problems that might affect or delay the completion of this project, such as failure of analytic or quality control procedures, breakdown of instrumentation and equipment, or changes in laboratory personnel. 6. The Contractor shall provide the IGF-1, IGFBP-3, and QC results (i.e. IGF-1 and IGFBP-3 results for serum from controls run with study samples) for each serum sample within an Excel spreadsheet within the period of the contract. 7. Upon completion of the assays, the Contractor shall return any unused frozen serum samples in their original tubes to an NCI bio specimen repository designated by the COR. 8. The Contractor shall collaborate with NCI on data interpretation, analysis, and manuscript preparation. Period of performance: Twelve months from the date of award. How to Submit a Response: 1. Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the ability to perform the requirements of the notice described above. All proprietary information should be marked as such. Responses should include a minimum of a one page resume of the individuals meeting the requirements, and up to two pages demonstrating experience over the past two years meeting the requirements of this notice. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferable placed under the eligible small business concern’s name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. 2. Due Date: <img src="file:///C:\Users\KITTRE~1\AppData\Local\Temp\msohtmlclip1\01\clip_image002.gif" alt="" width="2" height="54" /> Capability statements are due no later than 4:00PM EST on August 20, 2014. 3. Delivery Point: All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing and can be faxed to (240) 276-5401 or emailed to Tiffany Kittrell at Tiffany.kittrell@nih.gov. A determination by the Government not to compete this 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. In order to receive an award, contractors must have valid registration and certification in the System for Award Management through sam.gov. No collect calls will be accepted. Please reference number SBSS- N02CP42626-62 on all correspondence. Disclaimer and Important Notes : This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, an RFQ may be published in FBO. However, responses to this notice will not be considered adequate responses to a solicitation(s). Point of Contact: Inquiries concerning this Notice may be direct to: Tiffany Kittrell 9609 Medical Center Dr, Room 1E144 Bethesda, MD 20892-9705 Tiffany.Kittrell@nih.gov Confidentiality : No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
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