Procurement of Fresh, Frozen Tissue Samples and Blood DNA Samples for Epigenetic Characterization

1.0 DESCRIPTION The U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Integrative Tumor Epidemiology Branch (ITEB) plans to procure, on a sole source basis, fresh frozen tissue samples and blood DNA samples for epigenetic characterization from Trustees of Indiana University, at 980 Indiana Ave. RM 2232, Indianapolis, In, 46202-5130. The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority 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 541380 and the small business size standard is $16.5 million. It has been determined there are no opportunities to acquire green products or services for this procurement. 2.0 BACKGROUND DNA methylation, an epigenetic mechanism that can affect gene expression, has shown differences by race in healthy and tumor tissues from the breast. It is not well understood why black women in the U.S. (compared to other races) experience the highest rates of an aggressive type of breast cancer that is known to affect women at younger ages and have poor prognosis. By studying the tissue and blood samples to be procured under the subsequent purchase order, DCEG/ITEB aims to characterize normal breast tissues in black and white individuals, exploring potential molecular markers that have shown differences by race and may be related to breast cancer risk. In the absence of a breast cancer outcome, DCEG/ITEB aims to better understand the processes that may occur early in breast cancer development by studying relationships with breast cancer risk factors, including putative intermediate markers of breast cancer risk such as terminal duct lobular unit involution and mammographic breast density in the sample set. 3.0 SCOPE The Contractor shall query its sample database for eligible participants for 472 frozen tissue and 472 blood DNA samples (944 total). The Contractor shall retrieve the selected samples; organize them into shipment containers; create manifest files of sample location in shipment containers; and ship the samples to the NCI as stated below. 3.1 PURCHASE ORDER REQUIREMENTS The Contractor shall: 3.1.1 Retrieve from its repository existing, frozen tissue core biopsy samples and blood DNA samples collected from 236 black and 236 white participants (n=472 fresh frozen tissue and n=472 blood DNA specimens from each of the n=472 participants, for a total of 944 specimens). 3.1.2 Microscopically review the specimens, provide to the NCI Technical Point of Contact (TPOC) any issues with samples (e.g., insufficient tissue cellularity, sample depleted), and inform the NCI TPOC in order to determine if replacements are needed. 3.1.3 Deliver to the NCI repository one fresh frozen tissue block and one sample of blood DNA for each of 472 women. 3.1.3.1 Samples shall be shipped frozen on dry ice, at no additional cost to the Government; and 3.1.3.2 The Contractor shall provide a paper copy of the specimen manifest with the shipment; and provide an electronic copy (e.g. Excel file) to the NCI TPOC via email. 4.0 GOVERNMENT RESPONSIBILTIES The NCI shall: 4.1 Provide a list of 472 subject identification numbers to the Contractor for those who meet the following eligibility criteria: 236 premenopausal black and 236 premenopausal white women with sufficient tissue cellularity and not currently diagnosed with breast cancer. 4.2 Upon receipt of the specimens, store the samples at -20'C until analysis. 5.0 TYPE OF ORDER This is a firm fixed price purchase order. 6.0 NON-SEVERABLE SERVICES The services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end product of value to the Government. 7.0 PERIOD OF PERFORMANCE The anticipated period of performance shall be 12 months from date of award. 8.0 PLACE OF PERFORMANCE Services shall be performed at the Contractor's facility. 9.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The following deliverables shall be submitted to the Government's technical point of contact (TPOC) (TBD at award). The Government shall notify the Contractor of any discrepancies between the specimen manifest and specimens received within 30 business days of specimen receipt. DELIVERABLE / DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS / DUE DATE 1. Task #3.1.3: One fresh frozen breast tissue core and one sample of blood DNA for 472 women for epigenomic characterization at the NCI (n=472 fresh frozen tissue and n=472 blood DNA specimens from each of the n=472 participants, for a total of 944 specimens). Due 11 months from the date of award. 2. Task# 3.1.3: Specimen manifest; paper copy with sample shipment and electronic file (Excel file) via email. Due 11 months from the date of award. 10.0 INSPECTION AND ACCEPTANCE CRITERIA Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI TPOC, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor. Regardless of format, all digital content or communications materials produced as a deliverable under this purchase order, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor. HHS guidance regarding accessibility of documents can be found at: http://www.hhs.gov/web/section-508/making-files-accessible/index.html; Federal Government-wide guidance regarding accessibility of documents can be found at: https://www.section508.gov/best-practices, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as PDF. 11.0 INVOICE SUBMISSION / PAYMENT Payment shall be made once upon delivery and acceptance of the required deliverables in Section 9.0. Payment authorization requires submission and approval of invoices to the NCI TPOC and NIH Office of Financial Management (OFM). Electronic Email Submission: The current national emergency and the need to protect Federal and Contractor staff has resulted in a change to NIH's invoice submission process. Effective Wednesday, April 1, 2020, all NIH contractors/vendors invoices should be sent electronically via email to the NIH OFM and the NIH Contracting Officer (CO) using the electronic submission instructions contained in Attachment #1. Electronic invoice submission shall remain in effect until the Government formally notifies the Contractor of a return to mail-in invoice procedures detailed in this purchase order. By studying the tissue and blood samples required under the resulting purchase order, DCEG/ITEB aims to characterize normal breast tissues in black and white individuals, exploring potential molecular markers that have shown differences by race and may be related to breast cancer risk. Under a previous purchase order (#HHSN261201600082P), the NCI obtained blood DNA samples from the Susan G. Komen Tissue Bank at Indiana University to perform a genome-wide association study (GWAS) in order to identify genetic factors associated with terminal duct lobular unit (TDLU) involution in normal breast tissues. Since then, NCI has worked in collaboration with the Contractor to annotate study participants for standardized measures of TDLU involution as evidenced by multiple prior publications. In order to relate molecular markers to TDLU involution in these same women with previously annotated TDLU measures, DCEG/ITEB requires frozen tissues and corresponding blood DNA samples from the Komen Tissue Bank at Indiana University (Trustees of Indiana University). It is critical to use the same source population that was used under the previous award to ensure the scientific comparability of the new data with the previous data. Any deviation from the proposed acquisition strategy would result in the NCI being unable to combine the results provided under the subsequent award with the results provided under the previous award, as the findings would not be scientifically comparable. This notice is not a request for competitive quotation. However, if any interested party, especially a small business, believes it can meet the above requirements, it may submit a proposal/quote/capability statement for the Government to consider. The response 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. All responses must be sent via email to Contracting Officer, Megan Kisamore, at contact@example.gov by no later than 3:00 PM EST, on Tuesday, August 25, 2020 (8/25/20). 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. In order to receive an award, Contractors must be registered and have valid certification through SAM.GOV. Reference: 75N91020Q00173 on all correspondence.