SPECIAL NOTICE
Q -- Tissue samples and data preparation for the Sherlock-Lung study among never-smoking histologically confirmed female lung cancer cases in Taiwan.
- Notice Date
- 8/10/2021 8:15:21 AM
- Notice Type
- Special Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NIH NCI ROCKVILLE MD 20852 USA
- ZIP Code
- 20852
- Solicitation Number
- 75N91021Q00166
- Response Due
- 8/16/2021 12:00:00 PM
- Archive Date
- 08/31/2021
- Point of Contact
- Elizabeth Tucker, Megan Kisamore, Contracting Officer
- E-Mail Address
-
elizabeth.tucker@nih.gov, megan.kisamore@nih.gov
(elizabeth.tucker@nih.gov, megan.kisamore@nih.gov)
- Description
- 1.0�� �DESCRIPTION � The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology & Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB) intents to procure tissue samples and data preparation for the Sherlock-Lung study on a sole source basis from National Health Research Institutes located at 35 Keyan Road, Chunan Chen, Miaoli 35053, Taiwan. 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 Globally, over a million people are diagnosed with lung cancer each year, making it the most common type of cancer in the world. In addition, lung cancer is the leading cause of cancer death among both men and women, accounting for ~25% of all cancer deaths in the United States (U.S.) and ~19% of cancer deaths worldwide. Since lung cancer in smokers is highly preventable and targeting strategies for lung cancer screening have focused on smokers, it is critical to develop a thorough understanding of nonsmoking lung cancer to develop rational strategies for screening, prevention, and treatment. Moreover, the characterization of the risk factors and endogenous processes involved in lung tumorigenesis may improve prevention of lung cancer also in smokers. Lung cancer in never-smokers includes approximately 10-25% of all lung cancers worldwide; ranks among the most common causes of cancer mortality; and, has a distinct natural history; high proportion of adenocarcinoma histology; likely different profile of oncogenic mutations; and response to targeted therapy compared to lung cancer in smokers. Although a few risk factors are known to contribute to the etiology of lung cancer in never smokers, a large fraction of cancer cases cannot be explained by established environmental and genetic risk factors, highlighting the need for research in this area. �One promising approach to identify the etiological factors involved in lung tumorigenesis in never smokers is based on the study of the �mutational signatures� that the exogeneous and endogenous processes leave on the tumor tissue and surrounding areas.� The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology & Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB) is conducting an international whole-genome sequencing study of lung cancer tumors from never-smoking women in Asia, the U.S., Europe, South America and Africa to identify exposure-related mutational signatures to extend NCI�s findings, and shall compare results with signatures identified in cases NCI is analyzing from China, Asia, the West, and other regions as part of the Sherlock-Lung study. Taiwan has been selected as one of the key study sites for the Sherlock-Lung study because of occupational and environmental exposure patterns found in Taiwan and the availability of biological samples and questionnaire data from a high-quality case-control study of lung cancer.� 2.1�� �OBJECTIVE The primary objective of this procurement is to identify distinct mutational signatures in lung tumors likely to be produced by substantial occupational and environmental exposures. OEEB requires whole-genome sequencing of lung cancer tumors from 125 never-smoking women in Taiwan as part of the Sherlock-Lung study. In addition, OEEB requires the comparison of environmental risk factor distributions in cases with/without particular molecular signatures to environmental risk factor distributions obtained by a comparable questionnaire among comparable healthy controls. 3.0�� �SCOPE To support the Sherlock-Lung study, the NCI requires frozen tumor and normal lung tissues and blood samples from 125 never-smoking female cases in Taiwan who have a diagnosis of primary lung cancer with either adenocarcinoma or squamous cell carcinoma histology. The Contractor shall obtain samples from stored frozen tumor tissue and adjacent normal lung tissue, an accompanying H&E slide for each lung pathologic sample, a pre-surgery venous blood sample, a copy of the admission and discharge summaries, the pathology report, all test results done on the lung tissue samples, all radiologic studies (e.g., CT scan) and selected variables from the questionnaire from cases and send files to the NCI based on protocols that shall be provided by NCI via email to the Contractor within 15 business days after award. All samples, medical record reports, CT scans and questionnaire variables from cases and comparable controls, as determined by NCI, shall be coded and shall not have any personally identifiable information (PII) attached. Shipping costs for biological samples shall not be included in the price quote. Shipping shall be coordinated with NCI using the NCI shipping service.� 4.0�� �PURCHASE ORDER REQUIREMENTS / TASKS� The contractor shall perform the following tasks: 4.1�� �Select 125 never-smoking female cases that have a diagnosis of primary lung cancer with either adenocarcinoma or squamous cell carcinoma histology in Taiwan. 4.2�� �Cut up at least 1 frozen lung tumor tissue sample and up to 3 samples from the tumorous, non-necrotic non-hemorrhagic section of surgical lung tissue that is frozen and has been stored at least as low as -80�C with at least 50% tumor in each lung tumor from each of the 125 lung cancer cases and store it in 1.8ml sterile cryovials. In addition, a slide from either the actual study sample or an area adjacent should be made for tumor lung sample(s) should be made and H&E stained. An H&E slide from each block obtained from the resected sample for clinical diagnostic purposes or a high-quality photomicrograph of the slide shall be provided to NCI. All samples shall be coded and shall not have any PII attached.� 4.3�� �Cut up at least 3 frozen normal lung tissue samples from each of the 125 lung cancer cases and store them in 1.8ml sterile cryovials. In addition, a slide from either the actual study sample or an area adjacent should be made for non-tumor lung sample should be made and H&E stained. An H&E slide from each block obtained from the resected sample for clinical diagnostic purposes or a high-quality photomicrograph of the slide shall be provided to NCI. All samples shall be coded and shall not have any PII attached. � 4.4�� �Collect 5 ml pre-surgery venous blood sample shall be provided as whole blood or as plasma and white/red blood cells. All samples shall be coded and shall not have any PII attached.� 4.5�� �Prepare samples from 4.2 � 4.4 for shipment to NCI on dry ice for overnight express shipping services according to protocol provided by NCI.� 4.6�� �Copy or scan the admission and discharge summaries, the formal pathology report, all test results done on the lung tissue samples, and all radiologic studies (e.g., CT scan). The CT scan file itself shall be obtained on a CD or equivalent. In addition, the original CT scan digital data shall be uploaded to a secure site to be provided by NCI. � All medical record reports shall be coded and shall not have any PII attached. The Contractor shall securely send the electronic files to NCI.� 4.7�� �Complete the study subject log (to be provided by NCI, in Excel file format) to include the date of diagnosis, type of procedure used to obtain the sample, and age of study subject. The Contractor shall securely transmit the file to NCI. 4.8�� �Provide questionnaire variables from cases and comparable controls, as determined by NCI, to NCI to be used in the data analysis including variables related to indoor and outdoor air pollution, family history, and other known or suspected risk factors for lung cancer in never smokers in Taiwan. 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 September 15, 2021 to September 14, 2022.� � 8.0�� �PLACE OF PERFORMANCE All work shall be performed at the Contractor�s facility. 9.0�� �REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All electronic deliverables shall be submitted for review and comment by the Government�s technical point of contact (TPOC) (TBD at award), for a review period not to exceed fifteen (15) business days, in accordance with the following deliverables table below: DELIVERABLE �� �DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS�� �DUE DATE #1 (Task 4.1)�� �List of masked IDs of the selected 125 cases with sex, smoking status, diagnosis of lung cancer subtype in MS Excel format.�� �(45) business days prior to purchase order expiration date. #2 (Task 4.2-4.4)�� �H&E photomicrograph for each lung tissue samples shall be submitted as an electronic copy in form of JPEG files. �� �(15) business days prior to purchase order expiration date. #3 (Task 4.5)�� �Lung tissues samples, blood samples, and H&E slides.�� �(15) business days prior to purchase order expiration date. #4 (Task 4.6)�� �Medical record reports shall be submitted as an electronic copy in form of JPEG files. The CT scan file itself shall be obtained on a CD or equivalent.�� �(15) business days prior to purchase order expiration date. #5 (Task 4.7)�� �Study subject log in Excel workbook format.�� �(15) business days prior to purchase order expiration date. #6 (Task 4.8)�� �Questionnaire variables in MS Excel format.�� �(15) business days prior to purchase order expiration date. 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. Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without 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. Products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. � 1194.1 & Apps. A, C & D, and available at https://www.access-board.gov/guidelines-and- standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards- and-guidelines Per Section 508 and as mandated under HHS Policy for Section 508 Compliance and Accessibility of Information and Communications Technology (ICT) (07/2020) all documents or electronic files provided to the NIH NCI under contract must be conformant with Section 508 standards and accessible to persons with disabilities. �Conformance shall be confirmed by use of material provided at HHS OS Factsheets & Reference Guides and verified through the use of the HHS Checklist Documents (WCAG 2.0 Refresh); in addition, contractors and vendors are encouraged to make use of the instructional materials and checklists at GSA Section 508.gov�s Create Accessible Digital Products. 11.0�� �UNIQUE QUALIFICATIONS� The National Health Research Institutes (NHRI) is established by the government with its organization charter created by an Act of Congress in Taiwan to conduct health research. Scientists at the NHRI have carried out and published molecular epidemiology studies and have a well-conducted case-control study of lung cancer in Taiwan. The institute is well-qualified about all aspects required for the completion of this requirement and has staff and experience that are necessary to carry out the terms of this procurement. NHRI is the sole facility with access to the necessary samples required for the study. Moreover, NCI previously conducted a whole-genome sequencing study from never-smoking females on tissue samples provided by the National Health Research Institutes under purchase order 75N91019P00798. It is critical to maintain consistency between the data procured under the previous award, including both tumor and questionnaire data, and the additional whole-genome sequencing data that shall be generated on lung and blood samples obtained under the subsequent purchase order so that there will be scientific comparability between the samples and all accompanying data. Further, OEEB must be able to compare environmental risk factor distributions in cases with/without particular molecular signatures to environmental risk factor distributions obtained by a comparable questionnaire among comparable controls, which are only available from NHRI�s case-control study. This analysis shall benefit the U.S. government and the public by providing new information about the mutational signatures in lung tumors produced by substantial occupational and environmental exposures, which is an important public health concern.� 12.0�� �SUBMISSION INFORMATION 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 for the Government to consider. The statement of capabilities and/or 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 submitted via email to Contract Specialist, Elizabeth Tucker, at elizabeth.tucker@nih.gov by no later than 3:00 PM EST on August 16, 2021. 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: 75N91021Q00166 on all correspondence. �
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