SPECIAL NOTICE
Q -- Historical tissue samples and medical records preparation for Sherlock- Lung study among never-smoking histologically confirmed lung cancer cases in Asia-American women
- Notice Date
- 7/6/2023 1:09:06 PM
- Notice Type
- Special Notice
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- Contracting Office
- NIH NCI Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N91023Q00123
- Response Due
- 7/20/2023 12:00:00 PM
- Archive Date
- 08/04/2023
- Point of Contact
- Dana Summons, Phone: 2402765319
- E-Mail Address
-
dana.summons@nih.gov
(dana.summons@nih.gov)
- Description
- Contracting Office Address The Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Rockville, MD 20850, UNITED STATES 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) plans to procure services, on a sole source basis, from the University of California, San Francisco, 550 16th Street, Second Floor MH-2841, San Francisco, CA 94158. 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)(i); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 611310 and the small business size standard is $34.5 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. 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. �Comparing molecular perspective of lung cancer among never smoking Asia-American women with origins of China, Korea, Japan, Singapore, and other Asia countries to those who live in these countries in their lifetime is one of important approaches to unravel the roles played by genetics and life style factors such as exposure to cooking oil and environmental exposures women experience in the U.S. and Asia.� 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 worldwide including Asia, Europe, South America, Africa, and U.S. to identify exposure-related mutational signatures to extend NCI�s findings. NCI is collecting data and biological samples of the study subjects from China, Asia, the West, and other regions as part of the Sherlock-Lung study. University of California, San Francisco (UCSF) is conducting a population-based case-control study among never smoking Asia-American women [Female Asian Never Smokers (FANS) study]. �This case-control study recruits incident lung cancer cases through early-case ascertainment methods from cancer registries and unbiased controls from the study population. A comprehensive high-quality questionnaire is obtained for detailed information of study subjects. Biological samples including tumor tissue (case only) are collected from involved study subjects. � 3.0�� �SCOPE To support the Sherlock-Lung study, the NCI requires frozen tumor, normal lung tissues from never-smoking lung cancer female Asian-American cases. The Contractor shall obtain historical samples from stored frozen tumor tissue and adjacent normal lung tissue, an accompanying H & E diagnostic slide for each lung pathologic sample, a copy of the admission and discharge summaries and other medical reports including pathology, radiology (e.g. CT scan), all test results done on the lung tissue samples, and selected questionnaire data to the NCI based on protocols that will be provided by NCI. � 4.0�� �PURCHASE ORDER REQUIREMENTS / TASKS� 4.1�� �The Contractor shall perform the following tasks: 4.1.1�� �Receive protocols from the NCI via email within 15 business days after award. 4.1.2�� �Provide a monthly report to NCI, via email, containing the following: In the previous month number of cases, number of lung tissues, number of supporting documents including pathology report and CT scan report, and number of data files with CT scan data. 4.1.3�� �Select never-smoking histologically confirmed lung cancer cases with diagnosis of primary adenocarcinoma or squamous cell carcinoma histology with fresh-frozen tumor tissue from surgery clinics and has been stored at least as low as -80C. 4.1.4�� �Obtain at least 1 lung tissue sample and up to 3 samples from the tumorous, non-necrotic non-hemorrhagic section of the resected tumor from each of the lung cancer cases. � 4.1.5�� �Provide an H&E slide from each block obtained from the resected sample for clinical diagnostic purposes or a high-quality photomicrograph of the slide.� 4.1.6�� �Complete a study subject log (to be provided by NCI, in Excel file format) at the time of each sample shipment that includes the date of diagnosis, type of procedure used to obtain the sample and age of the subjects. No personally identifiable information (PII) should be attached to this file.� 4.1.7�� �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 should be obtained on a CD or equivalent. In addition, the original CT scan digital data should be uploaded to a secure site to be provided by NCI that strips out any PII.� 4.1.8�� �Provide data information from selected questionnaire variables determined by NCI. 4.1.9�� �All samples, medical documents, and data file shall be coded and shall not have any personally identifiable information (PII) attached. 4.1.10�� �Shipping costs for biological samples shall not be included in the price quote. Shipping shall be coordinated with NCI using the NCI shipping service. 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 award of the contract.� � 8.0�� �PLACE OF PERFORMANCE All work shall be performed at the Contractor�s facility. 9.0�� �REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All written deliverables shall be sent electronically to the NCI Technical Point of Contact (TPOC), TBD at award, in appropriate formats (including but not limited BAM, CRAM, VCF, Excel, DOC, CSV, PDF, PNG, etc.) unless approved by the TPOC in accordance with the deliverable schedule below. The TPOC shall review the contents of all draft deliverables. If no comments or requests for revisions are provided to the Contractor within 30 business days, the deliverables shall be considered acceptable. If revisions are required, NCI shall respond to the Contractor within five (5) business days of receiving the deliverable, specifying the required changes/revisions. Final copies of approved drafts shall be delivered to the NCI TPOC within five (5) business days after receipt of the Government�s comments. The TPOC for this order is: (TBD) DELIVERABLE �� �DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS�� �DUE DATE 1.�� �Task 4.1.1�� �Receive protocols from the NCI�� �Within 15 business days after award. 2.�� �Task 4.1.2�� �Monthly progress report in Excel workbook�� �1 month after award; and on the last day of each month thereafter. 3.�� �Task 4.1.3-4.1.6�� �Lung tissue for first half of study subjects.� H&E slides or photomicrograph for each lung tissue samples for first half of study subject samples, submitted as an electronic copy in the form of JPEG files. Study subject log in Excel workbook for first half of study subject samples. Prepare shipments of lung and H&E slides (or photomicrographs) and study subject log within approximately 4 months of award. 4.�� �Task 4.1.3-4.1.6�� �Lung tissue for 2nd half of study subjects.� H&E slides or photomicrograph for each lung tissue samples for 2nd half of study subject samples, submitted as an electronic copy in the form of JPEG files. Study subject log in Excel workbook for 2nd half of study subject samples. �Prepare shipments of lung and H&E slides (or photomicrographs) and study subject log within approximately seven months of award. 5.�� �Task 4.1.7�� �Electronic copy or scanned files of 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). �� �(15) business days prior to purchase order expiration date. �6. � �Task 4.1.8�� �Electronic copy of data file in MS Excel format �� �(15) business days prior to purchase order expiration date. � 7. � �Task 4.1.9�� �Checking sample and data been coded and delinked with PII�� �Before shipping samples and delivering data � 8. � �Task 4.1.10�� �Sample shipment coordinated with NCI �� �By end of 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. 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�� �UNIQUE QUALIFICATIONS OF THE CONTRACTOR The NCI conducted extensive internet and literature searches (i.e. PubMed and Scopus) and discussion with investigators and epidemiologists in Asia and the United States. The UCSF is identified as the only existing vendor with access to the required samples from never-smoking lung cancer cases involved in a population-based case-control study with a comprehensive questionnaire data available in Asia-American women in the U.S. Further, the UCSF has previously collected tumor samples for NCI Sherlock Lung study (75N91021P00977). The same protocol will be used to the current requested tasks but on additional samples from the same project. It is critically important to use the same vendor to ensure scientific comparability of the new samples with previous samples collected by this university. The University of California, San Francisco (UCSF) is a public land-grant research university in San Francisco, California. it is dedicated entirely to health science. It is a major center of medical and biological research and teaching in the U.S. and recognized as one of the world's preeminent medical and life sciences universities. UCSF is conducting a population-based case-control study to investigate what causes lung cancer in non-smoking Asia-American women. This study recruits incident lung cancer cases through early-case ascertainment methods from cancer registries and unbiased controls from the study population with biological samples collected from each associated subjects including tumor tissue among cases. A high-quality questionnaire is used to provide to collect information associated demographic and lung cancer risk variables. 12.0�� �SUBMISSION INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party believes it can meet the above requirements, it may submit a proposal or quote 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 and questions must be sent via email to the Contract Specialist, Dana Summons, at dana.summons@nih.gov by no later than 3:00 PM EST on July 20, 2023, (7/20/23). 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: 75N91023Q00123 on all correspondence.
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