SPECIAL NOTICE
B -- Black Women�s Health Study samples for a multi-ancestry genome-wide association study of lymphoid malignancies
- Notice Date
- 6/29/2023 7:50:22 AM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NIH NCI Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N91023Q00115
- Response Due
- 7/13/2023 12:00:00 PM
- Archive Date
- 07/28/2023
- 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 Division of Cancer Epidemiology and Genetics (DCEG), plans to procure services, on a sole source basis, from the Trustees of Boston University, Boston University Medical Campus, 85 East Newton Street, Boston, MA 02118-2340. 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 541715 and the small business size standard is 1,000 employees. It has been determined there are no opportunities to acquire green products or services for this procurement. 2.0�� �BACKGROUND The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Epidemiology and Genetics (DCEG), currently has ongoing research efforts in relation to lymphoid malignancies (LM). There are over fifty different lymphoid malignancies; however, the etiology of many lymphoid malignancies is largely unknown. Both environmental and genetic factors are thought to contribute to the risk of LM with some environmental risk factors being more strongly associated with some subtypes and others having a larger genetic component. DCEG has a long history of conducting research on environmental and genetic risk factors for LM. As part of the InterLymph consortium, DCEG previously conducted a large genome-wide association study (GWAS) of NHL in populations of European ancestry and discovered multiple new genetic loci. However, little is known about risk factors for LM in other populations. DCEG is currently conducting a multi-ancestry genome-wide association study for LM. This study will comprise cases and controls of European and non-European ancestry, including African, Asian, and Latino/Hispanic ancestry. African Americans are at an increased risk for multiple myeloma and T-cell lymphoma compared to non-Hispanic Caucasians in the U.S., but the reasons for these disparities are currently unknown. The ascertainment of LM cases of African ancestry is critical to our study so that we can evaluate genetic and environmental risk factors for LM among African Americans. 2.1�� �OBJECTIVE The objective of this procurement is to obtain DNA and phenotype data from LM cases and controls previously collected as part of the Black Women�s Health Study (BWHS). These cases and controls will be included in our multi-ancestry GWAS of lymphoid malignancies 3.0�� �SCOPE The Contractor shall select participants from the BWHS with DNA or blood/buccal specimens amenable to germline DNA extraction. The Contractor shall aliquot and ship the DNA specimens to NCI and provide select covariate data for the cases and controls. � 4.0�� �CONTRACT REQUIREMENTS The Contractor shall provide all labor, material, and resources necessary to perform the following Task: 4.1.1�� �Task #1 - The Contractor shall select participants from the BWHS with DNA or blood/buccal specimens amenable for germline DNA extraction for the study. All data shall be coded and shall not contain any personally identifiable information (PII): 4.1.2�� �Task #2 - The Contractor shall contact the NCI DNA Extraction and Staging Laboratory prior to aliquoting samples. The Contractor shall aliquot and ship DNA specimens for the above referenced samples to the NCI DNA Extraction and Staging Laboratory in accordance with their specifications. A minimum of 500ng of DNA from each participant is required.� 4.1.3�� �Task #3 - The Contractor shall provide the Technical Point of Contact (TPOC) and NCI DNA Extraction and Staging Laboratory with an excel manifest of samples at least one week prior to shipment. Additionally, at this time, the Contractor shall also provide a separate excel document containing phenotype and covariate data (e.g., age, sex, subtype, case-control status).� 4.1.4�� �Task #4 � The Contractor shall coordinate shipment of samples with the TPOC listed below in Section 8.0 and the NCI DNA Extraction and Staging Laboratory. All samples shall be shipped in barcode vials on dry ice to the NCI DNA Extraction and Staging Laboratory (DESL). �The shipment of specimens shall occur on either a Monday, Tuesday or Wednesday only via same-day or overnight delivery. All data shall be coded and shall not contain any personally identifiable information (PII). 4.1.5�� �Task #5 - The Contractor shall provide sample support to aid in resolving or answering any sample-related issues.� 4.2�� �PROHIBITION AGAINST PERSONAL SERVICES The Contractor shall not perform personal services under this contract. Contractor personnel are employees of the Contractor or its subcontractors and are under the administrative control and supervision of the Contractor. A Contractor supervisor must give all individual Contractor employee assignments and daily work direction. The Government shall not supervise or direct Contractor employees in the performance of their assignments. If at any time the Contractor believes that any Government action or communication has been given that would create a personal service relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action. The Contractor shall not perform any inherently governmental functions under this contract. No Contractor employee shall represent or give the appearance that he or she is a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. The Contractor is responsible for ensuring that all employees assigned to this contract understand and are committed to following the requirements of the Contract. 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 Period of performance shall be 12 months from award of the Purchase Order. 8.0�� �PLACE OF PERFORMANCE All work shall be performed at the Contractor�s facilitates.� 9.0�� �REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE 9.1�� �TECHNICAL POINT OF CONTACT The Technical Point of Contact (TPOC) is responsible for inspection and acceptance of all work in relation to this requirement and will serve as the Governments primary point of contact throughout the duration of the requirement. All efforts must be coordinated with this individual. The TPOC for this requirement is: (TBD) Note: The TPOC has limited authority as defined within this Statement of Work. They do not have the authority to commit or obligate Government funds or make changes to the terms and conditions of the purchase order. As such, any changes to the purchase order must be performed by a warranted Government Contracting Officer with appropriate delegated authority to do so. 9.2�� �DELIVERABLE AND SCHEDULE All written deliverables shall be sent electronically to the NCI Technical Point of Contact (TPOC), TBD at award, in a Microsoft-compatible format, such as Microsoft Excel or text file 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. All DNA specimens shall be sent directly the NCI DNA Extraction and Staging Laboratory (DESL) for sample handling and processing. In conjunction with the laboratory, the TPOC shall review the quality and quantity of the samples received. If no comments or requests are provided within 30 days, the specimens shall be considered acceptable. All deliverables shall be sent per the following deliverable schedule: DELIVERABLE �� �DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS�� �DUE DATE Task 4.1�� �Emails or phone calls with the NCI TPOC to discuss sample selection, aliquoting, and shipping�� �As needed Task 4.2�� �Emails or phone calls with the NCI DNA Extraction and Staging Laboratory to discuss technical details of sample aliquoting and shipping.�� �Prior to sample aliquoting Task 4.3�� �Excel spreadsheet containing the specimen manifest Excel spreadsheet or text file with phenotype data�� �One week prior to shipment of samples Task 4.4�� �Shipment of biospecimens�� �At least 30 days prior to purchase order expiration date 10.0�� �INSPECTION AND ACCEPTANCE Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this contract is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI TPOC, TBD, 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 OF THE CONTRACTOR Boston University controls access to the Black Women�s Health Study biorepository and is the only center that can provide prospectively collected specimens and data from over 250 African American women. �The required DNA samples and phenotype data from the BWHS are located at Boston University. Boston University enrolled participants in the BWHS and collected biospecimens from them as part of the study.� Until the 1990�s, most of the studies of women�s health included only small numbers of Black women or none at all. The Black Women�s Health Study (BWHS) was initiated in 1995 to study the risk factors for disease in this understudied population. Approximately 59,000 women were enrolled in the study and provide biological specimens. The BWHS has followed the subjects for cancer incidence and mortality since enrollment. The BWHS has the highest representation of African American women among existing U.S. cohorts, and prospectively collected data that can be utilized by researchers to address scientific questions about the causes of cancer. As most cohort studies in the United States consist of predominantly non-Hispanic whites, and very few cohort studies have prospectively collected biospecimens from African American women who have been diagnosed with a lymphoid malignancy. The prospectively collected DNA samples and phenotype data collected in the BWHS are critical to our multi-ancestry study and necessary so that we have sufficiently large sample size to evaluate lymphoid malignancies in African American women. 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 13, 2023, (7/13/2023). 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: 75N91023Q00115 on all correspondence.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/02a6400e5dff462a8bd976a77990d23a/view)
- Record
- SN06731595-F 20230701/230629230047 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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